[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 * 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[] * 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 --- 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 【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. $2.6 Billion) - [日本語] - [説明資料]
■Abbott
【米アボット】ソルベイの製薬部門買収‐新興国市場のインフラ獲得へ[2009.9.30] 【データモニター】ソルベイ買収でアボットの成長率は大幅改善[2009.10.9] ●決算 [各12月末]●売上
($ milllion) 2009 2008 2007 2006 2005 2004 2003 2002 2001 2000 備考 純売上高 30,764.7
旧25,527.625,914.2 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 6,235.7 5,693.8 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 7,193.8 5,856.3 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 5,745.8 4,880.7 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 2,743.7 2,688.8 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 170.0 97.3 - 2,014.0 17.1 279.0 100.2 従業員数 73,000 69,000 68,000 66,663 59,735 ? 72,181 71,819 71,426 60,571 ■セグメント別売上高 ●Pharmaceutical (a) 16,486(-1.3) 16,708(+14.2) 14,632(+18.0) 12,395(-9.5) 13,691
旧8,138(+16.1)11,913
旧7,0106,051 4,268 3,759 米国内医薬品 国内売上高 7,794(-8.3) 8,497(+8.9) 7,806(+19.2) 6,550(-19.5) 国際売上高 8,692(+5.8) 8,211(+20.3) 6,826(+16.8) 5,845(+5.3) ●Diagnostic (b) 3,578(+0.1) 3,575(+13.2) 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 939(+4.4) 899(+9.6) 820(+2.6) 1,356(+7.5) 1,252(+11.8) 国際売上高 2,639(-1.4) 2,676(+14.5) 2,338(+14.4) 2,633(+5.1) 2,504(+10.9) ●Nutritional 5,284(+7.3) 4,924(+12.2) 4,388(+1.7) 4,313(+9.6) 国内売上高(Ross) 2,636(+6.3) 2,479(+5.6) 2,348(-9.4) 2,629(+4.2) 国際売上高 2,648(+8.3) 2,445(+19.8) 2,040(+14.4) 1,684(+19.1) ●Vascular 2,692(+20.1) 2,241(+34.7) 1,663(+53.8) 1,082(+327.7) 国内売上高 1,599(+32.7) 1,205(+39.6) 863(+33.5) 647(+359.2) 国際売上高 1,093(+5.5) 1,036(+29.4) 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 27,448 23,841 21,769 21,637 19,101 16,548 17,268 15,972 Other 2,725(+31.1) 2,080 2,073(+12.5) 707 701 579 732 417 313 ■Net Sales 30,765(+4.2) 29,528(+13.9) 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 14,220(+0.4) 14,170(+10.1) 12,874(+12.0) 11,534(-7.5) 12,442(+13.0) 国際売上高 16,545(+7.7) 15,358(+17.8) 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 ■国別売上高 United States 14,453 14,,495 13,252 11,995 12,707 11,242 9,919 10,998 10,249 Japan 1,590 1,249 1,111 1,054 1,027 987 897 784 748 Germany 1,481 1,381 1,235 885 992 811 785 721 644 The Netherlands 1,801 1,,753 1,271 1,061 899 705 556 446 349 Italy 1,172 1,089 974 848 806 745 658 572 496 Canada 902 924 832 762 680 595 526 512 468 France 959 977 854 696 657 587 467 Spain 970 909 731 583 542 513 426 United Kingdom 779 725 627 517 504 496 397 その他 6,658 6,026 5,027 4,075 3,524 2,999 2,649 3,652 3,331 Consolidated 30,765 29,,528 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) 2009 2008 2007 2006 2005 2004 2003 2002 2001 2000 備考 ★Pharmaceutical Humira 5,488(+21.4) 4,521(+47.6) 3,064(+49.9) 2,064 1,400 852 280 - - - [adalimumab]リウマチ 米国 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 2,969(+31.0) 2,266(+60.4) 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 425(-68.8) 1,364(-13.4) 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 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) Clarithromycin 651(-10.1) 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 - 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) Kaletra 1,366(-7.3) 1,474(+11.2) 1,325(+16.7) 1,135 1,005 896 752 551 210(-) 83(-) [lopinavir/ritonavir]HIV 米国 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 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 1,337(-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/Sevorane - 787(+3.7) 759(-5.0) 799 874 774 674 567 192(+9.8) 309(+10.9) [Sevoflurane]全身麻酔剤 米国 - 193(-3.4) 200(-23.4) 260(-22.5) 336(+16.0) 290(+12.7) 257(+16.3) 221(15.0) 海外 - 594(+6.2) 559(+3.9) 539(+0.2) 538(+11.1) 484(+15.9) 417(+20.6) 346(11.9) Niaspan[米国] 855(+8.8) 786(+19.4) 658(-) - - [Niacin]脂質低下剤;2006Q4 Kos Pharmaceuticals Inc買収に伴う Synthroid 502(-4.3) 524(-1.6) 533(-0.3) 534 554 689 609 520 445(-) 22(-) [levothyroxine sodium]甲状腺 米国 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) 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 800(+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 540(+43.2) 377 海外 260(-5.3) 274 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) 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. 2,849(+7.8) 2,642(+13.6) 2,326(+14.8) 2,026 1,795 1,741 1,620 1,490 [] 米国 1,306(+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 1,543(+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 Nutritionals 2,375(+6.4) 2,232(+10.3) 2,024(+7.6) 1,882 1,792 1,597 1,400 1,366 [] 米国 1,269(+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 1,106(+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) Diabetes Care 1,242(-8.2) 1,353(+8.4) 1,249(+9.9) 1,136 1,067 791(+46.1) 541 494 [] 米国 498(-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 744(-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) Coronary Stents 1,618(+35.0) 1,199(+78.4) 672(-) - 米国 1,029(+53.8) 669(+118.5) 306(-) - 海外 589(+11.3) 530(+44.8) 366(-) - Core Laboratory Diagnostics 3,027(-2.3) 米国 605(-1.9) 海外 2,422(-2.4) Medical Optics 890(-) - 米国 337(-) - 海外 553(-) - Molecular Diagnostics 316(+18.3) 米国 150(+23.5) 海外 166(+14.0) Other Coronary - 642(+6.5) 604(+32.5) 米国 - 298(-0.5) 300(+13.0) 海外 - 344(+13.4) 304(+59.8) Endovascular - 400(+3.1) 388(+11.9) 米国 - 238(-7.6) 257(+0.8) 海外 - 162(+24.1) 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 - [1-4月]649 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 - [1-4月]182 645 662(-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 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] ●Products ■Investor Relations ●SEC Filings 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 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) 2008/1-4 2007 2006 2005 2004 2003 2002 2001 備考 売上高 853,093 3,001,738 3,362,672 3,259,850 3,361,634 4,034,000 販売原価 228,747 719,976 835,834 883,404 990,417 粗利益 2,526,838 2,376,446 2,371,217 営業利益 355,861 1,560,620 1,512,326 1,373,993 1,176,389 経常利益 356,101 1,564,488 1,523,326 1,379,331 1,181,052 当期純利益 237,994 996,030 951,621 882,772 749,969 研究開発費 54,381 161,013 245,476 219,412 167,625 従業員数[連結] 2,900 3,000 3,475 Prevacid米国 649,303 2,275,293 2,599,886 2,501,052 [Lansoprazole]潰瘍 Lupron米国 182,042 645,450 662,374 698,806 [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)
-
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)
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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*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) 2008 2007 2006 2005 2004 2003 2002 2001 2000 売上高 345,309 333,686
