●製品売上高
| ($000) | 2009 | 2008 | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 備考 |
|
| ★HIV製品 |
| Truvada | 2,489,682 | 2,106,687(+33) | 1,589,229(+33)[43%] | 1,194,292(+110)[46%] | 567,829(+737)[31%] | 67,865 | - | - | - | (emtricitabine/tenofovir)[日本]ツルバダ錠(製造販売元／日本たばこ産業 販売元／鳥居薬品) |
| 米 | | 992,100 | 789,709 | 785,301 | | | | | | |
| 欧 | | 986,648 | 711,650 | 380,699 | | | | | | |
| 他 | | 127,939 | 87,870 | 28,292 | | | | | | |
| Atripla | 2,382,113 | 1,572,455(+74) | 903,381(+339)[24%] | 205,729(-)[8%] | - | - | | | | [efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg]BMSとの合弁会社が販売 |
| 米 | | 1,317,168 | 900,009 | 205,565 | | | | | | |
| 欧 | | 225,754 | 276 | - | | | | | | |
| 他 | | 29,533 | 3,096 | 164 | | | | | | |
| Viread | 667,510 | 621,187(+1) | 613,169(-11)[16%] | 689,356(-11)[27%] | 778,783(-1)[43%] | 782,915(+) | 566,478(+151) | 225,815(+1349) | 15,586 | (FDA承認2001.10,発売2002.2) (tenofovir disoproxil fumarate)[日本]ビリアード錠300mg(製造販売元／日本たばこ産業 販売元／鳥居薬品) |
| 米 | | 254,216 | 257,598 | 294,302 | | | | | | |
| 欧 | | 259,897 | 260,001 | 304,961 | | | | | | |
| 他 | | 107,074 | 95,570 | 90,093 | | | | | | |
| Emtriva | 27,974 | 31,080(-1) | 31,493(-13)[1%] | 36,393(-23)[1%] | 47,486(-18)[3%] | 57,600 | 10,021 | - | - | (emtricitabine)[日本]エムトリバカプセル200mg(製造販売元／日本たばこ産業 販売元／鳥居薬品) |
| 米 | | 15,804 | 13,443 | 17,078 | | | | | | |
| 欧 | | 9,819 | 11,275 | 15,841 | | | | | | |
| 他 | | 5,457 | 6,775 | 3,474 | | | | | | |
| HIV 計 | 5,838,874 | 4,672,432 | 3,137,272 | 2,125,770(+52) | 1,394,098(+53) | 908,380(+58) | 576,499 | 225,815 |
| 米 | | | 1,960,759 | 1,302,246 | | | | | | |
| 欧 | | | 985,461 | 701,501 | | | | | | |
| 他 | | | 191,052 | 122,023 | | | | | | |
| ★その他 |
| Hepsera | 271,595 | 341,023(+13) | 302,722(31+)[8%] | 230,531(+24)[9%] | 186,532(+66)[10%] | 112,525 | 50,506 | 6,716 | - | (adefovir dipivoxil)B型肝炎[日本]ヘプセラ錠10[GSK]発売=2004.12;アジア・中南米等はGSKに委託 |
| 米 | | 131,404 | 123,479 | 97,325 | | | | | | |
| 欧 | | 191,112 | 138,758 | 107,066 | | | | | | |
| 他 | | 18,507 | 40,485 | 26,140 | | | | | | |
| AmBisome | 298,597 | 289,651(+10) | 262,571(+18)[7%] | 223,031(+1)[9%] | 220,753(+4)[12%] | 211,688(+7) | 198,350(+7) | 185,669(+13) | 164,533(+17) | (amphotericin B liposome)[日本]アンビゾーム点滴静注用50mg[大日本住友]2006.2.22医薬品第二部会；米加はアステラスが販売 |
| Letairis | 183,949 | 112,855(+437) | 21,020 | - | | | | | | [ambrisentan]肺高血圧：米発売2007.6 |
| Ranexa | 131,062 | - | - | | | | | | | [] |
| Vistide | - | - | - | - | 6,629(-16) | 7,904(+4) | 7,576 | 2,631 | - | (cidofovir)エイズ患者のCMV網膜炎；米国外25ヵ国はPfizerが販売 |
| DaunoXome | - | - | - | - | 1,287(-25) | 1,727(-49) | 3,410 | 3,048 | - | (liposomal daunorubicin);indicated as a first line cytotoxic therapy for advanced HIV-associated Kaposi's sarcoma. |
| その他 | | 9,858(+4) | 9,524(+7)
旧30,544 | 8,865(+12) | 7,916 | 9,631 | | | | |
|
| 製品売上高計 | 6,469,311 | 5,084,796(+36) | 3,733,109(+44) | 2,588,197(+43) | 1,809,299(+46) | 1,242,224(+49) | 836,341(+97) | 423,879(+122) | 190,970 |
| | | | | | | | | | |
| 米 | | | | | | | | | | |
| 欧 | | | | | | | | | | |
| 他 | | | | | | | | | | |
* ロイヤルティ収入の主な品目
Tamiflu (oseltamivir phosphate) by Roche
Vistide (cidofovir injection) by Pharmacia
from Form 10-K Annual report[2005.3.14] - [pdf,331p]
- 95p
| ●Cayston(aztreonam inhalation solution)嚢胞性線維症 |
| 【2009】Cayston (aztreonam for inhalation solution) is an inhaled antibiotic as a treatment to improve respiratory systems in cystic fibrosis (CF) patients with Pseudomonas aeruginosa (P. aeruginosa). In September 2009, we received conditional marketing approval of Cayston in Europe and Canada. In February 2010, we received marketing approval of Cayston in the United States.
Cayston. Cayston competes primarily with Tobi (tobramycin inhalation solution, USP), an inhaled medication sold by Novartis for the treatment of CF patients whose lungs contain P. aeruginosa.
Further, Cayston may only be taken by patients using a specific inhalation device that delivers the drug to the lungs of patients. Our commercial launch of Cayston and ongoing distribution of Cayston are entirely reliant upon the manufacturer of that device. For example, the manufacturer could encounter other issues with regulatory agencies related to the device or be unable to supply sufficient quantities of this device at the time of commercial launch or following a commercial launch. In addition, the manufacturer may not be able to provide adequate warranty support for the device after it has been distributed to patients. With respect to distribution of the drug and device to patients, we are reliant on the capabilities of specialty pharmacies. For example, the distribution channel for drug and device is complicated and requires coordination. The reimbursement approval processes associated with both drug and device are similarly complex. If the device manufacturer is unable to obtain reimbursement approval or receives approval at a lower.than.expected price, sales of Cayston may be adversely affected. Any of the previously described issues may limit or further delay the commercial launch of Cayston, which would adversely affect our financial results.
PARI GmbH
As a result of our acquisition of Corus Pharma, Inc. (Corus) in August 2006, we assumed all rights to the February 2002 between Corus and PARI GmbH (PARI) for the development of Cayston and development of an inhalation delivery device for of the agreement, we are obligated to pay PARI for services rendered, and subject to the achievement of specific milestones, milestone payments to PARI. In addition, we will make royalty payments based on net sales of Cayston. The agreement also the royalty rate payable to PARI. In November 2007, we paid PARI $13.5 million to reduce the royalty rate under the agreement. been approved for commercialization as of December 31, 2009, we recorded this payment in R&D expenses in our Consolidated April 2008, pursuant to the February 2002 development agreement, we entered into a commercialization agreement with PARI supply and manufacture of an inhalation delivery device and accessories for use with Cayston. Under the terms of this agreement, royalties on future net sales of these products pursuant to the 2002 development agreement.
In February 2010, we received marketing approval from the FDA for Cayston as a treatment to improve respiratory symptoms in CF patients with Pseudomonas aeruginosa (P. aeruginosa). Cayston was conditionally approved in Europe and Canada in September 2009.
|
|
| ● |
| 【2009】 |
|
●Products
Atripla(TM)(efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)
Emtriva(R)(emtricitabine)[日本]エムトリバカプセル200mg(製造販売元／日本たばこ産業 販売元／鳥居薬品)
Truvada(R)(emtricitabine/tenofovir)[日本]ツルバダ配合錠(製造販売元／日本たばこ産業 販売元／鳥居薬品)
Viread(R)(FDA承認2001.10,発売2002.2) (tenofovir disoproxil fumarate)[日本]ビリアード錠300mg(製造販売元／日本たばこ産業 販売元／鳥居薬品)
Hepsera(R)(adefovir dipivoxil)B型肝炎[日本]ヘプセラ錠10[GSK]発売=2004.12
Letairis(ambrisentan)肺高血圧症
Lexiscan(regadenoson)心機能検査補助剤
Ranexa(ranolazine)慢性狭心症
Cayston(aztreonam inhalation solution)嚢胞性線維症
Tamiflu(R)(osetamivir)抗インフルエンザ剤[日本]タミフルカプセル75 [中外製薬]
AmBisome(amphotericin B liposome)抗真菌剤[日本]アムビゾーム点滴静注用50mg
Macugen(pegaptanib sodium injection)黄斑変性治療薬[日本]マクジェン硝子体内注射用キット0.3mg[ファイザー]
Vistide(cidofovir)エイズ患者のCMV網膜炎
Flolan(epoprostenol sodium)肺高血圧症[日本]静注用フローラン0.5mg,1.5mg[GSK]
●News
Gilead Sciences Announces Record Fourth Quarter and Full Year 2009 Financial Results[2010.1.26]
Gilead Sciences Announces Record Fourth Quarter and Full Year 2008 Financial Results [2009.1.27]
Gilead Sciences Announces Fourth Quarter and Full Year 2007 Financial Results[2008.1.23]
Gilead Sciences Announces Fourth Quarter and Full Year 2006 Financial Results[2007.1.31]
Gilead Sciences Announces Fourth Quarter and Full Year 2005 Financial Results[2006.1.30]
Gilead Sciences Announces Fourth Quarter and Full Year 2004 Financial Results[2005.1.27]
Gilead Sciences Announces Fourth Quarter and Full Year 2002 Financial Results[2003.1.30]
Gilead Sciences Announces Fourth Quarter and Year End 2001 Financial Results[2002.1.31]
■Investors - Annual Reports等
●Annual Report
●SEC Filings
Form 10-K Annual report[2010.3.1] - [pdf] - [doc] - [xls]
Form 10-K Annual report[2009.2.27] - [pdf,248p] - [doc] - [xls]
Form 10-K Annual report[2008.2.27] - [pdf,358p]
Form 10-K Annual report[2007.2.27] - [pdf,186p]
Form 10-K Annual report[2006.3.3] - [pdf,186p]
Form 10-K Annual report[2005.3.14] - [pdf,331p]
Form 10-K[2004.3.11]
2005.12.08 加ID Biomedical Corporationを買収(インフルエンザワクチンメーカー；非上場)
●決算
| (￡ milllion) | 2010 | 2009 | 2008 | 2007 | 2006 | 2005 | 2004 | 2003 |
|
| 売上高 | | 28,368(+3) | 24,352(+7) | 22,716(-4) | 23,225(+7) | 21,660(+8) | 19,986(-5) | 21,070 |
| 営業利益 | | 8,425 | 7,141(-6) | 7,593(-3) | 7,808(+14) | 6,874(+19) | 5,756(-5) | 6,050 |
| 経常利益 | | 7,891 | 6,659(-11) | 7,452(-4) | 7,799(+16) | 6,732(+16) | 5,779(-3) | 5,954 |
| 純利益 | | 5,669 | 4,712(-11) | 5,310(-3) | 5,498(+14) | 4,816(+20) | 4,022(-7) | 4,308 |
|
| 研究開発費 | | 4,106 | 3,681(+11) | 3,327(-4) | 3,457 | 3,136 | 2,904(+2) | 2,865 |
|
| セグメント別売上高 |
| 医薬品 | | 23,714 | 20,381 | 19,233(-4) | 20,078(+8) | 18,661(+9) | 17,100(-6) | 18,114 |
| Consumer Health | | 4,654 | 3,971 | 3,483(+11) | 3,147(+5) | 2,999(+4) | 2,886(-2) | 2,956 |
|
| 従業員数 | | 98,854 | 101,133 | 103,401 | 101,802 | | | | | | |
| | | | | | | | | | | |
●個別製品売上高
| (￡ milllion) | 2010 | 2009 | 2008 | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 備考 |
|
| ●Respiratory | 7,238(+4) | 6,977 | 5,817(+16)[29%] | 5,032(+1)[26%] | 4,994(-1) | 5,054(+14) | 4,394(+7) | 4,417(+14) | 3,987(+16) | 3,537(+24) | 2,789(+15) |
| 米 | 3,394(+2) | 3,323 | 2,720(+14) | 2,377(-3) | 2,461(-5) | 2,580(+17) |
| 欧 | 2,149(-2) | 2,201 | 1,982(+14) | 1,772(+4) | 1,697(+2) | 1,660(+8) |
| Emerging Markets | 616(+21) | | | | | | | | | | |
| 他 | 1,079(+14) | 1,453 | 1,1115(+22) | 883(+5) | 837(+3) | 814(+13) |
