[資料]製薬各社製品売上(世界)




 Medical Letter日本語版では、参考データとして市場データを調査しているが、
 代表的な製薬企業のAnnual Reportから製品売上の部分を抜粋したものをここで掲載する。

●為替レート
為替レート一覧[Infoseek]
[02.1.15]$[USD]=\131.16, Euro[EUR]=\116.98, £[GBP]=\189.89, SFr[CHF]=\79.088, DKK=\15.73
[02.12.25]$[USD]=\120.45, Euro[EUR]=\124.10, £[GBP]=\191.97, SFr[CHF]=\85.52 , DKK=\16.71
[04.01.18]$[USD]=\106.57, Euro[EUR]=\131.83, £[GBP]=\191.56, SFr[CHF]=\84.12 , DKK=\17.79
[05.01.05]$[USD]=\104.14, Euro[EUR]=\138.08, £[GBP]=\196.07, SFr[CHF]=\89.09 , DKK=\18.58,豪$=79.62,カナダ$=84.96,NZ$=72.73
[06.02.01]$[USD]=\118.00, Euro[EUR]=\142.40, £[GBP]=\209.40, SFr[CHF]=\91.51 , 豪$=88.85,カナダ$=103.37,NZ$=80.65
[07.01.01]$[USD]=\117.91, Euro[EUR]=\139.53, £[GBP]=\203.26, SFr[CHF]=\? ,豪$=86.48,カナダ$=100.47,NZ$=79.40
[07.02.01]$[USD]=\121.96, Euro[EUR]=\158.99, £[GBP]=\241.55, SFr[CHF]=\98.060,豪$=95.76,カナダ$=104.48,NZ$=?
[08.01.04]$[USD]=\110.28, Euro[EUR]=\162.60, £[GBP]=\219.47, SFr[CHF]=\99.25,豪$=98.23,カナダ$=111.88,韓国100W=11.90(),DKK=21.53 ,NZ$=83.20
[09.01.01]$[USD]=\90.25, Euro[EUR]=\127.02, £[GBP]=\130.08, SFr[CHF]=\85.19,豪$=62.38,カナダ$=74.05,韓国100W=6.38(),DKK=15.54 ,NZ$=52.13, 中国元=12.99, ロシアルーブル=2.70
[10.01.04]$[USD]=\93.33, Euro[EUR]=\134.32, £[GBP]=\153.92, SFr[CHF]=\90.50,豪$=85.40,カナダ$=90.15,韓国100W=8.20(),DKK=18.15 ,NZ$=69.01, ロシアルーブル=3.32
[11.01.04]$[USD]=\82.78, Euro[EUR]=\110.57, £[GBP]=\130.55, SFr[CHF]=\88.40,豪$=85.40,カナダ$=83.93,韓国100W=7.49(),DKK=14.93 ,NZ$=65.22, ロシアルーブル=2.94
[11.12.30]$[USD]=\78.74, Euro[EUR]=\102.21, £[GBP]=\123.81, SFr[CHF]=\83.59,豪$=81.12,カナダ$=77.82,韓国100W=6.95(),DKK=13.85 ,NZ$=62.15, ロシアルーブル=2.68,CNY (中国元)=12.71
[12.12.30]$[USD]=\87.58, Euro[EUR]=\116.21, £[GBP]=\143.52, SFr[CHF]=\95.80,豪$=91.80,カナダ$=88.65,韓国100W=8.30(),DKK=15.67 ,NZ$=73.06, ロシアルーブル=3.12,CNY (中国元)=14.21
[13.12.30]$[USD]=\106.39, Euro[EUR]=\146.55, £[GBP]=\177.76, SFr[CHF]=\119.10,豪$=95.24,カナダ$=100.02,韓国100W=10.20(),DKK=19.74 ,NZ$=87.80, ロシアルーブル=3.49,CNY (中国元)=17.66
[14.12.30]$[USD]=\121.55, Euro[EUR]=\148.04, £[GBP]=\191.03, SFr[CHF]=\122.70,豪$=100.07,カナダ$=105.23,韓国100W=11.18(),DKK=19.98 ,NZ$=95.91, ロシアルーブル=2.29,CNY (中国元)=19.65
[15.12.30]$[USD]=\121.61, Euro[EUR]=\133.27, £[GBP]=\182.78, SFr[CHF]=\122.42,豪$=89.92,カナダ$=88.78,韓国100W=10.53(),DKK=17.97 ,NZ$=84.85, ロシアルーブル=1.92,CNY (中国元)=18.66
[16.12.30]$[USD]=\117.49, Euro[EUR]=\124.20, £[GBP]=\147.00, SFr[CHF]=\115.11,豪$=86.36,カナダ$=88.06,韓国100W=9.88(),DKK=16.80 ,NZ$=83.16, ロシアルーブル=2.19,CNY (中国元)=17.06
* 日経ネット:マネー&マーケット:外国為替クロスレート[]
* 三菱東京UFJ銀行:外国為替相場[]
* 外国為替相場過去履歴[]


●製薬企業ニュースサイト
Business.com :Pharmaceuticals - Web Sites
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GlaxoSmithKline| Johnson & Johnson| Merck & Co| Novartis AG| Novo-Nordisk A/S
Pfizer| Roche Holding Ag| Schering-Plough

Hoovers Online
PR Newswire : Company News Archive: Health/Biotech |Annual Report

●医薬品市場ニュースサイト
★IMS Health News Release
[]
[]
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■個別製薬会社
★A-F行 ★G-K行
Abbott
アボット ジャパン
TAP Pharmaceutical Products Inc.[US]
 〜米Abbottと武田薬品のJV *Abiogen Pharma S.p.A[伊] Abraxis BioScience Inc. ACADIA Pharmaceuticals Inc[US] Acorda Therapeutics Inc[米国] Actelion Ltd[スイス] ■新薬ベンチャー アクテリオン ファーマシューティカルズ ジャパン株式会社 Adams Laboratories Inc.[US]〜呼吸器疾患薬専門メーカー Aderis Pharmaceuticals Adolor Corporation[米] AEterna Zentaris Inc.[Ca] ■バイオ医薬  --Zentaris GmbH[GE] Affymax, Inc. Agouron Pharmaceuticals →see Pfizer  Agouron Pharmaceuticals, Incは、
Warner-Lambertに買収された[1999.5]。  その後Pfizerは、Warner-Lambertを
吸収合併した(2000.6.19)。 関連記事  現在Agouron独自のWeb-siteはない。 Akorn, Inc.〜眼科薬等の専門メーカー AKZO Novel N.V. Organon -AKZO Novel子会社 日本オルガノン Alcon Laboratories,Inc. ■医療機器 日本アルコン ■医療機器 Alfa Wassermann S.P.A.[伊] Alkermes, Inc.[US] Allergan アラガン Almirall Prodesfarma, S.A.[SP] Allos Therapeutics, Inc Alpharma Inc. Alseres Pharmaceuticals, Inc(旧Boston Life Sciences, Inc.) Altana AG Altana Pharma AG[旧Byk-Gulden AG] 医薬事業2007.1→Nycomed Alza Corporation - J&J子会社 American BioScience, Inc.[ABI,ABS] → Abraxis BioScience Inc. American Pharmaceutical Partners, Inc. (APP) → Abraxis BioScience Inc. Amersham Amersham Health(旧 Nycomed Amersham Imaging) アマシャム バイオサエインス株式会社 日本メジフィジックス株式会社 Amgen アムジェン Amylin Pharmaceuticals, Inc ASTA Medica AG(Degussa AGの子会社) →Degussa AG Anesiva,Inc[米;旧Corgentech Inc] Ark Therapeutics Group plc[英国] AstraZeneca アストラゼネカ AVANT Immunotherapeutics, Inc →Celldex Therapeutics, Inc.[旧AVANT Immunotherapeutics, Inc]米国ベンチャー Aventis 合併→Sanofi-AventisAventis Pharmaceuticals Inc.[US] アベンティスフアーマ(株) Aventis Behring
 →変更ZLB Behring [旧]Aventis Behring(2004.5変更)  → see CSL Limited[オーストラリア]の傘下に アベンティス ベーリング ジャパン株式会社
 →ZLBベーリング株式会社
[旧]アベンティス ベーリング ジャパン株式会社(2004.5変更) Aventis Pasteur 2005.1社名変更→Sanofi Pasteur SA[FR,ワクチン] Aventis Pasteur -US 2005.1社名変更→Sanofi Pasteur Inc. -US[US,ワクチン] アベンティスパスツール →サノフィパスツール[旧アベンティスパスツール] Dermik Laboratories[US] ★Aventis子会社 Avanir Pharmaceuticals,Inc. AVI BioPharma, Inc. Avigen, Inc[US] ■新薬ベンチャー Banner Pharmacaps Inc[US] ★製剤技術 Barr Laboratories Inc. →2008年12月Teva Pharmaceutical Industries Ltd.[イスラエル]に買収 Bausch & Lomb ■医療機器 ボシュロム・ジャパン株式会社 ■医療機器 Baxter Healthcare Corp ■医療機器 バクスター株式会社 ■医療機器 Bayer AG バイエル薬品 Beaufour-IPSEN →Ipsen Group[FR] Becton, Dickinson and Company ■医療機器 日本ベクトンディッキンソン  ■医療機器 Bertek Pharmaceuticals Inc[US]〜Mylan Laboratories,Inc.の子会社 BioAlliance Pharma SA[FR] Biocodex[FR] Biogen IDEC Inc.[2003.11 Biogen/IDEC合併] BioMarin Pharmaceutical Inc.[US] ■新薬ベンチャー bioMerieux SA[FR] ■診断薬 bioMerieux Inc.[US] ■診断薬 日本ビオメリュー株式会社 ■診断薬 Biovail Corporation[加] Boehringer Ingelheim 日本ベーリンガーインゲルハイム 旧Boston Life Sciences, Inc. →Alseres Pharmaceuticals, Inc Bristol-Myers Squibb[BMS] ブリストル・マイヤーズ株式会社 Medarex,Inc[BMS社に2009.9.1買収] Bryan Corporation[US] BTG International Ltd[UK] Altana Pharma AG ←[旧Byk-Gulden AG] 医薬事業2007.1→Nycomed Cambridge Laboratories Ltd[UK]〜ベンチャー Canyon Pharmaceuticals Celgene Corporation[US] Celldex Therapeutics, Inc.[旧AVANT Immunotherapeutics, Inc]米国ベンチャー Celltech Group[英国]〜バイオ企業2004.7 UCBにより買収 Cell Therapeutics, Inc.[US]〜制癌剤ベンチャー Centocor →- Centocor Ortho Biotech Inc - J&J傘下 | Johnson & Johnson傘下 Centocor Ortho Biotech Inc - J&J傘下 Cephalon Inc →2011年08月Teva Pharmaceutical Industries Ltd.[イスラエル]に買収 Chiesi Farmaceutici SpA Chiron →Novartis子会社に(2006) CollaGenex Pharmaceuticals, Inc. Ciba Vision Corporation[Novartis系列] チバビジョン[Novartis系列] Corgentech Inc →Anesiva,Inc[米;旧Corgentech Inc] Cornerstone Therapeutics Inc.[US] Covidien plc[アイルランド] コヴィディエン ジャパン株式会社[旧タイコヘルスケア・ジャパン株式会社] 日本コヴィディエン株式会社[旧日本シャーウッド株式会社] CSL Limited[オーストラリア] CSL Behring[米] CSLベーリング株式会社 ZLB Behring [旧]Aventis Behring(2004.5変更) →CSL Behring[米] Aventis Behring →CSL Behring[米] ZLBベーリング株式会社
[旧]アベンティス ベーリング ジャパン株式会社(2004.5変更) →CSLベーリング株式会社 Cubist Pharmaceuticals, Inc. ■新薬ベンチャー *Cumberland Pharmaceuticals Inc[米] CV Therapeutics, Inc[US] Cypress Bioscience, Inc[US] Debiopharm SA[SZ] ■新薬ベンチャー Degussa AG(2008.9 Evonik Industries AGの1部門) 参考  1990 Temmler Group を買収  1993 Muro Pharmaceutical Incの20.4%資本参加、Muro Pharmaceutical Incを買収[1996.10.1]  2001.6 DegussaがASTA Medica子会社AWD.pharmaをPLIVAに売却。   AWD.pharmaは旧Arzneimittelwerk Dresden GmbH   因みにArzneimittelwerk Dresden GmbHは2004.7 Hexal AGにより再買収。  2001 Baxter社にASTA Medica Onkologie GmbH & CoKG社を売却 (がん治療薬分野に進出) 対価525 million Euros (U.S. $470 million).   (ASTA Medica AGは1983年以来Degussa AGの子会社で、Oncology, Health Products, awd.pharma    and Zentaris.の各部門;2004.6 親会社Degussa AGがZentaris GmbHをAEterna Labsに売却。)  Asta Werke AGは1970年代末にDegussaに過半数を支配、1983年完全子会社に。  1987 Chemiewerk Homburg Branch, Asta Werke AG等が合併しAsta Pharma AGに。  1991 Arzneimittelwerk Dresden GmbHを買収。   →ASTA Medica AG   →独Viatrisに変更 →Meda AB Dendreon Corporation[US] Dermik Laboratories[US] ★Aventis子会社 DEY, L.P Discovery Laboratories, Inc.[米国] Dusa Pharmaceuticals, Inc.[US]〜新薬ベンチャー Dyax Corp ECR Pharmaceuticals[US] Elan Corporation, plc[IR] ■新薬ベンチャー Endo Pharmaceuticals Inc.[US]〜神経系薬剤専門メーカー Enzon Pharmaceuticals, Inc〜■新薬ベンチャー Exelixis, Inc.[US] Eyetech Pharmaceuticals, Inc.[US] →2005.11 OSI Pharmaceuticals, Inc.[US]に買収 Grupo Ferrer Internacional, S.A[スペイン] Ferring Pharmaceuticals[スイス] FibroGen, Inc. First Horizon Pharmaceutical Corporation[US]〜■新薬ベンチャー →Sciele Pharma, Inc. Forest Laboratories, Inc. Fournier Pharma[FR]
Galderma S.A.[仏] ...L'Oreal & Nestleの50:50合弁会社[設立1981]
Galderma USA
ガルデルマ株式会社
L'Oreal[仏]
Galen Holdings Plc[アイルランド]
  社名変更→Warner Chilcott, Inc.[米国](旧Galen Holdings Plc→2004)
Gedeon Richter Ltd[HU]
Genentech, Inc - Roche傘下
General Electric Company[GE]
GE Health
*Genmab A/S[DE]
Genome Therapeutics Corporation[US] 
合併→ Oscient Pharmaceuticals Corporation[US] ■新薬ベンチャー
Genzyme Corporation
ジェンザイム・ジャパン
Gilead Science
Glaxo SmithKleine[GSK]
グラクソ・スミスクライン
Graceway Pharmaceuticals LLC[米]
GTC Biotherapeutics, Inc[米]
Grunenthal GmbH[独]
Guilford Pharmaceuticals Inc.[米]〜新薬ベンチャー →2005.10 MGI Pharma,Inc[米国]〜新薬ベンチャーに買収
Helsinn Healthcare SA[スイス]
Hollister-Stier Laboratories[US]
Hospira,Inc
ホスピーラ・ジャパン
Laboratoire HRA Pharma[仏]
Human Genome Sciences, Inc
Institut Biochimique SA[IBSA]-[SZ]
ICOS
Lilly-ICOS
Immunex★2001.12 Amgenによる買収に合意。
Imclone Systems Inc. 新薬ベンチャー
Idenix Pharmaceuticals,Inc[旧Novirio Pharmaceuticals, Inc] 新薬ベンチャー
IDM Pharma, Inc[米] - 2009.5 武田薬品傘下に
Indevus Pharmaceuticals, Inc.
INOTECH Biotechnologies Ltd.
Ikaria
INO Therapeutics
InSite Vision Inc[US]
Insmed Inc.[US] 新薬ベンチャー
Inspire Pharmaceuticals Inc 新薬ベンチャー
Intendis GmbH(Schering AGの外用薬専門子会社)
Institut Biochimique SA[IBSA]-[SZ]
Intermune Inc.〜■新薬ベンチャー
Ipsen Group[FR]
Isis Pharmaceuticals, Inc.〜■バイオベンチャー
ISTA Pharmaceuticals,Inc
IVAX Corporation[US] →Teva Pharmaceutical Industries Ltd.[イスラエル]2006.1買収
Jazz Pharmaceuticals,Inc.
Jerini AG[独]〜新薬バイオ企業
Johnson & Johnson
Centocor →Centocor Ortho Biotech Inc - J&J傘下
Centocor Ortho Biotech Inc - J&J傘下
Janssen - J&J傘下
ヤンセン ファーマ株式会社
McNeil Consumer & Specialty Pharmaceuticals [J&J 系列]
Ortho-McNeil, Inc [J&J 系列]
Ortho-McNeil Pharmaceutical, Inc [J&J 系列]
Ortho-McNeil Neurologics, Inc [J&J 系列]
OrthoNeutrogena - Ortho-McNeil Pharmaceuticals, Inc.のスキンケア事業部門
Vistakon Pharmaceuticals [J&J系列]
Johnson & Johnson Vision Care,Inc [J&J系列]
Tibotec, Inc.[Division of Ortho Biotech Products, LP]
King Pharmaceuticals Inc.[US] ■新薬ベンチャー
KV Pharmaceutical Company[US]
 ■急成長の技術重視型ジェネリック企業
★L-O行 ★P-Z行
Labopharm Inc[加]
LEO Pharma A/S
Leo Japan
LG Life Science[韓国]
Ligand Pharmaceuticals Inc[米]
Lilly
日本イーライリリー
L'Oreal[仏]
Lundbeck A/S
Madaus AG[独]
Mallinckrodt Group Inc.
 [Tyco International Ltd〜医療機器]子会社
Meda AB
Meda Pharmaceuticals Inc.
Medarex,Inc[BMS社に2009.9.1買収]
The Medicines Company[米]〜新薬ベンチャー
Medicis Pharmaceutical Corporation[US]〜外用薬専門
MediGene AG[独]
Medimmune
日本メジフィジックス株式会社
MedPoint Pharmaceuticals Inc[US][旧Carter-Wallace, Inc.] (2007.8買収、社名変更)→Meda AB
Medtronic,Inc[US] ■医療機器
Menarini[IT]
Merck & Co.
Merck KGaA
メルク株式会社
メルク製薬株式会社[旧メルク・ホエイ株式会社] →マイラン製薬
Merck Sante SA[FR]
Lipha SA[FR]
Merck-Serono S.A.[スイス][旧Serono S.A.]
EMD Serono, Inc[旧Serono USA]
メルクセローノ株式会社
Merz Pharmaceutische GmbH
MGI Pharma,Inc[米国]〜新薬ベンチャー
Millennium Pharmaceuticals, Inc[US]〜新薬ベンチャー
3M [Minnesota Mining & Manufacturing Co.]
3M Healthcare
3M Pharmaceuticals (2007)→米国事業はGraceway Pharmaceuticals Incへ/欧州事業はMeda AB(米MedPointe Pharmaceuticalsの親会社)へ
住友スリーエム株式会社
NeurogesX, Inc[米国]
Mission Pharmacal Company
Mundipharma AG[瑞]
Mylan Laboratories,Inc.[US]
Mylan Pharmaceuticals,Inc.[US]
Bertek Pharmaceuticals Inc[US](閉鎖2006)〜Mylan Laboratories,Inc.の子会社
マイラン製薬
DEY, L.P〜Mylan Laboratories,Inc.の子会社
Novavax ,Inc.[US]
Novartis
ノバルティス ファーマ株式会社
Novartis Ophthalmics AG
Novartis Ophthalmics International
Novartis Ophthalmics US
Ciba Vision Corporation[Novartis系列]
チバビジョン[Novartis系列]
Speedel Holding Limited[スイス]/Speedel Pharmaceuticals Inc.(2008.7 Novartis 61.44%)
Noven Pharmaceuticals, Inc[米]2009.7 久光製薬により買収
Novo-Nordisk
ノボノルディスクファーマ
N.V. Organon -AKZO Novel子会社
日本オルガノン
NPS Pharmaceuticals,Inc[US] ■新薬ベンチャー
Nycomed[DE]
Odyssey Pharmaceuticals,Inc.[Pliva米国子会社]
Onyx Pharmaceuticals 
Optimer Pharmaceuticals, Inc[US]
Orexo AB[スエーデン]
Orion Group[FI]
Orphan Europe sarl[FR]
Orphan Medical, Inc[米国] ■新薬ベンチャー
Oscient Pharmaceuticals Corporation[US] ■新薬ベンチャー
  (1994 Collaborative Research Inc→Genome Therapeutics Corporationに社名変更
  (2004 Genesoft Pharmaceuticals社を吸収合併→Oscient Pharmaceuticals に社名変更)
OSI Pharmaceuticals, Inc.[US]〜新薬バイオ企業
Ovation Pharmaceuticals, Inc[US] ■新薬ベンチャー
PDL Biopharma Inc.[US][旧Protein Design Labs, Inc. 2006.1社名変更]
Pfizer
ファイザー株式会社
Pharmacia★2003.4.16 Pfizer社に経営統合。
ファルマシア・ジャパン★2003.8.1 ファィザー(株)に統合
Pharming NV[蘭]〜新薬ベンチャー
Pharmion Corporation[米]〜新薬ベンチャー
Photocure ASA[NO]
Laboratoires Pirre Fabre[仏]
Pliva d.d.[Croatia]
Odyssey Pharmaceuticals,Inc.[Pliva米国子会社]
POZEN Inc[US]
Praecis Pharmaceuticals,Inc[US] ■新薬ベンチャー
Presutti Laboratories, Inc.[US] ■新薬ベンチャー
Procter &Gamble
Progenics Pharmaceuticals Inc.[US]
Prometheus Laboratories Inc[US]
Protein Design Labs, Inc. →PDL Biopharma Inc.[US]
ProStrakan Group plc[スコットランド]
PTC Therapeutics,Inc[US]
Purdue Pharma L.P.[US]
Purdue Pharmaceutical Products L.P. → Purdue Pharma L.P.[US]グループ
Purdue Products L.P. → Purdue Pharma L.P.[US]グループ
The Purdue Frederick Company → Purdue Pharma L.P.[US]グループ
QLT Photo Therapeutics[Ca]
Q-Med AB[SW] ■ヒアルロン酸
Recip AB →Meda AB
Reckitt Benckiser plc[UK]家庭用品〜旧Reckitt & Colman plc
RECORDATI IND.CHIMICA FARM. S.P.A[IT]
Regeneron Pharmaceuticals, Inc.[US]
Repros Therapeutics Inc.[US]
Roche
日本ロシュ→★中外製薬に統合
Genentech, Inc - Roche傘下
Roche Diagnostics
ロシュ・ダイアグノスティックス株式会社
Salix Pharmaceuticals, Inc[米国]〜消化器官用薬専門メーカー
Sanofi-Aventis
Sanofi-Synthelabo ↑現Sanofi-Aventis
Sanofi-Synthelabo[US]
サノフィ・サンテラボ・ジャパン
Sanofi Pasteur SA[FR,ワクチン]
Sanofi Pasteur Inc. -US[US,ワクチン]
Santhera Pharmaceuticals Ltd.[瑞]
Savient Pharmaceuticals, Inc.[米]
Schering AG
日本シェーリング株式会社
Berlex[US] - Schering AG 子会社
Intendis GmbH(Schering AGの外用薬専門子会社)
Schering-Plough
シェリング・プラウ
Schwarz Pharma AG[ドイツ]
Sciele Pharma, Inc.
Sepracor Inc.[US]
Serono S.A. →Merck-Serono S.A.[スイス][旧Serono S.A.]
Merck-Serono S.A.[スイス][旧Serono S.A.]
EMD Serono, Inc[旧Serono USA]
セローノ・ジャパン →メルクセローノ株式会社
Servier[FR]
日本セルヴィエ株式会社
Shire Pharmaceuticals Group plc[UK]〜新薬ベンチャー
SkyePharma PLC[英]
Smith & Nephew plc[UK] ■医療製品
Solvay S.A.
ソルベイ製薬株式会社
Unimed Pharmaceuticals, Inc.[Solvayの子会社]
Somaxon Pharmaceuticals Inc[US]
Somerset Pharmaceuticals, Inc[US]
 - Mylan Labs)とWatson Pharmaceuticals, Incの合弁会社[50:50]
Speedel Holding Limited[スイス]/Speedel Pharmaceuticals Inc.(2008.7 Novartis 61.44%)
SuperGen, Inc.[米]
Tercica, Inc.
Teva Pharmaceutical Industries Ltd.[イスラエル]
*Theravance, Inc[米]
Tibotec, Inc.[Division of Ortho Biotech Products, LP]
Tillotts Pharma AG[SZ]〜消化器病薬専門メーカー
Titan Pharmaceuticals, Inc 
Transkaryotic Therapies, Inc.(TKT)[US] ■新薬ベンチャー
Trimeris
Tyco International Ltd〜医療機器
Tyco Healthcare →Covidien plc[アイルランド]
Mallinckrodt Group Inc.
コヴィディエン ジャパン株式会社[旧タイコヘルスケア・ジャパン株式会社]
日本コヴィディエン株式会社[旧日本シャーウッド株式会社]
UCB
ユーシービージャパン
Unimed Pharmaceuticals, Inc.[Solvayの子会社]
United Therapeutics Corporation[US] ■バイオ新薬ベンチャー
Valeant Pharmaceuticals International[旧ICN]
Vanda Pharmaceuticals,Inc
Vernalis Group plc[英国]
VeroScience, LLC[US]
Vertex Pharmaceuticals Inc[US]
Viatris(旧Asta Medica AG) →Meda AB
Vicuron Pharmaceuticals,Inc.[US] 旧Versicor ■新薬ベンチャー
Viropharma Inc[米]
VIVUS, Inc[US]
Warner Chilcott, Inc.[米国](旧Galen Holdings Plc→2004)
Watson Pharmaceuticals Inc
Wyeth
ワイス(株)
Xanodyne Pharmaceuticals, Inc
XenoPort, Inc
ZLB Behring
[旧]Aventis Behring(2004.5変更)
 → see CSL Limited[オーストラリア]の傘下に Zentaris GmbH[GE]
→親会社AEterna Zentaris Inc.[Ca] ■バイオ医薬 ZLBベーリング株式会社
[旧]アベンティス ベーリング ジャパン株式会社(2004.5変更)
 → see CSL Limited[オーストラリア]の傘下に
●企業情報

金融庁電子開示システム(EDINET) - 有価証券報告書 - 金融庁は「証券取引法に基づく有価証券報告書等の開示書類に関する電子開示システム」 (説明)の試験運用期間を終了し、 平成16年6月以降、開示書類等の電子化が原則義務化(EDINETへ移行) (Electronic Disclosure for Investors' NETwork) つまり株式公開を行う企業に提出を義務づけられている「有価証券報告書」などは、 ネット公開されることになる。 ●米国証券公正取引委員会[SEC] Filings検索 from 米国証券公正取引委員会[SEC][Securities and Exchange Commission] -SEC Filings & Forms (EDGAR) - Companies for SIC 2834 - Pharmaceutical Preparations[549社] - 企業名などで検索し、開くと当該企業のドキュメントが大量に出てくるが 「有価証券報告書」を見たい場合、Annual Reports Form 10-K EDGARR is... the SEC's Electronic Data Gathering, Analysis and Retrieval system 民間検索サイト★SEC Info[Fran Finnegan & Company]も便利 ●参考 Biotech's old soldiers[Pharmalicensing.com] (15 November 2005) -最近の合併動向 【米アボット】ソルベイの製薬部門買収‐新興国市場のインフラ獲得へ[2009.9.30] 【データモニター】ソルベイ買収でアボットの成長率は大幅改善[2009.10.9] 2009.9.3 大日本製薬かSepracor社を買収(総額U.S. $2.6 Billion) - [日本語] - [説明資料]





Abbott


【米アボット】ソルベイの製薬部門買収‐新興国市場のインフラ獲得へ[2009.9.30]
【データモニター】ソルベイ買収でアボットの成長率は大幅改善[2009.10.9]


●決算 [各12月末]
($ milllion)2015201420132012201120102009200820072006200520042003200220012000備考
純売上高20,40520,24719,65719,05018,663
旧38,851.3
16,923
旧35,166.7
30,764.7
旧25,527.6
25,914.222,476.322,337.8(+13.5)19,680.0(+13.9)17,280.317,684.7(+8.6)16,285.2(+18.5)13,745.9
営業利益2,8672,5992,1331,3601,017
旧4728.4
691
旧4,626.2
5,745.8
旧6,235.7
5,693.84,578.52,042.24,362.33,898.3(+31.1)2,974.03,530.11,894.03,400.6
経常利益3,1832,5182,041-2206563617,193.85,856.34,469.62,276.44,619.94,125.6(+21.8)3,387.23,673.41,883.13,816.4
純利益4,4232,2842,5765,9634,728.44,626.25,745.84,880.73,606.31,716.83,372.13,235.9(+17.5)2,753.22,793.71,550.42,786.0

研究開発費1,4051,3451,3711,4611,4241,1442,743.72,688.82,505.62,255.21,821.21,696.8(+4.5)1,623.81,561.81,577.61,351.0
取得研究開発費-170.097.3-2,014.017.1279.0100.2
従業員数77,00073,00069,00068,00066,66359,735?72,18171,81971,42660,571

■セグメント別売上高
●Abbie--18,380
●Pharmaceutical (a)3,7203,1182,8622,76916,486(-1.3)16,708(+14.2)14,632(+18.0)12,395(-9.5)13,691
旧8,138(+16.1)
11,913
旧7,010
6,0514,2683,759米国内医薬品
 国内売上高-9,455(+8)8,744(+12)7,794(-8.3)8,497(+8.9)7,806(+19.2)6,550(-19.5)
 国際売上高3,7207,567(+15)6,587(+15)8,692(+5.8)8,211(+20.3)6,826(+16.8)5,845(+5.3)
●Diagnostic (b)4,6464,7214,5454,2923,578(+0.1)3,575(+13.2)3,158(+11.1)3,979(+5.9)3,756(+11.2)3,3783,0402,8972,929
 国内売上高1,392939(+4.4)899(+9.6)820(+2.6)1,356(+7.5)1,252(+11.8)
 国際売上高3,2542,639(-1.4)2,676(+14.5)2,338(+14.4)2,633(+5.1)2,504(+10.9)
●Nutritional6,9756,9536,7406,4615,284(+7.3)4,924(+12.2)4,388(+1.7)4,313(+9.6)
 国内売上高(Ross)2,8682,636(+6.3)2,479(+5.6)2,348(-9.4)2,629(+4.2)
 国際売上高4,1072,648(+8.3)2,445(+19.8)2,040(+14.4)1,684(+19.1)
●Medical Devices5,042
 国内売上高1,982
 国際売上高3,060
●Vascular2,7922,9863,0123,0712,692(+20.1)2,241(+34.7)1,663(+53.8)1,082(+327.7)
 国内売上高1,1451,599(+32.7)1,205(+39.6)863(+33.5)647(+359.2)
 国際売上高1,6471,093(+5.5)1,036(+29.4)800(+83.9)435(+288.0)
★Ross----2,523(+8.5)2,3262,1362,0882,088
★International (a)(b)14,134----6,967(+13.0)6,1665,3215,0364,418
 国際医薬品----5,164(+12.8)
 国際栄養剤----1,803(+13.7)
★Total Reportable Segments17,77817,15916,59327,44823,84121,76921,63719,10116,54817,26815,972
Other2,4692,4982,4572,725(+31.1)2,0802,073(+12.5)707701579732417313

■Net Sales20,40520,24719,65719,05030,765(+4.2)29,528(+13.9)25,914(+15.3)22,476(+0.6)22,338(+13.5)19,68017,28017,68516,285
 国内売上高6,27114,220(+0.4)14,170(+10.1)12,874(+12.0)11,534(-7.5)12,442(+13.0)
 国際売上高14,13416,545(+7.7)15,358(+17.8)13,040(+18.8)10,942(+10.9)9,896(+14.2)

TAP Pharmaceutical3,260(-3.0)
Hospital*------3,0782,9792,778
 (a)2001,2002は、BASF医薬部門買収(2001)による数値反映
 (b)2003はドル弱化による好影響、2001-2002は強いドルが悪影響。

 * 2003.8 Abbottは病院製品部門の中核Hospira,Inc.(年間売上高$2.4 billion)の分離を
発表。 いずれ中止事業として処理。
 * 2006.1.1付けで事業再編。 Abbott InternationalからAbbott Nutrition Internationalを分化。
  事業報告では、Nutritional Products事業として、国内をRoss Products Division,国際Abbott Nutrition International

■国別売上高
United States6,1236,2086,24214,45314,,49513,25211,99512,70711,2429,91910,99810,249
China1,3211,083859
India1,009922919
Japan9681,0421,2211,5901,2491,1111,0541,027987897784748
Germany9789638371,4811,3811,235885992811785721644
The Netherlands7889601,1071,8011,,7531,2711,061899705556446349
Switzerland707792693
Russia536525485
Brazil508470448
Italy4364574121,1721,089974848806745658572496
Canada462493471902924832762680595526512468
France488480453959977854696657587467
Spain310276283970909731583542513426
United Kingdom447395396779725627517504496397
その他5,1664,5914,2246,6586,0265,0274,0753,5242,9992,6493,6523,331
Consolidated20,24719,65719,05030,76529,,52825,91422,47622,33819,68017,28017,68516,285
●売上
($ milllion)2015201420132012201120102009200820072006200520042003200220012000備考
★AbbVie
Humira14,01212,54310,6599,2655,488(+21.4)4,521(+47.6)3,064(+49.9)2,0641,400852280---[adalimumab]リウマチ
 米国8,4056,5245,2364,3773,427(+19)2,872(+14)2,519(+11.7)2,255(+36.6)1,651(+40.4)1,176(+38.4)849(+53.2)555(+125.6)246(-)
 海外5,6076,0195,4234,8884,505(+23)3,676(+24)2,969(+31.0)2,266(+60.4)1,413(+62.9)868(+57.6)551(+85.4)297(-)34(-)
Depakote425(-68.8)1,364(-13.4)1,575(+20.4)1,3081,0961,027927898869(+12.0)39(+1.9)[divalproex sodium]抗てんかん剤
 米国331(-73.8)1,262(-14.8)1,480(+20.3)1,230(+18.5)1,037(+6.1)978(+10.4)886(+2.9)861(-0.9)
 海外94(-7.5)102(+7.4)95(+21.7)78(+24.8)59(+20.3)49(+18.2)41(+12.3)37(-3.6)
Clarithromycin542(+4)521(-11)587(-8)651(-10.1)724(-11.2)8161,0651,1831,2211,102537(-7.2)622(-6.3)[Biaxin,Biaxin XL, Klacid, Klaricid]抗生物質
 米国-14(-)36(-75.9)151(-50.5)306(-33.2)458(-15.0)538(+10.5)487(-9.2)
 海外-637(-7.4)688(+3.5)665(-12.5)759(+4.8)725(+6.1)683(+11.0)615(-1.0)
Kaletra7008709621,0131,366(-7.3)1,474(+11.2)1,325(+16.7)1,1351,005896752551210(-)83(-)[lopinavir/ritonavir]HIV
 米国163213244279326(-10)363(-19)446(-12.9)513(-4.7)538(+5.0)512(+22.0)420(+5.5)398(+3.9)383(+20.6)318(51.3)
 海外537657718734844(-5)892(-3)920(-4.3)961(+22.1)787(+26.3)623(+6.5)585(+17.6)498(+35.0)369(+58.5)233(179.4)
TriCor/Trilipix 米国のみ1,372(+1)1,355(+1)1,337(-0.3)1,341(+10.1)1,218(+16.2)1,048(+13.1)927(+18.9)779(+37.6)566(+40.6)403(52.9)264(+74.1)-[fenofibrate]高脂血症
Ultane/Sevorane474550568602-787(+3.7)759(-5.0)799874774674567192(+9.8)309(+10.9)[Sevoflurane]全身麻酔剤
 米国8183491520-193(-3.4)200(-23.4)260(-22.5)336(+16.0)290(+12.7)257(+16.3)221(15.0)
 海外393467491520-594(+6.2)559(+3.9)539(+0.2)538(+11.1)484(+15.9)417(+20.6)346(11.9)
Niaspan[米国]976(+5)927(+8)855(+8.8)786(+19.4)658(-)--[Niacin]脂質低下剤;2006Q4 Kos Pharmaceuticals Inc買収に伴う
Androgel[米国]6949341,0351,152874(+35)649(-)-[testosterone gel]
Synthroid[米国]755709622551522451502(-4.3)524(-1.6)533(-0.3)534554689609520445(-)22(-)[levothyroxine sodium]甲状腺
 米国755709622551522(+16)451(+9)415(-4.5)435(-5.0)458(-2.7)470(-5.7)498(-21.7)637(+12.8)565(+15.5)489(+9.9)
 海外97(-3.1)89(+19.2)75(+17.2)64(+14.5)56(+7.8)52(+16.6)44(+42.9)31(+42.9)
Leuprolide 826778785800800(+22.8)651-230(+4.6)219(+11.0)198(+8.2)183(+6.3)105(13.6)163(+6.2)[Lupron,Lucrin]
 米国653580566569540(+12)483(-11)540(+43.2)377
 海外173198219231270(+2)265(+2)260(-5.3)274
Synagis[海外]740835827825[Palivizumab] respiratory syncytial virus (RSV)
Creon[米国]632516412353[pancrelipase]膵消化酵素補充剤
Dyslipidemia products[米国]3281,0762,145
Duodopa[海外]219220178149[carbidopa/levodopa]パーキンソン病
Duodopa[米国]12
Viekira1,639[ombitasvir/paritaprevir/ritonavir tablets]C型肝炎
Viekira PAK[米国]80448--
 海外835
Imbruvica754[Ibrutinib]慢性リンパ性白血病(CLL)
 米国659
 海外95
★Pharmaceutical
Mobic 米国のみ---1232(+107.8)593(+85.1)320(+40.0)229(40.1)163(-)-[Meloxicam]消炎鎮痛
Omnicef 米国のみ--235637(+28.6)495(+53.6)323(+30.5)247(+58.0)157(74.7)90(109.2)-[cefdinir]2007ジェネリック競合
Lansoprazole 海外のみ651(-)-173(+12.3)154(+8.0)142(+7.8)132(+25.4)172(5.6)93(+18.0)[Prevacid,Ogastro]
 米国377(-)
 海外274(+6.5)
Flomax---(B-Iとの併販解消04.8)724575[tamsulosin HCl]
 米国-----689(+24.7)553(34.6)411(+47.7)
 海外-----35(+54.9)22(+44.2)16(+60.0)
Meridia/Reductil-------272[sibutramine]
 米国------75(-10.7)84(-)
 海外------197(61.8)118(-)
★Medical Products Group
Pediatric Nutr.3,9702,849(+7.8)2,642(+13.6)2,326(+14.8)2,0261,7951,7411,6201,490[]
 米国1,5921,5211,5321,306(+3.0)1,268(+2.8)1,233(+9.4)1,128(+2.7)1097(-4.3)1146(+4.8)1093(+9.0)1004(-3.6)1041(-0.1)
 海外2,3782,3572,2571,543(+12.3)1,374(+25.7)1,093(+21.6)898(+28.7)698(+17.3)595(+13.0)527(+8.4)486(1.1)480(+8.5)
Adult Nutritionals3,0052,375(+6.4)2,232(+10.3)2,024(+7.6)1,8821,7921,5971,4001,366[]
 米国1,2761,3141,3501,269(+9.2)1,162(+7.8)1,077(+1.9)1,097(+1.9)1050(+12.4)934(+15.5)809(-3.5)838(0.7)833(+3.8)
 海外1,7291,7611,6011,106(+3.3)1,070(+13.0)947(+14.9)785(+9.7)742(+11.5)663(+12.1)591(+11.9)528(3.9)508(+0.2)
Core Laboratory Diagnostics3,7073,027(-2.3)
 米国813605(-1.9)
 海外2,8942,422(-2.4)
Molecular Diagnostics466316(+18.3)
 米国191150(+23.5)
 海外275166(+14.0)
Point of Care473
 米国388
 海外85
Immunochemistry3,6143,458
Vascular Devices2,792----253221(+19.3)185(+44.7)205(33.3)-[]
 米国1,145----141(+11.7)221(+19.3)185(+44.7)205(33.3)-
 海外1,647----112(+18.8)----
Diabetes Care1,1171,242(-8.2)1,353(+8.4)1,249(+9.9)1,1361,067791(+46.1)541494[]
 米国394498(-11.0)559(+1.1)553(+1.3)547(+4.8)522(+38.1)378(+84.8)204(-0.4)205(8.1)190(+0.5)
 海外723744(-6.3)794(+14.2)696(+18.0)589(+8.2)545(+31.8)413(+22.7)337(+16.8)289(8.8)265(+7.8)
Medical Optics1,133890(-)-
 米国443337(-)-
 海外690553(-)-
Coronary Stents2,1761,618(+35.0)1,199(+78.4)672(-)-
 米国7681,029(+53.8)669(+118.5)306(-)-
 海外1,408589(+11.3)530(+44.8)366(-)-
Other Coronary580579-642(+6.5)604(+32.5)
 米国-298(-0.5)300(+13.0)
 海外-344(+13.4)304(+59.8)
Drug Eluting Stents (DES) and Bioresorbable Vascular Scaffold (BVS)products 1,4631,563
Endovascular520527475-400(+3.1)388(+11.9)
 米国282-238(-7.6)257(+0.8)
 海外238-162(+24.1)130(+42.9)
★TAP Pharm (非連結)
Prevacid 米国のみ-[1-4月]6492,2752,600(+4.0)2,5012,592(-18.7)3,190(+1.0)3,157(7.0)2,951(+7.7)2,739[Lansoprazole]潰瘍
Lupron 米国のみ-[1-4月]182645662(-5.2)699770(-2.2)788(-10.1)876(5.2)833(+4.2)799[Leuprolide]前立腺癌
from- ABBOTT REPORTS 15.5 PERCENT SALES INCREASE IN THE FOURTH QUARTER; 13.9 PERCENT INCREASE FOR 2004[2005.1.18] from - Abbott Reports 14.3 Percent Sales Increase in the Fourth Quarter; 11.3 Percent Increase for 2003[2004.1.16] ●Kos Pharmaceuticals, Inc 2006.11.5 Abbottと合併契約締結。
($million)2006Q1+Q22005200420032002200120001999備考
売上高170.8+223.7746.197495.545293.907172.69391.44760.17436.340[]
Advicor142.6 w/+34.9116.0108.267.427.1[niacin+losvastatin]
Niaspan+131.0435.2319.1226.5145.6[niacin]
Azmacort22.9+26.5103.268.3-[]2004.3.8 Aventisから世界独占権獲得
Teveten,HCT+5.5
31.6 w/+31.3 w/
22.1--[eprosartan]販売開始2005.5;from Bioval
Cardizem LA+25.869.7--[diltiazem]販売開始2005.5;from Bioval
[]
Teveten(R) (eprosartan mesylate) and Teveten HCT (eprosartan mesylate/hydrochlorothiazide) Cardizem(R) LA (diltiazem hydrochloride) の米国販売権をKos Life Sciences(KLS; Kos子会社)が Biovail Corporation から獲得。2005.5.2に契約し2005.5から承継。 ★Niaspan Kos が1997.9米国販売開始。 欧州ではKosのパートナーとしてMerck KGaAが2003.11.3にNiaspan英国発売、2004.1 13の欧州諸国の承認取得。 Kosは2003.11.4 Niaspan and Advicorの米国の共同販売契約を 武田薬品と契約。 Kosは2003.8.20 Niaspan and Advicorのカナダの共同販売契約をOryx Pharmaceuticals, Incと契約し、    Oryxは2003.12に承認申請。 ★Advicor [niacin+losvastatin] FDA承認2001.12.17 by Kos、米国発売2002.1.28 Kosは2003.11.4 Niaspan and Advicorの米国の共同販売契約を 武田薬品と契約。 Kosは2003.8.20 Niaspan and Advicorのカナダの共同販売契約をOryx Pharmaceuticals, Incと契約し、    Oryxは2003.12に承認申請。 アッヴィ合同会社(AbbVie GK) アボット・ラボラトリーズ(Abbott Laboratories 、NYSE: ABT) 2013年、研究開発型医療用医薬品事業(新薬事業)をアッヴィに分離し、ヒュミラ、カレトラ等をアッヴィに承継した。 AbbVie Inc. アッヴィ合同会社
Abbott

Press release Abbott Reports Double-Digit Ongoing Earnings-Per-Share Growth in Fourth Quarter and Full-Year 2011[2012.1.25] Abbott Reports Double-Digit Sales and Ongoing Earnings Growth in Fourth Quarter; Issues Ongoing Earnings Outlook for 2011[2011.1.26] Abbott Reports Double-Digit Sales and Earnings Growth in Fourth Quarter; Issues Strong Earnings Outlook for 2010[2010.1.27] Abbott Reports Double-Digit Sales and Earnings Growth in Fourth Quarter; Issues Strong Earnings Outlook for 2010[2009.1.27] Abbott Reports 16.1 Percent Sales Growth in Fourth Quarter[2008.1.23] ●ProductsInvestor RelationsSEC Filings 10-K[2011.2.18] - [pdf] - [doc] 10-K[2010.2.19] - [pdf,252p] - [doc] - [xls] 10-K[2009.2.20] - [pdf,318p] - [doc] - [xls] 10-K[2008.2.19] - [pdf,137p] 10-K[2007.2.23] - [pdf,250] 10-K[2006.2.22] - [pdf] - [xls] 10-K[02/25/04] ●IR Fact BookAnnual Report ---Annual Report には製品個別やOperation reviewはあるが売り上げのデータ記載なし - Abbott Reports Strong Fourth-Quarter Results and Record Operating Cash Flow in 2006 [2007.1.24] - 2006 Annual Report - [pdf] - Abbott Reports Record Sales, Earnings and Cash Flow in 2005[2006.1.25] ★疾病サイト Pediatric Health Men's Health Women's Health Diabetes HIV Horizon Respiratory Infections Pain Management Animal HealthAbbott Lab Online - http://www.rxabbott.com/
アボット ジャパン

- http://www.abbott.co.jp 2003年2月1日、ダイナボット(株)と北陸製薬(株)が合併し、アボット ジャパン(株)設立 アボット ジャパン株式会社(ダイナボット(株)と北陸製薬(株)が合併) 米国アボット、ソルベイ製薬の買収を完了[2010.2.17] ソルベイ製薬(株) 社名変更のお知らせ[2010.4.12] アボット ジャパン、アボット製薬合併を完了[2011.4.1] - 合併完了に伴い、アボット製薬の業務拠点を廃止し、アボット ジャパンに移転。 またアボット製薬の製品、業務はすべてアボット ジャパンに承継されます。 医療関係者の皆様医療用医薬品血糖測定器 プレスリリース アボット ジャパン(株)、4月から医療用医薬品の自社販売を開始[2006.3.31] - 1953年、アボット(米国)の子会社であるアボットジャパン (旧ダイナボット(株 ))と大日本住友製薬株式会社(旧大日本製薬(株))との間で、アボット製品の国内にお ける総代理店契約が締結され、旧大日本製薬がアボット製品の販売を始めました。 両社 の販売提携契約は、2006年3月31日をもって契約期間満了により終結いたします。 アボット ジャパン(株)と大日本住友製薬(株)販売提携契約を満了[2006.3.27]
Tap Pharmaceutical Products Inc.[US]

- http://www.tap.com/ 1977年Abbott Laboratoriesと武田薬品工業の合弁会社として設立。 2008.5.1 武田薬品と米Abbottは合弁事業TAPを終了。 2008.7.1 Takeda Pharmaceuticals North America, Inc.[TPNA]及びTakeda Global Research & Development Center, Inc[TGRD]がTap Pharmaceutical Products Inc.と合併 従業員数3,000人(2006末)、年間売上(2006) $3,362 Million ●Products PrevacidPrescribing Information Diseases & Conditions
($ 000)2008/1-42007200620052004200320022001備考
売上高853,0933,001,7383,362,6723,259,8503,361,6344,034,000
販売原価228,747719,976835,834883,404990,417
粗利益2,526,8382,376,4462,371,217
営業利益355,8611,560,6201,512,3261,373,9931,176,389
経常利益356,1011,564,4881,523,3261,379,3311,181,052
当期純利益237,994996,030951,621882,772749,969
研究開発費54,381161,013245,476219,412167,625
従業員数[連結]2,9003,0003,475

Prevacid米国649,3032,275,2932,599,8862,501,052[Lansoprazole]潰瘍
Lupron米国182,042645,450662,374698,806[Leuprolide]前立腺癌







Abiogen Pharma S.p.A[伊]

 - http://www.abiogen.it/english/home.asp

1997年 創立 Istituto Gentili S.p.Aが米メルク社による買収時、同社創立者の孫がスピンアウト


●会社決算
(Eur 000)2007200620052004200320022001
売上高65,36472,190.5869,130.3169,410.20

内Pharma47,820[73.15%]57,136.1853,996.3649,290.6042,20036,30034,400
 Manufacturing12,880[19.72%]11,846.8412,277.7915,207.9012,60010,70010,700
 Royalty&Down payment4,660[7.13%]3,207.561,856.164,911.7012,0007,60013,950

EBITDA7,6408,961
EBIT2,687.282,814.942,672.57
純利益(639.24)(1,017.69)(478.72)
従業員数[連結]369
(2007 売上金額比) 骨粗鬆症・NSAIDS 47.75% 呼吸器系 12.66% 糖尿病 18.63% 皮膚科疾患 9.23% その他 11.73% 
Abiogen Pharma S.p.A[伊]

PharmaAbiogen Pharma's products  Nerixia (neridronic acid sodium) R & DLicensing In
製品名薬効ライセンス先備考
alendronate(Alendros)骨粗鬆症米Merck & Co
Lyophilised bacterial lysates(Broncho Munal)瑞O.M.
Calcium dobesilate(Doxium/Doxiproct Plus)瑞O.M.
E.Coli Bacteria exts(Uro Munal)瑞O.M.
diacerein(Fisiodar)瑞Tran Bussan
aceclofenac(Gladio)NSAIDs西Almirall Prodesfarma
tecalcitol(Vellutan)帝人
octopirox/sebomina/Norgel(Kourilles)伊Farmaka
clotiazepam(Tienor)伊Farmaka
lyophilised collagene(Condress)伊Euroresearch
xibornol(Bornilene)伊Euphar
clarithromycin(Soriclar)マクロライド抗生物質伊Abbott
Licensing Out
製品名薬効ライセンス先地域
clodronate骨粗鬆症伊SPA、伊Fidia伊e
英Beacon Pharmaceuticals欧州
ギリシャ・キプロス・トルコSamaritan Pharmaceuticals欧州
加Oryx Pharmaceuticals Inカナダ
E Vitamin 400 IU伊Bracco
glibenclamide+metformin糖尿病伊Fornier Pharma/Solvay Pharma
仏Merck Sante欧州
米BMS米国
メキシコProductos Rocheメキシコ
tacalcitol伊IDI Farmaceutici
17β-estradiol伊Solvay Pharma
Pipeline /2008.8.3
製品名成分薬効段階備考
CL-I.A.clodronate変形性関節症P3
Nerixianeridronate骨粗鬆症・AlgodistrophyP3
BTG1640isoxazoline誘導体不安症・パニック障害P2
TALL 104Human cytotoxic cell lineP1
CombotoxMOAB-Anti-CD19 Toxin
MOAB-Anti-CD22 Toxin
非ホジキンリンパ腫P1
IMTOX 22MOAB-Anti-CD22 Toxin非ホジキンリンパ腫P1
Manufacturing 受託加工など プレスリリース(の代わり)

Abiogen Pharma starts a clinical phase II in Panic Disorders (21st May 2008)
- ABIO 08/01のパニック障害P2試験を開始。 
Abiogen starts a Phase II in cancer with its new cell-therapy.(20th Nov 2006)
- ABIO 05/01 のP2試験実施を承認された。 本剤は異種細胞療法剤で慢性骨髄性白血病などに有効とされる。
Abiogen Pharma's new anti-anxiety drug starts a clinical phase II in Generalized Anxiety Disorders in Vienna.(1st Jul 2006)
- ABIO 08/01のGADのP2試験を開始。
Abiogen Pharma / Oryx Pharmaceutical: a license agreement for Disodium Clodronate(20th Jun 2005)
-
Abiogen Pharma's new cell therapy starts a clinical phase I-II in Peritoneal Carcinosis(14th Apr 2005)
-
A NEW VAGINAL AND SURGERY DOUCHE(6th Apr 2004)
-
EMEA grants to Abiogen Pharma the Orphan Drug status for a new compound in myelofibosis indication.(8th Oct 2003)
- OGP (10-14)L (H-Tyrosine-Glycine- Phenilalanine-Glycine-Glycine-OH) のオーファン申請をEMEAは2003.9.10に承認した。 適応はchronic idiopathic myelofibrosis (CIMF)慢性原発性骨髄線維症.
Abiogen Pharma Spa: authorized Phase I for an OGP drug(5th Dec 2002)
-
Clodronate for the treatment of Osteoarthritis: positive results for Abiogen Pharma.(2nd Oct 2002)
-
New trends in the research of new vaccines for Hepatitis C and Tetanus on a biotechnological basis in Italy.(26th Jun 2002)
-
The first drug Worldwide for Osteogenesis Imperfecta, the "illness of bones of crystal", developed and registered in Italy.(25th Jun 2002)
- 世界初の骨形成不全治療薬Neridronateが承認された。 骨折と苦痛をドラスチックに軽減。












Abraxis BioScience Inc.

 - http://www.abraxisbio.com/; (Nasdaq: ABII) 本社Los Angeles, California
2005.11.27 ABIとAPPの合併交渉に入り、2006.4.18に合併完了、Abraxis BioScience, Inc. (Abraxis)となった。 。
2007.7.2 Abraxis BioScience (Nasdaq: ABBI)は、病院向け医薬品中心にAbraxis Pharmaceutical Products(APP)を分離。
2007.11.13 残ったABBIはAbraxis Oncology and Abraxis Research事業を含み
;→APP Pharmaceuticals Inc[APPX→APCVZ]に社名変更。
2008.7.6   APP Pharmaceuticals, IncはFresenius SEに買収完了[09.10.9] NASDAQ=APCVZ
2009.1     新設子会社Abraxis Health Incをスピンオフ



●旧American BioScience, Inc.[ABI,ABS]
1994.6  設立。;  Santa Monica, CA ; 非上場
旧社名 VivoRx Pharmaceuticals, Inc
因みに健康食品・一般薬販売のAmerican BioScience, Inc. - http://www.americanbiosciences.com/
は別の企業。


アステラス製薬が一部資本参加しており、日本での拒否権を保有。[1998.6.9]

●旧American Pharmaceutical Partners, Inc. (APP)
 - http://www.appdrugs.com/; American BioScience, Inc.の子会社(67.9%)。 
   抗ガン剤と抗感染薬の注射剤に重点。 NASDAQ:  APPX
1996      ジェネリック医薬事業開始
1998.6  Fujisawa USA,Inc.のジェネリック注射薬事業を買収。
We are a Delaware corporation that was formed in 2001 as successor to a California corporation formed in 1996.
2003後期 Abraxis Oncology division 設立
2005.12末 American BioScience, Inc.は当社株式の66.2%を保有。
2005.11.27 ABIとAPPの合併交渉に入り、2006.4.18に合併完了、Abraxis BioScience, Inc. (Abraxis)となった。 Abraxis BioScience, Inc. (Abraxis) -http://www.abraxisbio.com/index.htm
At June 30, 2006, we had the following wholly owned subsidiaries, Pharmaceutical Partners of Canada, In
c., Pharmacetical Partners Switzerland, GmbH, Puerto Rico, LLP, VivoRx AutoImmune, Inc., Chicago BioSci
ence, LLC and Transplant Research Institute our majority owned subsidiary, Resuscitation Technologies, 
LLC and our investment in Drug Source Company, LLC, which is accounted for using the equity method



●会社決算
($000)200820072006200520042003200220012000

売上高345,309333,686
旧647,674
182,287
旧583,201
旧765,488(+47)
135,,675
旧385,082
旧520,757(+29)
237
旧405,010
旧405,247
351,315
旧351,744
283,616192,029165,495
粗利益306,241299,236
旧315,328
161,104
旧295,122
旧457,976
111,609
旧181,646
旧293,522
(103)
旧213,236
旧212,993
189,742
旧190,052
141,77870,41059,908
営業利益(292,332)(54,356)
旧160,160
(146,173)
旧140,797
旧3,756
(5,908)
旧86,270
旧87,328
(74,271)
旧136,819
旧64,949
120,621
旧87,921
50,58925,382-12,246
経常利益(278,709)(49,556)
旧137,180
(150,515)
旧123,785
旧(17,598)
(12,184)
旧60,865
旧55,646
(76,301)
旧120,466
旧46,566
101,539
旧67,261
35,57822,167(13,797)
純利益(276,771)(41,604)
旧34,358
(124,551)
旧(46,897)
(12,662)
旧17,657
(76,301)
旧18,221
26,35318,64712,628-8,759

研究開発費103,59088,717
旧46,497
63,073
旧27,787
旧96,891
50,121
旧18,454
旧68,896
34,896
旧16,707
旧51,462
17,422
旧39,269
35,34413,79013,016
取得研究開発費13,900-83,447--
従業員数7341,3751,8641,4881,381
  研究開発310722409273(Ph.D.=35)
  品質管理315376282301
  製造部門160779807798711
  販売営業13661247207175
  事務管理128148194109121
*2003-2006の旧データは2007.7.2 Abraxis BioScience (Nasdaq: ABBI)は、病院向け医薬 品中心にAbraxis Pharmaceutical Products(APP)の分離以前のデータ。 ●事業別売上高
($000)2008200720062005200420032002備考

Critical care-382,772302,244
旧303,485(+86)
163,581(-8)178,242(+5)169,849(+25)135,370oxytocin,heparin
Anti-infective-193,704213,489(+26)169,818(+36)125,052(+31)95,581(+29)74,082
Oncology-55,30857,872
旧57,983(+14)
51,084(-47)95,866(+18)81,049(+32)61,204
受託製造他-15,5909,595
旧9,485(-)
599(-90)5,850(+21)4,836(-29)6,818

純売上高-647,374583,201
旧584,442(+52)
385,082(-5)405,010(+15)351,315(+27)277,474
Abraxane335,631324,692174,906(+31)133,731(-)---[Paclitaxel-albumin]乳癌;米国発売2005.2.7
Research Revenue9,6788,9947,381
旧6,140(+216)
1,944(+720)237
総収入345,309333,686
旧647,374
182,287
旧765,488(+47)
135,675
旧520,757(+29)
237
旧405,247
351,744283,616
[ABRAXANE] 2001.11 旧American BioScience[ABI]から北米の販売権、全世界製造権を取得契約。 - 2004年米国paclitaxel市場規模は1億ドル(IMS) 2005.1.7 FDA承認、米国発売は2005.2.7。 2005.5.27 日本に関して大鵬薬品にライセンス 2006.4.26 AstraZenecaと米国で共同販売。 因みにAbraxis Oncology(従業員280人、うちMR 169人)
Taiho Pharmaceutical Co., Ltd.: On May 27, 2005, we entered into a license agreement with Taiho Pharmaceutical Co., Ltd. under which we granted to Taiho the exclusive rights to market and sell Abraxane(R) in Japan. We, along with Taiho, established a joint steering committee to oversee the development of AbraxaneR in Japan for the treatment of breast, lung and gastric cancer and other solid tumors. Under this license agreement, Taiho paid us a non-refundable, upfront payment and will make additional payments to us upon achievement of various clinical, regulatory and sales milestones, with total potential payments in excess of $50.0 million. In addition, we will receive royalties from Taiho based on net sales under the license agreement.

[Competition 2006]

We believe that Abraxane(R) competes, directly or indirectly, with the primary taxanes in the market place, including Bristol-Myers Squibb's Taxol(R) and its generic equivalents, Sanofi-Aventis' Taxotere(R) and other cancer therapies. Many pharmaceutical companies have developed and are marketing, or are developing, alternative formulations of paclitaxel and other cancer therapies that may compete directly or indirectly with Abraxane(R).



Abraxis BioScience Inc.

ProductsAbraxaneProduct CatalogResearchNDA pipelineIR/MediaPress Releases Abraxis BioScience Reports 2008 Fourth Quarter and Full-Year Financial Results[2009.3.3] Abraxis BioScience Reports Record Revenue of $765 Million in 2006 Versus $521 Million for 2005[2007.2.26] American BioScience Licenses ABRAXANE(TM) to Taiho Pharmaceutical Co., Ltd., One of the Largest Oncology Companies in Japan[2005.11.15] ★SEC Filings 10-K Annual report[2009.3.6] - [pdf,119P] - [doc] - [xls] 10-K Annual report[2008.3.17] - [pdf,528p] - [doc] - [xls] 10-K Annual report[2007.3.1] - [pdf] 10-K Annual report[2006.3.10] - [pdf]







ACADIA Pharmaceuticals Inc[US]

 - 1997.1創立; (Nasdaq: ACAD); 創薬技術を用い、神経系医薬開発を行うバイオ企業。
Our headquarters and biology research facilities are located in San Diego, Calif
ornia, and our chemistry research facility is located in Malmo, Sweden
従業員数=101 (2004.12末)うち研究開発87人。


■会社決算 (12月末)
($000)       2004     2003     2002     2001     2000
収入
 提携等による   4,529    4,953    3,655    3,714    4,193
 他の研究収入      75    2,425    2,621        -      119
   計         4,604    7,378    6,276    3,714    4,312
営業支出
 研究開発      23,454   16,935   14,921   13,090    9,728
 一般管理費     4,889    2,791    2,818    3,756    2,999
 株式償還       2,356    1,392    1,163    2,147    2,854
  計          30,699   21,118   18,902   18,993   15,581
     
営業損失       (26,095) (13,740) (12,626) (15,279) (11,269) 
受入利息           607      360      420    1,494    1,516
支払利息          (429)    (712)    (662)    (621)    (441) 
純損失       (25,917) (14,092) (12,868) (14,406) (10,194) 


●開発段階の医薬
ACP-103     P2 パーキンソン病治療薬による精神症状の治療
ACP-103     P2 統合失調症の併用療法
ACP-104     P2 統合失調症の治療; N-Desmethylclozapine
 *既知物質のため物資特許の対象とはならないので、用途特許を申請中。
AGN-XX & AGN-YY P1 神経因性疼痛
AC-262271       前臨床 緑内障

●提携
[Allergan] 2003.3 眼科用新薬開発で3年間契約
 $3.9 million(2004) and $2.7 million(2003)受領
 当初1997.9 神経因性疼痛及び眼科用薬の新薬創製で提携契約。
 1999.7 緑内障治療薬開発で提携。
[The Stanley Medical Research Institute, or SMRI] 2004.5  3年契約
 統合失調症の新薬開発
[Aventis] 2002.7 
[Amgen]   2001.12 
  small molecule drugs の創薬


ACADIA Pharmaceuticals Inc

InvestorsSEC Filings Annual Filings 10-K[2005.3.18] - [pdf][84p] ●Annual ReportsPress ReleasesNewsProgramsTechnologyPartnering




Acorda Therapeutics Inc

 - 
1995.3 設立。 spinal cord injury (SCI), multiple sclerosis (MS)などの神経分野
2008.2 Neurorecovery, Inc.を買収



●会社決算
($ 000)201420132012201120102009200820072006200520042003/122003/62002/6備考
Zanaflex売上1,5004,10013,20049,95947,72839,42626,9444,809(4,417)---[tizanidine HCl]筋弛緩剤;痙性麻痺
Ampyra 366,200302,600266,100[dalfampridine]多発性硬化症;米承認2010.1、発売2010.3
Qutenza947407[capsaicin]帯状疱疹後神経痛;NeurogesX transactionにより2013.7から販売
License収入9,1009,1009,1004,714----
Grant収入-9960407336479382474132
収入 合計401,480366,430305,814292,237191,00554,67347,82739,48627,3515,145(3,938)382474132
粗利益43,28436,47231,13020,22813(4,823)382474132
営業利益36,39130,36525,60235,054(8,430)(81,257)(73,439)(39,448)(23,467)(34,411)(44,767)(36,773)(25,706)(22,338)
当期純利益17,67216,441154,95830,605(11,769)(83,940)(74,340)(37,974)(24,019)(35,531)(44,741)(36,712)(25,734)(21,182)
研究開発費73,47053,87753,88142,10830,60034,61136,60422,41012,05512,89021,99916,74317,52711,147
研究開発関連Party------3,3432,2654,687
従業員数[連結]489249126
■製品&パイプライン
●Ampyra[dalfampridine (4-aminopyridine, 4-AP), 旧Fampridine-SR] 多発性硬化症
(Elanから全世界の権利獲得。 米国Acorda、米国外Biogen-IDEC)
【2009】
Ampyra was approved by the FDA in January 2010 for the improvement of walking in people with MS. This was demonstrated by an increase in walking speed. To our knowledge, Ampyra is the first and only product indicated to improve walking in people with MS. We intend to commercially launch Ampyra in the U.S. in March 2010, using our own specialty sales force. Under our 2009 Collaboration Agreement, Biogen Idec has the right to develop and commercialize Ampyra in markets outside the U.S. In January 2010, Biogen Idec announced that it submitted an MAA to the EMA and an NDS to Health Canada for Ampyra, known outside the U.S. as fampridine.

Ampyra is an oral treatment approved by the FDA on January 22, 2010 as a treatment to improve walking in patients with MS. This was demonstrated by an increase in walking speed. Ampyra demonstrated efficacy in people with all four major types of MS (relapsing remitting, secondary progressive, progressive relapsing and primary progressive). Ampyra can be used alone or with existing MS therapies, including immunomodulator drugs. Ampyra is an extended release tablet formulation of dalfampridine (4-aminopyridine, 4-AP), which was previously referred to as fampridine. We have obtained Orphan Drug designation from the FDA for dalfampridine in MS, which will provide Ampyra with seven years of market exclusivity for this use. We also have patents and pending patent applications covering Ampyra. We plan to file for patent term extension for Ampyra under the Hatch-Waxman law that allows for up to five additional years of patent protection based on the development timeline of a drug. We plan to submit the applications by the deadline of March 22, 2010. Although we plan to apply to extend the two patents that we expect to be listed in the FDA Orange Book (the list of approved drug products and their therapeutic equivalents, if any) for AMPYRA, we will ultimately need to select only one patent for extension, if granted.

Background

MS is a chronic, usually progressive disease in which the immune system attacks and degrades the function of nerve fibers in the brain and spinal cord. These nerve fibers consist of long, thin fibers, or axons, surrounded by a myelin sheath, which provides insulation and facilitates the transmission of electrical impulses. In MS, the myelin sheath is damaged by the body's own immune system, causing areas of myelin sheath loss, also known as demyelination. This damage, which can occur at multiple sites in the CNS, blocks or diminishes conduction of electrical impulses. People with MS may suffer impairments in any number of neurological functions. These impairments vary from individual to individual and over the course of time, depending on which parts of the brain and spinal cord are affected, and often include difficulty walking. Individuals vary in the severity of the impairments they suffer on a day-to-day basis, with impairments becoming better or worse depending on the activity of the disease on a given day.

Dalfampridine is a potassium channel blocker. In animal studies, dalfampridine has been shown to increase conduction of nerve signals in demyelinated axons through blocking of potassium channels. The mechanism by which dalfampridine exerts its therapeutic effect has not been fully elucidated.

Clinical Studies and Safety Profile

Our New Drug Application (NDA) for Ampyra was based on data from a comprehensive development program assessing the safety and efficacy of Ampyra, including two Phase 3 trials that involved 540 people with MS. The primary measure of efficacy in our two Phase 3 MS trials was walking speed (in feet per second) as measured by the Timed 25-foot Walk (T25FW), using a responder analysis. A responder was defined as a patient who showed faster walking speed for at least three visits out of a possible four during the double-blind period than the maximum speed achieved in the five non-double-blind, no treatment visits (four before the double-blind period and one after). A significantly greater proportion of patients taking Ampyra 10 mg twice daily were responders compared to patients taking placebo, as measured by the T25FW (Trial 1: 34.8% vs. 8.3%; Trial 2: 42.9% vs. 9.3%). The increased response rate in the Ampyra group was observed across all four major types of MS. During the double-blind treatment period, a significantly greater proportion of patients taking Ampyra 10 mg twice daily had increases in walking speed of at least 10%, 20%, or 30% from baseline, compared to placebo. In both trials, the consistent improvements in walking speed were shown to be associated with improvements on a patient self-assessment of ambulatory disability, the 12 item Multiple Sclerosis Walking Scale (MSWS-12), for both drug and placebo treated patients. However, a drug placebo difference was not established for that outcome measure.

As part of our continuing evaluation of safety, we have conducted extension studies that allowed subjects in completed clinical trials to receive Ampyra on an unblinded, or open-label, basis, with their progress followed at regular clinical visits. As of January 22, 2010, 177 subjects from our Phase 2 clinical trial had been enrolled in an extension trial and 83, or approximately 47%, remained active in the trial, with duration of treatment of active patients ranging from 5.35 to 5.9 years. As of the same date, 269 patients from our first Phase 3 clinical trial had been enrolled in a separate extension study and 173 of these, or approximately 64.3%, remained active, with duration of treatment of active patients ranging from 1.65 to 4.17 years. Also as of that same date, 214 patients from our second Phase 3 clinical trial had been enrolled in a third extension study and 165, or approximately 77%, remained active, with duration of treatment of active patients ranging from 1.78 to 2.45 years. The total exposure to Ampyra in our MS studies as of January 22, 2010, including both double-blind and open label studies, was over 2,000 patient-years. We are evaluating whether the extension studies will be continued after Amypra is commercially available.

The FDA approved Ampyra with a risk evaluation and mitigation strategy (REMS) consisting of a medication guide and communication plan. The goals of the communication plan include informing patients and healthcare providers about the serious risks, including seizures, associated with Ampyra, the importance of proper dosing, and the change of the established name from fampridine to dalfampridine. A medication guide will be dispensed to patients with each Ampyra prescription. We will implement a communication plan to support implementation of the REMS, consisting of letters to prescribers and pharmacists. In addition, the REMS includes a timetable for our submission of periodic assessments to the FDA of the REMS and patient and healthcare professional understanding of Ampyra's risks.

The FDA's approval letter also included certain post-marketing study requirements and confirmed certain commitments made by us with respect to Ampyra. The post-marketing requirements include additional animal toxicology studies to evaluate certain impurities, in vitro receptor binding and abuse potential studies in animals, and an evaluation of clinical adverse events related to abuse potential. In addition, we have committed to the FDA that we will conduct a placebo-controlled trial to evaluate a 5 mg twice daily dosing regimen of Ampyra, as well as an evaluation of a 7.5 mg dosage strength in patients with mild or moderate renal impairment. We have also committed to report all post-marketing seizure events on an expedited basis to the FDA.

In our two Phase 3 clinical studies of Ampyra in SCI, the results did not reach statistical significance on their primary endpoints. Based on the entire body of data in clinical trials of Ampyra in people with SCI, we may resume development of Ampyra for SCI in the future, but have no current plans to do so.

Biogen Idec

On June 30, 2009, we entered into the Collaboration Agreement with Biogen Idec, pursuant to which we and Biogen Idec have agreed to collaborate on the development and commercialization of products containing aminopyridines, including Ampyra, initially directed to the treatment of MS (licensed products). The Collaboration Agreement includes a sublicense of our rights under an existing license agreement with Elan. We have also entered into a related supply agreement (Supply Agreement) pursuant to which we will supply Biogen Idec with its requirements for the licensed products through our existing supply agreement with Elan. Biogen Idec Inc., the parent of Biogen Idec, has guaranteed the performance of Biogen Idec's obligations under the Collaboration Agreement and the Supply Agreement.

Under the Collaboration Agreement, Biogen Idec, itself or through its affiliates, has the exclusive right to commercialize licensed products in all countries outside of the U.S., while we retain the exclusive right to commercialize licensed products in the U.S. Each party will have the exclusive right to develop licensed products for its commercialization territory, although the parties may also decide to jointly carry out mutually agreed future development activities under a cost-sharing arrangement. If Biogen Idec does not participate in the development of licensed products for certain indications or forms of administration, it may lose the right to develop and commercialize the licensed products for such indication or form of administration. Biogen Idec may sublicense its rights to certain unaffiliated distributors. During the term of the Collaboration Agreement and for two years after the Collaboration Agreement terminates, neither party nor its affiliates may, other than pursuant to the Collaboration Agreement, research, develop, manufacture or commercialize any competing product, defined as one that contains aminopyridine or any other compound that acts at least in part through direct interaction with potassium channels to improve neurological function in MS, SCI or other demyelinating conditions, except that we may exploit the licensed products anywhere in the world following termination of the Collaboration Agreement.

In consideration for the rights granted to Biogen Idec under the Collaboration Agreement, we were entitled to a non-refundable upfront payment of $110.0 million as of June 30, 2009, which was received on July 1, 2009. Also, as a result of such payment to us, a payment of $7.7 million became payable by us to Elan. We currently estimate the revenue recognition period under the Collaboration Agreement for upfront and milestone payments to be approximately 12 years from the date of this agreement. The Company recognized $4.7 million in license revenue related to the $110.0 million received from Biogen Idec and $330,000 in cost of license revenue related to the $7.7 million paid to Elan during the year ended December 31, 2009. We are also eligible to receive up to $400 million from Biogen Idec if specified regulatory and sales milestones are met.

Under the Collaboration Agreement, we will also be entitled to receive double-digit tiered royalties on sales of licensed products by Biogen Idec, its affiliates or certain distributors outside of the U.S. Such royalties for products combining a licensed compound with at least one other clinically active therapeutic, prophylactic or diagnostic ingredient are determined based on the contribution of the licensed compound to the overall sales or value of the combination product. Biogen Idec may offset against the royalties payable to us a portion of certain royalties that it may need to pay to third parties.

Biogen Idec will exclusively purchase all of Biogen Idec's, its affiliates' and its sublicensees' requirements of the licensed products from us. The purchase price paid by Biogen Idec for licensed products under the Collaboration Agreement and Supply Agreement reflects the prices owed to our suppliers under our supply arrangements with Elan or other suppliers. In addition, Biogen Idec will pay us, in consideration for its purchase and sale of the licensed products, any amounts due to Elan for ex-U.S. sales, including royalties owed under the terms of our existing agreements with Elan.

The Collaboration Agreement will terminate upon the expiration of Biogen Idec's royalty payment obligations, which occurs, on a licensed product-by-licensed product and country-by-country basis, upon the latest of expiration of the last-to-expire patent covering a licensed product, fifteen years following first commercial sale of such licensed product, the expiration of regulatory exclusivity and the existence of certain levels of sales by competing products. The Collaboration Agreement and the Supply Agreement will automatically terminate upon the termination of our license agreement with Elan in its entirety or with respect to all countries outside of the U.S. We cannot terminate our license agreement with Elan without Biogen Idec's prior written consent under certain circumstances. Biogen Idec may terminate the Collaboration Agreement in its entirety or on a country-by-country basis at any time upon 180 days' prior written notice, subject to our right to accelerate such termination. The Collaboration Agreement may also be terminated by either party if the other party fails to cure a material breach under the agreement, which termination will be limited to a particular country or region under certain circumstances. However, if Biogen Idec has the right to terminate the Collaboration Agreement due to our material uncured breach, Biogen Idec may instead elect to keep the agreement in effect, but decrease the royalty rates they pay us by a specified percentage. We may also terminate the Collaboration Agreement if Biogen Idec does not commercially launch a licensed product within a specified time period after receiving regulatory approval for such licensed product or otherwise fails to meet certain commercialization obligations. In addition, we may terminate the Collaboration Agreement under certain circumstances if (i) Biogen Idec, its affiliates or its sublicensees challenge certain of our patents or (ii) there is a change in control of Biogen Idec or its parent company or certain dispositions of assets by Biogen Idec, its parent or its affiliated companies, followed by a change in the sales and marketing personnel responsible for the licensed products in Biogen Idec's territory of more than a specified percentage within a certain period of time after such change in control or disposition. The Supply Agreement may be terminated by either party if the other party fails to cure a material breach under the Supply Agreement. In addition, the Supply Agreement will terminate automatically upon termination of the Collaboration Agreement, and the Collaboration Agreement will terminate automatically if the Supply Agreement is terminated for any reason other than for a material breach that we are responsible for. To the extent permitted by law, each party may terminate the Collaboration Agreement and the Supply Agreement if the other party is subject to bankruptcy proceedings.

If the Supply Agreement is terminated by Biogen Idec for an uncured material breach, we will waive our right for Elan to exclusively supply the licensed products to us solely to permit Biogen Idec to negotiate terms with Elan for the supply of licensed products to Biogen Idec. If the Supply Agreement is otherwise terminated, Biogen Idec will not have any future obligations to purchase licensed products from us and we will not have any future obligations to supply Biogen Idec with licensed products. If the Collaboration Agreement is terminated, Biogen Idec will assign to us all regulatory documentation and other information necessary or useful to exploit the licensed products in the terminated countries and will grant us a license under Biogen Idec's and its affiliates' relevant patent rights, know-how and trademarks to exploit the licensed products in the terminated countries. Such assignment and license will be at no cost to us unless the Collaboration Agreement is terminated by Biogen Idec for a material uncured breach that we are responsible for, in which case the parties will negotiate a payment to Biogen Idec to reflect the net value of such assigned and licensed rights.

Neither party may assign the agreements without the prior written consent of the other, except to an affiliate or, in certain cases, to a third party acquirer of the party.

Elan Corporation plc

Ampyra

In September 2003, we entered into an amended and restated license agreement with Elan that replaced two prior license agreements for Ampyra in oral sustained release dosage form. Under this agreement, Elan granted us exclusive worldwide rights to Ampyra for all indications, including SCI, MS and all other indications. We agreed to pay Elan milestone payments of up to $15.0 million and royalties based on net sales of products with dalfampridine as the active ingredient. We also agreed to pay Elan 7% of any upfront and milestone payments that we receive from the sublicensing of rights to Ampyra or other aminopyridine products, and in the third quarter 2009, as a result of our Collaboration Agreement with Biogen Idec, we paid Elan $7.7 million. The FDA approval of Ampyra has triggered a milestone of $2.5 million to Elan that will be paid in 2010.

Elan is also obligated under this agreement to supply us with our commercial requirements for Ampyra in the U.S., as well as to supply Biogen Idec under the Supply Agreement and Consent Agreement with Ampyra for Biogen Idec's clinical trials and for Biogen Idec's commercial requirements.

Elan may terminate our license in countries in which we have a license, if we fail to file regulatory approvals within a commercially reasonable time after completion and receipt of positive data from all preclinical and clinical studies required for the related NDA equivalent. We could also lose our rights under the license agreement if we fail to launch a product in such countries within 180 days of NDA or equivalent approval or if we fail to fulfill our payment obligations under the license agreement. If Elan terminates our license in any applicable country, Elan is entitled to license from us our patent rights and know-how relating to the product and to market the product in the applicable country, subject to royalty payments to us.

We have the right to terminate the Elan license at any time by written notice. In addition, the Elan license may be immediately terminated by either party following an incurable breach of any term or provision by the other party. The Elan license may also be terminated by either party following notice and the expiration of a cure period with respect to an uncured breach by either party.

Subject to the early termination provisions, the Elan license terminates on a country by country basis on the last to occur of fifteen years from the date of the agreement, the expiration of the last to expire Elan patent or the existence of competition in that country.

Competition - MS

Current disease management approaches to MS are classified either as relapse management or disease course management approaches. For relapse management, the majority of neurologists treat sudden and severe relapses with a four-day course of intravenous high-dose corticosteroids. Many of these corticosteroids are available generically. For disease course management, there are a number of FDA-approved MS therapies that seek to modify the immune system. These treatments attempt to reduce the frequency and severity of exacerbations or slow the accumulation of physical disability for people with certain types of MS, though their precise mechanisms of action are not known. These products include Avonex from Biogen-IDEC, Betaseron from Schering AG, Copaxone from Teva Pharmaceutical Industries, Ltd., Rebif from Merck Serono, and Tysabri from Biogen-IDEC and Elan.

To our knowledge, Ampyra is the first product that is approved as a treatment to improve walking in patients with MS. This was demonstrated by walking speed. Several biotechnology and pharmaceutical companies, as well as academic laboratories, are involved in research and/or product development for various neurological diseases, including MS. Other companies also have products in clinical development, including products approved for other indications in MS, to address improvement of walking ability in people with MS. We are aware that Sanofi-aventis is developing a sodium/potassium channel blocker, nerispirdine, with a potential indication in MS and other conditions. We believe that nerispirdine is in clinical trials for walking in MS and, depending on the results of those trials, any resulting product might compete with Ampyra. BioMarin Pharmaceutical Inc. (BioMarin) acquired the rights formerly owned by EUSA Pharma to amifampridine phosphate, a 3,4-diaminopyridine compound, which in January 2010 received marketing authorization in the EU for use in Lambert Eaton Myasthenic Syndrome (LEMS). BioMarin has announced that it will be working to determine the regulatory path for approval in the U.S. for LEMS, as well as exploring developing the product for use in other indications, which may include MS. In the EU, and the U.S., if this product is successfully developed and approved, physicians might prescribe it instead of Ampyra even if it were not approved for MS. In certain circumstances, pharmacists are not prohibited from formulating certain drug compounds to fill prescriptions on an individual patient basis. We are aware that at present compounded dalfampridine is used by some people with MS. Although we expect this use to decrease substantially when Ampyra is commercially launched, it is possible that some people will continue to use compounded dalfampridine. Several companies are engaged in developing products that include novel immune system approaches and cell transplant approaches to remyelination for the treatment of people with MS. These programs are in early stages of development and may compete with Ampyra or our preclinical candidates in the future.