旧647,674182,287
旧583,201
旧765,488(+47)135,,675
旧385,082
旧520,757(+29)237
旧405,010
旧405,247351,315
旧351,744283,616 192,029 165,495 粗利益 306,241 299,236
旧315,328161,104
旧295,122
旧457,976111,609
旧181,646
旧293,522(103)
旧213,236
旧212,993189,742
旧190,052141,778 70,410 59,908 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64,949120,621
旧87,92150,589 25,382 -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46,566101,539
旧67,26135,578 22,167 (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18,22126,353 18,647 12,628 -8,759 研究開発費 103,590 88,717
旧46,49763,073
旧27,787
旧96,89150,121
旧18,454
旧68,89634,896
旧16,707
旧51,46217,422
旧39,26935,344 13,790 13,016 取得研究開発費 13,900 - 83,447 - - 従業員数 734 1,375 1,864 1,488 1,381 研究開発 310 72 240 92 73(Ph.D.=35) 品質管理 315 376 282 301 製造部門 160 779 807 798 711 販売営業 136 61 247 207 175 事務管理 128 148 194 109 121 [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) 2008 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 - 647,374 583,201
旧584,442(+52)385,082(-5) 405,010(+15) 351,315(+27) 277,474 Abraxane 335,631 324,692 174,906(+31) 133,731(-) - - - [Paclitaxel-albumin]乳癌;米国発売2005.2.7 Research Revenue 9,678 8,994 7,381
旧6,140(+216)1,944(+720) 237 総収入 345,309 333,686
旧647,374182,287
旧765,488(+47)135,675
旧520,757(+29)237
旧405,247351,744 283,616 [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 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 $2.7 million(2003)受領 当初1997.9 神経因性疼痛及び眼科用薬の新薬創製で提携契約。 1999.7 緑内障治療薬開発で提携。 [The Stanley Medical Research Institute, or SMRI] 2004.5 ３年契約 統合失調症の新薬開発 [Aventis] 2002.7 [Amgen] 2001.12 small molecule drugs の創薬
●ACADIA Pharmaceuticals Inc ■Investors ●SEC Filings Annual Filings 10-K[2005.3.18] - [pdf][84p] ●Annual Reports ●Press Releases ■News ●Programs ●Technology ●Partnering
■Acorda Therapeutics Inc
- 1995.3 設立。 spinal cord injury (SCI), multiple sclerosis (MS)などの神経分野 2008.2 Neurorecovery, Inc.を買収 ●会社決算[Fampridine-SR 2006] 2006.9 P3 Start for improvement of walking ability in people. In this trial, statistical significance was achieved on all three efficacy criteria defined in the SPA. In January 1997, we licensed from Elan exclusive worldwide rights to Elan’s sustained release formulation of fampridine, Fampridine-SR, for the treatment of SCI. In April 1998, we formed MS Research & Development Corporation, or MSRD, with Elan’s subsidiary, Elan International Services, Ltd., or EIS, to develop Fampridine-SR for treatment of MS. At that time, MSRD licensed from Elan exclusive worldwide rights to Fampridine-SR for the treatment of MS.
($ 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[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.
(CHF milllion) 2009 2008 2007 2006 2005 2004 2003 2002 2001 備考 売上 1,772.564(+23) 1,473.508(+12) 1,317.392(+) 945.7(+43) 663.6(+41) 471.9 307.5 132.4 14.0 Tracleer 1,508.0(+19) 1,294.1(+10) 1,180(+31) 898.7 633.2 449.2 299.7 121.8 3.4 (Bosentan)肺高血圧 Zavesca 53.1(+38) 40.1(+14) 35.3(+39) 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 Ventavis 136.9 94.6(+21) 78.2 [inhaled iloprost]肺高血圧 契約収入 74.574 44.602 25.309 21.5 16.0 16.5 7.2 10.6 10.6 営業経費 1,433.158 1,102.151(-6) 1,174.790(+) 677.5(+33) 511.3(+32) 386.3 309.2 164.5 116.6 経常利益[EBIT] 338.522 337.522
旧352.939168.274 268.2(+76) 152.3(+78) 85.6 (-1.7) (-32.0) (-102.5) 純利益 311.270 306.073
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 464.136 374.530 292.137 211.8 171.5 136.3 79.2 50.6 58.7 従業員数 2,263 1,900 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) ■Journalists ●News 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] ■Scientists ●Development Pipeline ★Tracleer (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 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 2009 US GAAP FY 2008 US GAAP FY 2007 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$125 million相当の株式を公開。 同社主力品MucinexはSudafed[Pfizer], Nyquil[P&G], Theraflu[Novartis] ,Claritin[Schering-Plough]と競合。 関連会社●Adams Respiratory Therapeutics, Inc. -http://www.adamsrt.com/ 同社はAdams Labsの呼吸器疾患用薬剤の開発、製造、販売を目的として設立。
●Adams Laboratories Inc. ●Products ★Mucinex ★Mucinex DM 咳止め 発売September 2004 ★http://www.mucinex.com/ Mucinex DrugFacts ●News ★Press Releases ★Product Launches
■Aderis Pharmaceuticals[US]
1994.4 Ethyl Corp子会社Whitby Research Incの研究プログラム買収により設立。 1998.8 Schwarz Pharmaとパーキンソン病用パッチ剤開発で提携 2001.11 rotigotine CDS P3へ 2002.1 Discovery TherapeuticsをAderis Pharmaceuticalsに社名変更
●Aderis Pharmaceuticals -http://www.aderis.com/index.asp ●Products ★Parkinson's Disease ★Restless Legs Syndrome ★Cardiac Imaging ★Atrial Fibrillation ★Wound Healing in Diabetic Foot Ulcers ●product candidates Rotigotine(SPM-962)～パーキンソン病NDA/RLS(P2) /Schwarz社提携 Binodenoson(MRE-0470)～心臓機能診断薬 P3 /King社提携 Selodenoson(DTI-0009)～抗不整脈剤 P2 / MRE-0094～糖尿病性足部潰瘍治療薬 P1 /King社提携 ●Press Releases
■Adolor Corporation[米]
- http://www.adolor.com/ ;本社Exton, Pennsylvania 1994 創立 2000 NASDAQ上場 ●会社決算
($ 000) 2008 2007 2006 2005 2004 2003 2002 2001 ENTEREG売上 1,248 - - - - - - - [alvimopan]術後腸閉塞;FDA承認08.5、発売08.6 契約収入 48,208 9,120 15,087 15,719 25,542 20,727 総収入 計 49,456 9,120 15,087 15,719 25,542 20,727 研究開発費 52,664 41,610 56,660 49,631 48,766 56,654 販売・一般管理費 31,115 23,970 37,689 26,293 22,870 17,648 (経費計) 83,983 65,580 94,349 75,924 71,636 74,302 営業外収支 4,405 8,017 9,524 3,408 2,508 2,369 当期純利益 (30,122) (48,443) (69,738) (56,797) (43,586) (51,206) 従業員数[連結] 128 108
●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 Insights ★NEWS 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 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/ ;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★武田薬品との提携
($ 000) 2008 2007 2006 2005 2004 2003 2002 2001 提携収入 82,162 44,303 11,688 - - - - ライセンス・ロイヤリティ 689 33 38 74 151 225 103 (収入合計) 82,851 44,336 11,726 74 151 225 103 研究開発費 137,492 69,398 54,347 24,051 17,338 13,660 16,834 営業経費 計 171,582 93,473 65,436 34,083 22,269 28,944 28,448 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 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 & D ■INVESTORS ●Press Releases ●Annual Reports ●SEC 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●セグメント別売上高
($000) 2006 2005 2004 2003 2002 2001 2000 1999 収入 71,250 44,484 50,708(+12) 45,491 51,419 41,545 66,221 64,632 粗利益 26,880 14,944 18,202(+50) 12,148 20,537 6,398 28,131 33,477 営業利益 -4,905 -7,479 -368 -6,276 -3,565 -21,074 -1,731 12,122 経常利益 -5,960 -8,592 -3,018 -12,496 -6,713 -24,926 -4,014 10,639 純利益 -5,963 -8,609 -3,026 -12,325 -12,952 -15,146 -2,414 6,670 研究開発費 11,797 4,510 1,861 1,465 1,886 2,598 従業員数 371 ●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.