| Seretide/Advair | 5,139(+3) | 4,977 | 4,317(+18) | 3,499(+6) | 3,313(+10) | 3,003(+22) | 2,441(+19) | 2,214(+39) | 1,631(+96) | 850(>100) | 208(+>100) | fluticasone/salmeterol |
| 米 | 2,604(-) | 2,592 | 2,161(+14) | 1,891(+1) | 1,870(+11) | 1,687(+26) |
| 欧 | 1,601(-) | 1,609 | 1,416(+17) | 1,236(+9) | 1,133(+10) | 1,033(+16) |
| Emerging Markets | 328(+19) | | | | | | | | | | |
| 他 | 606(+21) | 776 | 560(+42) | 372(+20) | 310(+10) | 283(+3) |
| Flixotide/Flovent | 804(+4) | 775 | 677(+9) | 621(-6) | 659(+3) | 638(+2) | 618(-7) | 705(-8) | 783(-12) | 915(+2) | 880(+29) | fluticasone propionate吸入剤 |
| 米 | 431(+9) | 396 | 317(+12) | 284(-5) | 298(+14) | 262(+4) |
| 欧 | 159(-11) | 178 | 175(+11) | 161(-7) | 173(-8) | 188(-3) |
| Emerging Markets | 48(+41) | | | | | | | | | | |
| 他 | 166(-1) | 201 | 185(+3) | 176(-6) | 188(-) | 188(+3) |
| Serevent | 201(-15) | 236 | 263(-2) | 269(-8) | 291(-12) | 330(-7) | 349(-15) | 433(-15) | 523(-17) | 645(+1) | 622(+8) | salmeterol xinafoate |
| 米 | 64(-12) | 73 | 72(-3) | 74(-14) | 86(-17) | 104(-20) |
| 欧 | 98(-16) | 116 | 136(+1) | 134(-4) | 140(-13) | 160(-3) |
| Emerging Markets | 2(-33) | | | | | | | | | | |
| 他 | 37(-16) | 47 | 55(-10) | 61(-6) | 65(-2) | 66(+12) |
| Avamys/Veramyst | 193(+36) | 142 | 72(+>100) | 21 | | | | | | | | [fluticasone furoate] |
| 米 | 69(+1) | | 56(+>100) | | | |
| 欧 | 56(+24) | | 11(-) | | | |
| Emerging Markets | 31(+>100) | | | | | | | | | | |
| 他 | 37(+>100) | | 5(+>100) | | | |
| Flixonase/Flonase | 164(-4) | 171 | 186(-7) | 199(-36) | 311(-53) | 656(+13) | 578(+7) | 594(+19) | 534(+10) | 504(+20) | 408(+16) | fluticasone 点鼻スプレー |
| 米 | 37(+37) | 27 | 52(-28) | 72(-61) | 184(-64) | 506(+12) |
| 欧 | 40(-7) | 43 | 52(+6) | 51(-) | 51(-15) | 60(-1) |
| Emerging Markets | 39(+>100) | | | | | | | | | | |
| 他 | 48(-27) | 101 | 82(+5) | 76(-) | 76(-16) | 90(+27) |
| Zyrtec | 82(+9) | 75 | | | | | | | | | | [cetirizine]アレルギー |
| 米 | - | - | | | | |
| 欧 | - | - | | | | |
| Emerging Markets | 14(-) | | | | | | | | | | |
| 他 | 68(+11) | 75 | | | | |
| Ventolin | 522 | 477 | - | - | - | - | - | 265(-1) | 265(-10) | 306(-9) | 343(-7) | albuterol |
| 米 | 179(+17) | | | | | | | | | | |
| 欧 | 142(-5) | | | | | | | | | | |
| Emerging Markets | 112(+20) | | | | | | | | | | |
| 他 | 89(+10) | | | | | | | | | | |
| Becotide | - | - | - | - | - | - | - | 111(-16) | 130(-18) | 161(-22) | 205(-25) | beclomethasone dipropionate |
| ●CNS | 1,753(-6) | 1,870 | 2,897(-13)[14%] | 3,348(-8)[17%] | 3,642(+13) | 3,219(-8) | 3,462(-16) | 4,455(+4) | 4,511(+17) | 4,007(+16) | 3,279(+16) |
| 米 | 505(-22) | 651 | 1,815(-24) | 2,377(-8) | 2,588(+26) | 2,051(-10) |
| 欧 | 540(-6) | 574 | 565(+12) | 513(-14) | 595(-15) | 704(-7) |
| Emerging Markets | 223(+17) | | | | | | | | | | |
| 他 | 485(+7) | 645 | 517(+11) | 458(-) | 459(-1) | 464(+2) |
| ★抗うつ剤 | | | | - | - | - | - | 2,830(+2) | 2,937(+22) | 2,504(+20) | 2,002(+17) |
| Seroxat/Paxil | 482(-8) | 523 | 514(-7) | 553(-11) | 620(+1) | 615(-42) | 1,063(-39) | 1,877(-4) | 2,055(+15) | 1,857(+16) | 1,550(+17) | paroxetine うつ病 |
| 米 | 27(-36) | 42 | 79(-45) | 143(-18) | 175(+32) | 133(-75) |
| 欧 | 82(-17) | 99 | 115(-4) | 122(-18) | 149(-20) | 187(-26) |
| Emerging Markets | 73(-4) | | | | | | | | | | |
| 他 | 300(-2) | 382 | 320(+10) | 288(-3) | 296(-) | 295(-) |
| Paxil IR | | - | - | 400(-11) | 448(-8) | 488(-27) | 667(-53) |
| 米 | | | - | 7(-63) | 19(+6) | 18(-87) |
| 欧 | | | - | 122(-18) | 149(-20) | 187(-26) |
| Emerging Markets | | | | | | | | | | | |
| 他 | | | - | 271(-3) | 280(-1) | 283(-1) |
| Paxil CR | | - | - | 153(-11) | 172(+35) | 127(-68) | 396(+14) |
| 米 | | | - | 136(-13) | 156(+36) | 115(-70) |
| 欧 | | | - | - | - | - |
| Emerging Markets | | | | | | | | | | | |
| 他 | | | - | 17(+6) | 16(+33) | 12(+40) |
| Wellbutrin | 81(-39) | 132 | 342(-35) | 529(-41) | 900(+22) | 739(-2) | 751(-12) | 953(+18) | 882(+42) | 647(+37) | 452(+19) | bupropion うつ病 |
| 米 | 24(-73) | 88 | 310(-39) | 512(-42) | 882(+22) | 723(-2) |
| 欧 | 39(+30) | 30 | 18(+>100) | 4(+100) | 2(-) | 2(+42) |
| Emerging Markets | 13(+30) | | | | | | | | | | |
| 他 | 5(+25) | 14 | 14(+8) | 13(-19) | 16(+14) | 14(-14) |
| Wellbutrin IR,SR | | - | - | 75(-23) | 102(+11) | 92(-68) | 284(-64) |
| 米 | | | - | 63(-29) | 89(+11) | 80(-70) |
| 欧 | | | - | 2(-) | 2(-) | 2(+42) |
| Emerging Markets | | | | | | | | | | | |
| 他 | | | - | 10(-9) | 11(+10) | 10(-35) |
| Wellbutrin XL | | - | - | 454(-39) | 798(+23) | 647(+38) | 467(>100) |
| 米 | | | - | 449(-43) | 793(+23) | 643(+37) |
| 欧 | | | - | 2(-) | - | - |
| Emerging Markets | | | | | | | | | | | |
| 他 | | | - | 3(-40) | 5(+25) | 4(>100) |
| ★Migraine | | | | | | - | - | 849(+1) | 888(+8) | 849(+5) | 782(+5) | 片頭痛薬 |
| Imigran/Imitrex | 22(-20) | 266 | 687(-) | 685(-4) | 711(+2) | 697(+1) | 682(-2) | 760(-) | 798(+9) | 758(+4) | 705(+3) | sumatriptan |
| 米 | 75(-39) | 123 | 550(-1) | 558(+1) | 551(+9) | 504(+2) |
| 欧 | 85(-11) | 96 | 96(+8) | 89(-25) | 118(-18) | 144(+1) |
| Emerging Markets | 5(-) | | | | | | | | | | |
| 他 | 47(+12) | 47 | 41(+8) | 38(-10) | 42(-14) | 49(-2) |
| Treximet | 56(+2) | 55 | 25(-) | | | | | | | | | [sumatriptan and naproxen sodium]片頭痛薬 |
| 米 | 55(-) | 55 | 25(-) | | | |
| 欧 | - | - | - | | | |
| Emerging Markets | - | | | | | | | | | | |
| 他 | 1(-) | - | - | | | |
| Naramig/Amerge | - | - | - | - | - | - | - | 89(+1) | 90(+1) | 91(+15) | 77(+20) | naratriptan |
| Lamictal | 504(+1) | 500 | 926(-16) | 1,097(+10) | 996(+17) | 849(+24) | 677(+32) | 556(+31) | 438(+27) | 355(+20) | 289(+28) | lamotrigine 抗てんかん剤 |
| 米 | 257(-1) | 267 | 711(-20) | 892(+17) | 765(+35) | 568(+36) |
| 欧 | 143(-7) | 154 | 147(+3) | 145(-17) | 175(-23) | 226(+3) |
| Emerging Markets | 57(+19) | | | | | | | | | | |
| 他 | 47(+52) | 79 | 68(+10) | 60(+7) | 56(+2) | 55(+15) |
| Requip | 233(+11) | 209 | 266(-23) | 346(+29) | 268(+72) | 156(+34) | 116(+25) | 99(+13) | 89(+21) | 75(+25) | 58(+20) | [ropinirole]パーキンソン病 |
| 米 | 44(+69) | 26 | 102(-57) | 238(+35) | 176(>+100) | 80(+50) |
| 欧 | 137(-1) | 138 | 133(+46) | 91(+12) | 81(+19) | 68(+21) |
| Emerging Markets | 3(+50) | | | | | | | | | | |
| 他 | 49(+14) | 45 | 31(+82) | 17(+55) | 11(+38) | 8(+22) |
| Requip XL | | 123 | 43(-) | - | | | | | | | | [ropinirole]パーキンソン病 |
| 米 | | 32 | 9(-) | | | |
| 欧 | | 89 | 34(-) | | | |
| Emerging Markets | | | | | | | | | | | |
| 他 | | 2 | - | | | |
| Zyban | | | | - | - | - | - | 75(-25) | 99(-21) | 129(+11) | 115(+54) | [bupropion] 禁煙補助剤 |
| ●Anti-Virals | 1,086(-55) | 2,416
旧4,150 | 3,206(+6)[16%] | 3,028(+7)[16%] | 2,827(+9) | 2,598(+9) | 2,359(+8) | 2,349(+5) | 2,299(+12) | 2,128(+10) | 1,899(+14) |
| 米 | 370(-68) | 1,897 | 1,600(+7) | 1,494(+10) | 1,354(+5) | 1,285(+10) |
| 欧 | 109(-73) | 1,074 | 850(-) | 870(+2) | 855(+11) | 773(+6) |
| Emerging Markets | 223(-1) | | | | | | | | | | |
| 他 | 384(-39) | 1,179 | 756(+10) | 664(+7) | 618(+14) | 540(+12) |
| ○HIV | 1,566(-2) | 1,605 | 1,513(+5) | 1,442(-5) | 1,515(-3) | 1,554(+5) | 1,462(+4) | 1,508(+6) | 1,465(+13) | 1,347(+14) | 1,145(+14) |
| 米 | 660(-8) | 716 | 640(-) | 637(-9) | 700(-9) | 766(+2) |
| 欧 | 585(-8) | 635 | 636(+7) | 612(-1) | 621(+2) | 607(+8) |
| Emerging Markets | 146(+39) | | | | | | | | | | |
| 他 | 175(+16) | 254 | 237(+13) | 193(-1) | 194(+7) | 181(+12) |
| Epzicom/Kivexa | 555(+2) | 546 | 442(+36) | 324(+34) | 241(>+100) | 118(>100) | 1 | - | - | - | - | abacavir/lamivudine |
| 米 | 210(-6) | 223 | 178(+25) | 142(+14) | 125(+47) | 85(-) |
| 欧 | 245(-) | 244 | 209(+20) | 149(+54) | 97(>+100) | 29(>100) |
| Emerging Markets | 29(+38) | | | | | | | | | | |
| 他 | 71(+22) | 79 | 55(+67) | 33(+74) | 19(>+100) | 4(>100) |
| Combivir | 363(-15) | 425 | 433(-5) | 455(-14) | 528(-9) | 583(+1) | 570(+4) | 589(+3) | 588(+1) | 606(+5) | 562(+21) | lamivudine/zidovudine |
| 米 | 143(-24) | 187 | 180(-8) | 195(-18) | 238(-16) | 283(+1) |
| 欧 | 117(-23) | 151 | 166(-8) | 192(-12) | 217(-4) | 227(-) |
| Emerging Markets | 63(+29) | | | | | | | | | | |
| 他 | 40(+5) | 87 | 87(+10) | 68(-7) | 73(-) | 73(+8) |
| Trizivir | 144(-28) | 201 | 212(-9) | 233(-13) | 268(-12) | 303(-6) | 322(-8) | 376(+22) | 315(+95) | 167(>100) | 7(+>100) | abacavir sulfate/lamivudine/zidovudine |
| 米 | 73(-30) | 104 | 106(-12) | 120(-15) | 141(-15) | 166(-7) |
| 欧 | 60(-27) | 82 | 92(-6) | 99(-12) | 113(-8) | 123(-5) |
| Emerging Markets | 4(-43) | | | | | | | | | | |
| 他 | 7(-13) | 15 | 14(-7) | 14(-) | 14(-) | 14(-8) |
| Agenerase/Lexiva | 155(-13) | 178 | 160(+13) | 141(+8) | 131(+17) | 112(+77) | 63(+80) | 31(-25) | 44(-8) | 50(-7) | 52(+60) | [amprenavir] |
| 米 | 80(-19) | 99 | 83(+6) | 78(+5) | 74(+6) | 70(+50) |
| 欧 | 51(-18) | 62 | 61(+15) | 53(+10) | 48(+37) | 36(>100) |
| Emerging Markets | 13(+86) | | | | | | | | | | |
| 他 | 11(+10) | 17 | 16(+80) | 10(+11) | 9(+29) | 6(+46) |
| Epivir | 115(-11) | 129 | 139(-11) | 156(-23) | 202(-23) | 261(-12) | 294(+7) | 293(+2) | 295(+1) | 302(-5) | 309(-7) | [lamivudine]HIV |
| 米 | 40(-17) | 48 | 47(-11) | 53(-23) | 69(-26) | 93(-33) |
| 欧 | 37(-24) | 49 | 58(-9) | 67(-26) | 90(-26) | 122(+4) |
| Emerging Markets | 18(+38) | | | | | | | | | | |
| 他 | 20(+5) | 32 | 34(-13) | 36(-16) | 43(-7) | 46(+12) |
| Ziagen | - | 105 | 106(-3) | 109(-7) | 117(-14) | 136(-14) | 155(-) | 167(-1) | 173(+10) | 167(+5) | 154(+75) | abacavir sulfate |
| 米 | | 51 | 45(-) | 45(-6) | 48(-13) | 55(-26) |
| 欧 | | 35 | 36(-) | 37(-10) | 41(-24) | 54(-8) |
| Emerging Markets | | | | | | | | | | | |
| 他 | | 19 | 25(-11) | 27(-4) | 28(+4) | 27(+11) |
| Retrovir | - | - | - | - | - | 41(-6) | 43(+2) | 45(-10) | 50(-6) | 55(-11) | 61(-30) | zidovudine |
| 米 | | | - | - | - | 14(-17) |
| 欧 | | | - | - | - | 16(-6) |
| Emerging Markets | | | | | | | | | | | |
| 他 | | | - | - | - | 11(+12) |
| Selzentry | 80(+>100) | 1 | | | | | | | | | | [maraviroc]HIV薬 |
| 米 | 34(-) | | | | | |
| 欧 | 41(+>100) | | | | | |
| Emerging Markets | 2 | | | | | | | | | | |
| 他 | 3 | | | | | |
| ○Herpes | 1,086(-55) | 2,416 | | 1,041(+8) | 965(+17) | 826(+14) | 718(+15) | 669(+6) | 653(+5) | 646(+5) | 616(+5) |
