[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W=11.90(),DKK=21.53 ,NZ$=83.20 * 日経ネット：マネー＆マーケット：外国為替クロスレート[] * 為替レート過去データ[] * レート・チャート・データリンク ●製薬企業ニュースサイト Business.com :Pharmaceuticals - Web Sites --- 収録項目profile | financials | competitors | people --- 収録項目AstraZeneca| Aventis| Bayer AG| Bristol-Myers Squibb| Eli Lilly GlaxoSmithKline| Johnson & Johnson| Merck & Co| Novartis AG| Novo-Nordisk A/S Pfizer| Roche Holding Ag| Schering-Plough Hoovers Online PR Newswire : Company News Archive: Health/Biotech |Annual Report ●医薬品市場ニュースサイト ★IMS Health News Release [] [] [] ■個別製薬会社
●企業情報 ●金融庁電子開示システム（EDINET) - 有価証券報告書 - 金融庁は「証券取引法に基づく有価証券報告書等の開示書類に関する電子開示システム」 (説明)の試験運用期間を終了し、 平成16年6月以降、開示書類等の電子化が原則義務化（EDINETへ移行） （Electronic Disclosure for Investors' NETwork） つまり株式公開を行う企業に提出を義務づけられている「有価証券報告書」などは、 ネット公開されることになる。 ●米国証券公正取引委員会[SEC] Filings検索 from 米国証券公正取引委員会[SEC][Securities and Exchange Commission] -SEC Filings & Forms (EDGAR) - Companies for SIC 2834 - Pharmaceutical Preparations[549社] - 企業名などで検索し、開くと当該企業のドキュメントが大量に出てくるが 「有価証券報告書」を見たい場合、Annual Reports Form 10-K EDGARR is... the SEC's Electronic Data Gathering, Analysis and Retrieval system 民間検索サイト★SEC Info[Fran Finnegan & Company]も便利 ●参考 Biotech's old soldiers[Pharmalicensing.com] (15 November 2005) -最近の合併動向
■Abbott
●決算 [各12月末]- ABBOTT REPORTS 15.5 PERCENT SALES INCREASE IN THE FOURTH QUARTER; 13.9 PERCENT INCREASE FOR 2004[2005.1.18] ●セグメント別売上高
($ milllion) 2007 2006 2005 2004 2003 2002 2001 2000 純売上高 25,914.2 22,476.3 22,337.8(+13.5) 19,680.0(+13.9) 17,280.3 17,684.7(+8.6) 16,285.2(+18.5) 13,745.9 営業利益 4,578.5 2,042.2 4,362.3 3,898.3(+31.1) 2,974.0 3,530.1 1,894.0 3,400.6 経常利益 4,469.6 2,276.4 4,619.9 4,125.6(+21.8) 3,387.2 3,673.4 1,883.1 3,816.4 純利益 3,606.3 1,716.8 3,372.1 3,235.9(+17.5) 2,753.2 2,793.7 1,550.4 2,786.0 研究開発費 2,505.6 2,255.2 1,821.2 1,696.8(+4.5) 1,623.8 1,561.8 1,577.6 1,351.0 取得研究開発費 - 2,014.0 17.1 279.0 100.2 従業員数 68,000 66,663 59,735 ? 72,181 71,819 71,426 60,571 (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。 from 10-K[02/25/04] * 2003.8 Abbottは病院製品部門の中核Hospira,Inc.(年間売上高$2.4 billion)の分離を 発表。 いずれ中止事業として処理。 * 2006.1.1付けで事業再編。 Abbott InternationalからAbbott Nutrition Internationalを分化。 事業報告では、Nutritional Products事業として、国内をRoss Products Division,国際Abbott Nutrition International ●国別売上高
($ milllion) 2007 2006 2005 2004 2003 2002 2001 備考 ●Pharmaceutical (a) 14,632(+18.0) 12,395(-9.5) 13,691
旧8,138(+16.1)11,913