($000) 2006 2005 2004 2003 2002 2001 2000 1999 収入 71,250 44,484 50,708 45,491 51,419 41,545 66,221 64,632 眼科用製品 19,528 22,659 29,812 26,056 29,579 16,936 注射用製品 42,489 13,719 12,341 12,155 12,977 9,663 受託製造 9,233 8,106 8,555 7,280 8,863 14,946
●Akorn, Inc. ●Investor Relations ★Overview ★News 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。 ●会社決算会計処理は、-2003迄NL GAAP,2004-以降はIFRS ●事業別売上高
(Euro milllion) 2006 2005 2004 2003 2002 2001 2000 売上高[IFRS] 13,737(+6) 13,000 12,833 13,106 14,059 14,158 14,069 営業利益[IFRS] 1,462 1,486 1,527 1,064 1,362 1,198 1,487 純利益[IFRS] 1,153(+20) 961 945 602 818 671 947 研究開発費 885 810 807
旧823887 うちOrganon 484[18.6%] 433[17.9%] 395[17%] ●事業別従業員数
(Euro milllion) 2006 2005 2004 2003 2002 2001 2000 売上高 13,737(+6) 13,000 12,688 13,051 Ornanon 2,611(+8) 2,425 2,344 Intervet 1,125(+3) 1,094 1,027 医薬 3,246 3,600
旧3,5504,061 4,085 Coating 6,209(+12) 5,555 5,237 5,162
旧5,1445,444 5,522 化学品 3,809(-2) 3,890 4,317
旧4,1924,473
旧4,3474,679 4,680 その他 -17 36 14 10 合計 13,737(+6) 13,000 12,833 ●会社決算～医薬事業部門
(人) 2006 2005 2004 2003 2002 2001 2000 従業員数 61,880 61,340 61,450
旧61,40064,600 Organon 13,710 14,100 14,090 15,500 INTERVET 5,370 5,260 5,270 5,200 医薬 20,000 21,300 Coating 31,660 29,200 28,860 29,300 化学品 9,680 11,430 11,890
旧13,60014,400
旧14,500その他 1,460 1,350 1,340
旧1,1001,200 計 61,880 61,340 61,450
旧63,60066,400 2005年度以降はOrganonとIntervetを合算 ●製薬事業部門[Pharm]
(Euro milllion) 2006 2005 2004 2003 2002 2001 2000 売上高 3,736 3,519 3,246 3,550 4,044 3,839 2,865 営業利益 354+219 415+238 522 692 768 831 765 EBITDA 475+278 541+292 690 868 948 995 932 従業員数 19,080 19,360 20,000 21,300 21,700 21,000 21,200 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) 2006 2005 2004 2003 2002 2001 2000 1999 備考 Organon 2,611(+8) 2,425 2,344
旧2,0102,279 2,593 2,504 1,980(+49%) 1,620 PRESCRIPTION DRUGS Intervet 1,125(+3) 1,094 1,027
旧1,0241,010 1,081 1,096 1,020(+26%) 515 VETERINARY PRODUCTS Diosynth - - 366 479 529 488 380(+9%) 335 ACTIVE INGREDIENTS FOR THE PHARMACEUTICAL INDUSTRY Organon Teknika - - - - - - 555(+14%) 530 HOSPITAL SUPPLIES CHEFARO - - - - - - 85(+2%) 90 NONPRESCRIPTION PRODUCTS Pharm. Total 3,736 3,519 3,246 3,550 4,008 4,044 3,839(+34%) 2,865 ★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
(Euro milllion) 2006 2005 2004 2003 2002 2001 2000 備考 � Contraception 669(+18) 564(+8) 522(+4) 517(+7) 521(-3) 540(+10%) 492(+20%) うちNuvaRing 213(+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%) Livial 151(-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/Follistim 384(+8) 355(+20) 285(-11) 331(-1) 356(+8) 329(+17%) 282 [follitropin beta](infertility product) � Depression - 800(+11) 720(+39%) - - Remeron 253(-11) 283(-22) 363 524 717(+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 ingredients 255(+2) 228(+8) Anesthesia 242(+28) [] 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)
Project Application Phase Description ●Gynecology Org 50081 Serotonin -2-Blocker (hot flushes) III NOMAC/E2 Oral contraceptive in-licensed from Theramex (Merck KGaA) III Org 39970 Androgen II ●Fertility Org 36286 Sustained Follicle Stimulant(corifollitropin alpha) III ●Neuroscience asenapine dopamine/serotonin antagonist III Org 50081 Serotonin-2-Blocker (insomnia) III farampator AMPAkine II Org 34517 GR antagonist II Org 25935 GlyT1 inhibitor II ●Anesthesia sugammadex Selective muscle relaxant binding agent III ●Other Org 42675 Antithrombotic dual inhibitor II/X II
Project Application Phase Launch Description Org 33628 Contraceptive II (progesteron receptor modulator) "Male pill" contraceptive II >2005 (androgen/progestagen combination) FSH-CTP infertility II long-acting FSH Livial 1.25mg HT/osteoporosis III Selective tissue estrogenic activity regulator (STEAR); 規格追加 Variza(R)
depression filed 5HT-1A partial agonist Asenapine/Org 5222 psychosis III 2005 DA/5HT-antagonist Org 24448 psychosis II AMPAKINE Org 34517/34850 depression II HPA axis modulator Org 4420 sleep II NASSA Org 25969 Anesthesia II muscle relaxant binding agent Org 37663 immunology II anti-inflammatory steroid Org 39141 immunology II auto-antigen ●終了分 NuvaringR contraceptive ring approved 2002 発売 Implanon[R] contraceptive implant market 2000(Europe) III 2002/3(USA) Puregon Pen. infertility launched 2001 (Europe) 申請 2003 (USA) Xyvion. osteoporosis III 2004 (USA) AndriolR Testocaps. male HRT III 2002 (Europe) 申請 2004 (USA) Org 34517 depression II 2006 Arixtra thrombosis market 2002 (USA) filed 2002 (Europe) SanOrg 34006 thrombosis III >2005 Org 39141 rheumatoid arthritis II 2007