We believe that Ampyra may be complementary to both the relapse management and disease course management therapies that are commercially available. Nonetheless, Ampyra may compete for market acceptance with these current treatments because they have been accepted and regularly prescribed to people with MS by physicians, or because they are being promoted to improve walking or other neurological functions.

【2006】
2006.9 P3 Start for improvement of walking ability in people.
In this trial, statistical significance was achieved on all three efficacy criteria defined in the SPA.  
In January 1997, we licensed from Elan exclusive worldwide rights to Elan’s sustained release formulation of fampridine, Fampridine-SR, for the treatment of SCI. In April 1998, we formed MS Research & Development Corporation, or MSRD, with Elan’s subsidiary, Elan International Services, Ltd., or EIS, to develop Fampridine-SR for treatment of MS. At that time, MSRD licensed from Elan exclusive worldwide rights to Fampridine-SR for the treatment of MS.

In September 2003, we entered into a termination and assignment agreement with Elan, EIS and MSRD pursuant to which MSRD assigned to us its assets, including the license from Elan for Fampridine-SR for MS. We paid MSRD approximately $11.5 million for all the assets and assumed liabilities of MSRD. MSRD distributed the purchase price to its shareholders according to their equity ownership interest. We received a distribution of approximately $9.5 million. We also purchased EIS’s shares at par value, and own approximately 88% of MSRD, which now has no assets or liabilities and is inactive.

In September 2003, we entered into an amended and restated license with Elan, which replaced the two prior licenses for Fampridine-SR in oral sustained release dosage form. Under this agreement, Elan granted us exclusive worldwide rights to Fampridine-SR for all indications, including SCI, MS and all other indications. We agreed to pay Elan milestone payments of up to $15.0 million and royalties based on net sales of the product, if approved. We have not made any payments under this agreement through December 31, 2006.

Elan is responsible for completing the chemistry, manufacturing and controls section of our New Drug Application, or NDA for Fampridine-SR and equivalent regulatory applications outside the United States. Elan is also supplying us with product for our clinical trials under this agreement.

Elan may terminate our license in countries in which we have a license, including the United States, if we fail to file regulatory approvals within a commercially reasonable time after completion and receipt of positive data from all preclinical and clinical studies required for the related NDA or any NDA equivalent. We could also lose our rights under the license agreement if we fail to launch a product in such countries within 180 days of NDA or equivalent approval or if we fail to fulfill our payment obligations under the license agreement. If Elan terminates our license in any applicable country, Elan is entitled to license from us our patent rights and know-how relating to the product and to market the product in the applicable country, subject to royalty payments to us.

We have the right to terminate the Elan license at any time by written notice. In addition, the Elan license may be immediately terminated by either party following an incurable breach of any term or provision by the other party. The Elan license may also be terminated by either party following notice and a cure period with respect to an uncured breach by either party.

Subject to the early termination provisions, the Elan license terminates on a country by country basis on the last to occur of fifteen years from the date of the agreement, the expiration of the last to expire Elan patent or the existence of competition in that country.


●[Zanaflex] (tizanidine) 筋弛緩剤(痙縮/spasticity)
【2009】
Sales of Zanaflex Capsules, which we launched in April 2005, and Zanaflex tablets increased from $53.4 million for the year ended December 31, 2008 to $58.3 million for the year ended December 31, 2009. Our Zanaflex Capsules and Zanaflex tablets commercial operations were cash flow positive in 2008 and 2009. Both products are FDA-approved as short-acting drugs for the management of spasticity, a symptom of many CNS disorders, including MS and SCI. These products contain tizanidine, one of the two leading drugs used to treat spasticity. We expect sales of Zanaflex Capsules will decline in 2010 due to increasing managed care pressure, among other factors.

Zanaflex Capsules and Zanaflex tablets contain tizanidine, one of the two leading active ingredients used for the management of spasticity. Tizanidine is approved by the FDA as a short-acting drug for the management of spasticity. We acquired from Elan Pharmaceuticals, Inc. (Elan) all of its U.S. sales, marketing and distribution rights to Zanaflex Capsules and Zanaflex tablets in July 2004. Zanaflex tablets were approved by the FDA in 1996 and lost compound patent protection in 2002. There are currently over 10 generic versions of tizanidine tablets on the market. However, substantial brand loyalty remains in the prescriber community for the Zanaflex brand. Most prescriptions for tizanidine tablets are written as "Zanaflex," although the majority are automatically substituted at the pharmacy for a generic tizanidine tablet. Zanaflex Capsules were approved by the FDA in 2002, but were never marketed by Elan. We began marketing Zanaflex Capsules in April 2005.

Background

Spasticity refers to the often painful involuntary tensing, stiffening or contracting of muscles. Spasticity is not a disease but a symptom of other conditions, such as MS, SCI, stroke, traumatic brain injury and cerebral palsy, where portions of the nervous system that control voluntary movement have been damaged. This damage results in the nerve cells in the spinal cord becoming disconnected from controlling centers in the brain and, as a result, transmitting unregulated impulses to the muscles. People who have spasticity may experience it intermittently-it may be triggered by a stimulus, such as pain, pressure sores, cold weather or a urinary tract infection. The majority of people with MS and SCI experience some form of spasticity, as do many people following stroke or brain injuries. We Move, a non-profit organization dedicated to movement disorders, estimates that spasticity affects approximately 500,000 people in the U.S. and over 12 million worldwide.

Clinical Studies

Clinical trials conducted by Elan demonstrated that Zanaflex Capsules, when taken with food, produce average peak levels of tizanidine in a person's blood that are lower and rise more gradually compared to the peak levels following a similar dose of the tablet form. The FDA recognizes these pharmacokinetic differences and therefore has determined that Zanaflex tablets and generic tizanidine tablets are not therapeutically equivalent, that is, are not AB-rated to Zanaflex Capsules. As a result, under state pharmacy laws, prescriptions written for Zanaflex Capsules may not be filled by the pharmacist with Zanaflex tablets or generic tizanidine tablets, although some substitution does take place in practice.

Elan Corporation plc

Zanaflex

In July 2004, we entered into an Asset Purchase Agreement with Elan pursuant to which we acquired all of Elan's research, development, distribution, sales and marketing rights to Zanaflex Capsules and Zanaflex tablets in the U.S. The assets acquired include the products' FDA registrations and FDA dossiers, proprietary product know-how, a patent and two related patent applications, certain inventory of Zanaflex tablets and certain product books and records. Elan also granted us a license allowing us to use the Zanaflex trademarks in the U.S., with the right to buy the Zanaflex trademark for a nominal sum once specified milestone and royalty payments were made. Those payments have been made, and we purchased and now own the trademarks. Elan also granted us an exclusive, perpetual and royalty-free license to certain intellectual property relating to technology contained in Zanaflex Capsules and Zanaflex tablets or used in the manufacture of Zanaflex Capsules, for use in connection with the sale and marketing of Zanaflex Capsules and Zanaflex tablets in the U.S. We also acquired the right to develop new indications, formulations, dosage forms, delivery systems and process improvements of Zanaflex. Under the agreement, Elan agreed not to directly or indirectly market, distribute or sell any products containing tizanidine as an active pharmaceutical ingredient in the U.S. until the later of the end of our obligation to pay royalties to Elan or valid termination of our supply agreement with Elan. In addition, we agreed not to directly or indirectly market, distribute or sell any products containing tizanidine as its active pharmaceutical ingredient in the United Kingdom or Ireland until July 2007.

Our agreement with Elan obligated us to pay a combination of sales-based milestone payments of up to $19.5 million, all of which have been achieved and paid, and royalties on sales of Zanaflex Capsules and Zanaflex tablets. We have no further Zanaflex milestone payment obligations with Elan. We also agreed to use commercially reasonable efforts to commercialize Zanaflex Capsules.

As part of the acquisition, we assumed certain of Elan's rights and obligations relating to Zanaflex under a license agreement with Novartis, to the extent that these rights and obligations arise subsequent to our acquisition of Zanaflex. Under this agreement we obtained certain rights to market and sell tizanidine products and rights to product improvements developed by Novartis.

Elan manufactures Zanaflex Capsules for us and we are in contract negotiations with Patheon Inc. for the manufacture of Zanaflex tablets. See "-Manufacturing."

In December 2005, we entered into a financing arrangement with Paul Royalty Fund, or PRF, pursuant to which we assigned PRF the right to receive a portion of our net revenues from Zanaflex Capsules, Zanaflex tablets and any future Zanaflex products. This agreement was amended in November 2006 potentially to increase the total amount of royalty payments to which PRF is entitled and to provide for additional lump-sum payments both from us to PRF and from PRF to us. The arrangement covers all Zanaflex net revenues generated from October 1, 2005 through and including December 31, 2015, unless the arrangement is terminated earlier. See "Management's Discussion and Analysis of Financial Condition and Results of Operations -Liquidity and Capital Resources -Financing Arrangements."

Competition - Spasticity

Tizanidine, the active pharmaceutical ingredient in Zanaflex Capsules, Zanaflex tablets and generic tizanidine tablets, is one of the two leading FDA-approved treatments for spasticity, a symptom suffered by both MS and SCI patients. Zanaflex tablets were approved by the FDA in 1996 and lost compound patent protection in 2002. Twelve generic manufacturers of tizanidine are distributing their own tablet formulations. As noted under " -Intellectual Property -Zanaflex" above, the Company is in litigation with Apotex with regard to its filing of an ANDA for the approval of a purported generic version of Zanaflex Capsules and certification against the Company's patent. In addition, several companies have reported that they are working on potential new delivery formulations of tizanidine. Baclofen, which is also available generically, is the other leading drug for the treatment of spasticity. The mechanism of action and associated effects of baclofen are different from those of tizanidine. Due to the different pharmacokinetic profile of Zanaflex Capsules, Zanaflex tablets and generic tizanidine tablets are not AB-rated with Zanaflex Capsules.

【2006】
2004.7 We acquired all marketing, sales and distribution rights in the United States
	 to Zanaflex Capsules and Zanaflex tablets from Elan.
These products contain tizanidine, one of the two leading treatments for spasticity.
 Zanaflex Capsules are the only approved capsule formulation of tizanidine and are
 protected by a patent that expires in 2021. 
These products contain tizanidine, one of the two leading treatments for the management of spasticity. Zanaflex tablets were approved by the FDA in 1996 and lost compound patent protection in 2002. There are currently 12 generic versions of tizanidine tablets on the market. However, substantial brand loyalty remains in the prescriber community for the Zanaflex brand. Approximately 90% of all prescriptions for tizanidine tablets are written as “Zanaflex,” although most are switched automatically at the pharmacy for a generic tizanidine tablet. Zanaflex Capsules were approved by the FDA in 2002, but were never marketed by Elan. We began marketing Zanaflex Capsules in April 2005.

Clinical trials conducted by Elan demonstrated that Zanaflex Capsules, when taken with food, produce average peak levels of tizanidine in a person’s blood that are lower and rise more gradually compared to the peak levels following a similar dose of the tablet form. The FDA recognizes these pharmacokinetic differences and therefore has determined that Zanaflex tablets and generic tizanidine tablets are not therapeutically equivalent, that is, are not AB-rated to Zanaflex Capsules. As a result, under state pharmacy laws, prescriptions written for Zanaflex Capsules may not be filled by the pharmacist with Zanaflex tablets or generic tizanidine tablets, although some substitution does take place in practice. Zanaflex Capsules are available in 2 mg, 4 mg and 6 mg doses, while tablet formulations are only available in 2 mg and 4 mg doses. Our goal is to convert sales of Zanaflex tablets and generic tizanidine tablets to sales of Zanaflex Capsules. We discontinued supply of the 2 mg dose of Zanaflex tablets in February 2006 due to a reduction in demand, and we do not intend to order additional supply of this product in the future. Demand for the 4 mg Zanaflex tablet is also declining, but supports continued supply. The 6 mg capsule gives patients and physicians an additional dosing choice and an opportunity to reduce the number of pills a patient must take daily. In addition, many patients may find capsules easier to swallow than tablets. Also, people who have difficulty swallowing may open the capsule and sprinkle it on food. The pharmacokinetic effect of sprinkling contents of the capsule on food, however, is different from when the intact capsule is taken with food.

In 2006, retail sales of Zanaflex capsules, Zanaflex tablets and generic equivalents of Zanaflex tablets (tizanidine) totaled approximately $290 million. For the same period, retail sales of Baclofen totaled approximately $181 million, for an approximate aggregate market of $471 million. The vast majority of these prescriptions were written by a relatively small group of prescribers. Specialists accounted for approximately 40% of tizanidine prescribing. High-volume specialist prescribers were responsible for approximately two or three-and-one-half times more prescriptions per physician than high-volume primary care prescribers. We believe that our internal specialty sales force including our tele-sales team, will be able to reach virtually all of these high-volume prescribers.

[Spasticity 2006]

Spasticity refers to the often painful involuntary tensing, stiffening or contracting of muscles. Spasticity is not a disease but a symptom of other conditions, such as MS, SCI, stroke, traumatic brain injury and cerebral palsy, where portions of the nervous system that control voluntary movement have been damaged. This damage results in the nerve cells in the spinal cord becoming disconnected from controlling centers in the brain and, as a result, transmitting unregulated impulses to the muscles. People who have spasticity may experience it intermittently?it may be triggered by a stimulus, such as pain, pressure sores, cold weather or a urinary tract infection. The majority of people with MS and SCI experience some form of spasticity, as do many people following stroke or brain injuries. We Move, a non-profit organization dedicated to movement disorders, estimates that spasticity affects approximately 500,000 people in the United States and over 12 million worldwide.

Current treatments for spasticity are focused on reducing spasm frequency, pain or irritating stimuli that can provoke spasticity. Treatment of spasticity often involves a combination of physical therapy and oral medications. Baclofen and tizanidine, the active ingredient in the Zanaflex products, are the two most frequently prescribed oral medications for spasticity. For more intractable spasticity, treatments sometimes include surgical or chemical destruction of nerve roots in the affected area.


【】
Acorda Therapeutics Inc

Investors RelationsNews & Announcements

Additional Phase 3 Clinical Trial Data Published in Annals of Neurology Showing Dalfampridine Extended Release Tablets Improved Walking Ability in People with Multiple Sclerosis[2010.11.17]
Acorda Therapeutics Reports Third Quarter 2010 Financial Results[2010.11.1] - AMPYRA(R) (dalfampridine) Extended Release Tabletsは2010.3.1発売、[Q1]$3.4 million , [Q2]$29.7 million , [Q3] $52.6 million
Acorda Therapeutics Announces Data on AMPYRA(R) (dalfampridine) Presented at 26th Congress of European Committee for Treatment and Research in Multiple Sclerosis[2010.10.15]
Acorda Therapeutics Announces Data on AMPYRA(TM) (dalfampridine) Presented at American Academy of Neurology Meeting[2010.4.13]
Acorda Therapeutics Announces Filing of Patent Extension Applications for AMPYRA(TM) (dalfampridine)[2010.3.22]
Acorda Therapeutics Announces Availability of AMPYRA(TM) (dalfampridine)[2010.3.1]
Acorda Therapeutics Announces Pricing and Patient Assistance Programs for AMPYRATM (dalfampridine)[2010.2.3]
Acorda Therapeutics Announces FDA Approval of AMPYRA(TM) (dalfampridine) to Improve Walking in People with Multiple Sclerosis - Demonstrated by Increases in Walking Speed[2010.1.22]
Acorda Therapeutics Announces Positive Vote by FDA Advisory Committee for Fampridine-SR[2009.10.14]
Acorda Therapeutics Announces Posting of Briefing Documents for October 14 FDA Advisory Committee Meeting on Fampridine-SR[2009.10.9]
Acorda Therapeutics Announces Data on Retention Rates and Safety from Two Phase 3 Fampridine-SR Extension Studies[2009.9.15]
Acorda Therapeutics Announces Interim Analysis of Two-Year Efficacy and Safety Data from Phase 3 Fampridine-SR Extension Study[2009.9.10]
Acorda Therapeutics Reports Date of FDA Advisory Committee Review of Fampridine-SR for Improvement of Walking Ability in People with MS[2009.8.25]
Biogen Idec and Acorda Therapeutics Announce Collaboration Agreement to Develop and Commercialize MS Therapy Fampridine-SR in Markets Outside the U.S.[2009.7.1]
Acorda Therapeutics Announces FDA Acceptance of Fampridine-SR New Drug Application for Filing[2009.5.6]
Study Highlights Economic Impact of Early Mobility Impairment in People with Multiple Sclerosis[2009.4.29]
Acorda Therapeutics Resubmits New Drug Application for Fampridine-SR for Improvement of Walking Ability in People with Multiple Sclerosis[2009.4.23]
Acorda Therapeutics Receives Refuse to File Letter from FDA on Fampridine-SR NDA[2009.3.31]
Data Published in The Lancet Show Fampridine-SR Improved Walking Ability in People with Multiple Sclerosis[2009.2.26]
Acorda Therapeutics Submits New Drug Application for Fampridine-SR for Improvement of Walking Ability in People with Multiple Sclerosis[2009.2.2]
Acorda Therapeutics Reports Fourth Quarter and Full Year 2007 Financial Results[2008.2.11]
Acorda Therapeutics Announces Acquisition of Aminopyridine and Pre-Clinical Assets from Neurorecovery, Inc.[2008.2.4]
Acorda Therapeutics Partners with Cardinal Health to Expand Sales Force for ZANAFLEX CAPSULES[2005.11.10]
Acorda Therapeutics Launches ZANAFLEX(R) CAPSULES for the Management of Spasticity in People with MS and Spinal Cord Injury[2005.4.4]
 - Acorda社はZANAFLEX(R) CAPSULES and ZANAFLEX(R) (tizanidine HCl) tablets
を1994.7 Elan Corpから取得。 今回はカプセル剤6mgを新発売。

SEC Filings
10-K Annual report[2010.2.26] - [pdf] - [doc] - [xls]
10-K Annual report[2007.3.26] - [pdf] - [word] - [xls]
Anual Reports

Products & ResearchPipelineZanaflex CapsulesTM(tizanidine hydrochloride) 
●AMPYRA  (dalfampridine) Extended Release Tablets







Actelion Ltd

 -http://www.actelion.com/
 創立1997.12; 本社スイス; 従業員数1,900人(2009.3); 世界に子会社15社(日本含む)
SWX Swiss Exchange (ticker symbol:ATLN)上場.

Actelion Ltd
Actelion Pharmaceuticals Ltd 

●決算
(CHF milllion)20112010200920082007200620052004200320022001備考
売上1,796.0631,928.9691,772.564(+23)1,473.508(+12)1,317.392(+)945.7(+43)663.6(+41)471.9307.5132.414.0

Tracleer1,522.11,636.11,508.0(+19)1,294.1(+10)1,180(+31)898.7633.2449.2299.7121.83.4(Bosentan)肺高血圧
Zavesca68.468.753.1(+38)40.1(+14)35.3(+39)25.414.46.10.7--(miglustat)[2003春に英独発売]脂質蓄積異常ゴーシェ病
Ventavis106.4118.7136.994.6(+21)78.2[inhaled iloprost]肺高血圧
契約収入74.57444.60225.30921.516.016.57.210.610.6

営業経費1,433.1581,102.151(-6)1,174.790(+)677.5(+33)511.3(+32)386.3309.2164.5116.6
経常利益[EBIT]338.522337.522
旧352.939
168.274268.2(+76)152.3(+78)85.6(-1.7)(-32.0)(-102.5)
純利益311.270306.073
旧321.490(+158)
124.586(+)241.1(+92)125.5(+44)87.2(-9.9)(-52.1)(-122.9)

研究開発費464.136374.530292.137211.8171.5136.379.250.658.7
従業員数2,2631,9001028854660412263
[09.01.01]SFr[CHF]=\85.19 ★パイプライン bosentan P3 Ischemic Digital ulcers in patients with systemic Sclerosis -RAPIDS-1 (RAndomized, double-blind, Placebo-controlled, multi-center Phase III study) 終了2004.12 - published in Arthritis and Rheumatism (Volume 50, Issue 12, page 3985-93). bosentan P3 Idiopathic Pulmonary Fibrosis (BUILD-1: Bosentan Use in Interstitial Lung Disease ;158例) and the scleroderma-related form of pulmonary fibrosis (BUILD-2; 162例)   2004.9開始、2005後半〜2006前半終了予定 *1998.11.4 Roche社から全世界独占開発製造販売権を獲得。 tezosentan 急性心不全 開発中止(2004.11) - VERITAS (Value of Endothelin Receptor Inhibition with Tezosentan in Acute heart failure Study), for futility reasons *tezosentanは、1998.3.19 Rocheから全世界独占製造販売権を獲得。 *miglustat(Zavesca)に関して、2002.11.22 Oxford GlycoSciences (OGS)と契約。  OGSはCelltech Group plc(UCB SAに買収) に買収された。 1998年にOGSはmiglustatをG.D.Searleからライセンスを受けている。  当社はOGSからイスラエルを除く全世界独占販売権を許諾されている。 2005.11.17からroyalty支払先がOGS/CelltechからUCBに変更。  なおイスラエルでのライセンスはTevaが保有。 [2006] Actelion's second product on the market, Zavesca(R) (miglustat), achieved sales of CHF 25.4 million in 2006, almost doubling from the previous year. Zavesca(R), currently indicated for mild to moderate type 1 Gaucher patients unwilling or unable to undergo enzyme replacement therapy with Genzyme's Cerezyme(R) (imiglucerase), combines a novel mode of action with a convenient oral form. The key to capturing a greater share of the current USD 900-million market is the MAINTENANCE study, which evaluates whether patients with type 1 Gaucher disease treated with imiglucerase remain stable after switching to Zavesca(R). Recently generated clinical data with Zavesca(R) in another rare liposomal storage disease, Niemann Pick Type C, has led to a regulatory filing in the European Union to expand the label in this indication.
Actelion Ltd

ProductsTracleer.com --- http://www.tracleer.com/ Full Prescribing Information[pdf] Full Prescribing Information[pdf, 9p] ●Zevesca (miglustat) 1 Gaucher disease治療薬(酵素補充療法) JournalistsNews Archives Tracleer Excellence Post Marketing Surveillance Programme (TRAX PMSTM) confirms long-term safety profile in various pulmonary arterial hypertension subgroups[2005.9.5] JACC publication on Tracleer in children with PAH[2005.8.16] - Journal of the American College of Cardiology (JACC) が長期研究を発表 (Rosenzweig E.B. et al. Volume 46 Issue 4 Pages 697-704).86例 Actelion launches Tracleer in PAH in Japan[2005.6.8] Japanese Approval for TracleerR in PAH[2005.4.11] Actelion provides update on bosentan in Japan[2005.2.18] Actelion files New Drug Application for TracleerR in Japan[2003.4.8] ScientistsDevelopment PipelineTracleer (bosentan)(sildenafilとの配合剤)P4 ★Zavesca (miglustat)(ゴーシェ病)P4 ★Clazosentan(動脈瘤性くも膜下出血)P3 ★Almorexant(不眠症)P3 ★Macitentan(肺高血圧)P3 ★Selexipag(肺高血圧)P3 ■Investors ●Financial Information〜年報、GAAP四半期報告 Actelion announces Full Year 2011 financial results[2012.2.14] Actelion announces Full Year 2010 financial results[2011.2.17] Actelion announces Full Year 2009 financial results[2010.2.18] Actelion announces Full Year 2008 financial results[2009.2.19] Actelion announces Full Year 2007 financial results[2008.2.21] Actelion announces Full Year 2006 financial results[2007.2.22] Actelion announces Full Year 2005 financial results[2006.2.23] Actelion announces 9-month results for 2005[2005.10.19] - In the first nine months of 2005, TracleerR sales were CHF 455.1 million (9 m onths 2004: CHF 325.4 m). 34カ国で発売 US GAAP FY 2011 US GAAP FY 2010 US GAAP FY 2009 US GAAP FY 2008 US GAAP FY 2007 Annual Report 2011[pdf] Annual Report 2010[pdf] Annual Report 2009[pdf,114p] Annual Report 2008[pdf,111p] Annual Report 2007[pdf,90p] Annual Report 2006 - [pdf] Annual Report 2005 - [pdf] Annual Report 2004 - [pdf] Annual Report 2003 - [pdf]
アクテリオン ファーマシューティカルズ ジャパン株式会社

- http://www.actelion.co.jp/ 2001年10月、スイスのActelion Ltd(アクテリオン社)の100%子会社として、東京に設立。 従業員数 109名(2007年3月1日現在) ●製品情報 ★トラクリア - 医療関係者 - 添付文書[pdf] ●活動状況 ★最近の活動状況ニュースリリース ●研究・開発 ★研究開発情報欧米の研究・開発







Adams Laboratories Inc.

 - http://www.adamslaboratories.com/

●会社決算(6月末)  Nasdaq上場申請中"ARxT." 
($Million) 2004/6 2003/6
純売上高   61.3    14.0
純利益    35.2   -23.3
従業員数   90人
1985年Adams Laboratories, Inc.は、John Q. Adams, Srにより創立。最近まで同社CEO。
同氏はBaylor Labs買収,Allerderm Labs設立に実施。
[Biz.Yahoo]Adams Laboratories, Inc. Company Profile
DFBT - Event Details(2003) - John Q. Adams, Sr Interview
UPDATE 2-Adams Laboratories seeks $125 mln IPO[Reuter 2005.3.25]
 - 私企業Adams Laboratories Inc.は$125 million相当の株式を公開。
 同社主力品MucinexはSudafed[Pfizer], Nyquil[P&G], Theraflu[Novartis] ,Claritin[Schering-Plough]と競合。

関連会社●Adams Respiratory Therapeutics, Inc. -http://www.adamsrt.com/
 同社はAdams Labsの呼吸器疾患用薬剤の開発、製造、販売を目的として設立。




Adams Laboratories Inc.

ProductsMucinexMucinex DM 咳止め 発売September 2004 ★http://www.mucinex.com/ Mucinex DrugFactsNewsPress ReleasesProduct Launches







Aderis Pharmaceuticals[US]

1994.4  Ethyl Corp子会社Whitby Research Incの研究プログラム買収により設立。
1998.8  Schwarz Pharmaとパーキンソン病用パッチ剤開発で提携
2001.11 rotigotine CDS P3へ
2002.1  Discovery TherapeuticsをAderis Pharmaceuticalsに社名変更



Aderis Pharmaceuticals

 -http://www.aderis.com/index.asp ●ProductsParkinson's DiseaseRestless Legs SyndromeCardiac ImagingAtrial FibrillationWound Healing in Diabetic Foot Ulcersproduct candidates Rotigotine(SPM-962)〜パーキンソン病NDA/RLS(P2) /Schwarz社提携 Binodenoson(MRE-0470)〜心臓機能診断薬 P3 /King社提携 Selodenoson(DTI-0009)〜抗不整脈剤 P2 / MRE-0094〜糖尿病性足部潰瘍治療薬 P1 /King社提携 ●Press Releases







Adolor Corporation[米]

 - http://www.adolor.com/ ;本社Exton, Pennsylvania
1994 創立
2000 NASDAQ上場




●会社決算
($ 000)20082007200620052004200320022001
ENTEREG売上1,248-------[alvimopan]術後腸閉塞;FDA承認08.5、発売08.6
契約収入48,2089,12015,08715,71925,54220,727
 総収入 計49,4569,12015,08715,71925,54220,727
研究開発費52,66441,61056,66049,63148,76656,654
販売・一般管理費31,11523,97037,68926,29322,87017,648
 (経費計)83,98365,58094,34975,92471,63674,302
営業外収支4,4058,0179,5243,4082,5082,369
当期純利益(30,122)(48,443)(69,738)(56,797)(43,586)(51,206)
従業員数[連結]128108
●Entereg(R) (alvimopan)(大腸および小腸切除術後の上部および下部消化管の回復期間短縮
【2008】Net shipments of ENTEREG through December 31, 2008 were $2.2 million. We recognized net product sales of $1.2 million on shipments to the approximately 185 hospitals that reordered ENTEREG during the year ended December 31, 2008. We have a customer deposit balance of $0.3 million at December 31, 2008. Customer deposits represent net shipments made for which payment has been received from Glaxo, but which have not yet been recognized as product sales revenue. The remaining $0.7 million difference represents product shipments for which payment has not yet been received from Glaxo and for which the conditions of revenue recognition have not been met.
【2007】Opioid analgesics provide pain relief by stimulating opioid receptors located in the central nervous system. There are, however, opioid receptors throughout the body, including the GI tract. By binding to the receptors in the GI tract, opioid analgesics can slow gut motility and disrupt normal GI function that allows for the passage, absorption and excretion of ingested solid materials. This disruption can cause patients to experience significant discomfort and abdominal pain and may result in their reducing or eliminating their pain medication.

Entereg is a small molecule, mu-opioid receptor antagonist intended to block the adverse side effects of opioid analgesics on the GI tract without affecting analgesia. Entereg has been under development for both acute and chronic conditions. The acute indication is for the management of post operative ileus (“POI”), a GI condition characterized by the slow return of gut function that can result from GI or other surgeries. The chronic indication is for the treatment of opioid bowel dysfunction (“OBD”), which is a condition characterized by a number of GI symptoms, including constipation, that often results from chronic use of opioid analgesics to treat persistent pain conditions.

In April 2002, we entered into a collaboration agreement with Glaxo for the exclusive worldwide development and commercialization of Entereg for certain indications. We are responsible for the development of acute indications, such as POI, and Glaxo is responsible for the development of chronic indications, such as OBD. In the United States, we and Glaxo are co-developing Entereg and intend to share profits that result from the sale of the product. For commercial sales of Entereg for POI in the United States, we would receive 45% and Glaxo would receive 55% of the net sales less certain agreed upon costs, subject to certain adjustments. After the first three years, each party’s share would become 50%. For commercial sales of Entereg for OBD in the United States, we would receive 35% and Glaxo would receive 65% of the net sales less certain agreed upon costs, subject to certain adjustments. Under the collaboration agreement, we have the right to convert our right to receive a profit share for OBD in the United States to a royalty on net sales of 20%. Outside the United States, Glaxo is responsible for the development and commercialization of Entereg, and we would receive royalties on net sales. We may receive additional milestone payments under the collaboration agreement upon the successful achievement, if any, of certain clinical and regulatory objectives, including up to $40.0 million related to the POI indication and up to $25.0 million related to the OBD indication.

【申請経緯】2004.6 Entereg 12mg capsulesのPOIの適応でFDAにNDA申請した(4つのP3研究に基づく)。 追加のP3国際治験が実施され2005.4にFDAに追加申請。 2005.7最初のapprovable letterをFDAから受領。 2006.5に回答。 2番目のapprovable letterを2006.11受領、2007.8に回答(OBD患者の12ヵ月長期安全性試験。リスク管理計画含む)。 2008.1 FDAはGastrointestinal Drug Advisory Committee(GIDAC)と共にEnteregの有効性と安全性を審査。2008.1.23のGIDACでは「acceleration of time to upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis」の適応に対して、総合ベネフィットに関して9-6、POIへの有効性には13-0(保留2)、OBD患者の12ヵ月長期安全性試験で観察された心管系イベント関連での懸念について8-6(保留1)、リスク管理計画が不十分との点に14-0(保留1)との結果。

【ライセンス】Glaxoと2002.4に全世界独占契約、2002Q2に$50 million受領。 2004Q3(NDA申請)に$10 million受領。 契約では米国でのEnteregのPOI適応での粗利のうちAdolor 45%,Glaxo 55%、OBDではAdolor 35%,Glaxo 65%、但しOBDのprofit shareを royalty 20%に変更する権利を保有。
Glaxoは2008.9 慢性OBD(オピオイド腸管機能不全)の適応に関して全世界独占契約を解消。
 alvimopanはEli Lillyが創製し、1996.11にRoberts Laboratories Inc(1999.12 Shireに買収)にライセンスした。 Adolor Corporationは1998.6 Roberts社からalvimopanの全世界独占権を獲得($1.6 million)。 これとは別に2002.8 Lillyとも契約。

Adolor Corporation

Products ENTEREG(alvimopan)(大腸および小腸切除術後の上部および下部消化管の回復期間短縮) ●RESEARCH & DEVELOPMENT Investor InsightsNEWS RELEASES ANNUAL REPORTS SEC FILINGS 10-K Annual report[2009.2.26] - [pdf] - [doc] - [xls] 10-K Annual report[2008.2.29] - [pdf] - [word] - [xls] PRESS ROOM - NEWS RELEASES Adolor Corporation Provides Update on R&D Programs[2008.12.18] オピオイド治療を受けている患者の慢性腸管機能不全(OBD)を対象にしたアルビモパン (alvimopan)の更なる開発はしないと発表した。 ENTEREG(R) (alvimopan) in Postoperative Ileus (POI) 承認 ENTEREG(R) (alvimopan) in Opioid Bowel Dysfunction (OBD) P3中止 ADL5859(PF-04856880) in DPN P2完了(Pfizerと共同) ADL5859(PF-04856880) in RA P2完了(Pfizerと共同) Adolor Regains Rights to Entereg(R) (alvimopan) for OBD[2008.9.2] Entereg(R) (alvimopan) Available for the Management of Postoperative Ileus[2008.6.9] Adolor and GlaxoSmithKline Announce FDA Approval of Entereg(R) (alvimopan) for the Management of Postoperative Ileus (POI)[2008.5.20]







AEterna Zentaris Inc.[Ca]

  カナダ籍企業。 従業員数200人(北米・欧州;2002)

★系列会社
Atrium Biotechnologies Inc[カナダ] 61.76% -http://www.atrium-bio.com/
Zentaris GmbH[GE] -100%




●決算
(Canada $000)  2003     2002     2001
Revenues       166,413  101,204   43,777
Operating loss (14,283) (20,566) (17,754)
Loss before
 income taxes  (18,546) (18,190) (14,844)
Net loss
 for the year  (28,147) (25,782)  (3,469)

●セグメント別売上高
(Canada $ 000)      2003      2002         2001
Biopharmaceutical    46,106       315         -
Cosmetics&nutrition  15,291    13,386     11,367
Distribution        105,526    87,859     32,629
連結調整               (510)     (356)      (219)
  収入 合計        166,413   101,204     43,777



AEterna Zentaris Inc.

Products on the marketInvestorsFinancials News Room *Zentaris GmbH[GE]
Zentaris GmbH[GE]

- http://www.zentaris.de/ - 旧 Asta Medica AGから2001年分社 2003 Zentaris AGと AEterna GmbHが合併し、Zentaris GmbHになった。 2004.6 親会社Degussa AGがZentaris GmbHをAEterna Labsに売却。 バイオ医薬企業AEterna Laboratories Inc.[カナダ]の100%子会社。 →現■AEterna Zentaris Inc.[Ca] AEterna Laboratories Holds 2004 Annual Shareholder Meeting and Announces Company Name Change to Aterna Zentaris[2004.5.26] - AEterna LabがAterna Zentaris Inc.に社名変更。 100%子会社としてZentaris GmbH[GE]を傘下に持つ。  日本では、塩野義製薬にライセンス品目あり。 ●News & FactsPress Releases AEterna acquires German biopharmaceutical Zentaris from Degussa[2004.6.1] Degussa sells Zentaris. Divestment of the former ASTA Medica now completed[2004.6.1] - 売却価格はEur 50million; Degussa AGは、AWD pharma[Arzneimittel Dresden]をPlivaに売却(2001.6)、 腫瘍事業をBaxterに売却(2001.8)、ViatrisをAdventに売却(2002.5)。 Zentaris AGは、従業員数70人、売上高EUR 21 million(2002)、設立2001年。 ●Products, projects, services




Affymax, Inc.

 - http://www.affymax.com/ ;本社Palo Alto, CA ; NASDAQ=

2001.8  ベンチャー数社が合同で設立。 GlaxoSmithKlineからのa spin-out 
2008末現在Hematideの開発に集中。現在P3(慢性腎不全による貧血、化学療法による貧血)



●会社決算
($ 000)20082007200620052004200320022001
提携収入82,16244,30311,688----
ライセンス・ロイヤリティ689333874151225103
(収入合計)82,85144,33611,72674151225103
研究開発費137,49269,39854,34724,05117,33813,66016,834
営業経費 計171,58293,47365,43634,08322,26928,94428,448
営業利益(88,731)(49,137)(53,710)(34,009)(22,118)(28,719)(28,345)
経常利益(86,228)(37,712)(48,288)(32,576)(21,398)
当期純利益(86,510)(43,069)(48,288)(32,576)(21,398)(28,197)(28,046)
従業員数[連結]147
★武田薬品との提携

In February 2006, we issued an exclusive license to Takeda for the development and commercialization of Hematide in Japan. Pursuant to this agreement, Takeda has paid us approximately $37 million to date, consisting of $17 million in upfront license fees, $10 million in milestone payments, and approximately $10 million for the purchase of 530,082 shares of our Series E Redeemable Convertible Preferred Stock at a price of $18.86 per share, which we determined was at fair value. In addition, we are eligible to receive additional clinical and regulatory milestone payments of up to an aggregate of $65 million upon Takeda's successful achievement of clinical development and regulatory milestones in Japan. Takeda is responsible for all development and commercialization costs in Japan and will purchase API for Hematide from us. Assuming Hematide is approved and launched in Japan, we will receive a royalty from Takeda on Hematide sales in Japan.

In June 2006, we expanded our collaboration to develop and commercialize Hematide worldwide, which includes the co-development and co-commercialization of Hematide in the U.S. Takeda received an exclusive license to develop and commercialize Hematide outside of the U.S. Beginning January 1, 2007, Takeda will bear the first $50 million of third-party expenses related to development in pursuit of U.S. regulatory approval of Hematide. Thereafter, Takeda will bear 70% of the third-party U.S. development expenses, while we are responsible for 30% of the expenses. Each company retains responsibility for 100% of its internal development expenses. Under the June 2006 agreement, Takeda paid us an upfront license fee of $105 million, and we are eligible to receive from Takeda up to an aggregate of $280 million upon the successful achievement of clinical development and regulatory milestones. Further, we may receive from Takeda up to an aggregate of $150 million upon the achievement of certain worldwide annual net sales milestones. We and Takeda will share equally in the net profits and losses of Hematide in the U.S., which include expenses related to the marketing and launch of Hematide. Takeda will pay us a variable royalty based on annual net sales of Hematide outside the U.S. The agreement establishes a joint steering committee to oversee the development, regulatory approval and commercialization of Hematide.

We will share responsibility with Takeda for clinical development activities required for U.S. regulatory approval of Hematide. Specifically, we have primary responsibility for Hematide's clinical development plan and clinical trials in the dialysis and pre-dialysis indications, while Takeda has primary responsibility in the chemotherapy induced anemia and anemia of cancer indications. We are responsible for U.S. regulatory filings in the dialysis, pre-dialysis, chemotherapy induced anemia and anemia of cancer indications, including holding the NDAs for those indications. Takeda is responsible for regulatory filings outside the U.S. and the creation of a global safety database.

We are also responsible for the manufacture and supply of all quantities of API to be used in the development and commercialization of Hematide worldwide. Takeda is responsible for the fill and finish steps in the manufacture of Hematide worldwide.

We have agreed to jointly develop the initial commercial marketing plan for Hematide in the U.S. pursuant to which we and Takeda will divide Hematide promotional responsibilities in the U.S. We and Takeda will jointly decide on promotional responsibility for markets outside of these initial indications.

Under the February 2006 agreement, Takeda also obtained a right of first negotiation to any backup products for Hematide developed by us or our third-party partners. Specifically, during the first ten years of the agreement, if we or our third-party partners develop a product that advances to Phase 2 clinical trials and competes with Hematide in the renal or oncology indications, we are obligated to offer to Takeda the right to develop and commercialize such product in Japan before offering the product opportunity in Japan to any other third party.

We have recognized $11.7 million of revenue under our Arrangement with Takeda during the year ended December 31, 2006. In December 2006, Takeda completed a Phase 1 trial of Hematide in Japan resulting in the payment in January 2007 to us of a $10 million milestone under the collaboration.

★貧血用 EPO市場

IMS Health推計によると、2008年度rEPO製剤は世界で$11.5 billion、米国$6.8 billion。 米国主要製品はPROCRIT[J&J]およびAranesp and EPOGEN[Amgen]
Aranesp, introduced in 2001, has significant market share, particularly in the oncology market. In late 2005, U.S. quarterly sales of Aranesp surpassed those of PROCRIT. Aranesp is approved for once-monthly dosing for treatment of anemia in pre-dialysis patients in Europe. In the U.S., Amgen reportedly is in the process of seeking approval for once-monthly dosing of Aranesp for treatment of anemia in pre-dialysis patients. In 2005, Amgen submitted a biologics license supplement to include a once-monthly dosing regimen for pre-dialysis patients in the label for Aranesp. In October 2006, the FDA responded to Amgen's filing with a request for additional clinical data for the once-monthly dosing regimen, including an additional clinical study.

Roche has obtained regulatory approval to market and has launched a PEGylated ESA, called Mircera, in Europe. Mircera reportedly has greater plasma stability than any of the currently marketed products. PEG is a polymer that increases the time rEPO remains in the circulation and consequently can be dosed less frequently. Mircera has also obtained regulatory approval in the U.S., but as a result of Roche and Amgen's patent infringement litigation, Mircera has been found to infringe several U.S. patents owned by Amgen and has been enjoined from being sold in the U.S. until the expiration of these patents in 2013. If Mircera enters the U.S. markets before Hematide or upon its entry, we believe that Mircera will be in direct competition with Hematide, and therefore could potentially limit the market for Hematide, because of its ability to be longer acting than currently marketed ESAs in the U.S. In addition to marketed ESAs, there are several ESA product candidates in various stages of active development, including small molecules, by a potential competitor, FibroGen, Inc., that may promote the production of naturally-occurring EPO in patients. In addition, Merck recently announced plans to develop its own version of EPO in yeast cells instead of mammalian cells which, if successful, may permit Merck to launch its product prior to the expiration of Amgen's U.S. patents.

In addition, several biosimilar versions of short-acting rEPO have recently been launched or are expected to launch in Europe in the near term. Biosimilar EPOGEN products are generally not expected to enter the U.S. market until 2013, when the last patent in Amgen's U.S. EPO patent estate expires.

According to IMS Health Incorporated, recombinant EPO, or rEPO, generated $13 billion in worldwide revenues for 12 months ended June 2006, of which we believe approximately $9 billion was generated in the U.S. Of this $9 billion, we estimate that approximately $3 billion is attributable to use of rEPO in patients on dialysis, and the remaining $6 billion is attributable to other indications, including oncology and use in predialysis patients. Despite the success of rEPO, we believe that worldwide markets for predialysis and cancer are underserved. Currently marketed rEPO is typically given up to three times per week to dialysis patients, and every one to three weeks to oncology patients. We believe the requirement for relatively frequent dosing has historically limited the use of these ESAs in predialysis and oncology treatment settings and that Hematide, with less frequent dosing, has the potential to expand these markets. While the dialysis market is currently well penetrated, we believe Hematide has the potential to offer reduced operational cost and complexity for healthcare providers compared to currently marketed ESAs

★Anemia Background

Anemia, a condition in which the blood is deficient in red blood cells and hemoglobin, is a frequent and serious complication associated with a number of common chronic diseases. Anemia is associated with chronic fatigue and, if left untreated, may increase the risk of other diseases or even death. Red blood cells are normally formed in the circulating blood from progenitor cells, known as stem cells, and from precursor cells which are initially present primarily in the bone marrow. These cells are stimulated to divide and differentiate and are mobilized into circulation by EPO, a hormonal factor produced by the kidney. EPO acts by binding to and activating the EPO receptor on precursor cells. The activation of the EPO receptor stimulates the proliferation and maturation of the precursor cells to form red blood cells that contain hemoglobin. Hemoglobin is an iron-containing protein in red blood cells that functions primarily in the transport of oxygen to, and carbon dioxide from, the tissues of the body. Anemia can be caused by conditions such as chronic kidney disease, or treatments such as chemotherapy, that result in underproduction of EPO or a muted response to EPO.

Anemia generally exists in men when the hemoglobin level in blood, which is a measure of red blood cells, is less than 12 g/dL, or the hematocrit, which is a ratio of the volume packed red blood cells to the volume of whole blood, is less than 37%, and in women when hemoglobin is less than 11 g/dL or hematocrit is less than 33%. The FDA, the medical community and others have recently raised significant safety concerns relating to currently marketed ESAs as a result of reports of increased mortality and side effects from a number of clinical trials. Some of these safety concerns relate to targeting and maintaining high hemoglobin levels for extended periods of time. The FDA recently required revised warnings, including black box warnings, be added to labels of currently marketed ESAs advising physicians to monitor hemoglobin levels and to use the lowest dose of ESA to increase the hemoglobin concentration to the lowest level sufficient to avoid the need for red blood cell transfusions. Black box warnings for currently marketed ESAs also note increased risk of death and serious cardiovascular events when administered to target a hemoglobin of greater than 12 g/dL.

★Anemia associated with Chronic Kidney Disease. One of the most common forms of chronic anemia is that which occurs in patients with chronic kidney disease. According to the American Journal of Kidney Disease, chronic kidney disease affects as many as 19 million Americans. As kidney function deteriorates due to the underlying disease, the ability of the kidney to produce adequate EPO is impaired, resulting in decreased production of new red blood cells and anemia.

Over time, chronic kidney disease usually progresses to irreversible end-stage renal disease, the most severe stage of the disease. End-stage renal disease patients require either lifetime dependence on renal dialysis, a medical procedure in which blood is cleansed of impurities, or a kidney transplant. Patients with end-stage renal disease are nearly always moderately to severely anemic unless treated with an ESA like rEPO. According to the Centers for Medicare and Medicaid Services, or CMS, there are approximately 320,000 end-stage renal disease patients on dialysis in the U.S. served by approximately 4,700 dialysis facilities. Funding and reimbursement for this care are predominately through the Medicare End Stage Renal Disease Program. In 2005, according to the CMS, reimbursement for many drugs, including ESAs, was at a rate of 106% of the average ESA sales price. This allows the dialysis facilities to realize a profit on the purchase and administration of ESAs, which constitutes an important component of their economic viability. IMS Health estimates that the U.S. sales of EPOGEN, the dominant therapy for anemia in dialysis patients, totaled $2.9 billion for the 12 months ended June 2006.

We estimate that approximately two-thirds of pre-dialysis patients with anemia are not treated with an ESA prior to progression to stage 5, end-stage renal disease, and initiating dialysis. While in the U.S., currently marketed ESAs are indicated for up to every two week dosing in predialysis, these patients often require much less frequent visits to their nephrologists or primary care physicians for treatment of their underlying disease. Because of the incongruity between the optimal dose scheduling of these ESAs and the timing of predialysis patient office visits, we believe that the predialysis market for ESAs is underserved by existing therapy and could be better served with a product that can be dosed once every four weeks.

★Anemia associated with Cancer. Anemia in cancer patients may be caused by chemotherapy or the cancer itself. For patients undergoing chemotherapy, the destruction of progenitor stem cells and precursor cells in the bone marrow by chemotherapy often leads to anemia. Severe fatigue associated with anemia affects approximately three-fourths of all cancer patients undergoing chemotherapy. In some cancer patients, such as those with multiple myeloma and acute leukemia, the underlying cancer itself causes anemia. In these patients, the production of and responsiveness to EPO is believed to be reduced by molecules known as cytokines that are produced by or in response to tumors. An oncologist's ability to treat a patient's cancer is often limited by the patient's ability to tolerate the side effects, including anemia, of highly toxic courses of chemotherapy. Better management of chemotherapy induced anemia could lead to better dose optimization of chemotherapy in cancer patients.

The FDA has recently issued a public health advisory re-evaluating the safe use of the ESA class and is scheduled to convene its Oncology Drugs Advisory Committee (ODAC) in May 2007 to consider the mechanism of action of ESAs and to review the effects of ESAs on survival and tumor progression in cancer patients. Use of ESAs has been associated with shortened time to tumor progression in certain patients with advanced head and neck cancer. Increased risk of death has been reported when ESAs are administered to target a hemoglobin of 12 g/dL in patients with active malignant disease receiving neither chemotherapy nor radiation therapy, a population for which ESAs are not approved or indicated.

Based on our marketing research, there are approximately 3 million actively treated cancer patients in the U.S. Of those patients, roughly 1.2 million undergo chemotherapy to treat their cancer. About 65% of chemotherapy patients become anemic, with 47% of those receiving ESA therapy. Further, based on the January to June 2005 Tandem cancer audit, over 90% of chemotherapy patients receive chemotherapy treatment in three or four week cycles or less frequently, yet the most prevalent dosing intervals of current ESAs for cancer patients are every one to two weeks. We believe that a less frequent, more convenient dosing regimen, every three to four weeks to coincide with chemotherapy, may increase market penetration and expand use of ESAs for oncology patients.

Anemia associated with Other Conditions. Anemia can also occur in any person with a chronic disease that causes significant inflammation, infection, or bleeding, such as rheumatoid arthritis or cardiovascular disease, and it can therefore be considered a characteristic disease of the elderly. We are testing Hematide in chronic kidney disease and cancer, but are not currently testing Hematide's effectiveness in treating anemia in other conditions.

★Current Therapy and Limitations

According to IMS Health, rEPO generated $13 billion in worldwide revenue for the 12 months ended June 2006, of which approximately $9 billion was generated in the U.S. Of the $9 billion in U.S. revenue, we estimate that $3 billion is attributable to use for dialysis patients, and the remaining $6 billion is attributable to other indications, including use in oncology and predialysis patients. ESAs, in the form of rEPO variants, have been used successfully to manage the anemia of dialysis, predialysis and cancer patients. rEPOs are similar, but not necessarily identical, to a patient's naturally occurring EPO. Differences exist among rEPOs with regard to composition and structure. As a result, differences may also exist among rEPOs with regard to frequency of dosing, duration of effect and rate of rise in hemoglobin. Stability in the blood and circulating half-life, which measure the time it takes the compound to disappear from the blood, generally correlate with less frequent dosing. One of our objectives is to develop a product with a duration of effect that results in a well-controlled hemoglobin response while still allowing optimal dosing, ideally once every four weeks.

Since its initial U.S. market introduction in 1989, rEPO has revolutionized the treatment of patients with anemia resulting from chronic diseases. To date, the therapeutic options have not progressed significantly beyond the relatively short-acting and inconvenient recombinant protein products currently on the market. Further, the majority of products in development are variations of the existing products on the market.

Two current types of ESAs, epoetin alfa and epoetin beta, are biologically engineered hormones produced in mammalian cells by recombinant DNA technology. Both are relatively short-acting forms of rEPO that typically require frequent dosing to obtain a sustained correction of anemia. Darbepoetin alfa, which is marketed by Amgen, Inc., or Amgen, under the trade name Aranesp, is a biologically engineered hormone product closely related to and functionally similar to epoetin alfa. However, darbepoetin alfa has a terminal half-life approximately three times longer than epoetin alfa, as a result of the addition of sialic acid to stabilize the protein. The currently available rEPOs are marketed under a variety of trade names in different territories.

★Frequency of Dosing. Currently marketed ESAs are hampered by short duration of effect resulting in the need for frequent dosing. We believe that the need for frequent dosing has limited the use of ESAs in treatment settings such as predialysis, where patient visits for the purpose of treating underlying disease are less frequent than for patients undergoing dialysis multiple times per week. The population of predialysis chronic kidney disease patients who may benefit from anemia management far outnumbers the population of patients who have reached end-stage renal disease. We believe the requirement for relatively frequent dosing has historically limited the use of ESAs in predialysis and oncology treatment settings and that, with its longer acting profile, Hematide has the potential to expand these markets. In the oncology setting, anemia management often involves administration of ESAs more frequently than typical chemotherapy regimens, which usually require treatment every three to four weeks. Although existing ESAs are sometimes given in larger doses in an effort to achieve extended dosing, and despite studies by the manufacturers of these ESAs aimed at extending the dose interval of these products, medical record audit data and oncologist survey response indicate that existing ESAs are still administered to chemotherapy patients once a week to once every two weeks on average. In addition, recent studies by manufacturers of ESAs indicate that the higher levels of hemoglobin associated with larger and more frequent doses result in a statistically significant increase in cardiovascular events. For these reasons, we believe that an ESA designed for every four weeks administration could expand the market opportunity for anemia management therapies in the oncology setting.

★Pure Red Cell Aplasia(赤芽球癆;純赤血球無形成症). Treatment of patients with rEPO has been shown in rare cases to cause the production of antibodies to both rEPO and naturally-occurring EPO. Typically these antibodies can bind to and neutralize both the rEPO drug and any naturally-occurring EPO in a patient's system. As a result, such patients become increasingly less sensitive to rEPO therapy and can develop a form of anemia called Pure Red Cell Aplasia, or PRCA. This hematological disorder is characterized by severe, transfusion-dependent anemia, a scarcity of reticulocytes and an almost complete absence of red blood cell precursors in otherwise normal bone marrow. Recently, the FDA has required marketers of rEPO in the U.S. to include in their product prescribing information warnings of potential for rEPO induced PRCA and a description of this adverse reaction. We believe that an ESA that does not cause PRCA and that can be used to treat PRCA will have advantages in the marketplace over rEPOs that can cause PRCA.

★Potential Hematide Advantages

Hematide is a relatively small synthetic peptide-based ESA which we are developing for the treatment of anemia in dialysis, predialysis, PRCA and cancer patients. Peptides are composed of amino acids, commonly known as the building blocks of proteins. Typically, a peptide is composed of fewer than 50 amino acids, while a protein contains from 50 to well over 5,000 amino acids. Peptide-based therapeutics may display certain advantages compared to recombinant proteins, including simplicity and cost of manufacture, and specificity of effect. Further, because they are composed of naturally-occurring amino acids, peptide-based therapeutics theoretically also carry the general advantage of reduced toxicity relative to small molecule drugs. In the past, development of peptide-based drug candidates was often slowed by low potency. A second problem historically associated with peptide-based drugs has been a requirement of frequent dosing in vivo. More recently, however, it has been possible to develop peptide-based drugs with potencies nearly equivalent to recombinant proteins and with less frequent dosing requirements.

Through the use of our technology, we have designed Hematide to require less frequent dosing than currently marketed ESAs. We believe that Hematide's properties are superior to the properties of rEPO drugs currently on the market, particularly in terms of required frequency of administration. As a long-acting ESA, we believe that Hematide may overcome many of the patient care limitations of currently marketed rEPOs. We believe that flexibility of dosing based on duration of effect will allow many patients to receive anemia management therapy concurrently with therapy for their underlying disease.

Hematide is being developed for room temperature stability, ease-of-handling and long shelf life in order to overcome many of the limitations which hamper the cost effectiveness, and thus the physician adoption, of rEPOs.

Our early clinical trials have shown similar positive effects on red blood cell formation when Hematide is given at equivalent doses either intravenously or subcutaneously. These results suggest that Hematide may be equally effective in humans when administered by either route. Additional clinical trials are underway to confirm this observation. We believe it may be easier to use Hematide than some forms of rEPO, which often have different clinical effects when given subcutaneously versus intravenously.

Although Hematide has the erythropoietic activity characteristic of naturally occurring EPO, its amino acid sequence is unrelated to EPO, rEPO or any other known naturally-occurring erythropoietic protein. Because Hematide does not appear to display immunologic cross-reactivity to naturally-occurring EPO, we believe that Hematide will not cause PRCA. We have conducted preclinical studies which have demonstrated that Hematide can stimulate reticulocytes and elevate hemoglobin levels in animal models of EPO antibody mediated PRCA. An ongoing Phase 2 clinical trial of Hematide in a small number of patients with PRCA has shown supportive results to date. These results suggest that Hematide is not neutralized by antibodies to rEPO and thus may be effective in rescuing patients that have developed PRCA.

Based on preclinical and clinical studies to date, we believe that the risk of developing antibodies to Hematide will be low. Thus far, we have observed that Hematide-induced antibodies do not appear to cross-react with rEPO and do not have any apparent effect on clinical response to the drug.






Affymax, Inc.

Hematide(TM) (a synthetic peptide-based erythropoiesis stimulating agent, or ESA, designed to stimulate production of red blood cells. Hematide is designed to be less frequently dosed than currently marketed ESAs, and therefore has the potential to offer both better care for patients and reduced cost and complexity for healthcare providers) P3 the treatment of anemia associated with chronic renal failure P2 for the treatment of anemia in cancer patients 前臨床  analogs for tissue protection ●R & DINVESTORSPress ReleasesAnnual ReportsSEC Filings 10-K annual report[2009.3.12] 10-K annual report[2008.3.13] 10-K annual report[2007.4.2]




Akorn, Inc.

 - http://www.akorn.com/ ; 眼科薬等の専門メーカー
  Akorn Manufacturing Inc.は子会社
1971 創立、Abita Springs, Louisianaにて。

droperidol(Inapsine[Akorn])を販売

●会社決算
($000)20062005200420032002200120001999

収入71,25044,48450,708(+12)45,49151,41941,54566,22164,632
粗利益26,88014,94418,202(+50)12,14820,5376,39828,13133,477
営業利益-4,905-7,479-368-6,276-3,565-21,074-1,73112,122
経常利益-5,960-8,592-3,018-12,496-6,713-24,926-4,01410,639
純利益-5,963-8,609-3,026-12,325-12,952-15,146-2,4146,670

研究開発費11,7974,5101,8611,4651,8862,598
従業員数371
●セグメント別売上高
($000)20062005200420032002200120001999

収入71,25044,48450,70845,49151,41941,54566,22164,632

 眼科用製品19,52822,65929,81226,05629,57916,936
 注射用製品42,48913,71912,34112,15512,9779,663
 受託製造9,2338,1068,5557,2808,86314,946
●研究開発 [2006]
In 2006, we received 11 ANDA product approvals from the Office of Generic Drugs. As of December 31, 2006, we had 35 ANDA product submissions for generic pharmaceuticals under review at the Office of Generic Drugs: 16 from internal development and 19 from various strategic agreements with nine external partners. In most, but not all, instances we own the ANDAs that are produced by our strategic partnerships. We plan to continue to file ANDAs on a regular basis as pharmaceutical products come off patent allowing us to compete by marketing generic equivalents. See “Government Regulation” beginning on page seven.



Akorn, Inc.

●Investor Relations ★OverviewNews Releases Akorn, Inc. Reports Net Sales of $12.6 Million in 2004 Fourth Quarter with
Gross Margin of 33% and EBITDA of $1.0 Million
[2005.2.28] ★SEC Filings 10-K[2007.3.16] - [pdf] 10-K[2004.3.30]




AKZO Novel

Akzo Nobel's Pharma Group はOrganonを中心に、2002年度売上 Euro 140億(約1兆7374
億円)、80か国に従業員67,000人。
 事業別では、医薬 EUR 40億, Coatings EUR 55億, and 化学品 EUR 46億.
Akzo Nobel Announces Intended Sale of Organon BioSciences to Schering-Plough[2007.3.12]
 - 完全子会社Organon BioSciences N.V. (OBS)をSchering-PloughにEUR 11 billionで売却。
Akzo Nobel Confirms OBS Sale on Schedule[2007.10.11]
 - European Commissionが認可した。



●会社決算
(Euro milllion)2006200520042003200220012000

売上高[IFRS]13,737(+6)13,00012,83313,10614,05914,15814,069
営業利益[IFRS]1,4621,4861,5271,0641,3621,1981,487
純利益[IFRS]1,153(+20)961945602818671947

研究開発費885810807
旧823
887
うちOrganon484[18.6%]433[17.9%]395[17%]
会計処理は、-2003迄NL GAAP,2004-以降はIFRS ●事業別売上高
(Euro milllion)2006200520042003200220012000

売上高13,737(+6)13,00012,68813,051

Ornanon2,611(+8)2,4252,344
Intervet1,125(+3)1,0941,027
 医薬3,2463,600
旧3,550
4,0614,085
Coating6,209(+12)5,5555,2375,162
旧5,144
5,4445,522
化学品3,809(-2)3,8904,317
旧4,192
4,473
旧4,347
4,6794,680
その他-17361410
合計13,737(+6)13,00012,833
●事業別従業員数
(人)2006200520042003200220012000

従業員数61,88061,34061,450
旧61,400
64,600

 Organon13,71014,10014,09015,500
 INTERVET5,3705,2605,2705,200
 医薬20,00021,300
Coating31,66029,20028,86029,300
化学品9,68011,43011,890
旧13,600
14,400
旧14,500
 その他1,4601,3501,340
旧1,100
1,200
61,88061,34061,450
旧63,600
66,400
●会社決算〜医薬事業部門
(Euro milllion)2006200520042003200220012000

売上高3,7363,5193,2463,5504,0443,8392,865
営業利益354+219415+238522692768831765
EBITDA475+278541+292690868948995932

従業員数19,08019,36020,00021,30021,70021,00021,200
2005年度以降はOrganonとIntervetを合算 ●製薬事業部門[Pharm]
(Euro milllion)20062005200420032002200120001999備考

Organon2,611(+8)2,4252,344
旧2,010
2,2792,5932,5041,980(+49%)1,620PRESCRIPTION DRUGS
Intervet1,125(+3)1,0941,027
旧1,024
1,0101,0811,0961,020(+26%)515VETERINARY PRODUCTS
Diosynth--366479529488380(+9%)335ACTIVE INGREDIENTS FOR THE PHARMACEUTICAL INDUSTRY
Organon Teknika------555(+14%)530HOSPITAL SUPPLIES
CHEFARO------85(+2%)90NONPRESCRIPTION PRODUCTS

Pharm. Total3,7363,5193,2463,5504,0084,0443,839(+34%)2,865
1) Chefalo - 2001初めに売却 2) Organon Teknikaの診断薬部門は、bioMerieuxに売却。<2000> Organon&Organon Tekn ika計は、2,254に修正された。 Organon&Organon Teknikaは、2001.5.1統合。 3) 医薬原料メーカーDiosynth社は2005.1にOrganon社に統合 ●製品別売上
(Euro milllion)2006200520042003200220012000備考
Contraception669(+18)564(+8)522(+4)517(+7)521(-3)540(+10%)492(+20%)
うちNuvaRing213(+67)127(+57)81(+115)----[Etonogestrel/Ethinyl Estradiol Vaginal Ring]避妊リング
Marvelon/Mercilon/Mircette-390(-12)431(+6)???-[desogestrel/ethinylestradiol](oral contraceptives)
Hormone Replacement Therapy-330(+5)314(+11%)
Livial151(-2)154(-4)160(-17)197(-1)208(+12)186(+20%)155(+40%)[tibolone](hormone replacement)世界90ヵ国
Infertility-402(+5)384(+10%)--
Puregon/Follistim384(+8)355(+20)285(-11)331(-1)356(+8)329(+17%)282[follitropin beta](infertility product)
Depression-800(+11)720(+39%)--
Remeron253(-11)283(-22)363524717(+14)627(+51%)414(+58%)[mirtazapine](antidepressant)
米国47(-75)208(-45)
米国外316(-)316(+26)
Hospital pharmaceuticals*-282(+3)272(-2%)
Pharmaceutical ingredients255(+2)228(+8)
Anesthesia242(+28)[]
★Implanon -the innovative contraceptive implant [2006] 米国FDA承認、発売2006 Late ★NuvaRing [2006] ・topped the 1.5 million user mark worldwide ・also approved for the Australian market. 32ヵ国目 ★Anesthesia revenues [2006] Anesthesia revenues grew 27%, boosted by muscle relaxant Esmeron(R) and the injectable Anzemet(R), for post-operative nausea and vomiting. Anzemet(R), which is licensed in by Organon from sanofi-aventis for the United States only, added to the already strong anesthesia franchise in the United States. ★Royalties and services revenues [2006] were mainly attributable to royalty payments from Janssen on RisperdalR sales in selected countries and from GlaxoSmithKline on sales from Arixtra(R). Service revenues were received mainly from Ligand, with whom our co-promotional collaboration on Avinza(R) was ended by the end of September 2006, although the royalty income from the product will remain for a number of years. ■Pipeline /2007.6
ProjectApplicationPhaseDescription
●Gynecology
Org 50081Serotonin -2-Blocker (hot flushes)III
NOMAC/E2Oral contraceptive in-licensed from Theramex (Merck KGaA)III
Org 39970AndrogenII
●Fertility
Org 36286Sustained Follicle Stimulant(corifollitropin alpha)III
●Neuroscience
asenapinedopamine/serotonin antagonistIII
Org 50081Serotonin-2-Blocker (insomnia)III
farampatorAMPAkineII
Org 34517GR antagonistII
Org 25935GlyT1 inhibitorII
●Anesthesia
sugammadexSelective muscle relaxant binding agentIII
●Other
Org 42675Antithrombotic dual inhibitor II/XII
from Form 20F 2006[pdf,239p;2006.6.22] p25 Currently, 39 compounds are in various stages of the development pipeline: 23 in pre-clinical development, 7 in Phase I clinical development, and 4 in Phase II clinical development, of which two are in advanced stages of Phase II developmen t. Five products are in Phase III clinical development. ●Annual Report 2003 -General[pdf,55p] - 53p★[Products and Markets - Pharma]Main human healthcare products in the pipeline (Phase II and later)
ProjectApplicationPhaseLaunchDescription
Org 33628ContraceptiveII(progesteron receptor modulator)
"Male pill"contraceptiveII>2005(androgen/progestagen combination)
FSH-CTPinfertilityII long-acting FSH
Livial 1.25mgHT/osteoporosisIII Selective tissue estrogenic activity regulator (STEAR); 規格追加
Variza(R)
depressionfiled 5HT-1A partial agonist
Asenapine/Org 5222psychosisIII2005DA/5HT-antagonist
Org 24448psychosisII AMPAKINE
Org 34517/34850depressionII HPA axis modulator
Org 4420sleepII NASSA
Org 25969AnesthesiaII muscle relaxant binding agent
Org 37663immunologyII anti-inflammatory steroid
Org 39141immunologyII auto-antigen
●終了分
NuvaringRcontraceptive ringapproved2002発売
Implanon[R]contraceptive implantmarket2000(Europe) 
III2002/3(USA) 
Puregon Pen.infertilitylaunched2001 (Europe) 
申請2003 (USA) 
Xyvion. osteoporosisIII2004 (USA)
AndriolR Testocaps.male HRTIII2002 (Europe)
申請2004 (USA)
Org 34517depressionII2006
Arixtrathrombosismarket2002 (USA)
filed2002 (Europe)
SanOrg 34006thrombosisIII>2005
Org 39141rheumatoid arthritisII2007
AKZO Novel

Akzo Nobel Announces Intended Sale of Organon BioSciences to Schering-Plough[2007.3.12] - 完全子会社Organon BioSciences N.V. (OBS)をSchering-PloughにEUR 11 billionで売却。 Akzo Nobel Confirms OBS Sale on Schedule[2007.10.11] - European Commissionが認可した。 ●Healthcare ★Healthcare ActivitiesProducts[Business] Organon News & Media - NewsとPressReleaseの違いは曖昧だが、重複はないので、双方Check要 ★News & Features --最近のものだけ Pressroom -PressRelease - 期間・部門指定検索(最新含む) Pressroom -News Stories - 期間・部門指定検索(最新含む) ★Reports & Presentation〜決算資料 Investor Relations ●News & Publications ●Financial Press ReleasesReports & Presentation〜決算資料 Form 20F 2006[pdf,239p;2006.6.22] Form 20F 2005[pdf,210p;2006.6.26] ●Annual Report Annual Report 2007[pdf,p,2008.2.19] Annual Report 2006[pdf,136p,2007.3.14] Annual Report 2005[pdf,2006.2.28] Annual Report 2004 Annual Report 2003 Annual Report 2002 Financial Overview
N.V. Organon

--- http://www.organon.com/ ■NewsProductGynecology - www.orgyn.comContraception - www.contraception.net NuvaRing(R) (etonogestrel/ethinylestradiol) Cerazette(R)(desogestrel) Gracial(R)(desogestrel / ethinylestradiol) -22-day combiphasic Implanon(R)(etonogestrel) -a single-rod contraceptive implant Laurina(R)(desogestrel / ethinylestradiol) Marvelon(R) / Desogen(R)(desogestrel / ethinylestradiol) Mercilon(R) / Mircette(R)(desogestrel / ethinylestradiol) ★Hormone Therapy - Managing the menopause Livial(R)(tibolone) - http://www.livial.com/ Ovestin(R)(estriol) Riselle(R)(17s-estradiol implant) Andriol(R)(testosterone undecanoate) - http://www.andriol.com/ Feretility - http://www.fertilityjourney.com/ Orgalutran(R)(ganirelix) - reduces IVF (in-vitro fertilization) treatment time Pregnyl(R)(human chorionic gonadotropin) since 1932 Puregon(R) / Follistim(R) (follitropin beta) since 1996 - http://www.puregon.com/Neuroscience - Mental Health ●Anesthesia
日本オルガノン

- http://www.organon.jp/ ●プレスリリース 「OCケータイ情報」サイト開設のお知らせ[2005.11.9] 低用量経口避妊剤「マーベロン(R)21」発売のお知らせ[2005.4.19] - マーベロン(R)21は20年以上前に欧州で初めて発売されて以来現在最も普及している経 口避妊剤のひとつとして、世界80カ国以上、400万人を越える女性に使用。 日本において低用量経口避妊剤を服用している女性の数は、1999年以降毎年10%以上の増 加をみせており、現在では50万人を上回るとみられています。 ●製品医療関係者向けの情報製品一覧泌尿器科領域産科婦人科領域 ファティリティー.jp - https://www.fertility.jp/ 自分で選ぶOC(ピル) - http://www.oc-rizum.jp/ ★精神科・神経科・心療内科領域循環器科・内科領域麻酔科領域その他の治療領域アクゾノーベル株式会社 ---







Alcon Laboratories,Inc.

 - http://www.alconlabs.com/; (2007)売上$5.6 Billion、従業員数14,500 

1945 設立
1977 Nesle SAに買収、傘下に入る。
     * しかしAlconで決算データを発表しているし、ネスレ社でのAlcon情報は殆どない。
2000 Summit Autonomous Inc.を買収。

●会社決算
($ milllion)200920082007200620052004200320022001
売上高6,4996,2945,5994,8974,3683,9143,407
営業利益2,2612,2131,8831,5721,1881,132879
経常利益2,3132,0831,9291,6171,2031,126858
当期純利益2,0072,0471,5861,348931872595
研究開発費665619564512422390350
従業員数[連結]15,70014,500
($ milllion)2009200820072006200520042003200220012000

★米国
眼科医薬品1,353[46.4%]1,321[47.1%]1,279.5(+9.3)[47.9%]1,170.6(+11.7)[47.5%]1,047.7[47.7%]941.3(+15.7)813.3(+15.1)706.9582.9513.9
眼科手術製品1,167[40.1%]1,084[38.6%]1,011.8(+6.5)[37.9%]950.4(+9.2)[38.6%]870.1[39.6%]778.0(+9.0)713.8(+5.2)678.3639.7589.2
消費者アイケア*394[13.5%]402[14.3%]381.2(+11.2)[14.2%]342.7(+23.5)[13.9%]277.6[12.7%]271.0(+4.7)258.8(+4.6)247.4242.0230.3
 計2,914[100%]2,807[100%]2,672.5(+8.5)[100%]2,463.7(+12.2)[100%]2,195.4[100%]1990.3(+11.4)1785.9(+9.4)1632.61464.61333.4

★国外
眼科医薬品1,324[36.9%]1,240[35.6%]1,034.3(+23.6)[35.3%]836.6(+16.2)[34.4%]720.0[33.1%]601.3(+21.1)496.6(+20.7)383.5344.9322.3
眼科手術製品1,830[51.1%]1,797[51.5%]1,488.0(+18.7)[50.9%]1,253.4(+9.3)[51.5%]1,146.8[52.8%]1036.4(+18.8)872.1(+4.0)760.2718.0674.7
消費者アイケア*431[12.0%]450[12.9%]404.8(+18.1)[13.8%]342.9(+11.9)[14.1%]306.3[14.1%]285.6(+13.2)252.3(+3.1)232.8220.2223.2
 計3,585[100%]3,487[100%]2,927.1(+20.3)[100%]2,432.9(+12.0)[100%]2,173.1[100%]1923.3(+18.6)1621.0(+8.5)1376.51283.11220.2

★合計
眼科医薬品2,677(+4.5)2,561(+10.7)2,313.8(+15.3)2,007.2(+13.5)1,767.71542.6(+17.8)1309.9(+20.1)1090.4--
眼科手術製品2,997(+4.0)2,881(+15.3)2,499.8(+13.4)2,203.8(+9.3)2,016.91818.4(+14.4)1585.9(+10.2)1438.5--
消費者アイケア*825(-3.2)852(+8.4)786.0(+14.6)685.6(+17.4)583.9556.6(+8.9)511.1(+6.4)480.2--
 合計6,499(+3.3)6,294(+12.4)5,599.6(+14.4)4,896.6(+12.1)4,368.53913.6(+14.9)3406.9(+9.0)3009.12747.72553.6
*消費者アイケア は2004年度迄は「コンタクトレンズ」 ●事業別売上
($ milllion)200920082007200620052004200320022001備考
感染症・抗炎症薬829(-5.1)874814.5(+11.5)730.2(+14.5)641.0572.7(+10.6)517.9(+16.1)446.0365.2
  (うちTobradex)-(?)(195.1)(176.0)[tobtamycin+dexamethasone]
  (うちCiloxan)-(?)(105.8)(88.3)[ciprofloxacin]
緑内障薬1,121(+17.4)955830.1(+19.6)693.8(+11.7)621.4526.3(+21.7)432.4(+23.7)349.6276.1
  (うちTravatan)-(135.3)(70.9)(15.8)[travoprost]
アレルギー薬486(+5.0)463446.8(+15.6)386.6(+8.1)357.5321.4(+16.2)276.6(+24.0)223.1181.1[/Patanol(R)等]
  (うちPatanol)-(+17.9)(252.0)+27%(198.3)(154.5)[olopatadine HCl]
耳鼻科用薬355(+12.3)316257.0(+8.4)237.0(+10.1)211.9171.3(+39.4)122.9(+37.0)89.768.2[/Cipro HC Otic]
他の医薬品等(114)(47)(34.6)(*)(40.4)(*)(64.1)(49.1)(*)(39.9)(+121.7)(18.0)-

医薬品 計2,677(+4.5)2,5612,313.8(+15.3)2,007.2(+13.5)1,767.71542.6(+17.8)1309.9(+20.1)1090.4927.8

IOL[眼内レンズ]1,133(+5.6)1,073919.4(+15.7)794.4(+15.2)689.4583.9(+17.1)498.6(+13.9)437.7405.4
白内障・硝子体手術用1,759(+4.0)1,6921,528.8(+12.6)1,357.7(+6.8)1,271.31167.7(+14.8)1017.0(+9.7)927.0875.7
屈折外科用105(-9.5)11651.6(-0.2)51.7(-8.0)56.262.8(-10.7)70.3(-4.7)73.876.6

眼科手術製品2,997(+4.0)2,8812,499.8(+13.4)2,203.8(+9.3)1,016.91814.4(+14.4)1585.9(+10.2)1438.51357.7

コンタクトレンズ消毒剤448(-4.5)469440.2(+18.8)370.6(+26.7)292.6298.9(+5.9)282.2(+2.6)275.1250.9[/Opti-Free(R)液]
人工涙液283(+4.0)272233.2(+16.4)200.4(+17.3)170.8141.5(+20.6)117.3(+18.2)99.296.5
その他94(-15.3)111112.6(-1.7)114.6(-4.9)120.5116.2(+4.1)111.6(+5.4)105.9114.8

消費者向けEye Care825(-3.2)852786.0(+14.6)685.6(+17.4)583.9556.6(+8.9)511.1(+6.4)480.2462.2

TOTAL SALES($)6,499(+3.3)6,2945,599.6(+14.4)4,896.6(+12.1)4,368.53913.6(+14.9)3406.9(+13.2)3009.12747.7
●TRAVATAN(R) 緑内障
【2007】
Our line of glaucoma products provided the largest percentage of sales growth. Combined sales of our family of TRAVATAN(R) products, including TRAVATAN(R) ophthalmic solution, TRAVATAN Z(R) ophthalmic solution and DuoTrav.
ophthalmic solution, grew 30.9% for the year ended December 31, 2007 compared to 2006. TRAVATAN Z(R) enables doctors to help glaucoma patients with a benzalkonium chloride ("BAC") free prostaglandin. The U.S. commercial launch of TRAVATAN Z(R) began in October 2006 and we launched this product as TRAVATANZ. ophthalmic solution in Japan during the fourth quarter of 2007. In the second quarter of 2006, we launched DuoTrav(TM), a combination of the prostaglandin analogue travoprost with the beta blocker timolol, in several European Union countries, Canada and Australia. During the year ended December 31, 2007, Azopt(R) ophthalmic suspension, the Company's topical carbonic anhydrase inhibitor, posted a 20.4% sales increase compared to 2006, driven by growth in both the U.S. and International markets.


In 2001, we launched TRAVATAN(R), our entry into the prostaglandin analogue class of glaucoma treatments, in the United States. Prostaglandin analogues are the largest class of compounds currently available to reduce intraocular pressure, which is a primary characteristic of glaucoma. We have continued to improve and enhance the TRAVATAN(R) brand with the launch outside the United States of DuoTrav. ophthalmic solution, which combines the prostaglandin in TRAVATAN(R) with a beta blocker, timolol, and with the launch in both the United States and international markets of TRAVATAN Z(R) ophthalmic solution, a new formulation of TRAVATAN(R) that replaces the preservative benzalkonium chloride ("BAC") with the SOFZIA(R) preservative system. Brands containing our proprietary prostaglandin have been launched in more than 100 countries, including an approval in Japan obtained before the end of 2007.
●Vigamox(R) ophthalmic solution(moxifloxacin) 感染
【2007】
Sales of Vigamox(R) ophthalmic solution, our leading anti-infective fluoroquinolone drug, increased 16.1% compared to 2006, due to increased sales around the world as physicians continued to convert to Vigamox(R) from older anti-infective drugs.
Sales of TobraDex(R) ophthalmic suspension and ointment, our leading combination therapy for infection and inflammation, increased 8.1% during the year ended December 31, 2007 over the prior year.


Our leading ocular anti-infective product is Vigamox(R) ophthalmic solution, utilizing moxifloxacin to treat bacterial conjunctivitis. According to the Wolters Kluwer Health Source Prescription Audit, Vigamox(R) was the leading ophthalmic topical antibiotic in the United States in 2007. During 2006, we received approval and launched Vigamox(R) in Japan under the trade name Vegamox(R) ophthalmic solution.
【2007特許】
VigamoxはAlconがBayer Healthcare AGからライセンスを受けていて、特許の2つ
はBayer Healthcareが保持、3つ目はAlconが保持するもので2020年迄。
Teva Pharmaceuticals USA, IncがApril 5, 2006最初のANDA申請
●NEVANAC(R) ophthalmic suspension 抗炎症
【2007】
NEVANAC(R) ophthalmic suspension is our ophthalmic non-steroidal anti-inflammatory drug ("NSAID") for the treatment of pain and inflammation associated with cataract surgery. Sales of NEVANAC(R) grew 30.0% in the year ended December 31, 2007 over the prior year.


During 2005, we launched a topical non-steroidal anti-inflammatory drug ("NSAID") in the U.S. market for the treatment of pain and inflammation associated with cataract surgery. NEVANAC(R) ophthalmic suspension is unique because it is a prodrug where the active ingredient is released upon instillation in the eye. During 2007, NEVANAC(R) maintained the number two NSAID market share in the United States, according to Wolters Kluwer Health Source Prescription Audit. We also executed several launches of NEVANAC(R) outside the United States during 2007.
●Patanol(R)点眼液 アレルギー
【2007】
Despite relatively flat growth in the U.S. allergy market, global sales of our allergy products, Patanol(R) ophthalmic solution and Pataday. ophthalmic solution, grew 16.5% in the year ended December 31, 2007 over 2006. An important contributor to this above-market growth was the U.S. launch of Pataday(TM), the only once-a-day ocular prescription allergy medicine, that led to total allergy franchise market share gains as reported by Wolters Kluwer Health Source Prescription Audit. Patanol(R) product sales also were supported by faster growth outside the United States, due in part to the market share gained by this product in the spring allergy season in 2007 in Japan, where it was launched in September 2006.