| 米 | 370(-68) | | | 678(+11) | 610(+28) | 476(+24) |
| 欧 | 109(-73) | | | 151(+5) | 144(+4) | 139(-) |
| Emerging Markets | 223(-1) | | | | | | | | | | |
| 他 | 384(-39) | | | 212(-) | 211(-) | 211(+4) |
| Hepsera | 128(+12) | 114 | | | | | | | | | | [adefovir dipivoxil]B型肝炎ウイルス |
| 米 | - | | | | | |
| 欧 | 1(-) | | | | | |
| Emerging Markets | 58(+14) | | | | | | | | | | |
| 他 | 69(+10) | | | | | |
| Valtrex | 532(-59) | 1,294 | 1,195(+28) | 934(+11) | 845(+22) | 695(+21) | 571(+24) | 499(+23) | 425(+26) | 350(+42) | 242(+32) | [valacyclovir]ヘルペス |
| 米 | 252(-73) | 942 | 870(+30) | 668(+11) | 600(+28) | 470(+26) |
| 欧 | 68(-58) | 160 | 144(+25) | 120(+10) | 109(+11) | 98(+9) |
| Emerging Markets | 28(+8) | | | | | | | | | | |
| 他 | 184(+11) | 192 | 181(+20) | 146(+7) | 136(+7) | 127(+12) |
| Zeffix | 233(+7) | 217 | 188(+12) | 168(+4) | 162(+12) | 145(+9) | 130(+7) | 129(+11) | 123(+23) | 103(+49) | 70(+>100) | [lamivudine]Ｂ型肝炎b |
| 米 | 13(-24) | 17 | 15(+15) | 13(-) | 13(+8) | 12(+11) |
| 欧 | 26(-10) | 29 | 27(+17) | 24(+4) | 23(+10) | 21(-8) |
| Emerging Markets | 136(+18) | | | | | | | | | | |
| 他 | 58(+4) | 171 | 146(+11) | 131(+4) | 126(+13) | 112(+13) |
| Zovirax | - | - | - | 107(-11) | 120(-8) | 131(-11) | 147(-10) | 170(-26) | 228(-29) | 296(-19) | 374(-7) | [aciclovir]ヘルペス |
| 米 | | | - | 10(-) | 10(+67) | 6(-32) |
| 欧 | | | - | 31(-11) | 35(-15) | 41(-16) |
| Emerging Markets | | | | | | | | | | | |
| 他 | | | - | 66(-12) | 75(-11) | 84(-6) |
| Relenza | 121(-83) | 720 | 57(-78) | 262(>+100) | 91(>+100) | 5 | 4 | ? | ? | ? | 32(+97) | [zanamivir]インフルエンザ |
| 米 | 43(-69) | 137 | 20(-85) | 131(-) | | |
| 欧 | 6(-97) | 212 | 6(-92) | 76(+23) | | |
| Emerging Markets | 1(-97) | | | | | | | | | | |
| 他 | 71(-79) | 371 | 31(-44) | 55(+90) | | |
| ●ANTI-Bacterials | | 1,592 | 1,429(+8)[7%] | 1,330(-3)[7%] | 1,369(-10) | 1,519(-3) | 1,547(-9) | 1,815(-16) | 2,210(-12) | 2,604(+3) | 2,472(+2) |
| 米 | | 173 | 174(-11) | 195(-10) | 217(-17) | 261(-27) |
| 欧 | | 662 | 635(+8) | 612(-3) | 628(-13) | 718(+3) |
| Emerging Markets | | | | | | | | | | | |
| 他 | | 757 | 620(+15) | 523(-) | 524(-3) | 540(+5) |
| Augmentin | | 667 | 587(+11) | 530(-7) | 570(-14) | 666(-7) | 708(-9) | 825(-29) | 1,191(-14) | 1,421(+13) | 1,219(+8) | amoxicillin/clavulanate potassium |
| 米 | | 45 | 49(-27) | 67(-29) | 94(-32) | 139(-38) |
| 欧 | | 295 | 272(+14) | 250(-7) | 268(-15) | 316(+5) |
| Emerging Markets | | | | | | | | | | | |
| 他 | | 327 | 266(+18) | 213(+2) | 208(-1) | 211(+11) |
| Augmentin IR | | - | - | - | - | 552(+2) | 533(-5) |
| 米 | | | | | | 40(-34) |
| 欧 | | | | | | 305(+3) |
| Emerging Markets | | | | | | | | | | | |
| 他 | | | | | | 207(+11) |
| Augmentin ES,XR | | - | - | - | - | 114(-35) | 175 |
| 米 | | | | | | 99(-40) |
| 欧 | | | | | | 11(+97) |
| Emerging Markets | | | | | | | | | | | |
| 他 | | | | | | 4(-19) |
| Augmentin ES | | - | | - | - | - | 74(-39) |
| Augmentin XR | | - | | - | - | - | 101(+6) |
| Zinnat/Ceftin | | - | - | - | 164(-17) | 197(-6) | 205(-7) | 246(-) | 243(-39) | 409(-7) | 430(-) | cefuroxime axetil |
| 米 | | | | | 12(+20) | 10(+2) |
| 欧 | | | | | 82(-27) | 112(-9) |
| Emerging Markets | | | | | | | | | | | |
| 他 | | | | | 70(-7) | 75(-4) |
| Altabax/Altargo | | - | 16(+45) | 11 | - | - | - | - | - | - | - | [Retapamulin]局所抗菌剤;膿痂疹（とびひ）;米発売2007.5 |
| 米 | | | 15(+36) | | | |
| 欧 | | | 1(-) | | | |
| Emerging Markets | | | | | | | | | | | |
| 他 | | | - | | | |
| Fortum | | - | - | - | - | - | - | 184(-9) | 201(-1) | 209(-2) | 213(-9) | ceftazidim |
| Amoxil | | - | - | - | - | - | - | 117(-11) | 136(-5) | 149(-26) | 199(+1) | amoxicillin |
| ●METABOLIC | 678(-43) | 1,181 | 1,191(-21)[6%] | 1,514(-19)[8%] | 1,875(+25) | 1,495(+18) | 1,251(+27) | 1,079(+20) | 1,429(+1) | 1,480(+10) | 1,232(+33) |
| 米 | 238(-59) | 581 | 590(-34) | 895(-30) | 1,277(+28) | 995(+16) |
| 欧 | 166(-40) | 275 | 294(+1) | 294(+17) | 252(+33) | 190(+39) |
| Emerging Markets | 91(-24) | | | | | | | | | | |
| 他 | 183(-11) | 325 | 307(-5) | 325(-6) | 346(+12) | 310(+12) |
| Avandia/Avandamet | 440(-43) | 771 | 805(-34) | 1,219 | | 1,329 | 1,116(+32) | 931(+24) | 809(+19) | 707(+46) | 462(>100) | rosiglitazone |
| 米 | 237(-44) | | | | | |
| 欧 | 88(-49) | | | | | |
| Emerging Markets | 42(-45) | | | | | | | | | | |
| 他 | 73(-26) | | | | | |
| Avandia | | 462 | 512(-42) | 877(-37) | 1,399(+21) | 1,154(+27) | 892 | - | - | - | - | rosiglitazone |
| 米 | | 276 | 299(-49) | 592(-45) | 1,068(+24) | 864(+31) |
| 欧 | | 67 | 82(-26) | 113(-10) | 125(+12) | 112(+20) |
| Emerging Markets | | | | | | | | | | | |
| 他 | | 119 | 131(-25) | 172(-17) | 206(+16) | 178(+15) |
| Avandamet | | 268 | 256(-12) | 292(+43) | 204(+17) | 175(-22) | 222 | - | - | - | - | rosiglitazone/metformin |
| 米 | | 122 | 109(-26) | 147(+71) | 86(-24) | 113(-43) |
| 欧 | | 99 | 111(-) | 111(+21) | 92(>+100) | 45(>100) |
| Emerging Markets | | | | | | | | | | | |
| 他 | | 47 | 36(+6) | 34(+31) | 26(+53) | 17(+2) |
| Avandaryl | | - | - | 50(+19) | 42(-) | - | | | | | | [rosiglitazone maleate - AVANDIA - and glimepiride - AMARYL]発売2006.2 |
| 米 | | | | 41(+3) | 40 | - |
| 欧 | | | | 3(-) | - | - |
| Emerging Markets | | | | | | | | | | | |
| 他 | | | | 6(>100) | 2 | - |
| Bonviva/Boniva | 78(-69) | 255 | 237(+47) | 161(+69) | 95(>100) | 18(>100) | - | - | - | - | - | ibandronate 骨粗鬆症;Roche導入品 |
| 米 | -(-100) | 155 | 156(+36) | 115(+39) | 83(>100) | 17(-) |
| 欧 | 64(-28) | 89 | 74(+68) | 45(>100) | 12(>100) | 1(>100) |
| Emerging Markets | 2 | | | | | | | | | | |
| 他 | 12(+33) | 11 | 7(+>100) | 1(-) | - | - |
| ●VACCINES | 4,326(+17) | 3,706 | 2,539(+27)[12%] | 1,993(+18)[10%] | 1,692(+22) | 1,389(+15) | 1,194(+11) | 1,123(+2) | 1,080(+16) | 948(+10) | 842(+11) |
| 米 | 763(-6) | 815 | 629(-) | 628(+35) | 465(+38) | 338(+26) |
| 欧 | 1,681(-4) | 1,744 | 1,155(+44) | 814(+15) | 709(+20) | 592(+12) |
| Emerging Markets | 927(+39) | | | | | | | | | | |
| 他 | 955(+100) | 1,147 | 755(+34) | 551(+6) | 518(+13) | 459(+10) |
| Hepatitis Vaccin | 720(+8) | 665 | 665(+26) | 529(+10) | 479(+8) | 444(+8) | 405(+3) | 417(-13) | 483(+12) | 445(-6) | 462(-3) |
| 米 | 307(+19) | 257 | 275(+38) | 199(+24) | 161(+18) | 137(+1) |
| 欧 | 242(-8) | 262 | 263(+14) | 235(+4) | 227(+2) | 224(+11) |
| Emerging Markets | 88(+10) | | | | | | | | | | |
| 他 | 83(+26) | 146 | 127(+27) | 95(+4) | 91(+10) | 83(+13) |
| Influenza | | | | 320(+88) | 170 | | | | | | | |
| 米 | | | | 193(>100) | | |
| 欧 | | | | 93(>100) | | |
| Emerging Markets | | | | | | | | | | | |
| 他 | | | | 34(-21) | | |
| Infanrix/Pediatrix | 700(+8) | 649 | 682(+26) | 543(+6) | 511(+28) | 431(+19) | 356(+12) | 336(+32) | 254(+8) | 238(+36) | 171(+47) | *Pediatrix(2003-) |
| 米 | 146(+9) | 134 | 212(+8) | 196(+14) | 172(+18) | 145(+13) |
| 欧 | 429(+6) | 406 | 377(+39) | 275(-2) | 281(+39) | 202(+24) |
| Emerging Markets | 50(+11) | | | | | | | | | | |
| 他 | 75(+17) | 109 | 93(+22) | 72(+24) | 58(+12) | 84(+20) |
| Boostrix | 181(+30) | 139 | 70(+6) | 66(+10) | 60(>+100) | 29 | | | | | | [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed]ジフテリア、破傷風、百日咳のブースターワクチン |
| 米 | 110(+51) | 73 | 35(-13) | 40(-2) | 41(>+100) | |
| 欧 | 43(+8) | 40 | 26(+37) | 19(+27) | 15(+88) | |
| Emerging Markets | 9(+29) | | | | | | | | | | |
| 他 | 19(-) | 26 | 9(+29) | 7(+75) | 4(+33) | |
| Rotarix | 235(-17) | 282 | 167(+84) | 91(>100) | 44 | | | | | | | |
| 米 | 74(-3) | 76 | 21(-) | - | | |
| 欧 | 38(-24) | 53 | 43(+87) | 23(>100) | | |
| Emerging Markets | 102(-21) | | | | | | | | | | |
| 他 | 21(-13) | 153 | 103(+51) | 68(+74) | | |
| Cervarix | 242(+29) | 187 | 125(+>100) | 10(-) | | | | | | | | |
| 米 | 13(+>100) | 4 | - | - | | |
| 欧 | 116(-16) | 138 | 104(+>100) | 9(-) | | |
| Emerging Markets | 25(+9) | | | | | | | | | | |
| 他 | 88(+>100) | 45 | 21(+>100) | 1(-) | | |
| Fluarix/FluLaval | 241(+14) | 211 | 215(+24) | 174 | | | | | | | | |
| 米 | 110(+51) | 73 | 85(-13) | | | |
| 欧 | 63(-11) | 71 | 78(+90) | | | |
| Emerging Markets | 40(-5) | | | | | | | | | | |
| 他 | 28(+12) | 67 | 52(+49) | | | |
| Flu-prepandemic | 1,192(+35) | 883 | 66(-55) | 146 | | | | | | | | |
| 米 | 1(-99) | 187 | 1(-99) | | | |
| 欧 | 488(-7) | 525 | 64(+25) | | | |
| Emerging Markets | 266(+>100) | | | | | | | | | | |
| 他 | 477(+>100) | 171 | 1(-) | | | |
| Synflorix | 221(+>100) | 73 | | | | | | | | | | 肺炎球菌ワクチン |
| 米 | - | - | | | | |
| 欧 | 43(+34) | 32 | | | | |
| Emerging Markets | 149(+>100) | | | | | | | | | | |
| 他 | 29(+>100) | 41 | | | | |
| ●ONCOLOGY&EMESIS | 688(+9) | 629 | 496(+4)[2%] | 477(-55)[2%] | 1,069(+5) | 1,016(+8) | 934(+2) | 1,001(+9) | 977(+21) | 838(+14) | 710(+11) |
| 米 | 350(+14) | 308 | 243(-11) | 272(-67) | 836(+10) | 761(+12) |
| 欧 | 201(-1) | 204 | 169(+25) | 139(-9) | 153(-7) | 164(-4) |
| Emerging Markets | 62(+9) | | | | | | | | | | |
| 他 | 75(+25) | 117 | 84(+20) | 66(-18) | 80(-12) | 91(+1) |
| Arzerra | 31(+>100) | 3 | | | | | | | | | | [ofatumumab]慢性リンパ性白血病;FDA承認2009年10月26日 |
| 米 | 26(+>100) | | | | | |
| 欧 | 4 | | | | | |
| Emerging Markets | - | | | | | | | | | | |
| 他 | 1 | | | | | |
| Votrient | 38(+>100) | 1 | | | | | | | | | | [pazopanib]進行性腎臓癌;FDA承認2009年10月19日 |
| 米 | 33(+>100) | | | | | |
| 欧 | 4 | | | | | |
| Emerging Markets | - | | | | | | | | | | |
| 他 | 1 | | | | | |
| Zofran | - | 109 | 110(-44) | 196(-77) | 847(+1) | 837(+9) | 763(+8) | 774(+16) | 708(+22) | 601(+19) | 491(+13) | [ondansetrone]鎮吐剤 |
| 米 | | 9 | 3(-96) | 78(-89) | 679(+6) | 639(+12) |
| 欧 | | 52 | 63(-10) | 71(-34) | 107(-14) | 124(-5) |
| Emerging Markets | | | | | | | | | | | |
| 他 | | 48 | 44(-8) | 47(-23) | 61(-18) | 74(+3) |
| Hycamtin | 144(-16) | 172 | 140(+18) | 119(+5) | 113(+14) | 99(-1) | 99(-3) | 110(+23) | 94(+7) | 90(-9) | 95(+1) | [topotecan HCl]卵巣癌と小細胞肺癌;06.5 FDA子宮頸癌を追加承認 |
| 米 | 83(-17) | 100 | 81(+16) | 70(-3) | 72(+9) | 66(+2) |
| 欧 | 48(-19) | 59 | 49(+23) | 42(+24) | 34(+26) | 27(-6) |