旧7,0106,051 4,268 3,759 米国内医薬品 国内売上高 7,806(+19.2) 6,550(-19.5) 国際売上高 6,826(+16.8) 5,845(+5.3) ●Diagnostic (b) 3,158(+11.1) 3,979(+5.9) 3,756(+11.2) 3,378 3,040 2,897 2,929 国内売上高 820(+2.6) 1,356(+7.5) 1,252(+11.8) 国際売上高 2,338(+14.4) 2,633(+5.1) 2,504(+10.9) ●Nutritional 4,388(+1.7) 4,313(+9.6) 国内売上高(Ross) 2,348(-9.4) 2,629(+4.2) 国際売上高 2,040(+14.4) 1,684(+19.1) ●Vascular 1,663(+53.8) 1,082(+327.7) 国内売上高 863(+33.5) 647(+359.2) 国際売上高 800(+83.9) 435(+288.0) ★Ross 2,523(+8.5) 2,326 2,136 2,088 2,088 ★International (a)(b) 6,967(+13.0) 6,166 5,321 5,036 4,418 国際医薬品 5,164(+12.8) 国際栄養剤 1,803(+13.7) ★Total Reportable Segments 21,769 21,637 19,101 16,548 17,268 15,972 Other 2,073(+12.5) 707 701 579 732 417 313 ■Net Sales 25,914(+15.3) 22,476(+0.6) 22,338(+13.5) 19,680 17,280 17,685 16,285 国内売上高 12,874(+12.0) 11,534(-7.5) 12,442(+13.0) 国際売上高 13,040(+18.8) 10,942(+10.9) 9,896(+14.2) TAP Pharmaceutical 3,260(-3.0) Hospital* - - 3,078 2,979 2,778 from 10-K[02/25/04] ●売上
($ milllion) 2007 2006 2005 2004 2003 2002 2001 United States 13,252 11,995 12,707 11,242 9,919 10,998 10,249 Japan 1,111 1,054 1,027 987 897 784 748 Germany 1,235 885 992 811 785 721 644 The Netherlands 1,271 1,061 899 705 556 446 349 Italy 974 848 806 745 658 572 496 Canada 832 762 680 595 526 512 468 France 854 696 657 587 467 Spain 731 583 542 513 426 United Kingdom 627 517 504 496 397 その他 5,027 4,075 3,524 2,999 2,649 3,652 3,331 Consolidated 25,914 22,476 22,338 19,680 17,280 17,685 16,285 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。
($ milllion) 2007 2006 2005 2004 2003 2002 2001 2000 備考 ★Pharmaceutical Humira 3,064(+49.9) 2,064 1,400 852 280 - - - [adalimumab]リウマチ 米国 1,651(+40.4) 1,176(+38.4) 849(+53.2) 555(+125.6) 246(-) 海外 1,413(+62.9) 868(+57.6) 551(+85.4) 297(-) 34(-) Mobic 米国のみ - - 1232(+107.8) 593(+85.1) 320(+40.0) 229(40.1) 163(-) - [Meloxicam]消炎鎮痛 Depakote 1,575(+20.4) 1,308 1,096 1,027 927 898 869(+12.0) 39(+1.9) [divalproex sodium]抗てんかん剤 米国 1,480(+20.3) 1,230(+18.5) 1,037(+6.1) 978(+10.4) 886(+2.9) 861(-0.9) 海外 95(+21.7) 78(+24.8) 59(+20.3) 49(+18.2) 41(+12.3) 37(-3.6) Clarithromycin 724(-11.2) 816 1,065 1,183 1,221 1,102 537(-7.2) 622(-6.3) [Biaxin,Biaxin XL, Klacid, Klaricid]抗生物質 米国 36(-75.9) 151(-50.5) 306(-33.2) 458(-15.0) 538(+10.5) 487(-9.2) 海外 688(+3.5) 665(-12.5) 759(+4.8) 725(+6.1) 683(+11.0) 615(-1.0) Kaletra 1,325(+16.7) 1,135 1,005 896 752 551 210(-) 83(-) [lopinavir/ritonavir]HIV 米国 538(+5.0) 512(+22.0) 420(+5.5) 398(+3.9) 383(+20.6) 318(51.3) 海外 787(+26.3) 623(+6.5) 585(+17.6) 498(+35.0) 369(+58.5) 233(179.4) TriCor 米国のみ 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/Sevorane 759(-5.0) 799 874 774 674 567 192(+9.8) 309(+10.9) [Sevoflurane]全身麻酔剤 米国 200(-23.4) 260(-22.5) 336(+16.0) 290(+12.7) 257(+16.3) 221(15.0) 海外 559(+3.9) 539(+0.2) 538(+11.1) 484(+15.9) 417(+20.6) 346(11.9) Niaspan[米国] 658(-) - - [Niacin]脂質低下剤;2006Q4 Kos Pharmaceuticals Inc買収に伴う Synthroid 533(-0.3) 534 554 689 609 520 445(-) 22(-) [levothyroxine sodium]甲状腺 米国 458(-2.7) 470(-5.7) 498(-21.7) 637(+12.8) 565(+15.5) 489(+9.9) 海外 75(+17.2) 64(+14.5) 56(+7.8) 52(+16.6) 44(+42.9) 31(+42.9) Omnicef 米国のみ 235 637(+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 Leuprolide 海外のみ - 230(+4.6) 219(+11.0) 198(+8.2) 183(+6.3) 105(13.6) 163(+6.2) [Lupron,Lucrin] Lansoprazole 海外のみ - 173(+12.3) 154(+8.0) 142(+7.8) 132(+25.4) 172(5.6) 93(+18.0) [Prevacid,Ogastro] Flomax - - (B-Iとの併販解消04.8) 724 575 [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. 