Patanol(R) ophthalmic solution was the first ocular allergy product with a dual-action active ingredient, which acts as both an antihistamine and a mast-cell stabilizer. According to Wolters Kluwer Health Source Prescription Audit, Patanol(R) was the leading ophthalmic topical anti-allergy prescription product in the United States in 2007. During 2006, we received approval and launched Patanol(R) in Japan, the second largest ophthalmic allergy market. We have a co-marketing agreement in Japan with Kyowa Hakko Kogyo Co., Ltd. (Kyowa Hakko), a leading Japanese pharmaceutical company, whereby Kyowa Hakko promotes Patanol(R) to non-eye care physicians and we promote the product to eye care physicians. In February 2007, we launched in the United States the first and only once-a-day ocular prescription allergy medicine, Pataday. ophthalmic solution, which is a new formulation of olopatadine, the active ingredient in Patanol(R). We currently sell Patanol(R) in more than 90 countries.
【2007特許】
Patanolの特許は協和発酵が保持し2010年迄。 もう一つは協和とAlconが共同で2015年迄。
カナダApotex Inc. and Apotex CorpがANDA申請し、協和とAlcon両社は2006.11.15提訴。
そのため、提訴が解決あるいは地裁がFDA承認の30ヵ月保留を変更しない限り、FDAはApotexのANDA申請を
30ヵ月遅らせねばならない。
 次にBarr Laboratories, IncがPatanolのANDA申請を行い、2007.10.1 Alcon社にその旨通知された。
Apotex ANDAと異なり、Barr ANDAは協和発酵単独特許に関するもの。
FDAがBarr ANDAを承認可能な30ヵ月後は、協和発酵特許失効の9ヵ月前のの2010.3に含むことになる。
●CIPRODEX(R) otic suspension 耳科感染
【2007】
U.S. sales of CIPRODEX(R) otic suspension were primarily responsible for an 8.4% increase in global sales of otic products during the most recent year. (CIPRODEX(R) is a registered trademark of Bayer AG, licensed to Alcon by Bayer Healthcare AG.) The vast majority of CIPRODEX(R) otic sales occur in the United States. According to Wolters Kluwer Health Source Prescription Audit, total U.S. prescriptions for CIPRODEX(R) otic increased 5.4% in the year ended December 31, 2007, while total U.S. prescriptions in the otic segment of the market declined 3.4%.


We also market combination anti-infective/anti-inflammatory products for ear infections. CIPRODEX(R) otic suspension for the treatment of otitis media in the presence of tympanostomy tubes ("AOMT") and of otitis externa, commonly known as swimmer's ear, is marketed in the United States and a small number of countries outside the United States. In addition, Cipro(R) HC Otic, for the treatment of otitis externa, is currently marketed in over 30 countries. Sales of our otic products are seasonal, with a higher percentage of prescriptions written during the summer months.
【2007】
Alcon Laboratories,Inc.

- http://www.alconlabs.com/ ●Products Healthcare hProfessionalPatients & FamilyInvestors & MediaFinancials Annual Reports & Quaterly Reports - 2009 Annual Report - 2008 Annual Report - 2007 Annual Report - 2006 Annual Report - 2005 Annual Report - 2004 Annual ReportSEC Filings - 2009 Form 20-F[16-Mar-2020] - [pdf,220p] - 2008 Form 20-F[17-Mar-2009] - [pdf] - Form 20-F[18-Mar-2008] - [pdf] - Form 20-F[19-Mar-2007] - [pdf] - Form 20-F[15-Mar-2006] - [pdf] - Form 20-F[15-Mar-2005] - [pdf] - Press Release - Alcon's Fourth Quarter Sales Rise 14.5 Percent[2010.2.11] - Alcon Fourth Quarter Diluted EPS Increased 12.8 Percent[2009.2.11] - Alcon's Fourth Quarter Sales Rise 20.0 Percent[2008.2.6] - Alcon's Fourth Quarter Sales Rise 16.1 Percent[2007.2.7]
日本アルコン

-http://www.alconlabs.com/jp/ 1973年に日本企業との合弁会社(「帝人アルコン株式会社」)として事業を開始。 1978年にアルコンの100%出資となり、社名を「日本アルコン株式会社」と変更。 サージカル事業/医薬品事業/ビジョンケア事業 1992  眼灌流・洗浄液「ビーエスエスプラスR」発売。 1993  超音波白内障手術装置「20000レガシーTM」発売。  フォールダブル眼内レンズ「アクリソフR」発売。 1994  緑内障・高眼圧症治療剤「ベトプティックR0.5%点眼液」発売。 1995  眼科手術補助剤「プロビスクR」発売。 1996  ソフトコンタクトレンズ用コールド消毒液「オプティ・フリーR」発売。  超音波白内障手術装置「ユニバーサルRII」発売。 1997  ソフトコンタクトレンズ用コールド消毒液「オプティ・フリー  (マルチパーパスソリューション)」発売。  硝子体手術装置「アルコンアキュラスR」発売。  眼科用超音波診断装置「アルコンウルトラスキャン」発売。 2002  創立30周年を迎える。 ソフトコンタクトレンズ用コールド消毒液「オプティ・フリー プラスR  (マルチパーパスソリューション)」発売。 眼圧降下剤「エイゾプト(R) 1%点眼液」発売。 2003 フォールダブル眼内レンズ 「アルコン アクリソフ シングルピース SA30AT/SA60AT」発売。 超音波白内障手術装置「インフィニティRビジョンシステム」発売 ●アイケア情報医療関係者のページ[要ID]  〜アルコン製品、学会セミナー等




Alfa Wassermann S.P.A.[伊]

 - http://www.alfawassermann.it/index.php
設立 1948年。 私企業。 年報などの詳細データは非公開。
 従業員数1000人超うちイタリア国内663人(2005.5.9 News)
子会社−ポーランド(2004.1創業)、中国、チュニジア、ハンガリーの四カ国
2003.2  Bama-Geve(スペイン製薬会社)買収完了
2004.2  Farmigea SpA[イタリア眼科・婦人科領域の製薬会社]の35%を取得。
2004    Pomezia工場売却交渉開始(2005年前半完了)
2004    Helena Laboratoriesのイタリア事業部門を買収。(2005年5.9完了)
        (Electrophoresis & Coagulation systemの国際企業)
2005.2  Biosaude(ポルトガルの製薬会社)を買収完了

2005年度売上高予想210 Million Euro(+12%)。

●決算[12月決算]
(千Euro)     2004    2003    2002
売上高          186,458 172,919 180,584
EBIT             16,321  10,363  18,113
EBITDA           33,813  28,628  29,501
純利益            4,884   7,499   4,766

●セグメント別売上高
(千Euro)     2004    2003    2002
Pharmaceuticals 125,733 111,694 103,626
Diagnostics      39,881  40,702  42,944
Others           20,844  20,523  19,197
 分離済み事業         -       -  14,817
 合 計         186,458 172,919 180,584
 from Alfa Wassermann: the consolidated balance sheet as of December 31, 2004[2005.7.11]

●主力製品
Rifaximin (伊国内名Normix) - 自社開発品でスペイン・米国等12か国で承認。
Alfaferone(天然interferon-α)
Fluxum (parnaparin -低分子ヘパリン)
世界65カ国で12製品を販売。

One of the strong points of Alfa Wassermann SpA is that more than 60% of turnover is generated by its own products, developed by in-house research.
These include market leaders such as Normix®, an innovative antibiotic with a topical intestinal activity, discovered and patented by Alfa Wassermann. Other important specialities are Alfaferone® (Alfa natural interferon) and Fluxum® (Parnaparin - patented low molecular weight heparin). Alfa Wassermann also has a Division marketing and selling non prescription specialities with an extensive network of direct promoters to pharmacies.

[The International Division] In 1989, Alfa Wassermann set its own International Division with two main aims - to increase exports of its speciality drugs by exploring new territories and to promote the international development of its original products with a network of strategic alliances.  Today Alfa Wassermann operates with a portfolio of 11 products in more than 60 countries throughout the world and an efficient network of distributors, efficiently backed by an in-house organisation able to provide all the assistance required.
Normix® (Rifaximin) is one of the main products abroad and has significant growth prospects.
The product internationalization plan is starting to give results.
Rifaximin is today registered in 12 countries and in October 2004 the product, under the name Spiraxin®, was introduced into the market in Spain by Bama-Geve S.L. and another Alfa Wassermann licensee company.
But the most important goal was without doubt the launch of the drug on the USA market under the name Xifaxan・




Alfa Wassermann S.P.A.[伊]

Press Releases Alfa Wassermann: the consolidated balance sheet as of December 31, 2005[2006.5.15] Alfa Wassermann: the consolidated balance sheet as of December 31, 2004[2005.7.11] JAPANESE LICENSEE FOR LICOFELONE[2004.5.28] - 本剤はMerckle GmbHにより創製され、the Euroalliance consortium内部で Alfa Wassermann SpA, Merckle GmbH and Lacer SA の共同開発する革新的消炎鎮痛剤。  住友製薬に変形性関節症の適応症で日本での独占権を付与する契約を締結。 FDA Approves rifaximin[2004.5.26] - 商品名Xifaxanとしてライセンス先Salix社から販売予定。(適応症−大腸菌感染による下痢) Alfa Wassermann: the consolidated balance sheet as of December 31, 2003 [2004.7.15]




Alkermes, Inc.[US]
Alkermes, Inc.

 - http://www.alkermes.com/ ;(Nasdaq) ALKS; 88 Sidney Street,Cambridge, MA 02139
1987.6  MITの4人の研究者が設立。


●会社決算 [3月決算]
($000)2012/32011/32010/32009/32008/32007/32006/32005/32004/32003/32002/32001/3備考
収入
Vivitrol売上4,467--------[naltrexone持続注]アルコール依存症1月1回:Cephalonと共同
 製品売上41,18428,92020,2454,467-
 製造Royalty収入326,444156,840149,917150,091131,157
 製造収入116,844101,700105,41664,90140,48825,73614,317-
 Royalty収入33,24729,45723,15116,5329,6363,7901,165-
 研究開発契約収入22,3498803,11742,08789,51074,48345,88326,0029,52831,78454,102
 Net collaborative profit--5,002130,19420,05036,91539,285----
総収入 計389,977186,640178,281326,839240,717239,965166,60176,12639,05447,26654,102

経費
製造原価127,57852,18549,43843,39640,67745,20923,48916,83419,03710,910-
研究開発費141,89397,23995,36389,478125,268117,31589,06891,06591,09785,38892,092
販売・一般管理費137,63282,84776,51459,00859,50866,39940,38328,82326,02926,69424,387
リストラ費用----6,423--11,527-2086,497-
原価・経費 合計478,258232,271221,,315191,882243,506228,923152,940148,249135,955129,489116,479

営業利益(88,281)(45,631)(43,034)134,957(2,789)11,04213,661(72,123)(96,901)(82,223)(62,377)
当期純利益(113,678)(45,540)(39,626)130,505166,9799,4453,818(73,916)(102,385)(106,898)(61,355)

従業員数1,200570760
●相手先部収入内訳 [3月決算]
($000)2012/32011/32010/32009/32008/32007/32006/32005/32004/3種類内訳
Janssen[46%][52%][47%]82,798[49%]50,446[66%]28,488[73%]製造&RoyaltyRISPERDAL CONSTA;持続性製剤で75ヵ国承認、発売は米国含む55ヵ国
Cephalon[41%][11%][24%]39,285[24%]--2005.6 持続性naltrexone製剤Vivitrolの共同開発・製造・販売契約。本剤は2006.4 FDA承認
Lilly[8%][23%][20%]34,946[21%]16,833[22%]333[1%]1)2001.4 吸入インスリンAIR insulinの共同開発契約。
2)2005.12 parathyroid hormone("PTH")吸入剤AIR parathyroid hormoneの共同開発契約。
Amylin[3%][14%][1%]7,882[5%]5,156[7%]3,797[10%]2000.5 exenatideの持続性製剤("exenatide LAR")の共同開発契約。
Genentech19[-%]526[1%]4,495[12%]
その他1,671[1%]3,165[4%]1,941[4%]
 合計166,601[100%]76,126[100%]39,054[100%]
Alkermes, Inc.

Products VIVITROL(naltrexone extended release injectable suspension)アルコール依存症・オピオイド依存症再発予防 Risperdal Consta(risperidone long-acting)統合失調症・双極性障害 Invega Sustenna(palperidone palmitate)統合失調症 Ampyra(dalfampridine)多発性硬化症 Bydureon(exenatide extended release injectable suspension)2型糖尿病 Newsroom - Press Releases FDA Grants Approval for Use of RISPERDAL(R) CONSTA(R) as Both a Monotherapy
and Adjunctive Therapy in the Maintenance Treatment of Bipolar I Disorder
[2009.5.18] Exenatide Once Weekly New Drug Application Submitted to FDA for Type 2 Diabetes[2009.5.5] RISPERDAL(R) CONSTA(R) Approved in Japan[2009.4.27] Alkermes Regains Full Commercialization Rights to VIVITROL(R) in US[2008.12.1] - Cephalonとの販売契約を2008.12.1解消。 FDA Approves New Injection Site for RISPERDAL(R) CONSTA(R) for Schizophrenia Treatment[2008.10.9] - 腕の筋注を承認 Supplemental New Drug Application for RISPERDAL(R) CONSTA(R) Submitted to the FDA for the Treatment of Bipolar Disorder[2008.7.24] Supplemental New Drug Application for RISPERDAL(R) CONSTA(R) Submitted to
the FDA for the Treatment of Frequently Relapsing Bipolar Disorder
[2008.4.14] FDA Approves New Dose of RISPERDAL(R) CONSTA(R) for Schizophrenia Treatment[2007.4.13] - 12.5 mg用量の認可。 RISPERDAL CONSTAは2003年承認済み(25 mg, 37.5 mg and 50 mg)。 Alkermes Submits Marketing Authorization Application for Vivitrol(R) in the United Kingdom and Germany[2007.4.2] Alkermes Announces Submission of New Drug Application for RISPERDAL(R) CONSTA(R) in Japan[2006.12.20] - ヤンセン社日本でRISPERDAL(R) CONSTA(R) ((risperidone) long-acting injection を申請。本剤はAlkermes社のMedisorb(R)技術使用。 VIVITROL(TM), the First, Once-Monthly Injectable Medication for Alcohol Dependence Now Available in the United States[2006.6.13] - 最初で唯一の1ヵ月1回投与のアルコール依存症治療薬。 米国では1800万人がアルコール依存症でうち220万人が要治療。75%が再発。 Alkermes and Cephalon Receive FDA Approval of Vivitrol(TM) for the Treatment of Alcohol Dependence[2006.4.13] - AlkermesはCephalonに米国での販売権をライセンスし承認時$110 MILLIONのマイルストーンを受け取る契約を 2005.6に締結。 Investor RelationsSEC Filings 10-K Annual[2012.5.18] - [pdf] 10-K Annual[2011.5.20] - [pdf] 10-K Annual[2010.5.21] - [pdf] 10-K Annual[2009.5.28] - [pdf] 10-K Annual[2008.5.30] - [pdf] 10-K Annual[2007.6.14] - [pdf] 10-K Annual[2006.6.14] - [pdf]




Allergan

http://www.allergan.com/

●会社決算
($Million)20102009200820072006200520042003200220012000備考

製品売上高4,819.6(+8.4)4,447.64,339.73,879.03,010.12,319.22,045.61,755.41,385.01,142.1992.1
 うち医薬3,973.4(+7.9)3,683.83,502.33,105.02,272.81,945.61,672.71,357.21,142.1992.1
 うち医療用具846.2(+10.8)763.8837.4774.046.4100.082.727.8--主に契約収入
その他収入99.856.063.759.953.223.413.39.4
研究サービス収入-------16.0
総収入 計4,919.44,503.64,403.43,938.93,063.32,342.62,058.91,780.8

営業利益258.6928.0796.1719.4(3.2)570.9527.4
旧1,658.9
(23.7)
旧1,435.1
1,163.3944.0794.4
経常利益170.8848.5787..2687.7(19.5)599.2
旧570.9
532.1
旧527.4
(52.5)
旧-23.7
129.0242.1
研究開発費804.6706.0797.9718.11,055.5388.3342.9762.6233.1227.5165.7
純利益4.9623.8578..6499.3(127.4)403.9377.1-52.575.2224.9215.1

国際売上比率37.4%34.6%34.8%34.3%32.6%32.5%30.9%29.6%29.4%
従業員数9,2008,7407,8865,0555,030
●事業別
($Million)2010200920082007200620052004200320022001200019991998備考

■医薬品 /Specialty Pharmaceuticals Segment Product
●眼科用薬2,262.0(+7.7%)2,100.62,009.11,776.51,530.61,321.71137.1(+13.8)999.5(+20.8)827.3753.7683.9576.2510.1
Alphagan401.6(-3.1)414.5398.1(+)341.4(+15.4)295.9277.2(+3.1)268.9(-6.2)286.8(+15.4)248.5(+1)250.9(+8.3)231.6(+36.9)??Brimonidine Tartrate 緑内障
Lumigan526.7(+15.4)456.5426.2391.7(+19.6)327.5267.6(+14.9)232.9(+28.5)181.3(+47.4)123.035.4---Bimatoprost 眼科用緑内障
他の緑内障薬14.815.3(-6.5)16.318.0(-5.9)19.1(-15.9)22.7(-7.7)24.6
Latisse81.8(+11.0)73.7----------[Bimatoprost]まつげ美容液(まつ毛育毛剤)FDA承認2008.12.26、米国発売2009.1
Restasis620.5(+18.7)522.9444.0344.5(+27.5)270.2190.9(+91.2)99.8(+160.6)38.3(-)-----cyclosporine/ドライアイ
●皮膚科用薬229.5(+10.3)208.0113.7110.7125.7120.2103.4(-5.4)109.3(+21.2)90.278.968.776.660.6
Tazorac/Avage--77.2(-3.4)79.9(-12.4)91.286.9(+15.7)75.1(-6.5)80.3(+29.3)62.145.4(+39.5)32.7(+57.2)--tazarotene
●Botox1,419.4(+8.4)1,309.61,310.91,211.8982.2830.9705.1(+25.0)563.9(+28.2)439.7309.5(+29.2%)239.5(+39)175.8125.3botulinum toxin A
●泌尿器用薬62.5(-4.7)65.668.66.0-
Sanctura62.5(-4.7)65.668.24.9-[trospium]
●その他-----46.4100.0(+20.9)82.7(+197.5)27.0主にコンタクトレンズ
医薬品合計3,973.4(+7.9)3,683.83,502..33,105.02,638.52,319.22045.6(+16.5)1755.4(+26.7)1385.01142.1992.1828.6716

■医療機器 /Medical Devices Segment Product
胸部エステ319.1(+11.0)287.5310.0298.4177.2-
肥満症用品243.3(-5.8)258.2296.0270.1142.3-
顔エステ283.8(+30.1)218.1231.4202.852.1-
その他---2.7--
医療機器 計846.2(+10.8)763.8837.4774.0371.6-
*註) Botox (2002) Cosmetic 40%を占める  from Allergan Reports Fourth Quarter Operating Results[2004.1.28]  Allergan Reports Year End Operating Results[2003.1.29]
ボツリヌス毒素 
[2010]

In 2008, the FDA announced in an “Early Communication” its review of certain adverse events following the use of botulinum toxins, including Botox® and Botox® Cosmetic. In 2009, simultaneously with its approval of Dysport™ , the FDA announced the completion of its review and has requested that we adopt a REMS program equivalent to the REMS program required for Dysport™ . In 2009, the FDA approved our REMS program for Botox® , which addresses the risks related to botulinum toxin spread beyond the injection site and the lack of botulinum toxin interchangeability. In the second quarter of 2010, the FDA requested that we submit an update to the Botox® Medication Guide to include the chronic migraine indication, updated REMS to include a physician training plan for chronic migraine, and a proposed physician communication, including a draft “dear healthcare practitioner” letter announcing the chronic migraine indication and providing information on the updated REMS. In the fourth quarter of 2010, the FDA approved Botox® for the prophylactic treatment of headaches in adults with chronic migraine. We cannot assure you that any other compounds or products that we are developing for commercialization will be approved by the FDA or foreign regulatory bodies for marketing or that we will be able to commercialize them on terms that will be profitable, or at all. If any of our products cannot be successfully or timely commercialized or our direct-to-consumer advertising materials fail to be approved by the FDA, our operating results could be materially adversely affected.

Total sales of Botox increased in 2010 compared to 2009 due to an increase in sales of Botox® for both cosmetic and therapeutic use in all of our principal geographic markets. We believe sales of Botox , primarily Botox® Cosmetic, were negatively impacted in 2010 by the introduction of a competitive product that was launched in the United States in June 2009. Based on internal information and assumptions, we estimate in 2010 that Botox® therapeutic sales accounted for approximately 51% of total consolidated Botox sales and grew at a rate of approximately 6% compared to 2009. In 2010, Botox® Cosmetic sales accounted for approximately 49% of total consolidated Botox sales and increased by approximately 11% compared to 2009. We believe our worldwide market share for neuromodulators, including Botox® , was approximately 77% in the third quarter of 2010, the last quarter for which market data is available.

Our neuromodulator product, Botox® (onabotulinumtoxinA), has a long-established safety profile and has been approved by the FDA for more than 20 years to treat a variety of therapeutic conditions, as well as for aesthetic use since 2002. In 2010, therapeutic uses accounted for approximately 51% and aesthetic uses for approximately 49% of total sales. With more than 2,000 publications on Botox® and Botox® Cosmetic in scientific and medical journals, results of approximately 50 randomized, placebo-controlled clinical trials involving more than 11,000 patients, Botox® is a widely researched medicine with more than 100 potential therapeutic and aesthetic uses reported in the medical literature. Over 18 million treatment sessions have been recorded with Botox® and Botox® Cosmetic in the United States alone over the past 16 years (1994-2009). Marketed as Botox® , Botox® Cosmetic, Vistabel® , Vistabex® or Botox® Vista® depending on the indication and country of approval, the product is currently approved in approximately 80 countries for up to 21 unique indications. In 2009, following the approval of a competitor product, Dysport™ in the United States, we adopted a Risk Evaluation and Mitigation Strategies program, or REMS, including a boxed warning about the potential spread of botulinum toxins from the site of injection and the lack of interchangeability among botulinum toxin products. Sales of Botox® represented approximately 29%, 29% and 30% of our total consolidated product net sales in 2010, 2009 and 2008, respectively. Botox® has been primarily used therapeutically for the treatment of certain neuromuscular disorders which are characterized by involuntary muscle contractions or spasms as well as upper limb spasticity. In the fourth quarter of 2010, the FDA approved Botox® for the prophylactic treatment of headaches in adults with chronic migraine. The approved therapeutic indications for Botox® in the United States are as follows:

・ blepharospasm, the uncontrollable contraction of the eyelid muscles which can force the eye closed and result in functional blindness;
・ strabismus, or misalignment of the eyes, in people 12 years of age and over;
・ cervical dystonia, or sustained contractions or spasms of muscles in the shoulders or neck in adults, along with associated neck pain;
・ severe primary axillary hyperhidrosis (underarm sweating) that is inadequately managed with topical agents;
・ the treatment of increased muscle stiffness in the elbow, wrist and fingers in adults with upper limb spasticity; and
・ the prophylactic (preventative) treatment of headaches in adults with chronic migraine.

In many countries outside of the United States, Botox® is approved for treating hemifacial spasm, spasticity associated with pediatric cerebral palsy and upper limb spasticity in post-stroke patients. We are currently in development for Botox® in the United States and Europe for new indications, including lower limb spasticity, neurogenic overactive bladder, idiopathic overactive bladder and benign prostatic hyperplasia.

In the third quarter of 2010, we received approval for Botox® for the prophylactic treatment of headaches in adults with chronic migraine in the United Kingdom. In 2009, we submitted regulatory files for the use of Botox® to treat chronic migraine in France, Switzerland and Canada and are currently seeking approval in the European Union. In the fourth quarter of 2010, we filed a supplemental Biologics License Application, or sBLA, with the FDA for the use of Botox® in the treatment of urinary incontinence due to neurogenic detrusor overactivity resulting from neurogenic bladder and we are currently seeking approval in the European Union and Canada. In 2010, we completed enrollment in our Phase III clinical trials for the use of Botox® to treat idiopathic overactive bladder. In 2005, we initiated Phase II clinical trials outside the United States for the use of Botox® to treat benign prostatic hyperplasia. In 2009, we filed an Investigational New Drug Application with the FDA relating to the use of Botox® to treat benign prostatic hyperplasia.

Botox® Cosmetic

The FDA approved Botox® Cosmetic in 2002 for the temporary improvement in the appearance of moderate to severe glabellar lines in adult men and women age 65 or younger. Referred to as Botox® , Botox® Cosmetic, Vistabel , Vistabex or Botox® Vista , depending on the country of approval, this product is administered in small injections to temporarily reduce the muscle activity that causes the formation of glabellar lines between the eyebrows that often develop during the aging process. Currently, more than 60 countries have approved facial aesthetic indications for Botox® , Botox® Cosmetic, Vistabel® , Vistabex® or Botox® Vista® . In Australia, New Zealand, Canada and certain countries in East Asia and Latin America, we have regulatory approvals for upper facial lines, including crow’s feet. Since we have launched Botox® Cosmetic, we have conducted comprehensive direct-to-consumer marketing campaigns in the United States. We continue to sponsor aesthetic specialty physician training in approved countries to further expand the base of qualified physicians using Botox® , Botox® Cosmetic, Vistabel® , Vistabex® or Botox® Vista® .

In 2005, we entered into a long-term arrangement with GlaxoSmithKline, or GSK, under which GSK agreed to develop and promote Botox® in Japan and China and we agreed to co-promote GSK’s products Imitrex STATdose System® (sumatriptan succinate) and Amerge® (naratriptan hydrochloride) in the United States until the third quarter of 2010. In the first quarter of 2010, we reacquired the rights from GSK to develop and sell Botox® in Japan and China for all current and future cosmetic indications. GSK retains the rights granted under the long-term arrangement to develop and sell Botox® in Japan and China for all current and future therapeutic indications. In 2009, Botox® was approved in Japan for the additional indications of glabellar lines and equinus foot due to lower limb spasticity in juvenile cerebral palsy patients and was launched in Japan for these indications with the glabellar lines indication marketed as Botox® Vista® . Botox® was also approved for the treatment of glabellar lines in China in 2009. In the fourth quarter of 2010, we received approval of Botox® in Japan for the treatment of upper and lower limb spasticity.

Competition

Botox® was the only neuromodulator approved by the FDA until 2000, when the FDA approved Myobloc® (rimabotulinumtoxinB), a neuromodulator formerly marketed by Elan Pharmaceuticals and Solstice Neurosciences Inc. and marketed by US Worldmeds since 2010. In 2009, the FDA approved Dysport™ (abobotulinumtoxinA) for the treatment of cervical dystonia and glabellar lines, which is marketed by Ipsen Ltd., or Ipsen, and Medicis Pharmaceutical Corporation, or Medicis, respectively. The approved package for Dysport™ included a boxed warning regarding the symptoms associated with the spread of botulinum toxin beyond the injection site. Additionally, the FDA approved Ipsen’s and Medicis’ REMS program, which addresses the lack of interchangeability of botulinum toxin products and the risks associated with the spread of botulinum toxin beyond the injection site. Ipsen has marketed Dysport for therapeutic indications in Europe since 1991, prior to our European commercialization of Botox® in 1992. In 2006, Ipsen received marketing authorization for a cosmetic indication for Dysport in Germany. In 2007, Ipsen granted Galderma, a joint venture between Nestle and L’Oreal Group, an exclusive development and marketing license for Dysport™ for cosmetic indications in the European Union, Russia, Eastern Europe and the Middle East, and first rights of negotiation for other countries around the world, except the United States, Canada and Japan. In 2008, Galderma became Ipsen’s sole distributor for Dysport™ in Brazil, Argentina and Paraguay. In 2009, the health authorities of 15 European Union countries approved Dysport™ for glabellar lines under the trade name Azzalure™ . In the fourth quarter of 2010, Galderma announced its plan to acquire Q-Med A.B., a Swedish company that markets several products for various therapeutic areas derived from hyaluronic acid, including Restylane® and Perlane™ dermal fillers.

In addition, Merz Pharmaceuticals’, or Merz’s, botulinum toxin product Xeomin® , is currently approved for therapeutic indications in Germany and several other countries in the European Union. Xeomin® was approved by the FDA in the third quarter of 2010 for cervical dystonia and blepharospasm in adults previously treated with Botox® . Merz is currently pursuing FDA approval of Xeomin® for cosmetic use in the United States. In 2009, Merz received approval of Bocouture® (rebranded from Xeomin® ) for glabellar lines in Germany. In 2010, Bocouture® was approved in significant markets within the European Union. Xeomin® is also approved for glabellar lines in Argentina and Mexico. In the first quarter of 2010, Merz acquired Bioform Medical Inc., or Bioform, a California-based company that markets Radiesse® , a calcium hydroxylapatite filler. Merz also previously acquired rights from Anteis S.A., a Swiss company, to market Belotero , a hyaluronic acid filler, in certain European markets, the United States and Canada. The FDA accepted Merz’s registration file for Belotero in 2009.

Mentor Worldwide LLC, a division of Johnson & Johnson, or Mentor, is conducting clinical trials for a competing neuromodulator in the United States which Mentor has indicated that it expects to be approved in 2012 or beyond. A Korean botulinum toxin, Meditoxin® , was approved for sale in Korea in 2006. The company, Medy-Tox Inc., received exportation approval from Korean authorities in early 2005 to ship their product under the trade name Neuronox® . Neuronox is marketed in Hong Kong, India and Thailand. Meditoxin® is approved in approximately seven South American countries, including Brazil and Columbia, under various trade names.

In addition, we are aware of competing neuromodulators currently being developed and commercialized in Asia, Europe, South America and other markets. A Chinese entity, Lanzhou Biological Institute, received approval to market a botulinum toxin in China in 1997 under the tradename HengLi, and has launched its botulinum toxin product in other lightly regulated markets in Asia, South America and Central America under several trade names. These lightly regulated markets may not require adherence to the FDA’s current Good Manufacturing Practice regulations, or cGMPs, or the regulatory requirements of the European Medical Evaluation Agency or other regulatory agencies in countries that are members of the Organization for Economic Cooperation and Development. While these products are unlikely to meet stringent U.S. regulatory standards, the companies operating in these markets may be able to produce products at a lower cost than we can.

Our sales of Botox® could be materially and negatively impacted by this competition or competition from other companies that might obtain FDA approval or approval from other regulatory authorities to market a neuromodulator.

緑内障
[2010]

The largest segment of the market for ophthalmic prescription drugs is for the treatment of glaucoma, a sight-threatening disease typically characterized by elevated intraocular pressure leading to optic nerve damage. Glaucoma is currently the world’s second leading cause of blindness, and we estimate that over 70 million people worldwide have glaucoma. According to IMS Health Incorporated, our products for the treatment of glaucoma, including Lumigan® (bimatoprost ophthalmic solution) 0.03%, Lumigan® 0.01%, Ganfort™ (bimatoprost/timolol maleate ophthalmic solution), Alphagan® (brimonidine tartrate ophthalmic solution) 0.2%, or Alphagan® , Alphagan® P 0.15%, Alphagan® P 0.1% and Combigan® (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, captured approximately 26.2% of worldwide market sales in their product categories for first nine months of 2010.

[2008]

当社製品はLumigan(R)(bimatoprost ophthalmic solution) 0.03%, or Lumigan(R), Alphagan(R)(brimonidine tartrate ophthalmic solution) 0.2%, or Alphagan(R), Alphagan(R)P (brimonidine tartrate ophthalmic solution) 0.15%, or Alphagan(R)P, Alphagan(R)P 0.1% (brimonidine tartrate ophthalmic solution)0.1%, or Alphagan(R)P 0.1%, Combigan TM (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, or Combigan TM and Ganfort(R)(bimatoprost/timolol maleate ophthalmic solution)。 2007年1-9月世界シェア18%

Lumigan 緑内障(bimatoprost ophthalmic solution) 0.03%,
[2010]

Lumigan® 0.03% and Lumigan® 0.01% are topical treatments indicated for the reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension. Lumigan 0.01% is an improved reformulation of Lumigan® 0.03%. We currently sell Lumigan® 0.01% and Lumigan® 0.03% in the United States and over 75 countries worldwide and, together, they are our second best selling eye care products.

According to IMS Health Incorporated, Lumigan® 0.01% and Lumigan® 0.03% were amongst the best selling glaucoma products in the world for the first nine months of 2010. In 2002, the European Commission approved Lumigan® 0.03%. In 2004, the European Union’s Committee for Proprietary Medicinal Products approved Lumigan® 0.03% as a first-line therapy for the reduction of elevated intraocular pressure in chronic open-angle glaucoma and ocular hypertension. In 2006, the U.S. Food and Drug Administration, or the FDA, approved Lumigan® 0.03% as a first-line therapy. We are party to an exclusive licensing agreement with Senju Pharmaceutical Co., Ltd., or Senju, under which Senju became responsible for the development and commercialization of Lumigan® 0.03% in Japan. In 2009, Senju received approval of Lumigan® 0.03% in Japan. Also in 2009, Lumigan® 0.01% was approved by Health Canada. In the first quarter of 2010, the European Commission granted a Marketing Authorization for Lumigan® 0.01% in the European Union member states. During the third quarter of 2010, the FDA approved Lumigan 0.01% as a first-line therapy indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. In 2006, we received a license from the European Commission to market Ganfort&trade in the European Union. Ganfort™ is now sold in over 37 countries outside the United States. Combined sales of Lumigan® 0.03%, Lumigan® 0.01% and Ganfort™ represented approximately 11%, 10% and 10% of our total consolidated product net sales in 2010, 2009 and 2008, respectively.

[2008]

70ヵ国で販売、2007年1-9月世界シェア第3位。
2002.3 EU承認。 2004.1 EU-CHMPはfirst-line therapyとして承認。
 米国FDAも2006.6 first-line therapyとして承認。
2004.5 千寿製薬にライセンス、これは2007.6に日本で申請された。
Ganfort&trade 緑内障(bimatoprost/timolol maleate ophthalmic solution)
[2010]

[2008]

In November 2003, we filed a New Drug Application with the FDA for Ganfort(R), a Lumigan(R)and timolol combination designed to treat glaucoma or ocular hypertension. In August 2004, we announced that the FDA issued an approvable letter for Ganfort(R), setting out the conditions, including additional clinical investigation, that we must meet in order to obtain final FDA approval. In May 2006, we received a license from the European Commission to market Ganfort(R)in the European Union. Combined sales of Lumigan(R)and Ganfort(R)represented approximately 10% of our total consolidated product net sales in 2007. Sales of Lumigan(R)represented approximately 11% of our total consolidated product net sales in 2006 and 12% of our total consolidated product net sales in 2005. The decline in the percentage of our total net sales represented by sales of Lumigan(R)primarily resulted from the significant increase in our net sales as a result of the Inamed acquisition.

Alphagan 緑内障(brimonidine tartrate ophthalmic solution)
[2010]

Our third best selling eye care products are the ophthalmic solutions Alphagan® , Alphagan® P 0.15% and Alphagan® P 0.1%. These products lower intraocular pressure by reducing aqueous humor production and increasing uveoscleral outflow. Alphagan® P 0.15% and Alphagan® P 0.1% are improved reformulations of Alphagan containing brimonidine, the active ingredient in Alphagan® , preserved with Purite . We currently market Alphagan® , Alphagan® P 0.15% and Alphagan® P 0.1% in over 70 countries worldwide. In 2002, based on the acceptance of Alphagan® P 0.15%, we discontinued the U.S. distribution of Alphagan . We are party to an exclusive licensing agreement with Senju, under which Senju is responsible for the development and commercialization of Alphagan® and Alphagan® P 0.15% in Japan. The marketing exclusivity period for Alphagan® P 0.1% expired in 2008 and Alphagan® P 0.15 % now faces generic competition in the United States, although we have a number of patents covering the Alphagan® P 0.1% and Alphagan® P 0.15% technology that extend to 2022 in the United States. In 2003, the FDA approved the first generic of Alphagan® . Additionally, a generic form of Alphagan® is sold in a limited number of other countries, including Canada, Mexico, India, Brazil, Colombia, Argentina and in the European Union.

[2008]

70ヵ国で販売、2007年1-9月世界シェア第5位。
Alphagan(R) Pの2006年発売に伴い、Alphaganは米国販売中止。 
2004.5 杏林製薬に独占ライセンス。 杏林は千寿製薬にサブライセンス。
2003.5 Alphaganの初ジェネリックがFDA承認。
The marketing exclusivity period for Alphagan(R)P expired in the United States in September 2004 and the marketing exclusivity period for Alphagan(R)P 0.1% will expire in August 2008, although we have a number of patents covering the Alphagan(R)P and Alphagan(R)P 0.1% technology that extend to 2021 in the United States and 2009 in Europe, with corresponding patents pending in Europe. In May 2003, the FDA approved the first generic of Alphagan(R). Additionally, a generic form of Alphagan(R)is sold in a limited number of other countries, including Canada, Mexico, India, Brazil, Colombia and Argentina. See Item 3 of Part I of this report, “Legal Proceedings” and Note 13, “Commitments and Contingencies,” in the notes to the consolidated financial statements listed under Item 15 of Part IV of this report, “Exhibits and Financial Statement Schedules,” for further information regarding litigation involving Alphagan(R). Falcon Pharmaceuticals, Ltd., an affiliate of Alcon Laboratories, Inc., or Alcon, attempted to obtain FDA approval for and to launch a brimonidine product to compete with our Alphagan(R)P product. However, pursuant to a March 2006 settlement with Alcon, Alcon agreed not to sell, offer for sale or distribute its brimonidine product until September 30, 2009, or earlier if specified sales conditions occur. The primary sales condition will have occurred if prescriptions of Alphagan(R)P have been converted to other brimonidine-containing products we market above a specified threshold.
Restasis ドライアイ(cyclosporine ophthalmic emulsion) 0.05%
[2010]

Restasis® (cyclosporine ophthalmic emulsion) 0.05% is the first, and currently the only, prescription therapy for the treatment of chronic dry eye worldwide. Restasis is our best selling eye care product. Chronic dry eye is a painful and irritating condition involving abnormalities and deficiencies in the tear film initiated by a variety of causes. The incidence of chronic dry eye increases markedly with age, after menopause in women and in people with systemic diseases such as Sjogren’s syndrome and rheumatoid arthritis. Until the approval of Restasis® , physicians used lubricating tears to provide palliative relief of the debilitating symptoms of chronic dry eye. We launched Restasis® in the United States in 2003 under a license from Novartis AG for the ophthalmic use of cyclosporine. During the third quarter of 2010, Health Canada approved Restasis for the treatment of moderate to moderately severe aqueous deficient dry eye disease. Restasis is currently approved in 41 countries.

Our over-the-counter artificial tears products, including the Refresh® and Refresh® Optive™ brands, treat dry eye symptoms including irritation and dryness due to pollution, computer use, aging and other causes. Refresh , launched in 1986, includes a wide range of preserved and non-preserved drops as well as ointments to treat dry eye symptoms. According to IMS Health Incorporated, an independent marketing research firm, our artificial tears products, including the Refresh® and Refresh® Optive™ brands, were again the number one selling artificial tears products worldwide for the first nine months of 2010.

[2008]

Novartis AGからライセンスを受け。2003.4 米国発売。現在28ヵ国で販売。
2005.4 NovartisからRestasis関連の全世界の全権をroyalty buy-out(総額$110 million)
Prolacria(TM) ドライアイ(diquafosol tetrasodium), or Prolacria(TM)
[2008]

2001.6 Inspire Pharmaceuticals, Incから独占開発権を取得。InspireにRestasisと
Prolacriaの販売を認めるのと交換。
2003.12 FDAはapprovable letterを発行し追加臨床試験を要求。 2005.2 Inspireは
primary endpointでの効果証明失敗を発表。その後secondary endpointsでの試験に基づき
2005Q2に再申請し、2005.12に2番目のapprovable letter受領。
Zymar 抗菌剤(gatifloxacin ophthalmic solution) 0.3% from Kyorin Pharmaceutical Co. Ltd
[2010]

Our leading anti-infective is Zymar® (gatifloxacin ophthalmic solution) 0.3%, which we license from Kyorin Pharmaceutical Co., Ltd. and have worldwide ophthalmic commercial rights excluding Japan, Korea, Taiwan and certain other countries in Asia and Europe. We launched Zymar® in the United States in 2003. Zymar® is a fourth-generation fluoroquinolone for the treatment of bacterial conjunctivitis and is currently approved in 33 countries. Laboratory studies have shown that Zymar® kills the most common bacteria that cause eye infections as well as specific resistant bacteria. During the second quarter of 2010, we received FDA approval of Zymaxid® (gatifloxacin ophthalmic solution) 0.5%, our next-generation anti-infective product indicated for the treatment of bacterial conjunctivitis. In February 2011, we announced the discontinuation of Zymar® due to strong physician acceptance of Zymaxid® with its increased concentration.

[2008]

アジアを除く全世界の権利獲得。第四世代の抗菌剤で29ヵ国で承認。
米国では2003.4発売。2007年は米国で眼科感染症で2番目の処方件数。 金額では世界第3位、米国第二位。
[2010]






Allergan

InvestorsEarnings Releases Q4 Allergan Reports Fourth Quarter 2010 Operating Results[2011.1] Q4 Allergan Reports Fourth Quarter 2009 Operating Results [2010.1 2008 Q4 Allergan Reports Fourth Quarter Operating Results [2009.1] 2007 Q4 Allergan Reports Fourth Quarter Operating Results[2008.1.30] Financial Reports 10-K Annual Report[2011.3.1] - [pdf] 10-K Annual Report[2010.2.26] - [pdf] 2009 Annual Report 10-K Annual Report[2009.2.27] - [pdf] 2008 Annual Report 10-K Annual Report[2008.2.28] - [pdf,188p] 2007 Annual Report - [pdf,16p]ProductsPress Releases
アラガン株式会社

●日本 2002年7月1日付をもちまして、アラガン株式会社は、医薬品事業を取り扱う「アラガン株式 会社」と眼科医療器具及びコンタクトレンズケア事業を取り扱う「エイエムオー・ジャパン 株式会社」の2社に分割いたしました。 ボツリヌストキシン療法研究会:眼瞼・顔面けいれん/痙性斜頸のページ -http://www.btx-a.net/




Allos Therapeutics, Inc

(Nasdaq: ALTH)headquartered in Westminster, Colorado
1992.09.01 HemoTech Sciences, Incとして設立。
1994.10.19 Allos Therapeutics, Incに社名変更
2000年に株式公開


●会社決算
($ 000)20092008200720062005
売上高3,585----
営業利益(74,010)(53,639)(42,664)(32,128)(21,905)
経常利益(73,630)(51,730)(39,370)(30,212)(20,137)
当期純利益(73,553)(51,730)(39,370)(30,212)20,137
研究開発費32,61830,59522,99216,60612,481
従業員数[連結]170
●FOLOTYN™ (pralatrexate injection) PTCL治療薬
【2009】We are currently focused on the development and commercialization of FOLOTYN™ (pralatrexate injection). FOLOTYN is a targeted antifolate inhibitor designed to accumulate preferentially in cancer cells. FOLOTYN targets the inhibition of dihydrofolate reductase, or DHFR, an enzyme critical in the folate pathway, thereby interfering with DNA and RNA synthesis and triggering cancer cell death. FOLOTYN can be delivered as a single agent, for which we currently have approval for the treatment of patients with relapsed or refractory peripheral T.cell lymphoma, or PTCL, and has the potential to be used in combination therapy regimens. We believe that FOLOTYN's unique mechanism of action offers us the ability to target the drug for development in a variety of hematological malignancies and solid tumor indications. We currently retain exclusive worldwide commercial rights to FOLOTYN for all indications. We may also seek to grow our product portfolio through product acquisition and in.licensing efforts.

On September 24, 2009, the U.S. Food and Drug Administration, or FDA, granted accelerated approval of FOLOTYN for use as a single agent for the treatment of patients with relapsed or refractory PTCL. This approval was based on overall response rate from our pivotal PROPEL trial. Clinical benefit such as improvement in progression.free survival or overall survival has not been demonstrated. FOLOTYN represents our first drug approved for marketing in the United States. FOLOTYN is the first and only drug approved by the FDA for this indication and represents a new treatment option for patients with relapsed or refractory PTCL. In connection with the accelerated approval, we are required to conduct several post.approval studies. We began making FOLOTYN available for commercial sale in the United States on October 5, 2009 and commenced our commercial launch in January 2010 with approximately 50 sales specialists.

FOLOTYN is a targeted antifolate inhibitor designed to accumulate preferentially in cancer cells. Based on preclinical studies, we believe that FOLOTYN selectively enters cells expressing RFC.1, a protein that is over expressed on cancer cells compared to normal cells. Once inside cancer cells, FOLOTYN is efficiently polyglutamylated, which makes it less susceptible to efflux.based drug resistance and leads to high intracellular drug retention. Inside the cell, FOLOTYN targets the inhibition of DHFR, an enzyme critical in the folate pathway, thereby interfering with DNA and RNA synthesis and triggering cancer cell death.

The antimetabolites, including antifolates such as FOLOTYN, are a group of low.molecular weight compounds that exert their effect by virtue of their structural or functional similarity to naturally occurring molecules involved in DNA synthesis. Because the cell mistakes them for a normal metabolite, the antimetabolites either inhibit critical enzymes involved in DNA synthesis or become incorporated into the nucleic acid, producing incorrect codes. Both mechanisms result in inhibition of DNA synthesis and ultimately, cell death. Because of their primary effect on DNA synthesis, the antimetabolites are most effective against actively dividing cells and are largely cell.cycle phase specific. There are three classes of antimetabolites; purine analogs, pyrimidine analogs and folic acid analogs, also termed antifolates. FOLOTYN is a folic acid analog.

The selectivity of antifolates for tumor cells involves their conversion to a polyglutamated form by the enzyme folypolyglutamyl synthetase. Polyglutamation is a time. and concentration.dependent process that occurs in tumor cells, and to a lesser extent, normal tissue. The selective activity of the folic acid analogs in malignant cells versus normal cells likely is due to the relative difference in polyglutamate formation. Polyglutamated metabolites have prolonged intracellular half.life, increased duration of drug action and are potent inhibitors of several folate.dependent enzymes, including DHFR.

We believe that the resistance of malignant cells to the effects of the folic acid analogs may, in part, be due to impaired polyglutamation. We believe the improved antitumor effects of FOLOTYN in comparison to methotrexate, as observed in preclinical studies, is likely due to the more effective uptake and transport of FOLOTYN into the cell followed by the greater accumulation of FOLOTYN and its metabolites within the tumor cell through the formation of the polyglutamated derivatives.

Competition

There are currently no FDA.approved drugs other than FOLOTYN for the treatment of patients with relapsed or refractory PTCL. However, we are aware of multiple investigational agents that are currently being studied in clinical trials for T.cell lymphoma, including romidepsin and belinostat, which, if successful, may compete with FOLOTYN in the United States. In addition, there are many existing approaches used in the treatment of relapsed or refractory PTCL, including combination chemotherapy and single agent regimens, which represent competition for FOLOTYN.

Many companies of all sizes, including a number of large pharmaceutical companies and several biotechnology companies, are developing product candidates that have disease targets similar to those we are pursuing. Some of these competitive product candidates are in clinical trials and others are approved. There are products and technologies currently on the market that will compete directly with FOLOTYN. Universities, governmental agencies and other public and private research organizations also conduct research and may market commercial products on their own or through joint ventures. These companies and institutions also compete with us in recruiting qualified scientific personnel. Many of these entities may have:

Allos Therapeutics, Inc

Products FOLOTYNInvestorsFinancial Reports - SEC Filings 10-K Annual report[2010.3.1] - [pdf] - [doc] - [xls] News

Allos Therapeutics' Pralatrexate Granted Orphan Medicinal Product Designation for the Treatment of Hodgkin Lymphoma by the European Commission[2010.10.15]
Allos Therapeutics Announces Presentation of Favorable Survival Data from Randomized Phase 2b Study of FOLOTYN(R) in Patients with Advanced Non-Small Cell Lung Cancer[2010.10.11]
Allos Therapeutics Announces FOLOTYN(R) Data Presentation at the 35th ESMO Congress[2010.9.9]
Allos Therapeutics Announces Topline Results from Phase 2b Study of FOLOTYN in Patients with Advanced Non-Small Cell Lung Cancer[2010.7.18]
Allos Therapeutics' Pralatrexate Granted Orphan Medicinal Product Designation for the Treatment of Cutaneous T-Cell Lymphoma by the European Commission[2010.6.17]
Allos Therapeutics' FOLOTYN Shows Activity and Tolerability in Phase 1 Dose Finding Study in Patients with Relapsed or Refractory CTCL[2010.6.11]
Allos Therapeutics Reports New Data Demonstrating that Responses to FOLOTYN are Correlated with Prolonged Survival in Patients with Relapsed or Refractory PTCL[2010.6.5]
Allos Therapeutics' Pralatrexate Granted FDA Orphan Drug Designation for the Treatment of Bladder Cancer[2007.5.18]
Allos Therapeutics Announces an Agreement with Idis for a Named Patient Program for FOLOTYN(TM) (pralatrexate injection)[2009.12.4]
Therapeutics Announces U.S. Availability of FOLOTYN(TM) (pralatrexate injection) for Relapsed or Refractory Peripheral T-Cell Lymphoma[2009.10.5]
Allos Therapeutics' FOLOTYN(TM) First and Only FDA-Approved Therapy for Relapsed or Refractory Peripheral T-cell Lymphoma[2009.9.25]
Allos Therapeutics Announces FDA Advisory Committee Recommends Accelerated Approval of FOLOTYN(TM) (pralatrexate) for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma[2009.9.2]
U.S FDA Grants Pralatrexate Orphan Drug Designation for the Treatment of Patients with Follicular Lymphoma[2008.12.1]
U.S. FDA Grants Pralatrexate Orphan Drug Designation for the Treatment of Patients with Diffuse Large B-Cell Lymphoma[2008.11.24]
[]
[]





Almirall Prodesfarma, S.A.

 - http://www.almirall.es/
1943  Laboratorios Almirall, S.A設立
1960  Prodes S.A.設立。 最初の製品Prodesmicina
1964  最初のジエネリックDiazepan Prodes
1979  初の自社開発品clebopride発売。海外ライセンス
1983  Funk S.A. and Berenguer Beneyto S.A.を買収。
1985  局所用消炎剤piketoprofen発売。
1986  Infale S.A買収。
1987  Almirall が国内market leaderとなる。
1990  Farmasimes[スペイン]及び Sintesa[ベルギー]を買収。
      gastroprokinetic cinitaprideの発売.
   抗ヒスタミン剤 ebastine発売。 国際ライセンス
1991  Prasfarma (Asta Medicaと合弁)をSpainに設立。
1992  抗炎症剤aceclofenac発売。
1993  Probiosの商業活動をポルトガルで開始。
1995  抗炎症剤aceclofenacを南ア, Portugal and Koreaで発売。
1996  aceclofenacを英国発売。
   ebastineを日本で発売。
1997  Grupo Farmaceutico Almirall S.A. and the Grupo Prodesfarma. が合併し
   Almirall Prodesfarma S.A.
2000  片頭痛薬almotriptanが欧州16カ国で相互承認、スペイン発売、FDA承認。
2001  almotriptanの欧州及びEEUU発売。
   Prasfarma(癌・病院製品)買収
   仏製薬会社Pharmafarm買収
   フランスでebastine発売
2002  独・伊・ポルトガルでebastine発売。
2005  PrasfarmaをMerck KGaAに売却、但しスペインでのCampto(irinotecan)の共同販売
   権は留保。

●会社決算(12月)
(Euro million)  2005予 2004  2003  2002  2001
売上高      946     900   886   833   734
 うち製品収入  750     738   676   632   583
      
   国内売上  564 559 523 487 439    国外売上  186 179 153 145 144 研究開発費    104 88 85 75 56 従業員数    3227 3196 3200 2843 2605  うち研究開発 500 508 516 508 425 ●研究開発主力分野  喘息、COPD、、乾癬、リウマチ ●開発中の新薬(自社品) LAS 34273 Bronchitis / asthma P-II / III LAS 35201 Bronchitis / asthma P-I / II LAS 37779 Psoriasis P-I FROM Molecules under development ●開発中の新薬(導入品) from News Sativex(R) P3 多発性硬化症 GW Pharmaceuticals (delta-9-tetrahydrocannabinol(THC)& cannabidiol(CBD)) *GW創製、2005.4カナダ承認 blonanserin(AD-5423) P2 統合失調症治療剤 2001.5 大日本住友から全世界ライセンス
Almirall Prodesfarma, S.A.

- http://www.almirall.es/ Strategic alliances  - 自社開発品の導出先・国・銘柄名一覧。 導入品目一覧 ●Products ・ almotriptan (片頭痛) ・ ebastine (抗ヒスタミン) −エバステル[大日本住友]発売 ・ aceclofenac (抗炎症) ・ almagate (制酸剤) ・ cinitapride (gastroprocinetic) ・ clebopride (胃潰瘍治療剤gastroprocinetic) −クラスト錠[明治製菓]発売 ・ piketoprofen (抗炎症) ●Communication - Almirall reaches sales figures of 900 million euros in 2004[2005.4.4] - ALMIRALL HAS TAKEN THE STRATEGIC DECISION OF REGISTERING ALMOTRIPTAN IN JAPAN[2004.6.9] -日本での開発 ●R&D Molecules under development




Alpharma Inc.

Alpharma Inc. (NYSE:ALO),
 is a multinational pharmaceutical company with global leadership positions in products for humans and animals
Grande Commons, 440 U.S. Highway 22 East,3rd Floor, Bridgewater, NJ 08807 908-566-3800
With 1,355 employees and revenues of $654 million, Alpharma is active in more than 60 countries around the world. Founded in Norway in 1903, Alpharma is currently positioned for growth atop three strong anchors: pharmaceutical products (KADIAN(R) capsules and the FLECTOR(R) Patch), animal health and active pharmaceutical ingredients. Together, these business units provide operational efficiencies and enable the company to continue to deliver sustainable growth and long-term value.



Alpharma Inc.

-http://www.alpharma.com/pages/default.aspx ●Our BusinessesKADIAN(R) capsules(morphine sulfate extended-release Capsules) ★FLECTOR(R) Patch(diclofenac epolamine topical patch) ●News Room Alpharma Reports Double-Digit Full Year and Fourth Quarter 2007 Revenue Growth [2008.2.26] The First and Only Anti-Inflammatory Pain Release Patch in the U.S. - FLECTOR(R) Patch - Now Available[2008.1.23] Alpharma Licenses Novel NSAID Topical Pain Drug [2007.9.5] - P3段階にあるketoprofen in Transfersome(R) gelに関して米国独占権を独IDEA AGから獲得した。  IDEA AG は2007.5 Europefor ketoprofen in Transfersome(R) gelの変形関節症の適応で申請した。 Alpharma to Market First Topical NSAID Patch in the U.S.[2007.8.21] - 米国初のNSAIDパッチ剤Flector Patchに関して、Institut Biochimique SAから米国独占販売権を獲得。 欧州ではIBSAが販売している。 1993年でスイスで初承認、以来39ヵ国で承認。




Alseres Pharmaceuticals, Inc

 - http://www.alseres.com/index.asp; (NASDAQ: ALSE)
85 Main Street, Hopkinton, MA 01748 Tel: (508) 497-2360 Fax: (508) 497-9964
創立1992

Boston Life Sciences, Inc. Changes Name to Alseres Pharmaceuticals, Inc.[2007.6.8]


●会社決算
($ )2008200720062005200420032002
売上高-------
営業費用18,710,81218,881,12526,434,73611,647,98410,381,4297,914,88710,302,008
当期純利益(20,847,459)(19,548,348)(26,355,243)(11,501,442)(11,250,877)(8,367,994)(10,993,142)
研究開発費10,851,84410,475,15818,538,1866,127,4866,400,132
従業員数[連結]272727
■開発中の新薬 /2008.3.13
製品適応段階備考
■Regenerative Therapeutics
CNS
Cethrin®Acute spinal cord injuryP2
2007.1 BioAxone Therapeutic Inc. of Montreal, Canadaから全世界独占開発販売権を獲得。a Rho Inhibitor。 米国では脊髄損傷が毎年11,000件発生し、現在methylprednisoloneの適応外使用が唯一の治療法
InosineStroke, SCI前臨床終了
ALSE-100, etal.Chronic SCI, TBI研究中
OCULAR
OncomodulinOptic Nerve Injury/
Glaucoma
研究中
ALSE-100Glaucoma/macular degeneration/
retinis pigmentosa
研究中
BONE
ALSE-100Bone repair/
osteo-induction
前臨床終了
CARDIOVASCULAR
ALSE-100, etal.Cardiomyopathy研究中
■Molecular Imaging
ALTROPANE(R)(123I-SPECT)Parkinson's Disease診断P3終了誤診率25-35%を改善
Tc-based agentsParkinson's Disease / ADHD前臨床終了
■DAT Blocker(Dopamine Transporter Blocker)
DAT BlockerParkinson's Disease前臨床終了3種
from Product-Pipeline ★Cethrin(R) -- In January 2007, enrollment was initiated at the 9 mg dosage level in our Phase I/IIa trial of Cethrin at sites in Canada. In June 2007, the Food and Drug Administration, or FDA, authorized an increase in the dose level to 9 mg for sites in the U.S. Each authorized dose is first given to thoracic SCI subjects and then, following review by the Data Safety Monitoring Board, or DSMB, the dose is extended to cervical subjects. In September 2007, the DSMB unanimously authorized expanding the 9 mg dose to include cervical subjects. -- In September 2007, the Company had a preliminary meeting with the European Medicines Agency to review our proposed clinical development plan for CETHRIN. In October 2007, the Company met with the FDA to review the Phase I/IIa results and its CETHRIN clinical development plan. The Company plans to meet with Health Canada in early 2008 for the same purpose. Based on discussions to date with the regulatory authorities and expert advisors, the Company is planning to begin a Phase IIb trial at sites in North America and Europe in the first half of 2008. from Alseres Pharmaceuticals, Inc. Reports Third Quarter 2007 Financial Results and Provides Development Pipeline Update[2007.11.14]
Alseres Pharmaceuticals, Inc

Product-PipelineInvestor RelationsFinancial InformationSEC Filings 10-K annual report[2009.3.31] 10-K annual report[2008.3.31] 10-K annual report[2007.4.2] ★Annual Reports Press Releases Alseres Pharmaceuticals, Inc. Reports Third Quarter 2007 Financial Results and Provides Development Pipeline Update[2007.11.14] Boston Life Sciences, Inc. Changes Name to Alseres Pharmaceuticals, Inc.[2007.6.8] Alseres Pharmaceuticals Concludes Enrollment in the Cethrin(R) Phase I/IIa Clinical Trial in Acute Spinal Cord Injury[2008.1.7] QSV Biologics, Ltd. and, Alseres Pharmaceuticals, Inc., Sign Contract for cGMP Manufacture of Cethrin(R) for Spinal Cord Injury[2007.7.10] Alseres Pharmaceuticals Announces FDA Clearance to Increase Dose Level in Cethrin(R) Phase I/IIa Clinical Trial for Acute Spinal Cord Injury at U.S. Sites[2007.6.27] Boston Life Sciences Acquires Rights to Develop and Commercialize Promising Phase II
Spinal Cord Injury Drug, Cethrin(R), in Exclusive Worldwide License
[2007.1.4]




Altana AG

 - http://www.altana.de/root/index.php

ALTANA AG completes sale of pharmaceuticals business to Nycomed[2006.12.29]

●決算[連結]
(Euro milllion)2006200520042003200220012000

売上高3,8673,2722,9632,735(+5)2,6092,3081,928

医薬事業2,5732,3652,1091,9801,8611,5911,262
 化学事業1,294907854755748717666

営業利益676604563(+5)538
経常利益EBT779684(+14)624580(+10)526448329
純利益3,872438379345(+6)324256179
研究開発費495(+6)465448412(+12)369285219
 医薬427418[17.7%]410(+8)[19.4%]376[19.0%]335252190
 化学68473836343329
従業員数13,40413,27610,783(+4)10,402(+6)9,8539,1228,556
 医薬8,920(+1)8,8328,200(+6)7,7027,5046,8676,489
 うち研究開発1,656(+9)1,514(+18)1,2811,052927
 化学4,4844,3842,5212,6342,2992,2172,036
●地域別[全体]
(Euro milllion)2006200520042003200220012000
欧州627454
旧1,674
1,504
 うち独223142
旧581
491
北米268156
旧927
880
 うち米国243144
旧796
769
中南米--
旧327
278
極東297214
旧285
250
その他10283
旧59
51
合計1,294907
旧3,272
2,963
●地域別[医薬]
(Euro milllion)2006200520042003200220012000

医薬事業2,573(+9)2,365(+12)2,109(+7)1,980(+6)1,8611,5911,262

欧州1,227(+1)1,219(+16)1,050(+8)972(+4)932
 うちドイツ380(-14)439(+18)371(-1)375(-4)390
北米936(+22)770(+3)749(+2)732(+16)633
 うち米国761(+17)651(+1)647(+1)638
中南米311(+12)279(+19)235(+10)213(-10)236
その他99(+3)97(+29)75(+18)63(+5)60
●セグメント別
(Euro milllion)2006200520042003200220012000

売上高3,8673,2722,9632,735(+5)2,6092,3081,928

医薬事業2,573(+9)2,365(+12)2,109(+7)1,9801,8611,5911,262

  治療薬2,261(+9)2,071(+13)1,839(+7)1,7241,5651,275980
    消化器1,702(+11)1,536(+12)1,367(+10)1,241(+15)1,083795
    呼吸器83(+20)69(+17)59(-1)59(+3)5753
    その他476466(+13)413(-3)424(-)425427
  Imaging108(-1)108(-)109(+3)10610091
  (OTC)149(+14)131(+13)115(+11)104110129
  その他55(+0)55(+19)46(-)468696
  合計2,573(+9)2,365(+12)2,109(+7)1,9801,8611,591

 化学事業1,294(+43)907854755748717666

  添加剤・機器
(Additives & Instruments)
409(+13)364348(+13)308304--
  電気断熱剤
(Electrical Insulation)
325(+11)293291(+29)225223--
  塗料・シール
(Coatings & Sealants)
221(+26)175215(-3)222221--
  Effect Pigments339(+13)75-----
  合計1,294(+43)907854755748717666
* 医薬事業が81%、うち北米が37% ●製品売上高
(Euro milllion)200620052004200320022001備考

Pantoprazole1,551(+14)[69%]1,361(+12)[57.6%]1,216[57.6%]1,113[26.2%]966680(Protozol)潰瘍
Alvesco18.28.1(-)---[cicletanide]喘息;発売2005.1
Contrast media10510610070
Ebrantil(R)67666361[urapidil]降圧剤;α遮断剤
Ferro29-3033[ferro polymaltose]鉄剤
Riopan(R)28303334[Magaldrat]制酸剤・胸やけ
Facial Topicals--26-
Theophylline--2526Euphyllin/Euphylong
Querto(R)--2423[Carvedilol]from Roche;特許切れ2004
Sanostol(R)--2017[]ビタミン剤
Chromagen--1618鉄剤*2003.6 KV Pharmaceuticalsに売却
CroFab(TM)-29-17蛇毒
★造影剤(Bracco S.p.A.と提携,)  Imeron & Solutrast - CTの増加で好調  ProHance & MultiHance - Magnetic resonance造影剤(MRI) ★ciclesonide (Alvesco) - 革新的な吸入ステロイド:喘息 (Eur1 Billion予想) [2005] (1990年代初めスペインELMUQUIMICA社買収により取得) 申請済み(2002) --- 英、オーストラリア、カナダ他 (2003) --- サノフィアベンティスが2003.末に米国申請。(契約2002) (2004) --- 帝人が日本で2004.1申請。(契約1998) 承認 --- Australian Health Agencyが2004.2 世界初承認。  発売  (2005.1)--- 英・独発売 2005末16ヵ国で販売、34ヵ国承認  点鼻薬:2005.12 FDA申請 by Altana [2004] 承認済み(2004) --- 英2004.4、オーストラリア2004.2、ブラジル・メキシコ2004.8            米国Approvable Letterを2004.10受領            EU相互承認手続き[MRP]2004.12完了 発売 (2005) --- 英国2005.1、ドイツ2005.2 ★roflumilast (Daxas) - COPD治療薬 (Eur1 Billion予想)革新的PDE4阻害剤 [2004] 申請済み(2004) --- EU2004.2  臨床試験(2004)   米国Pfizerは喘息・COPDでP3試験実施、日本の田辺は            喘息でBridging studyを開始。 [2003] ・COPDは"Smoker's lung"として知られ、世界4位の死因。 ・特異的PDE阻害剤で抗炎症作用がある。  COPDと喘息の療法に有効であることを実証した最初の特異的PDE4阻害剤 ・2002年以来Pfizerと共同開発。日本は田辺製薬と共同開発・共同販売 ・RECORD studyを2003.9開始。 有効性・安全性のため。 ・EU申請2004.2 ●パントプラゾール
(Euro milllion)2006200520042003200220012000

売上合計2,882(+4)2,768(+12)2,481(+6)2,350(+17)2,0071,326650

 自社売上分1,551(+14)1,361(+12)1,2161,113966680411

 独226(-23)292(+40)210(+9)193(+6)182
 仏155(+36)114(+37)83
 伊95(+20)79(+14)70
 スペイン116(+23)94(+34)70
 英38(+13)34(+56)22
 他の欧州277(+17)237(+25)190
欧州 計1,030(-2)1,049
旧757(+11)
681
 米国1,429(+5)1,356(+6)1,281
 カナダ212(+21)175(+19)147
北米 計1,641(+7)1,5311,428(-2)1,456(+17)1,247
中南米64(+21)52(+11)48(+3)46(-11)52
その他147(+8)136(+18)114(+17)97(+7)91
* ドイツPantozol, 米国ではProtonix[Wyeth] [年報2005] 1995世界発売以来、現在100ヵ国で販売。 PPI世界市場規模 Euro 14 million(2005) * pantoprazoleのPPI市場シェア20%(2005米国)16%(2003) * 市況(2003) esomeprazoleの発売、及びGeneric登場があった。 しかし堅調な伸び。 しかし数カ国ではomeprazoleの影響あり。 剤型は錠剤(20mg,40mg)、注射剤 * 特許  米国特許が5年間延長し、2010年7末迄に。  欧州は2009年まで。 * 第一製薬と1993.2.22にライセンス契約。 2000.10に契約終了。 Daiichi termination agreement On February 22, 1993, the Company and Daiichi Pharmaceutical Co., Ltd. entered into a licensing agreement pertaining to the development and commercialization of Pantoprazole by Daiichi in Japan. Daiichi terminated the agreement effective October 2000. Under the termination agreement, Daiichi agreed to pay the Company a total of Euro18.4 million in three annual installments as a settlement for termination. These payments are non-refundable and release Daiichi completely from its obligation under the licensing agreement. The first installment, totaling Euro6.1 million was paid during 2000. The second installment, was paid on October 1, 2001. The final installment, is due on October 1, 2002. In 2000, the Company initially recorded only the first installment as other income. The financial statements as of and for the year ended December 31, 2000, have been restated to reflect the entire settlement as other income in the year 2000 as ALTANA has no future obligations or commitments with respect to the termination of the licensing agreements or resulting payments. ●主要特許期限
製品欧州(1)米国日本
ciclesonide(物質)2011(2)2013(3)2011(3)
ciclesonide(Key中間体)201420152014
ciclesonide(精製工程)201720192017
ciclesonide(エアゾール)201820182018
ciclesonide(点鼻製剤)202020202020
roflumilast(物質)2014(3)2015(3)2014(3)
roflumilast(製剤)202320232023
soraprazan(物質)2019(3)2019(3)2019(3)
(1)主要国の欧州特許または各国特許 (2)欧州では2016年迄期間延長のためのSPCが認められている。 (3)特許期間延長が5年間迄認められるが、これを反映していない。 *SEC 20-F Annual Report 2005
Altana AG

Press Release ALTANA AG: Excellent business year 2006[2007.1.26] ALTANA AG completes sale of pharmaceuticals business to Nycomed[2006.12.29] - Investor RelationsPublications Annual Report 2006[pdf,188p] - Interactive Annual Report 2005[pdf,188p] - Interactive --- 医薬35-54; 174p 子会社と持株比率MAJOR CONSOLIDATED COMPANIES SEC-Filing 20-F 2005[pdf,196p] Annual Report 2004[pdf,172p] - Interactive --- 医薬27-44, 開発品目一覧42p; 164p 子会社と持株比率MAJOR CONSOLIDATED COMPANIES SEC-Filing 20-F 2004[pdf,p] Annual Report 2003[pdf,164p] --- 医薬24-39, 開発品目一覧36p; 149p 子会社と持株比率MAJOR CONSOLIDATED COMPANIES SEC-Filing 20-F 2003 Annual Report 2002 Annual Report 2001[pdf, 124p] - Geschaftsbericht 2001 --- 医薬30-, 開発品目一覧36p ●R&D/Products Pharmaceuticals research & development Top ten products
Altana Pharma AG[旧Byk-Gulden AG]

 --- Altana AGの製薬部門。 年間売上Euro 1.6 Billion(1860億円)[2001]、従業員総数7500、世界20か国に支社。 ●News March 21, 2003★ALTANA closes 2002 with seventh consecutive record year: Products - pantoprazole[要登録] Therapy & Diagnosis - 大した内容はない

●日本

ALTANA Pharma KK,Osaka (J) 100% BYK-Chemie Japan KK, Osaka (J) 100%




Alza Corporation

 - June 22, 2001 J&Jの完全子会社となる。 従業員数3000人以上[米国内のみ]
 従って決算は、J&Jで行い、個別決算は非公開。
 但し、サイトは存続。

Alza Corporation Annual Report 2000-Financial section[36p]

3p ALZA Corporation 2000 Annual Report[27] Management's Discussion and Analysis of Financial Condition and Results of Operations ●売上高
(Dollars in millions)200019991998備考
●ALZA Pharmaceuticals
Ditropan XL(R) 179.086.9(+84)47.2[oxybutynin Cl]過活動膀胱;発売1999Q1
Doxil(R)/欧州Caelyx(R)82.4(+24)66.2(+37)48.4[doxorubicin]卵巣癌
Concerta(TM)67.9--[methylphenidate HCl]ADHD治療薬;発売2000.8
Ethyol(R)48.448.332.6[amifostine];2002.10.1 Medimmuneへ
Elmiron(R)33.729.923.0[pentosan polysulfate sodium]間質性膀胱炎;1997.9 IVAXから米加の販売権取得
Mycelex(R) Troche19.5(-33)29.225.9[clotrimazole]抗真菌剤;
Testoderm TTS(R) line18.620.810.0[testosterone]
Other28.242.135.9
Total ALZA Pharmaceuticals477.7323.4175.8
●ALZA Technologies
Contract manufacturing129.5124.6113.6
Intersegment53.441.222.1
Total ALZA Technologies182.9165.8135.7
Intersegment eliminations(53.4)(41.2)(22.1)
Total net sales607.2448.0289.4
================================== ★SEQUUS Pharmaceuticals, Inc. (Nasdaq: SEQU) 1981 設立  1995 Liposome Technology Inc (HW)からSEQUUS Pharmaceuticals, Inc.に社名変更 1995 .12 Doxil発売。 .12 AMPHOTECに関してSchering-Plough Corpに販売ライセンス 1998 .10 Alzaに吸収合併される。 ALZA To Acquire SEQUUS[1998.10.5] SEQUUS Pharmaceuticals, Inc. ==================================
ALZA Corporation

--- http://www.alza.com/ ; ●Presse Release Johnson & Johnson Announces Completion of Merger with ALZA Corporation[01.6.22] --- Alzaは、J&Jの完全子会社になった。 会社はそのまま。 Concerta - A success story[12p; Winter 2001] --- - An Interview with Dr. Alejandro Zaffaroni, ALZA's Drug Delivery Visionary - Patterned Drug Delivery Using ALZA's OROS(R) Technology




AMAG Pharmaceuticals, Inc
AMAG Pharmaceuticals, Inc

 - http://www.amagpharma.com/
貧血治療薬および癌・循環器疾患の造影剤の開発に特化
100 HAYDEN AVENUE. LEXINGTON, MA, 02140; www.advancedmagnetics.com

1981年設立



●会社決算
($ 000)2009200820072006/10-122006/92005/9
(製品売上)16,4827511,2083531,449890
(ライセンス収入)5169591,0962229071,281
(ロイヤリティ収入)18022824844317274
売上高 合計17,1781,9382,5526192,6732,445
売上原価1.013292320287273204
研究開発費36,27331,71624,2366,39321,29412,037
販売・管理費77,82949,53620,3962,1978,0113,338
(原価および経費)115,11581,54444,9528,87729,57815,579
経常利益(94,619)(71,925)(33,894)(7,440)(25,365)(12,715)
当期純利益(93,351)(71,647)(33,894)(7,440)(25,365)(12,715)
従業員数[連結]283

Feraheme15,774-[Ferumoxytol ]
GastroMARK 708(+78)398[ferumoxsil]腹部造影
Feridex I.V. -333[ferumoxides]肝臓造影剤
その他製品-20
製品売上 計16,482(>+100)751
●Feraheme(Ferumoxytol) 鉄欠乏性貧血
【2009】On June 30, 2009, Feraheme was approved for marketing in the U.S. by the U.S. Food and Drug Administration, or the FDA, for use as an IV iron replacement therapy for the treatment of iron deficiency anemia, or IDA, in adult patients with chronic kidney disease, or CKD. We market and sell Feraheme through our own commercial organization, consisting of approximately 120 professionals, including an 80.person specialized sales force and account management and reimbursement teams. We sell Feraheme primarily to authorized wholesalers and specialty distributors and began commercial sale of Feraheme in the U.S. in July 2009.

In November 2009, the Centers for Medicare & Medicaid Services, or CMS, assigned Feraheme two unique Q.codes, one for the treatment of IDA in end.stage renal disease patients undergoing dialysis and one for the treatment of IDA in non.end.stage renal disease patients. These Q.codes, which are temporary product.specific codes that enable automated processing of Feraheme.related claims, became effective on January 1, 2010.

For the year ended December 31, 2009, we recognized net product sales of Feraheme of $15.8 million, including approximately $1.3 million of the $11.5 million in deferred product revenues we had recorded in the third quarter of 2009. During the third quarter of 2009, shortly after the launch of Feraheme, we implemented a Launch Incentive Program under which certain dialysis organizations purchased Feraheme directly from us. This program provided certain customers with, among other things, discounted pricing and expanded rights of return. As a result, we deferred revenues associated with this program which we will recognize as revenues as the participating organizations utilize their Feraheme inventory. We expect that utilization of the remaining deferred product revenues from the Launch Incentive Program will increase going forward as each Launch Incentive Program customer has begun to use Feraheme.

In December 2009, we submitted draft protocols for two proposed clinical trials to meet our FDA post.approval Pediatric Research Equity Act requirement to support pediatric labeling of Feraheme. In 2010, we intend to initiate these two randomized, active controlled pediatric studies in children with IDA. One study will be in dialysis dependent CKD patients, and the other will be in CKD patients not on dialysis. Each study will assess the safety and efficacy of Feraheme treatment as compared to oral iron in approximately 144 children.

We also plan to advance our Feraheme clinical development program in adults by initiating two Phase III multi.center clinical trials in mid.2010 to assess Feraheme for the treatment of IDA in a broad range of patients, which may include women with abnormal uterine bleeding, or AUB, patients with cancer and gastrointestinal diseases and postpartum women, for whom oral iron is unsatisfactory. One study will assess the efficacy and safety of two doses of 510 milligrams each of Feraheme compared to placebo in a total of approximately 800 patients with IDA. A second study will assess the efficacy and safety of two doses of 510 milligrams each of Feraheme compared to a total dose of 1,000 milligrams of an IV iron sucrose product in a total of approximately 600 patients with IDA. Further, we intend to initiate an open label extension study enrolling patients from the placebo controlled study who will be followed for six months and will be eligible to receive two doses of 510 milligrams each of Feraheme whenever they meet treatment criteria.

We continue to evaluate our strategy for seeking approval for Feraheme as an IV iron replacement therapeutic agent in countries outside of the U.S.

The commercial opportunity for Feraheme as an IV iron replacement therapeutic agent varies from country to country, and in determining which additional markets outside of the U.S. we intend to enter, we are assessing factors such as potential pricing and reimbursement, the role of iron in medical treatment protocols, and the regulatory requirements of each country. We expect to file a Marketing Authorization Application, or MAA, for Feraheme for the treatment of IDA in CKD patients with the European Medicines Agency, or EMEA, in mid.2010. In the fourth quarter of 2009, we received approval from the EMEA for our Pediatric Investigation Plan, which is a prerequisite for the submission of our Feraheme MAA. Our Pediatric Investigation Plan includes the two pediatric studies required to meet our Pediatric Research Equity Act requirement and two additional pediatric studies requested by the EMEA. To further support our MAA, we have initiated a global, randomized, Phase IV multi.center, active controlled trial with approximately 150 adult CKD patients both on dialysis and not on dialysis. This study will assess the safety and efficacy of two doses of 510 milligrams each of Feraheme compared to a total dose of 1,000 milligrams of an IV iron sucrose product.

In December 2009, we filed a New Drug Submission for Feraheme to treat IDA in patients with CKD with the Therapeutic Products Directorate of Health Canada, or Health Canada, the federal authority that regulates pharmaceutical drugs and medical devices for human use in Canada. In February 2010, we received a Screening Deficiency Notice from Health Canada requesting certain clarifications and additional documents. We have submitted our response to Health Canada and believe that all of these items are readily addressable. In addition, in December 2009, our partner in China, 3SBio Inc., or 3SBio, filed an application with the Chinese State Food and Drug Administration, or the SFDA, to obtain approval to begin a registrational clinical trial necessary to file for marketing approval in China. Once approved by the SFDA, 3SBio plans to commence a multi.center randomized efficacy and safety study in China involving approximately 200 CKD patients.

In addition to its use for the treatment of IDA, Feraheme may also be useful as a vascular enhancing agent in magnetic resonance imaging, or MRI. In August 2008, the FDA granted Fast Track designation to Feraheme with respect to its development as a diagnostic agent for vascular.enhanced MRI for the assessment of peripheral arterial disease, or PAD, in patients with CKD. We have enrolled over two.thirds of our 108 patient Phase II study of Feraheme in vascular.enhanced MRI for the detection of clinically significant arterial stenosis or occlusion, or narrowing or blocking of the arteries.

【2009 適応】Feraheme as an IV Iron Replacement Therapeutic

Overview

On June 30, 2009, Feraheme was approved for marketing in the U.S. by the FDA for use as an IV iron replacement therapy for the treatment of IDA in adult patients with CKD. In July 2009, we began to market and sell Feraheme in both the dialysis and non.dialysis CKD markets, including to nephrologists, hematologists, dialysis organizations, hospitals and other end.users who treat patients with CKD.

Chronic kidney disease, anemia, and iron deficiency

It has been estimated that approximately 10% to 15% of the U.S. adult population is affected by CKD, a condition generally characterized by damaged kidneys, or a reduction in kidney function below 60% of normal. Anemia, a common condition among CKD patients, is associated with cardiovascular complications, decreased quality of life, hospitalizations, and increased mortality. Anemia develops early during the course of CKD and worsens with advancing kidney disease. Iron deficiency is a common cause of anemia in CKD patients and can result from multiple blood draws, hospitalizations and interventional procedures, gastrointestinal bleeding, or poor nutritional intake. Regardless of the cause of anemia, iron replacement therapy is essential to increase iron stores and raise hemoglobin levels. Iron is also essential for effective treatment with erythropoiesis stimulating agents, or ESAs, which are commonly used in anemic patients to stimulate red blood cell production.

According to an estimate by the United States Renal Data System, approximately 400,000 CKD patients are projected to be on dialysis in the U.S. in 2010. Approximately 90% of these dialysis patients will receive IV iron as part of managing their anemia. In addition, data contained in a 2002 publication in the Journal of the American Society of Nephrology suggests that up to 1.6 million of stage 3 and 4 non.dialysis CKD patients with anemia may be iron deficient and could therefore benefit from receiving IV iron. We believe that less than 10% of these patients are currently being treated with IV iron.

Currently there are two methods used to treat IDA in CKD patients: oral iron supplements and IV iron. Oral iron supplements are often not absorbed well by the gastrointestinal tract and frequently have side effects, such as constipation, diarrhea, and cramping, which can cause patients to stop taking their medication. In addition, it can take an extended time for hemoglobin levels to improve following the initiation of oral iron treatment. Conversely, iron given intravenously allows larger amounts of iron to be provided to patients while avoiding many of the side effects and treatment compliance issues associated with oral iron, and can result in faster rises in hemoglobin levels. The administration of IV iron has been shown to be effective in treating anemia either when used alone or in combination with an ESA. Current U.S. treatment guidelines indicate that treating first with iron alone may delay or reduce the need for ESA therapy.

For IV iron replacement therapy in patients with CKD, the total therapeutic course of iron typically used in clinical practice is 1,000 milligrams, or one gram. Rapid administration of large doses of other IV iron products has been associated with an unfavorable safety profile. As a result, other IV iron products are typically administered as a slow push or a 15 to 60 minute infusion in doses of 100 to 200 milligrams, thus requiring five to ten physician visits and repeated IV access for patients to receive a standard one gram therapeutic course, potentially resulting in considerable burden to both providers and patients. Feraheme is administered as a 510 milligram injection followed by a second 510 milligram injection three to eight days later, each of which can be administered in as fast as 17 seconds at a regular office visit or during dialysis treatment without the use of infusion equipment or prolonged medical intervention.