| Emerging Markets | 7(+17) | | | | | | | | | | |
| 他 | 6(-14) | 13 | 10(+11) | 7(-) | 7(+17) | 6(-6) |
| Tyverb/Tykerb | 227(+34) | 169 | 102(+100) | 51(-) | - | | | | | | | [lapatinib]乳癌 |
| 米 | 70(+30) | 54 | 47(+31) | 36(-) | | |
| 欧 | 94(+25) | 75 | 42(+>100) | 13(-) | | |
| Emerging Markets | 30(+36) | | | | | | | | | | |
| 他 | 33(+83) | 40 | 13(+>100) | 2(-) | | |
| Promacta | 31(+>100) | 13 | - | | | | | | | | | [eltrombopag]慢性特発性血小板減少性紫斑病（ITP）患者の血小板減少症治療薬 |
| 米 | 25(+92) | 13 | | | | |
| 欧 | 5 | - | | | | |
| Emerging Markets | - | | | | | | | | | | |
| 他 | 1 | - | | | | |
●CARDIOVASCULAR
& Urogenital(2003-) | 2,570(+12) | 2,298 | 1,847(+19)[9%] | 1,554(-5)[8%] | 1,636(+23) | 1,331(+41) | 932(+31) | 771(+22) | 655(+14) | 591(+23) | 463(-) |
| 米 | 1,571(+11) | 1,415 | 1,107(+14) | 970(-10) | 1,072(+40) | 766(+36) |
| 欧 | 610(+5) | 583 | 512(+28) | 412(+4) | 395(-5) | 415(+57) |
| Emerging Markets | 134(+24) | | | | | | | | | | |
| 他 | 255(+33) | 300 | 228(+25) | 172(+2) | 169(+13) | 150(+32) |
| Coreg | 171(-1) | 172 | 203(-65) | 587(-25) | 779(+36) | 573(+32) | 432(+34) | 361(+28) | 306(+27) | 251(+56) | 148(+11) | [carvedilol] |
| 米 | 170(-1) | 171 | 200(-66) | 581(-25) | 773(+36) | 568(+33) |
| 欧 | - | - | - | - | - | - |
| Emerging Markets | - | | | | | | | | | | |
| 他 | 1 | 1 | 3(-50) | 6(-) | 6(+20) | 5(-30) |
| Coreg CR | | - | 165(+88) | 88 | | | | | | | | [carvedilol] |
| 米 | | | 163(+85) | | | |
| 欧 | | | - | | | |
| Emerging Markets | | | | | | | | | | | |
| 他 | | | 2(-) | | | |
| Coreg IR | | - | 38(-92) | 499 | | | | | | | | [carvedilol] |
| 米 | | | 37(-92) | | | |
| 欧 | | | - | | | |
| Emerging Markets | | | | | | | | | | | |
| 他 | | | 1(-83) | | | |
| Levitra | | 75 | 60(+22) | 49(+14) | 43(+8) | 40(-19) | 49(+41) | 37(-) | - | (FDA承認2003.8.19) | vardenafil/勃起不全治療薬 |
| 米 | | 70 | 57(+21) | 47(+15) | 41(+17) | 35(+79) |
| 欧 | | 4 | 3(+50) | 2(+100) | 1(-75) | 4(-78) |
| Emerging Markets | | | | | | | | | | | |
| 他 | | 1 | - | - | 1(-) | 1(-94) |
| Avodart | 629(+19) | 530(+33) | 399(+40) | 285(+32) | 216(+67) | 129(+100) | 64(>100) | 19(>100) | - | (FDA承認2002.10.10) | dutasteride/BPH治療薬 |
| 米 | 337(+6) | 319 | 242(+38) | 175(+34) | 131(>+100) | 65(+90) |
| 欧 | 175(+18) | 148 | 118(+39) | 86(+25) | 69(+25) | 55(>100) |
| Emerging Markets | 33(+50) | | | | | | | | | | |
| 他 | 84(+>100) | 63 | 39(+56) | 24(+50) | 16(+78) | 9(>100) |
| Arixtra | 301(+19) | 254 | 170(+70) | 100(+72) | 58(>+100) | 24(>100) | 6 | - | - | - | - | fondaparinux;抗血栓症 |
| 米 | 177(+26) | 141 | 88(+60) | 55(+72) | 32(>+100) | 15(>100) |
| 欧 | 99(+4) | 95 | 71(+82) | 39(+70) | 23(>+100) | 8(>100) |
| Emerging Markets | 10(+43) | | | | | | | | | | |
| 他 | 15(+36) | 18 | 11(+83) | 6(+100) | 3(>+100) | 1(>100) |
| Fraxiparine | 222(-3) | 229 | 226(+23) | 184(-12) | 209(-1) | 211(>100) | 56 | - | - | - | - | Nadroparin Calcium;抗血栓;Sanofi |
| 米 | - | - | - | - | - | - |
| 欧 | 154(-11) | 173 | 178(+18) | 160(-11) | 179(-) | 179(>100) |
| Emerging Markets | 55(+31) | | | | | | | | | | |
| 他 | 13(-7) | 56 | 48(+45) | 24(+) | 30(-6) | 32(>100) |
| Vesicare | 114(+10) | 104 | 71(+42) | 50(+56) | 32 | 13(-) | - | - | - | - | - | solifenacin;過活動膀胱;アステラス導入品 |
| 米 | 113(+9) | 104 | 71(+42) | 50(+56) | | 13(-) |
| 欧 | - | - | - | - | | - |
| Emerging Markets | - | | | | | | | | | | |
| 他 | 1 | - | - | - | | - |
| Lovaza | 530(+18) | 450 | 290(+>100) | 5 | | | | | | | | [omega-3-acid ethyl esters]脂質異常症 |
| 米 | 528(+18) | 448 | 289(+>100) | | | |
| 欧 | - | - | - | | | |
| Emerging Markets | - | | | | | | | | | | |
| 他 | 2 | 2 | 1(-) | | | |
| Volibris | 46(+>100) | 19 | - | | | | | | | | | [ambrisentan]肺動脈高血圧治療薬 |
| 米 | - | - | | | | |
| 欧 | 40(+>100) | 18 | | | | |
| Emerging Markets | 1 | | | | | | | | | | |
| 他 | 5(+>100) | 1 | | | | |
| ●その他 | | 1,063 | 959(+6)[5%] | 957(-2) | 973(-6) | 1,040(-) | 1,027(-7) | 1,171 | 1,310 | 916(-4) | 837(-2) |
| 米 | | 17 | 16(-75) | 65(-22) | 83(+19) | 69(-22) |
| 欧 | | 364 | 321(+26) | 266(+1) | 263(-18) | 321(-2) |
| Emerging Markets | | | | | | | | | | | |
| 他 | | 682 | 622(+7) | 626(-) | 627(-3) | 650(+3) |
| Zantac | | | - | 168(-28) | 232(-5) | 244(-12) | 273(-12) | 328(-13) | 382(-21) | 505(-11) | 575(-11) | ranitidine |
| 米 | | | | 33(-54) | 72(+24) | 58(-19) |
| 欧 | | | | 42(-19) | 52(-19) | 64(-15) |
| Emerging Markets | | | | | | | | | | | |
| 他 | | | | 93(-14) | 108(-11) | 122(-6) |
| Lotronex | | | - | - | - | - | - | ? | ? | ? | 36(>100) | [alosetrone]過敏性腸症候群[IBS] |
| ARTHRITIS(Relafen) | | | | | | - | - | ? | 23(-84) | 156(-29) | 210(-28) |
| DERMATOLOGICALS | | | | | | - | - | ? | ? | ? | 249(-4) |
|
| total Sales | | 23,466 | | 19,233(-4) | 20,078(+8) | 18,661(+8) | 17,100(+1) | 18,181 | 17,995(+8) | 17,205(+12) | 14,982(+11) |
| 米 | | 9,180 | | 9,273(-10) | 10,353(+14) | 9,106(+8) |
| 欧 | | 7,681 | | 5,692(+3) | 5,547(-) | 5,537(+8) |
| Emerging Markets | | | | | | | | | | | |
| 他 | | 6,605 | | 4,268(+2) | 4,178(+4) | 4,018(+9) |
| CONTINUING BUSINESS |
| Divested products | | | | | | - | - | ? | ? | ? | 447(-2) |
| Famvir | | | | | | - | - | - | (Novartisヘ譲渡) | 152(+11) | famciclovir |
| Kytril | | | | | | - | - | - | (Rocheヘ譲渡) | 219(-7) | granisetron |
| Other | | | | | | - | - | ? | ? | ? | 76(-9) |
|
| TOTAL PHARM. SALES | 23,382(-1) | 23,694 | | | | - | - | ? | ? | ? | 15,429(+10) |
| | | | | | | | | | | | |
| 米 | | | | | | |
| 欧 | | | | | | |
| Emerging Markets | | | | | | | | | | | |
| 他 | | | | | | |
■全般
[2006]
主要品目の好調な成長により2006 年度の医療用医薬品の売上高は9%増の201億ポンドを達成:
- 「アドエア」(喘息、COPD) 11%増 の33億ポンド
- 「アバンディア」とシリーズ製品(2型糖尿病) 25%増の16億ポンド
- ワクチン 23%増の17億ポンド
- 「ラミクタール」(てんかん) 19%増の9億9,600万ポンド
- 「バルトレックス」(ヘルペス) 24%増の8億4,500万ポンド
- 「コレッグ」(心臓病) 38%増の7億7,900万ポンド
開発後期段階のパイプラインの進捗:
- 4つの新規化合物と3つの新規ワクチンおよび3つの導入品(HuMax-CD20〔がん領域〕,gepirone ER
およびXP13512〔中枢神経領域〕)がこの12カ月の間に開発後期段階に進みました。
- 31の主な製品(13の新規化合物と6つのワクチンおよび12の適応/剤形追加)が現在フェーズ3段階もしくは承認申請済み。
2007年に5つの医療用医薬品の上市が期待されます。
- 乳がん治療のための新しい経口抗がん剤Tykerb
- 子宮頸がん予防ワクチン Cervarix:
欧州およびその他地域での発売、また米国での申請を4月までに予定。
- 新しいアレルギー性鼻炎治療薬「アラミスト」
- 3種類の循環器系疾患に対する1日1回投与の経口剤「コレッグCR」
- 新しい片頭痛治療薬 Trexima
| ■呼吸器系 |
| ★アドエア/Advair/Seretide(salmeterol, fluticasone propionate) 日本発売2007.6.8 | ぜんそく・COPD |
Seretide/Advair, a combination of Serevent and Flixotide, offers a long-acting bronchodilator and an antiinflammatory
in a single inhaler. It is approved for the treatment of asthma and COPD. |
[特許]The patent on the specific combination of salmeterol xinafoate and fluticasone propionate is not
due to expire until 2010 (USA) and 2013b (Europe). The US Patent has been re-issued by the US Patent and
Trademark Office (USPTO)e. Litigation under patents protecting the product is ongoing in certain European
marketse. The UK patent has been revoked by the UK courts. Patents on the individual ingredients have expired
except the patents on salmeterol xinafoate in the USA (August 2008), France (December 2008), and Italy (2009). |
| [2007] 「アドエア」の売上は10%増の35億ポンド
「アドエア」(ぜんそく・COPD)の売上は、米国では9%増の19億ポンド、欧州では9%増の12億ポンド、また世界のその他の地域においては、昨年6月の日本での発売もあり、23%増の3億7200万ポンドでした。
GSKはCOPD治療に対する「アドエア」の使用については、COPDの増悪抑制に関する臨床データの評価も含め、COPDの患者さんに「アドエア」が使えるよう適応拡大にむけてFDAと協議を行っていきます。 |
[競合2007]GSK’s respiratory franchise is driven by the growth of Seretide/Advair. Major respiratory competitors are Singulair
from Merck, especially in the USA, Symbicort from AstraZeneca and Spiriva from Pfizer/ Boehringer Ingelheim. |
| ★Veramyst/Avamys(fluticasone furoate) 日本申請2006.8.31 | アレルギー性鼻炎治療薬 |
Veramyst/Avamys, Flixonase/Flonase and Beconase are steroid intra-nasal preparations for the treatment of
perennial and seasonal rhinitis. |
[特許]The patent on fluticasone furoate is not due to expire until 2021 in the USA and 2022 in Europe |
| [2007] 2007売上は、2007年7月の米国での発売に伴い、2100万ポンドとなりました。2008年1月には欧州において成人と小児のアレルギー性鼻炎の治療としてAvamysが承認されました。また日本においても現在、当局において同剤の承認に向けた審査が行われています。 |
| [競合2007] |
| ★Serevent.(キシナホ酸サルメテロール) 日本発売セレベント | 気管支喘息等の気道閉塞性障害 |
Serevent is a long-acting bronchodilator used to treat asthma and COPD, and Ventolin is a selective short-acting
bronchodilator used to treat bronchospasm. |
[特許]The patent on salmeterol xinafoate expires in August 2008 in the USA. In Europe, the patent has expired,
except in France (December 2008b) and Italy (2009b). |
| [2007] |
| [競合2007] |
| ★Flixotide/Flovent and Becotide/Beclovent | |
Flixotide/Flovent and Becotide/Beclovent are inhaled steroids for the treatment of inflammation associated with
asthma and COPD. |
| [特許] |
| [2007] |
[競合2007]
|
| ■神経系 |
| ★Requip (ropinirole) 日本承認06.10.20 | パーキンソン病/レストレスレッグ症候群 |
Requip is a specific dopamine D2/D3 receptor agonist indicated for the treatment of Parkinson’s disease and
Restless Legs Syndrome (RLS). |
[特許]The patent on ropinirole expired in 2007a in the USA and is due to expire in November 2008b in Europe. A
patent relating to the use of ropinirole in Parkinson’s disease is not due to expire until May 2008 (USA) and 2011b
(Europe). Litigation challenging the validity of the Parkinson’s use patent in the USA has been dismissed by the
court, and generic entry is not expected until after expiry of the patent in May 2008e. |
| [2007] 2007売上は36%増の3億4600万ポンドでした。パーキンソン病治療のための新しい1日1回服用の「レキップXL」は欧州の13カ国で承認、7カ国で発売されています。2008年には更なる欧州諸国での承認が予定されています。米国においては、2008年上期に「レキップXL」申請に対するFDAからの回答が期待されています。 |
[2006]
高い可能性を持つ「レキップ」、
パーキンソン病治療薬/レストレスレッグ症候群(むずむず足症候群)の治療薬である「レキップ」の売上は74%増の2億6,800万ポンドでした。
GSKは昨年12月にFDAに対しRequip 14hrの申請を行いました。
Requip extended release 申請2006.10(米国：RLS)
Requip Modutab/XL 24 hour (パーキンソン病 １日１回) FDA申請2007.2 /EMEA申請2005.12
・Sales of Requip, for Parkinson's disease and Restless Legs Syndrome (RLS), grew 74% to ￡268 million
and, in December, the FDA accepted GSK’s file for approval of the new formulation Requip CR.
・In addition, in 2005 there was a rapid uptake of a number of high potential products such as Requip, for
restless legs syndrome (sales up 34% to ￡156 million).
・特許失効2007a (USA) and 2008b (Europe).