●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 Activities ★Products ★[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 Releases ★Reports & 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/ ■News ■Product ●Gynecology - www.orgyn.com ★Contraception - 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) 2009 2008 2007 2006 2005 2004 2003 2002 2001 売上高 6,499 6,294 5,599 4,897 4,368 3,914 3,407 営業利益 2,261 2,213 1,883 1,572 1,188 1,132 879 経常利益 2,313 2,083 1,929 1,617 1,203 1,126 858 当期純利益 2,007 2,047 1,586 1,348 931 872 595 研究開発費 665 619 564 512 422 390 350 従業員数[連結] 15,700 14,500 *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) 2009 2008 2007 2006 2005 2004 2003 2002 2001 2000 ★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) 706.9 582.9 513.9 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) 678.3 639.7 589.2 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) 247.4 242.0 230.3 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) 1632.6 1464.6 1333.4 ★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) 383.5 344.9 322.3 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) 760.2 718.0 674.7 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) 232.8 220.2 223.2 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) 1376.5 1283.1 1220.2 ★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) 1,767.7 1542.6(+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) 2,016.9 1818.4(+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) 583.9 556.6(+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) 4,368.5 3913.6(+14.9) 3406.9(+9.0) 3009.1 2747.7 2553.6
($ milllion) 2009 2008 2007 2006 2005 2004 2003 2002 2001 備考 感染症・抗炎症薬 829(-5.1) 874 814.5(+11.5) 730.2(+14.5) 641.0 572.7(+10.6) 517.9(+16.1) 446.0 365.2 (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) 955 830.1(+19.6) 693.8(+11.7) 621.4 526.3(+21.7) 432.4(+23.7) 349.6 276.1 (うちTravatan) - (135.3) (70.9) (15.8) [travoprost] アレルギー薬 486(+5.0) 463 446.8(+15.6) 386.6(+8.1) 357.5 321.4(+16.2) 276.6(+24.0) 223.1 181.1 [/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) 316 257.0(+8.4) 237.0(+10.1) 211.9 171.3(+39.4) 122.9(+37.0) 89.7 68.2 [/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) 2,561 2,313.8(+15.3) 2,007.2(+13.5) 1,767.7 1542.6(+17.8) 1309.9(+20.1) 1090.4 927.8 IOL[眼内レンズ] 1,133(+5.6) 1,073 919.4(+15.7) 794.4(+15.2) 689.4 583.9(+17.1) 498.6(+13.9) 437.7 405.4 白内障・硝子体手術用 1,759(+4.0) 1,692 1,528.8(+12.6) 1,357.7(+6.8) 1,271.3 1167.7(+14.8) 1017.0(+9.7) 927.0 875.7 屈折外科用 105(-9.5) 116 51.6(-0.2) 51.7(-8.0) 56.2 62.8(-10.7) 70.3(-4.7) 73.8 76.6 眼科手術製品 2,997(+4.0) 2,881 2,499.8(+13.4) 2,203.8(+9.3) 1,016.9 1814.4(+14.4) 1585.9(+10.2) 1438.5 1357.7 コンタクトレンズ消毒剤 448(-4.5) 469 440.2(+18.8) 370.6(+26.7) 292.6 298.9(+5.9) 282.2(+2.6) 275.1 250.9 [/Opti-Free(R)液] 人工涙液 283(+4.0) 272 233.2(+16.4) 200.4(+17.3) 170.8 141.5(+20.6) 117.3(+18.2) 99.2 96.5 その他 94(-15.3) 111 112.6(-1.7) 114.6(-4.9) 120.5 116.2(+4.1) 111.6(+5.4) 105.9 114.8 消費者向けEye Care 825(-3.2) 852 786.0(+14.6) 685.6(+17.4) 583.9 556.6(+8.9) 511.1(+6.4) 480.2 462.2 TOTAL SALES($) 6,499(+3.3) 6,294 5,599.6(+14.4) 4,896.6(+12.1) 4,368.5 3913.6(+14.9) 3406.9(+13.2) 3009.1 2747.7
●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 hProfessional ●Patients & Family ■Investors & Media ●Financials ★Annual Reports & Quaterly Reports - 2009 Annual Report - 2008 Annual Report - 2007 Annual Report - 2006 Annual Report - 2005 Annual Report - 2004 Annual Report ★SEC 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]●相手先部収入内訳 [３月決算]
($000) 2009/3 2008/3 2007/3 2006/3 2005/3 2004/3 2003/3 2002/3 2001/3 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 製造収入 116,844 101,700 105,416 64,901 40,488 25,736 14,317 - Royalty収入 33,247 29,457 23,151 16,532 9,636 3,790 1,165 - 研究開発契約収入 42,087 89,510 74,483 45,883 26,002 9,528 31,784 54,102 Net collaborative profit 130,194 20,050 36,915 39,285 - - - - 総収入 計 326,839 240,717 239,965 166,601 76,126 39,054 47,266 54,102 経費 製造原価 43,396 40,677 45,209 23,489 16,834 19,037 10,910 - 研究開発費 89,478 125,268 117,315 89,068 91,065 91,097 85,388 92,092 販売・一般管理費 59,008 59,508 66,399 40,383 28,823 26,029 26,694 24,387 リストラ費用 - 6,423 - - 11,527 -208 6,497 - 原価・経費 合計 191,882 243,506 228,923 152,940 148,249 135,955 129,489 116,479 営業利益 134,957 (2,789) 11,042 13,661 (72,123) (96,901) (82,223) (62,377) 当期純利益 130,505 166,979 9,445 3,818 (73,916) (102,385) (106,898) (61,355) 従業員数 570 760
($000) 2009/3 2008/3 2007/3 2006/3 2005/3 2004/3 種類 内訳 Janssen [46%] [52%] [47%] 82,798[49%] 50,446[66%] 28,488[73%] 製造&Royalty RISPERDAL 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。 Genentech 19[-%] 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 ●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$110 MILLIONのマイルストーンを受け取る契約を 2005.6に締結。 ●Investor Relations ★SEC Filings 10-K Annual[2009.5.28] - [pdf] 10-K Annual[2008.5.30] - [pdf] 10-K Annual[2007.6.14] - [pdf] 10-K Annual[2006.6.14] - [pdf]
■Allergan
http://www.allergan.com/ ●会社決算●事業別
($Million) 2008 2007 2006 2005 2004 2003 2002 2001 2000 備考 製品売上高 4,339.7 3,879.0 3,010.1 2,319.2 2,045.6 1,755.4 1,385.0 1,142.1 992.1 うち医薬 3,502.3 3,105.0 2,272.8 1,945.6 1,672.7 1,357.2 1,142.1 992.1 その他 837.4 774.0 46.4 100.0 82.7 27.8 - - 主に契約収入 その他収入 63.7 59.9 53.2 23.4 13.3 9.4 研究サービス収入 - - - - - 16.0 総収入 計 4,403.4 3,938.9 3,063.3 2,342.6 2,058.9 1,780.8 営業利益 796.1 719.4 (3.2) 570.9 527.4
旧1,658.9(23.7)
旧1,435.11,163.3 944.0 794.4 経常利益 787..2 687.7 (19.5) 599.2
旧570.9532.1
旧527.4(52.5)
旧-23.7129.0 242.1 研究開発費 797.9 718.1 1,055.5 388.3 342.9 762.6 233.1 227.5 165.7 純利益 578..6 499.3 (127.4) 403.9 377.1 -52.5 75.2 224.9 215.1 国際売上比率 34.8% 34.3% 32.6% 32.5% 30.9% 29.6% 29.4% 従業員数 8,740 7,886 5,055 5,030 *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]