Feraheme in indications other than CKD

IDA is widely prevalent in many different patient populations, including women with AUB, patients with cancer and gastrointestinal diseases, and postpartum women. We believe that the product characteristics of Feraheme support clinical development in these additional indications, and we are currently in the process of preparing for a global clinical development program for Feraheme in a broad range of patients with IDA, regardless of the underlying cause. We intend to initiate our Phase III program for Feraheme in IDA in mid.2010.

Included among the patient populations we are evaluating for additional indications for Feraheme are women with AUB and cancer patients.

AUB is defined as chronic, heavy, or prolonged uterine bleeding that can result from multiple causes, including uterine abnormalities, blood disorders, pregnancy, intrauterine devices, medications, and heavy menstrual bleeding. Both iron deficiency and IDA are commonly associated with AUB. The prevalence of anemia in AUB patients has been reported to range from 10% to 67%, and the prevalence of iron deficiency in AUB patients has been reported to range from 20% to 50%, depending on patient age and diagnostic criteria. IDA in patients with AUB, regardless of the cause, requires treatment with iron supplementation, either by oral or IV administration.

Anemia is also common in patients with cancer. Depending on the type of cancer, it has been estimated that between 30% and 90% of patients with cancer have anemia. Iron supplementation through both oral and IV administration has an important role in treating anemia in cancer patients. While there may be some differences in the underlying causes of anemia and iron deficiency in cancer patients who are receiving chemotherapy and those who are not, patients in both categories may develop absolute IDA due to blood loss and/or the inadequate intake or absorption of iron. Oral iron has been used to treat IDA in cancer patients, but its efficacy is variable due to inconsistent bioavailability and absorption, the high incidence of gastrointestinal side effects, potential interactions with other treatments and patient noncompliance. IV iron has been shown in small clinical trials to be well tolerated in the cancer patient population in both patients who are receiving chemotherapy and those who are not.

Ferumoxytol as a Diagnostic Agent for Vascular Enhancement in MRI

MRI is a non.invasive method used to visualize normal or abnormal anatomy or pathophysiology in patients in order to diagnose disease and injury.

Imaging agents or biomarkers play an important role in improving the quality of diagnostic images by increasing the contrast between different internal structures or types of tissues in various disease states.

Ferumoxytol is currently in development as an agent for vascular.enhanced MRI because of its ability to increase the magnetic relaxivity of blood, resulting in MRIs with enhanced vascular contrast. When used with the appropriate pulse sequence, ferumoxytol may provide high.quality diagnostic images. In addition to its superparamagnetic properties, ferumoxytol can be administered rapidly as an IV injection at a rate of up to one milliliter per second. It also has a long blood half.life of approximately 15 hours, which may permit repeated imaging of the same or different body regions. These features of ferumoxytol may make it useful as an MRI biomarker in vascular disorders.

The initial focus of our clinical development of ferumoxytol as an imaging agent has been in patients with PAD for the detection of clinically significant arterial stenosis or occlusion. PAD is a manifestation of atherosclerotic cardiovascular disease and can occur when plaque builds up on the inside wall of the arteries that carry blood from the heart to the head, internal organs and limbs causing the arteries to narrow, which can reduce or block blood flow. Symptomatic PAD is associated with decreased quality of life, and whether symptomatic or asymptomatic, PAD is associated with an increased risk of cardiovascular and cerebrovascular problems, and cardiovascular mortality.

The prevalence of PAD in the U.S. is estimated to be approximately 8 million adults, affecting up to 20% of individuals 65 years of age and older. The prevalence of PAD increases with age, diabetes, CKD, hypertension and smoking, as does the presence of known atherosclerosis in other parts of the body.

In the U.S., cardiovascular disease is a common cause of morbidity and mortality, with a prevalence of approximately one in three adults. Additionally, cardiovascular disease is the leading cause of death, accounting for approximately 35% of all deaths in 2005.

Both the diagnosis and clinical management of PAD and cardiovascular disease often require the accurate assessment of vascular anatomy, and therefore, there is an important medical need for the availability of safe and effective techniques for invasive and/or non.invasive imaging modalities in these patient populations. High.resolution imaging, including digital subtraction angiography, contrast.enhanced computed tomography, and contrast.enhanced magnetic resonance angiography all provide the depiction of vascular anatomy required for consideration of endovascular or surgical intervention. However, there are important side effects of these techniques that seriously impact the appropriate evaluation of patients. There is a well.known risk of kidney damage associated with the administration of certain contrast agents for computed tomography, digital subtraction angiography, and X.ray angiography. Several currently approved contrast agents used for MRI in the U.S. are gadolinium.based and are associated with rare but severe adverse events in patients with CKD. In September 2007, the FDA issued a "Black Box" warning for all gadolinium.based contrast agents in certain patients due to these agents' potential association with Nephrogenic Systemic Fibrosis, or NSF. NSF is a condition that so far has only occurred in patients with kidney disease. NSF can pose a serious and potentially fatal risk to patients with CKD, and the FDA has sought to limit the use of currently available contrast agents in this patient population. Currently there is no effective treatment for NSF.

Ferumoxytol is an iron.based agent with unique superparamagnetic properties that may be visualized by MRI. There are no iron.based PAD contrast agents currently approved for MRI in the U.S. The FDA has granted Fast Track designation to ferumoxytol for its development as a diagnostic agent for vascular.enhanced MRI to improve the assessment of suspected PAD in patients with known or suspected CKD. The Fast Track process is designed to facilitate the development and expedite the FDA's review of products and is intended to bring valuable treatments more quickly to patients in need. We have enrolled approximately two.thirds of our 108 patient Phase II study of ferumoxytol for vascular.enhanced MRI for the detection of clinically significant arterial stenosis or occlusion.

We currently have exclusive world.wide rights to market and sell ferumoxytol as an imaging agent.

【2009 Competition】The pharmaceutical and biopharmaceutical industries are subject to intense competition and rapid technological change. We have competitors both in the U.S. and internationally, and many have greater financial and other resources and more experienced trade, sales and manufacturing organizations than we do. In addition, many of our competitors have name recognition, established positions in the market and long.standing relationships with customers and distributors. Feraheme's two primary competitors are Venofer®, which is marketed in the U.S. by Fresenius Medical Care North America, or Fresenius, and American Regent Laboratories, Inc., or American Regent, a subsidiary of Luitpold Pharmaceuticals, Inc., or Luitpold, and Ferrlecit®, which is marketed by Sanofi.Aventis U.S. LLC. Products developed by our competitors may be or may be perceived to be safer, more effective, and/or easier to administer or have more favorable pricing, insurance coverage, coding and reimbursement than Feraheme. In addition, further technological and product developments may make other iron replacement therapy products more competitive than Feraheme, which would adversely impact sales of Feraheme as an iron replacement therapeutic agent if such products are approved by the FDA. We may not be able to compete successfully with these companies.

We believe that our ability to successfully compete depends on a number of factors, including the timing and scope of regulatory approval of additional indications and geographies for Feraheme and of products by our competitors, our ability to obtain and maintain favorable pricing, insurance coverage, coding and reimbursement for Feraheme, our ability to implement effective marketing campaigns, the effectiveness of our sales force, our ability to maintain favorable patent protection for Feraheme, market acceptance of Feraheme and our ability to manufacture sufficient quantities of Feraheme at commercially acceptable costs.

The iron replacement therapy market is highly sensitive to several factors including, but not limited to, the perceived safety profile of the available products, the ability to obtain appropriate insurance coverage, coding and reimbursement, price competitiveness, and product characteristics such as convenience of administration and dosing regimens. To date, we have not conducted any head.to.head clinical studies comparing Feraheme to other IV iron replacement products.

There are currently two options for treating IDA in CKD patients: oral iron supplements and IV iron. The National Kidney Foundation's Kidney Disease Outcomes Quality Initiative guidelines recommend IV iron administration for hemodialysis patients with stage 5 CKD, and either oral or IV iron for peritoneal dialysis patients and non.dialysis patients with stages 1 through 5 CKD. However, oral iron supplements are poorly absorbed by many patients, which may adversely impact their effectiveness, and are associated with certain side effects that may adversely affect patient compliance in using such products. The alternative, IV iron, is currently available in the U.S. as ferumoxytol, iron sucrose, sodium ferric gluconate, or iron dextran. The IV iron products comprised of iron sucrose or sodium ferric gluconate are typically administered as a slow push or a fifteen to sixty minute infusion in doses of 100 to 200 milligrams, thus requiring five to ten physician visits and repeated IV access for patients to receive a standard one gram therapeutic course. The iron dextran products are typically administered as a slow push in 100 milligram doses and also require five to ten physician visits to receive a standard one gram therapeutic course. Feraheme is administered as a 510 milligram injection followed by a second 510 milligram injection three to five days later, each of which can be administered in as fast as 17 seconds at a regular office visit or during dialysis treatment without the use of infusion equipment or prolonged medical intervention.

Feraheme currently competes with four IV iron products in the U.S. for the treatment of IDA in CKD patients. Its two primary competitors are Venofer®, an iron sucrose complex, and Ferrlecit®, a sodium ferric gluconate. Venofer® is currently approved for use in hemodialysis, peritoneal dialysis and non.dialysis dependent CKD patients. Ferrlecit® is approved for use only in hemodialysis patients. Dexferrum® is an iron dextran product marketed by American Regent, and INFeD®, also an iron dextran product, is marketed by Watson Pharmaceuticals, Inc., or Watson. Both iron dextran products are used in patients with documented iron deficiency in whom oral iron administration is unsatisfactory or impossible.

Based on sales data provided by IMS Health Incorporated, or IMS Health, we estimate that the size of the 2009 U.S. IV iron replacement therapy market was approximately 1.6 million grams, which represented an increase of approximately 8% over 2008. Of the estimated 1.6 million grams sold in the U.S. IV iron therapy replacement market in 2009, sales of Venofer® and Ferrlecit® represented approximately 67% and 21%, respectively. Dexferrum® and INFeD® together accounted for approximately 11% of sales of grams of iron in the U.S. market in 2009. Feraheme accounted for approximately 1% of sales of grams of iron in the U.S. market in 2009.

We compete primarily in two segments of the iron replacement therapy market: the dialysis market and the non.dialysis market.

The dialysis market is the largest and most established market for IV iron replacement therapies, with two companies serving a significant majority of all dialysis patients in the U.S. Fresenius, and DaVita, Inc., or DaVita, together treat more than two.thirds of the U.S. dialysis population. In September 2008, Fresenius finalized an exclusive sublicense agreement with Luitpold, the U.S. licensing partner of Vifor Pharma, a subsidiary of Galenica Ltd., or Galenica, to manufacture, sell and distribute Venofer® to independent outpatient dialysis clinics in the U.S. Luitpold retains the right to sell Venofer® in the U.S. to any other customer. In addition, Galenica, Vifor Pharma, and Fresenius entered into a strategic joint.venture, which became effective on January 1, 2009, to market and distribute Venofer® and Ferinject® in the dialysis market in Europe, the Middle East, Africa and Latin America. Fresenius has significant experience selling and distributing dialysis equipment and supplies to outpatient dialysis clinics and, as a result of these agreements, it may be more difficult for us to penetrate the dialysis market, in particular at their clinics.

We believe there is a significant opportunity for Feraheme in the treatment of IDA in CKD patients not yet on dialysis. The non.dialysis IV iron market is comprised primarily of three segments: hospitals, hematology clinics and nephrology clinics. The only primary competitor currently approved for use in non.dialysis dependent CKD patients is Venofer®. Our ability to effectively compete with Venofer® in the non.dialysis CKD market depends in part upon our ability to gain formulary access in hospitals and effectively promote Feraheme to physicians who treat non.dialysis CKD patients.

In December 2009, Pharmacosmos A/S, or Pharmacosmos, received a positive recommendation in 22 European countries and a final marketing authorization in Denmark, Iceland and the Netherlands to market Monofer® (iron isomaltoside 1000), its injectable iron preparation for the treatment of IDA. During 2008, Pharmacosmos completed two Phase III non.comparative open.label studies of IV iron oligosaccharide in CKD patients as well as in congestive heart failure patients. Pharmacosmos is currently recruiting patients for a Phase III comparative open.label study of IV iron oligosaccharide in patients with inflammatory bowel disease and IDA. It is too early to determine whether Monofer® will gain any meaningful share of the IV iron market in any country in which it has been approved.

In addition to the foregoing currently marketed products, there are several iron replacement therapy products in various stages of clinical and commercial development in the U.S. and abroad,

including Injectafer®, which is known as Ferinject® in Europe, and soluble ferric pyrophosphate, a form of iron given as part of the hemodialysis procedure.

Galenica, through its subsidiary Vifor (International) Inc., or Vifor, exclusively licenses Injectafer® to Luitpold and American Regent for marketing and sale in the U.S. and Canada. Injectafer® is in development for a variety of anemia.related indications, including the treatment of IDA in CKD patients, whether or not on dialysis. In March 2008, Luitpold received a non.approvable letter from the FDA for Injectafer® for the treatment of IDA in postpartum women and women with heavy uterine bleeding in the U.S. Luitpold initiated five clinical trials during 2008 and 2009 in an effort to provide additional data to address the concerns of the FDA. In June 2007, the UK Medicines and Healthcare Products Regulatory Agency approved the registration of Ferinject®, and it was simultaneously registered in a total of 18 EU countries. Ferinject® is currently marketed in at least 12 European countries. In November 2009, Vifor completed a Phase III study of patients with chronic heart failure and iron deficiency. In addition, Vifor is sponsoring ongoing Phase III trials for Ferinject® for the treatment of anemia in patients with inflammatory bowel disease and has stated that it is planning to initiate a Phase IIIb study to evaluate the long.term efficacy of Ferinject® in non.dialysis dependent CKD patients with IDA.

Rockwell Medical, or Rockwell, is developing an iron supplemented dialysate product, a form of iron given as part of the hemodialysis procedure, to be used as a treatment for IDA in dialysis patients. Rockwell has completed a Phase IIb clinical trial and has stated that it intends to initiate Phase III trials in the second half of 2010. We do not know when this product might be submitted to the FDA for approval or marketed. If shown to be safe and effective for the treatment of IDA, this product could compete with Feraheme in the dialysis market segment.

In addition to competition from other marketed products and products known by us to be currently under development, the market opportunity for Feraheme could be negatively affected if generic IV iron replacement therapy products were to be approved and achieve commercial success. For example, in July 2009, Watson announced that it entered into a license agreement with GeneraMedix, Inc., or GeneraMedix, for the exclusive U.S. marketing rights to a generic version of Ferrlecit®, which is indicated for the treatment of IDA in hemodialysis patients receiving supplemental ESA therapy. GeneraMedix has filed an Abbreviated NDA with the FDA, which is under expedited review. Companies that manufacture generic products typically invest far less resources in research and development than the manufacturer of a branded product and can therefore price their products significantly lower than those already on the market. It remains unclear if and when a generic product will enter this market. If any of these product candidates are approved for marketing and sale by the FDA, our efforts to market and sell Feraheme and our ability to generate additional revenues and achieve profitability could be adversely affected.


●GastroMARK
【2009】GastroMARK, our oral contrast agent used for delineating the bowel in MRI, is approved and marketed in the U.S., Europe, and other countries through our marketing partners. Sales of GastroMARK by our marketing partners have been at their current levels for the last several years, and we do not expect sales of GastroMARK to change materially.

GastroMARK was approved by the FDA in 1996. Our marketing partner, Covidien, Ltd., or Covidien, or its predecessors, have been marketing GastroMARK in the U.S. since 1997. We initially licensed the marketing rights to GastroMARK on an exclusive basis to Guerbet S.A., or Guerbet, in western Europe and Brazil. Guerbet has been marketing GastroMARK in several EU countries since 1993 under the tradename Lumirem® and subsequently acquired the rights to market GastroMARK in several other countries in South America, the Middle East, southeast Asia, Africa, and eastern Europe. See "Licensing, Marketing and Supply Arrangements."


【】

AMAG Pharmaceuticals, Inc

Products Feraheme® (ferumoxytol) GastroMARK® (ferumoxsil) InvestorsSEC Filings 10-K Annual report[2010.2.26] - [pdf,151p] - [doc] - [xls] Financial ReportAnnual Report 2009 Annual Report Press Releases

AMAG Pharmaceuticals and Takeda Announce Acceptance of Submission of Feraheme(R) Marketing Authorization Application to the European Medicines Agency[2010.6.29]
AMAG Pharmaceuticals to Host Conference Call to Discuss Strategic Collaboration with Takeda Pharmaceutical Company for Feraheme(R) in Select Ex-US Territories[2010.4.1]
AMAG Pharmaceuticals and Takeda Pharmaceutical Company Announce Strategic Collaboration for Feraheme(R) in All Therapeutic Indications in Select Ex-US Territories, Including Europe[2010.4.1]
AMAG Pharmaceuticals Provides Feraheme(R) Safety Update[2010.2.5]
AMAG Pharmaceuticals, Inc. Announces Data Presentations at the American Society of Nephrology (ASN) Renal Week Meeting[2009.10.7]
AMAG Pharmaceuticals Announces U.S. Launch of Feraheme(TM) (ferumoxytol) Injection[2009.7.13]
FDA Approves Feraheme(TM) to Treat Iron Deficiency Anemia in Adult Chronic Kidney Disease Patients[2009.6.30]
FDA Decision on Feraheme NDA Expected Within Next Few Days[2009.6.29]
AMAG Pharmaceuticals Announces New PDUFA Date for Feraheme(TM) (ferumoxytol injection)[2009.5.12]





Amersham Plc

 -http://www.amersham.com/index.html; 本社−英国;医用診断機器、ライフサイエンス
分野の世界企業。 従業員10,000以上、年間売上(2002) £1.62 billion ($2.54 billion)。
 世界30か国に研究・製造施設、50か国に販売施設をもつ。

  ★2003.10.10にGEによる買収が行われ、2004.4.8に完了。(詳細)
 GE Healthcare -http://www.gehealthcare.com/



★Amersham plcを2つの事業で組織される。
  Amersham Health (medical diagnostics and therapy products)および
  Amersham Biosciences (バイオ;discovery systems and protein separations).
★歴史
 Amersham plcは、1997年にAmersham International (UK), Pharmacia Biotech (Swede
n) and Nycomed (Norway)の3社合併により誕生。
 註) Pharmacia Biotech(1967-1997): それ以前はPharmacia
      Amersham International() ;当初英政府出資The Radiochemical Centreとして
       25年間、1982年私企業化Amersham

・The Radiochemical Centre; Amersham International; Nycomed Amersham; Amersham plc
・Nycomed; Nycomed Amersham Imaging; Amersham Health  
・Pharmacia; Pharmacia Biotech; Amersham Pharmacia Biotech; Amersham Biosciences



■売上
(単位£)          2003     2002     2001
●Amersham Health  973(+7)  948(+8%)  922(+13)
★医療用診断薬     924(+9)  886 
※造影剤
Omnipaque          218(+2)  222(+6%) (iohexol) 非イオンX線/CT循環器・神経・腫瘍[特許off]
Visipaque          122(+38)  91(+18) (iodixanol) 非イオンX線/CT循環器系 [特許2008-2011]
Omniscan           106(+12)  96(+17) (gadodiamide) MRI中枢神経・循環器 [2007-2009]
Optison                    (human albumin microspheres containing perflutren)
                           心筋[2012-2013]
※放射性医薬品
Myoview            149(+20) 133(+26) (99mTc-tetrafosmin kit) 心血流・乳癌[2009-2010]
★治療薬            49(-17)  62

●Amersham Biosci  679      670(+6%)  681(+12)
蛋白分離           295(+5)  276 
探索システム       384(-2)  394 

全売上 1652(+6) 1618 ■地域別売上 (単位£) 2002 2002 2001 従業員数 北米 807 799(+8) 2,900 欧州 462 428(+8) 6,200 日本 247 264(+1) 250 アジア太平洋 95 80 その他 41 47 700
全売上 1652(+6) 1618 ■Market Report: Medical Diagnostics/Radiotherapy[Amersham AnnualReport 2002] ※米国市場シェア Amersham 38%, Bracco 18%, Tyco Healthcare(Mallinckrodt Imaging) 14%, Schering 12%, Bristol-Myers Squibb(BMS) Medical Imaging(formerly Dupont) 12%, Guerbet 2%, その他 4% ※診断機器 X-ray/CT MRI 放射性診断薬 超音波診断 Total scans 630m 40m 140m Enhanced scans 75m 10m 28m 0.5m 市場規模 £1.4bn £320m £1.1bn £10m (1.5万台上) (1.5万台上) (15万台上) GammaCamera
Amersham Plc

-http://www.amersham.com/index.html ●Investors Annual reports Financial archivesNews & Events Preliminary Results for the 12 months ended 31 December 2003[2004.2.17] 1999/1-以降がWEB検索可 ●開発品目  Annual Report 2002に記載がなく Preliminary Results for the 12 Months ended 31 December 2002[2003.2.26]参照。 ●FastFact 2003 - 個別製品売り上げ、製品シートなど ■日本  Amersham KKとして日本支社あり。  日本メディフィジックス、第一製薬との契約あり。
Amersham Health

(旧 Nycomed Amersham Imaging) ●Product Information 要ID --米国以外 Amersham Health-USProduct Catalog
アマシャム バイオサエインス株式会社

 設立1998年4月、従業員数 約240名、売上高 約180億円(2003年) 事業内容 バイオテクノロジー関連機器および試薬の輸出入販売 主力製品 液体クロマトグラフィー装置、ゲル坦体、DNAシークエンサー、マイクロアレイ、 ラジオアイソトープ標識化合物など (略歴)  1973年 スウェーデン国 Pharmacia AB 日本法人設立  1981年 英国 Amerham International plc 日本法人設立  1998年 4月 アマシャム株式会社 とファルマシア バイオテク株式会社が合併        アマシャム ファルマシア バイオテク株式会社設立  2002年 1月 アマシャム バイオサイエンス株式会社へ社名変更 from 会社概要製品テクノロジープレスリリース
日本メジフィジックス株式会社

- http://www.nmp.co.jp/ - [設立]1973年3月20日 [出資比率] 住友化学工業株式会社 50%/アマシャムグループ 50% 事業目的 放射性医薬品、診断用薬、医療用具および関連製品の研究、開発、製造、販売ならびに輸出入  [沿革] 1973年 3月 米国メジフィジックス(MPI)、住友化学工業株式会社、住友商事株式会社の合弁会社として設立 1975年 3月 MPIに代わり、日本ロシュ株式会社が株主になる 1994年 3月 日本ロシュ株式会社が株主より撤退 12月 英国アマシャム・インターナショナルが株主となる 1996年 9月 アマシャム株式会社のヘルスケア事業部門と統合 10月 住友化学工業株式会社とアマシャム・インターナショナルの折半出資体制となる 1997年10月 英国アマシャム・インターナショナルのヘルスケア部門とニコメッド(ノル ウェー)との合併に伴い、新会社ニコメッド・アマシャム(現アマシャム)が株主となる 2000年 3月 NMPビジネスサポート株式会社設立 2001年 4月 住友製薬株式会社とそれぞれの体外診断薬事業を分離・統合し設立した住友 製薬バイオメディカル株式会社営業開始 2004年 4月 ゼネラルエレクトリック(GE)グループによるアマシャム買収が成立 ●核医学診断医療関係者のページ  〜放射性医薬品・製品一覧、添付文書情報 ●ニュースリリース




Amgen

 設立1980。 本社は米国Delaware

 2002.7.15 Immunexを吸収。同社Press Releaseは、Immunex Press Release Archivesとして別扱い
 2004.3.29 Tularikを吸収($1.3 Billion)。同社Press Releaseは、Tularik Press Release Archives
	(Tularikは5品目のCandidate、肝臓癌薬T67,消化器癌薬T607,抗炎症剤T487,糖尿病薬T131,抗肥満薬T71を開発)
 2005.12.14 Abgenix Inc.を吸収。同社Press Releaseは、Abgenix Press Release Archives
		同社は既発売品はなく、大腸癌治療薬panitumumabを開発中。
		Abgenix Inc 2005年決算





●会社決算
($ milllion)2009200820072006200520042003200220012000
売上高14,64215,00314,77114,26812,43010,5508,3565,5234,0163,629
うち製品売上14,35114,68714,31113,85812,0229,977(+27)7,868(+58)4,9913,5113,202
  他の収入291316460410408573488532505427

研究開発費2,8643,0303,2663,3662,3142,0281,6551,117865845
純利益4,6054,065
旧4,196
3,078
旧3,166
2,809
旧2,950
3,633
旧3,674
2,3632,259-1,3921,1201,139
従業員数17,20016,90017,50020,10016,50014,40012,90010,1007,7007,300
 うち研究開発7,8507,0008,2006,5005,6004,7003,4003,8003,800
 うち販売3,0502,9503,2003,0002,7002,6002,2001,8001,500
 うち製造3,6005,6006,6005,1004,4003,6002,5002,1002,000
 うちその他2,4001,9502,1001,9001,7002,0002,000
●製品売上高
($ milllion)20092008200720062005200420032002200120001999199819971996
EPOGEN [米国内]2,569(+5)2,456(-1)2,489(-1)2,5112,455(-6)2601(+7)2434.72260.62108.51962.91759.11382.01160.71071.9epoetin alfa/貧血症
Aranesp2,652(-15)3,137(-13)3,614(-12)4,121(+26)3,273(+32)2473(+60)1543.8415.641.5darbepoetin alfa/貧血症
 米国内1,251(-24)1,651(-23)2,154(-23)2,7902,104(+37)1533(+56)979.9284.7
 国外1,401(-6)1,486(+2)1,460(+10)1,3311,169(+24)940(+67)563.9130.9
Neulasta/NEUPOGEN4,643(+0)4,659(+9)4,277(+9)3,923(+12)3,504[]/好中球減少症
Neulasta3,3553,3182,8802,7102,28817401255.0463.5(2002.2nd発売)pegfilgrastim/好中球減少症
 米国内2,527(+1)2,505(+7)2,231(+6)2,217(+17)1,900(+29)14761175.7463.5
 国外828(+2)813(+25)649(+32)493(+27)388(+47)264(+230)79.3-
NEUPOGEN1,2881,3411,2771,2131,2161175126713801223.71256.61116.61055.71016.3-filgrastim/好中球減少症
 米国内901(+1)896(+4)861(+4)830(+3)805(+3)778(-12)880.51041.7
 国外387(-13)445(+7)416(+9)383(-7)411(+4)397(+3)386.2337.9
Enbrel3,493(-3)3,598(+11)3,230(+12)2,879(+12)2.573(+35)1900(+46)1300362.1[全期換算802]etanercept/リウマチ性関節炎
 米国内3,283(-3)3,389(+11)3,052(+12)2,736(+11)2,470(+35)1827(+46)1253.7346.2
 国外[加]210(+0)209(+17)178(+24)143(+39)103(+41)73(+59)46.315.9
Sensipar651(+9)597(+29)463(+44)321(+104)157(+324)37[cinacalcet HCl]腎不全に伴う副甲状腺機能亢進症および副甲状腺癌患者のhypercalcemia
 米国内429412333238122[]
 国外2221851308335[]
Vectibix 国内-170(+336)39(-)--[panitumumab]発売2006Q4;大腸癌
その他製品343(+43)240(+1)68(+6)64(+7)60(+18)51
旧88
68.0109.8
 米国内17515120336366439.4100.0
 国外168893528242428.69.8
Kineret------68.0109.812.0---------------01.11発売(anakinra)/リウマチ性関節炎 抗リウマチ剤;IL-1レセプター拮抗薬
 米国内------39.4100.0
 国外------28.69.8
INFERGEN---[2001.6 Intermuneに米・加の独占ライセンス]-14.526.216----(Interferon alfacon-1)
Total Product Sales14,351(-2)14,687(+3)14,311(+3)13,858(+15)12,022(+20)9977(+27)7868.2(+58)4991.23511.03202.23042.82514.42219.82088.2
 米国内11,135(-3)11,460(+0)11,443(+0)11,397(+15)9,892(+19)8279(+22)6763.94496.7
 国外3,216(+0)3,227(+13)2,868(+17)2,461(+16)2,130(+25)1,698(+54)1104.3494.5
[]
*Immunexを2002.7買収。Enbrelは2002末迄に8万人の患者に使用。Wyethは北米で販売パートナー *INFERGEN(Interferon alfacon-1) 1996年山之内製薬(現アステラス製薬)に日本での 共同開発・販売ライセンス

【2009】

●Nplate(R) (romiplostim)  ITP
Romiplostim (Nplate(R)) is a peptibody agonist of the thrombopoietin (“TPO”) receptor.

Nplate(R) is the first FDA-approved agent that acts directly to increase platelet production for the treatment of thrombocytopenia in splenectomized (spleen removed) and non-splenectomized adults with chronic ITP, who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.

In August 2008, Nplate(R) became the first FDA-approved peptibody protein, which works by raising and sustaining platelet counts representing a novel approach for the treatment of this chronic disease.

We are also evaluating romiplostim in pediatric ITP, myelodysplastic syndromes (“MDS”), and chemotherapy-induced thrombocytopenia (“CIT”). Phase 2 studies in each setting were initiated in 2006. The trials are currently ongoing and we continue to evaluate the safety and efficacy of romiplostim in these settings.

On August 22, 2008, the FDA approved Nplate(R), the first platelet producer for the treatment of thrombocytopenia in splenectomized (spleen removed) and non-splenectomized adults with chronic ITP. Nplate(R), the first FDA approved peptibody protein, works by raising and sustaining platelet counts. On February 6, 2009, we announced that the European Commission granted marketing authorization for Nplate(R) for the treatment of splenectomized adult chronic ITP patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). In the EU, Nplate(R) may also be considered as second line treatment for adult non-splenectomized ITP patients where surgery is contra-indicated.

【2008】On August 22, 2008, the FDA approved Nplate(R), the first platelet producer for the treatment of thrombocytopenia in splenectomized (spleen removed) and non-splenectomized adults with chronic immune thrombocytopenic purpura (“ITP”). Nplate(R), the first FDA approved peptibody protein, works by raising and sustaining platelet counts. As part of the approval for Nplate(R), a REMS was developed with the FDA to assure the safe use of Nplate(R) while minimizing risk. The Nplate(R) REMS involves, among other things, healthcare provider and patient enrollment registries, tracking of patient medical history and data and follow-up safety questionnaires to healthcare providers, all of which require extensive discussion with and education of healthcare providers. In addition, on February 6, 2009, we announced that the European Commission granted marketing authorization for Nplate(R) for the treatment of splenectomized adult chronic ITP patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). In the European Union (“EU”), Nplate(R) may also be considered as second line treatment for adult non-splenectomized ITP patients where surgery is contra-indicated.

●Vectibix(R) (panitumumab)  大腸癌
Vectibix(R) is our trademark for our first entirely human monoclonal antibody for the treatment of patients with EGFr expressing mCRC after disease progression on, or following fluoropyrimidine-, oxaliplatin- and irinotecan- containing chemotherapy regimens. EGFr is a protein that plays an important role in cancer cell signaling and is over-expressed in many human cancers. Vectibix(R) is an entirely human monoclonal antibody that binds with high affinity to EGFrs and interferes with signals that might otherwise stimulate growth and survival of the cancer cell. The goal of developing entirely human monoclonal antibodies is to offer effective targeted therapies with lessened risk of immune response against these agents. Vectibix(R) received FDA approval in September 2006. On December 5, 2007, the European Commission granted a conditional marketing authorization for Vectibix(R), which was renewed in December 2008, as a monotherapy for the treatment of patients with EGFr expressing mCRC with non-mutated (wild-type) KRAS genes after failure of standard chemotherapy regimens. We acquired full ownership of Vectibix(R) as part of our acquisition of Abgenix, Inc. (“Abgenix”) in April 2006.
【2009】
【2008】At the ODAC meeting on December 16, 2008, we discussed the clinical utility of the KRAS gene as a predictive biomarker in patients with metastatic colorectal cancer (“mCRC”) treated with anti-Epidermal Growth Factor Receptors (“EGFr”) antibody, Vectibix(R). We believe that data shared with the ODAC supports the suggestion that KRAS is a predictive biomarker for the anti-EGFr class of drugs in the monotherapy setting. In March 2008, the Journal of Clinical Oncology published results from an analysis of the first randomized, controlled clinical trial (“Study 408”), which showed that mCRC patients with mutated KRAS tumors do not respond to Vectibix(R) monotherapy. Conversely, patients with wild-type KRAS tumors treated with Vectibix(R) have a better response rate and prolonged progression-free survival (“PFS”).

●Denosumab 骨粗鬆症
【2009】・ We received Complete Response Letters from the FDA on our biologics license application ("BLA") for Prolia in the treatment and prevention of postmenopausal osteoporosis ("PMO") in women and bone loss in patients undergoing hormone ablation therapy ("HALT") for either prostate or breast cancer. These Complete Response Letters requested additional information to support approval of the treatment of the PMO indication and the HALT indication, and requested a new clinical program to support approval of the prevention of the PMO indication. (The FDA has provisionally approved the trade name Prolia in the indications noted above, for which the drug is administered twice yearly subcutaneously at a 60 milligram ("mg") dose. The trade name is only for these indications and may not apply for other indications of denosumab.)

・ On February 19, 2010, we announced that the FDA has evaluated the content of our Complete Response submission for Prolia in the treatment of PMO, which we submitted on January 25, 2010, and classified it as a Class 2 resubmission. With the Class 2 designation, the FDA set a corresponding Prescription Drug User Fee Act ("PDUFA") action date of July 25, 2010.

・ We received a positive opinion from the Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency ("EMA") (formerly known as the EMEA) for marketing authorization for the treatment of osteoporosis in postmenopausal women at increased risk of fractures and bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures.

・ We announced positive results from the following three phase 3 head-to-head trials evaluating denosumab versus Zometa® (zoledronic acid) in the treatment of bone metastases:
 ※in patients with advanced breast cancer, in which denosumab was superior to Zometa® in delaying the time to the first skeletal-related event ("SRE") and delaying the time to the first-and-subsequent SREs,
 ※in advanced cancer patients with solid tumors or multiple myeloma, in which denosumab was non-inferior to Zometa® in delaying the time to the first SRE,
 ※in men with advanced prostate cancer, in which denosumab was superior to Zometa® in delaying the time to the first SRE and delaying the time to the first-and-subsequent SREs.

These three studies will form the basis of the clinical evidence package for denosumab in advanced cancer, which will be submitted to regulatory authorities later in 2010.

Denosumab is a fully human monoclonal antibody that specifically targets a ligand known as RANKL (that binds to a receptor known as RANK) which is an essential regulator of osteoclasts. Denosumab is under regulatory review and is being studied across a range of conditions, including osteoporosis, treatment-induced bone loss, bone metastases, multiple myeloma and RA.

The following is a summary of certain key developments that occurred in 2009 and early 2010 with respect to denosumab:
Prolia (denosumab) for the Prevention and Treatment of PMO and the Prevention and Treatment of Bone Loss in Patients Undergoing HALT for either Prostate Cancer or Breast Cancer

In late 2008, we submitted the BLA to the FDA for Prolia in the treatment and prevention of PMO in women and bone loss in patients undergoing HALT for either prostate or breast cancer.

On August 13, 2009, we announced the results of our meeting with the FDA's Advisory Committee for Reproductive Health Drugs ("ACRHD") to review the potential use of Prolia for the treatment and prevention of PMO in women and the treatment and prevention of bone loss in patients undergoing HALT for either prostate cancer or breast cancer. The Committee recommended approval of Prolia for the treatment of PMO and for the treatment of bone loss in patients undergoing HALT for prostate cancer. The Committee recommended against approval of Prolia to treat or prevent bone loss in women with breast cancer undergoing HALT until additional data are available. The Committee also recommended against approval of Prolia to prevent bone loss in low-risk patients in all three populations. Finally, the Committee recommended that Prolia have a REMS. The ACRHD is an advisory committee of external experts who advise the FDA about the safety and effectiveness of marketed and investigational human drugs for use in the practice of obstetrics, gynecology and related specialties. This committee is advisory only and FDA officials are not bound to or limited by their recommendations.

In October 2009, the FDA issued Complete Response Letters for our BLA for Prolia for the above-noted indications. The FDA issues Complete Response Letters to request additional information needed to complete the review of applications for product approval.

The Complete Response Letter related to the Prolia application for the treatment and prevention of PMO in women requested several items, including further information on the design and background adverse event rates that will inform the methodology of our previously submitted post-marketing surveillance program, although the letter did not require additional pre-marketing clinical trials to complete the review of the treatment indication. The FDA has also requested a new clinical program to support approval of Prolia for the prevention of PMO indication. In addition, the FDA has determined that a REMS is necessary for Prolia and must include a medication guide and a healthcare provider communication plan. The FDA acknowledged receipt of our previously submitted proposed REMS materials. The FDA also requested all updated safety data related to Prolia. On February 19, 2010, we announced that the FDA has evaluated the content of our Complete Response submission for Prolia in the treatment of PMO, which we submitted on January 25, 2010, and classified it as a Class 2 resubmission. With the Class 2 designation, the FDA set a corresponding PDUFA action date of July 25, 2010.

The Complete Response Letter related to the Prolia HALT application requested additional information regarding the safety of Prolia in patients with breast cancer receiving aromatase inhibitor therapy and patients with prostate cancer receiving androgen deprivation therapy ("ADT"). Specifically, the FDA has requested results from additional adequate and well-controlled clinical trials demonstrating that Prolia has no detrimental effects on either time-to-disease progression or OS. We continue to work with the FDA to determine the appropriate next steps regarding our application for the HALT indication.

Prolia Received Positive Opinion from CHMP in the EU

In December 2009, the CHMP announced a positive opinion for the marketing authorization of Prolia for the treatment of osteoporosis in postmenopausal women at increased risk of fractures, and for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. If approved by the European Commission, we would receive marketing authorization for Prolia in all EU Member States. The timing of actual launch dates would vary by country based on reimbursement authority approval of pricing which could follow the EMA approval by many months. While the European Commission generally follows the CHMP's opinion, it is not bound to do so.

Prolia is also under regulatory review in Switzerland, Australia and Canada for the treatment and prevention of PMO and the treatment of bone loss in patients undergoing HALT for breast and prostate cancer. We are working closely with regulatory agencies in each of these countries.

Denosumab Phase 3 Bone Metastases Clinical Trials

In 2009, we announced that the phase 3 head-to-head trial evaluating denosumab versus Zometa® in the treatment of bone metastases in patients with advanced breast cancer met its primary endpoint of non-inferiority in time to first SRE and its secondary endpoints (superiority compared to Zometa® for both delaying the time to the first on-study SRE and delaying the time to the first-and-subsequent SREs). We also announced that the phase 3 head-to-head trial evaluating denosumab versus Zometa® in the treatment of bone metastases in advanced cancer patients with solid tumors (not including breast and prostate cancer) or multiple myeloma met its primary endpoint of non-inferiority in time to first SRE. On February 8, 2010, we announced that the phase 3 head-tohead trial evaluating denosumab versus Zometa® in the treatment of bone metastases in advanced cancer patients with prostate cancer met its primary endpoint of non-inferiority in time to first SRE and its secondary endpoints (superiority compared to Zometa® for both delaying the time to the first on-study SRE and delaying the time to the first-and-subsequent SREs). These three studies will form the basis of the clinical evidence package for denosumab in advanced cancer, which will be submitted to regulatory authorities later in 2010. For more information, see "Research and Development and Selected Product Candidates."

Patents and Competition

Our outstanding material patents for denosumab are described in the table below.

TerritoryGeneral Subject MatterExpiration(1)
U.S.RANKL antibodies12/22/2017
U.S.Methods of treatment11/11/2018
U.S.RANKL antibodies11/28/2023
EuropeRANKL antibodies12/22/2017
EuropeMethods of treatment4/15/2018
EuropeRANKL antibodies2/23/2021

(1) The expiration dates may be subject to change if delays in regulatory approval lead to extensions of patent terms in the United States and/or supplemental protection in Europe.

The following table and discussion reflect other companies and their currently marketed products that will compete with denosumab, if approved. This table and discussion of competitor marketed products and potential competitor products may not be exhaustive. Merck's patent covering the use of FOSAMAX® to treat bone loss expired in the United States in February 2008. Following the patent expiry, generic alendronate ("ALN") became available from Teva and other companies, which competes with FOSAMAX® .

Therapeutic AreaCompetitor Marketed ProductPotential Competitor
PMOFOSAMAX®Merck
PMOActonel®Warner Chilcott/Aventis
PMOBoniva® /Bonviva®Roche/GSK
PMOEvista®Eli Lilly
PMOForteo® /ForsteoEli Lilly
PMOMiacalcin®Novartis AG ("Novartis")
PMOAclasta® /Reclast®Novartis
PMOConbriza®Pfizer
PMOFablyn®Pfizer
OncologyZometa®Novartis
OncologyAredia®Novartis

【2008】Denosumab is the first fully human monoclonal antibody in late stage clinical development that specifically targets a ligand known as RANKL (that binds to a receptor known as RANK), an essential regulator of osteoclasts (the cells that break down bone). Denosumab is being investigated for its potential to inhibit all stages of osteoclast activity through a targeted mechanism. In December 2008, we submitted a biologics license application (“BLA”) to the FDA for denosumab for the treatment and prevention of postmenopausal osteoporosis (“PMO”) in women and bone loss in patients undergoing hormone ablation for either prostate or breast cancer. On February 18, 2009, the FDA accepted our BLA and informed us that it will target an FDA action within ten months of the BLA’s submission date, resulting in a Prescription Drug User Fee Act (“PDUFA”) action date of October 19, 2009. The FDA indicated that it intends to simultaneously review the data we submitted for both the PMO and bone loss in patients undergoing hormone ablation for prostate or breast cancer indications due to the interdependency of the data across the indications from more than 11,000 patients included in support of the BLA. Additionally, in January 2009, we submitted an application to the EMEA for the approval of denosumab for treatment of PMO in women and treatment of bone loss associated with hormone ablation therapy in patients with breast and prostate cancer. In addition, during 2008, we announced results of the following key trials involving denosumab.

Osteoporosis

On September 16, 2008 at the American Society of Bone and Mineral Research (“ASBMR”) annual meeting, we presented detailed results from the pivotal fracture trial (“Study 216”) evaluating denosumab in the treatment of PMO. In this pivotal, three-year, international, phase 3 study of approximately 7,800 women with osteoporosis, patients were randomized to receive either denosumab, given by subcutaneous injection once every six months, or placebo injections. For the primary endpoint, treatment with denosumab resulted in a statistically significant reduction (68%) in the incidence of new vertebral fractures compared with placebo treatment (2.3% for denosumab versus 7.2% for placebo, p=0.0001). In addition, women receiving denosumab experienced a statistically significant reduction (20%) in the incidence of new non-vertebral fractures compared with placebo treatment (6.5% for denosumab versus 8.0% for placebo, p=0.011) and a statistically significant reduction (40%) in the incidence of hip fractures compared with placebo treatment (0.7% for denosumab versus 1.2% for placebo, p=0.036), each a secondary endpoint. The incidence and types of both adverse and serious adverse events observed in this study, including serious infections and neoplasms, were similar between the denosumab and placebo groups. The most common adverse events across both treatment arms were arthralgia, back pain, hypertension and nasopharyngitis.

In addition to the detailed results of Study 216, we presented the results of two non-pivotal phase 3 studies of denosumab in osteoporosis at the ASBMR meeting. The first was a phase 3 head-to-head, double-blind trial known as the Study of Transitioning from AleNdronate to Denosumab trial (“STAND”) (“Study 234”). The results of this study demonstrated that subcutaneous injections of denosumab every six months achieved significantly greater increases in bone mineral density (“BMD”) versus those achieved with alendronate (“ALN”) at all sites measured. For the primary endpoint, denosumab resulted in significant increases in BMD at the total hip compared with ALN (1.9% for denosumab versus 1.05% for ALN, p<0.0001). Treatment with denosumab also resulted in significant increases in BMD compared with continued ALN treatment at all secondary endpoints, including the lumbar spine, femoral neck, hip trochanter and 1/3 radius. The incidence and types of adverse events observed in the study, including neoplasms and infection, were similar between the denosumab and ALN treatment groups. The most common adverse events across both treatment arms were back pain, arthralgia and nasal pharyngitis. The second non-pivotal study was a head-to-head trial comparing denosumab to weekly oral ALN, also known as the Determining Efficacy: Comparison of Initiating Denosumab versus Alendronate trial (“DECIDE”) (“Study 141”). As a part of this study, patients were given a questionnaire after 12 months of treatment to gauge preference on mode of administration as well as satisfaction with frequency of dosing of twice-yearly subcutaneous injections versus weekly oral tablet. More than three-quarters of patients in both study arms preferred subcutaneous injection over oral pills (77% versus 23%, p <0.0001). In addition, significantly more patients were more satisfied with twice-yearly dosing compared to weekly dosing (80% placebo injection versus 20% weekly oral ALN, and 79% for denosumab versus 21% weekly placebo tablet, p <0.0001 for both study groups).

Oncology

On July 14, 2008, we announced findings from a three-year pivotal phase 3 placebo-controlled trial evaluating denosumab in the treatment of bone loss in men undergoing androgen deprivation therapy (“ADT”) for non-metastatic prostate cancer (“Study 138”). In this study of more than 1,400 men, denosumab treatment produced statistically significantly greater increases in BMD at the lumbar spine (primary endpoint) and non-vertebral sites compared with placebo at multiple time points. These improvements in BMD were consistent with those seen in other denosumab studies evaluating BMD in women with breast cancer receiving aromatase inhibitor (“AI”) therapy, and in postmenopausal women with low bone mass. During the 36-month evaluation period, men receiving denosumab experienced less than half the incidence of new vertebral fractures (a secondary endpoint) compared with those receiving placebo, a statistically significant finding. Furthermore, in the denosumab arm there were fewer non-vertebral fractures over the 36-month period. The incidence and types of adverse events observed in this study were generally similar between the denosumab and placebo groups. The most common adverse events across both treatment arms were arthralgia, back pain, constipation and pain in extremity. Serious adverse infectious events occurred in approximately 5% of men receiving placebo treatment as compared with approximately 6% of those receiving denosumab.


●EPOGEN(R) (Epoetin alfa)
reduced red blood cell count can result in anemia (see “− Aranesp(R) (darbepoetin alfa)”). People with CRF suffer from anemia because they do not produce sufficient amounts of erythropoietin, which is normally produced in healthy kidneys.

We were granted an exclusive license to manufacture and market recombinant human erythropoietin in the United States under a licensing agreement with KA. We have retained exclusive rights to market EPOGEN(R) in the United States for dialysis patients. We granted Ortho Pharmaceutical Corporation (which has assigned its rights under the Product License Agreement to Ortho Biotech) a license to commercialize recombinant human erythropoietin as a human therapeutic in the United States in all markets other than dialysis (see “Joint Ventures and Business Relationships − Johnson & Johnson”).

We launched EPOGEN(R) in the United States in 1989 for the treatment of anemia associated with CRF for patients who are on dialysis. We market EPOGEN(R) for the treatment of anemic adult and pediatric patients with CRF who are on dialysis. EPOGEN(R) is indicated for elevating or maintaining the red blood cell level (as determined by hematocrit or Hb measurements) and decreasing the need for blood transfusions in these patients.

EPOGEN(R) sales in the United States were $2.5 billion for each of the three years ended December 31, 2008.

Our outstanding material patents for Epoetin alfa are described in the table below. 
Territory    General Subject Matter    Expiration 
U.S.    Process of making erythropoietin    8/15/2012 
U.S.    Product claims to erythropoietin    8/20/2013 
U.S.    Pharmaceutical compositions of erythropoietin    8/20/2013 
U.S.    Cells that make certain levels of erythropoietin    5/26/2015
Any products or technologies that are directly or indirectly successful in addressing anemia associated with CRF could negatively impact product sales of EPOGEN(R). In the United States, EPOGEN(R) and Aranesp(R) compete with each other, primarily in the U.S. hospital dialysis clinic setting, and there was a conversion from EPOGEN(R) to Aranesp(R) in this setting, however we believe that the conversion has stabilized. In addition, Affymax and Takeda are co-developing Hematide?, an ESA for the treatment of anemia in renal patients. FibroGen is developing FG-2216 and FG-4592, orally active ESAs for the treatment of anemia. Additionally, in December 2008, Merck announced the formation of a new biotech division, Merck Bioventures, which is developing a late stage pegylated ESA (MK-2578), which they have announced they expect to launch in 2012.
【2009 ESAs】

・ On February 16, 2010, we announced that the FDA approved a REMS program for our ESAs. On February 16, 2010, Amgen and Centocor Ortho Biotech Products, L.P. ("Centocor Ortho Biotech Products"), a subsidiary of Johnson & Johnson ("J&J"), announced that the FDA approved a REMS for ESAs which includes Aranesp® , EPOGEN® and Procrit® (Epoetin alfa). The FDA has determined that a REMS is necessary for ESAs to ensure the benefits of these drugs outweigh the risks of shortened overall survival ("OS") and/or increased tumor progression or recurrence as identified in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid and cervical cancers. As part of the REMS, a medication guide explaining the risks and benefits of ESAs must be provided to all patients receiving ESAs. To ensure continued access to ESAs for healthcare providers who prescribe, or prescribe and dispense, ESAs to patients with cancer, providers are required to train and enroll in the ESA APPRISE (Assisting Providers and cancer Patients with Risk Information for the Safe use of ESAs) Oncology Program and to document that a discussion about the risks of ESAs took place with each patient prior to the initiation of each new course of ESA therapy. The ESA APPRISE Oncology Program will be launched on March 24, 2010. Direct patient registration or approval prior to ESA administration is not required through the ESA APPRISE Oncology Program.

・ We published detailed results from the Trial to Reduce Cardiovascular Endpoints with Aranesp® Therapy ("TREAT") and updated the ESA labels to incorporate certain of the trial results regarding the increased risk of stroke and to reinforce the need to follow the approved label guidance to maintain appropriate hemoglobin ("Hb") levels. On December 16, 2009, after consultation with the FDA, Amgen and Centocor Ortho Biotech Products updated the safety information in the ESA product labeling to reflect certain results of our TREAT study. These changes include a revision to the BOXED WARNINGS section to include the increased risk of stroke and to reinforce the need to follow the approved label guidance to maintain Hb levels within the range of 10 to 12 grams per deciliter ("g/dL"). (See discussion of Aranesp® TREAT study results in "Research and Development and Selected Product Candidates.")

・ The FDA announced that it will call an advisory committee meeting in 2010 to re-evaluate the use of ESAs to treat anemia in patients with chronic kidney disease ("CKD") and could consider lowering targeted Hb levels and reducing approved dosing for ESAs.

・ The Centers for Medicare & Medicaid Services ("CMS") has scheduled a Medicare Evidence Development & Coverage Advisory Committee ("MEDCAC") meeting on March 24, 2010 to examine currently available evidence on the use of ESAs to manage anemia in patients who have CKD, which may consider the results of the TREAT study.

・ The CMS released its proposed rule to implement the bundled prospective payment system for end stage renal disease ("ESRD"), which could impact reimbursement for EPOGEN®

【2008】

貧血用薬の競合

Certain of our marketed products are under increased competitive pressures, including from biosimilar and other products in Europe, which compete or are expected to compete with Aranesp(R), Neulasta(R) and NEUPOGEN(R), as well as our marketed products in the United States, including ENBREL. For example, as a result of final regulatory guidelines issued by the EMEA in 2006 related to the development and approval of biosimilar products, we have experienced and expect to continue to experience increased competition throughout Europe, including from a number of biosimilar erythropoietin products, which compete with Aranesp(R). In addition, a number of granulocyte colony-stimulating factor (“G-CSF”) biosimilar products have received marketing authorization from the European Commission in 2008 and early 2009 and have been or are expected to be launched and compete with Neulasta(R) and NEUPOGEN(R). Further in the United States, ENBREL will continue to face increased competition primarily due to the expected launch of new products.

特許係争

On October 17, 2008, the Massachusetts District Court entered judgment that the patents in suit are valid and enforceable, and that the patents, identified below as the subject of the permanent injunction, would be infringed by the import, use and sale of F. Hoffmann-La Roche Ltd. (“Roche”) pegylated erythropoietin product in the United States. The Massachusetts District Court permanently enjoined Roche from infringing the ‘422 Patent, the ‘933 Patent, the ‘868 Patent and the ‘698 Patent for the remaining life of these patents. See Note 10, “Contingencies − Roche Matters − Amgen Inc. v. F. Hoffman-La Roche Ltd. et al.” for further discussion of this legal proceeding.

On July 11, 2008, we announced that we had reached an agreement to settle our antitrust litigation with Ortho Biotech Products L.P., a subsidiary of Johnson & Johnson (hereafter referred to as “Ortho Biotech” or “J&J”), which had alleged that discounts offered to oncology clinics on our NEUPOGEN(R) and Neulasta(R) and Aranesp(R) products violated antitrust laws. Under terms of the agreement, we paid Ortho Biotech $200 million and the pending litigation in New Jersey District Court was dismissed with prejudice.

【2008 癌リスク】赤血球生成促進製剤(ESA製剤)についての2つの新たな試験のデータによると、化学療法による貧血に対してESA製剤を投与された進行した乳癌、子宮頸癌の患者は、投与しない患者に比べて死亡までの期間が短縮し、腫瘍の増殖が早まった。(略)これら2つの試験は、前回2007年11月FDAがラベル改正をした後の新データである。全8つの試験で、患者はヘモグロビン値12g/dL以上を目標にESA製剤を投与されていたが、ほとんどの患者はその目標値に及んでいなかった。 医薬品安全性情報 Vol.6 No.26 ( 2008/12/25 ) 医薬品安全性情報 Vol.6 No.20 ( 2008/10/02 )

ESA Regulatory and Reimbursement Developments

The ESA regulatory and reimbursement developments in 2008 reflect a continuation of events that began in late 2006 that affected the class of ESA products, including Aranesp(R) and EPOGEN(R). Certain of the developments discussed below have had a material adverse impact on sales of our ESA products, in particular Aranesp(R) sales in the U.S. supportive cancer care setting.

Beginning in late 2006, adverse safety results involving ESA products were observed in various studies that were performed by us and by others (including our licensees or independent investigators) that explored the use of ESAs in settings different from those outlined in the FDA approved label, including targeting higher hemoglobin (“Hb”) levels and/or use in non-approved patient populations. The results of these studies culminated in significant regulatory and reimbursement developments affecting the class of ESA products, including Aranesp(R) and EPOGEN(R). For example, in February 2007, following the reported results from our Anemia of Cancer phase 3 study (the “AoC 103 study”), the United States Pharmacopoeia Dispensing Information (“USP DI”) Drug Reference Guides removed Aranesp(R) in the treatment of anemia of cancer (“AoC”). Thereafter, Aranesp(R) use in AoC essentially ceased. In addition, during 2007, we had discussions with the FDA and other regulatory authorities and meetings with certain of the FDA’s advisory panels, which led to further developments. For example, in March 2007, the product labeling information for the class of ESAs was updated, including a boxed warning in the prescribing information (“PI”). In addition, in November 2007, following our meeting with the Oncologic Drugs Advisory Committee (“ODAC”) in May 2007, various additional safety-related revisions were again made to the ESA label. Further, in July 2007, the Centers for Medicare and Medicaid Services (“CMS”) issued its National Coverage Decision Memorandum for Use of Erythropoiesis Stimulating Agents in Cancer and Related Neoplastic Conditions (the “Decision Memorandum”). The Decision Memorandum established the ESA reimbursement policy for Medicare and other government beneficiaries who are treated for chemotherapy-induced anemia (“CIA”) with ESAs. We believe that the restrictions in the Decision Memorandum changed the way ESAs are used in clinical practice by decreasing the number of treated patients, the average dose and duration of ESA therapy.

Discussions with regulatory authorities, including the FDA, regarding safety concerns with respect to the administration of ESA products in various settings continued throughout 2008, resulting in further regulatory developments. The following is a summary of selected key regulatory and related developments that occurred in 2008.

During 2008, the ESA labeling information was further revised to reflect various safety concerns, beginning in March 2008, with an updated boxed warning in the labeling information in the United States. This updated box warning states that ESAs shorten overall survival and/or time-to-tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid and cervical cancers when dosed to a target Hb level of greater than or equal to 12 grams per deciliter (“g/dL”). Additionally, on August 6, 2008, we revised the ESA product labeling, as the FDA directed, based on a complete response letter, received on July 30, 2008, from the FDA to the revisions to the ESA labeling we proposed following the March 13, 2008 ODAC meeting. The revised labeling included, among other things, (i) the addition to the boxed warning of a statement that ESAs are not indicated for patients receiving myelosuppressive therapy when the anticipated outcome of such therapy is cure, (ii) the addition of a statement in the DOSAGE and ADMINISTRATION section of the label that ESA therapy should not be initiated at Hb levels 3 10 g/dL and that dose should be adjusted to maintain the lowest Hb level sufficient to avoid red blood cell transfusions and (iii) the removal of reference to the upper safety limit of 12 g/dL. Further, following the closed meeting by the Scientific Advisory Group on Oncology (“SAG-O”) in May 2008, we received notification in October 2008 that the European Commission had approved updates to the Aranesp(R) product information. The product information for all ESAs was updated to advise that in some clinical situations blood transfusions should be the preferred treatment for the management of anemia in patients with cancer and that the decision to administer ESAs should be based on a benefit-risk assessment with the participation of the individual patient. This assessment should take into account the specific clinical context, including the type of tumor and its stage, the degree of anemia, life-expectancy, the environment in which the patient is being treated and patient preference.

In addition, on January 1, 2008, the CMS’ revisions to its Erythropoietin Monitoring Policy (“EMP”) became effective, which require a 50% reduction in Medicare reimbursement if a patient’s Hb level is above 13 g/dL for three or more consecutive months. In addition, the EMP reduces the monthly dosing limits to 400,000 international units (“IUs”) of EPOGEN(R), from 500,000 IUs, and to 1,200 micrograms (“mcgs”) of Aranesp(R), from 1,500 mcgs. We believe that the EMP implementation in January 2008 has significantly affected physician behavior resulting in declines in dosing trends as particularly noted in the quarter of implementation. However, this dose decline subsequently stabilized in 2008 but may further fluctuate in the future.

Further, on September 30, 2008, we announced that we had received a summary of preliminary results from the Cochrane Collaboration’s independent meta-analysis of patient-level data from previously conducted, randomized, controlled, clinical studies evaluating ESAs in cancer patients which we submitted to the FDA and the European Agency for the Evaluation of Medical Products (“EMEA”). These results were also presented by the Cochrane Haematological Malignancies Group in December at the 2008 American Society of Hematology (“ASH”) Congress.

This Cochrane meta-analysis of patient level data from previous studies corroborates prior analyses indicating that the use of ESAs may increase the risk of death in cancer patients. The studies in the analysis all predate the current label, which advises using the least amount of ESA necessary to avoid transfusion.

The analyses on all cancer patients were based on 53 previously conducted studies involving 13,933 patients. None of these studies utilized ESAs according to current label guidance. The overall survival results corroborate an earlier review by the Cochrane Collaboration, published in 2006, which is included in the WARNINGS section of the current U.S. PI (Hazard Ratio (“HR”): 1.08 [95% Confidence Interval (“CI”) 0.99 - 1.18]). The ESA treatment arm had increased on-study deaths (HR: 1.17 [95% CI 1.06 - 1.30]) and decreased overall survival (HR: 1.06 [95% CI 1.00 - 1.12]) compared to controls. The analyses on patients undergoing chemotherapy, the cancer indication for which ESAs are approved, were based on 38 studies with 10,441 patients. None of these studies utilized ESAs according to current label guidance. The ESA treatment arm had increased on-study deaths (HR: 1.10 [95% CI 0.98 - 1.24]) and decreased overall survival (HR: 1.04 [95% CI 0.97 - 1.11]) compared to controls. While neither of these results is statistically significant, they do not exclude the potential for adverse outcomes when ESAs are prescribed according to the current label. The final report on these endpoints is expected in 2009.

Our ESA products will continue to face future challenges. For example, we continue to work with the FDA to finalize a new protocol for a clinical trial to determine the effects of ESAs on survival and tumor outcomes in anemic patients with metastatic cancer receiving concomitant myelosuppressive chemotherapy. We have submitted an Aranesp(R) study protocol to the FDA and plan to initiate the study in 2009. In addition, in response to the FDA’s request under authority prescribed by the Food and Drug Administration Amendments Act of 2007 (the “FDAAA”), we continue to work closely with the FDA to develop a REMS program for the class of ESA products. We have submitted a proposed REMS in response to the FDA’s requests. The components of the REMS approved by the FDA could be different for the use of ESAs in the oncology and nephrology indications. We believe that a REMS program for our ESA products could have a material adverse impact on the future sales of Aranesp(R), especially in the U.S. supportive cancer care setting. Additionally, future Aranesp(R) sales could also be materially adversely impacted by further changes in reimbursement, including as a result of future regulatory developments.  

【2006】

EPOGEN(R) is Amgen's registered trademark for its recombinant human erythropoietin product, a protein that stimulates red blood cell production. A reduced red blood cell count can result in anemia (see “− Aranesp(R) (darbepoetin alfa)”). People with chronic renal failure suffer from anemia because they do not produce sufficient amounts of erythropoietin, which is normally produced in healthy kidneys.

We were granted an exclusive license to manufacture and market recombinant human erythropoietin in the United States under a licensing agreement with KA. We have retained exclusive rights to market EPOGEN(R) in the United States for dialysis patients. We granted Ortho Pharmaceutical Corporation (which has assigned its rights under the Product License Agreement to Ortho Biotech Products, L.P., a subsidiary of Johnson & Johnson, hereafter referred to as “Ortho Biotech Products, L.P.” or “Johnson & Johnson”) a license to commercialize recombinant human erythropoietin as a human therapeutic in the United States in all markets other than dialysis Table of Contents(see “Joint Ventures and Business Relationships − Johnson & Johnson”). Johnson & Johnson markets recombinant human erythropoietin under the trademark PROCRIT(R) in the United States (see Note 1, “Summary of significant accounting policies ? Product sales” to the Consolidated Financial Statements).

We launched EPOGEN(R) in the United States in 1989 for the treatment of anemia associated with chronic renal failure for patients who are on dialysis. EPOGEN(R) is approved for the treatment of anemic adult and pediatric patients with chronic renal failure who are on dialysis. EPOGEN(R) is indicated to elevate or maintain the red blood cell level (as determined by hematocrit or hemoglobin measurements) and to decrease the need for blood transfusions in these patients.

EPOGEN(R) sales for the years ended December 31, 2006, 2005 and 2004 were $2,511 million, $2,455 million and $2,601 million, respectively.

【2006】貧血用薬の競合

We are committed to growing our anemia business and maintaining our leadership in anemia management, which includes impacting patient health outcomes and supporting the development of new standards of care, exploring new technologies in anemia therapy, preparing to compete with F. Hoffmann-La Roche Ltd. (“Roche”) in the U.S. and with biosimilar and other competing products in Europe and defending our intellectual property. Roche is developing a pegylated recombinant human erythropoietin (“peg-EPO”) for which they have filed a biologic license application (“BLA”) with the FDA and, according to Roche's public statements, they expect to launch the molecule in the U.S. nephrology segment in 2007 despite our ongoing lawsuit and their acknowledgement of our U.S. erythropoietin patents

Certain of our products are expected to face competition in certain geographic areas from biosimilar products. Our principal European patent relating to erythropoietin expired on December 12, 2004 and our principal European patent relating to G-CSF expired on August 22, 2006. We believe that as these patents have expired, other companies could receive approval for and market biosimilar products to compete with our products in the European Union (“EU”). (See “Item 1A. Risk Factors - Our marketed products face substantial competition and other companies may discover, develop, acquire or commercialize products before or more successfully than we do.”)

While we do not market EPOGEN(R) in Europe as this right belongs to Johnson & Johnson (through KA), we do market Aranesp(R) in the EU, which competes with Johnson & Johnson's EPREX(R) product, Roche's NeoRecormon(R) product and others' erythropoietin products. We expect that biosimilar erythropoietin products may be approved in the EU in 2007 and could be available in the EU shortly after approval. Based on an announcement by Shire Pharmaceuticals Group plc ("Shire"), we expect that a competing erythropoietin product, manufactured by Shire, may appear on the market in the EU in 2007. In addition, Roche is developing its peg-EPO product which, upon regulatory approval, we expect they will launch in the EU nephrology segment in 2007. In 2006, the European Medicines Agency (“EMEA”) developed and issued final regulatory guidelines related to the development and approval of biosimilar products. The final guidelines included clinical trial guidance for certain biosimilar products including erythropoietins and G-CSFs, which guidance recommends that applicants seeking approval of such biosimilar products conduct fairly extensive pharmacodynamic, toxicological, clinical safety studies and a pharmacovigilance program. In the United States, there currently is no legal approval pathway for follow-on biologic products. A number of events would need to occur before these products could enter the market, including passage of legislation by Congress to create a new approval pathway and promulgation of associated regulations and guidance by the FDA.


●Aranesp(R) (darbepoetin alfa)
Aranesp(R) is our registered trademark for one of our ESAs, a protein that stimulates red blood cell production. Red blood cells transport oxygen to all cells of the body. Without adequate amounts of erythropoietin, the red blood cell count is reduced. A deficient red blood cell count can result in anemia, a condition where insufficient oxygen is delivered to the body’s organs and tissues. Anemia can be associated with CRF, both in patients on dialysis and not on dialysis. Anemia can also result from chemotherapy treatments for patients with non-myeloid malignancies.

We were granted an exclusive license by Kirin-Amgen, Inc. (“KA”), a joint venture between Kirin Holdings Company, Limited (“Kirin”) and Amgen (see “Joint Ventures and Business Relationships ? Kirin Holdings Company, Limited”), to manufacture and market darbepoetin alfa in the United States, all European countries, Canada, Australia, New Zealand, Mexico, all Central and South American countries and certain countries in Central Asia, North Africa and the Middle East.

We market Aranesp(R) primarily in the United States and Europe. Aranesp(R) was initially launched in 2001 in the United States and Europe for the treatment of anemia associated with CRF (both in patients on dialysis and patients not on dialysis) and is also indicated for the treatment of CIA in patients with non-myeloid malignancies.

Worldwide Aranesp(R) sales for the years ended December 31, 2009, 2008, 2007 and 2006 were $2.65 billion, $3.1 billion, $3.6 billion and $4.1 billion, respectively. For the years ended December 31, 2009, 2008 and 2007, U.S. Aranesp® sales were $1.25 billion, $1.65 billion and $2.15 billion, respectively and international Aranesp® sales were $1.40 billion, $1.49 billion and $1.46 billion, respectively.
As a result of certain of the regulatory and reimbursement developments discussed above in the “Key Developments” section, worldwide Aranesp(R) sales and, in particular, sales in the U.S. supportive cancer care setting, have and will continue to be materially adversely affected.

Our outstanding material patents for darbepoetin alfa are described in the table below. 

Territory    General Subject Matter    Expiration 
U.S.    Glycosylation analogs of erythropoietin proteins    5/15/2024 
Europe(1)    Glycosylation analogs of erythropoietin proteins    10/12/2010 
Europe(1)    Glycosylation analogs of erythropoietin proteins    8/16/2014 
(1) In some cases, these European patents may also be entitled to supplemental protection in one or more countries in Europe and the length of any such extension will vary by country.

Our principal European patent relating to Epoetin alfa expired on December 12, 2004. Although we do not market EPOGEN(R) in Europe, upon expiration of this patent, some companies have and other companies may receive approval for and market biosimilar or other products to compete with Aranesp(R) in Europe, presenting additional competition, as further discussed below.

Any products or technologies that are directly or indirectly successful in addressing anemia associated with chemotherapy and nephrology could negatively impact product sales of Aranesp(R). The following table reflects companies and their currently marketed products that primarily compete with Aranesp(R) in the United States and Europe in the supportive cancer care and nephrology segments, unless otherwise indicated.

Territory    Competitor Marketed Product    Competitor 
U.S.    PROCRIT(R)(1)    Centocor Ortho Biotech Products(2)
Europe    EPREXR/ERYPO(R)    Janssen-Cilag(2) 
Europe    NeoRecormon(R)    Roche 
Europe    Retacrit(TM)(3)/Silapo(R)(3)    Hospira Enterprises B.V. (“Hospira”)/Stada Arzneimittel AG (“Stada”)
Europe    BinocritR(3)/Epoetin alfa Hexal(R)(3)/Abseamed(R)(3)
    Sandoz GmbH (“Sandoz”)/Hexal Biotech Forschungs GmbH (“Hexal”)/Medice Arzneimittel Putter GmbH & Company KG (“Medice”)
Europe    MIRCERA(R)(4)     Roche 
Europe    Dynepo(R)(5)     Shire Pharmaceutical Group Plc (“Shire”) 
Europe Biopoin® CT Arztneimittel GmbH ("CT Arztneimittel")
(1) In the United States, Aranesp(R) competes with PROCRIT(R) in the supportive cancer care and pre-dialysis settings. 
(2) A subsidiary of J&J. 
(3) Biosimilar product approved and launched in certain EU countries. 
(4) Competes with Aranesp(R) in the nephrology segment only. 
(5) Shire announced in the second quarter of 2008 that it had decided to stop the commercialization of Dynepo(R). 
In the United States, Aranesp(R) also competes with EPOGEN(R), primarily in the U.S. hospital dialysis clinic setting. In addition to competition from the above-noted marketed products, the following product candidates could compete with Aranesp(R) in the future. Affymax Inc. (“Affymax”) and Takeda are co-developing Hematide?, an ESA for the treatment of anemia in renal patients. FibroGen is developing FG-2216 and FG-4592, orally active ESAs, for the treatment of anemia and is also studying FG-4592 for the treatment in anemia of chronic kidney disease (“CKD”). Ratiopharm is developing a biosimilar ESA, EpoTheta, expected to launch in the EU in 2009. Additionally, in December 2008, Merck & Company, Inc. (“Merck”) announced the formation of a new biotech division, Merck Bioventures, which is developing a late-stage pegylated ESA (MK-2578), which they have announced they expect to launch in 2012.
【2009】
【2008】
【2006】Aranesp(R) is Amgen's registered trademark for one of its novel erythropoiesis stimulating proteins, a protein that stimulates red blood cell production. Red blood cells transport oxygen to all cells of the body. Without adequate amounts of erythropoietin, the red blood cell count is reduced. A deficient red blood cell count could result in anemia, a condition where insufficient oxygen is delivered to the body's organs and tissues. Anemia can be associated with chronic renal failure, both in patients on dialysis and not on dialysis. Anemia can also result from chemotherapy treatments for patients with non-myeloid malignancies. Aranesp(R) relieves anemia symptoms and reduces the need for blood transfusions.

We were granted an exclusive license by Kirin-Amgen, Inc. (“KA”), a joint venture between Kirin Brewery Company, Limited (“Kirin”) and Amgen (see “Joint Ventures and Business Relationships - Kirin Brewery Company, Limited”) to manufacture and market darbepoetin alfa in the United States, Europe, Canada, Australia, New Zealand, Mexico, all Central and South American countries and certain countries in Central Asia, North Africa and the Middle East.

We primarily market Aranesp(R) in the United States and Europe. Darbepoetin alfa is also marketed under the brand name Nespo(R) in Italy. Aranesp(R) was initially launched in 2001 in the United States and Europe and is indicated for the treatment of anemia associated with chronic renal failure (both in patients on dialysis and patients not on dialysis) as well as for the treatment of chemotherapy-induced anemia in patients with non-myeloid malignancies. In March 2006, the FDA approved label changes to include every-three-week dosing of Aranesp(R) for the treatment of chemotherapy-induced anemia in patients with non-myeloid malignancies.

Worldwide Aranesp(R) sales for the years ended December 31, 2006, 2005 and 2004 were $4,121 million, $3,273 million and $2,473 million, respectively.


●ENBREL
ENBREL is our registered trademark for our TNF receptor fusion protein that inhibits its binding to TNF receptors, which can result in a significant reduction in inflammatory activity. TNF is one of the chemical messengers that help regulate the inflammatory process. When the body produces too much TNF, it overwhelms the immune system’s ability to control inflammation of the joints or of psoriasis-affected skin areas. ENBREL is similar to a protein that the body produces naturally, and like this protein, it binds and deactivates certain TNF molecules before they can trigger inflammation.

We acquired the rights to ENBREL in July 2002 as part of our acquisition of Immunex Corporation (“Immunex”).

We market ENBREL under a co-promotion agreement with Wyeth in the United States and Canada (see “Joint Ventures and Business Relationships ? Wyeth”). The rights to market ENBREL outside of the United States and Canada are reserved to Wyeth. ENBREL was initially launched in November 1998 by Immunex for the treatment of RA. In addition, ENBREL is now indicated for the treatment of adult patients with the following conditions: moderately to severely active RA; chronic moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy; active psoriatic arthritis and active ankylosing spondylitis. ENBREL is also approved for the treatment of moderately to severely active polyarticular-course juvenile RA in patients who have had an inadequate response to one or more disease-modifying medicines.

ENBREL sales for the years ended December 31, 2008, 2007 and 2006 were $3.6 billion, $3.2 billion and $2.9 billion, respectively.

Our outstanding material patents for etanercept are described in the table below. 
Territory    General Subject Matter    Expiration 
U.S.    Methods of treating TNF ? dependent inflammatory response    9/5/2009 
U.S.    TNFR proteins and pharmaceutical compositions    9/5/2009 
U.S.    TNFR DNA vectors, cells and processes for making proteins    10/23/2012 
Any products or technologies that are directly or indirectly successful in treating rheumatology, which includes moderate to severe RA, moderate to severe juvenile RA and psoriatic arthritis; and dermatology, which includes ankylosing spondylitis and moderate to severe plaque psoriasis, could negatively impact product sales of ENBREL. Current treatments for these indications include generic methotrexate and other products, as further discussed below.

The following table reflects companies and their currently marketed products that primarily compete with ENBREL in the United States and Canada in the inflammatory disease setting.

Territory    Therapeutic Area    Competitor/Marketed Product    Competitor
U.S. & Canada    Rheumatology & Dermatology    REMICADE(R)    Centocor, Inc.(1)/Schering Plough Corporation
U.S. & Canada    Rheumatology & Dermatology    HUMIRA(R)    Abbott Laboratories (“Abbott”)
U.S. & Canada    Rheumatology & Dermatology    Trexall(TM)    Duramed Pharmaceuticals, Inc.(2)
U.S. & Canada    Rheumatology    Orencia(R)    Bristol-Myers Squibb Corporation (“BMS”)
U.S. & Canada    Rheumatology    Arava(R)    Sanofi-Aventis
U.S. & Canada    Rheumatology    Rheumatrex(R)    DAVA Pharmaceuticals, Inc.
U.S. & Canada    Rheumatology    Rituxan(R)    Genentech, Inc. (“Genentech”)
U.S. & Canada    Dermatology    Raptiva(R)    Genentech
U.S. & Canada    Dermatology    Amevive(R)    Biogen IDEC Inc. (“Biogen”)
U.S. & Canada    Dermatology    Neoral(R)    Novartis AG (“Novartis”)
U.S. & Canada    Dermatology    Soriatane(R)    Connetics Corporation(3)
(1) A subsidiary of J&J. 
(2) A subsidiary of Barr Pharmaceuticals, Inc. (“Barr”) 
(3) A subsidiary of Stiefel Laboratories, Inc. 
In addition to competition from the above-noted marketed products, various companies are developing products which may compete with ENBREL in the future, including the following. In December 2007, J&J filed a BLA with the FDA and a market authorization application (“MAA”) with the EMEA for CNTO 1275 (ustekinumab) to treat adults with moderate to severe plaque psoriasis. Although the DODAC unanimously recommended CNTO 1275 for approval, in December 2008, the FDA declined approval and requested additional information from J&J. J&J is also developing CNTO 148 (golimumab) for the treatment of RA. Additionally, a number of companies have cytokine inhibitors in development, including GlaxoSmithKline plc (“GlaxoSmithKline”), Pfizer Inc. (“Pfizer”), Repligen Corporation and Taisho Pharmaceutical Co., Ltd. Roche filed a BLA for its RA candidate Actemra (tocilizumab) in November 2007 and received a complete response letter from the FDA in September 2008, requesting additional data on the labeling and manufacture of the drug. Abbott is developing ABT-874, which is a psoriasis drug, and is in phase 3 trials. UCB has partnered with Nektar Therapeutics to develop Cimzia(R) (PEGylated anti-TNF) for the treatment of RA. On January 5, 2009, the FDA issued a complete response letter relating to the BLA of Cimzia(R) for treatment of RA requesting additional information.
【2009】
【2008】
【2008安全性問題】On March 17, 2008, we and Wyeth Pharmaceuticals, a division of Wyeth, announced updates to the FDA approved labeling for ENBREL, in which the U.S. PI now contains a boxed warning relating to the risk of infections, including tuberculosis. This information in the boxed warning includes additional language regarding screening and monitoring patients for tuberculosis, including patients who tested negative for latent tuberculosis infection. As part of this labeling update, the FDA also required the implementation of a REMS for ENBREL in the form of a medication guide. Additionally, following the FDA web-alert on September 4, 2008 regarding their review of histoplasmosis and other opportunistic fungal infections in patients treated with TNF-blockers, the FDA requested that the boxed warning and WARNINGS sections of the U.S. PI and the medication guide for ENBREL (and other TNF-blockers) be strengthened to include the risk of unrecognized histoplasmosis and other invasive fungal infections with the goal of increasing timely diagnosis and treatment. The FDA also requested that the approved REMS for ENBREL be modified with a communication plan to healthcare providers regarding the risk of unrecognized fungal infections. In December 2008, we agreed with the FDA on the required revisions to the U.S. PI, and we continue to work with the FDA to finalize the requested updates to the ENBREL REMS.

In addition, there are several other outstanding regulatory matters that may also negatively impact future ENBREL product sales. For example, on June 4, 2008, the FDA issued an Early Communication regarding an ongoing safety review of TNF-blockers and the possible association between the use of these medicines and the development of lymphoma and other cancers in children and young adults and stated that it had decided to conduct further analyses to evaluate the risk and benefits of TNF-blockers in pediatric patients. Furthermore, following the June 18, 2008 Dermatologic and Ophthalmic Drugs Advisory Committee (“DODAC”) meeting, on July 24, 2008, we received notification from the FDA through a complete response letter that they would like additional information from us regarding the use of ENBREL in pediatric patients with chronic moderate to severe plaque psoriasis. We continue to work with the FDA to provide it with the above-noted requested information.


●Neulasta(R) (pegfilgrastim)/NEUPOGEN(R) (Filgrastim)
Neulasta(R) is our registered trademark for a pegylated protein that selectively stimulates production of certain white blood cells known as neutrophils and is based on the Filgrastim molecule. Neutrophils defend against infection. NEUPOGEN(R) is our registered trademark for our recombinant-methionyl human G-CSF, a protein that also selectively stimulates production of neutrophils. Treatments for various diseases and diseases themselves can result in extremely low numbers of neutrophils, a condition called neutropenia. Myelosuppressive chemotherapy, one treatment option for individuals with certain types of cancers, targets cell types that grow rapidly, such as tumor cells. Normal cells that divide rapidly, such as those in the bone marrow that become neutrophils, are also vulnerable to the effects of cytotoxic chemotherapy, resulting in neutropenia with an increased risk of severe infection. Very often, neutropenia is the dose limiting side effect of chemotherapy and can thus be responsible for a reduction in the amount of chemotherapy that can be administered safely. Such reductions in chemotherapy dose can compromise the effectiveness of chemotherapy on the cancer it is being used to treat, with the result of a higher treatment failure rate. As mentioned above, the pegfilgrastim molecule is based on the Filgrastim molecule. A polyethylene glycol molecule (“PEG”) is added to enlarge the Filgrastim molecule, thereby extending its half-life and causing it to be removed more slowly from the body. Because pegfilgrastim is eliminated through binding to its receptor on neutrophils and their precursors, pegfilgrastim remains in the circulation until neutrophil recovery has occurred. This neutrophil-mediated clearance allows for administration as a single dose per chemotherapy cycle, compared with NEUPOGEN(R), which requires more frequent dosing. Neulasta(R) and NEUPOGEN(R) are prescribed more frequently in the curative setting, in which myelosuppressive chemotherapy is administered with the intent to cure cancer, rather than in the palliative setting, in which myelosuppressive chemotherapy is administered to treat other complications of cancer by managing tumor growth.

We were granted an exclusive license to manufacture and market pegfilgrastim and G-CSF in the United States, Europe, Canada, Australia and New Zealand under a licensing agreement with KA (see “Joint Ventures and Business Relationships ? Kirin Holdings Company, Limited”).

We market Neulasta(R) and NEUPOGEN(R) primarily in the United States and Europe. Filgrastim is also marketed under the brand name GRANULOKINE(R) in Italy. Neulasta(R) was initially launched in the United States and Europe in 2002 and is indicated for reducing the incidence of infection associated with chemotherapy-induced neutropenia in cancer patients with non-myeloid malignancies. Administration of Neulasta(R) in all cycles of chemotherapy is approved for patients receiving myelosuppressive chemotherapy associated with at least a 17% risk of febrile neutropenia. NEUPOGEN(R) was initially launched in the United States and Europe in 1991. NEUPOGEN(R) is indicated for reducing the incidence of infection as manifested by febrile neutropenia for patients with non-myeloid malignancies undergoing myelosuppressive chemotherapy; reducing the duration of neutropenia and neutropenia-related consequences for patients with non-myeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation; reducing the incidence and duration of neutropenia-related consequences in symptomatic patients with congenital neutropenia, cyclic neutropenia or idiopathic neutropenia (collectively, severe chronic neutropenia); mobilizing peripheral blood progenitor cells (“PBPC”) in cancer patients who have undergone myeloablative chemotherapy for stem cell transplantation; and reducing the recovery time of neutrophils and the duration of fever following induction or consolidation chemotherapy treatment in adult patients with acute myeloid leukemia (“AML”).