Parkinson's disease用途特許切れは2008 (USA) and 2011b(Europe)
. Litigation challenging the validity of the Parkinson’s use patent is ongoing in the USAe
Requip
In April 2005, the Group commenced an action in the US District Court for the District of Delaware against
Teva Pharmaceutical USA Inc. alleging infringement of the Group’s compound patent for ropinirole
hydrochloride (the active ingredient in Requip) and a method of use patent for treatment of Parkinson’s
disease, both of which are listed in the FDA Orange Book. The compound patent expires in December
2007 and the method of use patent in May 2008. The defendant filed an ANDA with the FDA with a
certification of invalidity and non-infringement of those patents. FDA approval of that ANDA is stayed until
the earlier of August 2007 or resolution of the patent infringement action. In December 2006, the judge
ruled at the conclusion of the trial that the Group’s method of use of ropinirole to treat Parkinson’s Disease
is novel and nonobvious rejecting Teva’s claims on those grounds. Teva’s further claim that the patent is
unenforceable for inequitable conduct remains before the judge as the evidence was not reviewed at the
trial. This issue is to be decided on the basis of deposition testimony and documents and consideration of
further potential filings by the parties. Teva’s original challenge to the Group’s basic compound patent was
withdrawn before trial, and Teva has accepted that the FDA will not approve its product prior to expiration
of that patent. |
| [競合2007] |
| ★ラミクタール/Lamictal.(lamotrigine) 日本申請中 | てんかんおよび双極性障害治療薬 |
Lamictal, a well established treatment for epilepsy, is also indicated for bipolar disorder |
[特許]The patent on lamotrigine is not due to expire until 2009a,c (USA). Litigation challenging the validity of this
patent in the USA has been settled on terms allowing for generic entry of tablet forms in mid-2008. In Europe, the
corresponding patent has expired and generic competition exists. |
| [2007] 2007売上は、米国での売上(26%増の8億9200万ポンド)に牽引され18%増の11億ポンドとなりました。2008年中頃には、FDAからの「ラミクタールXR」の承認勧告も期待されます。 |
[競合2007]The major competitors for Lamictal in epilepsy are J&J’s Dilantin and generic phenytoin, Novartis’ egretol/Tegretol
XR and generic carbamazepine. UCB’s Keppra and Abbot’s Depakote/Depakote ER. In bipolar the major
competitors are generic lithium, other anti-epileptics including Abbott’s Depakote/Depakote ER and the atypical
anti-psychotics including AstraZeneca’s Seroquel. |
| ★Treximet(sumatriptan and naproxen sodium) 日本未開発 | 片頭痛治療薬 |
| [特許] |
| [2007] 2008.1月には新しい片頭痛治療薬Treximetの追加データがFDAに提出されました。Treximetは、片頭痛治療のゴールド・スタンダードであるスマトリプタンとナプロキセンナトリウムの2成分が1つの錠剤に入った薬剤であり、複数の片頭痛の発生機序に作用し、効果とその持続時間を増幅させたものです。米国においては、今年上期中に同申請に対するFDAからの決定が期待されています。 |
| ★Paxil/Seroxat(paroxetine HCl) 日本発売済み | 抗うつ剤 |
Seroxat/Paxil is a selective serotonin re-uptake inhibitor (SSRI) for the treatment of major depressive disorder,
panic, obsessive compulsive disorder, post traumatic stress disorder, social anxiety disorder and generalised
anxiety disorder. A controlled release formulation, Paxil CR, is available in the USA. |
[特許]The patent on the commercial form of paroxetine has expired and generic competition exists on Paxil
instant release (IR) forms in the USA, Europe and other markets. Litigation relating to patents protecting the product
is ongoing in the USAe. Paxil CR is protected by a patent issued in June 2007 relating to a delayed and controlled
release formulation of paroxetine hydrochloride. Litigation relating to this patent has been settled on terms allowing
for generic entry on all strengths of Paxil CR no later than fourth quarter 2008e.
Paxil/Seroxat
In the USA a number of distributors of generic drugs filed applications with the FDA to market generic versions of
Paxil/Seroxat (paroxetine hydrochloride) prior to the expiration in 2007 of the Group’s patent on paroxetine
hyrdrochloride hemihydrate. In response the Group filed a number of patent infringement actions, all of which have
concluded or been resolved except as described below. One distributor, Apotex, launched its generic product in the
USA in September 2003. Additional generic products were launched by other defendants after March 2004.
The Group had filed two separate patent infringement actions against Apotex, one in the US District Court for the
Northern District of Illinois and the other in the Eastern District of Pennsylvania. After appeals by the Group to the
US Court of Appeals for the Federal Circuit (CAFC), which hears all appeals from US District Courts on patent
matters, in each of these cases, and a remand of the matter to the same panel on one case, the relevant claim of
the patent on paroxetine hydrochloride hemihydrate was ruled invalid. Other claims of other patents have been
ruled invalid and/or not infringed, in some cases with appeals pending or planned, and other claims are pending
trial.
In Europe, generic products containing paroxetine hydrochloride are now on the market in most European
countries. Whilst some of these products are the subject of continuing litigation, most actions have now been
concluded or settled. With respect to two manufacturers, Synthon BV and FAL, litigation is ongoing and
counterclaims for unfair competition have been asserted against the Group.
Following the litigation in Canada with Apotex over several other patents related to paroxetine, Apotex launched its
generic product in Canada in October 2003. Apotex alleged that as a result of that litigation it had been enjoined
from launching that product after receipt of regulatory approval. An action by Apotex to recover damages related to
the delay occasioned by those injunctions is ongoing.
Paxil CR
In November 2005, Mylan Pharmaceuticals filed an ANDA for Paxil CR (paroxetine hydrochloride controlled release
formulation) with a certification of invalidity, unenforceability and non-infringement of several patents listed in the
FDA Orange Book. There was no such certification in respect of the patent covering paroxetine hydrochloride
hemihydrate, which Mylan admitted is the active ingredient in its product. That patent expired in June 2007, after
giving effect to a grant of paediatric exclusivity by the FDA. As the Group did not file a patent infringement action
against Mylan within the 45-day period provided under Hatch-Waxman, there is no 30-month stay of FDA approval
of the Mylan ANDA.
A new US patent covering a delayed and controlled release formulation of paroxetine hydrochloride (Paxil CR) was
issued to the Group in June 2007 and listed in the FDA Orange Book and thereafter the Group filed an action in the
US District Court for the District of New Jersey against Mylan for infringement of that newly issued patent. |
[2007]CNS sales decreased 2% to ￡3.3 billion. Sales decreased in the USA and Europe, reflecting generic competition to
Seroxat/Paxil in both regions. International sales grew 6% which included 4% growth in Paxil in Japan. Total
Seroxat/Paxil sales declined 6% to ￡553 million. |
[2006]CNS sales increased 15% to ￡3.6 billion. Sales increased in the USA and International, but declined in Europe due
to generic competition. Total Seroxat/Paxil sales grew 4% to ￡620 million, due to strong growth of Paxil CR in the
USA and Paxil IR in Japan partly offset by generic competition to Paxil IR in Europe. |
[競合2007]Major competitors in the USA to Paxil are its generic forms, as well as generic fluoxetine, the generic form of Eli
Lilly’s Prozac, generic sertraline, the generic form of Pfizer’s Zoloft, Cymbalta from Eli Lilly, Forest Laboratories’
Celexa and Lexapro, and Effexor XR from Wyeth. |
[訴訟2007(PL)]
Paxil and Paxil CR
The Group has received lawsuits and claims alleging that use of Paxil (paroxetine) during pregnancy resulted in the
birth of a child with birth defects or health issues. Separately, the Group has received lawsuits and claims that
patients who took Paxil committed or attempted to commit suicide and/or acts of violence. The Group also has
received lawsuits and claims filed on behalf of patients alleging that they suffered symptoms on discontinuing
treatment with Paxil.
The Group has received numerous lawsuits and claims alleging that use of Paxil during pregnancy resulted in the
birth of a child with a congenital malformation or persistent pulmonary hypertension of the newborn. In September
2005, the US label for Paxil was updated to reflect new information that suggested an increased risk of congenital
malformations (particularly cardiovascular malformations) in infants born to mothers who took Paxil during the first
trimester of pregnancy. In December 2005, the Paxil US label was further updated to include new data and to
strengthen the pregnancy warning from Category C to Category D, which indicates there is evidence of risk to the
foetus, but the potential benefits from the use of the drug in pregnant women may outweigh the risk. In May 2006,
the Paxil US label was again updated to include a class warning concerning persistent pulmonary hypertension of
the newborn arising in mothers who took selective serotonin reuptake inhibitor (SSRI) antidepressants after the
20th week of pregnancy.
The Group has received numerous claims and lawsuits alleging that treatment with Paxil has caused homicidal or
suicidal behaviour exhibited by users of the product. Class certification was denied in January 2007 in a purported
personal injury class action lawsuit. In January 2005, the FDA approved both a boxed warning that antidepressants
increased the risk of suicidal thoughts or behaviour in paediatric patients and other strengthened warnings for SSRI
products, including Paxil, as a class. In May 2006, the Paxil US label was updated to warn that young adults,
especially those with Major Depressive Disorder, may be at increased risk for suicidal behaviour during treatment
with paroxetine. In August 2007, FDA required updated US labels for antidepressants as a class to state in the
boxed warning that antidepressants increased the risk of suicidal thinking and behaviour in children, adolescents,
and young adults; that no increase was shown beyond age 24; that there was a reduction in risk in adults aged 65
and older; and that depression and other psychiatric disorders are themselves associated with increased risk.
The Group received lawsuits filed in state and federal courts in the USA and Canada on behalf of thousands of
plaintiffs, including purported class actions, alleging that paroxetine (the active ingredient in Paxil) is addictive and
causes dependency and withdrawal reactions. The US federal cases were consolidated in an MDL proceeding. In
January 2006, a conditional settlement agreement became effective. The Group did not admit liability with respect
to the allegations in the lawsuits. Virtually all the US actions have now been resolved. One purported class action
consumer fraud lawsuit, focused on discontinuation symptoms, is on appeal from denial of class certification in
California state court. There is purported class action litigation in Canada. The Group is also defending litigation
which has commenced in the UK on behalf of hundreds of plaintiffs who allege that paroxetine has caused them to
suffer from withdrawal reactions and dependency. |
| ★Wellbutrin SR, Wellbutrin XL and Zyban(bupropion HCl) Wellbutrin日本P3 | うつ病、禁煙補助(Zyban) |
Wellbutrin is an anti-depressant, available in the USA and many European and international markets in normal,
sustained-release (SR) and once-daily (XL) formulations. |
[特許]The patent on the active ingredient has expired. There is now generic
competition for the sustained release (SR) instant release (IR) and 300mg dosage form of Wellbutrin XL in the
USA. Litigation in the USA relating to formulation patents covering Wellbutrin XL has been settled on terms allowing
generic entry for the 150mg form in 2008. In Europe, regulatory data exclusivity provides protection until 2009 in
some markets.
In December 2004, Biovail commenced actions in the US District Court for the Central District of California against
Anchen Pharmaceuticals and in the US District Court for the Southern District of Florida against Abrika
Pharmaceuticals, in each case alleging infringement of Biovail formulation patents for Wellbutrin XL. In April 2005,
Biovail filed an action in the US District Court for the Eastern District of Pennsylvania against Impax Laboratories for
infringement of the same patents. Those patents expire in 2018. Each of Anchen, Abrika and Impax had filed an
ANDA with the FDA with a certification of invalidity or non-infringement of the Biovail patents. The Group is the
licensee under those patents.
In August 2006, the judge granted Anchen’s motion and ruled that Anchen’s ANDA product did not infringe Biovail’s
patent. Biovail has appealed that decision to the CAFC. The Group is not a party to any of those actions. In
September 2005, Biovail commenced actions in the US District Court for the Southern District of New York against
Watson Laboratories alleging infringement of the Biovail formulation patents. Watson’s third party counterclaim
against the Group based on listing activities associated with the FDA Orange Book was dismissed in October 2006.
requested by the parties, a comprehensive settlement with Anchen Pharmaceuticals, Impax Laboratories, Watson
Pharmaceuticals and Teva Pharmaceutical Industries. Certain aspects of the settlements remain confidential but
the parties did disclose that, with defined exceptions, Anchen, Impax, Watson and Teva may not market a generic
version of the 150mg strength of Wellbutrin XL until 2008.
The FDA has given final approval to Anchen’s ANDA for its generic version of Wellbutrin XL and to Impax for a
generic 300mg tablet product. The 300mg generic product was launched in the USA at the end of December 2006.
No generic version of the 150mg tablet has been launched as of the date of this report. |
[2007]Total Wellbutrin sales declined 37% to ￡529 million, owing to US
generic competition to Wellbutrin SR/IR and Wellbutrin XL 300mg tablet. |
[2006]Total Wellbutrin sales grew 24% to ￡900 million. Sales of Wellbutrin XL, a once-daily product, grew 25% to ￡798
million. In December 2006, generic competition to the Wellbutrin XL 300mg tablet (approximately 60% of Wellbutrin
sales) entered the US market. |
[競合2007]The principal competitors in the USA for Wellbutrin are generic
forms of bupropion, the generic forms of SSRIs, Lexapro, Effexor XR, and Cymbalta. Generic competition for
Seroxat/Paxil has also occurred in a number of other markets. |
| ★Imigran/Imitrex(sumatriptan succinate) 日本イミグラン | |
Imigran/Imitrex is a 5HT1 receptor agonist used for the treatment of severe or frequent migraine and cluster
headache and has become the reference product in this sector. Naramig/Amerge is also a 5HT1 receptor agonist
indicated for the treatment of migraine. |
[特許]The patent on sumatriptan is not due to expire until 2009c (USA) and has expired in Europe (except
Italy (December 2008)). Litigation challenging the validity of the patent protecting this product in the USA has been
settled allowing generic entry in the fourth quarter 2008 |
| [2007] |
[競合2007]The major competitors for Imitrex/Imigran are AstraZeneca’s
Zomig, Merck’s Maxalt and Pfizer’s Relpax. |
|
| ■抗ウイルス剤 |
| ★HIV | |
|
| [特許] |
| [2007] |
[競合2007]GSK is a pioneer in the HIV market, launching AZT (Retrovir) in 1987 and Epivir in 1995, which today are available
as Combivir in a single tablet, a cornerstone of HIV combination therapy. The launches of Ziagen, Agenerase,
Trizivir, Lexiva and Epzicom have broadened the Group’s portfolio of HIV products. Major competitors in the HIV
market include Gilead, Bristol Myers Squibb, Abbott, Roche and Boehringer Ingelheim. |
| ★Combivir.(zidovudine and lamivudine) [日本]コンビビル | HIV |
Combivir, a combination of Retrovir and Epivir, has consolidated the position of these two reverse transcriptase
inhibitors as the cornerstone of many multiple anti-HIV product regimens. Physician acceptance has clearly
demonstrated the value placed on minimising the pill burden faced by patients. |
[特許]The patent on the specific combination of lamivudine and zidovudine is not due to expire until 2012 (USA)
and 2013b (Europe). Litigation challenging the validity of the patent protecting the combination is ongoing in the
USAe. |
| [2007] |
| ★Epivir(lamivudine) [日本]エピビル | HIV |
|
[特許]The patent on lamivudine is not due to expire until 2010a,c (USA) and 2011b (Europe). |
| [2007] |
| ★Epzicom/Kivexa(abacavir sulfate and lamivudine) [日本]エプジコム | HV |
Epzicom/Kivexa, approved for use in the USA and Europe, is a combination of Epivir and Ziagen that is taken as
one tablet with once-daily dosing for HIV/AIDS in combination with at least one other anti-HIV drug. |
| [特許] |
| [2007] |
| ★Lexiva/Telzir(fosamprenavir calcium) 日本「レクシヴァ錠700」
| HIV |
Lexiva/Telzir is a protease inhibitor for the treatment of HIV that is well tolerated and more convenient than
Agenerase, which it supersedes. Lexiva may be taken twice-daily or once-daily when boosted with ritonavir. |
[特許]GSK is the exclusive licensee under the patent on fosamprenavir, which is not due to expire until
2017 (USA) and 2019b (Europe). |
| [2007] |
| ★Trizivir(abacavir sulfate/ lamivudine/zidovudine) [日本] | |
Trizivir is a combination of Combivir and Ziagen, combining three anti-HIV therapies in one tablet, for twice-daily
administration. |
[特許]The patent on the method of treatment using a combination of lamivudine, zidovudine and abacavir does
not expire until 2016 (USA) and 2016 (Europe). |
| [2007] |
| ★Valtrex(valacyclovir) [日本]バルトレックス | 単純疱疹、帯状疱疹、性器ヘルペス、水痘 |
Valtrex is a treatment for episodic genital herpes as well as the long term suppression and reduction of
transmission of genital herpes, zoster (shingles), cold sores and chicken pox. Valtrex supersedes Zovirax, which is
also used to treat herpes infections. |
[特許]The patent on valaciclovir is not due to expire until 2009a (USA) and 2009b (Europe, except Greece and
Spain (August 2008)). Litigation challenging the validity of the patent in the USA has been settled on terms allowing
for generic entry in late 2009e. |
| [2007] |
[競合2007]Valtrex has strengthened the Group’s position in the anti-herpes area, where GSK’s Valtrex and Zovirax compete
with Novartis’ Famvir. Valtrex is a market leader, whilst Zovirax faces competition from generic acyclovir. In the
hepatitis B market, GSK’s Zeffix was the first anti-viral on the market. Gilead’s Hepsera was the second. The Group
has secured marketing rights to Hepsera in some key markets. |
| ★Ziagen(abacavir sulfate) [日本]ザイアジェン | HIV |
Ziagen is a reverse transcriptase inhibitor. The product’s potency, ease of use and resistance profile allow it to play
a significant role in a variety of highly active, well tolerated and simplified HIV treatment regimens. |
[特許]The patent on abacavir is not due to expire until 2012a,c (USA) and 2014b (Europe). |
| [2007] |
| [競合2007] |
| ★Zeffix（一般名：ラミブジン） [日本]ゼフィックス | B型肝炎 |
Zeffix has been approved for marketing in the USA, Europe, China and other markets for the treatment of chronic
hepatitis B. |
| [特許] |
| [2007] |
| [競合2007] |
|
| ■代謝用剤 |
| ★アバンディア/Avandia, Avandamet and Avandaryl [日本]開発中止？ | 2型糖尿病治療薬 |
Avandia is a potent insulin sensitising agent which acts on the underlying pathophysiology of type 2 diabetes.