($Million) 2008 2007 2006 2005 2004 2003 2002 2001 2000 1999 1998 備考 ■医薬品 /Specialty Pharmaceuticals Segment Product ●眼科用薬 2,009.1 1,776.5 1,530.6 1,321.7 1137.1(+13.8) 999.5(+20.8) 827.3 753.7 683.9 576.2 510.1 Alphagan 398.1(+) 341.4(+15.4) 295.9 277.2(+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 Lumigan 426.2 391.7(+19.6) 327.5 267.6(+14.9) 232.9(+28.5) 181.3(+47.4) 123.0 35.4 - - - Bimatoprost 眼科用緑内障 他の緑内障薬 14.8 15.3(-6.5) 16.3 18.0(-5.9) 19.1(-15.9) 22.7(-7.7) 24.6 Restasis 444.0 344.5(+27.5) 270.2 190.9(+91.2) 99.8(+160.6) 38.3(-) - - - - - cyclosporine/ドライアイ ●皮膚科用薬 113.7 110.7 125.7 120.2 103.4(-5.4) 109.3(+21.2) 90.2 78.9 68.7 76.6 60.6 Tazorac/Avage 77.2(-3.4) 79.9(-12.4) 91.2 86.9(+15.7) 75.1(-6.5) 80.3(+29.3) 62.1 45.4(+39.5) 32.7(+57.2) - - tazarotene ●Botox 1,310.9 1,211.8 982.2 830.9 705.1(+25.0) 563.9(+28.2) 439.7 309.5(+29.2%) 239.5(+39) 175.8 125.3 botulinum toxin A ●泌尿器用薬 68.6 6.0 - Sanctura 68.2 4.9 - ●その他 - - - 46.4 100.0(+20.9) 82.7(+197.5) 27.0 主にコンタクトレンズ 医薬品合計 3,502..3 3,105.0 2,638.5 2,319.2 2045.6(+16.5) 1755.4(+26.7) 1385.0 1142.1 992.1 828.6 716 ■医療機器 /Medical Devices Segment Product 胸部エステ 310.0 298.4 177.2 - 肥満症用品 296.0 270.1 142.3 - 顔エステ 231.4 202.8 52.1 - その他 - 2.7 - - 医療機器 計 837.4 774.0 371.6 -
緑内障 [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%, [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 緑内障 (bimatoprost/timolol maleate ophthalmic solution) [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) [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% [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 [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。[2008]
●Allergan ■Investors ●Earnings Releases 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[2009.2.27] - [pdf] 2008 Annual Report 10-K Annual Report[2008.2.28] - [pdf,188p] 2007 Annual Report - [pdf,16p] ●Products ●Press 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/
■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 908-566-3800With 1,355 employees and revenues of $654 million, Alpharma is active in more than 60 countries around the world. Founded in Norway in 1903, Alpharma is currently positioned for growth atop three strong anchors: pharmaceutical products (KADIAN(R) capsules and the FLECTOR(R) Patch), animal health and active pharmaceutical ingredients. Together, these business units provide operational efficiencies and enable the company to continue to deliver sustainable growth and long-term value.
●Alpharma Inc. -http://www.alpharma.com/pages/default.aspx ●Our Businesses ★KADIAN(R) capsules(morphine sulfate extended-release Capsules) ★FLECTOR(R) Patch(diclofenac epolamine topical patch) ●News Room Alpharma Reports Double-Digit Full Year and Fourth Quarter 2007 Revenue Growth [2008.2.26] The First and Only Anti-Inflammatory Pain Release Patch in the U.S. - FLECTOR(R) Patch - Now Available[2008.1.23] Alpharma Licenses Novel NSAID Topical Pain Drug [2007.9.5] - P3段階にあるketoprofen in Transfersome(R) gelに関して米国独占権を独IDEA AGから獲得した。 IDEA AG は2007.5 Europefor ketoprofen in Transfersome(R) gelの変形関節症の適応で申請した。 Alpharma to Market First Topical NSAID Patch in the U.S.[2007.8.21] - 米国初のNSAIDパッチ剤Flector Patchに関して、Institut Biochimique SAから米国独占販売権を獲得。 欧州ではIBSAが販売している。 1993年でスイスで初承認、以来39ヵ国で承認。
■Alseres Pharmaceuticals, Inc
- http://www.alseres.com/index.asp; (NASDAQ: ALSE) 85 Main Street, Hopkinton, MA 01748 Tel: (508) 497-2360 Fax: (508) 497-9964 創立1992 Boston Life Sciences, Inc. Changes Name to Alseres Pharmaceuticals, Inc.[2007.6.8] ●会社決算■開発中の新薬 /2008.3.13
($ ) 2008 2007 2006 2005 2004 2003 2002 売上高 - - - - - - - 営業費用 18,710,812 18,881,125 26,434,736 11,647,984 10,381,429 7,914,887 10,302,008 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 10,851,844 10,475,158 18,538,186 6,127,486 6,400,132 従業員数[連結] 27 27 27 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]
製品 適応 段階 備考 ■Regenerative Therapeutics CNS Cethrin® Acute spinal cord injury P2 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 Inosine Stroke, SCI 前臨床終了 ALSE-100, etal. Chronic SCI, TBI 研究中 OCULAR Oncomodulin Optic Nerve Injury/
Glaucoma研究中 ALSE-100 Glaucoma/macular degeneration/
retinis pigmentosa研究中 BONE ALSE-100 Bone 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 agents Parkinson's Disease / ADHD 前臨床終了 ■DAT Blocker(Dopamine Transporter Blocker) DAT Blocker Parkinson's Disease 前臨床終了 ３種
●Alseres Pharmaceuticals, Inc ●Product-Pipeline ■Investor Relations ●Financial Information ★SEC 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]●地域別[全体]
(Euro milllion) 2006 2005 2004 2003 2002 2001 2000 売上高 3,867 3,272 2,963 2,735(+5) 2,609 2,308 1,928 医薬事業 2,573 2,365 2,109 1,980 1,861 1,591 1,262 化学事業 1,294 907 854 755 748 717 666 営業利益 676 604 563(+5) 538 経常利益EBT 779 684(+14) 624 580(+10) 526 448 329 純利益 3,872 438 379 345(+6) 324 256 179 研究開発費 495(+6) 465 448 412(+12) 369 285 219 医薬 427 418[17.7%] 410(+8)[19.4%] 376[19.0%] 335 252 190 化学 68 47 38 36 34 33 29 従業員数 13,404 13,276 10,783(+4) 10,402(+6) 9,853 9,122 8,556 医薬 8,920(+1) 8,832 8,200(+6) 7,702 7,504 6,867 6,489 うち研究開発 1,656(+9) 1,514(+18) 1,281 1,052 927 化学 4,484 4,384 2,521 2,634 2,299 2,217 2,036 ●地域別[医薬]