Worldwide Neulasta(R) sales for the years ended December 31, 2008, 2007 and 2006 were $3.3 billion, $3.0 billion and $2.7 billion, respectively. Worldwide NEUPOGEN(R) sales for the years ended December 31, 2008, 2007 and 2006 were $1.3 billion, $1.3 billion and $1.2 billion, respectively.

Our outstanding material patents for pegfilgrastim are described in the table below. 
Territory    General Subject Matter    Expiration 
U.S.    Pegylated G-CSF    10/20/2015 
Europe(1)     Pegylated G-CSF    2/8/2015 
(1) In some cases, this European patent may also be entitled to supplemental protection in one or more countries in Europe and the length of any such extension will vary by country.

Our outstanding material patents for Filgrastim are described in the table below. 

Territory    General Subject Matter    Expiration 
U.S.    G-CSF polypeptides    12/3/2013 
U.S.    Methods of treatment using G-CSF polypeptides    12/10/2013 
Our principal European patent relating to G-CSF expired on August 22, 2006. Upon expiration of this patent, some companies have and other companies may receive approval for and market biosimilar products and other products to compete with Neulasta(R) and NEUPOGEN(R) in Europe, presenting additional competition, as further discussed below.

Neulasta(R) and NEUPOGEN(R) could face competition in some circumstances from companies marketing or developing treatments for neutropenia associated with chemotherapy, for bone marrow and PBPC transplant patients, and AML. NEUPOGEN(R) competes with Neulasta(R) in the United States and Europe. U.S. and international NEUPOGEN(R) sales have been adversely impacted by conversion to Neulasta(R). However, we believe that the conversion in the United States is substantially complete and that a significant amount of the conversion in Europe had already occurred.

The following table reflects companies and their currently marketed products that primarily compete with Neulasta(R) and NEUPOGEN(R) in the United States and Europe in the supportive cancer care segment.

Territory    Competitor Marketed Product    Competitor
U.S.    Leukine(R)    Bayer HealthCare Pharmaceuticals 
Europe    Granocyte(R)    Chugai Pharmaceuticals Co., Ltd./Sanofi-Aventis
Europe    RatiograstimR(1)/Filgrastim RatiopharmR(1)    Ratiopharm 
Europe    BiograstimR(1)    CT Arzneimittel 
Europe    TevagrastimR(2)    Teva 
Europe    ZarzioR(3)/Filgrastim HexalR(3)    Sandoz/Hexal 
(1) Biosimilar products that received marketing authorization by the European Commission in September 2008 and launched in certain EU countries thereafter.
(2) Biosimilar product that received marketing authorization by the European Commission in September 2008 for which Teva has stated that it would begin marketing throughout Europe in 2009.
(3) Biosimilar products that received marketing authorization by the European Commission in February 2009.
【2009】
【2008】

●Sensipar(R) (cinacalcet)
Sensipar(R) is our registered trademark in the United States and Mimpara(R) is our registered trademark in Europe, for our first small molecule medicine used in treating CKD patients on dialysis who produce too much parathyroid hormone, a condition known as secondary hyperparathyroidism. In 2004, SensiparR/Mimpara(R) was approved in the United States and Europe for the treatment of secondary hyperparathyroidism in CKD patients on dialysis and for the treatment of hypercalcemia in patients with parathyroid carcinoma. We market Sensipar(R)/Mimpara(R) primarily in the United States and Europe.

Sensipar(R) sales for the years ended December 31, 2008, 2007 and 2006 were $597 million, $463 million and $321 million, respectively.

Our outstanding material patents for cinacalcet are described in the table below. 
Cinacalcet    General Subject Matter    Expiration 
U.S.(1)    Calcium receptor-active molecules    10/23/2015 
U.S.(1)    Calcium receptor-active molecules    12/14/2016 
U.S.(1)    Methods of treatment    12/14/2016 
Europe(2)    Calcium receptor-active molecules    10/23/2015 
(1) An application for patent term extension has been submitted and is currently pending in the United States.
(2) In some cases, this European patent may also be entitled to supplemental protection in one or more countries in Europe and the length of any such extension will vary by country.

Any products or technologies that are directly or indirectly successful in treating secondary hyperparathyroidism in patients with CKD on dialysis and/or hypercalcemia in patients with parathyroid carcinoma could negatively impact product sales of SensiparR/Mimpara(R).

The following table reflects companies and their currently marked products that primarily compete with Sensipar(R) in the United States and Mimpara(R) in Europe in the nephrology segment.

Territory    Competitor Marketed Product    Competitor
U.S.    Zemplar(R)    Abbott 
U.S.    Hectorol(R)    Genzyme Corporation (“Genzyme”) 
U.S.    Rocaltrol(R)    Roche 
Europe    Zemplar(R)    Abbott 
Europe    Renegel(R)    Genzyme 
Europe    Fosrenol(R)    Shire 
Europe    OsvaRen(R)    Fresenius Medical Care 
On July 25, 2008, we filed a lawsuit against Teva and Barr for infringement of four Sensipar(R) patents. The lawsuit is based on the Abbreviated New Drug Application (“ANDA”) filed by Teva and Barr which seeks approval to market generic versions of Sensipar(R). (See Note 10, “Contingencies” to the Consolidated Financial Statements.) These generic versions could compete with Sensipar(R) in the future.
【2009】

【2009】


★特許
ProductGeneral Subject MatterExpiration
Epoetin alfaU.S.− Process of making erythropoietin8/15/2012
− Product claims to erythropoietin8/20/2013
− Pharmaceutical compositions of erythropoietin8/20/2013
− Cells that make certain levels of erythropoietin5/26/2015
darbepoetin alfaEurope(2)− Glycosylation analogs of erythropoietin proteins10/12/2010
− Glycosylation analogs of erythropoietin proteins8/16/2014
FilgrastimU.S.− G-CSF polypeptides12/3/2013
− Methods of treatment using G-CSF polypeptides12/10/2013
pegfilgrastimU.S.− Pegylated G-CSF10/20/2015
Europe(2)− Pegylated G-CSF2/8/2015
etanerceptU.S.− Methods of treating TNF − dependent inflammatory response9/5/2009
− TNFR proteins and pharmaceutical compositions9/5/2009
− TNFR DNA vectors, cells and processes for making proteins10/23/2012
panitumumabU.S.− Human monoclonal antibodies to EGFr5/5/2017
cinacalcet HClU.S.(1)− Calcium receptor-active molecules12/14/2016
− Calcium receptor-active molecules12/14/2016
− Calcium receptor-active molecules12/14/2016
− Calcium receptor-active molecules10/23/2015
Europe(2)− Calcium receptor-active molecules10/23/2015
(1) An application for patent term extension has been submitted and is currently pending in the U.S. (2) In some cases these European patents may also be entitled to supplemental protection in one or more countries in Europe and the length of any such extension will vary country by country
Amgen

Media CenterPress Releases −★Abgenix Press Release Archives −★Tularik Press Release Archives −★Immunex Press Release Archives Medical ProfessionalsProducts InvestorsPipelineFact Sheet〜四半期報告、SEC ★SEC Filings 10-K Annual Report 2009[2010.3.01] - [pdf] - [doc] - [xls] 10-K Annual Report 2008[2009.2.27] - [pdf,358p] - [doc] 10-K Annual Report 2007[2008.2.28] - [pdf,213p] 10-K Annual Report 2006[2007.2.28] - [pdf,149p] 10-K Annual 2005[2006.3.10] - [pdf,319p] - [xls] 10-K Annual 2004[2005.3.9] - [pdf,140p]| [xls]| [doc]Annual reports Annual Report and 10-K[2009.3.17;pdf,190p] Annual Report 2006 - [pdf,38p] Annual 2004 10-K[pdf,124p] Annual Report 2004[pdf,38p] - Online版 Annual Report 2003 Annual Report 2002 Annual Report 2001 Amgen's Fourth Quarter 2006 Revenue Increased 17% to $3.8 Billion; Full Year 2006 Revenue Increased 15% to $14.3 Billion[2007.1.25] Amgen's Fourth Quarter 2003 Adjusted Earnings Per Share Increased 31 Percent to 46 Cents[pdf-11p,2004.1.22] AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2001 FINANCIAL RESULTS IN LINE WITH GUIDANCE[2002.1.23] On An Adjusted Basis, Amgen Reports Fourth Quarter Earnings Per Share Increase
17 Percent to 35 Cents, Full Year 2002 Increase 18 Percent to $1.39
[2003.1.23]
アムジェン

--- http://www.amgen.co.jp/ 広報資料







Amylin Pharmaceuticals, Inc

 - http://www.amylin.com/ ;本社San Diego, California; NASDAQ=AMLN
設立1987年。 糖尿病・肥満・循環器疾患の治療薬開発ベンチャー。ペプチド系
Eli Lilly と大きな提携関係にあり、人成長ホルモンHumatropeの販売で専門チームを提供。


●会社決算

($000)201120102009200820072006200520042003200220012000備考

製品売上高621,570651,113753,993765,342701,450474,08386,713-----
提携契約に基づく収入29,10817,7004,4264,286
旧74,767
19,286
旧79,547
4,286
旧36,837
39,285
旧53,761
34,26885,65213,395--
 総収入 計650,678668,813758,419769,628
旧840,109
720,736
旧780,997
478,324
旧510,875
125,998
旧140,474
34,26885,65213,395--

支出
研究開発費161,215171,312185,062222,614
旧293,095
216,339
旧276,600
189,502
旧222,053
117,652
旧132,128
119,558149,43194,45649,60133,807
販売及び一般管理費271,224288,650343,864395,112390,982281,950171,52066,95856,76125,33420,46910,716
外部研究開発取得--------3,300--
提携Profit-sharing222,,545257,127302,861302,600290,934194,19131,359-- --
リストラ7,19016,78016,98054,926--------
   支出 計1,142,137795,556931,7661,137,3291,023,973748,267349,791186,516209,492119,79070,07044,523
営業利益(126,743)(173,347)(297,220)(242,976)(237,392)(209,317)(152,248)()
純利益(543,399)(152,313)(186,256)(321,941)
旧(315,405)
(216,486)
旧(211,136)
(218,856)
旧(218,856)
(206,832)
旧(206,832)
(157,157)(122,808)(109,787)(71,972)(44,043)

従業員数1,4001,5001,8001,9001,550345
*外部研究開発取得=Acquired in-process research and development ●製品売上
($ million)2011201020092008200720062005備考
製品売上高621.6651.1754.0765.3701.5474.086.7

Byetta517.7559.3667.6678.5636.0430.275.2[exenatide]米国発売2005.6;2型糖尿病;incretin mimetics
Symln103.991.886.486.865.543.811.5[pramlintide acetate]米国発売2005.4;1型糖尿病;amylinomimetics
[]発売;
●BYETTA(R) (exenatide) injection  2型糖尿病の併用療法 (metformin, a sulfonylurea and/or a thiazolidinediene (TZD)で血糖管理が困難時)  最初で唯一のincretin mimetics。 1週間に1回(Alkermes社技術)。 2007年末で23ヵ国で発売。 米国はLillyと共販、米国外はLillyが開発・販売。  Nasal ExenatideをNastech Pharmaceutical Companyと契約(2006.6)開発中。  〜2007末P1。
[2007]
In April 2005, concurrently with BYETTA’s initial approval, the FDA issued an approvable letter for BYETTA when used as a monotherapy (stand-alone therapy) for people with type 2 diabetes. In December 2007, we announced the results of a 24-week BYETTA monotherapy study in drug-nai"ve patients. In this study participants taking 5 micrograms, or mcg or 10 mcg of monotherapy BYETTA twice daily showed reductions in A1C by 0.7% and 0.9%, respectively, from an average baseline A1C ranging from 7.8% to 7.9%. In addition, approximately 60% of study participants on either 5 mcg or 10 mcg of monotherapy BYETTA at the conclusion of the study had an A1C of 7% or less. Weight loss from baseline was significant and similar to that observed in previous BYETTA studies. There was a low incidence of nausea reported in both treatment arms of the study of approximately 3% and 13% in the 5 mcg and 10 mcg arms, respectively. There were no instances of severe hypoglycemia in this study. Overall hypoglycemia was similar to that seen in studies where BYETTA was used in conjunction with metformin only. We currently plan to file a regulatory submission to the FDA for BYETTA use as monotherapy in the first half of 2008.

[2006]
BYETTA is the first and only approved medicine in a new class of compounds called incretin mimetics. We began selling BYETTA in the United States in June 2005. It is approved as an adjunctive therapy to improve glycemic control in patients with type 2 diabetes who have not achieved adequate gylcemic control and who are taking metformin, sulfonylurea and/or a thiazolidinediene (TZD), the three most common oral therapies for type 2 diabetes. Net product sales of BYETTA were $430.2 million in 2006 and $75.2 million in 2005.

We have an agreement with Lilly for the global development and commercialization of exenatide. This agreement includes BYETTA and other formulations of exenatide such as exenatide LAR. Under the terms of the agreement, operating profits from products sold in the United States are shared equally between Lilly and us and Lilly will pay us royalties for product sales outside of the United States. Lilly has primary responsibility for developing and commercializing BYETTA outside of the United States, including any sustained-release formulations of exenatide such as exenatide LAR.




●SYMLIN(R) (pramlintide acetate) injection 1型または2型糖尿病の併用療法
(インスリンで管理困難な場合)
 最初で唯一のamylinomimetics。 Amylin社が全権を保有。
米国発売2005.4
[2007]
SYMLIN is used with insulin and has been associated with an increased risk of insulin-induced severe hypoglycemia. The risk can be reduced by appropriate patient selection, careful patient instruction and insulin dose adjustments. Other adverse effects commonly observed are primarily gastrointestinal, including nausea, which decrease over time in most patients.

Our SYMLIN marketing is focused on a target physician population of approximately 21,000, with a goal of educating these physicians on SYMLIN, including its mechanisms of action, potential benefits, use considerations, and appropriate patient selection for initiating SYMLIN therapy. These physicians write approximately 40% of all insulin prescriptions in the United States. In October 2007, we announced that the FDA approved the SymlinPen(TM) 120 and the SymlinPen ^(TM) 60 pen-injector devices for administering SYMLIN. The new pre-filled pen-injector devices feature fixed dosing to improve mealtime glucose control and are now available to patients. The devices can be stored at room temperature not to exceed 86 degrees F (30 degrees C) after first use. We are now educating physicians about the SYMLIN pen and believe the SYMLIN pen will not only enable patients to more easily deliver proper dosing than using a vial and syringe but will also improve the convenience of administering SYMLIN.

[2006]
SYMLIN is the first and only approved medicine in a new class of compounds called amylinomimetics. We began selling SYMLIN in the United States in April 2005. It is approved as an adjunctive therapy to improve glycemic control in patients with either type 2 or type 1 diabetes who are treated with mealtime insulin but who have not achieved adequate glycemic control. We own 100% of the global rights to SYMLIN. Net product sales of SYMLIN were $43.8 million in 2006 and $11.5 million in 2005.




Amylin Pharmaceuticals, Inc

- http://www.amylin.com/ ●PipelineNews & EventsInvestorsSEC Filings 10-K Annual Filings[2012.2.22] - [pdf] - [xls] 10-K Annual Filings[2011.2.25] - [pdf] - [doc] - [xls] 10-K Annual Filings[2010.2.26] - [pdf,246p] - [doc] - [xls] 10-K Annual Filings[2009.2.27] - [pdf] - [doc] - [xls] 10-K Annual Filings[2008.2.27] - [pdf,419p] - [doc] - [xls] 10-K Annual Filings[2007.2.26] - [pdf] - [doc] 10-K Annual Filings[2006.3.7] - [pdf] - [doc] 10-K Annual Filings[2005.3.10] - [pdf,201p] Annual/Quartery Reports 2011 Annual Report[2012.4.16] - [pdf] 2010 Annual Report[2011.5.10] - [pdf] 2009 Annual Report[2010.4.21] 2009 Annual Report (Interactive)[2010.4.21] ANNUAL REPORTS 2008 Form 10K[2009.3.29] Annual Report 2006[2007.4.13] - 2006 Form10K[pdf][2007.6.1] 2004 Annual Report[2005.5.9,pdf,84p] ●Press Releases Amylin Pharmaceuticals Reports Fourth Quarter and Full Year 2011 Financial Results[2012.2.6] Amylin Pharmaceuticals Reports 2010 Financial Results[2011.1.26] Amylin Pharmaceuticals Reports 2009 Financial Results[2010.1.27] Amylin Pharmaceuticals Reports 2006 Financial Results[2007.1.30] Amylin Pharmaceuticals Reports 2004 Financial Results[2005.3.2] ----------------------- FDA Approves BYETTA(R) (exenatide) Injection for Expanded Combination Use[2007.1.3] FDA Approves BYETTA(R) (exenatide) Injection for Expanded Combination Use[2006.12.22] BYETTA(R) (exenatide) Approved for Treatment of Type 2 Diabetes by European Commission[2006.11.21] Newly Approved First-in-Class Treatment for Type 2 Diabetes Is Now Available[2005.6.9] -- Amylin and Lilly Launch BYETTA(TM) (exenatide) injection for type 2 diabetes patients unable to control disease with common oral therapies -- Amylin and Lilly Announce FDA Approval of BYETTA(TM) (Exenatide) Injection[2005.4.29] Amylin Pharmaceuticals Announces FDA Approval of SYMLIN(R) for Insulin-Using Type 2 and Type 1 Diabetes[2005.3.16]







Anesiva,Inc[米;旧Corgentech Inc]

 - http://www.anesiva.com/ ;Anesiva (Nasdaq: ANSV); 本社South San Francisco, California 

1990年代  Dr.Victor J. Dzau, M.D.(Duke大学長;先天性心不全等の先駆者)により設立
(Clingenix and Corgentech)
当初から遺伝子治療分野に特化し、特にTF Decoyの開発を進めてきた。
 - edifoligide (E2F Decoy) [冠動脈バイパス・グラフト(CABG)の失敗を予防] P3(BMSと共同)が2005年に失敗。
以降大幅な開発方針の転換を行った。
2005.12.15 AlgoRx Pharmaceuticals, Incを買収
2005.12   大規模リストラを発表、人員および施設
2006.06.21 Corgentech Inc. (Nasdaq: CGTK) からAnesiva, Inc. (Nasdaq: ANSV)に社名変更。



●会社決算
($ 000)20082007200620052004200320022001
契約収入3045189--
旧36,382
100
旧8,678
--
研究開発費36,18623,261
旧35,660
20,593
旧35,259
13,302
旧19,294
11,309
旧17,169
旧62,997
12,191
旧46,004
21,5368,068
取得研究開発費--------
一般管理費13,00316,699
旧25,722
18,717
旧23,582
17,2346,468
旧15,013
3,477
旧6,067
3,2062,374
 営業経費 計49,18939,960
旧61,382
39,310
旧58,841
30,536
旧36,528
17,777
旧23,637
旧78,010
15,668
旧52,071
24,74210,442
営業利益(48,885)(39,909)
旧(61,331)
(39,221)
旧(58,752)
(30,536)
旧(36,528)
(17,777)
旧(23,637)
旧(41,628)
(15,568)
旧(43,393)
(24,742)(10,442)
経常利益(103,213)(59,282)(55,567)(35,243)(23,033)(15,486)
当期純利益(103,213)(59,282)(55,567)(33,518)(23,033)
旧(39,848)
(15,486)
旧(63,167)
(25,647)(10,093)
従業員数[連結]781006291132
●Zingo(TM) (lidocaine HCl皮内投与システム)
【2007概要】Zingo(TM) (lidocaine hydrochloride monohydrate) powder intradermal injection system, which was approved by the FDA in August 2007 to reduce the pain associated with peripheral IV insertions or blood draws in children three to 18 years of age. In October 2007, we announced that our Phase 3 clinical trial in adults requested by the Food and Drug Administration (FDA) met its primary endpoint. In March 2008, we submitted to the FDA a supplemental New Drug Application for the use of Zingo in adults.

【技術】Anesiva,Inc社は2002.3.22にPowderJect Research Limited(現在PowderMed Limited,Pfizer社の完全子会社)からZingo関連の150以上の特許および応用技術を獲得した。 特許の失効は2014年迄。

【販売提携】欧州6ヵ国に関してSigma-Tau SpAへのライセンス契約済みだったが2008.5.1に更に他の欧州諸国も加える契約変更。  2008.4.29に中近東に関してGreen Vision Companyにライセンス。 2007.10.11にSagent Pharmaceuticals, Inc.とZingoの米国での共同販売契約締結。 ★2007.12.11にMedical Futures Incにカナダの独占販売権をライセンス。 ★2007.10にZingo製品化および米国への供給を目的として、中国Jiangsu Wanbang Biological Pharmaceutical Corporation Limited(Fosun Pharmaceuticals (Group) Corporationの子会社)およびYat Ming Lau(香港市民)と合弁会社 Wanbang Anesiva (Jiangsu) Pharmaceutical Co., Ltd(当社49%)設立契約。


Anesiva,Inc

Product Portfolio〜パイプライン Adlea(TM) (formerly 4975)〜鎮痛剤 InvestorsAnnual Reports SEC Filings 10-K annual report[2009.3.25] 10-K annual report[2008.3.14] Media

Anesiva Announces Adlea ACTIVE-1 Phase 3 Clinical Results, Ceasing of Zingo Commercial Operations and Restructuring[2008.11.10] - [pdf]★未出荷品の有効期限問題などの理由から、Zingoの販売中止を決めた。 米国外の契約はキャンセル予定。 尚2番手製品として期待していた鎮痛剤高純度capsaicin製剤Adlea(TM)の第3相試験(ACTIVE-1試験)に失敗、従業員リストラを発表。
Anesiva Launches Needle-Free Zingo(TM) to Reduce Pain from IV Starts and Blood Draws in Children[2008.6.30] - [pdf]
FDA Accepts Zingo(TM) Supplemental New Drug Application to Reduce Pain Associated With Peripheral Needle Insertion Procedures in Adults[2008.5.21] - [pdf]
Anesiva Announces Publication of Phase 3 Zingo(TM) Data in the Journal Pediatrics[2008.5.5] - [pdf]
Anesiva Announces Expansion of Zingo Agreement in Europe[2008.5.1] - [pdf]★Sigma-Tau SpAへの欧州6ヵ国ライセンスに追加
Anesiva Announces New Zingo Marketing and Distribution Agreement[2008.4.29] - [pdf]★中近東に関してGreen Vision Companyにライセンス
Anesiva Announces Submission of Supplemental New Drug Application for to Reduce Pain Associated With Needle Insertion Procedures in Adults[2008.3.10] - [pdf]★Zingo(TM)は3−18才用に承認されているが、本日成人用の適応追加を申請
Anesiva and Sigma-Tau Announce Exclusive Marketing and Distribution Agreement for Zingo(TM) in Six European Countries[2008.2.11] - [pdf]
Anesiva Announces Hiring of Sales Force for FDA-Approved Product Zingo(TM)[2008.1.30] - [pdf]
Anesiva and Medical Futures Announce Exclusive Marketing and Distribution Agreement for Zingo(TM) in Canada[2008.12.11] - [pdf]
Anesiva Outlines Comprehensive Commercialization Plan for FDA Approved Product Zingo(TM)[2007.10.12] - [pdf]
Anesiva Signs Co-Promotion and Distribution Agreement With Sagent Pharmaceuticals for Zingo(TM) in U.S. Hospitals[2007.10.11] - [pdf]
Anesiva to Unveil Zingo(TM) Commercialization Plans[2007.10.4] - [pdf]
Anesiva Receives FDA Approval for Zingo(TM), a New, Innovative Product to Reduce Pain Associated with Needle Insertion Procedures in Children[2007.8.17] - [pdf]
Anesiva Announces FDA Acceptance for Filing of Zingo(TM) New Drug Application to Reduce Pain Associated With Needle Insertion Procedures in Children[2007.2.7] - [pdf]







Ark Therapeutics Group plc[英国]

1993に創立・遺伝子療法の治療薬開発

●会社決算
(£000)201020092008200720062005
総収入7572,9649291,1253442,347
営業利益(17,017)(20,820)(20,461)(22,219)(20,941)(18,622)
当期純利益(15,903)(18,923)(15,885)(18,181)(17,513)(15,135)
研究開発費11,06815,56216,46114,61112,84513,941
従業員数[連結]107147155152148122
薬剤名ステージ適応症備考
●OUT-LICENSING対象品目
Cerepro®EU申請取下げ2010.3malignant glioma 
【メモ】Indicated for the treatment of GBM and benefiting from orphan drug status, Cerepro® has completed three clinical trials and demonstrated significant efficacy in a recent Phase III trial, but a further trial is required to meet regulatory requirements for approval. Ark is seeking co-development and commercialisation partners.
Trinam®Phase IIbmaintaining vascular access grafts米欧Orphan Drug
【メモ】A product of innovative Ark research which demonstrated a novel vascular protective activity of VEGF, Trinam® is under investigation as a treatment to maintain vascular access in haemodialysis patients and has successfully completed a Phase I trial. Trinam® has Fast Track designation by the FDA and is registered for Orphan Drug Development by the FDA and the EMA. Ark is seeking co-development and commercialisation partners for the USA and other markets where PTFE graft surgery is performed.

●Gene-based Medicines
EG011Phase Irefractory angina(治療抵抗性狭心症) 
【メモ】This VEGF-D-gene-based therapy is being developed to restore blood flow in heart tissue in refractory angina or post-MI patients. A Phase I clinical trial is underway in collaboration with the AIV Institute. Ark is seeking co-development and commercialisation partners. This programme could have application to a very large market where an estimated 200,000 people in the US and EU following successful recovery from a heart attack suffer from continued chest pain after mild exertion or even at rest.
EG013前臨床fetal growth restriction(胎児発育遅延)  
【メモ】Ark's EG013 VEGF-D based therapy is designed to restore the inadequate uterine blood flow to the placenta that can result in devastating defects in fetal growth. The programme has now achieved impressive in vivo proof of concept data. Safety studies discussed with regulatory authorities are progressing well and Ark is on course to commence a clinical programme in 2012. Ark is seeking co-development and commercialisation partners for this unique opportunity for an important clinical need for which presently there is no available medical therapy.
EG016前臨床peripheral vascular disease(末梢血管疾患) 
【メモ】This therapy is being developed to re-capillarise the tissue before femero-popliteal bypass surgery or percutaneous revascularisation procedures in patients suffering from peripheral vascular disease, with an estimated potential market of 300,000 patients. EG016 employs Ark's vascular endothelial growth factor-D constructs with known angiogenic activity in this setting. The first patients have now been enrolled in a Phase I study in collaboration with the AIV Institute. Ark is seeking partners to co-develop and commercialise this product.

●Small molecule therapeutics
Neuropilin-1 antagonists(EG014)前臨床 for anti-tumour therapy() 
【メモ】NRP-1 receptor is a highly promising target integral to the VEGF receptor system. Ark has developed the first ever effective and drug-like small molecule antagonists, around which it has established comprehensive composition of matter patents. These compounds have demonstrated their anti-tumour and anti-angiogenesis qualities in in vivo models of solid tumours. Ark would welcome contact from any party interested in partnering the development and commercialisation of this exciting programme.
Ark Therapeutics Group plc[英]

Company Info Partnering & Licensing Investor Relations Company Facts Report Financial Reports Interim Report 2011 Annual Report & Accounts 2010 Press Release

Ark Therapeutics Group PLC - Half Yearly Report - Part 1[2011.8.24]
の Expenditure on research and development for the period totalled £4.3m (six months ended 30 June 2010: £6.1m). The decrease in the period was principally due to the cessation of clinical trial activity on Cerepro®, Trinam® and Vitor™ during 2010, and the reduction in headcount and operational support expenditure as a result of the restructuring measures announced last year. We have maintained, and in some cases increased, investment in our early-stage research programmes, as we recognise their vital importance to the future of the Company.
Selling, marketing and distribution costs for the period were negligible for the period compared to £0.1m for the six months ended 30 June 2010, due to the cessation of all pre-commercial activity relating to Cerepro® in early 2010. Ark Therapeutics Group PLC - Interim Management Statement[2011.5.17]
- Work continues to identify a suitable partner to complete the clinical development for Cerepro® which the Company believes can provide a clinical benefit to patients
Preliminary results for the year ended 31 December 2009[2010.3.10]
- Named Patient Supply approval for Cerepro® in France and Finland
- First annual update of Cerepro® Phase III trial showed results strengthened in Cerepro®'s favour
- Updated Cerepro® Phase III results presented by Investigators at Society of Neuro-Oncology Conference in New Orleans
- EMA adopts negative opinion on Cerepro® MAA
Ark withdraws Cerepro® MAA after SAG-O requests further trial before approval[2010.3.9]
The Board of Ark Therapeutics Group plc ("Ark" or "the Company") today announces an update relating to the Marketing Authorisation Application ("MAA") for its brain cancer treatment, Cerepro®. Following a presentation to the EMEA's Scientific Advisory Group on Oncology ("SAG-O") as part of the re-examination procedure, the SAG-O did not consider that the current study provides sufficiently reliable evidence of clinical benefit. The recommendation was made that the Company needed to conduct a further clinical trial before the product could be approved. The Company has therefore withdrawn from the current MAA process to examine this recommendation.

The SAG-O did not consider that the current study provides sufficiently reliable evidence of clinical benefit. The decision to re-intervene following tumour recurrence was made by the individual neurosurgeon on a case by case basis and thus there was no standardised decision making. Therefore, despite the use of a blinded re-intervention committee and the Phase III data showing no evidence of bias on all available re-intervention related study measurements, the SAG-O advised that the data on the primary endpoint could not be considered reliable and therefore did not provide appropriate evidence of a therapeutic benefit for a marketing authorisation. The Company was advised that it must conduct a further study which would need to be powered to show a benefit on an endpoint which was or could be established as clinically and statistically robust.

Following the withdrawal of the Cerepro® MAA, Ark has initiated a full review of its substantial portfolio of assets, their potential and alternative strategies and options to optimise shareholder value. The review will also consider strategic alternatives in light of approaches that have already been received.

Ark Therapeutics Group PLC - Ark files for re-examination of Cerepro[2010.1.5]
Ark Therapeutics Group PLC - EMEA recommendation on Cerepro[2009.12.18]〜否決
Ark Therapeutics Group PLC - Cerepro Named Patient Supply approved in Finland[2009.5.15]







AstraZeneca

2007.6  MedImmune社の買収完了


●会社決算
($ Million)20132012201120102009200820072006200520042003200220012000
連結売上高33,591(+1)33,26932,80431,601(+7)29,559(+12)26,47523,950(+12)21,426(+14)18,84917,84116,22217,882

営業利益12,79511,49411,5439,144(+16)8,094(-1)8,2166,502(+39)4,547(+12)
旧4,770
4,007
旧4,111
4,0063,9544,008
経常利益12,36710,97710,8078,681(+13)7,983(-7)8,5436,667(+41)4,625(+13)
旧5,085
4,077
旧4,202
4,0874,0773,847
当期純利益10,0169,6429,1596,101(+13)5,6276,0634,724
旧3,813

旧3,036
2,8362,9062,277

研究開発費[対売上比]5,5235,3184,4095,179(+3)[16.4%]5,162(+32)3,9023,379(-4)3,467(+6)
旧3,803
3,012
旧3,451
3,0692,7732,893
従業員数[連結]66,10067,90066,60064,90064,20061,00059,400
*2002迄&2003-2004旧=UK GAAP; 2003-= ●地域別売上高
($ milllion)20132012201120102009200820072006200520042003200220012000
米 国13,727(-7)14,77713,510(+1)13,366(+7)12,449(+16)10,771(+12)9,631(+10)8,747(-6)9,351(+10)8,483(+7)8,153
欧 州9,168(+2)9,2529,743(+7)9,115(+13)8,903(+5)8,463(+11)7,649(+14)6,709(+2)5,695(+5)5,238(+8)5,166
日 本1,957(+18)1,661(+11)1,503(-2)1,527(+7)1,430(+20)1,189(+14)977(+21)851(+16)825
その他6,3915,4172,5893,189(+12)2,716(+23)2,204(+16)1,818(+13)1,650(+9)1,660
 合計31,601(+7)29,559(+12)26,475(+11)23,950(+12)(+)21,426(+14)18,849
●製品グループ
($ milllion)20132012201120102009200820072006200520042003200220012000
成長群 Growth 1)15,344(+15)13,318(+23)10,849(+29)8,426(+41)5,986(+53)3,753(+144)
特許切群Patent Expiry 2)3,230(-16)2,042(-16)2,458(-17)2,976(-21)3,7616,469(-17)
安定群 Base10,985(+18)11,115(+5)10,643(+6)10,024(+10)9,1027,619(+9)
 合計29,559(+12)26,47523,950(+12)21,426(+14)18,84917,84116,22217,882
1) Arimidex, Crestor, Nexium, Seroquel, Symbicort 2) Losec, Nolvadex, Plendil, Seloken/Toprol-XL, Zestril ●製品売上高
($ milllion)20142013201220112010200920082007200620052004200320022001200019991998備考
★Cardiovascular10,212(+9)9,403(+11)8,376(+20)6,963(-)6,686(+9)6,118(+15)5,332(+10)4,777(+17)3,910(+3)3,569(+1)3,483(+6)3,477(+6)3,416(+14)3,017
Seloken/Toprol-XL758(+1)750(-18)918986(-20)1,210(-17)1,443(+79)807(-46)1,438(-20)1,795(+3)1,735(+24)1,387(+6)1,280(+38)901(+27)711(+28)577(+13)531(+19)450[metoprolol]
Crestor5,512(-2)5,622(-8)6,2536,622(+13)5,691(+24)4,502(+25)3,597(+26)2,796(+38)2,028(+60)1,268(+38)908(-)129(-)-----[rosuvastatin]スタチン;高脂血症;塩野義
Atacand501(-18)611(-39)1,0091,450(-6)1,483(+3)1,436(-2)1,471(+10)1,287(+16)1,110(+1)974(+8)879(+10)750(+21)569(+36)410(+46)293(+82)171(+312)43[candesartan]ARB;高血圧
Plendil249(-4)260252256(-)255(+4)241(-10)268(-7)271(-1)275(-24)360(-23)455(-20)540(+5)489(+5)463(+2)480(+11)452(+24)367[felodipine]Ca拮抗剤;高血圧、心疾患
Tenormin161(-15)197229270(-2)-296(-5)313(+2)308(-4)320(-9)352(-5)368(+8)342(-8)370???471(-4)509(+2)502[atenolol]
Zestril144(-8)157(-14)184(-22)236(-24)295(-4)307(-8)332(-27)440(-15)478(-50)877(-18)1,067(-6)1,188(+1)1,221(+9)1,126[lisinopril]ACE阻害剤;高血圧、CV疾患
ONGLYZA(TM)820(+117)378(+17)323211(+206)69(-)11(-)-[saxagliptin]2型糖尿病
Brilinta/Brilique476(+70)283(+216)8921()[ticagrelor]抗血小板薬;急性冠症候群
Byetta327(+59)206(+181)74[exenatide]糖尿病
Bydureon440(+191)151(+308)37[exenatide持続性注]糖尿病
Forxiga10-[dapagliflozin]糖尿病;SGLT-2阻害薬
その他252(-4)263(-3)271(-7)291(+2)283(-9)311(-12)340(-20)391(-4)363(-15)429
他Ramace (ramipril): Inderal (propranolol hydrochloride): Sular (nisoldipine):
Imdur (isosorbide-5-mononitrate): Canef (fluvastatin): 他
★Gastrointestinal6,0886,011(-5)6,344(-4)6,443(-3)6,631(+4)6,355(+5)5,918(-4)5,943(-16)6,664(+7)6,190(+2)6,322(+9)5,957(+24)4,845
Nexium4,429(-12)4,969(-)4,959(-5)5,200(-2)5,216(+1)5,182(+12)4,633(+18)3,883(+15)3,302(+62)1,978(-)568(-)17(-)--[esomeprazole]PPI;
Losec/Prilosec946(-11)986(+1)946(-10)1,055(-14)1,143(-17)1,371(-7)1,652(-17)1,947(-30)2,565(-49)4,623(-18)5,578(-7)6,260(+9)5,909(+24)4,799[omeprazole]初のPPI
その他106(+19)89(+6)84(+8)78(+4)70(+5)88(+9)76(+13)63(+43)44
★Neuroscience7,204(+7)6,704(+7)6,237(+7)5,837(+6)5,340(+14)4,704(+16)4,059(+15)3,496(+19)2,833(+12)2,418
 米4,325(+8)4,003(+8)
 西欧1,517(+6)1,433(-3)
 Established ROW682(+10)618(+17)
 Emerging Markets680(+5)650(+20)
(★CentralNerv.System)------1,505(+53)980(+48)685(+58)433(+139)183
Seroquel 計5,828(+10)5,302(+9)4,866(+9)4,452(+11)4,027(+18)3,416(+24)2,761(+35)2,027(+33)1,487(+27)1,145(+67)685(+67)424(+85)232(+254)66[quetiapin] 精神病
Seroquel IR4,338(+3)4,148(-1)4,171[quetiapin] 精神病
 米3,344(+8)3,107(+1)
 西欧546(-3)560(-14)
 Established ROW228(+2)223(+10)
 Emerging Markets220(-15)258(+7)
Seroquel XR1,490(+29)1,154(+66)695[quetiapin] 精神病
 米779(+22)640(+87)
 西欧490(+36)359(+30)
 Established ROW89(+46)61(+85)
 Emerging Markets132(+40)94(+114)
Vimovo34(-)-[naproxen / esomeprazole magnesium]関節リウマチ
 米21(-)
 西欧6(-)
 Established ROW6(-)
 Emerging Markets1(-)
Zomig413(-4)428(-1)434(-3)448(+3)434(+9)398(+13)352(-3)356(-3)349(-1)328(+19)273(+20)237(+31)189(+88)102[zolmitriptan] 片頭痛
 米158(-10)176(-3)
 西欧174(+1)172(-4)
 Established ROW68(-1)69(+17)
 Emerging Markets13(+18)11(-15)
(★Pain Control&Infection)------1,418(-5)1,496(-)1,376(-5)1,506(+2)1,490
Diprivan294(-9)322(+11)290(+4)278(+6)263(-13)304(-18)369(-27)500(+5)458(-2)443(-3)456(-4)507(-14)608(-6)653propofol
 米12(-73)45(-)
 西欧42(-16)50(-19)
 Established ROW83(+9)76(+29)
 Emerging Markets157(+4)151(+22)
局所麻酔剤602(-)605(+1)599(-1)605(+9)557(+5)529(+4)511(-8)542(+8)466(-)432(-)434(+19)383
 米10(-66)29(-28)
 西欧242(-9)265(-4)
 Established ROW205(+10)186(+9)
 Emerging Markets145(+16)125(+13)
Xylocaine--------?179(-14)212(-5)238(-3)249(+2)240[Lidocaine HCl]局所麻酔剤
Marcaine--------?77(-11)87(-)92(+8)88(+11)80[Bupivacaine HCl]局所麻酔剤
その他33(-21)47(-2)48(-11)54(-8)59(+4)57(-14)66(-8)71(-10)73(-7)70(-54)149
★Oncology3,705(-12)4,045(-12)4,518(-9)4,954(+3)4,819(+13)4,262(+11)3,845(+12)3,376(+16)2,743(+8)2,369(+13)2,111(+16)1,929(+12)1,764(+15)1,538
 米353(-51)721(-41)
 西欧935(-19)1,153(-10)
 Established ROW1,440(+8)1,328(+3)
 Emerging Markets977(+16)843(+15)
Arimidex756(-53)1,512(-22)1,921(+3)1,857(+7)1,730(+15)1,508(+28)1,181(+44)811(+48)519(+46)331(+75)188(+27)156(+19)140(+19)121[anastrozole]乳癌;Aromatase阻害剤
 米42(-91)494(-44)
 西欧260(-55)580(-7)
 Established ROW308(+7)287(+10)
 Emerging Markets146(-3)151(-3)
Casodex550(+32)579(-34)844(-34)1,258(-6)1,335(+11)1,206(+7)1,123(+10)1,012(+11)854(+22)644(+15)561(+37)433(+31)340(+41)245[bicalutamide]前立腺癌
 米-6(-138)16(-89)
 西欧80(-29)113(-39)
 Established ROW364(+5)347(-14)
 Emerging Markets112(+9)103(-6)
Zoladex1,179(+3)1,115(-)1,086(-5)1,138(+3)1,104(+10)1,008(-)1,004(+7)917(-1)869(-)794(+12)718(+5)734(+10)686(+9)626[goserelin]乳癌、前立腺癌
 米39(-15)46(-15)
 西欧262(-5)276(-19)
 Established ROW494(+10)451(+8)
 Emerging Markets384(+12)342(+24)
Iressa554(+32)393(+28)297(+12)265(+11)238(-)237(-13)273(-31)389(+65)228(+227)67(-)----[gefinitib]肺癌
 米2(+50)4(-20)
 西欧127(+159)49(+600)
 Established ROW204(+12)182(+15)
 Emerging Markets221(+40)158(+24)
Nolvadex-89(-3)8885(+2)83(-7)89(-22)114(-16)134(-31)178(-66)480(-21)618(+12)576(+1)573(+7)526[tamoxifene]乳癌
Faslodex546345(+33)262249(+16)214(+15)186(+33)140(+39)99(+28)77(+120)35(-)----[fulvestrant]乳癌
Abraxane--64(+3)62(+244)18(paclitaxel protein-bound particles for injectable suspension) (albumin-bound)乳癌;米国でAbraxis BioScienceと共販
Ethyol-15(-46)28(-)43(-)-[amifostine]放射線防護剤;Medimmune
その他666(+46)446(+21)355(-13)10(-)10(-)10
旧303(+15)
264
旧10(-36)
14(-28)18(-6)18(-31)26
★Respiratory4,099(-1)4,132(-)4,128(+11)3,711(+18)3,151(+10)2,873(+9)2,583(+8)2,261(+15)1,818(+16)1,539(+17)1,372(+10)1,339(+10)1,256
Plumicort946867866892872(-34)1,310(-12)1,495(+3)1,454(+13)1,292(+11)1,162(+9)1,050(+4)968(+12)812(+5)766(+14)705(+5)730(+9)691[budesonide]喘息
Symbicort3,8013,4833,1943,148(+11)2,746(+20)2,294(+14)2,004(+27)1,575(+33)1,184(+18)1,006(+22)797(+32)549(+61)299(+)83(-)-----[budesonide/formoterol]喘息・COPD
Rhinocort177212227(-16)264(-18)322(-9)354(-2)360(-7)387(+6)361(-3)364(+19)299(+13)265(+25)221(+37)167(+8)158[budesonide]鼻炎
Accolate57(-15)66(-10)73(-4)76(-6)81(+13)72(-39)116(+6)107(-28)144(+2)143(-2)152(-2)156(+4)152[zafirlukast]喘息;ロイコトリエン受容体拮抗
Oxis63(-2)63(-11)71(-17)86(-2)88(-3)91(-14)101(-24)120(-12)120(-9)127(+15)116(+48)87(+107)44[formoterol]喘息・COPD;β作動薬
Bricanyl-------??????107(-7)125(-6)142(-5)154[terbutaline]
その他135(-17)163(-2)166(+14)146(-6)155(-5)158(-5)153(-6)144(-7)155他 : Salbutamol:Bambec (bambuterol)
★Infection and Other2,176(-18)2,631(+7)2,451(+43)1,714(+96)875(+4)839
旧607(+9)
539(+7)628(+24)505
Merrem817(-7)872(-3)897(+16)773(+28)604(+20)505(+15)423(+15)346(+21)285(+26)227(+40)170(+18)153(+29)128[meropenem] 抗生物質
Synagis*975(-6)1,038(-4)1,082(-12)1,230(-)618(-)-(palivizumab) RSV感染予防;Medimmune
FluMist*174(+20)145(+39)104(+96)53(-)-(経鼻インフルエンザワクチン) ;Medimmune
非季節性インフルエンザワクチン39(-90)389
その他143(-35)220(-19)270(-)875(+4)
旧271(-19)
334
旧102(-14)
116(-16)130(-24)155(-9)171

Aptium Oncology393(-1)395402374(+)335
Astra Tech506(-4)529444360(+15)312

 米
 西欧
 Established ROW
 Emerging Markets
これらMedImmune製品の売上高は2007年6月1日からアストラゼネカに連結計上しており、それ以前の売上高は含まれない。 ■2005/2006/2007年決算メモ ・2006.2.14 抗血液凝固剤Exanta^(TM) (melagatran / ximelagatran) の市場回収 &開発中止。 肝臓障害発生による。 ●循環器 ★Crestor [2008] Since its launch in 2003, our statin, Crestor, has continued to gain market share, based on its differentiated profile in managing cholesterol levels and its unique recent label indication for treating atherosclerotic disease. Following new approvals during 2008 in Germany, Spain, Poland, Norway and Malta, Crestor is now approved in every EU country. Less than half of the people thought to have high levels of low-density lipoprotein cholesterol (LDL-C) ‘bad cholesterol’ get diagnosed and treated and of those people, only about half reach their physician’s recommended cholesterol target using existing treatments. Crestor is the most effective statin in lowering LDL-C and the majority of patients reach their LDL-C goals using the usual 10mg starting dose. Crestor also produces an increase in high-density lipoprotein cholesterol (HDL-C) ‘good cholesterol’, across a range of doses. At its usual 10mg starting dose, Crestor has been shown, versus placebo, to reduce LDL-C by up to 52% and raise HDL-C by up to 14% with eight out of 10 patients reaching their lipid goals. In the US, Crestor is also approved for use as an adjunct to diet for slowing the progression of atherosclerosis in patients with elevated cholesterol. Crestor is the only statin with an atherosclerosis indication in the US which is not limited by disease severity or restricted to patients with coronary heart disease. Clinical trial developments GALAXY, our long-term global clinical research programme for Crestor investigating links between optimal lipid control, atherosclerosis and CV morbidity and mortality, has completed a number of studies involving over 69,000 patients in over 55 countries. Data from the latest study, JUPITER, published in November 2008, demonstrated that Crestor 20mg significantly reduced major CV events (defined in this study as the combined risk of myocardial infarction, stroke, arterial revascularisation, hospitalisation for unstable angina, or death from CV causes) by 44% compared to placebo among men and women with elevated high-sensitivity C-reactive protein (hsCRP) (and other risk factors) but low to normal cholesterol levels. Results also showed that for patients taking Crestor, the combined risk of heart attack, stroke or CV death was reduced by nearly half, risk of heart attack was cut by more than half, risk of stroke was cut by nearly half and total mortality was significantly reduced by 20%. Crestor 20mg was well tolerated in nearly 9,000 patients during the course of the study. There was no difference between treatment groups for major adverse events, including cancer or myopathy. There was a small increase in physician reported diabetes consistent with data from other large placebo controlled statin trials. GISSI-HF, an investigator sponsored study published in September 2008, evaluated Crestor 10mg and placebo in a heart failure population and confirmed the results of our CORONA study in showing no difference between the treatments in the primary endpoints of death or CV hospitalisation in patients with heart failure, over and above optimised heart failure treatment. Both studies were also consistent with the safety profile of Crestor in this vulnerable population. In both studies, outcome events appeared to be driven primarily by heart muscle failure rather than ischemic events where statins would be expected to have an effect. Ongoing studies of Crestor include SATURN, which is designed to measure the impact of Crestor 40mg and atorvastatin (Lipitor.) 80mg on the progression of atherosclerosis in high-risk patients and is expected to report in 2011. AURORA, an outcomes study in patients with end stage renal disease is expected to present data by mid 2009. [2007] クレストールの通年売上高は33%増の27億9,600万ドルで、米国で24%増でした。米国以外の市場では45%増でクレ ストールの世界全体での売上高の半分を占めるまでになりました。2007年11月、クレストールは米国FDAから食事療 法に加えることにより高コレステロール血症患者のアテローム性動脈硬化の進展を抑制する新たな適応症の承認を 受けました。 米国のクレストールの通年売上高は前年比24%増の14億2,400万ドルでした。米国スタチン市場の総処方数は本年度 8%上昇し、クレストールの処方数は22%上昇しました。米国市場の総処方数に占めるクレストールのシェアは12月時 点で8.6%でした。第4四半期のクレストールの米国内売上高は8%上昇し、処方数の増加とほぼ一致しています。 ・ 2007年11月、クレストールは米国FDAから食事療法に加えることにより高コレステロール血症患者のアテローム 性動脈硬化の進展を抑制する新たな適応症の承認を受けました。 ・ 2008年1月15日に、当社は新たな臨床試験SATURNの開始を発表しました。SATURNでは、アテローム性動脈硬化の 進展抑制または退縮に対するクレストールの作用をアトルバスタチンと比較評価します。 ・ 米国以外のクレストールの通年売上高は45%増加し、13億7,200万ドルでした。これは世界全体の売上高のほぼ 半分を占めます。欧州市場はフランスとイタリアでの好調な売上に牽引され、26%増加しました。カナダは成長率 は43%でした。日本でも発売以降、売上は順調に推移しており、2007年11月の数量ベースのシェアは8.8%でした。 ・ 米国以外のクレストールの第4四半期売上高は38%増加しました。 [2006] ・ クレストールの年間売上高は2006年に初めて20億ドルを超えました。クレストールは現在84カ国で承認され、74カ国で販売 されています。2003年初めの発売から、900万人以上の患者さんがクレストールによる治療を受け、7,000万件以上の処方箋が発行されました。 ・ 米国でのクレストールの売上高は当期75%、年間57%の増加を示しました。米国スタチン市場の新規処方数は年間17%上昇し、 クレストールの新規処方数は58%上昇しました。2006年12月現在のクレストールの新規処方市場の占有率は9.6%であり、前年比 2.7ポイントのアップとなりました。これにより、クレストールは2006年にブランドスタチン薬のなかで最大のシェア獲得率を 記録しました。しかし、2007年1月初めにはシンバスタチンの後発競合製品がいくつか発売されるため、新規処方市場の占有率 は低下する見込みです。 ・ 米国以外の市場ではクレストールの第4四半期売上高は70%増加しました。欧州(56%増)市場の堅調な売上増と、日本での 下半期の売上拡大によるアジア太平洋地域の成長に牽引され、年間で61%の増加しました。クレストールの販売量ベースのスタ チン市場シェア率は現在、カナダ17.4%、オランダ11.5%、イタリア19.3%、フランス12.9%です。 [2005] クレストールはこれまでに75カ国の市場で承認され、69カ国で発売されました。2003年初 めの最初の発売以来、600万人がクレストールによる治療を受け、処方数は4,000万件に上 ります。クレストールの年間売上高は38%増の12億6,800万ドルに達しました。 ・ 米国でのクレストールの年間売上高は34%増で7億3,000万ドルを計上、米国スタチン市 場の新規処方に占めるクレストールのシェアは1月20日終了週で6.9%でした。ダイナミッ クマーケット(新規、切り替えの患者)のシェアは先週8.8%を記録しました。 ・ 米国以外の市場ではクレストールの欧州(44%増)およびカナダ(25%増)の好調な伸 びに支えられ、年間売上高は41%増を記録しました。クレストールのスタチン市場におけ る数量ベースでのシェアは現在、カナダ13.4%、オランダ11.2%、イタリア11.7%、フランス6.0%です。 ・2005.3, FDAはPublic Citizenの請願(Crestorの販売中止)を安全性データと市販後調査 データに基づき公式に却下した。 ・2006年上半期にクレストールに関する新しいデータを発表する予定であり、これには冠動脈アテローム性硬化症の退行 に対するクレストールの作用を評価したASTEROID試験のデータが含まれます。最近完了した薬剤疫学試験の結果も同時期 に発表の予定です。 [2003] ・ Crestor の通年(発売25カ国)の売上は、米国での6,200万ドルを含む1億2,900万ドルでした。 ・ 2003年2月のカナダでの最初の発売以降、75万人以上の患者がCrestorの投与を受け、 150万件を超える処方がなされたと当社は推測しています。市販後調査(PMS)の結果 Crestorの優れた忍容性と安全性は他の既存のスタチン製品と同様であることが確認されています。 ・ Crestorの初期の発売国はカナダ、オランダ、英国などです。最新の市場調査データ によると、これらの市場の処方総数におけるCrestorのシェアはそれぞれ6.9%(カナダ) 、8.2%(オランダ)、および2.9%(英国)に達しました。 ・ 米国ではCrestorは9月中旬に発売されました、1月16日終了週で、米国のスタチン市場 の新規処方におけるCrestorのシェアは4.6%で、非常に競合の激しい市場において良い スタートを切りました。新規スタチン治療(新規処方ならびに他剤からの切り替え処方 のみ)におけるCrestorのシェアは13.7%です。 ★Exanta [2005] Exantaについては2005年12月、新しい中央審査方式にもとづき欧州の規制当局に心房細動 患者の脳卒中の予防を適応とする承認申請を提出しました。米国ではFDAとの話し合いを 継続していますが、目下のところ米国でのExanta承認への道筋が見出される可能性は低いと考えられます。 [2003] ・ 12月23日に、Exantaが整形外科手術時および手術後の静脈血栓塞栓症予防の適応症で フランスで最初に承認されました。フランスは、この適応症の承認取得における欧州 相互認証方式の幹事国です。12月にはまた、心房細動における脳卒中の予防を含む最初 の主な長期使用の適応症に関する承認申請を欧州と米国で行いました。 ★テノルミン [2005] ・全体で5%ダウン、しかし最大市場の日本では3%増の$130 millionに。 ★Seloken [2003] ・ Seloken/Toprol-XL の通年の売上は、米国における大幅な伸長(47%増)を反映して 初めて10億ドルを超えました。 ※米国で2001年早期にうっ血性心不全の適応取得 ・ 米国でのToprol-XL の総処方件数は25%増で、12月にはベータ遮断剤の総処方件数 におけるシェアは前年度比2.6ポイント増の26.2%でした。 ★Atacand [2008] Atacand, first launched in 1997, is approved for the treatment of hypertension in over 100 countries and for symptomatic heart failure in over 70 countries. Angiotensin II antagonists are the fastest growing sector of the global hypertension market. Available as a once a day tablet, launches of the 32mg dosage strength outside the US continued during the year, and this dosage is now available in most Established Markets. In July 2008, we sought approval in Europe for two dose strengths of Atacand Plus (candesartan cilexetil/hydrochlorothiazide) which is a fixed combination of Atacand and the diuretic hydrochlorothiazide (HCTZ), indicated for the treatment of hypertension in patients who need more than monotherapy. The clinical programme (DIRECT) investigating the effect of Atacand (up to 32mg dosage) on retinopathy in hypertensive and normotensive diabetic patients completed in 2008 but failed to meet the primary endpoint. The results were published in September 2008. [2003] ・ Atacand の通年の売上は米国で28%増、全世界の売上の3分の2近くを占める米国以外 の市場で18%増でした。米国の売上増は総処方件数の伸びを上回っており、卸在庫が増加 したことを示しています。 ★Zestril [2003] ・ 米国でのZestril (ゼストリル)の処方量は、2002.7月に後発品が発売されて以来、急減。 ■抗血栓 [2008] Patients surviving an acute coronary event are at increased risk from further thrombosis and treatment guidelines advocate anti-platelet therapy. New guidelines issued in 2007 by the European Society of Cardiology for the treatment of acute coronary syndrome (ACS), have highlighted the negative consequences of drug induced bleeding in conjunction with the treatment of ACS, reinforcing the need for new anti-thrombosis drugs with acceptable bleeding risk. During the year, two new anti-coagulants (dabigatran and rivaroxaban) were approved in Europe for use in prevention of deep vein thrombosis in conjunction with orthopaedic surgery. No Phase III data are yet available for the ability of new anti-coagulants to prevent strokes in AF, the major chronic indication for anti-coagulants, without the risks and repeated monitoring of warfarin or other vitamin K antagonists. ★Brilinta (ticagrelor AZD6140), [2008] Brilinta (ticagrelor AZD6140), the first reversible, oral, adenosine diphosphate (ADP) receptor antagonist, is being developed to reduce the risk of blood clots and thrombotic events in patients diagnosed with ACS. Ticagrelor is currently being studied in the Phase III PLATO clinical trial, involving over 18,000 ACS patients in 43 countries, to determine if it is superior to clopidogrel for reducing the risk of thrombotic events in ACS patients. ★AZD0837 (an oral, direct thrombin inhibitor) [2008] The effectiveness of AZD0837 (an oral, direct thrombin inhibitor) in preventing strokes and other embolic events in AF patients will be studied in more than 35 countries, using a once-daily extended release formulation that provides sustained anti-coagulation effect throughout the dosing interval. We anticipate starting these Phase III studies in 2009. ★AZD1305, a combined ion channel blocker [2008] Our lead compound in the treatment of AF is AZD1305, a combined ion channel blocker, which has progressed into Phase IIa testing in both the IV and oral form. ●消化器 ★Nexium [2008] GI Sales for 2008 were down 2% on a reported basis to $6,344 million from $6,443 million in 2007 Global Nexium sales were down 2%, excluding the effects of exchange, to $5,200 million from $5,216 million the previous year. The decline was driven by the decrease in the US of 8% to $3,101 million, however this was largely mitigated by sales in other markets increasing by 9% to $2,099 million. In the US, dispensed retail tablet volumes increased by 2% and Nexium was the only major PPI brand to do so in 2008< In the Rest of World, growth in Canada (9%), Japan (5%) and Emerging Markets (20%) more than offset the 5% decline in Western European sales Nexium is an effective, long-term therapy for patients with GERD. For the treatment of active peptic ulcer disease, seven-day Nexium triple therapy (in combination with two antibiotics for the eradication of H.pylori) heals most patients without the need for follow-up anti-secretory therapy. Since it was first launched in 2000, Nexium has been used in the treatment of acid-related diseases in over one billion patient treatments. Nexium is available in approximately 100 countries for the treatment of acid-related diseases. In the US and EU, Nexium is also approved for the treatment of children aged 12 to 17 years with GERD and in 2008 was approved for use in these countries in children aged one to 11 years old. Nexium is also approved in the US, the EU, Canada and Australia for the treatment of patients with the rare gastric disorder, Zollinger-Ellison syndrome. In Europe, Nexium is approved for the healing and prevention of ulcers associated with non-steroidal anti-inflammatory drug (NSAID) therapy including Cox2 inhibitors. In the US, Nexium is approved for reducing the risk of gastric ulcers associated with continuous NSAID therapy in patients at risk of developing gastric ulcers. Nexium IV, which is used when oral administration is not suitable for the treatment of GERD and upper GI side effects induced by NSAIDs, is approved in 86 countries including the US and all EU countries. During 2008, we announced the submission of a supplemental new drug application (sNDA) to the FDA for Nexium IV (esomeprazole sodium) injection, seeking approval for use in patients with peptic ulcer bleeding following therapeutic endoscopy. This was followed by an EU submission for Nexium IV and tablets, seeking approval for the short-term maintenance of haemostasis and prevention of re-bleeding in patients with peptic ulcer bleeding following therapeutic endoscopy. In late November 2008, we received the FDA Complete Response Letter regarding our Nexium IV sNDA for peptic ulcer bleed. The application has not received FDA approval in its present form. We are reviewing their comments and will respond in due course. The EU submission is still being reviewed by the European regulatory authorities. Data from the Nexium IV Peptic Ulcer Bleed study (a multinational, randomised trial of 767 patients with peptic ulcer bleeding) is the basis for submissions in the US and EU referred to above. The study shows that use of Nexium IV for three days, followed by oral Nexium therapy for 27 days, was statistically more effective in reducing gastric ulcers compared to placebo after both three and 30 days. On 15 April 2008, AstraZeneca announced it had settled its Nexium patent infringement litigation against Ranbaxy Pharmaceutical Industries and affiliates (Ranbaxy). As a consequence of the settlement, the patent litigation filed by AstraZeneca following Ranbaxy’s submission to the FDA of an ANDA for a generic version of Nexium has been dismissed. Under the settlement Ranbaxy concedes that all six patents asserted by AstraZeneca in the patent litigation are valid and enforceable. Ranbaxy also accepts that four of the patents would be infringed by the unlicensed sale of Ranbaxy’s proposed generic product. The settlement agreement allows Ranbaxy to commence sales of a generic version of Nexium under a licence from AstraZeneca from 27 May 2014, the expiry date of US Patent Numbers 5,877,192 and 6,875,872. We are co-operating fully with the Federal Trade Commission inquiry regarding this settlement. AstraZeneca’s Nexium patent infringement litigation against Teva/IVAX and Dr Reddy’s Laboratories remains ongoing. No trial date has been set in either case. During 2008, we received additional notices that patent challenges had been filed by generic drug manufacturers in respect of 20mg and 40mg delayed-release esomeprazole magnesium capsules. Details of these filings and of new and continuing litigation are set out in Note 25 to the Financial Statements on page 153. The European Patent Office ruled in 2007 that the European process patent for Nexium and the European patent for the multiple unit pellet (MUPS) formulations of PPI, which expire in 2015, are valid in amended form following post-grant oppositions. These decisions are now subject to appeal proceedings. Further, the European Patent Office granted a new European patent on 19 November 2008 for the MUPS formulations of esomeprazole and omeprazole, which expires in 2015. We continue to have full confidence in our intellectual property protecting Nexium and will vigorously defend and enforce it. The decision of the European Court of First Instance on our appeal against the European Commission’s Decision in 2005 to impose fines on us totalling .60 million ($75 million) for alleged infringements of European competition law relating to certain omeprazole intellectual property and regulatory rights is still pending. [2007] Nexiumの通年売上高はわずかに減少し、2%減の52億1,600万ドルでした。米国内の売上高は4%減でした。Nexiumは 米国PPI市場の先発医薬品部門で依然シェアを拡大していますが、オメプラゾールの後発品の継続的な堅調な伸びと Nexiumの実質価格の下落がマイナスに作用しました。米国以外の市場でのNexiumの売上高は2%増でした。 Nexiumの米国の通年売上高は4%減の33億8,300万ドルでした。本年度の数量ベースでの推定売上成長率は2%でした。 PPIの先発品市場に占めるNexiumのシェアは、本年度1.5ポイント上昇し、主要先発製品のなかで唯一シェアを拡大 しました。しかし、PPI市場におけるオメプラゾール後発品のシェアは2007年12月までに27.4%増加しており、2006 年12月からほぼ7ポイントの成長です。Nexiumの実勢価格は1年間に約8%低下しました。 ・ 米国以外のNexiumの売上高は新興市場での伸びが欧州の売上減を上回り、通年売上高は2%増の18億3,300万ドルでした。 ・ 2008年のNexiumの売上高は2007年を下回ると予想しています。 ・ 米国のPrilosec(オメプラール)の通年売上高は3%減少し、米国以外でのLosecの売上高は24%減少しましたが、 日本と中国では伸長しました。 [2006] ・ Nexiumの米国での年間売上高は13%増の35億2,700万ドルに達しました。Nexium錠の処方量は年間で17%増加したのに対して、 他のPPIクラスの製品は全体で4%の減少を示しました。 ・ Nexiumの米国での第4四半期売上高は17%増でした。Nexium錠の処方量は当四半期で13%増加しました。米国国防省TRICARE 開業薬局処方プログラム(Deparent of Defence TRICARE Retail Pharmacy Prescription Program:DoD/TRRx)に関連する引 当金の解除により、当四半期は価格が上昇しました。 ・ 米国以外の市場でのNexiumは、フランスおよびイタリアでの良好な売上成長がドイツでの大幅な価格崩壊を補い、年間売上 高は10%増の16億5,500万ドルでした。第4四半期の米国以外の売上高は5%増加しました。 ・ 2006年12月、欧州特許庁(EPO)はドイツのジェネリック製造業者からの訴えを受け、Nexiumの欧州物質特許の1つを却下す ることを決めました。EPOの決定は残念ですが、当社はNexiumを保護する一連の知的財産の正当性を確信しています。この知的 財産には製法、用途および別の物質特許などがあり、有効期限は2009年から2019年です。Nexiumに関する欧州物質特許の1つが 却下されたとはいえ、当社が米国内でNexium特許権を擁護し、行使する能力には何ら影響ありません。当社はNexiumに関する 米国特許をいくつか取得しており、いずれの権利も、無効と認められた欧州特許とは異なるものです。 [2005] ・ Nexiumの米国での年間売上高は15%増の31億2,500万ドルに達しました。米国PPI市場の 総処方数に占めるNexiumのシェアは、前年12月から3.4ポイント増の30.3%を記録しました。 Nexiumは2005年にPPI市場でシェアを拡大した唯一の先発品です。 ・ 米国以外の市場におけるNexiumの売上高は通年で15億800万ドル(25%増)に達し、市 場シェアも2ポイント上昇しました。 ・60ヵ国患者7.3万人の大規模臨床試験により有効性・安全性を実証。 ・スエーデン2000.8発売を皮切りに100ヵ国で販売され、2005年末まで3.4億人に処方。 ・ジェネリック関連では、Dr.Reddy's Labsが2004.3にFDA Drug Master Fileをオープン、 2005.10 Ranbaxy PharmaceuticalsがANDA申請。 2006.1 IVAXがANDA申請。 [2003] ・ Nexium の米国における通年の売上は62%増の24億7,700万ドルでした。Nexium の 総処方件数は46%増、米国PPI市場の総処方のシェアは年間を通じ5%近く増加し、 12月には25.3%に達しました。 ・ Nexium の米国以外の地域での通年の売上は、欧州の主要国、特にフランス、ドイツ、 英国での大幅な売上増とオーストラリアにおける好業績により、60%増でした。 ※2000年にスウェーデン、英、独発売。米国は2001.3発売 ・ 当社は、Nexiumの注射製剤の欧州相互承認手続きが完了したことを2004年1月14日に 発表しました。米国においては現在FDAによる承認審査中です。 ★Prilosec [2008] Since its launch in 1988, we estimate that patients have benefited from over 900 million treatments with Losec/Prilosec. We continue to maintain patent property covering Losec/ Prilosec. For the full year, sales of Losec fell 14% to $1,055 million. Prilosec sales in the US were down 25% as a result of generic competition for the 40mg dosage form in the second half of the year. In the Rest of World, sales declined by 11%, despite increases in China (19%) and Japan (5%). [2007] For the full year, Losec sales declined by 20% to $1,143 million. Prilosec sales in the US were down 3% to $226 million. Losec sales in other markets were down 24%, although sales increased in Japan and China; sales in these two markets accounted for almost 30% of the brand’s performance. [2006] ・ 米国でのPrilosec(オメプラール)の年間売上高は12%減少し、他市場でのLosecの売上高は17%減少しました。 [2005] ・ Prilosecの米国での年間売上高は28%減少しました。米国以外の市場でもLosecの売り 上げは15%減少しましたが、日本では25%増、中国では16%増を記録しました。 [2003] ・ Prilosec の米国における売上は、処方減を反映し、通年で70%減でした。年末の時点 で、オメプラゾールの処方総数におけるPrilosec のシェアは27.4%まで減少しましたが、 売上減少分は後発品が占めています。 ※オメプラゾールの後発品が2002.12月8日米国で発売。 ※1999年ドイツでジェネリック品との競合で27%低減、しかし同年度米+33%,仏+51%(NSAIDS 併用による増加)と好調だった。 ・ 米国以外の市場では、Losec の売上は日本で引き続き大幅に伸長(39%増)しましたが 、日本以外では全ての主な市場で売上は減少し、全体としては16%減でした。 ★Entocort [2008] Entocort has better tolerability than other corticosteroids in inflammatory bowel disease and greater efficacy than aminosalicylic acid medicines. It is prescribed as first-line therapy for both acute treatment and maintenance of clinical remission of mild to moderate, active Crohn’s disease and is approved in more than 40 countries. In 2008 we filed complaints for patent infringement against two generic manufacturers (Barr Laboratories and Mylan Pharmaceuticals) in response to notices of ANDA submissions in respect of generic forms of Entocort EC. ●呼吸器 [2008] COPD is expected to become the world’s third biggest health threat by 2020. Current treatment has recently demonstrated some survival benefit but the prognosis of the COPD patient remains poor. In asthma, morbidity and mortality remain important issues and disease normalisation is not achieved by any treatment. The typical treatment across COPD and asthma is a fixed-dose combination of an inhaled corticosteroid (ICS) with a long-acting beta-agonist (LABA) or for COPD specifically, inhaled long-acting muscarinic agonist (LAMA). Other major asthma treatments include oral leukotriene receptor antagonists and oral steroids for severe disease and (in combination with antibiotics) for exacerbations. Significant new product classes impacting the asthma market up to 2015 are unlikely. First novel anti-inflammatory compounds aimed mainly at prevention and/or treatment of COPD exacerbations, such as oral phosphodiesterase 4 inhibitors, may appear on the market before 2015. ★Symbicort [2008] Sales of Symbicort grew by 22% to $2,004 million. In the US, sales of the product were $255 million, up 410%. Product trial rate among target specialist physicians is now approaching 90%; these specialists are now starting more than 30% of patients new to combination therapy on Symbicort. More than half of target primary care physicians have prescribed Symbicort, and share of new patient starts is just under 18%. Overall, Symbicort share of new prescriptions for fixed combinations reached 11.7% in the week ending 16 January, with market share among patients newly starting combination treatment at 18.3%. Symbicort sales in other markets in the year were $1,749 million, up 9%. Symbicort SMART has now been approved in 91 markets. Symbicort Turbuhaler provides rapid, effective control of asthma and effective reduction of exacerbations, improving symptoms and providing a clinically important improvement in the health of patients with severe COPD. Symbicort Rapihaler (pMDI) approved for the long-term maintenance treatment of asthma in patients 12 years of age and older, was launched in the US in 2007. Further information about the progress of Symbicort since its launch in the US is set out in the Geographical Review on page 49. In December 2008, the Joint Advisory Committees of the FDA completed a review of the benefits and risks of asthma medications containing LABAs. This concluded that the benefits of Symbicort outweigh the risks in adult and adolescent asthma patients. Symbicort SMART provides increased asthma control and simplifies asthma management through use of only one inhaler for both maintenance and relief of asthma symptoms. It is also a cost-effective treatment option for many healthcare payers. Symbicort SMART is included in the Global Initiative for Asthma, the international treatment guidelines. The US sNDAs for Symbicort Rapihaler (pMDI) in COPD and paediatric asthma in the US were submitted as planned during the second quarter of 2008. Our existing regulatory filings for Symbicort Rapihaler (pMDI) in the EU for asthma and COPD were supplemented with data supporting two additional strengths in the second half of 2008. Symbicort SMART flexible dosing introduced a step change to asthma care in Europe resulting in lower ICS and oral steroid use. Novel ICS/LABA combination products for this area are expected from 2009 and generic ICS/LABA combinations may be available from the early part of the next decade. Several companies are developing new biologics for severe asthma, including improved versions of anti-IgE and differentiated anti-cytokine antibodies. Post-2015, immune response modifiers could deliver intermittent therapy for moderate to severe asthma. [2007] Symbicortの通年売上高は22%増の15億7,500万で、このうち5,000万ドルは2007年6月発売以降の米国内の売上です。 米国では、新たに定量合剤の使用を開始した患者のSymbicortのシェアは、1月18日終了週に11.5%であり、合剤の 新規処方数全体の5.8%でした。米国以外の売上高は通年で18%増でした。 Symbicortの通年売上高は22%増の15億7,500万ドルでした。西ヨーロッパでの売上高は第4四半期に12%増、通年で 16%増加し、Symbicort SMARTレジメンの発売とCOPDへの使用による販売量の増加により、市場シェアは前年よりも さらに1ポイント上昇しました。カナダおよび新興市場でも通年売上高は堅調な伸びを示しました(それぞれ25%増および26%増)。 ・ 2007年6月末の発売以来、米国のSymbicortの売上高は5,000万ドルでした。専門医が本製品を迅速に採用してお り、アレルギー専門医のほぼ75%、および肺専門医の60%超がすでに本製品を処方しています。定量合剤の新規処 方に占めるSymbicortのシェアは1月18日終了週に5.8%でした。また、新規に配合剤の使用を開始する患者の市場の シェアは11.5%です。 For example, originally introduced for treating asthma, Symbicort is now also used to combat chronic obstructive pulmonary disease, the fifth greatest cause of death worldwide. We also continued to look at how we could further improve Symbicort as an asthma therapy and we now market Symbicort Maintenance and Reliever Therapy (Symbicort SMART). Symbicort SMART represents a change in medical practice because it puts patients more in control of their variable disease by combining both the maintenance therapy and rapid relief treatment in a single inhaler, instead of the usual two. Symbicort Turbuhaler (budesonide/formoterol in a dry powder inhaler) is a combination of an inhaled corticosteroid and a fast onset, long-acting bronchodilator for the treatment of asthma and COPD. Symbicort Turbuhaler is also available as Symbicort SMART. Symbicort pMDI (budesonide/formoterol in a pressurised metered-dose inhaler) for the treatment of asthma. 2007 IN BRIEF >Symbicort sales of $1.6 billion, up 22%. >Symbicort pMDI for long-term maintenance treatment of asthma launched in the US to specialists and primary care physicians. >Outside the US, Symbicort SMART now launched in over 40 countries. >European Patent Office revoked the European combination patent for Symbicort for use in asthma. Other patent property and data exclusivity for Symbicort not affected by the decision [2006] ・ Symbicortの売上高は、欧州での継続的な市場成長とシェア獲得により、第4四半期に15%増加し、年間では18%増の11億8,400万ドルでした。 ・ 2006年10月のEU相互認証手続きの完了を受け、11月にスウェーデンでSymbicort SMART(Symbicort維持・リリーバー療法) が発売されました。さらに本年中に他の欧州諸国でも発売の予定です。 ・ 当社は米国でも、成人喘息患者における治療薬としてのSymbicortの発売を従来どおり本年中頃に予定していますが、この 発売時期は、技術移転に成功し、必要な製品バッチのバリデーションを終了できるかどうかにかかっています。 [2005] ・成人および青年期の定用量喘息治療薬としてのSymbicort pMDI製剤の米国承認申請は9 月23日に提出され、FDAの審査が継続中です。一方、米国での第III相COPD試験が進行中で す。欧州では長年にわたりSymbicortのタービュヘーラー製剤が喘息およびCOPDの維持療 法薬として使用されていますが、「維持とリリーバー療法(SMART:Symbicort Maintena nce and Reliever Therapy)」としての使用に関する追加承認申請が予定通り第3四半期 に提出され、現在、審査調整国としてのスウェーデンとの相互認証手続きが進められてい ます。pMDI用Symbicortの欧州開発プログラムは拡大し、本製品の2つの新用量の効果を裏 付けるデータが収集されています。これにより、既存のタービュヘーラーから新規pMDIデ バイスへの切り替えが容易になると予想されます。このデータは2008年の承認申請までに 準備される予定です。 ・ Symbicortの年間売上高は10億600万ドルに達しました。喘息およびCOPD市場で急速に 成長している配合剤市場でのシェアが引き続き拡大し、売上高は第4四半期および通年 ともに22%増を記録しました。 ・ 米国内での喘息治療用pMDI製剤の承認申請は9月23日に当局に提出されました。 ・ 2005年にSTAYおよびCOSMOS両臨床試験のデータが発表されました。これらの試験は大 規模臨床試験プログラムの一環です。これらのデータから、新しい治療コンセプトである 「Symbicort維持・リリーバー療法」は、固定用量の吸入コルチコステロイドまたは併用 療法よりも、生命にかかわる喘息発作の発現を予防することが一貫して示唆されました。 EU規制当局に対するこの治療コンセプトの承認申請を2005年10月に提出しました。 [2003] ・ Symbicort の通年の売上は61%増の5億4,900万ドルでした。これは急成長を遂げてい る配合剤喘息治療薬市場において同製品が引き続きシェアを獲得したためです。 慢性閉塞性肺疾患の適応での上市と喘息治療におけるユニークな調節可能な用法用量の プロモーションがこの売上増を牽引しました。 ※[2002]本製品は40カ国以上で上市されました。欧州全域における喘息の配合剤の金額 ベースシェアは11月時点で22%を超えましたが、スウェーデン(48%)およびドイツ(30%) でより顕著でした。COPD(慢性閉塞性肺疾患)治療の申請がEUで審査されています。 ・ 当社は、EUで新しい喘息治療法である SymbicortSingle inhaler Therapy(SiT) に関する承認申請を行ったことを、12月9日に発表しました。 SiTとはSymbicortの調節可能な維持療法の用法用量を更に改良したものです。Symbicort SiTの導入により、医師にとっても患者にとっても、喘息治療の利便性がさらに改善され ることが期待されます。 ★パルミコート [2008] Pulmicort sales were flat at $1,495 million, with US sales up 2% as the generic competition from the Teva product affected quarter four sales. US sales for Pulmicort were down 15% to $260 million in the fourth quarter and Pulmicort Respules sales were down 18% as a result of the “at risk” launch of generic budesonide inhalation suspension (BIS) on 18 November. The patent litigation between Teva and AstraZeneca was subsequently settled on 26 November. The agreement allows Teva to commence sales of BIS under an exclusive licence from AstraZeneca beginning 15 December 2009. The agreement also provided that any product already shipped by Teva would remain in the market to be further distributed and dispensed. As a result, Teva products accounted for nearly 15% of total prescriptions for BIS products dispensed during the fourth quarter, including a 40% share in December 2008. US sales for Pulmicort for the full year were $982 million. Pulmicort Respules accounted for around 90% of total Pulmicort sales in the US. Sales of Pulmicort in Rest of World were down 2% for the full year to $513 million. Pulmicort remains one of the world’s leading asthma medicines and is available in several forms. Pulmicort pMDI is now approved in 98 countries. Information about our settlement of the patent infringement action against IVAX in the US, which began in October 2005, in relation to IVAX’s ANDA for a budesonide inhalation suspension is set out in Note 25 to the Financial Statements from page 154. [2007] ・ 米国のパルミコートの売上高は第4四半期に13%増、年間で15%増でした。米国市場のパルミコート吸入液の通年 売上高は20%超増加し、数量ベースでは推定15%増加しました。喘息の治療を受けている8歳未満の小児患者約600 万人のうち、100万人超がパルミコート吸入液による治療で効果を示しています。 ・ 米国以外のパルミコートの売上高は第4四半期に2%減少しましたが、通年売上高は横ばいでした。 [2006] ・ 世界全体でのパルミコートの売上高は第4四半期に16%、年間で11%の伸びを記録しました。引き続き米国でのパルミコート 吸入液の成長が主な原動力となり、同製品の売上高の増加率は第4四半期に31%、年間で24%程度に達しました。米国での販売数 量の年間伸び率は10%程度であり、売上高の伸び率との差は価格の変更、マネージドケアの払い戻し調整および在庫量の変動によります。 [2005] ・ パルミコートの年間売上高は9%増加しました。他の市場では2%減となりましたが、米 国内での18%増(パルミコート Respules の28%増によって牽引)により、全体では売り上げ増となりました。 [2003] ・ パルミコートの通年の売上は米国市場での伸長(41%増)により12%増でした。この 売上増の大部分は米国市場の処方総数が年間32%伸びたパルミコート Respulesによるものでした。 [2002] ・ Pulmicort Turbuhaler (パルミコートタービュヘイラー)の世界での売上高は、 配合剤製品の受容の伸びにもかかわらず、気管支喘息の吸入ステロイド市場の縮小が 反映されています。これは、米国でのPulmicort Respules の好調な伸び(75%増)に よる相殺を上回るもので、このためPulmicort は通年で5%増を達成することができました。 ※2001年度も米国好調+80%、欧州は競合により-4%だった。 ★Rhinocort [2008] Rhinocort combines powerful efficacy with rapid onset of action and minimal side effects and is available as a once-daily treatment in the Rhinocort Aqua (nasal spray) and the Turbuhaler dry powder inhaler forms. [2007] [2005] ・ Rhinocortは価格の変更とマネージドケアの払い戻し調整がプラスに作用し、総処方数 は10%減少したものの、主に米国市場でのRhinocort Aquaの堅調な売り上げ(7%増)に支 えられ、年間売上高は6%増を記録しました。 [2003] ・ 全世界の通年のRhinocortの売上は19%増でしたが、この伸長の大部分は米国における Rhinocort Aquaの売上増(58%増)により達成されました。 [2002] ・ Rhinocort Aqua の米国での売上高は点鼻ステロイド市場で3ポイント以上のシェアを 伸ばしたことにより、通年で39%増でした。これは、2002年度の世界におけるRhinocort フランチャイズが売上を13%伸ばした主な理由です。 ※ Rhinocort Aqua は米国で2000年12月シェア6.8%から2001年12月11.6%にアップ。 ★MEDI-563 喘息 [2008] MEDI-563 is an investigational approach that may treat or help prevent asthma by targeting the interleukin-5 (IL-5) receptor to neutralise the binding of IL-5 and deplete the cells expressing the IL-5 receptor, typically eosinophils, as both IL-5 and eosinophils are thought to play key roles in the pathology of asthma. In 2008, the results of a Phase I study presented at the European Respiratory Society meeting showed that MEDI-563 exhibited an acceptable safety profile and showed pharmacological activity in mild asthmatics. In addition, a Phase I study to measure the depletion of eosinophils in the airways of asthmatics and a Phase II study with this anti-IL-5 receptor MAb to assess whether it can reduce the incidence of asthmatic relapse in subjects following an asthmatic episode that required hospitalisation have been initiated. ★MEDI-528 (anti-IL-9 MAb) 喘息 [2008] Also in 2008, we completed two out of three ongoing Phase IIa studies evaluating the potential for MEDI-528 (anti-IL-9 MAb) to treat or prevent symptomatic, moderate to severe persistent asthma, and a fourth Phase IIa clinical trial, designed to assess its effectiveness in patients with stable asthma and exercise-induced bronchoconstriction, was initiated. ★CAT-354 喘息 [2008] CAT-354 targets interleukin-13 (IL-13). In 2008, we initiated two new studies with CAT-354: a Phase II trial in Europe and Australia designed to assess the potential of this MAb in patients with uncontrolled asthma despite optimal treatment, and a US Phase I study to assess pharmacokinetics in healthy adult patients. ★AZD1236 (A potent MMP inhibitor) COPD [2008] The early pipeline has been reshaped to focus more on COPD, looking for novel strategies to inhibit exacerbations in COPD which include regulation of inflammatory cell migration and activation with MAbs directed to antigen. These include CXCR3, as well as inhibition of molecules involved in both viral and bacterial mediated exacerbations. A number of small molecule approaches for the treatment of COPD are in development. AZD1236 is a potent MMP inhibitor currently in Phase II, the expression of these proteins are associated with key pathological features of the disease including bronchiolitis, vasculitis and emphysema. ★AZD9668 COPD [2008] Human Neutrophil Elastase (HNE) is a key factor in cigarette smoke induced inflammation, lung injury and emphysema and AZD9668, a potent and selective oral, reversible inhibitor of HNE, also in Phase II, is expected to reduce the progression and severity of COPD. ★  [2008] ●癌 ★Zactima(vandetanib) [2008] Zactima (vandetanib) is a potential new oral anti-cancer therapy, which has a unique anti-cancer profile through two clinically proven mechanisms. It blocks the development of a tumour’s blood supply (anti-angiogenesis) and blocks the growth and survival of the tumour itself (anti-EGFR). Zactima also inhibits RET-kinase activity, an important growth driver in certain types of thyroid cancer. During 2008, we announced results from two Phase III clinical studies of Zactima in combination with chemotherapy agents, docetaxel (ZODIAC) and pemetrexed (ZEAL), and one monotherapy clinical study (ZEST) in pre-treated advanced NSCLC. The observed safety profile in these three Phase III studies was consistent with previous studies with Zactima in NSCLC. Results from the ZODIAC and ZEAL studies showed advantages for Zactima in combination with standard chemotherapy, compared to chemotherapy alone. The addition of Zactima to chemotherapy prolonged PFS, the primary endpoint, which achieved statistical significance in the ZODIAC study, but not in the smaller ZEAL study. Clinical benefits were seen in secondary endpoints. Both studies showed that adding Zactima to chemotherapy significantly improved objective response rate, which is a measurement of tumour shrinkage. Additionally, positive trends in prolonging overall survival (OS) were seen, although these did not reach statistical significance and the data are still immature. Importantly, the studies also showed that adding Zactima to chemotherapy controlled the symptoms of lung cancer better than chemotherapy alone, allowing patients to maintain their quality of life for significantly longer. ZEST, which evaluated the efficacy of Zactima monotherapy versus erlotinib, did not meet the primary objective of demonstrating a statistically significant prolongation of PFS for Zactima. However, Zactima and erlotinib showed equivalent efficacy for PFS and OS in a pre-planned non-inferiority analysis. We plan to file a regulatory submission in the second quarter of 2009 following discussion with regulatory agencies for combination therapy. Full results from studies ZODIAC, ZEAL and ZEST will be presented at an international medical congress in 2009. Results from the Phase III ZETA study in hereditary and sporadic medullary thyroid cancer are expected in the second quarter of 2009. The anti-cancer activity of Zactima continues to be evaluated in NSCLC and other tumour types, including colorectal, glioma, head and neck, breast and prostate cancers. [2005] 非小細胞肺癌および甲状腺髄様癌の治療に用いる血管内皮増殖因子(VEGF)/上皮成長因 子(EGF)チロシンキナーゼ阻害剤のZactimaは、米国FDAにより、甲状腺の適応症に関し て優先審査薬およびオーファンドラッグの認定を受けました。2005年12月にEU COMP(希 少薬審査委員会)は甲状腺髄様癌の治療におけるZactimaのオーファンドラッグ認定につ いて前向きな見解を示し、2006年1月にこれが採択されました。 ★Recentin (cediranib) [2008] Recentin (cediranib) is a highly potent and selective-inhibitor of vascular endothelial cell growth factor (VEGF) receptor signalling in solid tumours, which inhibits all three VEGF receptors irrespective of activating ligand, and is suitable for once-daily oral dosing. It is currently in Phase III development in first-line colorectal cancer (CRC) and recurrent glioblastoma (rGBM). In early 2008, our HORIZON III Phase II/III head-to-head study of Recentin with chemotherapy versus Avastin. with chemotherapy in patients with first-line metastatic CRC progressed directly into Phase III. Patient recruitment was subsequently completed for both HORIZON III and HORIZON II, our Phase III study of Recentin with chemotherapy versus chemotherapy alone. The Phase III REGAL trial in rGBM comparing Recentin monotherapy versus lomustine +/- Recentin began enrolling patients in the fourth quarter of 2008. Following the announcement that the National Cancer Institute of Canada Clinical Trial Group’s (NCIC CTG) Recentin BR24 NSCLC trial would not be progressing straight into Phase III, we worked in close collaboration with the NCIC CTG to understand the BR24 data further and to assess the potential of Recentin in this disease area. Subsequently the NCIC CTG announced it would now investigate Recentin at 20mg plus carboplatin/paclitaxel versus carboplatin/ paclitaxel alone in the BR29 study, which is expected to start recruitment in early 2009. Encouraging Phase II data for Recentin from completed and continuing studies to investigate renal, rGBM, ovarian and prostate cancers were also presented in 2008. ★ZD4054 [2008] ZD4054 is an oral once-daily potent and specific endothelin A-receptor antagonist in Phase III development. Data from Phase II studies suggested that ZD4054 10mg has the potential to increase median overall survival time by approximately seven months in men with metastatic hormone-resistant prostate cancer (HRPC), with the benefit of a generally well-tolerated side effect profile and a convenient once-daily tablet. The Phase III ENTHUSE studies are investigating efficacy in metastatic HRPC, both as monotherapy and in combination with docetaxel, and in non-metastatic HRPC. ★IPI-504 (MEDI-561) and IPI-493 [2008] In December 2008, we ceased our collaboration with Infinity Pharmaceuticals for the development and commercialisation of Infinity’s drug candidates IPI-504 (MEDI-561) and IPI-493 for the treatment of cancer and related conditions. This decision was taken after reviewing the potential opportunity for these projects and to take account of competing R&D investment priorities. ★AZD6244, [2008] Our early oncology pipeline includes a range of novel compounds that target signalling pathways believed to be pivotal in cancer cell growth, invasion DNA repair and survival, with nine products in Phase II and 15 others in Phase I development. Phase II data from AZD6244, a potent MEK inhibitor licensed from Array BioPharma, showed biological activity in lung cancer and melanoma and studies will now focus on its use in combination with standard and other novel therapies, rather than its development as monotherapy. ★AZD2281 [2008] Phase II studies with the poly-ADP-ribose-polymerase (PARP) inhibitor AZD2281 have started and will initially focus on BRCA-mutated breast and ovarian cancer as well as other cancers where DNA repair could be defective. ★AZD0530 [2008] The dual-specific Src/Abl kinase inhibitor, AZD0530, has shown a dramatic effect on biomarkers of cell motility and bone resorption and has started Phase II studies in ovarian cancer with others to follow. ★AZD1152 [2008] AZD1152, an aurora kinase inhibitor, has shown activity in acute myelogenous leukaemia and will commence Phase II/III studies in 2009. We are also developing potential new cancer treatments using biological approaches with highly defined molecular targets for patient populations with unmet medical needs. ★CAT-8015 [2008] CAT-8015 is an immunotoxin fusion protein that targets CD22, which is a receptor expressed on the surface of a wide variety of B-cell malignancies. CAT-8015 has orphan drug designation for hairy cell leukaemia in the US and EU. In 2008, the enrolment for studies continued in the CAT-8015 Phase I development programme. ★Blinatumomab (MEDI-538) [2008] Blinatumomab (MEDI-538) is a recombinant single-chain bi-specific T-cell engager (BiTE.) molecule that is being studied for use in certain patients suffering from certain lymphomas and leukaemias. Exclusive rights to develop and commercialise blinatumomab in North America have been granted from Micromet. The US Phase I programme with blinatumomab was suspended during 2008 in order to make appropriate modifications to the dosing regimen based on preliminary results from the EU studies. ★ ★Abraxis [2008] 1 In November 2008, we entered into an agreement with Abraxis under which Abraxis re-acquired exclusive rights to market Abraxane R in the US. AbraxaneR, discovered, developed and owned by Abraxis, uses a novel technology to deliver paclitaxel for the treatment of breast cancer. During 2008, we co-promoted AbraxaneR in the US under an agreement with Abraxis. In November 2008, we entered into an agreement with Abraxis under which Abraxis re-acquired exclusive rights to market AbraxaneR in the US. Under the agreement, the board of Abraxis’ parent ended the Co-Promotion Agreement. Upon termination, Abraxis will pay AstraZeneca a $268 million fee on 31 March 2009. ★Ethyol [2008] Outside the US, we have various distribution and marketing arrangements for branded Ethyol. As of June 2008, our two main distribution partners are Pinnacle Biologics for Western Europe, Turkey and Israel, and Schering-Plough International for Rest of World. In April 2008, Sun Pharmaceuticals launched generic amifostine in the US. In response, we extended an agreement with Bedford Laboratories to launch an authorised generic amifostine for oncology in the US. We have ceased all active promotion of branded Ethyol in the US. We have an active infringement action against Sun Pharmaceuticals regarding certain Ethyol patents. ★カソデックス [2008] Casodex sales increased by 6% to $1,335 million. Sales in the US for the full year were up 1% to $298 million. Sales in other markets, which accounted for more than 75% of product sales, were up 8%, on 6% growth in Western Europe and 13% sales growth in Japan. Casodex is used as a 50mg tablet for the treatment of advanced prostate cancer, and as a 150mg tablet for the treatment of locally advanced prostate cancer. European sales declined due to generic erosion following patent and/or marketing exclusivity expiries in July 2008. Sales growth continued in Japan, where Casodex is available as an 80mg tablet and is approved for all stages of prostate cancer. In the US, the FDA granted an additional six months’ paediatric extension providing marketing exclusivity in the US to April 2009. [2007] カソデックスの米国の通年売上高は1%増でした。製品売上高の75%以上を占める米国以外では8%増加し、西ヨー ロッパで6%増、日本で13%増でした。 [2006] ・ カソデックスの米国での年間売上高は23%増加しました。米国以外の市場でも年間5%増加し、日本では10%の売上成長を遂げました。 [2005] ・ カソデックスの米国での売上高は通年では3%増の2億3,900万ドルを計上しました。総 処方数は前年比3%減となりました。 ・ カソデックスの米国以外の売上高は通年で11%増でした。この売上増のほぼ半分は日本 での業績によるものです。 [2003] ・ カソデックスの米国以外の市場での通年の売上は、早期前立腺がん治療への継続的な 浸透により、23%増でした。日本の売上は28%増、ドイツおよびイタリアの良好な伸びが 寄与した欧州の売上は20%増でした。 [2002] ・ Casodex (カソデックス)の米国以外の2002年の売上高は42%増、4億6,400万ドル。 これは、Casodex 150 mg 錠が早期前立腺がん治療薬として41カ国で認められたことに よります。FDAの抗腫瘍剤諮問委員会は12月、この適応で米国での承認を推奨しませんでした0 。ただ、この新適応症の恩恵を受けませんでしたが、米国市場で昨年Casodex (カソデックス)の処方は約5%伸びた。※抗アンドロゲン剤で世界のリーディングブランド。 2000年度日本では前年比56%増。早期前立腺癌への適応追加は2000.12.20 FDA申請 ★アリミデックス [2008] Oncology sales grew by 8% at CER. Arimidex sales reached $1,730 million, up 10%. In the US, sales of Arimidex rose by 13% to $694 million. Total prescriptions for Arimidex increased nearly 5.3% compared with 1.3% growth in the market for hormonal treatments for breast cancer. Arimidex sales in other markets increased by 8% to $1,036 million. Sales for the full year were up 6% in Western Europe and increased 9% in Japan. During 2008, our breast cancer treatment, Arimidex maintained its position as market leader in sales of branded hormonal agents, with approximately four million patient years of clinical experience. This success is largely based on the extensive long-term efficacy and safety results of the ATAC study, which showed Arimidex to be significantly superior to tamoxifen at preventing breast cancer recurrence during and beyond the five-year treatment course. (Breast cancer recurrence is defined as loco-regional recurrence, distant recurrence or contra-lateral breast cancer). Arimidex continues to be the leading branded hormonal therapy for new patients in the US, Japan and France, and is also approved in a number of markets in Europe for a switch indication for patients who have already received two to three years of tamoxifen. [2007] アリミデックスの通年売上高は10%増の17億3,000万ドルに達し、米国で13%増、米国以外の市場で8%増でした。 米国のアリミデックスの第4四半期の売上高は7%増、年間では13%増の6億9,400万ドルでした。乳がんのホルモン 治療薬市場の成長率1.3%に対して、アリミデックスの総処方数は約5.3%増加しました。 ・ 当社は、2007年11月に、米国FDAが乳がんを適応症とするアリミデックスの先発品としての販売期間を2010年6月 まで6カ月間延長することを承認したことを発表しました。 ・ 米国以外のアリミデックスの売上高は第4四半期に9%増、年間では8%増の10億3,600万ドルでした。通年売上高 は西ヨーロッパで6%増、日本で9%増でした。 [2006] ・ 米国内のアリミデックスの年間売上高は29%増加し、6億1,400万ドルを計上しました。総処方数は21%増加し、乳がん治療用 ホルモン療法薬の総処方数に占める市場シェア率は12月に37.5%に達し、通年で2.7ポイント上昇しました。第4四半期のアリミ デックスの米国売上高は33%増加しました。 ・ 米国以外でのアリミデックスの売上高は第4四半期18%増、年間29%増でした。欧州の年間売上高は30%増加し、アジア太平洋 地域は27%増加しました。 [2005] ・ アリミデックスの年間売上高は44%増の11億8,100万ドルを記録しました。乳癌のホル モン治療剤の市場に占めるアリミデックスの金額ベースでのシェアは先月50%に達し、最 も近い競合製品のシェアの2倍を超えました。本剤は乳癌の主要補助療法としての安定し た特性により、アロマターゼ阻害剤のトップの地位にあり、ATAC試験から早期補助療法と してタモキシフェンよりも優れていることが立証されました。12月に3つの国際臨床試験 の新しいメタアナリシスデータが報告され、タモキシフェン治療からアリミデックスに切 り替えた症例は、タモキシフェン継続例よりも全生存期間(overall survival)が改善することが確認されました。 ・ 米国でのアリミデックスの第4四半期売上高は58%増加し、年間で59%増加しました。総 処方数は前年比40%増、市場シェアは7.1ポイントの上昇となりました。 ・ アリミデックスの米国以外の売上高は第4四半期に31%増加しました。欧州(35%増)と 日本(27%増)での好調な伸びに支えられ、年間売上高は35%増を記録しました。 [2003] ・ アリミデックスは乳がん治療薬としてのアロマターゼ阻害剤のリーディングプロダクト です。57カ国で同剤の早期乳がんのアジュバント療法(術後補助療法)での使用が承認 されています。通年の売上は米国で47%増、米国以外の市場では45%増、うち日本では61%増でした。 ※日本で2000.2発売
★イレッサ
【2011】Iressa is approved in 81 countries and is one of the leading epidermal growth factor receptor-tyrosine kinase (EGFR-TK) inhibitors in Japan and the Asia Pacific region where it is marketed for pre-treated advanced non-small cell lung cancer (NSCLC). Outside the EU, indications are being sought or expanded from the pre-treated setting to include 1st line patients whose tumours harbour activating mutations of the EGFR-TK inhibitor.