Avandamet is a combination of Avandia and metformin HCI that targets insulin resistance and decreases glucose
production in one convenient pill.
Avandaryl/Avaglim is a combination of Avandia and Amaryl, a Sanofi-Aventis product. Avandaryl/Avaglym targets
insulin resistance and stimulates pancreatic insulin production. |
[特許]The patent on rosiglitazone is not due to expire until 2012a,c (USA) and 2013b
(Europe). Patents on the commercial form of the active ingredient rosiglitazone maleate are not due to expire until
2015 (USA) and 2014b (Europe). Litigation challenging the validity of the patents protecting these products in the
USAe has been settled on terms allowing for generic entry late in the first quarter 2012e. |
| [2007] 「アバンディア」のシリーズ製品の売上は12億ポンドに減少
2型糖尿病治療薬の「アバンディア」のシリーズ製品の米国での売上は、2007年5月のメタアナリシスの発表以来、第4四半期の売上は55%減の1億3000万ポンドとなり、通年では29%減の7億8000万ポンドとなりました。米国以外の国においては、欧州において4%増の2億2700万ポンドであり、世界のその他地域の市場においては7%減の2億1200万ポンドとなりました。 |
[競合2007]The major competitor for Avandia is Takeda Chemical’s Actos, whose co-promotion with Eli Lilly in the USA ended
in 2007. Takeda also market Actoplusmet/Competact (a combination of metformin HCI and Actos) in the USA and
some EU markets and DuetAct (a combination of glimepiride and Actos) in the USA. |
| ★Boniva(ibandronate sodium) 日本R484（イバンドロン酸ナトリウム水和物） 注/経口[中外製薬]（注）第Ⅱ/Ⅲ相（経口)第Ⅱ相 | 骨粗鬆症 |
Bonviva/Boniva is a long-acting bisphosphonate available in once-monthly oral and quarterly injection forms for the
treatment of osteoporosis (co-promoted with Roche). |
[特許]GSK has co-promotion rights under the patent on ibandronate which is not due to expire until 2012a (USA)
and 2011b (Europe). Litigation challenging the validity of the patent protecting this product is ongoing in the USAe. |
| [2007] |
[競合2007]Monthly Boniva/Bonviva competes with Merck’s weekly Fosamax and Proctor & Gamble/Sanofi-Aventis’ twicemonthly
Actonel, and Novartis’ Reclast/Aclasta which is dosed as an annual infusion. Generic Fosamax
(alendronate) is now available in many markets, including the USA, UK, Germany and Canada. |
|
| ■ワクチン |
|
| [特許] |
| [2007] |
[競合2007]The vaccine market is dominated by five key players. GSK’s major competitors are SanofiPasteur (SP), Merck,
Novartis and Wyeth. Within the paediatric vaccine field, Infanrix’s main competitor is SP’s range of DTPa-based
combination vaccines, although the Infanrix hexa combination is the only available hexavalent paediatric
combination in Europe. Merck and the joint venture between Merck and SP in Europe market two new vaccines
against rotavirus induced infection and HPV, that respectively compete against Rotarix and Cervarix. |
| ★Cervarix 日本申請2007.9.26 | 子宮頸がん予防ワクチン |
|
| [2007] 世界51カ国で承認されており、各国で保険償還に向けた協議や支払いに関する決定が行われています。さらに、日本も含め27カ国で承認申請が行われており、日本では優先審査品目に指定されました。米国においては、2007年初頭に提出された承認申請に対して、FDAより12月にコンプリート レスポンス レターが発表されました。GSKは、2008年第2四半期にFDAに対して回答を提出する予定であり、引き続き当局と協議を行っていきます。
|
| ★Synflorix | 肺炎球菌ワクチン |
|
| [特許] |
| [2007] また2007年12月にGSKは欧州および世界のその他の地域で肺炎球菌ワクチンSynflorixの承認申請を行いました。肺炎連鎖球菌と無莢膜型/非分類型のインフルエンザ菌(NTHi)の2つに対する効果により、Synflorixは、既存のワクチン以上に、侵襲性肺炎球菌疾患や中耳炎のようなバクテリア性呼吸器感染症から子供を守ることができると期待されています。 |
| ★Hiberix | HIBワクチン |
paediatric booster for Haemophilus influenzae type b; FDA承認Aug09、EU承認Nov07 |
| [2008] Hiberix, Infanrix Hexa and Menitorix On 3rd August 2009, Novartis sued the Group in Belgium for patent infringement in relation to Hiberix, Infanrix Hexa, and Menitorix vaccine products and in relation to phase 3 development vaccine projects HibMenCY and MenACWY.
Parallel infringement proceedings were also filed by Novartis in the UK for Infanrix Hexa, Menitorix and Hiberix. The European Patent Office granted the Group’s request for an accelerated review to reconsider the validity of the patent and in December 2009, all Novartis claims relevant to the Group’s products were held invalid. The UK and Belgian infringement trials will be dismissed. |
|
| ■循環器系 |
| ★Coreg(carvedilol) [日本] | |
Coreg is an alpha/beta blocker which has been proven to be effective in treating patients with mild, moderate and
severe heart failure, heart attack or hypertension. GSK has sole marketing rights in the USA and Canada. A
controlled release formulation, Coreg CR is also available in the USA. Generic versions of Coreg are available in
the USA and Canada. |
[特許]GSK is the exclusive licensee under the US patent on carvedilol, which expired in 2007a,c. Coreg CR is
protected by a formulation patent that is not due to expire in the USA until 2016, and a patent on the active form
carvedilol phosphate that is not due to expire until 2023. Litigation challenging the validity of the patent on the active
form is ongoing in the USAe |
| [2007] |
[競合2007]GSK markets Coreg in the USA where its major competitors are Toprol XL and generic betablockers. |
| ★アリクストラ/Arixtra(fondaparinux sodium) 欧米発売 日本申請2007.8.24 | 深部静脈血栓症および肺塞栓症の予防 |
Arixtra, a selective Factor Xa inhibitor, is indicated for the treatment of deep vein thrombosis (DVT) and pulmonary
embolism (PE) and for the prevention of DVT and PE in patients undergoing major orthopaedic surgery, abdominal
surgery and acutely ill medical patients (EU only). Also in the EU, Arixtra is indicated for the treatment of patients
with acute coronary (unstable angina, NSTEMI and STEMI). 2004年9月1日、GlaxoSmithKline社は、Aventis社とSanofi社の買収が完了したことに伴い、抗トロンビン薬・Fraxiparine (Fraxodi:nadroparine calcium)、Factor Xa阻害剤・Arixtra (fondaparinux sodium)と2つの薬剤に関する工場をSanofi-Aventis社から獲得 |
| [特許] |
| [2007] 2007売上は81%増の1億ポンドと好調な成長を示しています。2007年の急性冠症候群(ACS)治療での適応症取得に伴い、欧州における「アリクストラ」の売上は70%増の3900万ポンドと力強い成長を示しました。ACSでの適応追加取得は、「アリクストラ」が同クラスのLovenoxと同等の効果を示しながらも、Lovenoxと比べて出血のリスクが著しく低く、同剤のLovenoxと比べた死亡率低下のベネフィットが高いというデータに基づくものです。米国においてはACSの適応に関するFDAからの承認勧告に対する回答を2008年上期に提出する予定です。 |
[競合2007]The major competitor
for Arixtra is the low molecular weight heparin enoxaparin, a product marketed by Sanofi-Aventis. |
| ★Fraxiparine [日本] | |
Fraxiparine is a low-molecular weight heparin indicated for prophylaxis of thromboembolic disorders (particularly
deep vein thrombosis and pulmonary embolism) in general surgery and in orthopedic surgery, treatment of deep
vein thrombosis and prevention of clotting during haemodialysis. 2004年9月1日、GlaxoSmithKline社は、Aventis社とSanofi社の買収が完了したことに伴い、抗トロンビン薬・Fraxiparine (Fraxodi:nadroparine calcium)、Factor Xa阻害剤・Arixtra (fondaparinux sodium)と2つの薬剤に関する工場をSanofi-Aventis社から獲得 |
| [特許] |
| [2007] |
| ★Integrilin(eftifibatide) [日本未開発] | 急性冠動脈症候群患者の心筋梗塞予防 |
Integrilin is a GP IIb-IIIa inhibitor, approved in the EU for the prevention of early myocardial infarction in patients
with unstable angina or non-Q-wave MI.
米国Millennium Pharmaceuticals社(2008.5武田薬品傘下に)は英国GlaxoSmithKline社に2004年6月23日、欧州でのライセンス契約を締結。
|
| [特許] |
| [2007] |
| [競合2007] |
|
| ■泌尿器系 |
| ★Avodart(dutasteride) [日本]P3 | 良性前立腺過形成(前立腺肥大症)治療薬/前立腺癌発症の抑制 |
Avodart is a 5-ARI inhibitor currently indicated for benign prostatic hyperplasia. A large clinical study is underway
examining its efficacy in reducing the risk of prostate cancer. |
[特許]The patent on dutasteride is not due to expire until 2015a (USA) and 2017b (Europe). Litigation challenging
the validity of the patent protecting this product in the USA is ongoinge. |
| [2007] 2007売上は38%増の2億8500万ポンドと引き続き好調に推移しています。Avodartとαブロッカーのタムスロシンの併用の効果を検証したCombATスタディと呼ばれる試験での肯定的なデータがthe Journal of Urologyで最近発表されました。米国、欧州およびその他の地域においてGSKは併用療法の適応で申請を行っています。米国においては、2008年下期中に同申請に対するFDAからの回答が期待されています。
|
[競合2007]Avodart
competes directly with Merck’s Proscar within the BPH (enlarged prostate) market. |
| ★Levitra [日本発売] | |
Levitra is a PDE-5 inhibitor indicated for male erectile dysfunction. GSK has co-promotion rights in the USA and
more than 20 other markets. |
[特許]GSK has co-promotion rights under the US patent on vardenafil, which is not due to expire until 2018. |
| [2007] |
[競合2007]The Group has co-promotion
rights in the USA for Levitra, which faces competition from Pfizer’s Viagra and Lilly’s Cialis. |
| ★Vesicare(solifenacin succinate) [日本発売06.6.8]ベシケア錠2.5mg,5mg[アステラス製薬] | |
Vesicare is an anti-muscarinic indicated for overactive bladder. GSK has co-promotion rights with Astellas in the
USA. Its major competitors are Detrol LA, Ditropan XL/generic oxybutynin, and Enablex. |
| [特許] |
| [2007] |
|
| ■抗菌剤 |
| ★Altabax/Altargo(Retapamulin) 米発売2007.5 日本未開発 | 外用抗菌剤 |
Altabax/Altargo, approved in 2007 for the topical treatment of certain bacterial skin infections, represents the first
new class of topical antibiotics approved by the FDA in nearly two decades. Altabax/Altargo co |
| [特許] |
[2007]FDA承認2007.4.12、発売2007.5 外用抗生物質の認可は２０年ぶり。
外用抗生物質市場は、mupirocin, fusidic acid等のジェネリックメーカーを含め競争が激しい。
Altabax/Altargoは、効果が長いことと既存薬との交差耐性がないことを訴求する。
2007年度売上高￡11 million; |
[競合2007]Altabax/Altargo competes in the topical antibiotic market against a number of generic competitors, including generic
mupirocin and fusidic acid. Altabax/Altargo's offers less frequent and shorter duration of therapy and lack of cross
resistance to other established classes of anti-bacterials. |
| ★Bactroban(mupirocin) 日本未開発 | 外用抗菌剤 |
|
| [特許] |
| [2007] |
| [競合2007] |
| ★Augmentin [日本] | |
Augmentin is a broad-spectrum antibiotic suitable for the treatment of a wide range of common bacterial infections
and is particularly effective against respiratory tract infections. Augmentin ES-600 is an extra strength suspension
specifically designed to treat children with recurrent or persistent middle ear infections. Augmentin XR is an
extended release formulation for the treatment of patients with community acquired pneumonia or acute bacterial
sinusitis. |
| [特許] |
| [2007] |
[競合2007]Generic versions of both Augmentin and Ceftin/Zinnat are available in the USA. Augmentin also faces generic
competition in various European countries. Augmentin XR and Augmentin ES compete against a broad range of
other branded and generic antibiotics. |
| ★Ceftin/Zinnat [日本] | |
Ceftin/Zinnat is an oral antibiotic used primarily for community-acquired infections of the lower respiratory tract. |
| [特許] |
| [2007] |
| ★Malarone(atovaquone and proguanil hydrochloride) 日本未開発 | マラリア |
Malarone is an oral anti-malarial used for the treatment and prophylaxis of malaria caused by Plasmodium
falciparum. |
| [特許] |
| [2007] |
[競合2007]Malarone’s safety profile and convenient dosing regimen have helped put
this product in a strong position versus mefloquine for malaria prophylaxis. |
| ★Mepron(atovaquone) 日本未開発 | マラリア |
|
| [特許] |
| [2007] |
| [競合2007] |
|
| ■癌 |
| ★Arzerra(ofatumumab) | refractory chronic lymphocytic leukaemia 米承認2009.10.26 / 欧2010.4.26 |
|
| [特許] 米欧2023迄 |
| [2009]
In October 26, 2009, GlaxoSmithKline (GSK) and Genmab A/S (OMX: GEN) announced the accelerated approval of Arzerra TM (ofatumumab) from the US Food and Drug Administration for use in patients with chronic lymphocytic leukemia (CLL) that is refractory to fludarabine and alemtuzumab.
“The approval of Arzerra brings an important new treatment option to patients with refractory CLL,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. “This approval also marks a key milestone for Genmab as it is our first antibody to reach the market. All of us involved in the development of Arzerra are pleased that we have been able to move the product so quickly through research and development and meet our goal of providing this innovative therapy to patients.”
The approval is based on results from a pivotal study in which 42% of patients with CLL who were refractory to both fludarabine and alemtuzumab (two therapies used in treating CLL) responded to treatment with Arzerra (ofatumumab). These patients had a median duration of response of 6.5 months. The most common adverse reactions (nﾝ10%) seen were neutropenia, pneumonia, pyrexia, cough, diarrhea, anemia, fatigue, dyspnea, rash, nausea, bronchitis, and upper respiratory tract infections. The most common serious adverse reactions seen were infections (including pneumonia and sepsis), neutropenia, and pyrexia.