2,326(+14.8) 2,026 1,795 1,741 1,620 1,490 [] 米国 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 1,093(+21.6) 898(+28.7) 698(+17.3) 595(+13.0) 527(+8.4) 486(1.1) 480(+8.5) Adult Nutritionals 2,024(+7.6) 1,882 1,792 1,597 1,400 1,366 [] 米国 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 947(+14.9) 785(+9.7) 742(+11.5) 663(+12.1) 591(+11.9) 528(3.9) 508(+0.2) Diabetes Care 1,249(+9.9) 1,136 1,067 791(+46.1) 541 494 [] 米国 553(+1.3) 547(+4.8) 522(+38.1) 378(+84.8) 204(-0.4) 205(8.1) 190(+0.5) 海外 696(+18.0) 589(+8.2) 545(+31.8) 413(+22.7) 337(+16.8) 289(8.8) 265(+7.8) Coronary Stents 672(-) - 米国 306(-) - 海外 366(-) - Other Coronary 604(+32.5) 米国 300(+13.0) 海外 304(+59.8) Endovascular 388(+11.9) 米国 257(+0.8) 海外 130(+42.9) Vascular Devices - 253 221(+19.3) 185(+44.7) 205(33.3) - [] 米国 - 141(+11.7) 221(+19.3) 185(+44.7) 205(33.3) - 海外 - 112(+18.8) - - - - ★TAP Pharm (非連結) Prevacid 米国のみ 2,275 2,600(+4.0) 2,501 2,592(-18.7) 3,190(+1.0) 3,157(7.0) 2,951(+7.7) 2,739 [Lansoprazole]潰瘍 Lupron 米国のみ 645 662(-5.2) 699 770(-2.2) 788(-10.1) 876(5.2) 833(+4.2) 799 [Leuprolide]前立腺癌 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。
($million) 2006Q1+Q2 2005 2004 2003 2002 2001 2000 1999 備考 売上高 170.8+223.7 746.197 495.545 293.907 172.693 91.447 60.174 36.340 [] Advicor 142.6 w/+34.9 116.0 108.2 67.4 27.1 [niacin+losvastatin] Niaspan +131.0 435.2 319.1 226.5 145.6 [niacin] Azmacort 22.9+26.5 103.2 68.3 - []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 +25.8 69.7 - - [diltiazem]販売開始2005.5;from Bioval []
●Abbott ●Press release Abbott Reports 16.1 Percent Sales Growth in Fourth Quarter[2008.1.23] ●Products ●Investor Relations ★SEC Filings 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 Book ★Annual 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 Health ●Abbott 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） ●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) $3,362 Million ●Products Prevacid ●Prescribing Information ●Diseases & Conditions
($ 000) 2007 2006 2005 2004 2003 2002 2001 備考 売上高 3,001,738 3,362,672 3,259,850 3,361,634 4,034,000 販売原価 719,976 835,834 883,404 990,417 粗利益 2,526,838 2,376,446 2,371,217 営業利益 1,560,620 1,512,326 1,373,993 1,176,389 経常利益 1,564,488 1,523,326 1,379,331 1,181,052 当期純利益 996,030 951,621 882,772 749,969 研究開発費 161,013 245,476 219,412 167,625 従業員数[連結] 3,000 3,475 Prevacid米国 2,275,293 2,599,886 2,501,052 [Lansoprazole]潰瘍 Lupron米国 645,450 662,374 698,806 [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(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%