In the EU, Iressa has been launched as the first personalised medicine for the treatment of adults with locally advanced or metastatic NSCLC with activating mutations.

【2010】Iressa sales increased by 28% to $393 million, including $49 million of sales in Western Europe. Sales in Japan were up 8%. Sales in Emerging Markets were up 20%, including a 23% increase in China.

【2008】 Iressa sales were unchanged for the full year. Sales in Japan increased 4% for the year; sales in China were up 24%. Iressa is approved in 36 countries and is the leading epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) in the Asia Pacific region where it continues to be marketed for pre-treated advanced NSCLC. Based on data from the Phase III INTEREST study comparing Iressa with docetaxel, a marketing authorisation application for Iressa has been submitted to the European Medicines Agency.

[2007]
イレッサの通年売上高は横ばいでした。通年で、日本の売上高は4%増加し、中国の売上高は24%増加しました。
[2006]
・ イレッサの米国以外の市場における売上高は第4四半期に5%、年間で10%増加しました。アジア太平洋地域での年間売上高は15%増加しました。 
[2005]
・ イレッサの年間売上高は、主に米国での63%減により全体で31%の減少となりました。
アジア太平洋地域の年間売上高は7%増であり、中国を初めとする市場の売り上げ増が日本
での15%減を相殺し、さらに売上高の増加に貢献しました。 
[2003]
・ イレッサの通年の売上は2億2,800万ドルで、日本(1億100万ドル)と米国(1億200万ドル)でほぼ二分しています。12月単月で米国において7,300件を超えるイレッサの小売処方が調剤され、5月の発売以降の累計処方件数は42,000件を超えました。

★Faslodex
[2008]
Faslodex sales increased 10% to $214 million for the full year, on growth of 3% in the US and 18% sales growth in other markets.

Faslodex, now approved in more than 60 markets, offers an additional hormonal therapy for patients with hormone-sensitive, advanced breast
cancer, delaying the need for cytotoxic chemotherapy. It is a once-monthly injection approved for the second-line treatment of hormone-receptor
positive, advanced breast cancer in post-menopausal women.

[2007]
Faslodexの通年売上高は10%増の2億1,400万ドルでした。米国で3%増、米国以外で18%増でした。
[2006]
・ Faslodexの世界全体の売上高は通年で32%増加し、これには主に欧州での74%増が貢献しました。 
[2005]
・ Faslodex は昨年3月の販売承認以降、欧州で堅調に推移し、年間売上高1億4,000万ド
ルを計上しました(39%増)。米国での売上高は通年で11%増でした。 
[2003]
・ Faslodex の通年の売上は7億7,000万ドルに達し、これは、実質、米国市場における売上です。
Faslodex のEUにおける正式な承認を近い将来取得する見通しで、最初の発売は第2四半期を予想しています。 

★ゾラデックス
[2008]
Zoladex is approved in 120 countries. It is approved for the treatment of prostate cancer, breast cancer and gynaecological disorders. In
non-metastatic prostate cancer, Zoladex is the only luteinising hormone-releasing hormone (LHRH) agonist shown to improve overall survival both
when used in addition to radical prostatectomy and when used in addition to radiotherapy. The 10-year follow-up results of a study for the European
Organisation for Research and Treatment of Cancer confirmed the long-term survival benefits of Zoladex when used as adjuvant to radiotherapy in
patients with locally advanced prostate cancer.

In breast cancer, Zoladex is widely approved for use in advanced breast cancer in pre-menopausal women. In a number of countries, Zoladex is
also approved for the adjuvant treatment of early stage pre-menopausal breast cancer as an alternative to and/or in addition to chemotherapy.
Zoladex offers proven survival benefits for breast cancer patients with a favourable tolerability profile.

Competition in the LHRH agonist market is expected to increase in Europe during 2009, with the anticipated launches of generic goserelin. This
follows the announcement of the approval of generic goserelin (one-month depot) in Germany in December.

[2005]
・ ゾラデックスは米国での23%減を他市場の好調な売れ行き(13%増)が補い、年間売上
高は7%増の10億400万ドルに達しました。 
[2003]

★Nolvadex (ノルバデックス)[タモキシフェン]
[2008]
[2003]
・ 米国におけるNolvadex (ノルバデックス)の第4四半期の売上高は9,900万ドルで、
当社とBarr Laboratoriesとの販売契約満了に伴う影響から、タモキシフェン製品の
売上がいくぶん回復したことによります。第4四半期の売上高は依然として24%減、
通年で21%減。米国におけるNolvadex (ノルバデックス)の売上は、2月の特許切れ後
に大幅な減少が予想されます。


●神経科学
★セロクエル
[2008]
Seroquel is a leading atypical anti-psychotic treatment for adult schizophrenia and bipolar disorder. Seroquel remains the most commonly
prescribed atypical anti-psychotic in the US, where it is the only atypical anti-psychotic approved as monotherapy treatment for both bipolar
depression and bipolar mania as well as the leading atypical brand globally by sales value. Its clinical development programme was substantially
completed during 2008 resulting in worldwide launches of Seroquel XR for schizophrenia. We have also made the associated regulatory
submissions and data presentations in bipolar disorder, major depressive disorder (MDD) and generalised anxiety disorder (GAD).

First launched in 1997, Seroquel is now approved in 92 countries. Seroquel XR, an extended release formulation that offers patients and doctors
a once-daily treatment, was launched in the US for the treatment of schizophrenia in 2007 and is now approved in 45 countries for schizophrenia,
12 countries for bipolar mania, seven countries for bipolar depression and four countries, including the US, for bipolar maintenance, in one
market for MDD, and in one market for GAD.

In 2008, the FDA approved Seroquel XR for the treatment of depressive episodes associated with bipolar disorder, the manic and mixed episodes
associated with bipolar 1 disorder and both Seroquel and Seroquel XR for the maintenance treatment of bipolar 1 disorder as adjunctive therapy to
lithium or divalproex. In addition, Seroquel XR and Seroquel were approved in the EU for the treatment of major depressive episodes in bipolar
disorder. Seroquel XR was also licensed in the EU for moderate to severe manic episodes in bipolar disorder.

During 2008, regulatory submissions were made in both the US and in the EU for GAD and for MDD. AstraZeneca received a Complete Response
Letter from the FDA for its sNDA for Seroquel XR for the treatment of MDD in adult patients. AstraZeneca is continuing discussions with the FDA. A
separate regulatory submission was made to the FDA for the treatment of schizophrenia in adolescents (13 to 17 year olds) and for the treatment of
acute manic episodes in children and adolescents (10 to 17 year olds) with bipolar 1 disorder. The US prescribing information for Seroquel and
Seroquel XR is being updated to include new safety information regarding use in children and adolescents. Seroquel and Seroquel XR are not
approved currently for use in paediatric patients under 18 years of age.

In January 2009, the FDA granted an additional six-month period of market exclusivity to Seroquel for its licensed indications, based on studies we
conducted in adolescents with schizophrenia and children and adolescents with bipolar mania. The Seroquel patent expires in September 2011.
The allowed six-month paediatric exclusivity period, which takes effect upon expiration of the patent, will extend the exclusivity of Seroquel to
March 2012.

[2007]
セロクエルの売上高は15%増の40億2,700万ドル、米国で15%増、米国以外の市場で16%増でした。セロクエルXRの
追加適応症である統合失調症の上市活動が展開されており、今後とも包括的なライフサイクルマネジメントが計画
されています。急性双極性うつ病および双極性うつ病については米国で先月承認申請を行いました。欧州でも2008
年第1四半期にこれらの適応症の申請を予定しています。大うつ病性障害および全般性不安障害についても欧米で今
年中に申請する予定です。 
・ セロクエルの米国の売上高は第4四半期に16%増、通年で15%増でした。セロクエルの総処方数は本年度10%増
加し、市場成長率の2倍以上でした。米国抗精神病薬市場の総処方数に対するセロクエルの市場シェアは、2007年12
月に31.8%に増加し、前年比1.3ポイントの上昇となりました。この増加分の3分の1は、8月に発売したセロクエルX
Rの5ヶ月間の売上高です。
・ 米国以外のセロクエルの売上高は、ほとんどの市場でのシェアの拡大により、第4四半期で14%増、通年で16%増でした。
・ 12月にセロクエルXRの欧州での相互承認手続きが完了し、現在欧州諸国における承認を取得中です。セロクエル
XRの広範なライフサイクル間マネジメントプログラムが進行中です。2007年12月に米国で急性双極性躁病および双
極性うつ病の承認申請を行いました。欧州でも2008年第1四半期にこれらの適応症の申請を予定しています。欧米で
大うつ病性障害および全般性不安障害についても今年中に申請する予定です。
[2006]
・ 米国市場では、セロクエルの売上高は第4四半期に20%、年間で24%増の24億8,600万ドルでした。総処方数は通年で12%増加
し、市場成長率をを大きく上回りました。米国の抗精神病薬市場に占めるセロクエルの総処方数のシェアは2006年12月に30.2%
上昇し、前年比1.7ポイント増加しました。 
・ 米国以外の市場におけるセロクエルの売上高は第4四半期に17%増加しました。年間で23%増加し、欧州で25%、アジア太平洋
地域で15%の堅調な売上増が認められました。 
・ 統合失調症の治療薬として規制当局に提出したセロクエル1日1回徐放(SR)製剤の承認申請は現在、米国および欧州で審査中です。 
[2005]
セロクエルの年間売上高は、米国市場の20億300万ドルを含め、総額27億6,100万ドル(35
%増)に達しました。世界の非定型抗精神病薬市場に占めるセロクエルの金額ベースでの
シェアは、2005年9月30日までの12カ月間に2.7ポイント上昇しました。 
・ 米国市場でのセロクエルは、処方数は20%増でしたが、実勢価格の上昇および契約払戻
金の調整がプラスに作用し、売上高は通年で33%増を記録しました。米国の抗精神病薬市
場での新規処方数に占めるシェアは2005年12月に29.8%に増加し、前年比2.2ポイント上昇となりました。 
・ 米国以外の市場におけるセロクエルの年間売上高は欧州(48%増)、アジア太平洋地域
(22%増)およびカナダ(29%増)での好調な業績により40%増加しました。 
・ 2005年10月、BOLDER II試験の結果が発表されました。画期的なBOLDER I試験の結果を
裏付けるもので、セロクエルの単独療法は双極性うつ病をプラセボよりも統計学的に有意
に軽減することが確認されました。12月30日にはうつ病エピソードを伴う双極性障害の治
療を新規適応症とする追加新薬承認申請を米国FDAに提出しました。これが承認されれば、
セロクエルは躁うつ両エピソードに伴う双極性障害の治療に使用できる唯一の薬剤となります。 
[2003]
・ セロクエルの米国以外の市場での通年の売上は44%増でした。欧州の売上は40%増、
日本の売上は67%増でした。 
・ セロクエルの米国での通年の売上は22%増の11億3,400万ドルでした。
米国のセロクエルの年間総処方件数は34%増でした。米国の抗精神薬市場における
セロクエルのシェアは12月に過去最高の21.2%に達し、前年同期と比べ3.4%増でした。
セロクエルは上位3ブランドのうち2003年にマーケットシェアを伸ばした唯一の製品でした。
・ 当社は、セロクエルの双極性障害における急性期躁病の適応症の承認を米国FDAから
取得したと2004年1月12日に発表しました。 
[2002]
・ Seroquel (セロクエル)の売上高は、67%の好調な伸びを示し、メガブランドの
指標である10億ドルを2002年に超えました。米国市場での新規処方シェアは12月時点で
19.2%、通年では3.7ポイント増でした。Seroquel (セロクエル)の日本における金額
ベースのマーケットシェアは発売後1年で25%です。Seroquel (セロクエル)双極性
障害を伴う急性の躁病(躁鬱病)の治療の適応追加を米国で申請することを1月2日に
発表しました。欧州での申請は本年第1四半期後半に予定されています。
※欧州は相互承認により1999.12承認


★ゾーミッグ
[2007]
ゾーミッグの通年売上高は米国で5%増、米国以外の市場で4%増でした。
[2006]
・ ゾーミッグの米国での売上比較には、2005年4月1日に国内での商品化に関する全責任が回復したことが引き続き反映されて
います。米国市場でのゾーミッグの売上高は第4四半期に5%増、通年では39%増でした。ゾーミッグの総処方数は年間で6%減少しました。 
・ ゾーミッグの米国以外の市場の売上高は第4四半期に8%増加し、通年では前年から変化がありませんでした。 
[2005]
・ ゾーミッグの年間売上高は、米国以外の市場では成長したものの(8%増)、米国での1
8%減が響き、全体で3%減となりました。 
[2003]
・ ゾーミッグの通年の売上は米国以外の市場で7%増、米国市場で8%減でした。
2004年1月1日から、スペシャルティ医薬品企業であるMedpointe Inc.が2003年第3四半期
発売のZomigNasal Sprayを含む一連の片頭痛治療薬ゾーミッグブランドの医療用医薬品
の米国におけるプロモーションおよび販売を担当しています。 
★ディプリバン [2006] [2005] ・ ディプリバンの年間売上高は米国以外の市場では8%減でした。米国では後発品の参入 による実勢価格の低下で44%減となりました。 ■糖尿病 ★Dapagliflozin [2008] The number of people affected by Type 2 diabetes continues to grow, driven by obesity in western markets. Type 2 diabetes is a chronic progressive disease and patients often require multiple medications to control their condition. There are a number of established oral generic and branded classes, such as sulfonylureas and thiazolidinediones (TZDs), however, newer classes, such as oral dipeptidyl peptidase-IV (DPP-IV) are entering the market successfully by offering effective blood sugar control and improved tolerability. Several new classes of drugs are in development in this area. The safety of anti-diabetic drugs continues to be an important focus of regulatory agencies and additional patient safety requirements for new medicines can be anticipated. OUR FOCUS In 2007, AstraZeneca and Bristol-Myers Squibb (BMS) announced the collaboration on a worldwide basis excluding Japan to develop and commercialise two compounds discovered by BMS (saxagliptin and dapagliflozin) being studied for the treatment of Type 2 diabetes. The development and commercial strategy for the two compounds is agreed jointly with BMS. In December 2008, AstraZeneca and BMS announced the extension of their collaboration to include dapagliflozin in Japan. During 2008, AstraZeneca and BMS submitted a New Drug Application to the FDA and received the validation of a Marketing Authorisation Application to the European Medicines Agency for saxagliptin (Onglyza.). Onglyza. was specifically designed to be a selective inhibitor with extended binding to the DPP-IV enzyme, with dual routes of clearance. Phase III data published during 2007 and 2008 showed improved glycaemic control when assessed as a monotherapy, as well as when assessed in combination with metformin, sulfonylureas and TZDs. Dapagliflozin is a potential oral anti-diabetic belonging to the novel class of sodium-glucose cotransporter 2 (SGLT2) inhibitors. It is selective and designed to be used both as monotherapy and in combination with other therapies for Type 2 diabetes. Phase IIb data demonstrated that, when compared with a placebo, 12 weeks treatment with dapagliflozin improved blood glucose parameters, resulted in weight loss and was well tolerated in patients with Type 2 diabetes. An extensive Phase III programme is ongoing. Our activities in the GKA (glucokinase activator) area continued during 2008, and clinical studies in Phase II are ongoing. The GKA mechanism of action induces insulin release from the pancreas and reduces glucose output from the liver, with marked blood glucose reducing effects in situations of hyperglycaemia. ★AZD4017 (11-sHDS inhibitor) project [2008] We also progressed our AZD4017 (11-sHDS inhibitor) project into early clinical testing which aims to increase insulin sensitivity and thereby induce better glycaemic control with potential beneficial effects also on body weight and blood lipids. We have stopped work on cannabinoid receptor 1 inhibitors because the tolerability profile of these inhibitors was considered unacceptable. In July 2008, AstraZeneca and Columbia University Medical Center announced a strategic research collaboration to develop novel therapeutics for Type 2 diabetes and obesity. The research will focus on discovering mechanisms and identifying new biological targets for successful and commercially viable treatments for these diseases. ■リウマチ [2008] The RA market has grown from $1.3 billion in 1998 to over $10 billion in 2008, driven largely by the introduction of biologic tumour necrosis factor alpha (TNFa) blockers (first Amgen/ Wyeth’s Enbrel., followed by Centocor/ Schering-Plough’s Remicade. and Abbott’s Humira.), which together account for over $8 billion in this disease alone. Launches of additional TNF blockers are imminent, and use of other biologic approaches, currently reserved for TNF failures, is expected to increase. Targeted novel oral drugs aimed at patients that currently choose not to take, are ineligible for or don’t respond to biologics, are in development to provide anti-TNF-like efficacy with safety benefits and more convenient dosing. Current treatment of systemic lupus erythematosus (SLE) focuses on controlling disease flares, preventing renal failure and suppressing symptoms to an acceptable level while minimising toxicity. Despite considerable recent development activity, no targeted disease-modifying agents have yet been successfully launched for SLE. Most emerging biologic agents will likely be used initially in combination with corticosteroids or immunosuppressants to provide incremental benefit and/or allow reduced doses or numbers of these agents. In 2008, we invested in several novel multi-functional MAbs that allow simultaneous inhibition of either two secreted proteins or surface receptors. Our first disease being studied is RA, where TNF inhibitors with other molecules may improve both the efficacy and prevent the establishment of TNF refractory disease while maintaining an acceptable safety profile. ★MEDI-545 リウマチ [2008] MEDI-545 is a MAb targeting interferon-alpha, which regulates processes involved in autoimmune diseases. In 2008, we initiated a Phase IIa trial in patients with SLE and a Phase I study in patients with active dermatomyositis. ★CAM-3001 リウマチ [2008] CAM-3001 is a MAb with potential to help patients with RA. The antibody targets the alpha sub-unit of the granulocyte-macrophage colony stimulating factor receptor. In September 2008, preliminary results were reviewed from the first Phase I study of CAM-3001, which had been initiated to evaluate the safety profile and tolerability of single doses in patients with RA. AstraZeneca, through its acquisition of MedImmune, acquired exclusive development rights to the CAM-3001 programme from CSL Limited in 2007. ★AZD9056 and AZD5672 リウマチ [2008] AZD9056 and AZD5672 are novel oral compounds being primarily developed as a new generation of disease modifying anti-rheumatoid arthritis drugs. Currently in Phase IIb, their different mechanisms of action (a P2X7 antagonist and a CCR5 antagonist) provide multiple chances of success to provide significant new choice in the management of RA. ★ リウマチ [2008] 20-F[2008.3.12] - [pdf,539p] --- IMS Data等を使用し、世界市場分析。[DIRECTORS' REPORT] - [BUSINESS ENVIRONMENT] p71-p75 [世界市場2007] The world pharmaceutical market in 2007 was valued at $629 billion. This represents an increase in constant US dollar terms of 6% over the year, down from 7% during 2006. The US is still the world’s largest pharmaceutical market, accounting for $286 billion (45%) of total sales. US growth fell to 6% in 2007 (from 8% in 2006), as growth driven by the 2006 Medicare Part D prescription drug benefit scheme peaked, so removing a counter to the impact on market value of increasing cost-containment pressures from payers, continuing patent expiries for branded medicines and the consequent increase in the use of generic pharmaceuticals. Japan is the second largest pharmaceutical market with sales of $57 billion (9% of worldwide sales). Market growth during 2007, on a constant exchange rate basis, was 2%, up from 1% in 2006. Europe accounts for 30% of the world market and experienced growth of 6% in 2007, up from 5% in 2006. Growth across major markets in Europe ranged from -1% in Italy to 10% in Spain, with Germany, France and the UK showing growth of 4%, 6% and 5%, respectively. Asia Pacific and Latin America accounted for 7% and 4%, respectively, of worldwide sales. Notable growth from countries in these regions in 2007 came from China (sales of $13.1 billion, growth of 22%), Brazil (sales of $9.6 billion, growth of 10%), Korea (sales of $9.5 billion, growth of 10%) and India (sales of $6.4 billion, growth of 12%), which ranked ninth, 10th, 11th and 15th respectively in world markets. [世界市場2006] The world pharmaceutical market in 2006 was valued at $574 billion. This represents an increase in constant US dollar terms of 6% over the previous year, which is lower than in 2005 (when growth was 7%). The US is by far the largest pharmaceutical market in the world, accounting for $267 billion of sales (47% of the worldwide total). US growth rose to 7% in 2006 (from 5% in 2005), despite continuing cost-containment pressures and the growing use of generic pharmaceuticals. This rise was largely due to the increased uptake of products following implementation of the Medicare prescription drug benefit scheme in 2006. [バイオ製剤・ワクチン 2007] バイオ製剤は2007年トップ100の世界売上高のシェア24%(2006年20%)。 2012年には37%と予測。 [循環器2007] 循環器薬剤世界市場規模 $145 billion 高血圧用薬世界市場規模 $ 51 billion 高脂血症薬世界市場規模 $ 34 billion 抗血栓(心筋梗塞発作・脳卒中含む)用薬剤世界市場規模 $19 billion 糖尿病薬世界市場規模 $23 billion CV disease claims more lives each year than the next four leading causes of death combined. It accounts for 17 million deaths worldwide annually, making it the greatest risk to life for most adults. [循環器2006] 循環器薬剤世界市場規模 $137 billion 高血圧用薬世界市場規模 $48 billion 高脂血症薬世界市場規模 $35 billion 抗血栓(心筋梗塞発作・脳卒中含む)用薬剤世界市場規模 $17 billion 糖尿病薬世界市場規模 $20 billion [循環器2003] 循環器薬剤世界市場規模 $98 billion スタチン剤世界市場規模 $22 billion Crestor(rosuvastatin) -2003年中に米・加・欧州13か国を含む40か国以上で承認  2004.1末迄に処方箋150万件が書かれ、患者数75万人が服用。  GALAXY programが実行中で患者3万人が参加し、循環系リスク低減に向け、14研究中2つが終了。 Zestril (ACE阻害剤) lisinopril 米英日の特許切れにより半減。米国lisinopril市場は80%がジェネリックがしめた。(2003)  ★開発品 Exantaがフランスが初承認(2003.12)、米・EU申請(2003.12)。 60年ぶりの経口抗凝固剤、 血栓を予防・治療するトロンビン阻害剤。 3万人の大規模臨床試験。 脳卒中予防目的 でSPORTIF 2&3(arterial fibrillation), THRIVE(VTE:静脈塞栓症)が2003年に実施。 Galida ...P3; インスリン抵抗性改善 [循環器2002] スタチン剤世界市場規模 $19 billion 循環器薬剤世界市場規模 $87 billion Atacand (AII拮抗剤・降圧剤) 世界シェア 10% Seloken ZOK/Toprol-XL (心不全・高血圧) β遮断剤シェア 世界20% 米国29% Zestril (ACE阻害剤) ACE阻害剤 世界15% 米国19% [消化器系2007] 消化器系薬世界市場規模 $37 billion. PPI世界市場規模 $25 billion. GERD患者は欧米の成人10-20%が罹患。アジアは罹患率が低いものの増加。 PPIによるGERD治療効果にもかかわらず、患者の40%が症状の克服に至っていない。 [消化器系2006] 消化器系薬世界市場規模 $35 billion. PPI世界市場規模 $23 billion. GERD患者は欧米の成人10-20%が罹患。アジアは罹患率が低いものの増加。 [消化器系2005] 消化器系薬世界市場規模 $30 billion. PPI世界市場規模 $23 billion. GERD患者は欧米の成人10-20%が罹患。アジアは罹患率が低いものの増加。 Irritable bowel syndrome is a common GI disease that is inadequately trea ted and inflammatory bowel disease is an area of significant unmet medical need [消化器系2003] PPI世界市場規模 $19.1 billion. Nexium(esomeprazole) ...他のPPIを顕著に上回る臨床改善効果が57カ国6.8万人の臨床試験で実証。  2000.8 スエーデン発売以来、100カ国で発売。2003年末迄に1億4500万人に処方。 Losec/Prilosec(omeprazole) ...1980〜1990年代の酸関連疾患の短期・長期治療のグロ ーバルスタンダードを確立した最初のPPI。 7億2000万人に処方。 Losec MUPS錠は57カ国で発売。  omeprazole特許が数カ国で失効し、米国でも製剤特許をめぐり係争中。 2002.12米国 で初のジェネリックが発売。 またP&GがOTC製剤を発売。 米国で全omeprazole処方の27.4%がgeneric(4製品以上)  [日本] (2003)$138m(+39%) (2002)$92m(+40%) -- オメプラール[A-Z]/オメプラゾン[三菱] [消化器系2002] PPI世界市場規模 $16.3 billion.  うちLosec/Prilosec 34% [神経系2007] 世界神経系用薬剤市場は$120 billion。 内訳は 統合失調症薬市場 $53 billion neurology 市場  $35 billion 鎮痛剤市場    $27 billion 麻酔薬市場    $ 4 billion この分野は医療ニーズが顕著。 ・うつ病・不安症は人口の15%が生涯1度以上罹患。 ・統合失調症は人口の1%。 双極性障害患者は1700万人。 ・アルツハイマー病患者は世界で2400万人、2020年迄に4000万人と予測。 ・慢性疼痛は人口比20%以上に罹患。。 [神経系2006] 世界神経系用薬剤市場は$108 billion。 内訳は 統合失調症薬市場 $49 billion neurology 市場  $30 billion 鎮痛剤市場    $25 billion 麻酔薬市場    $ 4 billion [神経系2005]  Neuroscience世界市場規模は、$103 Billion以上 統合失調症薬市場 $45 billion neurology 市場  $28 billion 鎮痛剤市場    $26 billion 麻酔薬市場    $ 4 billion [神経系2003]  Neuroscience世界市場規模は、$85 Billion以上 精神病[Psychiatry] $37 Billion 統合失調症患者 600万人、双極性障害患者 1700万人 神経症[Neurology] $20 billion 片頭痛等 鎮痛剤[Analgesia] $25 billion 西欧の成人46%が慢性の痛みに苦しむ 麻酔薬[Anesthesia] $3 billion 米国では毎年2600万人が麻酔薬を必要とする疾患で治療を受ける。 Diprivan(propofol),  全身麻酔薬シェア第一位。売上の90%以上が抗菌Diprivan EDTA Naropin(ropivacain), 局所麻酔薬 [神経系2002] Zomig 偏頭痛薬 シェア 世界16% [Pain Control2002] Pain control 世界市場$27.1 billion. Diprivan,  全身麻酔薬シェア 世界25% 米国24% 第一位 [癌2007] 制癌剤世界市場規模 $39 billion 治療法の劇的進歩にもかかわらず、癌は依然先進国で死亡数第2位。 癌による死亡数は760万人で、世界の年間死亡数の13%を占める。 2015年900万人、2030年1140万人と増加予測。 西欧では乳癌、前立腺癌、大腸癌が多いが、アジアは胃癌・肝臓癌が多い。 [癌2006] 制癌剤世界市場規模 $32 billion [癌2005] 制癌剤世界市場規模 $26 billion More than 11 million people are diagnosed with cancer every year worldwide; by 2020 this is forecast to reach 16 million. Seven million people die from can cer every year -- representing 12.5% of deaths worldwide. Breast cancer is the m ost prevalent cancer in the world and lung cancer is the most common cause of cancer death. [癌2003] 制癌剤世界市場規模 $15 billion Casodex(bicalutamide) 進行性前立腺癌治療薬シェア 世界70%  抗アンドロジェン剤で、最近の伸びは主に「早期前立腺癌(EPC)」への使用による。  Casodex 150mgはEPCへの適応で50カ国で承認(FDAは2002年に承認拒否)。 Zoladex(goserelin acetate) 世界的ベストセラーのLHRHアゴニスト  前立腺癌、乳癌、婦人科障害に適応。  前立腺癌では前立腺全摘出術や放射線療法後の生存率改善を示す唯一のLHRHアゴニスト。 Arimidex アロマターゼ阻害剤シェア 世界50% [癌2002] 制癌剤世界市場規模 $15 billion Casodex 進行性前立腺癌治療薬シェア 世界70% Arimidex アロマターゼ阻害剤シェア 世界50% [呼吸器・抗炎症2007] 呼吸器系薬世界市場規模 $48 billion.  喘息患者数はWHO推計で世界で1億人。 抗炎症薬剤世界市場規模 $17 billion.うち50%は関節リウマチ薬で売上面ではバイオが主流。 [呼吸器・抗炎症2006] 呼吸器系薬世界市場規模 $43 billion.  喘息患者数はWHO推計で世界で1億人。 抗炎症薬剤世界市場規模 $16 billion.うち40%は関節リウマチ薬で売上面ではバイオが主流。 [呼吸器・抗炎症2005] 呼吸器系薬世界市場規模 $41 billion.  喘息患者数はWHO推計で世界で1億人。 抗炎症薬剤世界市場規模 $12 billion.うち40%は関節リウマチ薬で売上面ではバイオが主流。 COX-2阻害剤の市場回収の影響も大きい。 [感染症2007] 感染症治療薬世界市場規模 $67 billion.うち抗菌剤が50%、抗ウイルス薬25% 抗菌剤の世界的需要はいぜん高いが、耐性菌の増加ならびに低免疫患者と高齢者での重症 感染リスクの増加による。 ・新規の有効な抗ウイルス薬は予防・治療ともに必要性が高い。 現在満足できる選択肢が少ない。 ・C型肝炎患者は世界で1億7000万人。欧米で治療に12ヵ月を要しながら治癒率は50%程度。 ・RSVは幼児がかかりやすく、50%が生後1年以内に、ほぼ100%が生後2年以内に罹患。 ・結核が世界的に脅威となっている。 世界で800万人(うちインド200万人)の患者。 [感染症2006] 感染症治療薬世界市場規模 $59 billion.うち抗菌剤 $31 billion Infectious diseases cause more than 11 million deaths each year.World demand for antibiotics remains high, due to escalating resistance and the increased risk of serious infections. Tuberculosis remains a worldwide threat and is newly diagnosed in approximately two million people every year in India and over eight million people worldwide. [感染症2005] 感染症治療薬世界市場規模 $57 billion. Infectious diseases cause more than 11 million deaths each year. World demand fo r antibiotics remains high due to escalating resistance and the increased risk o f serious infections [感染症2003] 感染症治療薬世界市場規模 $49 billion. [感染症2002] 感染症治療薬世界市場規模 $49 billion. AstraZeneca Annual Report 2002 -Review by Therapeutic Area AstraZeneca Annual Report 2001 -Review by Therapeutic Area AstraZeneca Annual Report 2000 -Review by Therapeutic Area --- IMS Data等を使用し、世界市場分析。
AstraZeneca

InvestorsSEC FILINGS 20-F[2012.3.28] 20-F[2011.4.28] - [pdf] - [doc] - [xls] 20-F[2010.3.25] - [pdf,309p] - [doc] - [xls] 20-F[2009.3.17] - [pdf,389p] - [doc] - [xls] 20-F[2008.3.12] - [pdf,539p] 20-F[2007.3.27] - [pdf,p] 20-F[2006.3.23] - [pdf,511p] 20-F[2005.3.21] - [pdf,365p] Annual Reports 2011 Annual Report and 20-F Information 2010 Annual Report and 20-F Information 2009 Annual report and 20-F Information 2009 2008 Annual report and 20-F Information 2008 2007 Annual report 2006 Annual report 2005 Annual reports and notice of 2006 AGM 2004 Annual reports and notice of 2005 AGM 2003 Annual Reports Annual Report 2002 Research AstraZeneca pipeline summary AstraZeneca製品サイトNews - AstraZeneca PLC Fourth Quarter and Full Year Results 2010[2011.1.27] - AstraZeneca PLC Fourth Quarter and Full Year Results 2009 [2010.1.28] - AstraZeneca PLC Fourth Quarter and Full Year Results 2008[2009.1.29] - Fourth Quarter and Full Year Results 2007[2008.1.31] - Fourth quarter and full year results 2006[2007.2.1] - FOURTH QUARTER AND FULL YEAR RESULTS 2004[2005.1.27] - AstraZeneca PLC Fourth Quarter and Full Year Results 2003[2004.1.29]
AstraZeneca-US

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アストラゼネカ[AstraZeneca]

■日本サイト ●プレスリリース アテローム性動脈硬化に及ぼす影響を検討するSATURN試験を開始 −クレストールとアトルバスタチンを初めて直接比較−[2008.1.21] - 2011年に終了の予定 クレストール担当のグローバル・メディカル・サイエンス・ディレクターElisabeth Bjrkは述べています。 「アトルバスタチンとの比較において、クレストールの優れたLDL-C低下効果およびHDL-C上昇効果がアテローム性 動脈硬化の治療に大きく貢献することをSATURN試験から確認できると考えています。」 AstraZeneca PLC 2011年第3四半期・9ヶ月累計業績[2011年10月27日] AstraZeneca PLC2010年第4四半期・通年業績(全文)[2011.2.8] AstraZeneca PLC2009年第4四半期・通年業績(全文)[2010.2.8] AstraZeneca PLC2008年 第4四半期・通年業績(全文)[2009.2.6] AstraZeneca PLC2007年第4四半期・通年業績(全文)[2008.2.08] AstraZeneca PLC2006年第4四半期・通年業績(全文)[2007.2.27] AstraZeneca PLC2005年第4四半期・通年業績(全文)[2006.2.10] AstraZeneca PLC2003年第4四半期・通年業績[2004.2.4] AstraZeneca PLC 2002年度第4四半期および通年業績[2003.2.5] AstraZeneca PLC 第4四半期および2001年度年間業績[2002.2.8] ●製品情報 - 添付文書など ●専門情報 ※全領域 ※VRI(Virtual Research Institute) - 日本の科学者、研究者と世界各国のアストラゼネカ研究開発者との間で、密接なコミ ュニケーションを行うことを目的としたメンバー制のコミュニティサイトです。 ※AstraZeneca Research Grant ※癌領域 ※AstraZeneca ONCOLOGY Congress Information - 外科、泌尿器科、癌関連医学会情報 ※www.iressa.com/- イレッサ錠250を適正にご使用いただくためのサイト ※Cancer Update Nature JapanサイトのCancer Updateは、アストラゼネカが支援しているページです。 ここでは癌関連の重要な研究成果や最新ニュース・政策を広く紹介しています。 ※Dr.lung - 肺癌の診療と研究に携わる医療関係者のための情報交流のページ ※呼吸器領域 ※パルミコートタービュヘイラーの吸入をご指導するサイトアストラゼネカ喘息研究奨励助成
(AstraZeneca Asthma Research Award)
※中枢神経領域 ※ADITUS Japan(アディタス ジャパン) 「ADITUS」(アディタス)の活動を継承し、日本国内において、片頭痛の診断や治療の向上 を目指して、啓発活動、情報提供活動を行っています。 ※麻酔領域 ※AZAS.net AZASネットは、麻酔および鎮静関連領域における情報提供サービスの向上を目指した、 当該専門医を対象とした専用のポータルサイトです。




Dermik Laboratories[US]

 - http://www.dermik.com/index.jsp
★外用薬部門 Dermik社が外用処方薬を扱う
[2003]
・2003.9.1 Aventisは外用処方薬を扱うDermik社を含めて、全世界的に外用薬について統合した。
・Dermik社製品は、外用処方薬、マメ・タコ等の足治療製品[podiatry products]、
最近はエステティック・フランチャイズを設立。
Within the prescription dermatology and podiatry business, Dermik focuses on treatments for a wide variety of skin and nail problems, including acne, nail fungus, pre-cancerous lesions, rosacea, psoriasis, dermatitis and eczema.
The leading products in the traditional prescription business currently include: BenzaClin (clindamycin 1%-benzoyl peroxide 5%) Topical Gel, Penlac Nail Lacquer (ciclopirox) Topical Solution (sold as Batrafen in most of Europe), Carac (5 fluorouracil) and Dermatop. The key product within the new aesthetic dermatology franchise is New-Fill, which is currently marketed in 26 countries, including the European Union. An IDE (Investigational Drug Exemption) was filed in the U.S. with the Food and Drug Administration in March 2003.
A PMA (Premarket Approval Application) was filed with the U.S. FDA in December 2003 to market this injectable drug device under the brand name Sculptra in the United States. A regulatory submission in Canada is planned in 2004.

An additional contributor to growth in 2003 was the strong performance of U.S.-based Dermik, now conducting the North American prescription dermatology business of Aventis Dermatology. Dermik achieved sales of e 377 million in 2003, as compared with e 391 million in 2002 (+ 15.0% activity growth). Dermik sales were driven primarily by the performance of BenzaClin, which is the leading branded prescription topical combination product for the treatment of acne, by growing sales of Penlac Nail Lacquer, the first and so far only prescription topical therapy approved in the U.S. for the treatment of onychomykosis (nail fungus), by Carac, a once-a-day topical 5FU (5 fluorouracil) product for pre-cancerous skin lesions and Klaron, an acne medication.

Dermik, our dermatology pharmaceutical products business based in the United States, achieved sales of e 391 million in 2002. The success of Benzaclin enabled Dermik to grow market share to 21% at the end of 2002 in the U.S. topical anti-acne market segment.

1964 外用benzoyl peroxideをAcne治療用に初めて発売した企業のひとつ。
1985 Benzamycin(benzoyl peroxide+erythromycin)を発売。

●Our ProductsPenlacSkin Problems〜疾病サイト
★Nail Fungus








Avanir Pharmaceuticals,Inc.

 - http://www.avanir.com/ ;(Nasdaq: AVNR);20 Enterprise, Suite 200,Aliso Viejo, CA 92656
  a biopharmaceutical company focused on acquiring, developing, and commercializing novel therapeutic products for the treatment of central nervous system disorders
1988年08月 Californiaで設立。




●会社決算
($ )2010/92009/92008/92007/92006/92005/9
売上高2,895,4744,176,5096,958,5689,224,56115,185,852
営業経費29,794,55826,017,81524,709,90133,945,90059,369,701
営業利益(27,096,724)(21,924,665)(18,962,458)(29,368,855)(51,677,459)
経常利益
当期純利益(26,694,148)(21,996,016)(17,495,739)(20,933,453)(62,552,814)
研究開発費13,322,04015,867,04914,110,743
従業員数[連結]128
●NUEDEXTA for the treatment of PBA
【2010】
NUEDEXTA TM is the first and only FDA-approved treatment for PBA, which occurs secondary to a variety of otherwise unrelated neurological conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the patient’s underlying emotional state.

NUEDEXTA is an innovative combination of two well-characterized components: dextromethorphan hydrobromide (20 mg), the ingredient active in the central nervous system, and quinidine sulfate (10 mg), a metabolic inhibitor enabling therapeutic dextromethorphan concentrations. NUEDEXTA acts on sigma-1 and NMethyl- D-aspartic acid, or NMDA, receptors in the brain, although the mechanism by which NUEDEXTA exerts therapeutic effects in patients with PBA is unknown.

Studies to support the effectiveness of NUEDEXTA in PBA were performed in patients with amyotrophic lateral sclerosis, or ALS, and multiple sclerosis, or MS. NUEDEXTA has not been shown to be safe and effective in other types of emotional lability that can commonly occur, for example, in Alzheimer’s disease and other dementias. The primary outcome measure, laughing and crying episodes, was significantly lower in the NUEDEXTA cohort compared to placebo. The secondary outcome measure, the Center for Neurologic Studies Lability Scale (CNS-LS), demonstrated a significantly greater mean decrease in CNS-LS score from baseline for the NUEDEXTA cohort compared to placebo.

NUEDEXTA safety information

NUEDEXTA can interact with other medications causing significant changes in blood levels of those medications and/or NUEDEXTA. NUEDEXTA is contraindicated in patients receiving drugs that both prolong QT interval and are metabolized by CYP2D6 (e.g., thioridazine and pimozide) and should not be used concomitantly with other drugs containing quinidine, quinine, or mefloquine. NUEDEXTA is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs) or in patients who have taken MAOIs within the preceding 14 days. NUEDEXTA is contraindicated in patients with a known hypersensitivity to its components.

NUEDEXTA may cause serious side effects, including possible changes in heart rhythm. NUEDEXTA is contraindicated in patients with a prolonged QT interval, congenital long QT syndrome or a history suggestive of torsades de pointes, in patients with heart failure as well as patients with, or at risk of, complete atrioventricular (AV) block, unless the patient has an implanted pacemaker. NUEDEXTA causes dose-dependent QTc prolongation. When initiating NUEDEXTA in patients at risk of QT prolongation and torsades de pointes, electrocardiographic (ECG) evaluation of QT interval should be conducted at baseline and 3-4 hours after the first dose.

The most common adverse reactions in patients taking NUEDEXTA are diarrhea, dizziness, cough, vomiting, weakness, swelling of feet and ankles, urinary tract infection, flu, elevated liver enzymes, and flatulence.

NUEDEXTA may cause dizziness. Precautions to reduce the risk of falls should be taken, particularly for patients with motor impairment affecting gait or a history of falls.

PBA indication and market

PBA is a distinct neurologic syndrome that is characterized by a lack of control of emotional expression, typically involving episodes of involuntary or exaggerated motor expression of emotion such as laughing, crying or other emotional displays.

There are an estimated 18 to 20 million people in the United States who suffer from the underlying neurological conditions that can give rise to PBA. These underlying neurologic conditions include but are not limited to ALS, MS, Alzheimer’s disease, Parkinson’s disease, stroke and traumatic brain injury. Extrapolating from the epidemiologic medical literature, physician estimates and an AVANIR-sponsored patient survey, which surveyed a total of 2,464 patients and caregivers of patients with underlying neurologic conditions associated with PBA (including ALS, Alzheimer’s disease/dementias, MS, Parkinson’s disease, stroke and traumatic brain injury), we estimate that approximately 10% of people in the United States who suffer from neurological disease or injury suffer from moderate to severe PBA, with many more suffering from mild PBA.

Other than NUEDEXTA, there are no approved therapies indicated to treat PBA. Currently, some physicians treat PBA using a range of drugs off-label, including: selective serotonin reuptake inhibitors/serotonin-norepinephrine reuptake inhibitors, or SSRIs/SNRIs, antidepressants and atypical antipsychotics. According to our market research, physicians are generally only moderately satisfied with these off-label therapies as a treatment for PBA. We conducted this market research through an Internet-based survey of 215 physicians, consisting of Neurologists, Internal Medicine/Geriatrics, Psychiatrists and Physical Medicine and Rehabilitation specialists.

We believe that NUEDEXTA represents a more attractive treatment option for patients suffering from PBA. In our Phase III STAR trial that was completed in 2009 with patients suffering from either ALS or MS as the underlying neurological condition, patients treated with NUEDEXTA reported an average overall 80% reduction in episodes at the end of the 12-week study compared to baseline, with an average 50% reduction in episodes in the first week of treatment. Over the course of the 12-week study, patients receiving NUEDEXTA experienced significantly lower PBA episode rates versus placebo ( P<0.0001 ). Over the final two weeks of the STAR trial, one-half of patients treated with NUEDEXTA achieved episode-free remission.

Our market research, conducted pursuant to the physician survey described above, indicates that 85% of surveyed physicians within targeted physician specialties would likely or very likely prescribe NUEDEXTA to treat their patients suffering from PBA. Of the surveyed physicians, the highest use was expected to be in PBA patients who have underlying conditions of either stroke or traumatic brain injury, but physicians expect to treat all PBA patient populations with NUEDEXTA. Among those physicians expressing an intent to prescribe NUEDEXTA, 78% indicated that NUEDEXTA would likely be used as a first-line therapy or an add-on therapy.

NUEDEXTA Commercialization Strategy

We intend to market NUEDEXTA initially to approximately 14,000 physicians who primarily specialize in psychiatry and neurology. Our commercialization strategy for NUEDEXTA includes the following elements: increase awareness of PBA, promote trial and adoption of NUEDEXTA, increase brand awareness of NUEDEXTA and minimize payment and distribution barriers.

【2010 Competition】

NUEDEXTA for Pseudobulbar Affect. Although NUEDEXTA is the first product to be marketed for the treatment of PBA, we are aware that physicians may prescribe other products in an off-label manner for the treatment of this disorder. For example, NUEDEXTA may face competition from the following products:
・Antidepressants, including Prozac ® , Celexa ® , Zoloft ® , Paxil ® , Elavil ® and Pamelor ® and others;
・Atypical antipsychotic agents, including Zyprexa ® , Risperdal ® , Seroquel, Abilify ® , Geodon ® and others; and
・Miscellaneous agents, including Symmetrel ® , Lithium and others.
While it is also possible that compounding pharmacies could combine the components of NUEDEXTA in an unauthorized fashion, it is inconsistent with the policies of the Pharmacy Compounding Accreditation Board.


●NUEDEXTA(AVP-923) for the Treatment of Neuropathic Pain Indications
【2010】
AVP-923 for the treatment of diabetic neuropathic pain

Diabetic peripheral neuropathic pain (“DPN pain”), which arises from nerve injury, can result in a chronic and debilitating form of pain that has historically been poorly diagnosed and treated. It is often described as burning, tingling, stabbing, or pins and needles in the feet, legs, hands or arms. An estimated 3.5 million people in the United States experience DPN pain according to the American Diabetes Association. DPN pain currently is most commonly treated with antidepressants, anticonvulsants, opioid analgesics and local anesthetics. Most of these treatments have limited effectiveness or undesirable side effects resulting in a high degree of unmet medical need.
The neuropathic pain market is continuing to grow rapidly, and in 2006, was estimated to be worth $2.6 billion in sales among the seven largest markets, consisting of the United States, Japan, France, Germany, Italy, Spain and the United Kingdom.

AVANIR has successfully completed a Phase III clinical trial for AVP-923 in the treatment of patients with DPN pain. In April 2007, we announced positive top-line data from our first Phase III clinical trial of AVP-923 for the treatment of patients with DPN pain. The primary endpoint of the trial was based on the daily diary entries for the Pain Rating Scale as defined in the SPA with the FDA. In the trial, two doses of AVP-923, 45/30 mg DMQ dosed twice daily (“AVP-923 45/30”) and 30/30 mg DMQ dosed twice daily (“AVP-923 30/30”), were compared to placebo based on daily patient diary entries for the Pain Rating Scale. Both AVP-923 treatment groups had lower pain ratings than placebo patients (p <0.0001 in both cases). In the AVP-923 45/30 patient group, average reductions were significantly greater than placebo patients at Days 30, 60, and 90 (p <0.0001 at each time point). In the AVP-923 30/30 patient group, average reductions were also significantly greater than placebo patients at Days 30 and 60 (p <0.0001) and Day 90 (p=0.007).

AVP-923 also demonstrated statistically significant improvements in a number of key secondary endpoints including the Pain Relief Ratings Scale and the Pain Intensity Ratings Scale. The secondary endpoints compared the baseline value to the average rating values at each study visit after randomization. The average pain relief reductions, as measured on the Pain Relief Rating Scale, were greater for the AVP-923 45/30 patient group (p=0.0002) and for the AVP-923 30/30 patient group (p=0.0083), compared with placebo. In addition, the DMQ 45, but not the DMQ 30, patient group demonstrated statistically significant improvements in the Pain Intensity Rating Scale compared with placebo (p=0.029). Although not powered to detect differences in the secondary endpoint of the Peripheral Neuropathy Quality of Life Scale Composite score and thus not achieving statistical significance, the AVP-923 45/30 patients showed a greater improvement than placebo patients (p=0.05) and the AVP-923 30/30 patients showed a trend towards greater improvement than placebo patients (p=0.08).

The most commonly reported adverse events from this Phase III study were dizziness, nausea, diarrhea, fatigue and somnolence, which were mild to moderate in nature. A higher number of patients in the AVP-923 45/30 and AVP-923 30/30 treatment groups (25.2% and 21.0%, respectively) discontinued due to an adverse event than compared to placebo (11.4%). There were no statistically significant differences in serious adverse event with 7.6%, 4.8% and 4.1% reported in the AVP-923 45/30, AVP-923 30/30 and placebo groups, respectively, and no deaths occurred during the study.

Due to safety concerns raised by the FDA in our October 2006 approvable letter for AVP-923, we conducted a formal pharmacokinetic (“PK”) study to identify a lower quinidine dose formulation that may have similar efficacy to the doses tested in the Phase III study. In May 2008, we reported a positive outcome of the formal PK study and announced that we identified alternative lower quinidine dose formulations of AVP-923 for the next DPN pain phase III clinical trial. The new dose is intended to deliver similar efficacy and improved safety/tolerability versus the formulations previously tested in DPN pain.

In September 2008, we submitted our Phase III protocol and related program questions for AVP-923 in the treatment of patients with DPN pain to the FDA under the SPA process. In subsequent communications regarding the continued development of AVP-923 for DPN pain, the FDA has indicated that it may be necessary to test a lower quinidine dose formulation in the DPN pain indication, such as the formulation that was identified in our PK study.
Additionally, based on feedback from the FDA, we believe that it is likely that two large well controlled Phase III trials utilizing a new lower quinidine dose formulation would be needed to support a New Drug Application (“NDA”) filing for this indication. Due to our limited capital resources and focus on the commercialization of NUEDEXTA, we do not expect that we will be able to initiate the trials needed for this indication without additional capital or a development partner for AVP-923. Accordingly, we are evaluating our options to fund this program, including the potential for a development partner.

AVP-923 for the Treatment of MS Pain

In September 2009, we reported on secondary efficacy endpoints from the double-blind phase of the AVP-923 STAR trail in PBA, including an endpoint measuring reduction of pain in patients with underlying MS. AVP-923 30/10 mg demonstrated statistically significant relief of MS-related pain compared to placebo in the subset of MS patients with moderate-to-severe pain. Based on these data and the previous proof of concept pain data in MS patients with PBA, we are conducting a strategic assessment of the optimal clinical development path for AVP-923 to obtain an MS pain indication.

【2010 Competition】

AVP-923 for DPN pain. We anticipate that AVP-923 for the treatment of DPN pain, if further developed by us and approved by the FDA for marketing, would compete with other drug products that are currently prescribed by physicians, including those identified below. Additionally, many other companies are developing drug candidates for this indication and we expect competition for AVP-923, if approved to treat DPN pain, to be intense. Current approved competitors include: ・Cymbalta ® ;・Lyrica ® ;・Narcotic products; and ・Off-label uses of non-narcotic products, such as the anticonvulsants phenytoin, carbamazepine and topamax,and the antidepressant amitriptyline.


●Docosanol 10% Cream − Cold Sore Treatment
【2010】
Docosanol 10% cream is a topical treatment for cold sores. In 2000, we received FDA approval for marketing docosanol 10% cream as an over-the-counter product. Since that time, docosanol 10% cream has been approved by regulatory agencies in Asia, North America, and Europe. In March 2000, we granted a subsidiary of GlaxoSmithKline, SB Pharmco Puerto Rico, Inc. (“GSK”), the exclusive rights under a license to market docosanol 10% cream in the United States and Canada (“GSK License Agreement”). GSK markets the product under the name Abreva ® in these markets. Under the terms of the GSK License Agreement, GSK is responsible for all sales and marketing activities and the manufacturing and distribution of docosanol 10% cream. Under the GSK license agreement, the Company received a total of $25 million in milestone payments from GSK and the Company was entitled to receive an 8% royalty on net sales of Abreva by GSK.

In November 2002, the Company sold to Drug Royalty USA an undivided interest in the Company’s rights to receive future Abreva royalties under the GSK License Agreement for $24.1 million (the “Drug Royalty Agreement”). Under the Drug Royalty Agreement, Drug Royalty USA has the right to receive royalties from GSK on sales of Abreva until December 2013. The Company retained the right to receive 50% of all royalties (a net of 4%) under the GSK License Agreement for annual net sales of Abreva in the U.S. and Canada in excess of $62 million. From the effective date of the GSK License Agreement up to the 2002 sale of the Company’s royalty rights to Drug Royalty USA, Inc. (“DRC”) the Company received a total of approximately $5.9 million in royalty payments from GSK attributed to the 8% royalty on net sales by GSK.

Under the terms of our docosanol license agreements, our partners are generally responsible for all regulatory approvals, sales and marketing activities, and manufacturing and distribution of the product in the licensed territories. The terms of the license agreements typically provide for us to receive a data transfer fee, potential milestone payments and royalties on product sales. We purchase the active pharmaceutical ingredient (“API”), docosanol, from a large supplier in Western Europe and have, on occasion, sold material to our licensees. We currently store our API in the United States. Any material disruption in manufacturing could cause a delay in shipments and possible loss of sales.

【2010 Competition】

Docosanol 10% cream. Abreva faces intense competition in the U.S. and Canada from the following established products:
・Over-the-counter preparations, including Carmex ® , Zilactin ® , Campho ® , Orajel ® , Herpecin ® and others;
・Zovirax ® acyclovir (oral and topical) and Valtrex ® valacyclovir (oral) prescription products marketed by Biovail Corporation and GSK, respectively; and
・Famvir ® famciclovir (oral) and Denavir ® penciclovir (topical) prescription products marketed by Novartis.


●Xenerex Human Antibody Technology − Anthrax/Other Infectious Diseases
【2010】
In March 2008, we entered into an Asset Purchase and License Agreement with Emergent Biosolutions for the sale of our anthrax antibodies and license to use our proprietary Xenerex Technology platform, which was used to generate fully human antibodies to target antigens. Under the terms of the Agreement, we completed the remaining work under our NIH/NIAID grant (“NIH grant”) and transferred all materials to Emergent. Under the terms of the agreement, we are eligible to receive milestone payments and royalties on any product sales generated from this program. In connection with the sale of the anthrax antibody program, we also ceased all ongoing research and development work related to other infectious diseases on June 30, 2008.

In September 2008, we entered into an Asset Purchase Agreement with a San Diego based biotechnology company for the sale of our non-anthrax related antibodies as well as the remaining equipment and supplies associated with the Xenerex Technology platform. In connection with this sale, we received an upfront payment of $210,000 and are eligible to receive future royalties on potential product sales, if any.


【2010】

Avanir Pharmaceuticals,Inc.

Products NUEDEXTA™(dextromethorphan hydrobromide and quinidine sulfate) abreva® (docosanol 10% cream) - HSV1 - GSKから北米販売権をライセンス ★Product pipeline AVP-923 P3  for Diabetic Peripheral Neuropathic Pain Xenerex 前臨床 from Novartis MIF Inhibitor 前臨床 from Emergent BioSolutions - Avanir has licensed macrophage migration inhibitory factor (MIF) program to Novartis International Pharmaceutical Ltd. and has sold its anthrax monoclonal antibody program to Emergent BioSolutions InvestorsFinancial Reports 2010 Annual Report[2010.9.30] SEC Filings 10-K Annual Report[2010.12.8] - [pdf] - [doc] - [xls] 10-K Annual Report[2009.11.25] - [pdf] - [doc] - [xls] 10-K Annual Report[2008.12.17] - [pdf] - [doc] - [xls] Press Releases

Avanir Pharmaceuticals Files Lawsuits Against Par and Actavis for Infringement of NUEDEXTA Patents[2011.8.11]
Avanir Pharmaceuticals Provides Update on European Regulatory Filing for NUEDEXTA[2011.7.26]
Avanir Pharmaceuticals Announces Paragraph IV ANDA Filing for NUEDEXTA[2011.7.1] - GEが2011.3.7に申請された。
Avanir Pharmaceuticals Announces Landmark 'PRISM' Pseudobulbar Affect Patient Registry[2011.5.4]〜推定200万人の患者。 1万人を目標
AVANIR Pharmaceuticals Announces U.S. Launch and Availability of NUEDEXTA™ for Pseudobulbar Affect[2011.1.31]
AVANIR Pharmaceuticals Announces FDA Approval of NUEDEXTA™ [2010.10.29]
AVANIR Submits Expanded Neurodex New Drug Application For The Treatment Of Involuntary Emotional Expression Disorder[2006.1.30]






AVI BioPharma, Inc.

 - http://www.avibio.com/ ;本社Corvallis, Oregon; NASDAQ=AVII
1980.7.22  創立。 antisense and cancer immunotherapy technologyに基づく製品開発
2008.3.12  Ercole Biotech, Inc.を買収。(RNAスライス技術)




●会社決算
($ )200820072006200520042003
収入21,258,15510,985,191115,2914,783,760430,461969,866
研究開発費29,002,50434,760,40225,345,58817,117,75020,738,72515,284,396
獲得研究開発9,916,271-----
一般管理費9,796,9479,332,3657,752,7525,182,3694,735,7314,558,948
当期純利益(23,952,625)(27,167,725)(28,687,510)(18,205,885)(21,936,843)(13,781,534)
従業員数[連結]83125
Registered NameCompanyStatusIndication備考
AVI-4658AVI BioPharma, Inc.米IDuchenne muscular dystrophy (DMD)- Exon51 局所筋注SSO-PMO
AVI-4658AVI BioPharma, Inc.米前臨床Duchenne muscular dystrophy (DMD)- Exon50 静注SSO-PPMO
 【メモ】AVI-4658 is designed to skip exon 51 of the dystrophin gene, thus repairing the mutated reading frame in the mRNA sequence coding for dystrophin, a vital protein which is absent or virtually absent in boys with DMD. By skipping this exon, a truncated, yet functional, form of the dystrophin protein is produced and this could ameliorate the disease process, potentially prolonging and improving the quality of life in these patients.  AVI-4658の前臨床データを発表[2008.6.12] EMEAオーファン指定[2008.10.14] AVI BioPharma to Co-Host Exon Skipping Conference for Duchenne Muscular Dystrophy[2008.10.14] 
AVI-5126AVI BioPharma, Inc.米I/II再狭窄(Restenosis)予防
 【メモ】AVI社のNeuGene(R) antisense drug。Global Therapeutics, a Cook Medical companyと共同開発。 AVI-5126 の再狭窄予防の前臨床結果穂報告[2007.7.25] 
 【メモ】
Mechanism = SSO/TSO Chemistry = PMO(proprietary antisense compounds)/PPMO/PMO+
AVI BioPharma, Inc.[US]

Product Pipeline News SEC Filings 10-K[2009.3.10] 10-K[2008.3.17]







Avigen, Inc

 - http://www.avigen.com/ ; バイオベンチャー
設立1992。 NADAQ上場1996.5
従業員数 95人(2004.3.1現在)うち26 with Ph.D. degrees and 5 with M.D. degrees


●決算
($000)          2003     2002     2001
Revenue            463       57       94
経費
 研究開発費    21,805   24,809   22,333
 一般管理費     7,399    8,146    7,559
  計          29,204   32,955   29,892
営業損失       (28,741) (32,898) (29,798)
当期純損失     (25,774) (27,739) (20,849)
 註)[収入]2003.3 Bayerから$375,000(総額では$2.5 million)


●開発中の新薬[遺伝子組み換え]
Coagulin-B  血友病          P2 →2004.5.27中止発表。 Bayer提携品。
AV201       パーキンソン病 IND申請2003.11.5
AV333       慢性神経痛

★血友病市場
National Hemophilia Foundationによると、hemophilia Bは世界で3万人男性に一人。
先進国の患者数は10,000 to 15,000。 うち40-50%は重症。年間市場$400 million。
hemophilia Aは1万人男性に一人。
先進国の患者数は40,000 to 50,000。患者一人あたりfactor VIII が10万ドル。
年間市場$2 billion

★パーキンソン病
 患者数2.5 million 
 世界パーキンソン病薬市場 $1 billion 
 うち L-dopa 50%
★Neuropathic Pain 市場
International Association for the Study of Pain 等によると
米国では年間70 million が通院
American Pain Society study(1999)によると、非癌性疼痛患者の50%が痛みがひどい。
diabetic neuropathy 60万人
post-herpetic neuralgia (shingles) 50万人
cancer patients 30万人
spinal cord injuries 10万人
with complex regional pain syndrome, multiple sclerosis, phantom pain, stroke
 and HIV suffer neuropathic pain. 20万人

 In 2002, sales of oral opioids were estimated to exceed $2 billion and in 2003,
 sales of Gabapentin, prescribed for both moderate neuropathic pain and for epil
epsy, were estimated to exceed $2.7 billion. 



Avigen, Inc

Company InformationPress ReleaseAnnual ReportProduct PipelineInvestor InformationFinancial Press ReleasesSEC Filings AVIGEN INC \DE 10-K [12/31/2003][2004.3.15]







Banner Pharmacaps Inc

 - http://www.banpharm.com/ ;非上場; High Point, NC  27265
ゼラチン系drug delivery開発企業。
1980年代後半から1990年代前半に飼料大手Vion, NVにより設立。
Vionはまず最初にPharmacaps, Incを買収。
1992年 Chase Pharmaceutical Companyを買収.
1994年 3社合併Banner Pharmacapsになる。
※VION社は従業員1.5万人、年間売上Eur 7.4 billion 




Banner Pharmacaps Inc

Research and Development Drug Delivery & Technology Press Releases Banner Pharmacaps Receives FDA Approval for Valproic Acid Delayed Release Softgel Capsules[2008.7.31] - Stavzor(TM)はゼラチン軟カプセルでEnteriCare(TM)技術を使用。 Banner Pharmacaps Inc. and JDS Pharmaceuticals LLC Announce License and Supply Agreement[2007.6.12] - JDSはBannerのValproic Acid Delayed Release Softgelの商品化独占権を獲得。







Bausch & Lomb

 - http://www.bausch.com/ ;2006年売上$2.29 billion; 従業員13,000
 1853年創立。
2007.10.26 Warburg Pincus LLC により買収された。

●買収関連記事
●NewsRoom
 - Warburg Pincus Completes Acquisition of Bausch & Lomb[2007.10.26]
    買収価額総額$4.5 billion(負債$830 million含む).

 -  Bausch & Lomb Announces Entry Into Agreement to Sell $650 Million of Notes[2007.10.16]
 - Bausch & Lomb Shareholders Approve Merger with Affiliates of Warburg Pincus[2007.9.21]
★全国紙
Bausch & Lomb Shareholders Approve Merger with Affiliates of Warburg Pincus[Forbes 2007.9.21]
Bausch & Lomb cut to 'B' on takeover by Warburg Pincus - S&P[Forbes 2007.10.04]
 - 買収によりB&Lの格付けが「BB+」→「B+」
Warburg Pincus to buy Bausch & Lomb[USA Today 2007.5.16]
Warburg Pincus(買収ファンド)
Warburg Pincus has been a leading private equity investor since 1971.
 The firm currently has approximately $20 billion of assets under management
 investing from nine offices around the world. Since inception, Warburg Pincus 
has invested $26 billion in 570 companies in 30 countries and across a range of
 sectors, including healthcare, consumer and retail, industrial, financial
 services, energy, real estate and technology, media and telecommunications.
 The firm has invested $4.8 billion in healthcare-related companies around the
 world, including approximately $1.5 billion in medical devices and $1.65 billio
n in life science and pharmaceutical companies.
Bausch & Lomb Enters into Merger Agreement with Warburg Pincus[2007.5.16]
 - Ronald L. Zarrella, chairman and CEO of Bausch & Lomb, said, “We believe
 this transaction with Warburg Pincus is good for the Company's employees, partn
ers in the eye care profession, and customers, as well as our shareholders."
 - $4.5 billion, including approximately $830 million of debt.
 - Bausch & Lomb common stock for $65.00 per share in cash

★他紙
AMO Bids $75/Share for Bausch & Lomb, Trumping Warburg Pincus' Offer[2007.7.6]
 - Rival Advanced Medical Optics Inc. offered to buy the company for about $4.3
 billion, or $75 a share, topping a bid from Warburg Pincus LLC by 15 percent.
 - In March, Bausch & Lomb recalled more than 1 million bottles of ReNu MultiPlu
s solution after excess levels of iron were found in it. There were no reports o
f serious harm to users. Potentially Blinding The company recalled its ReNu with
 MoistureLoc contact lens solution in May 2006 after some users developed infect
ions with the fusarium fungus.