他の適応症はfollicular lymphoma (relapsed patients)P2/ chronic lymphocytic leukaemia, first line therapy &use in relapsed patients P3 /diffuse large B cell lymphoma (relapsed patients) P3/ follicular lymphoma (refractory patients) P3 /rheumatoid arthritis P3 /multiple sclerosis P2 |
| [競合2009] MabThera/Rituxan
|
| ★Tykerb/Tyverb(lapatinib) 日本申請2007.3.30 | 乳がん治療 |
Tykerb is an oral treatment for patients with advanced or metastatic breast cancer whose tumours overexpress
HER2 and who have received prior therapy including an anthracycline, a taxane and trastuzumab. Tykerb was
approved in the USA in 2007 and is submitted for European approval. |
[特許]The Patent on lapatinib is not due to expire until 2020a in the USA and 2022b in Europe. |
| [2007] 米国では2007年3月の発売以来3600万ポンドの売上を記録し、全体の2007年の売上は5100万ポンドとなりました。2007.12月には欧州において同剤の承認に関する肯定的意見がEMEAより出され、日本においても、2008年後期には同剤の承認に関する審査当局の決定が出されると期待されています。 |
| ★Hycamtin(topotecan HCl/和一般名：ノギテカン塩酸塩) [日本承認2000.12]ハイカムチン[日本化薬] | 卵巣癌、小細胞肺癌、子宮頸癌 |
Hycamtin is a second line treatment for ovarian, cervical and small cell lung cancer. ハイカムチン注射用（一般名：ノギテカン塩酸塩）は、英国スミスクラインビーチャム社（現グラクソ・スミスクライン社）で開発された半合成カンプトテシン誘導体で、Ｉ型トポイソメラーゼを阻害することによりDNA合成を阻害し、細胞死を誘導する新しい抗悪性腫瘍剤である。 カンプトテシンは1950年代に米国国立がん研究所（NCI）におけるスクリーニングで、抗腫瘍作用があることが認められた中国原産の喜樹（Camptotheca acuminata）抽出物から単離されたＩ型トポイソメラーゼ阻害作用を有する物質であるが、臨床試験において血液毒性、膀胱内出血等の重度な副作用が発現したため、開発は中止された。その後、スミスクラインビーチャム社では、カンプトテシンの安全性の向上を主たる目的として各種カンプトテシン誘導体を合成し、その結果、カンプトテシンの毒性を軽減し、かつ各種腫瘍モデルに対し広範囲な抗腫瘍スペクトラムを有するノギテカン塩酸塩の合成に成功した。
海外における臨床試験では、静脈内投与で抗腫瘍効果が確認され、アメリカ、スイス、カナダ等の38ヵ国（2003年１月現在）で既治療の小細胞肺癌に対する適応を取得している。
本邦では、1992年１月より臨床試験が開始され、小細胞肺癌に対する有用性が確認されたことから、2000年12月に承認され、2001年４月グラクソ・スミスクライン株式会社より発売された。 日本化薬株式会社は、2003年２月グラクソ・スミスクライン株式会社より輸入承認を承継し、同年３月発売した。 その後、2000年９月19日付医薬発第935号厚生省医薬安全局長（当時）通知「医療事故を防止するための医薬品の表示事項及び販売名の取扱いについて」に基づき販売名に含量を表示することとし、2007年３月28日に「ハイカムチン注射用1.1mg」として承認された。 |
| [特許] |
| [2007] |
| ★Bexxar [日本] | |
Bexxar is a treatment for patients with CD20 follicular, non-Hodgkin’s lymphoma with and without transformation
whose disease is refractory to rituximab and who have relapsed following chemotherapy |
| [特許] |
| [2007] |
| ★Arranon (nelarabine) 日本「アラノンジー(R)静注用250mg」承認2007.10.19 | 再発・難治性のＴ細胞急性リンパ芽球性白血病/Ｔ細胞急性リンパ芽球性リンパ腫 |
Arranon (nelarabine) a treatment for patients with T-cell acute lymphoblastic leukaemia and T-cell lymphoblastic
lymphoma. |
| [特許] |
| [2007] |
| ★Zofran [日本] | |
Zofran is used to prevent nausea and vomiting associated with chemotherapy and radiotherapy for cancer, and is
available in both oral and injectable forms. It is also approved for use in the prevention and treatment of postoperative
nausea and vomiting. |
[特許]The patent on ondansetron has expired in the USA and Europe, (except Italy (November 2008b)). A patent
on use in treating emesis has also expired. Generic competition exists in the USA, Europe and other markets |
| [2007] |
|
| ■その他 |
| ★Promacta | 慢性特発性血小板減少性紫斑病 |
|
| [特許] |
| [2007] 2007年12月、GSKは慢性特発性血小板減少性紫斑病の短期治療のための、経口血小板増殖因子であるPromactaをFDAに申請しました。また同月には、同剤が長期にわたって血小板を増幅する効果が示された追跡調査のデータが米国血液学会で発表されました。現在進行中のフェーズ3試験の完了後、GSKは長期の治療用としてPromactaの申請を2008年下期中に行う予定です。
|
| ★ | |
|
| [特許] |
| [2007] |
| [競合2007] |
| ■ |
●市販品 /2008.10.22
- ★GlaxoSmithKline - PRODUCT PIPELINE /Feb 2008
| 薬品名 | タイプ | 適応症 | 段階 | EU申請
予定 | FDA申請
予定 |
| ●Cardiovascular & Metabolic |
| Cardiovascular projects |
| 256073 | high affinity nicotinic acid receptor
(HM74A) agonist | dyslipidaemia | I | | |
| rilapladib† | Lp-PLA2 inhibitor | atherosclerosis | I | | |
| 681323 | p38 kinase inhibitor | atherosclerosis (also chronic obstructive pulmonary disease -
COPD, neuropathic pain & rheumatoid arthritis) | ll | | |
| 856553 | p38 kinase inhibitor | atherosclerosis (also COPD, depression & rheumatoid arthritis) | ll | | |
| darapladib† | Lp-PLA2 inhibitor | atherosclerosis | ll/III | | |
| Coreg CR† + ACE inhibitor | beta blocker + angiotensin converting
enzyme inhibitor | hypertension - fixed dose combination | III | N/A | 2008 |
| Volibris† | endothelin A antagonist | pulmonary arterial hypertension | Submitted | S:Mar07 | N/A |
| Arixtra | synthetic factor Xa inhibitor | treatment of acute coronary syndrome | Approved | A:Aug07 | AL:Feb07
& Sep07 |
| Metabolic projects |
remogliflozin etabonate
(189075)† | sodium dependent glucose transport (SGLT2)
inhibitor | obesity | I | | |
| 376501 | PPAR gamma partial agonist | type 2 diabetes | I | | |
| 756050 | bile acid receptor agonist | type 2 diabetes | l | | |
| otelixizumab (TRX4)† | anti-CD3 monoclonal antibody | type 1 diabetes | ll | | |
remogliflozin etabonate
(189075)† | SGLT2 inhibitor | type 2 diabetes | ll | | |
| Syncria† | glucagon-like peptide 1 agonist | type 2 diabetes | II | | |
| Avandamet XR | PPAR gamma agonist + metformin | type 2 diabetes - extended release | III | N/A | |
| Avandia | PPAR gamma agonist | atherosclerosis in type 2 diabetes | IIl | | |
| Avandia + simvastatin | PPAR gamma agonist + statin | type 2 diabetes | III | N/A | |
| Avandia | PPAR gamma agonist | prevention of disease progression | Submitted | | S:Feb07 |
| ●Infectious Diseases |
| 580416 | ribosome inhibitor | treatment of bacterial infections | l | | |
| 945237 | topoisomerase ll inhibitor | treatment of bacterial infections | l | | |
| 1349572† | HIV integrase inhibitor | HIV infections | l | | |
| farglitazar(GI262570;GW-262570) | PPAR gamma agonist | hepatic fibrosis(肝線維症) | II | | |
| アルコール性肝線維症と先天性肝線維症、「患者調査」でゼロで肝硬変7.4万人に含む。有効な治療薬はない。； |
| sitamaquine(WR6026) | 8-aminoquinoline | treatment of visceral leishmaniasis(内臓型リーシュマニア症) | II | | N/A |
| 内臓型リーシュマニア症は先進諸外国にほぼ存在しないが、社会福祉的観点からWHO は2005～2015 年の10 年間にバングラデッシュ、インド、ネパールの貧困層に蔓延する疾患である内臓型リーシュマニア症を1/10000 のレベルに疾患コントロールすることを目指している。 from 内臓型リーシュマニア感染制御のための研究 |
| tafenoquine†(Etaquine)(252263) | 8-aminoquinoline | Plasmodium vivax malaria | II | | |
| ●Musculoskeletal, Inflammation, Gastrointestinal & Urology |
| 315234 | monoclonal antibody | rheumatoid arthritis | I | | |
| 768974† | parathyroid hormone agonist | osteoporosis | I | | |
| 962040 | motilin receptor agonist | delayed gastric emptying | l | | |
| 971086 | androgen modulator | sarcopaenia[骨格筋減少症] | l | | |
| 加齢による筋肉の量の減少は主に筋力低下が原因とされる。DHEAサプリメントも使用。標準的な治療薬はない。 ミトコンドリア機能異常がsarcopeniaに主に寄与しているという多くのエビデンスがある。 |
| 1827771 | interleukin 1 antagonist | rheumatoid arthritis | l |
| belimumab†(LymphoStat-B(R)) | anti-B lymphocyte stimulator monoclonal
antibody (s.c.) | systemic lupus erythematosus(全身性エリテマトーデス（SLE）) | l | | |
| Human Genome Sciences(HGS)は2005.7.7GSKと共同開発契約。2007.2 P3（BLISS-76 試験）開始。 LymphoStat-B(R) (belimumab) - HGS；SLEは多臓器に組織損傷を引き起こす複雑な自己免疫疾患である。高用量のステロイド内服、ステロイドパルス療法、シクロフォスファミドパルス療法などが行われ、そのほか病態に応じては血漿交換や免疫グロブリン大量投与が行われることがある。また、アザチオプリン、メトトレキサート、シクロスポリンを使用する場合もあるほか、新しい治療法としてリツキシマブ、造血幹細胞移植が脚光を浴びている（いずれも日本国内での適応はない）。患者数は４．６万人。 |
| pazopanib | multi-kinase angiogenesis inhibitor | age-related macular degeneration (also cancer indications) | l | | |
| 221149 | oxytocin antagonist | threatened pre-term labour(早期分娩) | Il | | |
| 早期分娩には、βアドレナリン交感神経作用薬リトドリン、テルブタリン等が使用されている。 |
| 232802 | 3G-selective oestrogen receptor modulator | treatment of menopausal symptoms | ll | | |
| 274150 | selective iNOS inhibitor | rheumatoid arthritis | II | | |
| 681323 | p38 kinase inhibitor (oral) | rheumatoid arthritis (also atherosclerosis, COPD
& neuropathic pain) | II | | |
| 856553 | p38 kinase inhibitor (oral) | rheumatoid arthritis (also atherosclerosis, COPD & depression) | II | | |
| 876008† | corticotrophin releasing factor (CRF1) antagonist | irritable bowel syndrome (also depression & anxiety) | II | | |
| ronacaleret† | calcium antagonist | osteoporosis & fracture healing | ll | | |
| solabegron | beta3 adrenergic agonist | irritable bowel syndrome | II | | |
| solabegron | beta3 adrenergic agonist | overactive bladder | II | | |
| Avodart | 5-alpha reductase inhibitor | reduction in the risk of prostate cancer | III | | |
| Avodart + alpha blocker | 5-alpha reductase inhibitor + alpha blocker | benign prostatic hyperplasia - fixed dose combination | III | 2008 | 2009 |
| belimumab†(LymphoStat-B(R)) | anti-B lymphocyte stimulator monoclonal
antibody (i.v.) | systemic lupus erythematosus(全身性エリテマトーデス（SLE）) | III | | |
| Human Genome Sciences(HGS)は2005.7.7GSKと共同開発契約。2007.2 P3（BLISS-76 試験）開始。 LymphoStat-B(R) (belimumab) - HGS |
| Bosatria (mepolizumab;SB-240563) | anti-IL5 monoclonal antibody | hypereosinophilic syndrome (also severe asthma & nasal
polyposis)(好酸球増多症候群) | III | 2008 | 2008 |
| 「D721好酸球増加症」の患者数は１千人前後；大部分の好酸球増加症候群患者はコルチコステロイドに反応するが、 しばしば副作用を伴う。L－5抗体 mepolizumab(Bosatria)を服用した多くのHES患者で、ステロイドを中止可能であったという報告があり、ステロイドに置き換わる可能性あり。 Phase III study of Bosatria (mepolizumab) showed disease control with reduced corticosteroid use in hypereosinophilic syndrome[2008.3.14] |
| alvimopan(Entrareg/Entereg;ADL 8-2698)† | peripheral mu-opioid antagonist | opioid-induced bowel dysfunction | III | | |
| |
| ofatumumab† | anti-CD20 human monoclonal antibody | rheumatoid arthritis (also cancer indications) | lll | | |
| alvimopan(Entrareg/Entereg;ADL 8-2698)† | peripheral mu-opioid antagonist | post operative ileus | FDA承認2008.5.20 | | AL:Jul05
& Nov06 |
| Adolor Corporationと共同開発。 術後腸管通過障害（術後腸閉塞、便秘）の治療薬。 5％ぐらいの頻度で回復手術後に腸閉塞が発生。 腸閉塞には、高気圧酸素治療器が有効としている。 FDA承認2008.5.20は術後腸閉塞(postoperative ileus (POI))、厚労省資料では日本ではP3(術後の消化管麻痺); 本剤はAdolor Corporationが創製しGSKに世界ライセンス導出。２つの適応症があり、もう一つはオピオイド腸管機能不全opioid bowel dysfunction (OBD)P3、しかし2008.9 GSKはOBD全世界権をADORに返還。 日本はODBは2007期リスト除外 |
| ●Neurosciences |
| 163090 | 5HT1 antagonist | depression & anxiety | I | | |
| 239512 | histamine H3 antagonist | dementia | l | | |
| 249320 | monoclonal antibody | neuronal injury | l | | |
| 現在まで、脊髄損傷を含む中枢神経系損傷や脳梗塞等の神経機能不全疾患に対する有効な治療薬はなく、新しい治療薬の開発が切望されている。 |
| 424887 | NK1 antagonist/SSRI | depression & anxiety | l | | |
| 561679† | CRF1 antagonist | depression & anxiety | I | | |
| 586529† | CRF1 antagonist | depression & anxiety | l | | |
| 598809 | dopamine D3 antagonist | drug dependency | I | | |
| 618334 | dopamine D3 antagonist | drug dependency | l | | |
| 729327 | AMPA receptor modulator | schizophrenia | I | | |
| 933776 | monoclonal antibody | Alzheimer's disease | l | | |
| 1014802 | sodium channel blocker | bipolar disorder | l | | |
| 1018921 | type 1 glycine transport inhibitor | schizophrenia | l | | |
| orvepitant | NK1 antagonist | depression & anxiety | l | | |
| 189254 | histamine H3 antagonist | narcolepsy | ll | | |
| 372475† | triple (5HT/noradrenaline/dopamine) re-uptake
inhibitor | depression | II | | |
| 468816 | glycine antagonist | smoking cessation | II | | |
| 649868† | orexin antagonist | sleep disorders | II | | |
| 681323 | p38 kinase inhibitor | neuropathic pain (also atherosclerosis, COPD & rheumatoid
arthritis) | II | | |
| 742457 | 5HT6 antagonist | dementia | II | | |
| 773812 | mixed 5HT/dopaminergic antagonist | schizophrenia | II | | |
| 842166 | non-cannabinoid CB2 agonist | inflammatory pain | II | | |
| 856553 | p38 kinase inhibitor | depression (also atherosclerosis, COPD & rheumatoid arthritis) | ll | | |
| 876008† | CRF1 antagonist | depression & anxiety (also irritable bowel syndrome) | II |
| 1838262 (XP13512)† | voltage-gated calcium channel modulator | migraine prophylaxis | ll | | |
| 1838262 (XP13512)† | voltage-gated calcium channel modulator | neuropathic pain | ll | | |
| casopitant | NK1 antagonist | depression & anxiety (also as Zunrisa/Rezonic for
chemotherapy-induced & postoperative nausea & vomiting) | II | | |