(Eur 000) 2007 2006 2005 2004 2003 2002 2001 売上高 65,364 72,190.58 69,130.31 69,410.20 内Pharma 47,820[73.15%] 57,136.18 53,996.36 49,290.60 42,200 36,300 34,400 Manufacturing 12,880[19.72%] 11,846.84 12,277.79 15,207.90 12,600 10,700 10,700 Royalty&Down payment 4,660[7.13%] 3,207.56 1,856.16 4,911.70 12,000 7,600 13,950 EBITDA 7,640 8,961 EBIT 2,687.28 2,814.94 2,672.57 純利益 (639.24) (1,017.69) (478.72) 従業員数[連結] 369
●Abiogen Pharma S.p.A[伊] ■Pharma ●Abiogen Pharma's products Nerixia (neridronic acid sodium) ■R & D ●Licensing In
●Licensing Out
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 ●Pipeline /2008.8.3
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 伊 glibenclamide+metformin 糖尿病 伊Fornier Pharma/Solvay Pharma 伊 仏Merck Sante 欧州 米BMS 米国 メキシコProductos Roche メキシコ tacalcitol 伊IDI Farmaceutici 伊 17β-estradiol 伊Solvay Pharma 伊 ■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)
製品名 成分 薬効 段階 備考 CL-I.A. clodronate 変形性関節症 P3 Nerixia neridronate 骨粗鬆症・Algodistrophy P3 BTG1640 isoxazoline誘導体 不安症・パニック障害 P2 TALL 104 Human cytotoxic cell line 癌 P1 Combotox MOAB-Anti-CD19 Toxin
MOAB-Anti-CD22 Toxin非ホジキンリンパ腫 P1 IMTOX 22 MOAB-Anti-CD22 Toxin 非ホジキンリンパ腫 P1
- 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)
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Abiogen Pharma's new cell therapy starts a clinical phase I-II in Peritoneal Carcinosis(14th Apr 2005)
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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: ABBI) 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)の分離。 2007.11.13 残ったABBIはAbraxis Oncology and Abraxis Research事業を含み ;→APP Pharmaceuticals Inc[APPX]に社名変更。 2008.7.6 APP Pharmaceuticals, IncはFresenius SEと合併計画。 ●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*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) 2007 2006 2005 2004 2003 2002 2001 2000 売上高 647,674 583,201
旧765,488(+47)385,082
旧520,757(+29)405,010
旧405,247351,315
旧351,744283,616 192,029 165,495 粗利益 315,328 295,122
旧457,976181,646
旧293,522213,236
旧212,993189,742
旧190,052141,778 70,410 59,908 営業利益 160,160 140,797
旧3,75686,270
旧87,328136,819
旧64,949120,621
旧87,92150,589 25,382 -12,246 経常利益 137,180 123,785
旧(17,598)60,865
旧55,646120,466
旧46,566101,539
旧67,26135,578 22,167 (13,797) 純利益 34,358 (46,897) 17,657 18,221 26,353 18,647 12,628 -8,759 研究開発費 46,497 27,787
旧96,89118,454
旧68,89616,707
旧51,46217,422
旧39,26935,344 13,790 13,016 従業員数 1,375 1,864 1,488 1,381 研究開発 72 240 92 73(Ph.D.=35) 品質管理 315 376 282 301 製造部門 779 807 798 711 販売営業 61 247 207 175 事務管理 148 194 109 121 [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.