Are promises of job protection at Bausch & Lomb just a fairytale?[2007.6.19]
 - Warburg Pincus LLCが過去、会社買収後に大規模リストラ後売却して収益を上げてきた。





●会社決算

($ milllion)200620052004200320022001
売上高2,292.42,353.82,233.52,018.5
営業利益114.0283.5279.1228.2
当期純利益14.919.2153.9106.0
研究開発費196.6177.5162.5149.9
従業員数[連結]13,000
●セグメント別
★売上($million)20062005200420032002200120001999

Contact lens710.0(+)728.5(+9)671.0(+13)593.2(+13)523.9(+13)462.7(-3)475.8466.1
Lens care413.8(-21)522.2(+0)523.3(+5)496.5(+7)465.5(+12)415.9(-15)488.3518.5
Pharmaceuticals658.4(+13)584.6(+11)528.2(+12)471.2(+18)396.1(+15)344.7(+23)279.4300.9
Cataract
&Vitreoretinal
381.9(+1)377.8(+6)358.2(+10)327.1(+9)301.8(-1)304.2(-1)308.2312.0
Refractive128.3(-9)140.5(-8)152.8(+17)130.5(-1)129.4(-6)138.0(-17)167.0123.1

売上 合計2,292.4(-3)2,353.8(+5)2,233.5(+11)2019.5(+11)1816.7(+11)1665.5(-3)
★売上構成 [2003]  コンタクトレンズ 29%  PureVision, SofLens66 Toric, SofLens One Day, SofLens Comfort, SofLens Multi- Focal, Boston and Optima FW.  レンズケア    25% ReNu, Sensitive Eyes(殺菌剤) Boston(レンズクリーナー)  医薬品      23% Lotemax and Alrex(点眼ステロイド), carteol(β遮断剤;             米国外) ; Minims(保存剤不要点眼剤); and Vidisic(ドライアイ)              Ocuvite and PreserVision(点眼ビタミン剤OTC)  白内障・硝子体網膜16% 眼内レンズ、Millennium( phacoemulsification equipment) (Cataract &Vitreoretinal) 他外科装置  屈折(Refractive) 7%  Zyoptix(LASIK用); Hansatome microkeratome ★地域別構成[2003(2002)]〜医薬品売上 アメリカ52%(53)、欧州47%(46)、アジア1%(1)
地域金額$million構成比
2006200520042003200220012000199920032001
アメリカ1,007.51,005.3960.2903.3844.1763.1878.2943.645%
欧州831.9859.9818.9724.4613.2581.7472.0448.936%
アジア・太平洋453.0488.6454.4390.8359.4320.7368.5328.119%
合計2,292.42,353.82,233.52,018.51,816.71,665.51,718.71,720.6100%
●市場シェア ★レンズケア 2003[市場規模 $1.7 Billion(1.7)] ()内2002年 B&L 29%(27), Alcon 23%(20), AMO 16%(16), Ciba 12%(12), 他25%(20) [地域別] 米国48%、欧州24%、アジア28% ★コンタクトレンズ 2003[市場規模 $4.0 Billion(3.4)] J&J 32%(34), Ciba 27%(26), B&L 15%(15), OSI 8%(8), Cooper 8%(7), 他10%(10) [地域別] 米国38%、欧州32%、アジア30% [タイプ別]  全 8100万人  OneDay 20%(10), RGP 11%(15), Traditional 10%(27) PRP/Disposable 55%(47), Continuous Wear 4%(1) ★白内障・硝子体網膜Cataract &Vitreoretinal 2003[市場規模 $2.8 Billion(2.6) /手術件数9.4 Million(9.1)] Alcon 54%(54), B&L 12%(12), AMO 11%(10), Pfizer 6%(6), Staar 2%(2), 他15%(16) IOLs 33%(32), Phacoemulsification Equipment 16%(21) Viscoelastics 14%(14), Vitreoretinal装置 6%(8), 他 31%(25) ★屈折矯正 Refractive 2003[市場規模 $535 Million(520)] [Laser米国 ] VISX 50%(49), Alcon 23%(20), Nidek 8%(12), B&L 12%(8), 他7%(11) [Laser米国外] B&L 32%(32), VISX 15%(16), Nidek 11%(14), Alcon 10%(10),Wavelight 11,Zeiss-Meditec 11, 他10%(28) [Microkeratome設置数]B&L 50%,Moria 26%, AMO 7%, NIDEK 5%, Intralase 3%, Others 9% [地域別2003] 米51%(58)、欧州29%(25)、アジア20%(17) ★眼科用医薬品 2003[市場規模 $8.4 Billion(6.5)] -[2002] Alcon 18%, Pharmacia 14%, Allergan 14%, Merck 10%, Novartis 8%, Santen9%, B&L 7%, 他 20% [薬効別] 緑内障39%(41), アレルギー13%(14), 抗感染10%(10), ドライアイ8%(8), 抗炎症6%(6), 配合剤5%(6), AMD 4%(-), Back-of-the-Eye -%(3), 他15%(12) from - Bausch & Lomb FactBook 2002 YearEnd[pdf, 14p] - Bausch & Lomb FactBook 2003 YearEnd[pdf,10p]
Bausch & Lomb

CorporateNewsRoom - Bausch & Lomb Receives FDA Approval of Besivance™, New Topical Ophthalmic Antibacterial for the Treatment of Bacterial Conjunctivitis (“Pink Eye”)[2009.5.29] - Bausch & Lomb Announces Entry Into Agreement to Sell $650 Million of Notes[2007.10.16] - Bausch & Lomb Shareholders Approve Merger with Affiliates of Warburg Pincus[2007.9.21] - Bausch & Lomb Fourth-Quarter Sales Up 15 Percent,Comparable-Basis EPS Rise 38 Percent[2004.1.29] - Investor RelationsAnnual Reports - 2006 Form 10-K[pdf,157p] - 2005 Form 10-K[pdf] - Annual Report 2004[pdf] - Annual Report 2003[pdf,76p] ★SEC Filings - 10-K[2007.4.25] - 10-K[2007.2.7] - 10-K[2005.3.9] - 10-K[2004.3.8] - Bausch & Lomb FactBook 2002 YearEnd[pdf, 14p] - Bausch & Lomb FactBook 2003 YearEnd[pdf,10p] ■Eyecare ProfessionalsLaser Surgery ZyoptixRx Pharmaceutical Products Retisert Consumers
ボシュロム・ジャパン株式会社

- http://www.bausch.co.jp/; 従業員数271名(2002年12月現在) コンタクトレンズ、レンズケア用品及び眼内レンズ、眼科手術用機器の製造、 輸入、販売 ●サージカル事業本部 ボシュロム社は、 1997年に先端の技術と開発力を持ったカイロン ビジョン社とストルツ インスツルメント 社を買収し、ボシュロム・サージカルを設立し、眼科手術器械、器具の分野に参入、更に 1999年には手術に関連した診断機器を製造するオーブテック社を傘下に加えた。 ボシュロム・サージカル米国本社は、個々人の眼の形状を詳細に測定する診断装置、Orbs can-IIや合理的かつ最新の設計思想にもとづき開発されたTechnolas-Excimer Laser手術 システムやHansatome-Microkeratomeといった優れた製品を開発し、より高いレベルの手 術を可能にしています。 眼科手術の中でボシュロム・サージカルのビジネスを支えているひとつに白内障の分野が あります。白内障によって視力が低下してくると通常は水晶体を取り除き、代わりに眼内 レンズ(IOL)という人工のレンズを挿入します ●Zyoptix(ザイオプティックス)システムの構成 最新レーザーZyoptix 217z100(ザイオプティックス)と ウェーブフロント解析装置ZywaveU(ザイウェーブU)からなる。




Baxter Healthcare Corp

 - http://www.baxter.com/
☆履歴
1931 Don Baxter Intravenous Products, Inc.(輸液製品会社)として創立
1935 社名をBaxter Laboratories Inc.と改称 
1952 ハイランド社を買収(初めてヒト血漿の治療用製品化に成功した企業) 
1956 人工腎臓(血液透析装置)世界初の製品化 
1959 フェンウォール社を買収(世界初のプラスチック製採血バッグと血液成分分離法を開発した企業)
1961 バクスター、ニューヨーク株式市場に上場 
1962 体外循環用人工肺、世界初の開発  開心術が初めて可能に。 
     社名をBaxter Travenol Laboratories Inc.と改称
    (Travenolは、輸液を意味するintravenous solutionsに由来する造語で、87年まで続く)
1966 血友病A治療用の第VIII因子濃縮製剤、世界初の製品化成功 
1970 ・ 輸液用プラスチックバッグ、世界初の製品化 
        外気中の感染物質に触れることなく安全な投与を可能に。 
     ・ 世界初のディスポーザブル気泡型人工肺を開発 
1979 ・ CAPD(連続携行式腹膜透析)、世界初の開発、製品化成功  
        腹膜を介して血液を浄化する、腎不全の在宅療法が初めて可能に。 
     ・ 初の全自動血液成分分離装置開発、製品化成功 
1982 ・ インフューザー(携帯型ディスポーザブル注入ポンプ)開発 
       抗癌剤、鎮痛剤の持続投与が容易になり、癌や慢性疾患の在宅治療にも貢献。 
1983 米国の医療保険制度にDRG/PPSが導入され、定額制に移行
     ・ 加熱第VIII因子濃縮製剤、米国で世界初の開発成功 
1985 アメリカン ホスピタル サプライ コーポレーションを買収
(心臓血管製品、メディカル製品製造・販売・配送、病院経営コンサルティング等の事業が加わる)
1987 社名をバクスターに統一 
1988 ・ S/D(有機溶剤・界面活性剤)処理およびモノクローナル抗体による純化精製第VIII因子製剤を開発 
    血漿由来の製剤としては最も高い評価を受け、日本では1992年、この製造技術をバクスターから日本赤十字社に技術供与。 
1991 ・ 金属針を使用しない輸液システムを開発
       針刺し事故による感染を防ぐことが容易に。 
1992 ・ 遺伝子組換え第VIII因子製剤 世界に先駆け米国・カナダ・スウェーデンにて発売 
1995 11月  会社を二分割することを発表
     (メディカル製品製造・販売・配送・病院経営コンサルティングの部分が、翌年アリージャンス社となる) 
     Nextran社を100%所有(異種間移植を研究)  
1996  8月 イムノ社買収を発表
     (血漿たん白製剤、ワクチン、 生物学的組織接着剤等の 製造開発能力を増強) 
     10月  アリージャンス社分離
     (分離後のバクスター社員数は3万7千名、売上高54億ドル) 
1998 ソマトジェン社買収を発表
     (遺伝子組換えによるヘモグロビン療法開発中) 
1999 11月 ノースアメリカンワクチン社買収を発表
     (感染症治療、遺伝子組換え技術、免疫学分野の能力増強) 
2000  4月 心臓血管製品事業を会社分割Edwards Lifesciences Corporationとなる。 
2001 ASTA Medica Onkologie GmbH & CoKG社を買収 (がん治療薬分野に進出)Degussa AG(2008.9 Evonik Industries AGの1部門)から。
     対価525 million Euros (U.S. $470 million). 
  (ASTA Medica AGはDegussa AGの子会社で、Oncology, Health Products, awd.pharma
   and Zentaris.の各部門;2004.6 親会社Degussa AGがZentaris GmbHをAEterna Labsに売却。)
     遺伝子組換えエリスロポエチン製剤エポエチンオメガの製造販売権を取得
   (貧血治療薬として腎不全、がん治療等に需要)
    米国政府からバイオテロ対策のため、天然痘ワクチン1億5千万人分の製造契約を、
    提携先の英国アカンビス社と共同で受託  
2002 次世代の遺伝子組換え第[因子製剤PFMをFDA(米国食品医薬品局)に申請
     輸血用血小板製剤の病原体不活化システム用キット、EUにてCEマーキング(販売承認)を取得
  (輸血用製剤にふくまれる、核酸を持つ病原体を不活化するシステムとして米国シーラス社と共同開発)  



●会社決算 [Baxter International Inc.]
($ milllion)200520042003200220012000
連結売上高9,8499,5098,904

売上原価5,7565,5944,951
販売・管理費2,0301,9601,805
原価・経費計8,4059,0797,775
営業利益1,4444301,129
経常利益
当期純利益956388866
研究開発費[対売上比]533(+3)[5.4%]517(-7)[5.4%]553[6.2%]
従業員数[連結]
●売上
($ milllion)20052004200320022001備考

Medication Delivery3,990(-1)4,047(+6)3,827(+16)3,317(+14)2,905
BioScience3,852(+10)3,504(+7)3,269(+6)3,096(+11)2,786
Renal2,007(+3)1,958(+8)1,808(+6)1,697(+2)1,665

 合計9,849(+4)9,509(+7)8,904(10)8,110(+10)7,356
 うち米国4,383(-2)4,460(+4)4,279(+8)3,974(7)3,721
   国外5,466(+8)5,049(+9)4,625(+12)4,136(+14)3,635
 日本417415403388427
★主要製品の対売上構成比
($ milllion)20052004200320022001備考
●Medication Delivery
Intravenous therapies21,225(+6)[12%]1,154(+5)[12%]1,100[12%][12%][13%]
Drug Delivery818(-3)840(+13)744
Infusion System853(-8)928(+5)885
Anesthesia1,021(-2)[10%]1,037(+6)[11%]976[11%]
Others73(-17)88(-28)122
合計3,990(-1)4,047(+6)3,827
●Bioscience
Recombinant products1,527(+15)[16%]1,329(+18)[14%]1,123[13%]12%11%
Plasma proteins11,023(-1)[10%]1,037(+3)[11%]1,005[11%]12%14%
Antibody Therapy452(+35)336(+8)311
Transfusion Therapies547(-1)550(-1)553
その他303(+20)252(-9)277
合計3,852(+10)3,504(+7)3,269
●Renal
Peritoneal dialysis(PD) therapies1,534(+6)[16%]1,445(+8)[15%]1,344[15%]16%17%
Hemodialysis(HD) therapies454(-9)499(+12)447
その他19(+36)14(-17)17
合計2,007(+3)1,958(+8)1,808
1 Includes plasma-derived hemophilia (FVII, FVIII, FIX and FEIBA), albumin, plasma-based biosurgery (Tisseel), and other plasma-based products. Excludes anti-body therapies. 2 Principally includes intravenous solutions and nutritional products. ★概況 [BioScience 2003] ・Acambis社(天然痘ワクチンの政府契約あり)への投資からの収入 ・Recombinate Antihemophilic Factor (rAHF) (Recombinate)が需要増 ・遺伝子組み替え製品のADVATE (Antihemophilic Factor (Recombinant) , Plasma/Albumin-Free Method) rAHF-PFM (ADVATE)が2003.7 FDA承認。
Vaccines Litigation As of December 31, 2005, the company has been named as a defendant, along with others, in approximately 140 lawsuits filed in various state and U.S. federal courts, seeking damages, injunctive relief and medical monitoring for claimants alleged to have contracted autism or attention deficit disorders as a result of exposure to vaccines for childhood diseases containing the preservative, thimerosal. These vaccines were formerly manufactured and sold by North American Vaccine, Inc., which was acquired by Baxter in June 2000, as well as by other companies.


Baxter

Products Anesthesia - Anesthetic Pharmaceuticals Biopharmaceuticals〜血液製剤など - HemophiliaTherapies Hemophilia Therapy ADVATE rAHF-PFM (遺伝子組換血液凝固第[因子製剤)〜血漿/アルブミン除去 RECOMBINATE rAHF (遺伝子組換血液凝固第[因子製剤)〜人血漿由来 HEMOFIL M AHF ヘモフィルM(乾燥濃縮人血液凝固第[因子)〜人血漿由来 FEIBA VH AICC ファイバ (乾燥人血液凝固因子抗体迂回活性複合体) PROPLEX T (加熱処理濃縮血液凝固第\因子) BEBULIN Factor IX Complex, Vapor Heated (蒸気加熱処理血液凝固第\因子複合体) Conditions〜癌、腎臓疾患、免疫 Hemophilia News Baxter Reports Financial Results for the Fourth Quarter and Full-Year 2005[2006.1.26] Baxter's Sales and Earnings Grow in 2002[2003.1.22] ●Investor InformationAnnual Reports Annual Report 2005 - [pdf] (2005) Form 10-K Annual Report 2003 (2003) Form 10-K - Dex 13 Annual Report 2001[pdf, 65p] - Development pipeline [11p] ★SEC Filings 10-K Annual Filing 2005[2006.3.7] - [pdf] 10-K Annual Filing 2004[2005.3.16] - [pdf] 10-K Annual Filing 2003[2004.3.12] - [pdf] 10-K Annual Filing 2002[2003.3.12] - [pdf] 10-K Annual Filing 2001[2002.3.13] - [pdf]
バクスター株式会社

1969 米国バクスター・トラベノール社と住友化学との合弁会社として、大阪市に [日本トラベノール株式会社]設立 (人工腎臓、臨床検査薬、輸血システム、血漿分画製剤等の導入を開始) 1975 バクスター・トラベノール社の100%出資会社として、 [トラベノール・パシフィック株式会社]設立 1979 9月 日本トラベノール株式会社において、住友化学との合弁を解消、 [日本トラベノール株式会社大阪本社]となる 10月 東京のトラベノール・パシフィック株式会社も会社統合に備えて商号変更、 [日本トラベノール株式会社東京本社]となる 1981 9月 [日本トラベノール株式会社]大阪本社と東京本社を合併し、東京に本社を構 える 1985 3月 [トラベノール株式会社]と社名変更 1986 9月 アメリカン ホスピタル サプライ社の日本法人 エイ・エッチ・エス・ジャパ ン株式会社と合併これを機に、[バクスター・トラベノール株式会社]と社名変更 1988 バクスター株式会社]と社名変更 2000 4月 メディカル製品事業部をアリージャンス株式会社に事業譲渡 2002 10月 心臓血管製品事業を、エドワーズ ライフサイエンス株式会社に承継


1988 S/D(有機溶剤・界面活性剤)処理およびモノクローナル抗体による純化精製第VIII因子製剤を発売 1991 血漿由来の第[因子製剤として最も高い評価を得た、S/D処理およびモノクローナ ル抗体による純化精製第[因子製剤の製造技術を、日本赤十字社に技術供与 1996 6月 遺伝子組換え第[因子製剤を発売 ●ニュース/トピツクス腎不全とその治療法血漿蛋白製剤医療従事者向け情報〜添付文書など ★日本語版ヘモフィリアファーマシーサービスニュース血液成分採取と輸血療法薬剤投与システム機器のサービス







Bayer AG

Bayer Schering Pharma AG officially launched[2006.12.29]
 - Bayer Schering Pharma AG(旧Schering AG) が2007.1.17にスタートする。
Bayer AG がSchering AGを買収し、Bayerの医薬事業をこれに統合した。



●決算
(Euro milllion)20142013201220112010200920082007200620052004200320022001
純売上高*35,088(+12.6)31,168(-5.3)32,91832,385(+11.8)28,956(+17.2)24,701
旧27,383(+17.6)
20,925
旧23,278(+3.8)
22,41722,28321,981
営業利益EBIT2,730(-9.2)3,006(-15.2)3,5443,1542,762(+9.9)2,514
旧2,812(+50.0)
1,875(-)-1,119
旧575
8151,518
営業外収支-1,136-1,188-782(-29.9)-602
旧-613(+6.1)
-632
旧-653(+7.8)
-708-423-467
経常利益1,721(-8.0)1,8702,3562,2341,9801,912
旧2,199(+80.0)
1,222(-)-1,994
旧-133
3921,051
純利益1,301(-4.3)1,359(-20.9)1,7194,7161,695
旧1,683(+5.4)
1,597(+133.1)682
旧685(-)
-1,349
旧-1,303
1,075932
研究開発費3,053(+11.2)2,7462,6532,5782,297(+32.9)1,729
旧1,886(-2.1)
1,927(-12.0)2,404
旧2,190
従業員数111,400108,400108,600106,200106,00082,60091,700115,400
*継続事業 1)従業員数(2005.12.末)世界93,700、独37,600 [年報2005,p41] 2)研究開発費:ヘルスケア事業Euro 954million(51%);&支出用途説明 [年報2005,p46] ●事業別セグメント
(Euro milllion)20142012201120102009200820072006200520042003
●ヘルスケア16,913(+5.8)15,988(+3.8)15,40714,807(+26.3)11,724[40.5%]7,996[32.4%]
旧9,425
6,736[32.2%]
旧8,058
8,497
 医薬10,90810,46710,03010,267(+37.3)7,478[25.8%]4,067[16.5%]3,961[18.9%]4,371
 コンシューマー6,0055,5215,377
旧4,703(+3.6)
4,540(+6.9)4,246[14.7%]3,929[15.9%]2,775[13.3%]
 旧コンシューマー--2,770(+5.2)2,634(2,531)2,3551,3361,403
 糖尿病ケア--970(+2.1)950(+17.3)810718
旧2,151
653
旧1,975
1,933
 動物薬--963(+0.7)956(+5.6)905856786790
●Crop Science6,830(+4.9)6,510(+2.0)6,3825,826(+2.2)5,700[19.7%]5,896[23.9%]5,946[28.4%]5,764
 Crop Protection5,4935,4245,3394,781(+3.0)4,644[16.0%]4,874[19.7%]4,957[23.7%]4,801
 環境科学製品1,3371,0861,0431,045(-1.0)1,056[3.7%]1,022[4.2%]989[4.7%]963
●材料科学製品10,154(+35.0)7,520(-22.8)9,73810,435(+2.7)10,161[35.1%]9,466[38.2%]
旧10,695
7,566[36.2%]
旧8,597
7,453
 材料3,041(+4.0)2,925[10.1%]2,837[11.4%]
旧4,086
2,217[10.6%]
旧3,248
2,777
 システム7,394(+2.2)7,236[25.0%]6,609[26.8%]5,349[25.6%]4,676
●Reconsilation1,1911,1501,3911,371[4.7%]1,363[5.5%]677[3.2%]703
■継続事業 合計35,08831,16832,91828,956[100.0%]24,701[100.0%]
旧27,383
20,925[100.0%]
旧23,278
22,417
中止事業 収入2,8453,3098,833
医薬 ...2006年度数値は2006.6.23買収のSchering AG分を含む コンシューマー...2006年度、Schering AG買収とDiagnostics divisionの売却に伴い、,Diabetes Care、旧Consumer Care およびAnimal Healthを統合して新Consumer Healthとした。 ●地域別セグメント〜医薬
(Euro milllion)201420132012201120102009200820072006200520042003
欧州4,082(-0.6)4,1074,181
旧4,403(+0.8)
4,3673,0461,6001,5771,412
北米2,531(-6.7)2,7122,646
旧2,966(+3.6)
2,8622,2261,1291,1721,817
アジア・太平洋2,629(+23.1)2,1361,805
旧1,867(+12.5)
1,6591,313900851704
南米・アフリカ・中近東1,666(+10.2)1,5121,398
旧1,468(+6.5)
1,379893438361338
合計10,908(+4.2)10,46710,030
旧10,704
10,2677,4784,0673,9614,371
●製品別売上高〜医薬品
(Euro million)2014201320122011201020092008200720062005200420032002200120001999備考
★抗菌剤
Ciprobay/Cipro191(-3.0)197232(-11.5)262(-20.8)331(-2.1)338(-11.7)383(-25.3)513525(-37.3)837(-41)1,411(0)1,411(-28)1,964(+10%)1,785(+18%)1,519(+17%)[ciprofloxacin]
Avelox/Avalox381(-10.6)426486(-2.2)497(+8.0)460(-0.4)462(+3.8)445(+12.4)396364(+14.5)318(+6.4)299(+6.8)280(+55)181--[moxifloxacin] 抗菌剤
Canesten/Bayclear[一般用]----162145140(+3.7)135(-4.9)142206(+5%)??Mycelex*[clotrimazole]抗真菌剤
★循環器系
Xarelto1,679(+76.9)949[rivaroxaban]経口抗凝固薬
Adalat588(-2.5)603640(-3.6)664(+4.9)633(+1.1)626(+2.0)614(-6.5)657659(-1.6)670(-0.9)676(-15.5)800(-18)975(-16%)1,155(+13%)1,021(+ 6%)nifedipine
Lipobay/Baycol--------[販売中止]-?636(+82%)345(+205)cerivastatin
Aspirin Cardio486(+7.5)452404(+12.8)358(+13.7)315(+16.7)270(+17.9)229(+9.6)209[aspirin]
Aspirin-----630(+4.8)615(+7.1)574(-2.5)589(-14)723(+2%)632(+12%)580(+6%)
内医療用Aspirin-----177147111
Trasylol-----230(+34.5)171(+8.9)157(+1.9)154???aprotinin
Zetia168(-2.3)172179(+29.7)138
(蛋白分解酵素阻害剤)[適応:急性循環不全(外傷性ショック,細菌性ショック)]
Kinzal(R)/Pritor(R)172(-3.4)178(+8.5)164(+13.9)144[telmisartan]
★血液・生物製剤
Kogenate1,109(-7.7)1,2021,075(+7.1)1,004(+13.1)888(+4.7)848(+3.7)818(+3.9)787663(+17.8)563(+13.3)497(+24.3)400(+60)250(-49%)491(+30%)377(- 2%)Factor 8
Gamimune N-----*事業譲渡343(+12.8)304(-8.7)333(-3)343(-2%)350(+22%)287(+59%)免疫グロブリン
Prolastin-----*事業譲渡166(0)166(+9.9)151???Alpha1 Proteinase Inhibitor (Human)(antitrypsin欠乏症)
★糖尿病薬
Glucobay443(+4.7)423362(+4.3)347(+10.2)315(+3.6)304(+2.0)298(-3.2)308295(+6.1)278(+1.8)273(-4.9)287(-8)310??acarbose 糖尿病
★泌尿器系
Levitra245(-15.5)290332(-22.6)429(+19.2)360(+5.6)341(+2.7)332(+5.7)314260(+34.7)193(+34)144(-)(発売2003)---Vardenafil 勃起不全治療薬
★女性保健
Yasmin/YAZ[S]768(-10.0)8531,070(-3.7)1,111(-13.1)1,278(+4.6)1,222(+17.3)1,042451
通期794
586(+36)429(+48)290(+91)152(>100)--[drospirenone/ethinylestradiol]避妊薬
Mirena[S]819(+13.9)719581(+7.8)539(+10.0)490(+6.1)462(+28.0)361166
通期301
243(+22)199(+21)164(+20)137(+41)100(+42)70(+17)子宮内ホルモン徐放システム
[levonorgestrel-releasing intrauterine system]
Diane182(+6.4)171-164(-6.3)175(-)88
通期175
[2mg cyproterone acetate and 0.035mg ethinyl estradiol.]OC,PMDD
★Diagnostics 造影剤
Magnevist[S]215(-1.8)219(-9.1)241(-19.9)301171
通期323
328(+8)303(+1)300(-7)322(+6)320(+12)286(+23)[gadopentetate dimeglumine]
Ultravist313(+19.5)262(+0.4)261(+11.1)235(-)86
通期222
[]
Iopamiron185(-7.0)199(+0)199(-5.7)211(-)117
通期221
[]
★その他
Eylea759(+127.9)33314[aflibercept]加齢黄斑変性症;米承認2011.11.18、欧承認2011.6.7;米国リジェネロン・ファーマシューティカル社より導入/
Fosrenol147(+48.5)99[]
Betaferon/Betaseron[S]819(-21.1)1,0381,216(+8.9)1,117(-7.4)1,206(-0.7)1,214(+6.1)1,144(+11.3)1,028535
通期991
867(+11)782(+2)770(-2)783(+20)681(+15)593(+31)interferon 1b ;MS多発性硬化症;特許切れ米2007,日欧2008
Nexavar773(+0.3)771725(+2.8)705(+16.7)604(+30.7)462(+71.1)270(+107.7)130-------[Sorafenib]腎細胞癌
Stivarga224(+13.7)197[regorafenibレゴラフェニブ]消化管間質腫瘍(GIST);スチバーガ
医薬合計8,013[73%]7,732[74%]7,324[73%]6,742[66%]
★消費者製品
Ascensia[旧Glucometer]934(+18.5)788701(+11.8)627(+8.5)593(-13.9)515(+5)492(+4%)472(+33%)354(+18%)血糖測定
Contour602(+0.2)601554(+13.5)488--------血糖測定
Breeze125(-9.4)138145(-4.6)152--------血糖測定
内一般用Aspirin418(+4.5)400449(-2.4)460(-1.1)465453454463
Aleve®/naproxen273(+25.8)217
Bepanthen/Bepanthol212(+14.0)186
Canesten210(+11.7)188
One A Day178(+16.3)153
Supradyn138(+1.5)136
ADVIA Centaur System-----512(+16.1)441(+14.0)387(+13.8)340(+31)259(+46%)??診断
Baygon-------??372(0%)????殺虫剤
Alka-Seltzer----1019594?????240(+10%)
*事業譲渡: 2005.4.1 Bayerは、米国血漿事業を投資会社(Cerberus Capital Management, L.P., New York, New York and Ampersand Ventures,Wellesley, Massachusetts.)に譲渡し、新設されたTalecris BioTherapeutics, Inc.,が事業開始。  対象となる主要製品はPolyglobin, Gamimune N, Gamunex and Prolastin。  Kogenateは対象外。 *2006年度はSchering AG製品一部を付加。 [S]製品
*血糖測定器
は2008年度Ascensia Contour and Ascensia Breezeが主体でAscensia Eliteに代替
【2009】Blood glucose monitoring devices:
In 2005, Abbott Laboratories commenced a lawsuit in the United States against Bayer and another party alleging infringement of two of Abbott’s patents relating to blood glucose monitoring devices. The devices concerned are sold by Bayer as part of its Ascensia® Contour® system and its dex® and Autodisc® system. The Ascensia® Contour® system is supplied to Bayer by a Japanese manufacturer, who originally designed the product and is contractually obligated to indemnify Bayer. In 2006, Abbott added a separate claim of infringement against the devices sold by Bayer as part of its dex® and Autodisc® system. Bayer is not entitled to indemnifi cation on this separate claim. In 2008 the court granted summary judgment in favor of Bayer with regard to one of the two patents and held the patent claims at issue invalid. After a trial on the issue of invalidity, the court also held the second patent invalid. In January 2010, the u.s. Court of Appeals for the Federal Circuit affi rmed both decisions. It is not clear whether Abbott will pursue further legal remedies.

In 2007, Roche Diagnostics Operations and Corange International commenced a lawsuit in the United States against Bayer and several other parties alleging infringement of two of Roche’s patents relating to blood glucose monitoring devices. Two of the accused devices are sold by Bayer as part of its Breeze® 2 and Contour® systems. Bayer believes that these patents are covered by an existing license agreement between the parties, and the litigation has been dismissed in favor of an arbitration under this earlier license agreement. The arbitration proceeding is currently pending. Roche has added to the arbitration four additional patents which Roche alleges the Bayer Contour® systems infringe.


*Yasmin / yaz ジェネリック
【2011】
Yasmin™: In 2005, Bayer filed suit against Barr Pharmaceuticals, Inc. and Barr Laboratories, Inc. in u.s. federal court alleging patent infringement by Barr for the intended generic version of Bayer’s Yasmin™ oral contraceptive product in the United States. In 2008, the u.s. federal court invalidated Bayer’s ’531 patent for Yasmin™. In 2009, the u.s. Court of Appeals for the Federal Circuit affi rmed this decision. In 2010, the u.s. Supreme Court rejected Bayer’s petition for review.

In 2008, Bayer and Barr Laboratories, Inc. signed a supply and licensing agreement for the supply of a generic version of Yasmin™ which Barr markets solely in the United States under the Ocella™ brand. Barr pays Bayer a fi xed percentage of the revenues from the product sold by Barr. The agreement is under investigation by the u.s. Federal Trade Commission (ftc).

In 2008 Bayer received two and in 2010 another three notices of an Abbreviated New Drug Application with a Paragraph iv certifi cation (an “anda iv”) pursuant to which Watson Laboratories Inc., Sandoz Inc., Lupin Ltd., Famy Care Ltd. and Sun Pharma Global fze each seek approval to market a generic version of Bayer’s oral contraceptive Yasmin™ in the United States. Bayer has fi led suit against Watson, Sandoz and Lupin in u.s. federal court alleging patent infringement for the intended generic version of Yasmin™. In reply, Watson and Sandoz have fi led counterclaims alleging, among other things, the invalidity of various Bayer patents. Sandoz has further alleged that Bayer and Barr have made arrangements that are anticompetitive and violate antitrust and unfair competition laws; the u.s. federal court dismissed these allegations in 2011. In 2010, the u.s. federal court dismissed Bayer‘s infringement claims against Watson, Sandoz and Lupin. Bayer appealed these decisions to the u.s. Court of Appeals for the Federal Circuit. The appeals were consolidated and heard in December 2011.

YAZ™ : In 2007 and 2008 Bayer received notices from Barr Laboratories, Inc., Watson Laboratories Inc. and Sandoz Inc., and in 2010 Bayer received notices from Lupin Ltd. and Sun Pharma Global fze, that each company has fi led an anda iv seeking approval of a generic version of Bayer’s yaz™ oral contraceptive in the United States. Bayer further received such notices from Famy Care and Pharmaceutics International Inc. in 2011 and 2012. Bayer has fi led patent infringement suits against Watson, Sandoz, Lupin, Sun Pharma Global and Famy Care in u.s. federal court claiming that certain of Bayer’s patents have been infringed. Bayer may take legal action against Pharmaceutics International at a later point of time. In its defense statement, Sandoz has alleged, among other things, that Bayer and Barr have made arrangements that are anticompetitive and violate antitrust and unfair competition laws. Sandoz withdrew these allegations in 2011.

In 2008 Bayer and Barr agreed that Bayer will grant Barr a license to market a generic version of yaz™ in the United States starting July 2011 and will supply Barr with the product for this purpose. Barr agreed to pay Bayer a fi xed percentage of the revenues from the product sold by Barr. In December 2008, Barr was acquired by Teva Pharmaceutical Industries Ltd. In 2010 Teva announced that it had commercially launched Gianvi™, a generic version of yaz™, in the United States. Litigation between Bayer and Teva / Barr in several u.s. federal courts on infringement of certain of Bayer’s patents by the distribution of Gianvi™ was settled in 2010. Bayer and Barr amended the aforementioned licensing and supply agreement of 2008, which is also under investigation by the ftc, and Bayer has supplied Barr with the product for Gianvi™ since December 2010.

Beyaz™: In 2012 Bayer received a notice from Watson Laboratories Inc. that Watson has fi led an anda iv seeking approval of a generic version of Bayer’s Beyaz™ oral contraceptive in the United States. Bayer has fi led a patent infringement suit against Watson in u.s. federal court.

Yasmin™/ Yasminelle™/ YAZ™ : In July 2011 a board of appeal of the European Patent Offi ce revoked a formulation patent (“micronization”) for Yasmin™, Yasminelle™ and yaz™. Bayer fi led a petition for review of the decision by the Enlarged Board of Appeal of the European Patent Offi ce. In 2004, Hexal Pharmaforschung GmbH fi led an opposition against Bayer’s patent. An opposition division of the European Patent Offi ce rejected the opposition in 2006. The latest ruling follows an appeal by Hexal of the 2006 decision. In December 2011, the European Patent Offi ce revoked the other formulation patent (“dissolution“) for Yasmin™, Yasminelle™ and yaz™. Bayer will appeal. The appeal will have suspensive effect.


*Yasmin / yaz PL訴訟
【2011】
Yasmin™/ YAZ™ : As of February 1, 2012, there were about 11,300 lawsuits pending in the United States served upon Bayer on behalf of persons alleged to have suffered personal injuries, some of them fatal, from the use of Bayer’s oral contraceptive products Yasmin™ and / or yaz™ or from the use of Ocella™ and / or Gianvi™, generic versions of Yasmin™ and yaz™, respectively, marketed by Barr Laboratories, Inc. in the United States. (For details on the generic versions of Yasmin™ and yaz™, please refer to the section on “Patent disputes” below.) Pursuant to agreements in 2008 and 2010, Bayer manages product liability litigation for Ocella™ and Gianvi™, Bayer retains product liability for Ocella™ product supplied by Bayer with certain exceptions, and the parties have allocated potential product liability relating to Gianvi™ product supplied by Bayer. Plaintiffs seek compensatory and punitive damages, claiming, in particular, that Bayer knew, or should have known, of the alleged risks and should be held liable for having failed to disclose them or adequately warn users of Yasmin™ and / or yaz™. All cases pending in u.s. federal courts have been consolidated in a multidistrict litigation (MDL) proceeding for common pre-trial management. Bayer has also been served with three putative class actions in federal court. The MDL court dismissed a class action brought by third party payors and plaintiffs did not appeal. The court also struck class claims in a putative nationwide class action brought by consumers also involving personal injury claims. A third class action for economic loss claims by California consumers remains pending. In Canada, 13 class actions have been served upon Bayer as of February 1, 2012.
【2010Q1】April 12, 2010時点で, 約1,750件の訴訟が米国で係争中。 2つの カナダ消費者集団訴訟は8件に増加。
【2009】Feb 15, 2010時点で, 約1,100件の訴訟が米国で係争中。 バイエル社のYasmin / yaz及びジェネリック製品Ocella[Barr Laboratories, Inc]による健康被害(致死的ケースを含む)に関するもの。 原告はYasmin / yazの利用者に対するリスクの警告と情報開示が不十分であったとして、補償及び懲罰を求めている。 バイエル社は経済損失を主訴とする3つの消費者集団訴訟(class actions)を提訴されており、うち一つは個人の障害も提訴し、すべて連邦裁判所で広域訴訟として統合されている。 更に2つの カナダ消費者集団訴訟も提訴されている。 追加訴訟も見込まれる。 防衛コストの予算措置を実施済み。 なおPL保険でカバーする予定。
【2008】PL訴訟は報告されていない。
Bayer社はEUでYasmin添付文書改訂[2010.3.26]
〜EMEA CHMP’s Pharmacovigilance Working Party (PhVWP)の12万人のOC服用患者を対象とした2つの疫学研究発表に伴うYasminのVTEリスク

*
【2011】
■パイプライン 2007.3
ProjectIndicationStatus
Avelox(R)New indicationsPhase III
【メモ】
Nexavar(R)(sorafenib)Advanced renal cell carcinomaFDA approval
Hepatocellular carcinomaPhase III
Malignant melanomaPhase III
NSCLCPhase III
Other cancer typesPhase II
【メモ】co-developed by Bayer HealthCare and Onyx Pharmaceuticals, Inc., is a novel multikinase inhibitor that targets serine/threonine and receptor tyrosine kinases in both the tumor cell and the tumor vasculature. At the end of 2005, the FDA granted U.S. approval for Nexavar(R) for the treatment of patients with advanced renal cell carcinoma (RCC). It was approved by the EMEA in July 2006 for the same indication. During 2006, Nexavar(R) was approved in nearly 50 countries for the treatment of advanced RCC.

In addition to the launch of Nexavar(R) for advanced RCC, we actively pursued our Phase III clinical trial programs for the treatment of hepatocellular carcinoma (HCC), malignant melanoma and non-small cell lung cancer (NSCLC). In April 2006, the FDA and the EMEA both granted "orphan drug" designation to Nexavar(R) for the treatment of HCC. Furthermore, Nexavar(R) received "fast track" status by the FDA for the treatment of HCC and malignant melanoma. In February 2007, an independent data monitoring committee (DMC) reviewed the safety and efficacy data of the Phase III clinical trial on the treatment of HCC with the conclusion that the trial met its primary endpoint. The DMC recommended stopping the trial early and Bayer and Onyx followed that recommendation. The companies will continue discussions with health authorities worldwide regarding the next steps in filing for approval for the treatment of HCC, and intend to make those filings as rapidly as possible. In December 2006, results were announced from the Phase III malignant melanoma study evaluating the combination of Nexavar(R) or placebo tablets with the chemotherapeutic agents carboplatin and paclitaxel in patients with advanced malignant melanoma. This trial did not meet its primary endpoint of improving progression-free survival (PFS). Other tumor types are under investigation in earlier stages of clinical development.

Rivaroxaban (BAY 59-7939)VTE preventionPhase III
VTE treatmentPhase III
Stroke prevention in patients with atrial fibrillationPhase III
Acute Coronary Syndrome/Myocardial InfarctionPhase II
【メモ】is a novel oral direct Factor Xa inhibitor, being developed to meet currently unmet clinical needs in the anticoagulation market for prevention and treatment of thrombotic events. In October 2005, Bayer HealthCare and the Johnson & Johnson subsidiary Ortho-McNeil entered into an alliance under which Ortho-McNeil is contributing to the development of Rivaroxaban, and initiated Phase III clinical trials in December 2005 for the prevention of venous thromboembolism (VTE) after major orthopedic surgery. In June 2006 we announced Phase III clinical trials in the two chronic indications stroke prevention in atrial fibrillation and treatment of VTE in a once-daily dose regimen. Also in 2006, we began Phase II clinical trials in the indication acute coronary syndrome/myocardial infarction.
VEGF TrapTreatment of eye diseasesPhase II
【メモ】
from FORM 20-F ANNUAL 2007[pdf,292p,2007.3.15] p25
Bayer AG

Investor RelationsInvestor News Financial and innovation targets for 2011 achieved[2012.2.28] Bayer proposes dividend increase to EUR 1.50 per share for 2010[2011.2.24] 2009: operationally one of the strongest years - optimism for the future/Bayer successful in a difficult environment[2010.2.26] Annual Reports Annual Report 2011[pdf;2012.2.28] - [online] Annual Report 2010[pdf;2011.2.28] - [online] Annual Report 2009[pdf,274p;2010.2.26] - [online] Annual Report 2008[2009.3.03] - [online] Annual Report 2007[pdf,239p;2008.2.28] - [html] - Annual Report 2005[pdf,224p;2006.3.6] - [html] [Management Report : Healthcareに個別製品売上,p25] - Annual Report 2004[pdf,159p;2005.3.15] [Management Report : Healthcareに個別製品売上] - Annual Report 2003 [Management Report : Healthcareに個別製品売上] - Annual Report 2002[pdf,124p] - Annual Report 2001 FORM 20-F FORM 20-F ANNUAL 2007[pdf,292p,2007.3.15] FORM 20-F ANNUAL 2006[pdf,292p,2006.3.6] - [html] Press Release - Archives ●Press Release〜Healthcare ★Press Release〜PharmaPress Release〜DiagnosticsPress Release〜Biological ProductsPress Release〜Consumer CarePress Release〜Diabetes CarePress Release〜Animal Health Research & InnovationBayer HealthcareProductsBayer Healthcare Bayer Healthcare - Pharma - Diagnostics - Consumer Care - Diabetes Care - Animal Health


Bayer Healthcare AG

-http://www.bayerhealthcare.com/ ●ProductsHealthcare NewsPress〜報道関係者向け情報 ●Health〜糖尿病、呼吸器感染、片頭痛 Bayer Pharma - http://www.pharma.bayer.com/ ■Bayer Diagnostics - http://www.bayerdiag.com/ ■Bayer Biological Products - http://www.bayerbiologicals.com/
Bayer Healthcare Pharmaceuticals [US]

- http://www.pharma.bayer.com/ ; Berlex LaboratoriesはBayer HealthCareと統合、Bayer HealthCare Pharmaceuticals社として活動再開。 ●Women's health products Mirena ---Levonorgestrel - releasing Intrauterine system Climara ...estradiol transdermal system Yasmin ...drospirenone + ethinylestradiol tablets Levlen21 /Levlen28 ...levonorgestrel + ethinylestradiol tablets Tri-Levlen21 /Tri-Levlen28 ...levonorgestrel + ethinylestradiol tablets Levlite ...levonorgestrel + ethinylestradiol tablets Menostar ... estradiol patch ●News RoomProducts Erectile Dysfunction - News Room Oncology - News Room Infections Cardiovascular Disease SinusFacts www.cipro.com - http://www.ciprousa.com/ www.avelox.com www.trasylol.com www.levitra.comLicensingIn the Pipeline
Bayer HealthCare Pharmaceuticals[GE;旧Bayer Schering Pharma AG]

- http://www.bayerpharma.com/en/press/index.php ●Therapeutic AreasTherapeutic Areas A-ZImaging TechniquesProducts Research and DevelopmentResearch and Development NewsFacts & FiguresResearch areasDevelopment PipelineThe Lab TourInnovation & EthicsClinical Trials PressPress Archive ●Pipeline /2007.10.23
Therapy area:ProjectIndication Status: NME / LCM
Diagnostic ImagingAV1/ZKAlzheimer PET ImagingPhase INME
Diagnostic ImagingGadovistMagnetic resonance imaging (MRI) (USA, Japan)Phase IILCM
Diagnostic ImagingMagnevist MRAMagnetic resonance angiography (MRA)SubmittedLCM
Diagnostic ImagingPrimovistMagnetic resonance imaging (MRI) (USA, Japan)SubmittedLCM
Diagnostic ImagingUltravist 370Computer tomographyPhase IIILCM
Hematology / CardiologyAdenosine A1 AgonistAtrial fibrillation / Stable angina pectorisPhase IINME
Hematology / CardiologyAspirin i.V.Acute Coronary Syndrome (ACS)Phase ILCM
Hematology / CardiologyElastase InhibitorPulmonary hypertension in Chronic Obstructive Pulmonary Disease (COPD)Phase INME
Hematology / CardiologyKogenateLiposomal FormulationPhase IILCM
Hematology / CardiologyRivaroxabanAcute Coronary Syndrome (ACS)Phase IINME
Hematology / CardiologyRivaroxabanPrevention of venous thromobembolism (VTE)Phase IIINME
Hematology / CardiologyRivaroxabanStroke prevention in atrial fibrillation (SPAF)Phase IIINME
Hematology / CardiologyRivaroxabanTreatment of deep-vein thrombosisPhase IIINME
Hematology / CardiologyrThrombinBleeding controlSubmittedNME
Hematology / CardiologysGC ActivatorAcute Decompensated Heart Failure (ADHF)Phase IINME
Hematology / CardiologysGC StimulatorHypertension / Heart failurePhase INME
Hematology / CardiologysGC StimulatorPulmonary hypertensionPhase IINME
OncologyBonefosPrevention of bone metastases in patients with breast cancerPhase IIILCM
OncologyCampathCLL 2nd linePhase IIILCM
OncologyCampathCLL 1st lineSubmittedLCM
OncologyDAST InhibitorSolid tumorsPhase INME
OncologyL19-Interleukin 2Pancreatic cancerPhase INME
OncologyL19-Interleukin 2RCC 1st / 3rd linePhase IINME
OncologyL19-SIPSolid tumorsPhase INME
OncologyL19-TNFSolid tumorsPhase INME
OncologyNexavarBreast cancerPhase IILCM
OncologyNexavarAdditional indicationsPhase IILCM
OncologyNexavarMelanomaPhase IIILCM
OncologyNexavarNon-small cell lung cancer (NSCLC)Phase IIILCM
OncologyNexavarHepatocellular carcinoma (HCC)SubmittedNME
OncologySagopilone (ZK-EPO)Solide TumorenPhase IINME
OncologyZevalinIndolent / aggressive NHL 1st linePhase IIILCM
OncologyZK-PRABreast cancerPhase IINME
Primary CareAveloxNew indications (US)Phase IIILCM
Primary CareAveloxPelvic inflammatory disease (PID) / new indicationsSubmittedLCM
Primary CareCipro InhaleLung infectionPhase ILCM
Primary CareeF-MentHypogonadism TreatmentPhase INME
Primary CareLevitraFast dissolving tabletPhase ILCM
Primary CareLevitraNew indicationsPhase IILCM
Specialized TherapeuticsAlemtuzumabMultiple sclerosisPhase IILCM
Specialized TherapeuticsBetaferon high dose (BEYOND-Study)Multiple sclerosisPhase IIILCM
Specialized TherapeuticsFosrenolChronic Kidney Disease (CKD) (Japan)SubmittedNME
Specialized TherapeuticsLipoxinInflammatory Bowel DiseasePhase INME
Specialized TherapeuticsSpheramineParkinson's DiseasePhase IINME
Specialized TherapeuticsVEGF-Trap EyeDiabetic Macular Edema (DME)Phase INME
Specialized TherapeuticsVEGF-Trap EyeWet Age-related Macular Degeneration (wet AMD)Phase IINME
Women's HealthcareAngeliq low-lowMenopausal ManagementPhase IIILCM
Women's HealthcareDUB-OC (E2/DNG)Fertility control / uterine bleedingPhase IIILCM
Women's HealthcareE2 / LNGMenopausal ManagementSubmittedLCM
Women's HealthcareEr? AgonistMenopausal ManagementPhase INME
Women's HealthcareFC patch FidenciaFertility controlPhase IILCM
Women's HealthcareLCSFertility controlPhase IIILCM
Women's HealthcareMenostar transdermalVasomotor symptomsSubmittedLCM
Women's HealthcareMirenaMenorrhagiaPhase IIILCM
Women's HealthcareValette lowFertility controlPhase IILCM
Women's HealthcareVisanneEndometriosisPhase IIILCM
Women's HealthcareYasmin plus / YAZ plusFertility controlPhase IIILCM
Women's HealthcareYAZDysmenhorrea (Japan)Phase IIILCM
Women's HealthcareYAZ Extended RegimenFertility controlPhase IIILCM
*NME = New molecular entity LCM = Life Cycle Management
Bayer Biological Products

- http://www.bayerbiologicals.com/ ; このサイトは閉鎖され、以下に移行。[2007.5.7] ●www.livingwithhemophilia.com ★米国Kogenate(R) FS製品は→ www.KogenateFS.com
Bayer Corporation [US]

- http://www.bayerus.com/ ●NewsProducts -Healthcare Pharmaceutical | Biologicals〜各製品データ
バイエル薬品

日本のバイエル ヘルスケア事業をバイエル薬品に集約[2007.4.11] - バイエル薬品株式会社は、バイエル ヘルスケア社(本社:ドイツ)が日本で営む4事業(医療用医薬品、一般用医薬品、 ダイアベティスケア、動物用薬品)を同社に集約します。これは、2007年および2008年に予定されている一連の組織改変に伴 うものです。 バイエル薬品は、今年4月1日にダイアベティスケア事業部全製品の販売機能をバイエルメディカルから承継し、7月1日をもっ て同事業部の統合が完了します。また、同日7月1日には、バイエルメディカルの診断薬事業部が、シーメンス社傘下となる予 定です。さらに、2008年上半期を目処に、動物用薬品事業部をバイエル薬品に統合することを計画しています。尚、ダイアベ ティスケア事業部および動物用薬品事業部の本拠は、統合後も、現所在地である東京都千代田区丸の内に引き続き置かれます。 ドイツにおけるバイエル・シエーリング・ファーマ社設立とバイエル薬品、日本シエーリング両社社長交代のお知らせ[2006.12.22] バイエル社のシエーリング社統合における支配契約がドイツ当局により承認され、両社を実質的に統合できる段階となりまし た。現在、ドイツでは、バイエル ヘルスケア社医療用医薬品事業部とシエーリング社を統合し、バイエル・シエーリング・フ ァーマ社(本社:ベルリン)の設立に向けた最終調整に入っています。 日本シエーリング株式会社(本社:大阪)は、すでに日本のバイエルグループの傘下にあり、現在、バイエル薬品株式会社 (本社:大阪)との統合が順調に進められています。両社の統合は2007年7月を予定しており、統合後の社名は、「バイエル薬 品株式会社」となります。 ●ニュース 医療関係者向け情報 〜製品情報;領域別View[循環器・糖尿病・アレルギー・感染症・ED関連情報] ●一般向け健康情報血友病患者さんのための情報サイトBayer Hemophilia VillageASPIRIN-Japan.com -http://www.aspirin-japan.com/ ★アスピリンレディドットコム -http://www.aspirin-lady.com/ ★MSゲートウェイ - http://www.ms-gateway.jp/ ★すこやか血管情報局 Chojurin.jp - http://www.chojurin.jp/ ★EDネットクリニック - http://www.ed-netclinic.com/ ★femalelife.jp - http://www.femalelife.jp/ ★コレステロールゼミナール - http://corezemi.jp/ ★「大切にしたい、いのちのビジョン。」 inochi-vision.jp - http://www.inochi-vision.jp/scripts/index.php [バイエルホールディング株式会社]ニュース 日本のバイエル2009年度(1月〜12月)の業績を発表[2010.4.6] 2009年:経営面で最も好調な年の一つ ― 将来については明るい見通し/バイエル: 厳しい事業環境の中で成功を収める[2010.3.3] 日本のバイエル2008年度(1月〜12月)の業績を発表[2009.3.26] 2008年の利益目標を達成:バイエル: 厳しい事業環境の中で企業戦略の有効性を証明[2009.3.9] 日本のバイエル2007年度(1月〜12月)の業績を発表[2008.4.17] 日本のバイエル2006年度(1月〜12月)の業績を発表[2007.4.11] 日本のバイエル2005年度(1月〜12月)の業績を発表[2006.4.11] 日本のバイエル2004年度(1月-12月)業績発表[2005.4.13] ●バイエル株式会社決算
(百万円)2009200820072006200520042003200220012000
売上高220,525228,792223,715199,105
旧197,687
165,930
旧208,461(+7)
193,951
旧221,366
216,661
 ヘルスケア153,388147,997141,662116,187
旧113,820
83,044
旧101,025(+5)
95,78594,587
 農薬関連36,20936,56437,24137,899
旧36,552
37,752(-10)41,95542,509
 素材化学30,92844,23144,66444,915
旧47,117
44,757
旧69,307(+23)
56,184
旧55,931
50,701
 ランクセスxxxxx27,669-
従業員数3,4793,2513,4612,220
旧2,628
2,514
旧2,607
2,774
●バイエル薬品
薬価(億円)200920082007200620052004200320022001備考
売上高919(+4.0)885870
アダラート403(+1.8)400400[ニフェジピン]
グルコバイ140(+5.3)138125[アカルポース]糖尿病
コージネイトFS65(+10.2)[Factor 8]
シプロ60(+1.7)[シプロフロキサシン]抗菌剤
バイアスピリン63(+18.9)5342(+50)[アスピリン]血栓症
バイナス-30(+57.9)19151515[ラマトロバン]アレルギー性鼻炎;発売=2000.5.23;2006.7.3から継承した日本新薬から販売
レビトラ18[Vardenafil]勃起不全薬
[]
MR数730830[]
 うちコージネイト30[]
[]

●2007概況 ヘルスケア事業グループ

ヘルスケア事業グループの2007年度の売上高は、前年比21.9%増の1,417億円の売上を達成した。これは主に日本シエーリングとの統合効果が寄与している。
2007年の新製品については、プライマリーケア事業においては、シェリング・プラウ社との共同販売の高脂血症治療剤「ゼチーア」に加え、7月に勃起不全治療剤「レビトラ錠」の高用量製剤(20mg)を発売。オンコロジー事業では、すでに発売中の慢性リンパ性白血病治療薬「フルダラ静注用」に続き、外来診療が可能となる「フルダラ錠」が低悪性度B細胞性非ホジキンリンパ腫およびマントル細胞リンパ腫を適応として7月に発売された。ウイメンズ ヘルスケア事業では、4月に子宮内避妊システム「ミレーナ52mg」が発売となったほか、資生堂との共同事業契約に基づき、更年期障害治療薬「ル・エストロジェル0.06%」の独占販売を8月に開始した。画像診断薬事業では、MRI用造影剤「マグネビスト」のMRアンギオグラフィー(MRA: 磁気共鳴血管造影)における用法・用量追加承認を取得とともに、シリンジ剤を5月に発売。また、動物用薬品事業については、猫用寄生虫駆除剤の新製品「プロフェンダースポット」を4月に上市した。開発面では、「ネクサバール錠200mg」を腎細胞癌を適応症として、2008年1月に販売承認申請を取得したほか、2007年9月末には肝細胞癌に対する適応についても追加申請を行っている。
販売面については、高血圧・狭心症治療剤「アダラートCR錠」は引き続き伸長したものの、アダラートブランド全体としては前期を下回る売上高となった。抗血小板剤「バイアスピリン錠」は、順調に市場に浸透し、前期を上回る売上高を達成。7月に上市した「ゼチーア」は、顕著な売上高を達成した。遺伝子組換え型血液凝固第[因子製剤「コージネイトFSバイオセット」は、前期を若干下回る売上高であった。専門治療薬事業では、多発性硬化症の再発予防・進行抑制治療薬「ベタフェロン」が売上増を記録した。また、ダイアベティスケア事業については、血糖自己測定器「アセンシア」ブランド製品などが売上高に貢献した。

●2005概況 ヘルスケア事業グループ

ヘルスケア事業グループの2005年度の売上高は医療用医薬品事業が引き続き好調であったことから、前年比5%増の1,010億円の売上を達成した。

動物用薬品市場では、バイエル製品は市場成長率1.5%を大幅に上回る10%の売上成長を達成した。家畜用飼料原料が前年比14%の伸びを示し、コンパニオンアニマル製品も大きく成長した。これは主に、ニューキノロン系抗菌剤「バイトリル」が好調だったほか、犬用マダニ・ノミ駆除剤「フォートレオン」の上市、寄生虫駆除剤「アドバンテージハート」の大日本住友製薬株式会社との共同販売による流通量の増加などによるものである。

ダイアベティスケアの市場成長率は血糖自己測定装置のリース販売に関する規制が影響し約7%にとどまったが、新製品「アセンシア ブリオ」の上市などにより、ダイアベティスケア事業の売上は前年比19%の増加となった。

診断薬事業の売上は、免疫測定装置の売上が前年比20%、尿分析器が10%伸びたことに伴い、前年比9%の増加を達成した。一方、血液ガス分析装置の売上は微減した。免疫測定装置の成長は、「アドヴィアケンタウルス」の設置台数が大幅に増加したためであり、引き続き成長が見込まれている。

医療用医薬品業界では、医療費抑制政策の影響が引き続き課題となっている。こうした厳しい状況が続く中で、バイエルの「アダラート」「バイアスピリン」「グルコバイ」「シプロキサン」の売上は前年を上回る結果となった。また、2005年10月には「アベロックス」が承認され、12月に塩野義製薬株式会社から発売された。その結果、医療用医薬品事業の売上は前年比4%増加となった。

販売戦略支援の一環である設備投資に関しては、滋賀工場における生産機械の追加、新製品発売のための生産設備の増設および個人情報保護法施行に伴うITインフラ補強など、総額7億5千万円の投資を行った。また、研究開発では、「ネクサバール」「フォスレノール」「BAY59-7939(第Xa因子阻害剤)」の早期開発に注力した。血友病関連市場は、年率3%と緩やかな成長の中、血漿(けっしょう)分画製剤の売上が前年比11%減少したのに対し、「コージネイトFS」の売上が11%増加し、バイエル製品の売上は前年並みに推移した。

また、2006年1月1日、バイエルのヘルスケア事業グループは、バイオロジカルプロダクト事業を、医療用医薬品事業に統合し、動物用薬品、コンシューマーケア、ダイアベティスケア、診断薬とともに5事業からなる新体制となった。新体制における医療用医薬品事業は、プライマリーケア、血栓止血領域製剤、オンコロジーの3つの事業ユニットを置き、旧バイオロジカルプロダクト事業が扱っていた、血友病治療薬「コージネイト」は、血栓止血領域製剤ユニットで扱う。日本の医療用医薬品事業においても同様の組織とし、抗がん剤「ネクサバール」の販売に備え、オンコロジーユニットを近く設立する。現在の一般MR760名、コージネイト専門MR30名に加え、抗がん剤専門のMRを40-50人採用する予定である。











Bayer Schering Pharma AG [旧Schering AG]

2006.12 Bayerによる買収の結果、Schering AGはBayer Schering Pharma AGに名称変更。
www.schering.de は旧Schering AGの情報を公開する。




●会社決算
(Euro milllion)2006200520042003200220012000

売上高5,6675,3084,907(+2)4,828(-4)5,023(+4)4,842(+8)4,493(+22)
粗利益4,3734,0523,7013,5953,811
営業利益1,1499287686861,197781723
経常利益2,381624507446869428345
純利益783619504443432201227

研究開発費1,026982[19%]918[19%]924947864811
従業員数[年平均]15,72624,12426,13126,56126,24525,05623,720
●地域別セグメント
(Euro milllion)2006200520042003200220012000

売上高5,6675,3084,907(+2)4,828(-4)5,023(+4)4,842(+8)4,493(+22)

欧州2,525(+3)2,4562,472(+4)2,372(+1)2,357(+8)2,183
米国1,209(+14)1,063
旧1,391
1,242(+3)1,203(-6)1,282(+15)1,113
日本379(-13)434468(-10)517(-11)579(-13)663
中南米・カナダ577464411(+7)383(-11)430(-16)511
アジア・太平洋293249234(+9)214(-4)224(+5)213
その他684642
旧314
80(-42)139(-8)151(-4)159
 thereof: Medrad, Inc371328
 thereof: Intendis237223

●日本売上高
★Gynecology & Andrology24(+0)24(-8)26(-5)28
★Therapeutics81(-9)89(-2)91(-8)117
★Diagnostics
Imaging
260(-15)305(+0)306(-11)342
★Dermatology28(-7)30
★Oncology14(-11)16(-6)16
日本 計379(-13)434(-1)439(-10)517(-11)

●米国売上高
Berlex1,063(+11)954(+2)951
Medrad328(+21)271(+7)252
米国 計1,391(+14)1,225(+3)1,203(-6)

●米国売上高
Betaferon299(+6)284(-1)
Yasmin282(+34)211(+39)
Magnevist151(+13)133(+1)
Mirena91(+44)1333(-1)
Leukin59(-5)61(-4)
 米国売上高計882752

●欧州売上高
Betaferon445(+13)393(+1)
Yasmin224(+31)171(+47)
Ultravist149(+2)146(+0)
Mirena128(+7)119(+12)
Magnevist105(+5)100(+5)
 欧州売上高計1,051929

●日本売上高
Iopamiron207(+1)206(-9)
Magnevist48(-2)49(-10)
Betaferon31(+11)28(+11)
Aspenon21(-1)21(-3)
Isovist11(+1)11(-8)
 日本売上高計318315
●売上
(Euro milllion)2006200520042003200220012000備考

★Therapeutics
Betaferon/Betaseron991(+14)867(+11)782(+2)770(-2)783(+20)681(+15)593(+31)interferon 1b ;MS多発性硬化症
Fludara120(+14)105(+2)103(-26)140(-6)149(+21)131(+18)111(+30)[fludarabine]慢性リンパ性白血病(CLL)代謝拮抗剤
Betapace-??95(-43)168(+7)[sotalol HCl]
Noctamid-???42(+8)[lormetazepam]睡眠薬
★Diagnostics 造影剤
Iopamiron221(-9)242(+1)241(-8)263(-12)299(-8)356(-4)372(+21)
Magnevist323(-2)328(+8)303(+1)300(-7)322(+6)320(+12)286(+23)[gadopentetate dimeglumine]
Ultravist222(-11)248(+5)236(0)236(-2)241(+4)239(+1)238(+9)[iopromide]
★Gynecology
Diane175(+2)172(-8)186(-8)202(-10)226(+12)214(+7)200(+17)[cyprotereone acetate]Acne/経口避妊薬
★Fertility control
Yasmin794(+37)586(+36)429(+48)290(+91)152(>100)--[drospirenone/ethinylestradiol]
Microgynon144(+8)133(+4)128(+3)122(-6)130(+7)139(+7)130(+21)/Levlen
Meliane123(-1)124(+3)120(+2)119(-6)127(+15)123(+21)102(+26)超低用量ピル
Femovan-??106(-3)109(+5)[gestodene/EE]
Mirena301(+24)243(+22)199(+21)164(+20)137(+41)100(+42)70(+17)子宮内ホルモン徐放システム
[levonorgestrel-releasing intrauterine system]
Triquilar-??92(+1)92(-4)/Tri-Levlen
Miranova-??49(+23)?[Levonorgestrel/EE]
★Hormone therapy
Climara-??109(+3)106(+14)[Estradiol transdermal system]
★Therapeutics/Gynecology
Androcur-??101(-3)103(+5)[cyproterone acetate]

Total3,414(+12)3,048(+12)2,727(+5)2,606(+2)2,5662,8552,722
(全体シェア)60%57%56%54%51%59%
●Net sales by Business Area
(Euro milllion)20062005200420032002200120001999
★Gynecology & Andrology2,311(+17)1,979(+12)[37%]1766(+9)[36%]1618(+1)[33%]1613(+7)[32%]1510(+12)[31%]1353(+15)[30%]1,173[32%]
Female contraception1,9801,681
Menopause management181169
Fertility control1491(+12)[30%]1333(+6)[28%]1256[25%]
Hormone therapy274(-4)[6%]286(-8)[6%]350[7%]
★Therapeutics1,256(+7)1,179(+5)[22%]1,542(-1)[31%]1,560(-5)[32%]1637(+10)[33%]1491(+6)[31%]1402(+24)[31%]1,128[31%]
中枢神経系(CNS)1,055(+13)936861(+1)[18%]852(-2)[18%]873[17%]
Cardiovascular140(-3)144141(-7)[3%]152(-21)[3%]192[4%]
★Oncology457(+7)429420(-7)[9%]449(+8)[9%]414[8%]
★Diagnostic Imaging1,332(-5)1,404(+7)[27%]1,308(-0)[27%]1,312(-7)[27%]1406(-3)[28%]1452(+7)[30%]1360(+31)[30%]1,040[28%]
X-ray contrast media537(-8)583574(-4)[12%]598(-9)[12%]654[13%]
MRI contrast agents373(+3)362332(+3)[7%]322(-4)[7%]334[7%]
Radiopharmaceuticals125(-5)[2%]133(-9)[3%]146[3%]
CM application tech371(+13)329271(+7)[6%]254(-4)[5%]264[5%]
★Oncology429(+2)[8%]420(-7)[9%]449[10%]
★Other sources311(-2)317(+10)[6%]287(-14)[5%]
旧82(-40)[2%]
334[7%]
旧134(-10)[3%]
150(-7)[3%]162(+3)[3%]157(+17)[4%]134[4%]
Dermatology237(+6)223207(+4)[4%]200(-7)[4%]217(-5)[4%]227(+3)[5%]221(+11)[5%]199[5%]

Total5,667(+7)5,307(+8)[100%]4,907(+2)[100%]4,828(-4)[100%]5,023(+4)[100%]4,842(+8)[100%]4,493(+22)[100%]3,674[100%]
from ●Preliminary Report:Schering AG Group reports organic growth of 6% in 2003[2004.2.5,pdf,5p] Annual Report 2002[pdf,158p しおり付き] - Important tables[excel] - To-selling products / Sales by region /Sales by business area



●Important market launches and projects
★上市済み Market launch
ProductIndication2001-2004Peak sales
Yasmin(R)oral contraceptive米欧(2001)300
Mirena(R)intrauterine system for contraception米(2001)150
Campath(R)treatment for leukemia米欧(2001)150
Resovist(R)liver-specific MRI contrast agent欧(2001)日(2002)50
Climodien(R)oral hormone replacement therapy欧(2001)50
★上市予定 Planned market launch
ProjectIndication2001-2004Peak sales
Betaseron/Betaseron充填済みシリンジ米(2004)**
Climara Pro
(estradiol+levonorgestrel)
hormone replacement patch米(2004)100
Nebido男性用testosterone療法Depot欧(2004)100
Zevalin放射性免疫療法 for
non-Hodgkin's lymphoma
欧(2004)>50
Angeliq(R)
(estradiol+drospirenone)
oral HRT米(2005)欧(2004)250
Menostar(R)骨粗鬆症予防パッチ米(2004)欧(2007)100
Primovist(R)liver-specific MRI contrast agent欧(2004)日(2005)50
YAZ(TM)低用量経口避妊薬米(2005)200
Betaseron(BENEFIT study)早期MS(拡大適応)米欧(2006)**
Contraceptive Patchestrogen/progesterone patch欧(2006)100
MS-325MRI contrast agent for angiography欧(2006)100
PTK/ZKVEGF receptor阻害剤、metastatic colorectal cancerの適応の経口angiogenic阻害剤米欧(2006)***
Asoprisnil選択的progesterone受容体modulatorでmyomas(uterine fibroids)の適応欧(2007)>250
Leukine(R)(sargramostim)Hematopoetic growth factor (GM-CSF);クローン病米(2007)>250
* Peak sales は市販3年後予測 Euro million from Top 10 Products & Development Projects[2005.4.22]
●婦人科&Andrology
AsoprisnilPhase IIISelective progesterone receptor modulator for the treatment of myomas (benign tumors of the uterine muscle)
Climodien(R) 1/2EU: 申請Low dose variation of Climodien(R) provides relief of menopausal symptoms
E2/DNG pillPhase IIIOC containing natural estradiol and dienogest, which is also being evaluated for the treatment of dysfunctional bleeding
Endometrion(R)Phase IIIOral dienogest-containing product for the treatment of endometriosis (proliferation of endometrial tissue outside the uterus)
FC patchEU: 申請Low dose patch containing ethinylestradiol and progestin for fertility control, which is applied once a week
"Male pill"Phase IICombination of progestin implant with a testosterone injection for the suppression of sperm concentration
Menopausal levonorgestrel system (MLS)Phase IIIIntrauterine system (IUS) using the technology of MirenaR. Developed for menopausal women to protect the endometrium from growing while being treated with estrogen
YAZ(TM)U.S.: 申請Low-dosed oral contraceptive containing a reduced ethinylestradiol dose and drospirenone with a unique regimen; has a positive effect on premenstrual dysphoric disorder (PMDD), a severe form of premenstrual syndrome (PMS)
●専門治療薬
Fasudil OralPhase IIActive ingredient for the oral treatment of angina pectoris
Leukine(R)Phase IIIHematopoetic growth factor (GM-CSF). Used in hematological oncology to stimulate cells of the innate immune system. In addition, LeukineR is currently in clinical development for the treatment of Crohn's disease.
PTK/ZKPhase IIIOral VEGF receptor tyrosine kinase inhibitor; anti-angiogenic small molecule designed to inhibit the formation of blood vessels that support tumor growth; is being developed for metastatic colorectal cancer
Spheramine(R)Phase IIConsists of human cells that are attached to microcarriers and produce dopamine; used for cell therapy in Parkinson's disease
●診断薬・放射性医薬品
MS-325U.S.: 申請
EU: 申請
MRI contrast agent based on gadolinium with a high signal intensity and a prolonged retention time in the bloodstream; improves imaging of the entire vascular system
Scintimun(R)GranulocyteEU: 申請Visualization of localized inflammations and infections in the body plus visualization of bone metastases
SHU 555 CPhase IIIMRI contrast agent for angiography
from Annual Report 2004[pdf,112p;2005.3.4] - Management report / Research & Development / 50p
Bayer Schering Pharma AG [旧Schering AG]

- http://www.schering.de/scripts/en/index.php ; [2003.10.20]最近同社WEBページの全面更新が行われた。 従来の全リンクが無効に なった[Press releaseも全件]。 ■製品 製品ページは特に無い。 関連サイト●MS Gateway -The Multiple Sclerosis Gateway[多発性硬化症] Press News ■Investor Relations ●Facts & Figures - Top-selling products [pdf] | [excel] (売上トップ10)、事業別・地区別売上高など Research & Development -開発品目一覧[年度・地域・年商見込][画像] ●Current Financial ReportAnnual Reports[最新] Annual Report 2006[pdf,116p] Annual Report 2005[pdf,198p,2006.3.10] 2005 Annual Report on Form 20-F[pdf,204p,2006.3.10] Annual Report 2004Annual Report on Form 20-F 2004 Annual Report on Form 20-F[pdf,204p;2005.4.4] Annual Report 2004[pdf,112p;2005.3.4] - /Business Activities/Products and Market 70-76pに主力製品の市況 2004 Annual Report on Form 20-F[pdf,204p;2005.4.4] 2003 Annual Report on Form 20-F[pdf,207p] IR Download Center Press Release[累積2001〜最新] Financial Reports[累積Annual Reports等] ★Annual Report 2002[pdf,158p しおり付き] - Important tables[excel] - To-selling products / Sales by region /Sales by business area  個別分割ファイル Business Areas & Production - 疾病分野事業・会社事業説明 ■Research & Development  〜開発品目



ドイツにおけるバイエル・シエーリング・ファーマ社設立とバイエル薬品、日本シエーリング両社社長交代のお知らせ【東京・大阪発】 [2006.12.22]
バイエル社のシエーリング社統合における支配契約 (Domination Agreement) がドイツ当局により承認され、両社を実質的に統合できる段階となりました。現在、ドイツでは、バイエル ヘルスケア社医療用医薬品事業部とシエーリング社を統合し、バイエル・シエーリング・ファーマ社(本社:ベルリン)の設立に向けた最終調整に入っています。
日本シエーリング株式会社(本社:大阪)は、すでに日本のバイエルグループの傘下にあり、現在、バイエル薬品株式会社(本社:大阪)との統合が順調に進められています。両社の統合は2007年7月を予定しており、統合後の社名は、「バイエル薬品株式会社」となります。また、本社を大阪に置くことが決定しています。代表取締役社長には、現バイエル ヘルスケア社アジア太平洋地域責任者、ジャン-リュック・ロビンスキーが就任します。
日本での両社の統合を円滑に進めるために、来年1月1日付けで、バイエル薬品、日本シエーリング両社の代表取締役社長に、ロビンスキーが就任します。現バイエル薬品社長、栄木憲和は、バイエル薬品の代表取締役会長に就任します。
来年7月に予定されている統合作業が完了するまでは、バイエル薬品と日本シエーリングは、引き続き独立した別会社として業務を行ないます。

シエーリングAG 2001年決算暫定報告[2002.2.5]
2000年度シエーリング グループ決算暫定速報[2001.2.7]

★製品総合
2000年には、ヤスミン、ミレーナ、レブラン、フルダラ経口剤、及びクリモデンの5製剤が承認された。
[2000]新しく取得したCIS bio インターナショナルと三井製薬(この2社は4月から連結決算に計上されている)及びダイアタイド社(1999年11月から計上)の売り上げを除外しても、グループの売り上げは、17%増加した。
[2000]米国での加速度的な成長は、28%に上る売上増を記録した。(為替変動による調整をすれば12%)。競争の激しい市場でベタフェロンが31%増という目覚しい業績をあげたことは、特筆に値することである。マグネビストも41%増という平均以上の成長を示した。

★フィメルヘルス:ヤスミンの市場導入に成功
受胎調節及びホルモン療法の事業分野の2001年度売り上げは12%増の1,510百万ユーロ(1646億円)に上った。のミレーナは現在、150万人の女性に使用されており、米国では、2000年12月に承認、2001年1月に発売に至った。
ヤスミンは、ドイツで2000年11月に発売され、2001年には、その他の国々でも市場導入。

日本では、トリキュラーが30%の市場シェアを有し、受胎調節分野のリーダー的存在。
ホルモン療法では、クリモディエンは、2001年第4四半期、ドイツでの新発売に成功。これは、更年期後半期の女性に起こる更年期障害の周期的症状に対して信頼のおける治療法を提供するとともに、皮膚や頭髪、また睡眠にも良い影響を与えるものである。
2002年1月には、フランスで、我々の新しいホルモン補充であるアバデン(Avaden)療法が保健当局により認可された。この製剤は、更年期症状を緩和すると共に骨粗しょう症の予防にもなる。

★治療薬:ベタフェロンで拡大
2001年もベタフェロンは成長を続け、15%増の681百万ユーロ。そのうち、285百万ユーロが米国(16%増)。
最新のベタフェロンの長期臨床試験で、多発性硬化症の治療にインターフェロンの多用量投与が、優れた結果を示したことが確認され、市場での地位をさらに強化するものと考えられる。さらに2002年1月には、ベタフェロンの製剤処方の変更が米国で承認され、これにより常温で2年間保存することが可能になった。
2001年に発売された初のヒトモノクローナル抗体である慢性リンパ性白血病(CLL)治療薬キャンパスCampath(ヨーロッパでの商品名はマブキャンパスMabCampath)は大成功で、初年度ですでに30百万ユーロ(33億円)を売り上げた。キャンパス/マブキャンパスは、他の薬剤による治療が有効でないCLLの患者に残された唯一の選択肢である。キャンパスの成功は、血液学の分野における我々の主導的地位を強調するものであり、この分野はヨーロッパでゼバリンが承認されるとさらに拡大される見込みである。
CLLの治療におけるフルダラの重要性がキャンパス/マブキャンパスの登場で更に強調された。フルダラの売り上げは素晴らしいもので、131百万ユーロ(143億円)に上った。
10月には、アベンティスからレフルダン(Refludan)の世界規模での権利を取得した。レフルダンは、ヘパリン起因性血小板減少症(HIT)により起こる血栓症の有力な治療薬である。レフルダンは、稀にしか見られないが命にかかわることもある同疾患の治療薬として、今や主導的製品である。レフルダンの権利の取得は我々の循環器領域におけるポートフォリオを強化し、特に米国での専門治療薬事業の支えになるものと見られる。
ボネフォス(Bonefos; =clodronate)の売り上げは際立って好調で、33%増の39百万ユーロ(43億円)に上った。ボネフォスは骨転移および腫瘍誘発性高カルシウム血症の治療に使用されている。将来は、我々の腫瘍領域の事業に良い影響があると期待されている。

★診断薬及び放射性医薬品:マグネビストは世界のリーダー
診断薬および放射性医薬品分野の2001年度売り上げは、7%増の1,452百万ユーロ(1、583億円; 2000年度1,360百万ユーロ+31%)に上った。X線造影剤は722百万ユーロ(787億円; 2000年度738 +14%)、MRI製剤は327百万ユーロ(356億円)、造影剤注入機器の売り上げは242百万ユーロ(264億円; 2000年度205 +35%)、放射性医薬品は151百万ユーロ(165億円; 2000年度117百万)に上った。 2000年度からダイアタイド社とCISバイオインターナショナルの決算が計上されている。 2001年第4四半期には、ヨーロッパの数カ国でMRI造影剤リゾビストの新発売に成功した。リゾビストは、肝臓腫瘍の精密な診断に用いられる。

★皮膚系:アドバンタンが大きく成長
皮膚系領域での売り上げは、3%増の227百万ユーロ(247億円)に上った。湿疹治療薬のアドバンタンの売り上げが26%増で、この市場における地位の向上に大きく貢献した。AK治療の光線力学的療法に用いられるレブランは2000年秋に米国で発売された。
2001年にシエーリングは、アボット社から、アトピー性皮膚炎およびその他の皮膚炎も対象にしたABT-281の世界的な開発・販売の権利を取得した。ABT-281は、局部免疫モデュレーター(調整物質)“TIM" と呼ばれる新たな化合物に属する。前臨床試験の結果によると、この非ステロイド系活性成分は、皮膚炎の治療に相当な効力が期待できそうである。



低用量Climara、更年期障害の治療を適応に北米で承認[2001.4.10]
--- シエーリングAGは、アメリカの食品医薬品庁(FDA)が、経皮貼付剤クリマラの新しい適応拡大を承認したことを発表した。1週1回貼付のエストローゲン補充療法としてClimara 0.025mg/一日(Climara(r)25)を、更年期障害に伴う諸症状の治療開始時の用量として承認した。
Climara(r)25 は現在、北米では最低量のエストローゲンで効果のある経皮剤として、更年期の諸症状の治療、及び骨粗鬆症の予防に認められている唯一のエストラジオール経皮剤である。ヨーロッパでも、2001年3月に承認申請がなされている。
Climaraは、最初に北米で1995年に更年期症状の治療を適応として50と100の2用量で承認され、1996年には骨粗鬆症の長期予防の適応で承認された。ヨーロッパや中南米でもこの適応での承認が間近い。

シエ−リング、オランダでクリモディエンの承認を取得[2001.1.8]
--- ドイツ(ベルリン)2001年1月8日 : シエ−リングAG(ニュ−ヨ−ク証券取引所:SHR)は、オランダ保健当局が2000年12月にクリモディエンを承認したことを本日発表した。クリモディエンは画期的な持続投与型ホルモン補充療法配合剤で、血流の阻止を目的としている。クリモディエンは抗アンドロゲン作用を持つプロゲスティンであるジエノゲストと吉草酸エストラジオ−ルを含有し、更年期障害の治療に使用される。
持続投与型配合剤であるクリモディエンを服用すると、いわゆるホルモン周期的投与法で生じる定期的消退出血を防ぐことができる。これは女性にとって大きな利点を意味する。クリモディエンはエストロゲン欠乏による閉経後の障害を治療するものである。
「この決定によって、クリモディエンのEUでの認可条件は整った。シエ−リングは他のEU加盟国における相互承認を提案し、これによってクリモディエンのEU保健当局承認を本年中に取得できると予定している」とシエ−リングAG執行取締役会長ジュゼッペ・ビタ博士は語っている

★2002年8月8日日本シエーリング、8月19日に会社創立50周年を迎える
 - 2001年の売り上げ(子会社を含む)約700億円。旧三井製薬との統合(2001年)
(MRI診断薬領域)MRI造影剤リゾビストも発売を予定
(治療薬領域)
腫瘍領域では、ミフロール、タスオミンなどの既存薬に加え、革新的な作用機序に基づいたがんの治療薬を開発中です。また、血液がん領域では、2000年に慢性リンパ性白血病治療薬フルダラを新発売。腫瘍特異性放射性医薬品である「放射標識モノクローナル抗体」の開発も進めています。
(フィメルヘルス領域)日本初の避妊用デリバリーシステム「子宮内ホルモン徐放システム」を開発中

★2002年6月10日 ベルリン発シエーリングAGが国際閉経学会で新薬について発表
クリモディエンは、ほてりや寝汗または意欲低下などの典型的な更年期症状を緩和するだけでなく、血管機能や就寝パターンの改善と、肌や毛髪に良い効果をもたらす製剤として開発に成功した。
クリモディエンは、吉草酸エストラジオールとジエノゲスト*を含有している。そして28日間休薬期間無しで継続的に服用される。それは、最後の月経が終わった閉経後の女性を出血から開放する製剤である。2001年10月以降、ドイツではこの製剤の入手が可能になっている。今年並びに来年にかけて、ヨーロッパの数カ国で導入される予定である。
*ジエノゲスト:抗アンドロゲン作用を持つプロゲスティン

★2001年6月8日 ベルリン発シエーリングAG ClimodienがEUで相互承認を完結
製剤に関しては、昨年12月にオランダ保健局がヨーロッパ諸国では始めて承認、ドイツでは、今年の秋に新発売される。その後、ヨーロッパの数カ国が続いて発売に踏み切る予定である。当製剤は、新しい組み合わせによる更年期障害を対象としたホルモン補充療法で、他の製剤と違って、多くの女性が経験する月経時のような出血がないのが特長である。

★2001年4月10日 ベルリン発低用量Climara、更年期障害の治療を適応に北米で承認
シエーリングAGは、アメリカの食品医薬品庁(FDA)が、経皮貼付剤クリマラの新しい適応拡大を承認したことを発表した。1週1回貼付のエストローゲン補充療法としてClimara 0.025mg/一日(Climara(r)25)を、更年期障害に伴う諸症状の治療開始時の用量として承認した。
Climara(r)25 は現在、北米では最低量のエストローゲンで効果のある経皮剤として、更年期の諸症状の治療、及び骨粗鬆症の予防に認められている唯一のエストラジオール経皮剤である。ヨーロッパでも、2001年3月に承認申請がなされている。
Climaraは、最初に北米で1995年に更年期症状の治療を適応として50と100の2用量で承認され、1996年には骨粗鬆症の長期予防の適応で承認された。ヨーロッパや中南米でもこの適応での承認が間近い。

★2001年1月8日 シエ−リング、オランダでクリモディエンの承認を取得
オランダ保健当局が2000年12月にクリモディエンを承認したことを本日発表した。クリモディエンは画期的な持続投与型ホルモン補充療法配合剤で、血流の阻止を目的としている。クリモディエンは抗アンドロゲン作用を持つプロゲスティンであるジエノゲストと吉草酸エストラジオ−ルを含有し、更年期障害の治療に使用される。

★2001年1月4日 >日本シエーリング、三井製薬工業を合併
2000年3月23日に旧三井製薬工業の発行済の全株式を取得していましたが、本年1月1日付けをもって合併。

★2000年10月30日 シエ−リングと Population Council(人口問題に関する国際研究機構)が、ホルモン補充療法並びに避妊を適応
 シエ−リングAGがホルモン補充療法(HRT)並びに受胎調節を適応に、様々な形の薬物送達システムとして、MENT(tm)の調査、開発、製造、及び世界的販売を行うことで、ライセンス契約を締結したことを本日発表した。






日本シェーリング株式会社

プレスリリース事業領域フィメルヘルスケアMSゲートウェイ[多発性硬化症] ●医療用医薬品情報 2002年決算「5%の減収に」 日本シエーリング [薬事日報2003.3.24]

日本シエーリングの2002年度売上高は661億円で、前年比5%減となった。昨年4月に実施された薬価や診療報酬の改定が、業績面でも大きく影響を受けた。

 主力製品の販売実績では、多発性硬化症治療薬ベタフェロンが希少疾病治療薬として患者QOL向上に寄与し、使用患者が継続的に増えたこともあり、27億円(前年比66%増)と伸長した。低用量経口避妊剤トリキュラーは7億円(33%増)でシェアは34%を超え、マーケットリーダーとしての基盤を確立した。
 さらに,慢性リンパ性白血病治療薬フルダラ6億円(14%増)、昨年10月にはバイアル製剤を発売した血液凝固阻止剤「ローモリン」10億円(33%増)、不整脈治療剤「シンビット」5億円(13%増)とそれぞれ伸長した。
 その一方で造影剤は、非イオン性X線造影剤イオパミロンが308億円、MRI用造影剤マグネビストが74億円と、それぞれ前年を9%、5%下回った。

 新製品としては、有用性加算(I)が認められた肝臓特異性のMRI造影剤「リゾビスト」を、昨年12月に発売している。

 国内での開発状況(フェーズIII)は、MRI造影剤(Line extention:一般名ガドペンテト酸メグルミン)、MRI造影剤(肝臓領域:一般名ガドキセテート)、子宮内避妊システム(一般名レボノルゲストレル)、多剤耐性克服薬など。







Intendis GmbH

- http://www.intendis.com/scripts/en/index.php - 2005.1 Schering AGの皮膚外用薬事業を独立。 ・200 Million Euro sales in 2004 ・650+ employees worldwide ・Subsidiaries in all major markets ・Development Center in Berlin, Germany ・Manufacturing capabilities in Milan, Italy ●Press and MediaDisease AreaResearch & Development ■Products ●Advantan(0.1% methylprednisolone aceponate) -Eczema ●Finacea(azelaic acid) -酒さ ●Dardia()
Berlex Laboratories[US]

--- http://berlex.bayerhealthcare.com/index.html?WT.mc_id=www.berlex.com ;Schering AG 子会社 Berlex LaboratoriesはBayer HealthCareと統合、Bayer HealthCare Pharmaceuticals社として活動再開。 ●Women's health products Mirena ---Levonorgestrel - releasing Intrauterine system Climara ...estradiol transdermal system Yasmin ...drospirenone + ethinylestradiol tablets Levlen21 /Levlen28 ...levonorgestrel + ethinylestradiol tablets Tri-Levlen21 /Tri-Levlen28 ...levonorgestrel + ethinylestradiol tablets Levlite ...levonorgestrel + ethinylestradiol tablets Menostar ... estradiol patch ●ProductsPress RoomInvestor Relations







Becton, Dickinson and Company

 - http://www.bd.com/

Becton, Dickinson and Company

Press Release - ●Investors - ●Clinician BD Diabetes Injury treatment and prevention Blood/urine collection Microbiology Consulting services Ophthalmic systems Critical care Patient safety Diagnostic testing★迅速検査薬 Physician office laboratory BD Education Center Sharps disposal Healthcare worker safety Surgical & anesthesia Immunization Syringes & Needles Immunocytometry systems Thermometers Infusion therapy Product Catalog Injection systems - ●Researcher Antibodies & reagents Immunology Blood collection Engineered labware Cell culture Microbiology Clontech Molecular/cell biology Discovery Labware Pharmingen Flow cytometry Prefillable syringes &delivery systems Immunocytometry Systems Product Catalog - ●Consumer ACE® bandages BD thermometers ACE Kidz™ Stardox™ premium sports braces &supports Bauer & Black™support hosiery& braces Tru-Fit® sports braces and supports BD BeAware™ (STD awareness) Product Catalog BD Diabetes - ●Industry HTS/Drug discovery products OEM precision glass Immunization Pharmaceutical systems Microbiology Product Catalog OEM medical products - ●Provider BD Diabetes Patient Safety Consulting services Thermometers Immunization Product Catalog Injury treatment & prevention -
日本ベクトンディッキンソン

- http://www.bdj.co.jp/ ■製品分野 ●バイオサイエンス フローサイトメトリー(機器・試薬) 細胞組織培養(BDファルコン・BDバイオコート) 遺伝子解析(BDクロンテック)検体採取と微生物検査 クリニカル・マイクロバイオロジー インダストリアル・マイクロバイオロジー(食品・環境検査) 迅速診断製品(POCT) 採血管関連製品メディカルデバイス 医療用器材 医薬品用キット製品 糖尿病ケア セーフティ「患者と医療従事者の安全のために」 ●BDの取り組み セーフティ「患者と医療従事者の安全のために」医療従事者向け フローサイトメトリー 細胞組織培養器具 微生物検査 迅速診断(POCT) 採血管 輸液関連 麻酔関連 循環器関連 外科・眼科関連 糖尿病ケア 感染制御 針刺し事故防止研究者向け フローサイトメトリー 細胞組織培養機具 遺伝子解析 臨床微生物検査 食品微生物検査 迅速診断(POCT) 環境モニタリング患者様向け 糖尿病ケアインダストリー向け フローサイトメトリー 細胞組織培養器具 食品微生物検査 環境モニタリング キット製剤関連 ■BD総合インフォメーション 会社案内 製品情報 添付文書(医療用具) 学会・セミナー プレスリリース BDお問合せ先一覧 ■Articles ドクターの立ち話 -第6回 おなかが痛い 話題の感染症 - 第2回 β-ラクタマーゼについてサイトマップ
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BioAlliance Pharma SA[仏]

 - http://www.bioalliancepharma.com/eng/ ; 49 boulevard du General Martial Valin,75015 PARIS
 1997年創立。 癌、ウイルス、感染症を主力。


●会社決算
(Euro)201020092008200720062005
売上高7,536,3128,173,943
他の収入198,503-
総収入
営業利益(15,478,244)(23,192,485)
経常利益(15,382,885)(21,364,918)
当期純利益(15,382,885)(21,366,072)
研究開発費9,007,00013,073,00011,865,0007,012,0004,557,000
従業員数[連結]6792
●会社決算
(Euro)201020092008200720062005
売上高913,0001,084,0631,153,066826,676211,833
経常利益()(8,847,030)(15,217,550)(16,385,584)(11,108,911)(10,247,651)
当期純利益()(22,398,410)(14,560,997)(15,721,589)(11,022,461)(7,705,221)
従業員数[連結]6575534745
●主要製品
●2.3.1. Loramyc®/Oravig™ and the oropharyngeal candidiasis market for immunocompromised patients
【2009】
2.3.1.1. Disorder

Oropharyngeal mycosis is primarily caused by yeasts: Candida albicans and non-albicans species. Although the most common species is Candida albicans (Ellepola A. N., et al., 2000), the pattern of strains involved has been changing over the last few years with the emergence of resistant isolates and species of C. non-albicans (Ruhnke M., 2006).