(Euro milllion) 2006 2005 2004 2003 2002 2001 2000 欧州 627 454
旧1,6741,504 うち独 223 142
旧581491 北米 268 156
旧927880 うち米国 243 144
旧796769 中南米 - -
旧327278 極東 297 214
旧285250 その他 102 83
旧5951 合計 1,294 907
旧3,2722,963 ●セグメント別
(Euro milllion) 2006 2005 2004 2003 2002 2001 2000 医薬事業 2,573(+9) 2,365(+12) 2,109(+7) 1,980(+6) 1,861 1,591 1,262 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 * 医薬事業が81%、うち北米が37% ●製品売上高
(Euro milllion) 2006 2005 2004 2003 2002 2001 2000 売上高 3,867 3,272 2,963 2,735(+5) 2,609 2,308 1,928 医薬事業 2,573(+9) 2,365(+12) 2,109(+7) 1,980 1,861 1,591 1,262 治療薬 2,261(+9) 2,071(+13) 1,839(+7) 1,724 1,565 1,275 980 消化器 1,702(+11) 1,536(+12) 1,367(+10) 1,241(+15) 1,083 795 呼吸器 83(+20) 69(+17) 59(-1) 59(+3) 57 53 その他 476 466(+13) 413(-3) 424(-) 425 427 Imaging 108(-1) 108(-) 109(+3) 106 100 91 (OTC) 149(+14) 131(+13) 115(+11) 104 110 129 その他 55(+0) 55(+19) 46(-) 46 86 96 合計 2,573(+9) 2,365(+12) 2,109(+7) 1,980 1,861 1,591 化学事業 1,294(+43) 907 854 755 748 717 666 添加剤・機器
(Additives & Instruments)409(+13) 364 348(+13) 308 304 - - 電気断熱剤
(Electrical Insulation)325(+11) 293 291(+29) 225 223 - - 塗料・シール
(Coatings & Sealants)221(+26) 175 215(-3) 222 221 - - Effect Pigments 339(+13) 75 - - - - - 合計 1,294(+43) 907 854 755 748 717 666 ★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) 2006 2005 2004 2003 2002 2001 備考 Pantoprazole 1,551(+14)[69%] 1,361(+12)[57.6%] 1,216[57.6%] 1,113[26.2%] 966 680 (Protozol)潰瘍 Alvesco 18.2 8.1(-) - - - [cicletanide]喘息；発売2005.1 Contrast media 105 106 100 70 Ebrantil(R) 67 66 63 61 [urapidil]降圧剤;α遮断剤 Ferro 29 - 30 33 [ferro polymaltose]鉄剤 Riopan(R) 28 30 33 34 [Magaldrat]制酸剤・胸やけ Facial Topicals - - 26 - Theophylline - - 25 26 Euphyllin/Euphylong Querto(R) - - 24 23 [Carvedilol]from Roche;特許切れ2004 Sanostol(R) - - 20 17 []ビタミン剤 Chromagen - - 16 18 鉄剤＊2003.6 KV Pharmaceuticalsに売却 CroFab(TM) - 29 - 17 蛇毒 * 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
(Euro milllion) 2006 2005 2004 2003 2002 2001 2000 売上合計 2,882(+4) 2,768(+12) 2,481(+6) 2,350(+17) 2,007 1,326 650 自社売上分 1,551(+14) 1,361(+12) 1,216 1,113 966 680 411 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) 1,531 1,428(-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 (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
製品 欧州(1) 米国 日本 ciclesonide(物質) 2011(2) 2013(3) 2011(3) ciclesonide(Key中間体) 2014 2015 2014 ciclesonide(精製工程) 2017 2019 2017 ciclesonide(エアゾール) 2018 2018 2018 ciclesonide(点鼻製剤) 2020 2020 2020 roflumilast(物質) 2014(3) 2015(3) 2014(3) roflumilast(製剤) 2023 2023 2023 soraprazan(物質) 2019(3) 2019(3) 2019(3)
●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 Relations ●Publications 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================================== ★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. ==================================
(Dollars in millions) 2000 1999 1998 備考 ●ALZA Pharmaceuticals Ditropan XL(R) 179.0 86.9(+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) 48.4 48.3 32.6 [amifostine];2002.10.1 Medimmuneへ Elmiron(R) 33.7 29.9 23.0 [pentosan polysulfate sodium]間質性膀胱炎；1997.9 IVAXから米加の販売権取得 Mycelex(R) Troche 19.5(-33) 29.2 25.9 [clotrimazole]抗真菌剤; Testoderm TTS(R) line 18.6 20.8 10.0 [testosterone] Other 28.2 42.1 35.9 Total ALZA Pharmaceuticals 477.7 323.4 175.8 ●ALZA Technologies Contract manufacturing 129.5 124.6 113.6 Intersegment 53.4 41.2 22.1 Total ALZA Technologies 182.9 165.8 135.7 Intersegment eliminations (53.4) (41.2) (22.1) Total net sales 607.2 448.0 289.4
●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
■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 archives ●News & 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-US ★Product 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($1.3 Billion)。同社Press Releaseは、Tularik Press Release Archives (Tularikは５品目のCandidate、肝臓癌薬T67,消化器癌薬T607,抗炎症剤T487,糖尿病薬T131,抗肥満薬T71を開発) 2005.12.14 Abgenix Inc.を吸収。同社Press Releaseは、Abgenix Press Release Archives 同社は既発売品はなく、大腸癌治療薬panitumumabを開発中。 Abgenix Inc 2005年決算 ●会社決算●製品売上高
($ milllion) 2008 2007 2006 2005 2004 2003 2002 2001 2000 売上高 15,003 14,771 14,268 12,430 10,550 8,356 5,523 4,016 3,629 うち製品売上 14,687 14,311 13,858 12,022 9,977(+27) 7,868(+58) 4,991 3,511 3,202 他の収入 316 460 410 408 573 488 532 505 427 研究開発費 3,030 3,266 3,366 2,314 2,028 1,655 1,117 865 845 純利益 4,196 3,166 2,950 3,674 2,363 2,259 -1,392 1,120 1,139 従業員数 16,900 17,500 20,100 16,500 14,400 12,900 10,100 7,700 7,300 うち研究開発 7,850 7,000 8,200 6,500 5,600 4,700 3,400 3,800 3,800 うち販売 3,050 2,950 3,200 3,000 2,700 2,600 2,200 1,800 1,500 うち製造 3,600 5,600 6,600 5,100 4,400 3,600 2,500 2,100 2,000 うちその他 2,400 1,950 2,100 1,900 1,700 2,000 2,000 *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