($000) 2007 2006 2005 2004 2003 2002 備考 Critical care 382,772 302,244
旧303,485(+86)163,581(-8) 178,242(+5) 169,849(+25) 135,370 oxytocin,heparin Anti-infective 193,704 213,489(+26) 169,818(+36) 125,052(+31) 95,581(+29) 74,082 Oncology 55,308 57,872
旧57,983(+14)51,084(-47) 95,866(+18) 81,049(+32) 61,204 受託製造他 15,590 9,595
旧9,485(-)599(-90) 5,850(+21) 4,836(-29) 6,818 純売上高 583,201
旧584,442(+52)385,082(-5) 405,010(+15) 351,315(+27) 277,474 Abraxane 324,692 174,906(+31) 133,731(-) - - - [Paclitaxel-albumin]乳癌;米国発売2005.2.7 Research Revenue 6,140(+216) 1,944(+720) 237 総収入 647,374 765,488(+47) 520,757(+29) 405,247 351,744 283,616 [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. ●Products ★Abraxane ★Product Catalog ●Research ★NDA pipeline ●IR/Media ★Press Releases 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[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 $2.7 million(2003)受領 当初1997.9 神経因性疼痛及び眼科用薬の新薬創製で提携契約。 1999.7 緑内障治療薬開発で提携。 [The Stanley Medical Research Institute, or SMRI] 2004.5 ３年契約 統合失調症の新薬開発 [Aventis] 2002.7 [Amgen] 2001.12 small molecule drugs の創薬
●ACADIA Pharmaceuticals Inc ■Investors ●SEC Filings Annual Filings 10-K[2005.3.18] - [pdf][84p] ●Annual Reports ●Press Releases ■News ●Programs ●Technology ●Partnering
■Acorda Therapeutics Inc
- 1995.3 設立。 spinal cord injury (SCI), multiple sclerosis (MS)などの神経分野 2008.2 Neurorecovery, Inc.を買収 ●会社決算[Fampridine-SR 2006] 2006.9 P3 Start for improvement of walking ability in people. In this trial, statistical significance was achieved on all three efficacy criteria defined in the SPA. In January 1997, we licensed from Elan exclusive worldwide rights to Elan’s sustained release formulation of fampridine, Fampridine-SR, for the treatment of SCI. In April 1998, we formed MS Research & Development Corporation, or MSRD, with Elan’s subsidiary, Elan International Services, Ltd., or EIS, to develop Fampridine-SR for treatment of MS. At that time, MSRD licensed from Elan exclusive worldwide rights to Fampridine-SR for the treatment of MS.