Opportunistic infections, like oropharyngeal candidiasis, take advantage of a deficiency in the immune system and/or a local imbalance to infect patients. The conditions associated with their development are often physiological, associated with a local trauma (irritation of the mucous membranes, poor dental hygiene) or with immune anomalies (advanced HIV infection, bone marrow or organ transplant, diabetes mellitus, severe malnutrition and debilitating age-related conditions). Furthermore, treatments such as immunosuppressive therapies, radiotherapy, chemotherapy, long-term antibiotic therapy and chronic or inhaled corticosteroid therapy promote the development of severe fungal infections.

These diseases impair the quality of life of patients, who are in pain and have difficulty eating and, in the case of severely immunocompromised patients, may also spread throughout the body and become life threatening (with a high patient mortality rate of 40%(4) for candidaemia). For cancer patients, oropharyngeal candidiasis is often associated with mucositis. It is essential that treatment should start as soon as the first symptoms appear to avoid the disease from recurring or getting worse.

On such fragile terrain, oropharyngeal candidiasis and the associated mucositis are disarming for physicians. Local therapies are the most appropriate for treating this pathology. Unfortunately, topical therapies in the form of mouth washes only have a short-term effect treatments in 1996, the prevalence of oropharyngeal candidiasis has fallen sharply and now stands at around 16-20% versus 80-90% previously (De Repentigny L. et al., 2004 ; Patton L. et al., 2000).

In cases of immunodeficiency related to HIV, the Company estimates, on the basis of existing scientific data, that oropharyngeal candidiasis in developing countries affects between 15% and 30% of patients, and nearly 90% of patients when the disease is progressing rapidly. Indeed, when the viral load is high (primary infection, progression to the AIDS stage, treatment failure), 100% of patients will develop oropharyngeal candidiasis.

Other patients concerned

Other medically fragile patient populations are concerned by oropharyngeal candidiasis. These include hospitalised elderly patients taking multiple medications for co-morbidities. The prevalence of oropharyngeal candidiasis in elderly patients is estimated at 30-70%.

2.3.1.3. Market and existing competitors

There is a public health risk associated with the treatment of oropharyngeal disease in immunodeficient populations. In order to avoid the emergence of non-albicans strains and preserve the maximum chances of treatment for these patients, clear recommendations have been issued and published (Powderly W. G., et al., 1999: SOR Standards, Options et Recommendations pour la prevention, le diagnostic et le traitement des candidoses en cancerologie FNCLCC 1999; Delfraissy J. F., 2004, Yeni P., 2008).

The national and international recommendations advise using locally active agents as first-line treatment and reserving systemic agents for disseminated candidiasis due to the significant risk of drug interaction for patients receiving several medications and to the risk of emergence of Candida resistance, favoured by prolonged systemic antifungal treatment. In clinical practice, these recommendations have not been widely applied until now due to the constraints involved in administering topical treatments. Accordingly, there was a real need for treatments targeting the affected mucous membrane, with a broad spectrum of activity covering all Candida, thus avoiding drug resistance and greatly reducing the risk of drug interactions.

On the European market (France, Germany, the United Kingdom, Italy and Spain), the sales of antifungals indicated for oropharyngeal candidiasis totalled Eur 433 million in the Moving Annual Total of September 2009 (sales for all indications, WHO data).

Based on prescription data (WHO), the Company estimates that the oropharyngeal candidiasis market in adults was about e100 million in the September 2009 MAT.

In the United States, BioAlliance’s commercial partner, PAR Pharmaceuticals, estimated that the oropharyngeal candidiasis market in adults was 1.8 million prescriptions based on WHO data, i.e. a potential market of $400 million.

Competitors

The competitors are the treatments currently used for oropharyngeal candidiasis. The pharmaceutical specialities currently sold for the treatment of oropharyngeal candidiasis may be administered locally (mouth washes) or systemically (oral administration, drinkable suspension) to produce their effect via the general route.

The antifungal active pharmaceutical ingredients used for the treatment of oropharyngeal candidiasis essentially belong to four specific chemical classes:

1. Antibiotics of the polyene class: amphotericin B, the active pharmaceutical principle in Fungizone® and nystatin, the active principle in Mycostatin®.
2. Azoles can be divided into two sub-groups: - Imidazoles: miconazole, the active principle in Daktarin® oral gel and ketoconazole, the active principle in Nizoral®;
- Triazoles: fluconazole, the active principle in Triflucan®; itraconazole, the active principle in Sporanox® , oral suspension (for use in hospitals only); voriconazole, the active principle in Vfend®(reserved for hospital use in severe or resistant systemic mycosis) and posaconazole, the active principle in Noxafil® , indicated for the treatment of systemic and oropharyngeal candidiasis when a weak response to topical treatments is expected.
3. DNA 5-fluorocytosine analogues: flutocytosine, the active principle in Ancotil®(reserved for hospital use in severe systemic mycosis).
4. Echinocandins: - caspofungin Cancidas® available for administration by one-hour intravenous infusion is indicated for aspergillosis;
- anidulafungin, for intravenous administration, approved in 2005 for systemic Candida infections (candidaemia, septicaemia and oesophageal candidiasis);
- micafungin Micamine® , approved in 2005 in the USA and available for administration by one-hour intravenous infusion for invasive infections.

In oropharyngeal candidiasis, the two types of antifungal agents that compete with Loramyc®(miconazole Lauriad®) are systemic antifungal agents, the most significant of which in terms of value is fluconazole (a generic drug used in most markets), and locally active antifungal agents, among which the mostcommonly prescribed is the generic nystatin(5).

The systemic or general treatments for oropharyngeal candidiasis are primarily oral (fluconazole by Pfizer or laboratories selling the generic drug, ketoconazole and itraconazole by Johnson & Johnson).

These topical treatments for the mouth all require several daily applications. This is the case for nystatin and amphotericin B (various players), ketoconazole and miconazole gel (Johnson & Johnson or laboratories selling the generic drug) and clotrimazole (Alza, Johnson & Johnson or laboratories selling the generic drug).

Other systemic products are currently indicated for invasive candidiasis; these drugs could also be developed later on for oral candidiasis but would be of limited use due to their systemic effects. Noxafil (posaconazole, Schering-Plough) has obtained an indication in Europe for oral candidiasis, as first-line treatment for patients for whom topical treatments are expected to be ineffective.

The companies offering medications indicated for oral candidiasis are either generic drug companies or major pharmaceutical laboratories, which remain limited in number.

2.3.1.4. Competitors currently being developed

Tibozole is a local treatment developed by Tibotec, a subsidiary of the Johnson & Johnson group, in the form of an adhesive tablet competing with miconazole Lauriad®(Loramyc®). Tibozole contains 10 mg of miconazole nitrate (a chemical form of miconazole not registered in the European Union or in the United States for the oral candidiasis indication). This product was tested in Africa, and publications indicate efficacy results of the same magnitude as ketoconazole, given systemically(6). A phase III trial comparing Tibozole for 14 days with Sporanox (itraconazole) was initiated in China in December 2008. At the present time, this product is part of a compassionate programme in developing countries.

Finally, the Danish company Fertin Pharma has developed a local formulation of miconazole in the form of gum to be chewed four times daily (14.4 mg/day), for which the published results(7) show an efficacy equivalent to that of miconazole gel at 200 mg/day (in four doses) and greater than that of a placebo. The six-week treatment period seems abnormally long and the dose chosen for the reference treatment is lower than the normally recommended dose (500 mg/day).

2.3.1.5. The BioAlliancePharma product: Loramyc®/Oravig™

The BioAlliance Pharma product, miconazole Lauriad®, was registered under the trademarks Loramyc® or Sitamic® in Europe and in many other countries (see section 2.2.4.5 of this reference document). The Oravig™ trademark is registered in the United States. Except in paragraphs specifying the territories covered by the authorisations or the indications granted by regulatory authorities of the various countries for this product, the term “Loramyc®” used in this reference document designates the BioAlliance Pharma product irrespective of its trademark.

The Loramyc® , mucoadhesive gingival miconazole tablet is based on a novel oral delivery system allowing mucous membrane targeting for the rapid and sustainable release of an effective concentration of active principle that impregnates the infected tissues, without systemic transfer. Loramyc® is the first antifungal medical product to use this mucoadhesive gingival technology.

Mucoadhesive gingival tablets are designed to remain in place in the oral cavity (in the canine fossa) and release the active principle on a controlled basis.
The gingival tablet disintegrates gradually. The tablet matrix, which gives the tablet its mucoadhesive properties, consists of a milk protein concentrate.
This natural protein excipient gradually becomes hydrated and sticks to the proteins of the mucous surface, whereupon it releases the active principle on a continued basis. This excipient has been chosen for its long-lasting adhesive properties, and is moreover widely used in the food industry.

Miconazole Lauriad®(Loramyc®) is indicated for the treatment of oropharyngeal candidiasis in immunocompromised patients. In the United States, Oravig™ is indicated for the treatment of oropharyngeal candidiasis in adults. Oropharyngeal candidiasis, caused by a Candida, fungus is an opportunistic infection that often occurs in fragile patients. If this infection is not treated adequately and quickly, it may become life threatening for certain immunocompromised patients due to the risk of dissemination. A fragile terrain facilitates the proliferation of this fungus; this is the case for cancer patients treated by chemotherapy or radiotherapy, patients infected with HIV, elderly patients with co-morbidities receiving several medications, patients undergoing corticosteroid treatment or those receiving immunosuppressive treatment.

(5) WHO Study, October 2005. (All rights reserved, WHO Health, 2005).
(6) J.J. Roey 2004.
(7) H. L. Bastian Oral Surg Oral Med Oral Radiol Endod 2004; 98:423-8.

Loramyc® , which uses Lauriad® adhesive technology, takes into account these medical needs and the ecological changes observed with the increasingly common occurrence of resistant strains. It has been developed on the following bases:

- miconazole was chosen because of its broad antifungal spectrum, which makes it active on all kinds of Candida albicans and non-albicans (no known resistance) and because of its tolerance profile and widely proven local efficacy;
- the development of a sustained-release mucoadhesive gingival tablet providing an early and prolonged concentration of antifungal in the saliva;
- an increased duration of contact of the active principle with the fungus with prolonged effective concentrations (greater than the minimum inhibitory concentration or MIC) that increase efficacy at the site of the infection;
- application at the very site of infection, thus limiting the absorption of miconazole through the general or systemic route and avoiding the risk of drug interactions in patients who are often taking multiple medications;
- sustained release requiring only one daily application.

Miconazole is an antifungal agent from the azole family and acts by inhibiting the synthesis of ergosterol. This molecule, widely described in the scientific medical literature and marketed throughout the world, is particularly indicated in cases of candidiasis. It has proven tolerance and efficacy profiles for the treatment of oral and intestinal candidiasis. It has an antifungal profile that is particularly adapted to oropharyngeal candidiasis, with a broad spectrum of activity against different types of Candida, including Candidaalbicans, as well as Candida non-albicans strains (C. krusei, C. glabrata, C. pseudotropicalis and C. parapsilosis).

The sensitivity profile for miconazole is comparable to that of voriconazole (a new azole for systemic use) with respect to the various species of Candida, no initial drug resistance having been described to date with this antifungal agent (Kuriyama T., et al., 2005). In September 2007 at the ICAAC “Interscience Conference on Antimicrobial Agents and Chemotherapy” the Company presented data generated by Professor M.A. Ghannoum (Centre for Medical Mycology of the Cleveland University Hospitals, Cleveland, OH, United States) which shows the mycological profile of miconazole. At the ECCMID (European Congress of Clinical Mycology and Infectious Diseases) in April 2008, the Company presented Professor M.A. Ghannoum data, which shows that miconazole fails to induce resistance even after repeated exposure to the molecule. These results confirm the potency and the broad spectrum of activity of the antifungal agent miconazole Lauriad® with respect to all Candida responsible for oral pathologies.

In addition to its good tolerance profile, its absorption is limited. In this regard, digestive absorption of miconazole after administration of 500 mg of gel is minimal, as shown by the very low or even undetectable plasma concentrations (Sawyer P. R., et al., 1975).
These results were confirmed in a study conducted with Loramyc® in HIV-infected patients.

Compared to systemic oral antifungal treatment, Loramyc® offers the advantage of having a spectrum covering all Candida. It also has the advantage of limiting systemic side effects and drug interaction in patients who are often taking several different drugs. Compared to topical treatments, it ensures a sustained presence of efficient salivary concentrations for about 13 hours at the very site of infection, which allows for a single daily application and contributes to a better observance of treatment by patients.

Loramyc® had been available on the French market since the end of 2007 and has been approved in twenty-six European countries (cf. the Company press release of 25th March 2010 disclosing the approval of Loramyc® in thirteen other European countries).
BioAlliance Pharma has licensed the marketing rights for Loramyc® in Europe to the group Therabel Pharma, through an agreement signed on 31st March 2010.

In the United States, BioAlliance Pharma received the marketing authorisation for Oravig™ on 16th April 2010. Oravig™ may be launched on the American market during the second half of 2010 by Strativa Pharmaceuticals, the proprietary product division of Par Pharmaceutical Companies, Inc., the BioAlliance Pharma commercial partner in the United States.

In addition, BioAlliance Pharma set up strategic partnerships in 2008 for the marketing of Loramyc® in Asia: with the company Handok for Korea, Taiwan, Singapore and Malaysia, and with NovaMed for China.
The marketing authorisation was obtained for Korea in April 2009.


【2009】

BioAlliance Pharma SA[仏]

Products Loramyc® / Oravig®(miconazole) - 経口DDS技術Lauriad&trade technology Loramyc®は2006.10フランスで初承認、現在欧州26ヵ国で承認。また米国と韓国で承認。 フランスではTherabel Lucien Pharma Laboratoriesが販売。 at a public price of Euro 71.55 per bottle of 14 tablets. It is entitled to a 65% reimbursement R & D - Development product portfolio InvestorsAnnual reports / Registration Documents Annual Report 2009 2009 Annual Financial Report Reference Document 2009

Press releases
Full-year financial results for 2010 - The company posts a profit as a result of an exceptional revenue - High potential for further growth [2010.3.3]
BioAlliance Pharma announces the launch of Oravig® on the US market by its commercial partner, Strativa/Par Pharmaceutical[2010.8.24]
BioAlliance Pharma presents phase III results with Loramyc® (miconazole Lauriad®) and ongoing phase II trial with clonidine Lauriad® - MASCC/ISOO 2010 International Symposium (Vancouver, Canada, June 24-26, 2010)[2010.6.28]
BioAlliance Pharma gains US FDA approval for Oravig® (Loramyc® in EU) and is eligible for a $20 million milestone payment from Strativa Pharmaceuticals, its commercial partner in the US[2010.4.16]
BioAlliance Pharma is now relying on partnerships to insure its growth strategy and is licensing European commercialization rights for Loramyc® and Setofilm® to theTherabel Group in a Eur48.5 million deal [2010.4.6]
BioAlliance Pharma announces extension of Loramyc® approval in 13 European countries - It is bringing total European approvals to 26 European countries[2010.3.25]
Epidemiological study on Oropharyngeal Candidiasis and results on miconazole MBT compliance were presented at the 51st ASTRO Annual Meeting [2009.11.5]
BioAlliance Pharma presents additional US pivotal Phase III results on LoramycTM (miconazole Lauriad®) at the 47th Annual Meeting of the IDSA[2009.11.4]
Loramyc® obtains Marketing Authorization in Switzerland [2009.8.14]
FDA Accepts Drug Application for Miconazole Lauriad® (Loramyc®) to Treat Oropharyngeal Candidiasis[2009.8.19]
BioAlliance Pharma submits Loramyc® NDA to US FDA and announces a general shareholders' meeting to amend its by-laws [2009.6.15]
BioAlliance Pharma reacquires the rights to Loramyc® in Europe[2009.2.27]〜仏以外の欧州の販売契約を2007年に締結していたSpeBio (a joint venture with SpePharm)との契約を解消した。
BioAlliance Pharma receives market approval for Loramyc® in the United Kingdom and Denmark [2008.1.9]
BioAlliance Pharma receives market approval for Loramyc® in Germany, Belgium and Luxemburg[2008.3.27]
BioAlliance Pharma expands its LoramycTM franchise by signing a South East Asia deal worth up to $12 million with the leading Korean pharma company Handok [2008.3.31]
BioAlliance Pharma extends its Loramyc™ License to China through an agreement with NovaMed Pharmaceuticals [2008.6.23]
BioAlliance Pharma launches Loramyc® in the United Kingdom, Germany and Denmark[2008.7.10]
BioAlliance Pharma launches its first product, Loramyc®, on the French market[2007.9.4]
BioAlliance Pharma licenses loramyc™ U.S. commercialization rights to Par Pharmaceutical in a $65 million deal[2007.7.3]
BioAlliance Pharma announces acceptance of EUR 4 per day pricing for Loramyc® on the French market pending publication in France’s Journal Officiel [2007.6.12]
BioAlliance Pharma establishes new subsidiary, SpeBio, to sell Loramyc® in Europe [2007.6.7]
BioAlliance Pharma sets up European Joint Venture with SpePharm to sell Loramyc®[2007.3.8]
BioAlliance Pharma receives marketing authorization for its first product, Loramyc®[2006.10.13]






Biocodex[FR]

 - http://www.biocodex.com/index.php ; Gastroenterology/Neurology and Psychiatry/Pain Treatment; 株式非公開
1953 設立
2006 sales : 77 M Euro. 
430 people at 3 sites. 


Biocodex[FR]

Products Gastroenterology ---------------- ULTRA-LEVURE(R), Saccharomyces boulardii, intestinal flora replacement, antidiarrheic HEPADIAL(R), dimecrotic acid, cholagogue, choleretic Neurology & Psychiatry --------------------- DIACOMIT(R), stiripentol, antiepileptic MOCLAMINE(R), moclobemide, antidepressant STRESAM(R), etifoxine, anxiolytic Pain Treatment --------------- ACUPAN(R), nefopam, injectable non-morphine analgesic BIODALGIC Ge(R), tramadol, analgesic DOLAL(R), phenylpropyl salicylate, ethyl methoxysalicylate, topical analgesic OTIPAX(R), lignocaine and phenazone, analgesic and anti-inflammatory for the ears Others --------- LOGIFLOX(R), DECALOGIFLOX(R), lomefloxacine hydrochloride, antibiotic STIMOL(R), citrulline malate, antiasthenic




Biogen IDEC Inc.

 - https://www.biogen.com/
08/07/2003★IDEC Pharmaceuticals and Biogen Announce U.S. Federal Trade Commission Clearance of Merger
 - 2003.6.23発表の両社合併をFTCが承認。 新会社名はBiogen IDEC Inc.
 −合併手続きは2003.11に完了し、既に新会社はスタート。
Biogen Idec Becomes Biogen[23-Mar-2015]



●会社決算
($000)20142013201220112010200920082007200620052004200320022001

 製品売上高8,203,4005,542,3004,166,1003,836,1003,470,0563,152,9412,839,6512,136,8211,781,3131,617,0041,486,344171,56113,711-
 合弁会社収入1,195,4001,126,0001,137,900966,6001,077,2441,094,8631,128,238926,098810,864708,881615,743493,049385,809251,428
 ロイヤリティ304,500263,900212,500215,900137,401124,400116,224102,19886,27293,19398,94512,010--
 Partner31,7225,10013,3946,6004,6003,42210,5302,5634,70221,249
収入 合計9,703,3006,932,2005,516,5005,048,6004,716,4234,377,3484,097,,5073,171,6172,683,0492,422,5002,211,562679,183404,222272,677

営業利益3,972,4002,515,5001,855,9001,724,7001,248,8891,295,4271,213,611779,772440,020236,04043,416-869,669
経常利益3,946,6002,480,6001,855,1001,711,2001,229,9061,332,6791,148,943910,595492,163256,19564,093-880,624231,522161,604
純利益2,941,5001,862,3001,380,0001,266,700898,573970,132783,167638,172217,511160,71125,086-875,097148,090101,659

研究開発費1,893,4001,444,1001,334,9001,248,6041,283,0681,072,058925,164718,390747,671686,872233,337
取得研究開発費244,976-25,00084,172330,520--823,000
従業員数7,5504,8504,7504,7004,3003,340
●売上
($000)2014201320122011201020092008200720062005200420032002200120001999備考
Avonex3,013,100(+0.3)3,005,500(+3.2)2,913,1052,686,6242,518,3562,322,8942,202,5331,867,8421,706,7001,543,0851,417,157(+27)142,603
*1,170,00
1,000,000971,600(+27.7)761,100620,600[Interferon beta-1a]多発性硬化症
 うち米国1,956,7001,902,4001,793,7001,628,3001,491,6001,406,2001,276,5001,085,0001,022,200938,700922,60092,600
*
 うち米国外1,056,4001,103,1001,119,4001,058,3001,026,800916,700926,100782,800684,500604,400494,60050,000
*
148,000260,500208,500178,400
Plegridy44,500--[PEG-IFN-Beta1a]
 米国内27,800--
 米国外16,700--
Tysabri1,959,500(+28.4)1,526,500(+34.4)1,135,896 1,079,448900,250776,030588,598229,84435,8004,6563,121-----(natalizumab)多発性硬化症
 米国内1,025,100814,200383,100326,500252,800231,800196,400104,40025,8004,700
 米国外934,400712,300752,800753,000647,400544,200392,200125,50010,000--
Tecfidera2,909,200(+232.1)876,100(-)-[dimethyl fumarate]多発性硬化症
 米国内2,426,600(+180.7)864,400-
 米国外482,60011,700
Fampyra[海外のみ]80,20074,00057,40013,600--[持続性fampridine]多発性硬化症;欧2011.7-;Acorda製品
Rituxan*1,137,900996,6001,077,2001,094,9001,128,200926,100513,800457,000(rituximab)米国内B社売上分;決算上Royalty収入
Zevalin4,4004,80016,90017,80020,80023,00019,600----(ibritumomab tiuxetan)悪性リンパ腫/発売2002.4
 米国内13,90016,40019,40018,700
 米国外3,0001,4001,4004,300EMEA承認=2004.1
Fumaderm[国外]62,500(+3.8)60,200(+0.8)59,67554,72851,19449,62443,42221,5479,500--[dimethylfumarate and monoethylfumarate salt]重症乾癬
Amevive-30070011,50048,45743,0309,356----(alefacept)乾癬(psoriasis)
 米国内3005,00034,900
 米国外4006,50013,600
Alprolix76,000--[遺伝子組換え血液凝固第IX因子Fc 領域融合タンパク質製剤]血友病B
Eloctate58,400--[遺伝子組換え血液凝固第VIII因子Fc領域融合タンパク質製剤]血液凝固第VIII因子欠乏患者の出血傾向の抑制

製品売上計8,203,4005,542,3004,166,074 3,836,1173,470,0563,152,9412,839,6512,136,8211,781,3131,617,0041,486,344171,5611,148,0001,042,000761,000621,000
 米国内5,566,7003,581,0002,176,8001,638,0001,472,9001,203,6001,069,500997,671986,050121,589
 米国外2,636,7001,961,3001,989,3001,514,9001,366,800933,200711,800619,333500,29449,972
*2003年度は合併後のBiogen社の1月分のみ [Fumaderm] 2006.6買収したFumapharm AG製造。 2006.12 Fumadermのドイツ販売権を獲得。 創製はAlmirall [Amevive] アステラス製薬の米国法人がAmeviveの全世界の権利取得[2006.4.4] [Zevalin] 2007.12 米国販売権を売却 [Rituxan] 米国Genentech, 日本は中外&全薬 、他全世界Roche Biogen-IDECは米国でGenentechと共同販売。

●多発性硬化症製剤
【2014 Competition】
AVONEX, PLEGRIDY, TYSABRI and TECFIDERA each compete with one or more of the following products:

Competing Product Competitor
--------------------- ------------
COPAXONE (glatiramer acetate) Teva Pharmaceuticals Industries Ltd.
REBIF (interferon-beta-1) Merck KGaA (and co-promoted with Pfizer Inc. in the U.S.)
BETASERON/BETAFERON (interferon-beta-1b) Bayer Group
EXTAVIA (interferon-beta-1b) Novartis AG
GILENYA (fingolimod) Novartis AG
AUBAGIO (teriflunomide) Sanofi
LEMTRADA (alemtuzumab) Sanofi

Competition in the MS market is intense. Along with us, a number of companies are working to develop additional treatments for MS that may in the future compete with AVONEX, PLEGRIDY, TYSABRI, TECFIDERA or all of them. In addition, the commercialization of our own products, including new products such as TECFIDERA and PLEGRIDY, and the possible future introduction of generics, related prodrug derivatives or biosimilars of existing products may negatively impact future sales of our MS products.

●Tysabri (natalizumab) 多発性硬化症
本剤はElanがBiogen Idecと共同で商品化したもの。 製造はBiogen Idecが担当し、開発と販売は共同。 販売地域については、米国は両社が共同、欧州はBiogen Idec。
【2014】
TYSABRI (natalizumab), a monoclonal antibody approved in numerous countries as a monotherapy for the treatment of patients with relapsing forms of MS. TYSABRI is also approved in the U.S. to treat Crohn's disease, an inflammatory disease of the intestines. The principal markets for TYSABRI in MS are the U.S., the United Kingdom, France, Germany, Italy and Spain. TYSABRI was approved in Japan in March 2014.

In May 2013, we completed patient enrollment in a Phase 3 study of TYSABRI in secondary progressive MS, known as ASCEND. The study has a duration of approximately two years and involves approximately 875 patients. Secondary progressive MS is characterized by a steady progression of nerve damage, symptoms and disability.

We have patents and patent applications covering TYSABRI in the U.S. and other countries. These patents and patent applications cover TYSABRI and related manufacturing methods, as well as various methods of treatment using the product. The principal patents covering the product and use of the product to treat MS are U.S. patent nos. 5,840,299 and 6,602,503 and EP 0804237, which expire between 2017 and 2020 (including supplementary protection certificates in many European countries). Additional U.S. and E.U. patents and applications covering methods of treatment using the product expire in 2023. In addition to patent protection, TYSABRI is entitled to regulatory exclusivity until 2016 in both the U.S. and the E.U

【2009】
We believe that TYSABRI is one of the most efficacious treatments for MS. TYSABRI is a monoclonal antibody (natalizumab) that was initially approved by the FDA in November 2004 to treat relapsing MS. In February 2005, in consultation with the FDA, we and our collaborator Elan Corporation plc (Elan) voluntarily suspended the marketing and commercial distribution of TYSABRI based on reports of cases of progressive multifocal leukoencephalopathy (PML) in patients treated with TYSABRI in clinical studies. PML is an opportunistic viral infection of the brain that often leads to death or severe disability. In July 2006, TYSABRI was reintroduced in the U.S., and introduced in the European Union, as a monotherapy treatment for relapsing MS. TYSABRI is also approved in the U.S. to treat CD, which is an inflammatory disease of the intestines.

TYSABRI is marketed under risk management or minimization plans as agreed to with local regulatory authorities. In the U.S., TYSABRI was reintroduced with a risk minimization action plan known as the TOUCH Prescribing Program, a rigorous system intended to educate physicians and patients about the risks involved and to assure appropriate use of the product.

We collaborate with Elan on the development and commercialization of TYSABRI. Please read Note 17, Collaborations to our Consolidated Financial Statements for a description of this collaboration.

2009 Developments

・ In November 2009, we revised the U.S. prescribing information for TYSABRI to reflect that the risk of developing PML increases with longer treatment duration, and for patients treated for 24 to 36 months is generally similar to the rates seen in clinical trials. The revised label also reflects that there is limited experience beyond three years of treatment.
・ In the fourth quarter 2009, the European Medicines Agency (EMA) began a review of TYSABRI to determine whether any additional measures were necessary to ensure the safe use of TYSABRI. In January 2010, the EMA recommended updating the TYSABRI label in the E.U. to reflect that the risk of PML increases after two years of therapy. The EMA also recommended that patients have regular MRI scans and be re-informed of the risk of PML after two years on therapy. Competition

AVONEX and TYSABRI both compete primarily with three other products:

・ BETASERON (interferon-beta-1b), which is marketed by Bayer HealthCare Pharmaceuticals, the U.S. pharmaceuticals affiliate of Bayer Schering Pharma AG, in the U.S. and is marketed under the name BETAFERON by Bayer Schering Pharma AG in the European Union. BETASERON and BETAFERON together generated worldwide revenues of approximately $1.7 billion in 2008. EXTAVIA, a branded version of interferon beta-1b marketed by Novartis AG, is sold in the European Union and was launched in the U.S. in October 2009.
・ COPAXONE (glatiramer acetate), which is marketed by Teva Pharmaceutical Industries Ltd. in the U.S. and copromoted by Teva Pharmaceutical Industries and Sanofi-Aventis in Europe. COPAXONE generated worldwide revenues of approximately $2.3 billion in 2008.
・ REBIF (interferon-beta-1a), which is co-promoted by EMD Serono, a subsidiary of Merck Serono, and Pfizer Inc. in the U.S. and is marketed by Merck Serono in the European Union. REBIF generated worldwide revenues of approximately $2.0 billion in 2008.

Along with us, a number of companies are working to develop products to treat MS that may in the future compete with AVONEX and TYSABRI. For example, an oral formulation of cladribine (developed by Merck Serono) was filed with the EMA and is the subject of discussions with the FDA regarding a refiling for approval as therapy for MS and FTY720 (fingolimod) (developed by Novartis AG) has been filed with the EMA and FDA for approval as an oral therapy for MS. In addition, alemtuzumab (developed by Genzyme Corporation) and laquinimod (developed by Teva Pharmaceutical Industries) are in late-stage development for the treatment of MS.

AVONEX and TYSABRI also face competition from off-label uses of drugs approved for other indications

Elan

We collaborate with Elan on the development, manufacture and commercialization of TYSABRI. Under the terms of our collaboration agreement, we manufacture TYSABRI and collaborate with Elan on the product’s marketing, commercial distribution and ongoing development activities. The agreement is designed to effect an equal sharing of profits and losses generated by the activities of our collaboration. Under the agreement, however, once sales of TYSABRI exceeded specific thresholds, Elan was required to make milestone payments to us in order to continue sharing equally in the collaboration’s results. As of December 31, 2009, Elan has made milestone payments to us of $75.0 million in the third quarter of 2008 and $50.0 million in the first quarter of 2009. We have recorded these amounts as deferred revenue upon receipt and are recognizing the entire $125.0 million as product revenue in our consolidated statements of income over the term of the collaboration agreement based on a units of revenue method whereby the revenue recognized is based on the ratio of units shipped in the current period over the total units expected to be shipped over the remaining term of the collaboration. No additional milestone payments are required under the agreement to maintain the current profit sharing split. Our collaboration agreement provides Elan or us with the option to buy the rights to TYSABRI in the event that the other company undergoes a change of control (as defined in the collaboration agreement).

In the U.S., we sell TYSABRI to Elan who sells the product to third party distributors. Our sales price to Elan in the U.S. is set prior to the beginning of each quarterly period to effect an approximate equal sharing of the gross margin between Elan and us. We recognize revenue for sales in the U.S. of TYSABRI upon Elan’s shipment of the product to the third party distributors, at which time all revenue recognition criteria have been met. As of December 31, 2009 and 2008, we had deferred revenue of $23.6 million and $6.2 million, respectively, for shipments to Elan that remained in Elan’s ending inventory pending shipment of the product to the third party distributors. We incur manufacturing and distribution costs, research and development expenses, commercial expenses, and general and administrative expenses. We record these expenses to their respective line items within our consolidated statements of income when they are incurred. Research and development and sales and marketing expenses are shared equally with Elan and the reimbursement of these expenses is recorded as reductions of the respective expense categories. During the years ended December 31, 2009, 2008 and 2007, we recorded $25.3 million, $23.6 million, and $21.5 million, respectively, as reductions of research and development expense for reimbursements from Elan. In addition, for the years ended December 31, 2009, 2008 and 2007, we recorded $62.5 million, $33.7 million, and $37.9 million, respectively, as reductions of selling, general and administrative expense for reimbursements from Elan.

In the rest of world, we are responsible for distributing TYSABRI to customers and are primarily responsible for all operating activities. Generally, we recognize revenue for sales of TYSABRI in the rest of world at the time of product delivery to our customers. Payments are made to Elan for their share of the rest of world net operating profits to effect an equal sharing of collaboration operating profit. These payments also include the reimbursement for our portion of third-party royalties that Elan pays on behalf of the collaboration relating to rest of world sales. These amounts are reflected in the collaboration profit sharing line in our consolidated statements of income. For the years ended December 31, 2009, 2008 and 2007, $215.9 million, $136.0 million, and $14.1 million, respectively, was reflected in the collaboration profit sharing line for our collaboration with Elan. As rest of world sales of TYSABRI increase, our collaboration profit sharing expense is expected to increase.

[2007]
TYSABRIは多発性硬化症の再発の治療で承認。 June 5, 2006,両社はFDAに再発型多発性硬化症の単独療法のsBLA申請。 2006.6.29 両社はEMEAから同様の適応症の認可を得た。 TYSABRI is also approved for MS in Switzerland, Canada, Australia, New Zealand and Israel.

TYSABRI was initially approved by the FDA in November 2004 to treat relapsing forms of MS to reduce the frequency of clinical relapses. In February 2005, in consultation with the FDA, we and Elan voluntarily suspended the marketing and commercial distribution of TYSABRI based on reports of cases of PML in patients treated with TYSABRI in clinical studies. In consideration of these events, TYSABRI is marketed under risk management or minimization plans as agreed with local regulatory authorities. In the U.S., TYSABRI was reintroduced with a risk minimization action plan, or RiskMAP, known as the TYSABRI Outreach: Unified Commitment to Health, or TOUCH, Prescribing Program, a rigorous system intended to educate physicians and patients about the risks involved and assure appropriate use of the product.

As of late December 2007, more than 21,000 patients were on commercial and clinical TYSABRI therapy worldwide. As of mid-December 2007, up to 30,900 patients had been treated with TYSABRI cumulatively in the combined clinical trial and post-marketing settings. There have been no new cases of PML since relaunch in the U.S. and launch internationally in July 2006.

TYSABRI binds to adhesion molecules on the immune cell surface known as alpha-4 integrin. Adhesion molecules on the surface of the immune cells play an important role in the migration of the immune cells in the inflammatory process. Research suggests that by binding to alpha-4 integrin, TYSABRI prevents immune cells from migrating from the bloodstream into tissue where they can cause inflammation and potentially damage nerve fibers and their insulation.

Under the terms of the collaboration, we are solely responsible for the manufacture of TYSABRI, and we collaborate with Elan on the product’s marketing, commercial distribution and ongoing development activities. The collaboration agreement with Elan is designed to effect an equal sharing of profits and losses generated by the activities of the collaboration between Elan and us. Under our agreement with Elan, however, in the event that sales of TYSABRI exceed specified thresholds, Elan is required to make milestone payments to us in order to continue sharing equally in the collaboration’s results.

In the U.S., we sell TYSABRI to Elan who sells the product to third party distributors. Elan and we co-market the product. The sales price to Elan in the U.S. is set at the beginning of each quarterly period to effect an approximate equal sharing of the gross margin between Elan and us. In addition, both parties share equally in the operating costs, which include research and development, selling, general and administrative expenses and other similar costs. Sales of TYSABRI to Elan are reported as revenues and are recognized upon Elan’s shipment of the product to third party distributors, at which time all revenue recognition criteria have been met. As of December 31, 2007 and 2006, we had deferred revenue of $9.0 and $5.0 million, respectively, for shipments to Elan that remained in Elan’s ending inventory. Elan’s reimbursement of TYSABRI operating costs is reflected as a reduction of the respective costs within our consolidated statement of income.

For sales outside of the U.S., we are responsible for distributing TYSABRI to customers and are primarily responsible for all operating activities. We and Elan share equally in the operating results of TYSABRI outside the U.S. Sales of TYSABRI are reported as revenue and are recognized at the time of product delivery to our customer, at which time all revenue recognition criteria have been met. Payments to or from Elan for their share of the collaboration operating losses relating to sales outside the U.S. are reflected in the collaboration profit (loss) sharing line in our consolidated statement of income. For 2007 and 2006, we provided and received net payments of $14.1 million and ($9.7) million, respectively, related to reimbursements made in connection with this arrangement.

In July 2006, we began to ship TYSABRI in both the United States and Europe. In 2007, we recorded sales of TYSABRI in the U.S. and Europe of $104.4 million and $125.5 million, respectively. In 2006, we recorded sales of TYSABRI in the U.S. and Europe relating to current activity of $11.9 million and $10.0 million, respectively. Prior to the suspension of TYSABRI in 2005, we shipped product to Elan in the U.S. and recognized revenue in accordance with the policy described above. As a result of the suspension of TYSABRI, we deferred $14.0 million in revenue from Elan as of March 31, 2005 related to TYSABRI product that remained in Elan’s ending inventory. This amount was paid by Elan during 2005 and was subsequently recognized as revenue during 2006, when the uncertainty about the ultimate disposition of the product was eliminated.

PHASE 3 Studies of TYSABRI in MS

Prior to the suspension of dosing in clinical studies of TYSABRI we, along with Elan, completed the AFFIRM study and the SENTINEL study. The AFFIRM study was designed to evaluate the ability of natalizumab to slow the progression of disability in MS and reduce the rate of clinical relapses. The SENTINEL study was designed to evaluate the effect of the combination of natalizumab and AVONEX compared to treatment with AVONEX alone in slowing progression of disability and reducing the rate of clinical relapses. Both studies were two-year studies which had protocols that included a one-year analysis of the data.

The AFFIRM study

The one-year data from the AFFIRM study showed that TYSABRI reduced the rate of clinical relapses by 66% relative to placebo, the primary endpoint at one year. AFFIRM also met all one-year secondary endpoints, including MRI measures. In the TYSABRI treated group, 60% of patients developed no new or newly enlarging T2 hyperintense lesions compared to 22% of placebo treated patients. On the one-year MRI scan, 96% of TYSABRI treated patients had no gadolinium-enhancing lesions compared to 68% of placebo treated patients. The proportion of patients who remained relapse free was 76% in the TYSABRI treated group compared to 53% in the placebo treated group. In February 2005, we and Elan announced that the AFFIRM study also achieved the two-year primary endpoint of slowing the progression of disability in patients with relapsing forms of MS. In the TYSABRI treated group, there was a 42% reduction in the risk of disability progression relative to placebo, and a 67% reduction in the rate of clinical relapses over two years relative to placebo which was sustained and consistent with the one-year results. Other efficacy data, including MRI measures, were similar to the one-year results.

In May 2007 at the annual meeting of the American Academy of Neurology in Boston, we presented extension study data that showed that TYSABRI has a sustained treatment effect on clinical relapses and the risk of disability progression in MS patients treated for up to three years. Patients who participated in the Phase 3 TYSABRI program (including the AFFIRM trial) were eligible to enroll in an open-label extension study that evaluated the therapy’s long-term effects. In the intent-to-treat analysis, the annualized relapse rate for patients treated with TYSABRI over the three-year period was 0.23, translating into an average of one relapse every 4.3 years. The relapse rate also continued to remain low over the three-year treatment period with TYSABRI: 0.27 during the first year; 0.20 during the second year; and 0.15 during the third year (based on 531 patients who entered the extension study, which includes approximately 250 patients with nearly three years of continuous therapy). In addition, TYSABRI also decreased the cumulative probability of disability progression sustained for six months compared to placebo. The estimated proportion of patients who had 24-week sustained disability progression at two years was 11% in patients treated with TYSABRI compared to 23% in patients treated with placebo, a 54% relative reduction. This effect was maintained in patients treated with TYSABRI for up to three years with 13% showing 24-week sustained disability progression.

In October 2007 at the 23rd Congress of ECTRIMS in Prague, Czech Republic, we presented a poster on a post hoc analysis of the Phase 3 AFFIRM study. The study data suggest the proportion of disease-free patients over two years was significantly higher in the TYSABRI-treated group compared with the placebo group, as determined based upon both clinical and MRI criteria. Using clinical and MRI disease-free criteria combined, the most stringent definition of disease free, 36.7% of TYSABRI-treated patients had no relapses, disability progression or MRI activity compared with 7.2% of placebo patients (p0.0001). In the clinical analysis, 64.3% of TYSABRI-treated patients vs. 38.9% placebo-treated patients (p0.0001) were disease free or without relapses and disability progression. Using MRI measures, 57.7% of TYSABRI-treated patients vs. 14.2% placebo-treated patients (p0.0001) were disease free, or without gadolinium-enhancing lesions and new or enlarging T2-hyperintense lesions.

The SENTINEL study

The one-year data from the SENTINEL combination study also showed that the study achieved its one-year primary endpoint. The addition of TYSABRI to AVONEX resulted in a 54% reduction in the rate of clinical relapses over the effect of AVONEX alone. SENTINEL also met all secondary endpoints, including MRI measures. In the group treated with TYSABRI plus AVONEX, 67% of the patients developed no new or newly enlarging T2 hyperintense lesions compared to 40% in the AVONEX plus placebo group. On the one-year MRI scan, 96% of TYSABRI plus AVONEX-treated patients had no gadolinium-enhancing lesions compared to 76% of AVONEX plus placebo treated patients. The proportion of patients who remained relapse free was 67% in the TYSABRI plus AVONEX-treated group compared to 46% in the AVONEX plus placebo-treated group. In the TYSABRI-treated group, 60% of patients developed no new or newly enlarging T2 hyperintense lesions compared to 22% of placebo treated patients. On the one-year MRI scan, 96% of TYSABRI treated patients had no gadolinium-enhancing lesions compared to 68% of placebo treated patients. In July 2005, we and Elan announced that the SENTINEL study also achieved the two-year primary endpoint of slowing the progression of disability in patients with relapsing forms of MS. The addition of TYSABRI to AVONEX resulted in a 24% reduction in the risk of disability progression compared to the effect of AVONEX alone, and a 56% reduction in the rate of clinical relapses over two years compared to that provided by AVONEX alone. Other efficacy data, including MRI measures, were similar to the one-year results.

競合

AVONEX, which generated $1.9 billion of worldwide revenues in 2007, and TYSABRI, which generated $230 million of worldwide revenues for us in 2007, both compete primarily with three other products:

・REBIF (interferon-beta-1a), which is copromoted by EMD Serono (a subsidiary of Merck Serono) and Pfizer in the U.S. and sold by Merck Serono in Europe. REBIF generated worldwide revenues of approximately $1.5 billion in 2006.
・BETASERON (interferon-beta-1b), sold by Bayer Healthcare Pharmaceuticals (the U.S. pharmaceuticals affiliate of Bayer Schering Pharma AG) in the U.S. and sold under the name BETAFERON(R) by Bayer Schering Pharma AG in the EU. BETASERON and BETAFERON together generated worldwide revenues of approximately $1.2 billion in 2006.
・COPAXONE (glatiramer acetate), sold by Teva Neuroscience, Inc., or Teva, in the U.S. and copromoted by Teva and Sanofi-Aventis in Europe. COPAXONE generated worldwide revenues of approximately $1.4 billion in 2006.

Along with us, a number of companies are working to develop products to treat MS that may in the future compete with AVONEX and TYSABRI. Some of our current competitors are also working to develop alternative formulations for delivery of their products, which may in the future compete with AVONEX and TYSABRI.

AVONEX and TYSABRI also face competition from off-label uses of drugs approved for other indications.

●Tysabri (natalizumab) クローン病
【2009】
[2007]
On January 14, 2008, we and Elan announced the FDA’s approval of the sBLA for use of TYSABRI for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn’s disease, or CD, with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-alpha. TYSABRI will be available for the treatment of CD upon the completion of key implementation activities related to the approved risk management plan. We anticipate TYSABRI will be available to Crohn’s patients by the end of the first quarter of 2008.

The FDA granted approval based on its review of overall safety data and the results of three randomized, double-blind, placebo-controlled, multi-center trials of TYSABRI assessing the safety and efficacy as both an induction and maintenance therapy ? ENCORE (Efficacy of Natalizumab in Crohn’s Disease Response and Remission), ENACT-1 (Efficacy of Natalizumab as Active Crohn’s Therapy) and ENACT-2 (Evaluation of Natalizumab As Continuous Therapy). The approval contains labeling and a risk management plan, both of which are similar to those approved for the MS indication. One of the confirmed cases of PML was in a patient who was in a clinical study of TYSABRI in Crohn’s disease.

In September 2004, Elan submitted a Marketing Authorisation Application, or MAA, to the EMEA for approval of TYSABRI as a treatment for Crohn’s disease. A committee of the EMEA adopted a negative recommendation in November 2007. The European Commission affirmed the committee’s decision in the first quarter of 2008, which means that Crohn’s disease will not be included in our label for TYSABRI in the EU.

Phase 3 Studies of TYSABRI in Crohn’s Disease

We, along with Elan, have completed three Phase 3 studies of TYSABRI in Crohn’s disease, a chronic and progressive inflammatory disease of the gastrointestinal tract, which commonly affects both men and women. The three completed Phase 3 studies are known as ENACT-2 (Evaluation of Natalizumab as Continuous Therapy-2), ENACT-1 (Evaluation of Natalizumab as Continuous Therapy-1), and ENCORE (Efficacy of Natalizumab for Crohn’s Disease Response and Remission).

ENACT-1/ENACT-2

In ENACT-2, 339 patients who were responders in ENACT-1, the Phase 3 induction study, were re-randomized to one of two treatment groups, TYSABRI or placebo, both administered monthly for a total of 12 months. In ENACT-1, the primary endpoint of “response,” as defined by a 70-point decrease in the Crohn’s Disease Activity Index, or CDAI, at week 10, was not met. In ENACT-2, the primary endpoint, which was met, was maintenance of response through six additional months of therapy. A loss of response was defined as a greater than 70 point increase in CDAI score and a total CDAI score above 220 or any rescue intervention. Through month six, there was a significant treatment difference of greater than 30% in favor of patients taking TYSABRI compared to those taking placebo. Twelve-month data from ENACT-2 showed a sustained and clinically significant response throughout 12 months of extended TYSABRI infusion therapy, confirming findings in patients who had previously shown a sustained response throughout six months. Maintenance of response was defined by a CDAI score of less than 220, and less than 70-point increase from baseline, in the absence of rescue intervention throughout the study. Response was maintained by 54% of patients treated with natalizumab compared to 20% of those treated with placebo (p0.001). In addition, 39% of patients on TYSABRI maintained clinical remission during the study period, versus 15% of those on placebo (p0.001). By the end of month six, 58% of patients treated with TYSABRI who had previously been treated with corticosteroids were able to withdraw from steroid therapy compared to 28% of placebo-treated patients.

The ENCORE study

In June 2005, we and Elan announced that ENCORE, the second Phase 3 induction trial of TYSABRI for the treatment of moderately to severely active Crohn’s disease in patients with evidence of active inflammation, met the primary endpoint of clinical response as defined by a 70-point decrease in baseline CDAI score at both weeks 8 and 12. The study also met all of its secondary endpoints, including clinical remission at both weeks 8 and 12. Clinical remission was defined as achieving a CDAI score of equal to or less than 150 at weeks 8 and 12. At the time of the TYSABRI suspension, all ENCORE study patients had completed dosing based on the study protocol and collection of data and analysis followed.

●Tysabri (natalizumab) その他
[2007]
TYSABRI in Oncology

We plan to initiate a Phase 1/2 study of TYSABRI in multiple myeloma in 2008.


●Avonex[interferon beta-1a] 多発性硬化症
【2014】
AVONEX (interferon beta-1a), an intramuscular injectable therapy, indicated for the treatment of patients with relapsing forms of MS. AVONEX is a recombinant form of the interferon beta protein produced in the body in response to viral infection. The principal markets for AVONEX are the U.S., United Kingdom, France, Germany, Italy and Spain.

We have several U.S. patents and patent applications, and a number of corresponding foreign counterparts, related to AVONEX and/or PLEGRIDY. Our U.S. patent no. 7,588,755 claims the use of recombinant beta interferon for immunomodulation or treating a viral condition, viral disease, cancers or tumors. This patent, which expires in September 2026, covers the treatment of MS with AVONEX and PLEGRIDY. A discussion of legal proceedings related to this patent is set forth in Note 21, Litigation to our consolidated financial statements included in this report.

Additionally, we and another party each own a pending U.S. patent application related to recombinant interferon-beta protein. These applications, which fall outside of the General Agreement on Tariffs and Trade (GATT) amendments to the U.S. patent statute, are not published by the USPTO and, if they mature into granted patents, may be entitled to a term of seventeen years from the grant date. There is a pending interference proceeding in the USPTO involving these applications. We do not know whether either of these applications will mature into patents with claims relevant to AVONEX or to PLEGRIDY. Additional protection for PLEGRIDY is provided by patents and patent applications with expiration dates out to 2025 in the U.S. and 2019 in the E.U., with the potential for patent term extension. PLEGRIDY is also entitled to regulatory exclusivity until 2026 in the U.S. and 2024 in the E.U.

【2009】
AVONEX is one of the leading therapeutic products for relapsing forms of MS with over 135,000 patients currently using AVONEX. MS is a progressive neurological disease in which the body loses the ability to transmit messages along nerve cells, leading to a loss of muscle control, paralysis and, in some cases, death. Patients with active relapsing MS experience an uneven pattern of disease progression characterized by periods of stability that are interrupted by flare-ups of the disease after which the patient returns to a new baseline of functioning. AVONEX is a recombinant form of the interferon beta protein produced in the body in response to viral infection. AVONEX has been shown in clinical trials in relapsing MS both to slow the accumulation of disability and to reduce the frequency of flare-ups.

2009 Developments

・ In September 2009, we were issued a U.S. patent for the use of beta interferon for immunomodulation or treating a viral condition, viral disease, cancers or tumors. This patent, which expires in September 2026, covers the treatment of multiple sclerosis with AVONEX.
・ In April 2009, we announced data results from an open label, ten-year extension study of MS patients, known as CHAMPIONS, indicating that early treatment with AVONEX reduces relapse rates and may reduce disease progression for up to ten years.


●ZINBRYTA(Daclizumab) 多発性硬化症
【2014】
Phase 3 completed; Expect to submit MAA to FDA and EMA in 2015; AbbVie Biotherapeuticsと共同開発

ZINBRYTA is a monoclonal antibody that is being tested in RRMS. In June 2014, we announced positive top-line results from the Phase 3 DECIDE clinical trial, which investigated ZINBRYTA as a potential once-monthly, subcutaneous treatment for RRMS. Results showed that ZINBRYTA was superior on the study's primary endpoint, demonstrating a statistically significant reduction in annualized relapse rates when compared to interferon beta-1a (AVONEX).

【2009】
Daclizumab is a monoclonal antibody that is being tested in relapsing MS. A Phase 2b trial of daclizumab in MS, known as SELECT, is currently underway. The SELECT trial has a one year treatment period and is expected to involve approximately 600 patients worldwide. The SELECT trial is the first of two registrational trials required by regulatory authorities. We expect to begin patient enrollment in a Phase 3 trial of daclizumab in relapsing MS, known as DECIDE, during the first half of 2010. The DECIDE trial has a two year treatment period and is expected to involve approximately 1,400 patients worldwide. The DECIDE trial is the second registrational trial required by regulatory authorities.

We collaborate with Facet Biotech Corporation (Facet) on the development and commercialization of daclizumab. In January 2010, we agreed with our collaborator, Facet, to assume the manufacture of daclizumab and began the process of transferring from Facet the manufacturing technology necessary for us to manufacture daclizumab. Any delay in completing or implementing such transfer could adversely affect the timing of our daclizumab trials. Please read Note 17, Collaborations to our Consolidated Financial Statements for a description of this collaboration.


●FAMPYRA[Fampridine prolonged-release tablet] 多発性硬化症
【2014】
FAMPYRA (prolonged-release fampridine tablets), is indicated for the improvement of walking ability in adult patients with MS. FAMPYRA is a prolonged-release tablet formulation of the drug fampridine. We have a license from Acorda Therapeutics, Inc. (Acorda) to develop and commercialize FAMPYRA in all markets outside the U.S. Our principal markets for FAMPRYA are France, Germany, Spain and Canada. For information about our agreement with Acorda, please read Note 20, Collaborative and Other Relationships to our consolidated financial statements included in this report.

We have an exclusive license under two European granted patents, several pending European patent applications and numerous corresponding non-U.S. counterpart applications related to FAMPYRA. EP 0484186B1 claims pharmaceutical formulations containing aminopyridines including fampridine. This patent expired in November 2011 but is subject to pending and granted supplemental protection certificates which, where granted, will extend the patent term to 2016 on a country-bycountry basis. EP 1732548B1, which claims sustained-release aminopyridine compositions for increasing walking speed in patients with MS, and EP 2377536B1, which claims sustained-release aminopyridine compositions for treating multiple sclerosis, expire in 2025 but are subject to pending and granted supplemental protection certificates which, where granted, will extend one of the patents’ term to 2026 on a country-by-country basis. In addition to these patent rights, FAMPYRA is covered by regulatory exclusivity in Europe until 2021.

[競合]

FAMPYRA is indicated as a treatment to improve walking in adult patients with MS who have walking disability and is the first treatment that addresses this unmet medical need with demonstrated efficacy in people with all types of MS. FAMPYRA is currently the only therapy approved to improve walking in patients with MS.

【2009】
Fampridine is an oral compound that is being developed as a treatment to improve walking ability in people with MS. In December 2009, we filed for approval of fampridine in the European Union and Canada for this indication. Fampridine was approved in the U.S. on January 22, 2010 under the trade name AMPYRA (dalfampridine). AMPYRA is indicated to improve walking in patients with MS. This was demonstrated by an increase in walking speed. Acorda is developing and marketing AMPYRA in the U.S. We collaborate with Acorda on the development and commercialization of fampridine in markets outside the U.S. Please read Note 17, Collaborations to our Consolidated Financial Statements for a description of this collaboration.

Acorda

On June 30, 2009, we entered into a collaboration and license agreement with Acorda Therapeutics, Inc. (Acorda) to develop and commercialize products containing fampridine in markets outside the U.S. The transaction represents a sublicensing of an existing license agreement between Acorda and Elan. The parties have also entered into a related supply agreement. The $110.0 million upfront payment made on July 1, 2009 to Acorda was recorded as research and development expense during the second quarter 2009 as the product candidate had not received regulatory approval. Fampridine was approved in the U.S. on January 22, 2010 under the trade name AMPYRA (dalfampridine). AMPYRA is indicated to improve walking in patients with MS. This was demonstrated by an increase in walking speed. Acorda is developing and marketing AMPYRA in the U.S.

Under the terms of the agreement, we will commercialize fampridine and any aminopyridine products developed in our territory and will also have responsibility for regulatory activities and future clinical development of fampridine in those markets. We may incur additional milestone payments of up to $400.0 million based upon the successful achievement of regulatory and commercial sales milestones. We will also make tiered royalty payments to Acorda on sales outside of the U.S. The consideration that we pay for products will reflect all amounts due from Acorda to Elan for sales in markets outside the U.S., including royalties owed. We can also carry out future joint development activities under a cost-sharing arrangement.

Elan will continue to manufacture commercial supply of fampridine based upon its existing supply agreement with Acorda. Under the existing agreements with Elan, Acorda will pay Elan 7% of the upfront and milestone payments that Acorda receives from us.


●TECFIDERA (dimethyl fumarate) 多発性硬化症
【2014】
TECFIDERA (dimethyl fumarate), an oral therapy indicated in the U.S. for the treatment of patients with relapsing forms of MS and in the EU for people with RRMS. TECFIDERA was approved by the FDA in March 2013 and the EC in February 2014

●PLEGRIDY (peginterferon beta-1a) 多発性硬化症
【2014】
PLEGRIDY (peginterferon beta-1a), a subcutaneous injectable therapy, indicated in the U.S. for the treatment of patients with relapsing forms of MS and in the European Union (E.U.) for relapsing-remitting MS (RRMS). PLEGRIDY received approval from the European Commission (EC) in July 2014 and the U.S. Food and Drug Administration (FDA) in August 2014.

●Rituxan 非ホジキン悪性リンパ腫
【2009】
RITUXAN is one of the most prescribed oncology therapeutics in the world with over 2.1 million patient exposures across all indications. RITUXAN is a monoclonal antibody that is used worldwide to treat NHL and RA. NHL is a cancer that affects lymphocytes, which are a type of white blood cell that help to fight infection. RA is a chronic disease that occurs when the immune system mistakenly attacks the body’s joints, resulting in inflammation, pain and joint damage.

We collaborate with the Roche Group, through its wholly-owned member Genentech, Inc., on the development and commercialization of RITUXAN. Please read Note 17, Collaborations to our Consolidated Financial Statements for a description of this collaboration.

2009 Developments

・ In November 2009, the U.S. Food and Drug Administration (FDA) issued a complete response on applications for RITUXAN plus fludarabine and cyclophosphamide for the treatment of people with CLL, a cancer that affects white blood cells. The FDA has not requested any new data to complete its review of these applications. We and Genentech have engaged in final label discussions with the FDA and expect to finalize these discussions during the first quarter of 2010.
・ In October 2009, we announced that the FDA issued a complete response indicating that they did not believe that approval could be supported for RITUXAN in RA patients with an inadequate response to non-biological disease modifying agents.
・ In October 2009, data from a Phase 2/3 clinical trial of RITUXAN in ANCA-associated vasculitis, known as RAVE, was presented at the American College of Rheumatology. The trial met its primary endpoint of noninferiority, showing that RITUXAN is as effective as cyclophosphamide in treating ANCA-associated vasculitis, a type of inflammation of the blood vessels.
・ In September 2009, we announced that a Phase 3 study showed that RITUXAN provided significant clinical benefit to patients with low-grade follicular lymphoma who were treated with RITUXAN as maintenance therapy after primary treatment with RITUXAN and chemotherapy.
・ In March 2009, we announced that a Phase 3 study of RITUXAN in lupus nephritis did not meet its primary endpoint.

Competition

RITUXAN IN ONCOLOGY

RITUXAN competes with several different types of therapies in the oncology market, including:
・ CAMPATH (marketed by Bayer HealthCare Pharmaceuticals), which is indicated for B-cell CLL (an unapproved and unpromoted use of RITUXAN).
・ TREANDA (marketed by Cephalon) and ARZERRA (marketed by GenMab in collaboration with GlaxoSmithKline), which is indicated for refractory CLL patients to both alemtuzumab and fludarabine (an unapproved and unpromoted use of RITUXAN).
We are also aware of other anti-CD20 molecules in development that, if successfully developed and registered, may compete with RITUXAN in the oncology market.

RITUXAN IN RA

RITUXAN competes with several different types of therapies in the RA market, including:
・ traditional therapies for RA, including disease-modifying anti-rheumatic drugs such as steroids, methotrexate and cyclosporine, and pain relievers such as acetaminophen.
・ TNF inhibitors, such as REMICADE (infliximab) and SIMPONI (golimumab) (marketed by Johnson & Johnson), HUMIRA (adalimumab) (marketed by Abbott Laboratories), ENBREL (etanercept) (marketed by Amgen, Inc. and Pfizer) and CIMZIA (certolizumab pegol) (marketed by UCB, S.A.).
・ ORENCIA (abatacept) (marketed by Bristol-Myers Squibb Company).
・ ACTEMRA (tocilizumab) (marketed by the Roche Group).
We are also aware of other products in development that, if successfully developed and registered, may compete with RITUXAN in the RA market.


●ZEVALIN (ibritumomab tiuxetan) 非ホジキン悪性リンパ腫
【2009】
Our product line previously included ZEVALIN (ibritumomab tiuxetan), which is part of a treatment regimen for certain B-cell NHL. In December 2007, we sold the rights to market, sell, manufacture and develop ZEVALIN in the U.S. to Cell Therapeutics, Inc. (CTI), for an upfront payment of $10.0 million and agreed to supply ZEVALIN product to CTI through 2014. In the European Union, we continue to sell ZEVALIN to Bayer Schering Pharma AG (Schering), our licensee for sales of ZEVALIN outside the U.S.

Under the terms of our agreement with CTI, we are further entitled to receive additional payments contingent upon the achievement of certain milestone events. In September 2009, the FDA approved an expansion of ZEVALIN’s label as part of the first line therapy in the treatment of follicular non-Hodgkin’s lymphoma. This approval triggered a $5.5 million payment to us in October 2009. We may receive up to an additional $10.0 million in milestone payments.

In addition, during December 2008 we received an additional $2.2 million payment from CTI pursuant to an amendment to our agreement with CTI as well as a $0.8 million consent fee received from CTI upon assigning their rights under the agreement to a third party in March 2009.

We recognize our sales of ZEVALIN to Schering for distribution in the European Union as product revenue, and we recognize sales related to our supply of ZEVALIN to CTI as corporate partner revenue. We continue to recognize royalties received from Schering on their sales of ZEVALIN in the European Union within the royalty revenue component of other revenues. The $10.0 million upfront and $7.7 million milestone payments received to date are being recognized in our results of operations over the term of our supply agreement with CTI.


【】
Biogen IDEC Inc.

News & Media CORRECTING and REPLACING Biogen Idec Reports Full Year and Fourth Quarter 2010 Results[2011.2.1] Biogen Idec Reports Full Year and Fourth Quarter 2010 Results[2011.2.1] TherapiesResearch and Development - Pipeline品目一覧含む ●InvestorsSEC Filings Annual 10-K[2011.2.4] - [pdf] - [doc] Annual 10-K[2010.2.9] - [pdf] - [doc] - [xls] 10-K[2009.2.6] - [pdf,193]- [doc]- [xls] 10-K[2008.2.14] - [pdf,259p] - [doc] 10-K[2006.3.3] -[pdf,167p] -[xls] 10-K[2005.3.31] -[pdf,165p] 10-K[2004.3.10] Financial Reports [Annual Reports] Annual Report 2010[pdf] Annual Report 2009[pdf] Annual Report 2008[pdf] Annual Report 2004[pdf] Annual Report 2003[pdf] Biogen's Annual Report 2002 IDEC's Annual Report 2002 Annual Report 2001[pdf,58p] -- 31p MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS RESULTS OF OPERATIONS 2001 AS COMPARED TO 2000 Revenues Total revenues 2001 - $1,043.4 million(+13%) Product sales in 2001 - $971.6 million(+28% ; $761.1 million in 2000) AVONEX売上が総収入の93%を占める。 AVONEX sales in 2001 were $972 million versus $761 million in 2000 AVONEX sales [海外] - $260.5 million ( $208.5 million in 2000)




BioMarin Pharmaceutical Inc.

 - http://www.biomarinpharm.com/; 1997年設立、酵素療法専門の医薬開発ベンチャー。
米国カリフォルニア。 NASDAQ=BMRN(1999.7上場)
従業員数=525人(2008.2.8) -製造243  開発130  販売81  管理71


  第1号製品がAldurazyme。

●売上
($ 000)20082007200620052004200320022001備考
製品売上高49,60686,80249,60613,03918,641---(Orapred等売上高)
Milestone収入18,74028,26418,74012,630-12,100--
Royalty and license15,8636,51515,863----

総収入84,209121,58184,20925,669-12,100--(Aldurazyme)

販売コスト8,72018,3598,7402,6293,953---
研究開発費66,73578,60066,73556,39149,78453,93226,81122,144
販売管理費48,50777,53948,507
旧49,030
41,55637,60615,27817,3476,828
取得研究開発費----31,453-11,22311,647
取得資産保全費---68,251---

営業経費 計127,633178,869127,633
旧128,156
101,720195,034
旧198,006
69,210
旧87,903
55,381
旧78,847
40,619
合弁会社損益19,27430,52519,27411,838(2,972)(18,693)(23,466)(18,663)(Biomarin/Genzyme LLC)
営業利益(43,424)(57,288)(43,424)
旧(24,673)
(76,051)
旧(64,213)
(176,393)
旧(179,365)
(57,110)
旧(75,803)
(78,847)(59,282)
純損失(28,533)(15,803)(28,533)(74,270)(187,443)(75,798)(77,461)(67,606)
従業員数649525410314359

●製品売上高
Naglazyme132,70086,20046,5006,100[galsulfase;rhASB] -MPS VI(Maroteaux-Lamy syndrome)
- FDA承認=2005.5.31、発売=2005.6.21、EMEA申請=2004.12.6,承認2006.1.30
Orapred-200-6,90018,600(prednisolone sodium phosphate oral solution)
- FDA承認=2000.12、BioMarinが2004.5 Medicis PharmaceuticalからAscent Pediatrics businessを買収したに伴い取得。
 2005.8 Orapred ODT (prednisolone sodium phosphate orally disintegrating tablets)をFDA申請、2006.6.1承認2006.8.28発売
Kuvan46,700400------[sapropterine]PKU;米発売2007.12
★BioMarin/Genzyme LLC
($ Million)2008200720062005200420032002備考
Aldurazyme96.291123.67196.291(+26)76.41742.58311.5-(α-L-iduronidase;laronidase)/ムコ多糖症T型
- FDA承認=2003.4,発売=2003.5、EMEA承認=2003.6,発売=2003.6
(服用患者数)(370)(273)(146)

粗利益73.11896.79473.11860.32836.88.5-

純利益38.54861.05038.54823.676(19.3)18.7
[2005] Aldurazyme 2005/Q1-Q3 $55.2 million (前年同期$27.0 million ,+104%); 2005年間見込み=$74 million to $77 million Naglazyme 2005/Q1-Q3 $2.4 million (2005.6.21発売);; 2005年間見込み=$4 million to $6 million ★Orapred (prednisolone sodium phosphate)
In May 2004, we completed the transaction to acquire the Orapred product line from Ascent Pediatrics, a wholly owned subsidiary of Medicis. In March 2006, we entered into an agreement with Alliant Pharmaceuticals, Inc., which was subsequently acquired by Sciele Pharma Inc. (Sciele), for the continued sale and commercialization of the Orapred product line. Through the sublicense agreement, Sciele acquired exclusive rights to market these products in North America. Sciele is responsible for the costs of commercializing the products in North America. In June 2006, the FDA granted marketing approval for Orapred ODT (prednisolone sodium phosphate orally disintegrating tablets), the first orally disintegrating tablet form of prednisolone available in the United States.

★KUVAN (sapropterine)
[2007]
(FDA承認) On December 13, 2007, we announced that the U.S. Food and Drug Administration (FDA) granted marketing approval for Kuvan, an orally administered preparation for the treatment of phenylketonuria (PKU). Kuvan has received orphan drug designation from the FDA, conferring upon it seven years of market exclusivity in the United States, until 2014. We began shipping product to the distribution channel the day after the announcement of Kuvan approval, and immediately began promotion. Our list sales price for Kuvan is $0.29 per mg.

(カナダの権利を戻した) On December 18, 2007, we announced that we re-acquired the Canadian rights for tetrahydrobiopterin (BH4), including Kuvan, from Merck Serono, a division of Merck KGaA. The terms of the agreement specified a reduction in royalties owed to BioMarin on Merck Serono sales outside the United States and Japan. Based on the structure of the amended agreement, the reduction in royalties cannot exceed an undisclosed amount.

(EMEA申請) On November 8, 2007, we announced that our partner Merck Serono submitted the Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for Kuvan as an oral treatment for patients suffering from significant hyperphenylalaninemia (HPA) due to PKU or BH4 deficiency. We received the $15.0 million milestone related to the filing from Merck Serono in December 2007.

Kuvan was granted marketing approval for the treatment of PKU in the U.S. in December 2007. We market Kuvan in the U.S. using our own sales force and commercial organization. Kuvan has been granted orphan drug status in the U.S., which provides for seven years of market exclusivity. Kuvan net product sales for the approximate two-week period after approval and launch in December 2007 were $0.4 million.

Kuvan is a proprietary synthetic oral form of 6R-BH4, a naturally occurring enzyme co-factor for phenylalanine hydroxylase (PAH) indicated for patients with PKU. Kuvan is the first drug for the treatment of PKU. PKU is an inherited metabolic disease that affects at least 50,000 diagnosed patients under the age of 40 in the developed world. We believe that approximately 30-50% of those with PKU could benefit from treatment with Kuvan. PKU is caused by a deficiency of activity of an enzyme, PAH, which is required for the metabolism of phenylalanine (Phe). Phe is an essential amino acid found in all protein-containing foods. Without sufficient quantity or activity of PAH, Phe accumulates to abnormally high levels in the blood resulting in a variety of serious neurological complications, including severe mental retardation and brain damage, mental illness, seizures and other cognitive problems.

In the U.S. and most developed countries, PKU is diagnosed at birth through a blood test. To manage the disease and maintain non-toxic blood Phe levels, people with PKU must adhere to a highly-restrictive diet comprised of foods that are low in Phe and supplemented with medical foods. Compliance with this diet is difficult for patients and usually only occurs through middle childhood, a critical period to ensure normal brain development. Recent data demonstrates that adolescent and adult PKU patients who no longer follow restricted diets suffer from a number of psychological and neurological symptoms. In October 2000, a Consensus Panel convened by the National Institutes of Health recommended that all people with PKU should adhere to this special diet throughout their lives. Kuvan is intended to provide PKU patients with a more convenient and effective way to manage their disease and maintain blood Phe levels at the recommended levels.

In May 2005, we entered into an agreement with Merck Serono for the further development and commercialization of Kuvan and PEG-PAL for PKU and 6R-BH4, the active ingredient in Kuvan, for other diseases such as cardiovascular indications including those associated with endothelial dysfunction. Through the agreement, Merck Serono acquired exclusive rights to market these products in all territories outside the U.S. and Japan, and we retained exclusive rights to market these products in the U.S. On December 8, 2007, we announced that we re-acquired Canadian rights for BH4 from Merck Serono. We and Merck Serono will generally share equally all development costs following successful completion of Phase 2 clinical trials for each product candidate in each indication. In November 2007, Merck Serono submitted a MAA to the EMEA for sapropterin dihydrochloride as an oral treatment for patients suffering from HPA due to PKU or BH4 deficiency. Kuvan has received orphan drug designation in the E.U. We are entitled to receive a $30.0 million milestone payment from Merck Serono upon approval of Kuvan in the E.U. We recorded collaborative agreement revenue associated with Kuvan in the amounts of $28.3 million in 2007, $18.7 million in 2006, and $12.6 million in 2005.

(競合 Kuvan and PEG-PAL ) There are currently no other approved drugs for the treatment of PKU. PKU is commonly treated with a medical food diet that is highly-restrictive and unpalatable. We perceive medical foods as a complement to Kuvan and PEG-PAL and not a significant competitive threat. Dietary supplements of large neutral amino acids (LNAA) have also been used in the treatment of PKU. This treatment may be a competitive threat to Kuvan and PEG-PAL. However, because LNAA is a dietary supplement, the FDA has not evaluated any claims of efficacy of LNAA.

With respect to Kuvan, we are aware of one other company that produces forms of 6R-BH4 (or BH4) for sale outside of Japan, and that BH4 has been used in certain instances for the treatment of PKU. We do not believe, but cannot know for certain, that this company is currently actively developing BH4 in sponsored trials as a drug product to treat PKU in the U.S. or E.U. Although a significant amount of specialized knowledge and resources would be required to develop and commercially produce BH4 as a drug product to treat PKU in the U.S. and E.U., this company may build or acquire the capability to do so. Additionally, we are aware that another company is developing an oral enzyme therapy to treat PKU; however we understand that the therapy is in an early stage of preclinical development.

With respect to BH4 as a drug product to treat endothelial dysfunction, there is currently no comparable directly competing product on the market. However, there is a significant amount of competition for the treatment of hypertension, peripheral arterial disease and other conditions associated with endothelial dysfunction through other active ingredients, some of which are currently on the market or are in development. We believe that the BH4 mechanism of action is unique and has multiple levels of benefit, with a good safety profile. We are not currently aware of other companies that are actively developing or conducting clinical trials of BH4 for the treatment of hypertension, peripheral arterial disease and other conditions associated with endothelial dysfunction.

(特許等) With respect to Kuvan and BH4, we have or have licensed a number of patents and pending patent applications that relate generally to formulations and forms of our drug substance, and methods of use for various indications under development and the dose regimen. With respect to the pending patent applications, unless and until actually issued, the protective value of these applications is impossible to determine.



★Naglazyme (galsulfase)
[2006]
BioMarin received marketing approval for Naglazyme(R) (galsulfase) in the U.S.
 in May 2005, and in the E.U. in January 2006. 
Naglazyme is a recombinant form of N-acetylgalactosamine 4-sulfatase (arylsulfatase B) indicated for patients with mucopolysaccharidosis VI (MPS VI). MPS VI is a debilitating life-threatening genetic diseas