($ milllion) 2008 2007 2006 2005 2004 2003 2002 2001 2000 1999 1998 1997 1996 EPOGEN [米国内] 2,456(-1) 2,489(-1) 2,511 2,455(-6) 2601(+7) 2434.7 2260.6 2108.5 1962.9 1759.1 1382.0 1160.7 1071.9 epoetin alfa/貧血症 Aranesp 3,137(-13) 3,614(-12) 4,121(+26) 3,273(+32) 2473(+60) 1543.8 415.6 41.5 darbepoetin alfa/貧血症 米国内 1,651(-23) 2,154(-23) 2,790 2,104(+37) 1533(+56) 979.9 284.7 国外 1,486(+2) 1,460(+10) 1,331 1,169(+24) 940(+67) 563.9 130.9 Neulasta/NEUPOGEN 4,659(+9) 4,277(+9) 3,923(+12) 3,504 []/好中球減少症 Neulasta 3,318 2,880 2,710 2,288 1740 1255.0 463.5 (2002.2nd発売) pegfilgrastim/好中球減少症 米国内 2,505(+7) 2,231(+6) 2,217(+17) 1,900(+29) 1476 1175.7 463.5 国外 813(+25) 649(+32) 493(+27) 388(+47) 264(+230) 79.3 - NEUPOGEN 1,341 1,277 1,213 1,216 1175 1267 1380 1223.7 1256.6 1116.6 1055.7 1016.3 - filgrastim/好中球減少症 米国内 896(+4) 861(+4) 830(+3) 805(+3) 778(-12) 880.5 1041.7 国外 445(+7) 416(+9) 383(-7) 411(+4) 397(+3) 386.2 337.9 Enbrel 3,598(+11) 3,230(+12) 2,879(+12) 2.573(+35) 1900(+46) 1300 362.1 [全期換算802] etanercept/リウマチ性関節炎 米国内 3,389(+11) 3,052(+12) 2,736(+11) 2,470(+35) 1827(+46) 1253.7 346.2 国外 209(+17) 178(+24) 143(+39) 103(+41) 73(+59) 46.3 15.9 Sensipar 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 333 238 122 [] 国外 130 83 35 [] Vectibix 国内 - 170(+336) 39(-) - - [panitumumab]発売2006Q4;大腸癌 その他製品 240(+1) 68(+6) 64(+7) 60(+18) 51
旧8868.0 109.8 米国内 36 36 64 39.4 100.0 国外 28 24 24 28.6 9.8 Kineret - - - - - 68.0 109.8 12.0 --- --- --- --- --- 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 - - - - - 39.4 100.0 国外 - - - - - 28.6 9.8 INFERGEN - - [2001.6 Intermuneに米・加の独占ライセンス] - 14.5 26.2 16 - --- (Interferon alfacon-1) Total Product Sales 14,687(+3) 14,311(+3) 13,858(+15) 12,022(+20) 9977(+27) 7868.2(+58) 4991.2 3511.0 3202.2 3042.8 2514.4 2219.8 2088.2 米国内 11,460(+0) 11,443(+0) 11,397(+15) 9,892(+19) 8279(+22) 6763.9 4496.7 国外 3,227(+13) 2,868(+17) 2,461(+16) 2,130(+25) 1,698(+54) 1104.3 494.5 []
●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. 【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 【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 5/26/2015Any 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.【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, 2008, 2007 and 2006 were $3.1 billion, $3.6 billion and $4.1 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) J&J 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”) (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.【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 10/23/2012Any 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.【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 12/10/2013Our 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.【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 CareOn 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.【2008】 ● 【2008】 (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
Product 国 General Subject Matter Expiration Epoetin alfa U.S. － Process of making erythropoietin 8/15/2012 － Product claims to erythropoietin 8/20/2013 － Pharmaceutical compositions of erythropoietin 8/20/2013 － Cells that make certain levels of erythropoietin 5/26/2015 darbepoetin alfa Europe(2) － Glycosylation analogs of erythropoietin proteins 10/12/2010 － Glycosylation analogs of erythropoietin proteins 8/16/2014 Filgrastim U.S. － G-CSF polypeptides 12/3/2013 － Methods of treatment using G-CSF polypeptides 12/10/2013 pegfilgrastim U.S. － Pegylated G-CSF 10/20/2015 Europe(2) － Pegylated G-CSF 2/8/2015 etanercept U.S. － Methods of treating TNF － dependent inflammatory response 9/5/2009 － TNFR proteins and pharmaceutical compositions 9/5/2009 － TNFR DNA vectors, cells and processes for making proteins 10/23/2012 panitumumab U.S. － Human monoclonal antibodies to EGFr 5/5/2017 cinacalcet HCl U.S.(1) － Calcium receptor-active molecules 12/14/2016 － Calcium receptor-active molecules 12/14/2016 － Calcium receptor-active molecules 12/14/2016 － Calcium receptor-active molecules 10/23/2015 Europe(2) － Calcium receptor-active molecules 10/23/2015
●Amgen ●Media Center ★Press Releases －★Abgenix Press Release Archives －★Tularik Press Release Archives －★Immunex Press Release Archives ●Medical Professionals ★Products ●Investors ★Pipeline ★Fact Sheet～四半期報告、SEC ★SEC Filings 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*外部研究開発取得=Acquired in-process research and development ●製品売上
($000) 2009 2008 2007 2006 2005 2004 2003 2002 2001 2000 備考 製品売上高 753,993 765,342 701,450 474,083 86,713 - - - - - 提携契約に基づく収入 4,426 4,286
旧74,76719,286
旧79,5474,286
旧36,83739,285
旧53,76134,268 85,652 13,395 - - 総収入 計 758,419 769,628
旧840,109720,736
旧780,997478,324
旧510,875125,998
旧140,47434,268 85,652 13,395 - - 支出 研究開発費 185,062 222,614
旧293,095216,339
旧276,600189,502
旧222,053117,652
旧132,128119,558 149,431 94,456 49,601 33,807 販売及び一般管理費 343,864 395,112 390,982 281,950 171,520 66,958 56,761 25,334 20,469 10,716 外部研究開発取得 - - - - - - 3,300 - - 提携Profit-sharing 302,861 302,600 290,934 194,191 31,359 - -� - - リストラ 16,980 54,926 - - - - - - - - 支出 計 931,766 1,137,329 1,023,973 748,267 349,791 186,516 209,492 119,790 70,070 44,523 営業利益 (173,347) (297,220) (242,976) (237,392) (209,317) (152,248) () 純利益 (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 1,500 1,800 1,900 1,550 345 ●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.