($ 000) 2006 2005 2004 2003/12 2003/6 2002/6 備考 Zanaflex売上 26,944 4,809 (4,417) - - - [tizanidine HCl]筋弛緩剤;痙性麻痺 Grant収入 407 336 479 382 474 132 収入 合計 27,351 5,145 (3,938) 382 474 132 粗利益 20,228 13 (4,823) 382 474 132 営業利益 (23,467) (34,411) (44,767) (36,773) (25,706) (22,338) 当期純利益 (24,019) (35,531) (44,741) (36,712) (25,734) (21,182) 研究開発費 12,055 12,890 21,999 16,743 17,527 11,147 研究開発関連Party - - - 3,343 2,265 4,687 従業員数[連結] 126 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 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 Relations ●News & Announcements 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[2007.3.26] - [pdf] - [word] - [xls] ●Anual Reports ■Pipeline ●Marketed Products 市販製品はZanaflex CapsulesTM (tizanidine hydrochloride) のみ Zanaflex full prescribing information ●Clinical Stage Fampridine-SR - multiple sclerosis and spinal cord injury P3
■Actelion Ltd
-http://www.actelion.com/ 創立1997.12； 本社スイス； 従業員数681人(2004.3); 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★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.
(CHF milllion) 2006 2005 2004 2003 2002 2001 備考 売上 945.7(+43) 663.6(+41) 471.9 307.5 132.4 14.0 Tracleer 898.7 633.2 449.2 299.7 121.8 3.4 (Bosentan)肺高血圧 Zavesca 25.4 14.4 6.1 0.7 - - (miglustat)[2003春に英独発売]脂質蓄積異常ゴーシェ病 契約収入 21.5 16.0 16.5 7.2 10.6 10.6 operating支出 677.5(+33) 511.3(+32) 386.3 309.2 164.5 116.6 経常利益[EBIT] 268.2(+76) 152.3(+78) 85.6 (-1.7) (-32.0) (-102.5) 純利益 241.1(+92) 125.5(+44) 87.2 (-9.9) (-52.1) (-122.9) 研究開発費 211.8 171.5 136.3 79.2 50.6 58.7 従業員数 1028 854 660 412 263
●Actelion Ltd ■Products ●Tracleer.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) ■Media ●Media Releases 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] ■Research Pipeline ●Research Pipeline ■Development Pipeline ●Development Pipeline ★Tracleer (bosentan) ★Zavesca (miglustat) ★Clazosentan ★Actelion-1 ★Orexin RA ★Palosuran ■Investors ●Financial Information〜年報、GAAP四半期報告 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 Annual Report 2006 - [pdf] Annual Report 2005 - [pdf] Annual Report 2004 - [pdf] Annual Report 2003 - [pdf] ●Media Releases Actelion announces Full Year 2004 financial results[2005.2.24] Actelion announces Full Year 2003 financial results[2004.3.2] - 2003年末でTracleerは18か国で販売。 ●Company Information〜製品一覧・治験薬一覧
●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. ●Products ★Mucinex ★Mucinex DM 咳止め 発売September 2004 ★http://www.mucinex.com/ Mucinex DrugFacts ●News ★Press Releases ★Product 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 ●Products ★Parkinson's Disease ★Restless Legs Syndrome ★Cardiac Imaging ★Atrial Fibrillation ★Wound Healing in Diabetic Foot Ulcers ●product 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
■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 market ●Investors ★Financials ●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 & Facts ★Press 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/ 2001.8 ベンチャー数社が合同で設立。 GlaxoSmithKlineからのa spin-out 2007現在Hematideの開発に集中。 ●会社決算★武田薬品との提携
($ 000) 2006 2005 2004 2003 2002 2001 提携収入 11,688 - - - - ライセンス・ロイヤリティ 38 74 151 225 103 (収入合計) 11,726 74 151 225 103 研究開発費 54,347 24,051 17,338 13,660 16,834 営業経費 計 65,436 34,083 22,269 28,944 28,448 営業利益 (53,710) (34,009) (22,118) (28,719) (28,345) 経常利益 当期純利益 (48,288) (32,576) (21,398) (28,197) (28,046) 従業員数[連結] 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
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 blo