($ million) 2009 2008 2007 2006 2005 備考 製品売上高 754.0 765.3 701.5 474.0 86.7 Byetta 667.6 678.5 636.0 430.2 75.2 [exenatide]米国発売2005.6;２型糖尿病;incretin mimetics Symln 86.4 86.8 65.5 43.8 11.5 [pramlintide acetate]米国発売2005.4;１型糖尿病;amylinomimetics []発売; [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/ ●Pipeline ●News & Events ■Investors ●SEC Filings 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 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 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) 2008 2007 2006 2005 2004 2003 2002 2001 契約収入 304 51 89 - -
旧36,382100
旧8,678- - 研究開発費 36,186 23,261
旧35,66020,593
旧35,25913,302
旧19,29411,309
旧17,169
旧62,99712,191
旧46,00421,536 8,068 取得研究開発費 - - - - - - - - 一般管理費 13,003 16,699
旧25,72218,717
旧23,58217,234 6,468
旧15,0133,477
旧6,0673,206 2,374 営業経費 計 49,189 39,960
旧61,38239,310
旧58,84130,536
旧36,52817,777
旧23,637
旧78,01015,668
旧52,07124,742 10,442 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] 78 100 62 91 132
●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 ■Investors ●Annual 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]
■AstraZeneca
2007.6 MedImmune社の買収完了 ●会社決算*2002迄&2003-2004旧=UK GAAP; 2003-= ●地域別売上高
($ Million) 2009 2008 2007 2006 2005 2004 2003 2002 2001 2000 連結売上高 31,601(+7) 29,559(+12) 26,475 23,950(+12) 21,426(+14) 18,849 17,841 16,222 17,882 営業利益 9,144(+16) 8,094(-1) 8,216 6,502(+39) 4,547(+12)
旧4,7704,007
旧4,1114,006 3,954 4,008 経常利益 8,681(+13) 7,983(-7) 8,543 6,667(+41) 4,625(+13)
旧5,0854,077
旧4,2024,087 4,077 3,847 当期純利益 6,101(+13) 5,627 6,063 4,724
旧3,813
旧3,0362,836 2,906 2,277 研究開発費[対売上比] 5,179(+3)[16.4%] 5,162(+32) 3,902 3,379(-4) 3,467(+6)
旧3,8033,012
旧3,4513,069 2,773 2,893 従業員数[連結] 66,100 67,900 66,600 64,900 64,200 61,000 59,400 ●製品グループ
($ milllion) 2009 2008 2007 2006 2005 2004 2003 2002 2001 2000 米 国 13,510(+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 9,743(+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 6,391 5,417 2,589 3,189(+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 1) Arimidex, Crestor, Nexium, Seroquel, Symbicort 2) Losec, Nolvadex, Plendil, Seloken/Toprol-XL, Zestril ●製品売上高
($ milllion) 2009 2008 2007 2006 2005 2004 2003 2002 2001 2000 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) 3,761 6,469(-17) 安定群 Base 10,985(+18) 11,115(+5) 10,643(+6) 10,024(+10) 9,102 7,619(+9) 合計 29,559(+12) 26,475 23,950(+12) 21,426(+14) 18,849 17,841 16,222 17,882 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
($ milllion) 2009 2008 2007 2006 2005 2004 2003 2002 2001 2000 1999 1998 備考 ★Cardiovascular 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-XL 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] Crestor 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 Atacand 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 Plendil 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 Tenormin 296(-5) 313(+2) 308(-4) 320(-9) 352(-5) 368(+8) 342(-8) 370 ??? 471(-4) 509(+2) 502 [atenolol] Zestril 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) 11(-) - [saxagliptin]２型糖尿病 その他 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★Gastrointestinal 6,011(-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 Nexium 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/Prilosec 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 ★Neuroscience 6,237(+7) 5,837(+6) 5,340(+14) 4,704(+16) 4,059(+15) 3,496(+19) 2,833(+12) 2,418 (★CentralNerv.System) - - - - - - 1,505(+53) 980(+48) 685(+58) 433(+139) 183 Seroquel 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 Zomig 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 (★Pain Control&Infection) - - - - - - 1,418(-5) 1,496(-) 1,376(-5) 1,506(+2) 1,490 Diprivan 290(+4) 278(+6) 263(-13) 304(-18) 369(-27) 500(+5) 458(-2) 443(-3) 456(-4) 507(-14) 608(-6) 653 propofol 局所麻酔剤 599(-1) 605(+9) 557(+5) 529(+4) 511(-8) 542(+8) 466(-) 432(-) 434(+19) 383 Xylocaine - - - - - - ? 179(-14) 212(-5) 238(-3) 249(+2) 240 []局所麻酔剤 Marcaine - - - - - ? 77(-11) 87(-) 92(+8) 88(+11) 80 []局所麻酔剤 その他 48(-11) 54(-8) 59(+4) 57(-14) 66(-8) 71(-10) 73(-7) 70(-54) 149 ★Oncology 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 Arimidex 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 Casodex 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 Zoladex 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 Iressa 297(+12) 265(+11) 238(-) 237(-13) 273(-31) 389(+65) 228(+227) 67(-) - - - - [gefinitib]肺癌 Nolvadex - 85(+2) 83(-7) 89(-22) 114(-16) 134(-31) 178(-66) 480(-21) 618(+12) 576(+1) 573(+7) 526 [tamoxifene]乳癌 Faslodex - 249(+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 355(-13) 10(-) 10(-) 10
旧303(+15)264
旧10(-36)14(-28) 18(-6) 18(-31) 26 ★Respiratory 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 Plumicort 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 Symbicort 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 Rhinocort 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 Accolate 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 Oxis 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 Other 2,631(+7) 2,451(+43) 1,714(+96) 875(+4) 839
旧607(+9)539(+7) 628(+24) 505 Merrem 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* 1,082(-12) 1,230(-) 618(-) - (palivizumab) RSV感染予防;Medimmune FluMist* 145(+39) 104(+96) 53(-) - (経鼻インフルエンザワクチン) ;Medimmune 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 Oncology 393(-1) 395 402 374(+) 335 Astra Tech 506(-4) 529 444 360(+15) 312
★イレッサ [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。
●AstraZenaca
●Investors ★SEC FILINGS 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 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