| firategrast(SB683699;T-0047)†フィラテグラスト | dual alpha4 integrin antagonist (VLA4)細胞接着阻害剤[α4β7/α4β1阻害剤] | multiple sclerosis | II | | |
| 田辺製薬が創薬、英GSKに導出；natalizumabと同様メカニズム。 |
| 1838262 (XP13512)† | voltage-gated calcium channel modulator | restless legs syndrome | lll | | 2008 |
| Lamictal XR | sodium channel inhibitor | epilepsy - partial generalised tonic-clonic seizures, once-daily | III | N/A | 2008 |
| rosiglitazone XR(Avandia XR) | PPAR gamma agonist | Alzheimer's disease | III | | |
| Lunivia† | non-benzodiazepine GABA agonist | insomnia | Submitted | S:Jul07 | N/A |
| Lamictal XR | sodium channel inhibitor | epilepsy - partial seizures, once-daily | Approvable | N/A | AL:Sep07 |
| Treximet† | 5HT1 agonist(sumatriptan) + naproxen
(※POZEN Inc導入品) | migraine - fixed dose combination | FDA承認2008.4.5 | N/A | AL:Jun06
& Aug07 |
| ReQuip Modutab/XL† | non-ergot dopamine agonist | Parkinson's disease - once-daily controlled release
formulation | Approved | A:Mar07 | AL:Dec07 |
| ●Oncology |
| 461364 | polo-like kinase inhibitor | cancer | l | | |
| 690693 | AKT kinase inhibitor | cancer | l | | |
| 923295† | centromere-associated protein E (CENP-E)
inhibitor | cancer | l | | |
| Armala (pazopanib) | multi-kinase angiogenesis inhibitor | colorectal cancer | l |
| iboctadekin† + rituximab | lL18 immunomodulator + anti-CD20
monoclonal antibody | non-Hodgkin's lymphoma | l | | |
| totrombopag(SB-559448)† | thrombopoietin agonist | thrombocytopaenia(血小板減少症) | I | | |
| Ligand Pharmaceuticalsと共同開発;eltrombopagの予備としての位置づけ |
| 1363089 (XL-880)† | C-met kinase inhibitor | papillary renal cell carcinoma, gastric cancer and head &
neck squamous cell carcinoma | ll | | |
| ofatumumab† | anti-CD20 human monoclonal antibody | relapsed diffuse large B cell lymphoma | ll | | |
| Armala (pazopanib) | multi-kinase angiogenesis inhibitor | non-small cell lung cancer | ll | | |
| Armala (pazopanib) | multi-kinase angiogenesis inhibitor | ovarian cancer | ll | | |
| Armala (pazopanib) | multi-kinase angiogenesis inhibitor | sarcoma | ll | | |
| Armala (pazopanib) + Tykerb | multi-kinase angiogenesis inhibitor + ErbB-2
and epidermal growth factor receptor
(EGFR) dual kinase inhibitor | metastatic breast cancer | II | | |
| Armala (pazopanib) + Tykerb | multi-kinase angiogenesis inhibitor + ErbB-2
and EGFR dual kinase inhibitor | other cancers | II | | |
| Revolade/Promacta† | thrombopoietin agonist | chemotherapy-induced thrombocytopaenia(癌化学療法誘発性血小板減少症) | II | | |
| Ligand Pharmaceuticalsと共同開発; |
| Tyverb/Tykerb | ErbB-2 and EGFR dual kinase inhibitor | head & neck squamous cell carcinomas (unresectable disease) | ll | | |
| Tyverb/Tykerb | ErbB-2 and EGFR dual kinase inhibitor | refractory inflammatory breast cancer | ll | | |
| Armala (pazopanib) | multi-kinase angiogenesis inhibitor | renal cell cancer | III | | |
| Armala (pazopanib) + Tykerb | multi-kinase angiogenesis inhibitor + ErbB-2
and EGFR dual kinase inhibitor | inflammatory breast cancer | lll | | |
| elesclomol (STA-4783)† | oxidative stress inducer | metastatic melanoma(転移性メラノーマ) | lll | | |
| stage IVの転移性メラノーマ患者のP2試験で顕著な延命効果[2008.5.20];Synta Pharmaceuticals Corpが創製、共同開発。 |
| Hycamtin | topoisomerase I inhibitor | ovarian cancer, first-line therapy | III | | |
| ofatumumab† | anti-CD20 human monoclonal antibody | refractory chronic lymphocytic leukaemia (also rheumatoid
arthritis) | III | 2008 | 2008 |
| ofatumumab† | anti-CD20 human monoclonal antibody | refractory follicular lymphoma (also rheumatoid arthritis) | lll | | |
| Revolade/Promacta† | thrombopoietin agonist | hepatitis C | IIl | | |
| Revolade/Promacta† | thrombopoietin agonist | long-term idiopathic thrombocytopaenic purpura(特発性血小板減少性紫斑病[ITP]長期療法) | III | 2008 | 2008 |
| Ligand Pharmaceuticalsと共同開発; |
| Tyverb/Tykerb | ErbB-2 and EGFR dual kinase inhibitor | breast cancer, adjuvant therapy | III | | |
| Tyverb/Tykerb | ErbB-2 and EGFR dual kinase inhibitor | breast cancer brain metastases | lll | | |
| Tyverb/Tykerb | ErbB-2 and EGFR dual kinase inhibitor | breast cancer, first-line therapy | III | | |
| Tyverb/Tykerb | ErbB-2 and EGFR dual kinase inhibitor | head & neck squamous cell carcinomas (resectable disease) | III | | |
| Zunrisa/Rezonic | NK1 antagonist | chemotherapy-induced & postoperative nausea & vomiting
(also depression & anxiety) | III | 2008 | 2008 |
| Revolade/Promacta† | thrombopoietin agonist | short-term idiopathic thrombocytopaenic purpura(特発性血小板減少性紫斑病[ITP]短期療法) | Submitted | 2008 | S:Dec07 |
| Ligand Pharmaceuticalsと共同開発; ITP患者P3研究で血小板数を増加、出血が極めて少ない。If approved, PROMACTA would be the first oral thrombopoietin receptor agonist therapy for the short-term treatment of previously treated patients with chronic ITP to increase platelet counts and reduce or prevent bleeding. 審査中[2008.9.19] |
| Hycamtin | topoisomerase I inhibitor (oral) | small cell lung cancer, second-line therapy | Approved | S:May07 | A:Oct07 |
| Tyverb/Tykerb | ErbB-2 and EGFR dual kinase inhibitor | refractory breast cancer | Approved | S:Oct06 | A:Mar07 |
| ●Respiratory |
| SB-656933 | interleukin 8 antagonist | cystic fibrosis | l | | |
| |
| 835726 | histamine H1/H3 dual antagonist (oral) | allergic rhinitis | l | | |
| 1004723 | histamine H1/H3 dual antagonist (intranasal) | allergic rhinitis | l | | |
| 2190914 (AM-103)† | 5 lipoxygenase activating protein (FLAP) inhibitor | respiratory diseases | l | | |
| 159797† | long-acting beta2 agonist | COPD, also COPD & asthma in combination with a
glucocorticoid agonist | II | | |
| 159802† | long-acting beta2 agonist | COPD, also COPD & asthma in combination with a
glucocorticoid agonist | II | | |
| 256066 | PDE IV inhibitor (inhaled) | COPD | Il | | |
| 256066 | PDE IV inhibitor (inhaled) | asthma | II | | |
| 256066 | PDE IV inhibitor (intranasal) | allergic rhinitis | II | | |
| 573719 | muscarinic acetylcholine antagonist | COPD | Il | | |
| 642444† | long-acting beta2 agonist | COPD, also COPD & asthma in combination with a
glucocorticoid agonist | II | | |
| 679586 | monoclonal antibody | severe asthma | Il | | |
| 681323 | p38 kinase inhibitor (oral) | COPD (also atherosclerosis, neuropathic pain &
rheumatoid arthritis) | II | | |
| 685698 | glucocorticoid agonist | asthma, also COPD & asthma in combination with a
long-acting beta2 agonist (also as Avamys/Veramyst for
allergic rhinitis) | II | | |
| 856553 | p38 kinase inhibitor (oral) | COPD (also atherosclerosis, depression & rheumatoid arthritis) | II | | |
| 870086 | novel glucocorticoid agonist | asthma | II | | |
| 961081† | muscarinic antagonist, beta2 agonist | COPD | Il | | |
| darotropium (233705) | muscarinic acetylcholine antagonist | COPD | II | | |
| mepolizumab | anti-IL5 monoclonal antibody | severe asthma & nasal polyposis (also hypereosinophilic
syndrome) | II | | |
| Avamys/Veramyst | glucocorticoid agonist | allergic rhinitis | Approved | A:Jan08 | A:Apr07 |
| ●Paediatric Vaccines |
| Hib-MenCY-TT | conjugated | Neisseria meningitis groups C & Y disease &
Haemophilus influenzae type b disease prophylaxis | III | | |
| MenACWY-TT | conjugated | Neisseria meningitis groups A, C, W & Y disease prophylaxis | IIl | | |
| Infanrix-IPV/Kinrix | subunit-inactivated | diphtheria, tetanus, pertussis & poliomyelitis prophylaxis
(booster-5th dose) | Submitted | | S:Apr07 |
| Synflorix | conjugated | Streptococcus pneumoniae & non-typeable Haemophilus
influenzae disease prophylaxis for children | Submitted | S:Dec07 | |
| Rotarix† | live attenuated (oral) | rotavirus-induced gastroenteritis prophylaxis | Approved | A:Feb06 | S:Jun07 |
| ●Other Vaccines |
| Cytomegalovirus | recombinant | cytomegalovirus infection prophylaxis | l | | |
| HIV | recombinant | HIV infection prophylaxis | l | | |
| S. pneumoniae adult | recombinant - conjugated | Streptococcus pneumoniae disease prophylaxis | l | | |
| Dengue fever | attenuated tetravalent | Dengue fever prophylaxis | ll | | |
| Epstein-Barr virus† | recombinant | EBV infection prophylaxis | ll | | |
| Hepatitis E virus† | recombinant | hepatitis E prophylaxis | ll | | |
| Mosquirix | recombinant | malaria prophylaxis | ll | | |
| Tuberculosis | recombinant | tuberculosis prophylaxis | II | | |
| Varicella Zoster virus | recombinant | Varicella Zoster prevention | II | | |
| Flu pandemic† | H5N1 inactivated split - monovalent (Quebec) | pandemic influenza prophylaxis | lll | 2008 | |
| Flu pre-pandemic† | H5N1 inactivated split - monovalent (Quebec) | pandemic influenza prophylaxis | lll | 2008 | 2008 |
| |
| New generation flu vaccine | inactivated split - trivalent | seasonal influenza prophylaxis for the elderly | IIl | | |
| Simplirix | recombinant | genital herpes prophylaxis | lll | | |
| Boostrix | subunit | adult booster for diphtheria, tetanus & pertussis | Submitted | | S:Feb08 |
| Flu pandemic† | H5N1 inactivated split - monovalent (Dresden) | pandemic influenza prophylaxis | Submitted | S:Feb07 | |
| Flu pre-pandemic† | H5N1 inactivated split - monovalent (Dresden) | pandemic influenza prophylaxis | Submitted | S:Jan07 | |
| |
| Cervarix† | recombinant | human papilloma virus infection prophylaxis | Approved | A:Sep07 | AL:Dec07 |
| ●Antigen Specific Cancer Immunotherapeutic(ASCI) |
| MAGE-A3 ASCI | recombinant | treatment of melanoma | ll | | |
| MAGE-A3 ASCI | recombinant | treatment of non-small cell lung cancer | lll | | |
| |
| | | | | |
Key
(v) Vaccine
(p) Pharmaccine
† In-license or other alliance relationship with third party
* Subject to completion of ongoing regulatory discussions
S Date of first submission
A Date of first regulatory approval (for MAA, this is the first EU
approval letter)
AL Date approvable or Complete Response letter received - indicates
2003.12時点； OriginalにはPhase I以降の大量の薬剤を含むが、以下はP2以降のみ抜粋
| Compound | Type | Indication | Phase | 承認
予定 | 申請
予定 |
| ●Therapeutic area: Cardiovascular, Urogenital & Metabolic |
| Coreg CR** | β遮断剤 | 高血圧・鬱血性心不全(１日１回)[適応追加] | I | N/A | 2005 |
| odiparcil(424323)** | indirect thrombin inhibitor | prevention of thrombotic complications of cardiovascular disease | II | | |
| piboserod (207266) | 5HT4 antagonist | atrial fibrillation | II | | |
| talnetant | NK3拮抗剤 | 過活動膀胱、IBS、統合失調症 | II | | |
| Avodart | 5-alpha reductase inhibitor | prostate cancerリスク低減 | III | | |
| Avodart | 5-alpha reductase inhibitor | 前立腺肥大(BPH)(α遮断剤併用) | III | | |
| Noratak(nesiritide)** | recombinant ß-type natriuretic peptide | acute heart failure | Submitted | S:Sep02 | N/A |
| Vesicare(YM905)** | muscarinic antagonist | 過活動膀胱 | Appravable | N/A | AL:Oct03 |
| Levitra (vardenafil)** | PDE-5 inhibitor | erectile dysfunction | 承認 | S:Jan02
A:Mar03 | AL:Jul02
A:Aug03 |
| Avandaryl(Avandia + Amaryl) | PPAR gamma agonist plus sulphonylurea | type 2 diabetes | 申請 | 2004 | S:Oct03 |
| Avandamet (Avandia + metformin) | PPAR gamma agonist plus metformin combination tablet | type 2 diabetes | Approved | S:Oct02
A:Oct03 | A:Oct02 |
| Avandia | PPAR gamma agonist | type 2 diabetes - in combination with insulin | 承認 | N/A | AL:Feb01
A:Feb03 |
| ●Therapeutic area: Infectious Diseases |
| Augmentin (１日１回)** | beta lactam antibiotic | respiratory tract infections | I | | N/A |
| chlorproguanil,dapsone + artesunate(CDA)** | antifolate + artemisinin | treatment of uncomplicated malaria | II | 2006 | N/A |
| Augmentin-ES Chewable | beta lactam antibiotic | acute otitis media (incl. penicillin-resistant S. pneumoniae) - high-dose chewable tablet | III | N/A | 2003 |
| LAPDAP** | antifolate | treatment of uncomplicated malaria | 承認 | S:Oct02
A:Jul03 | N/A |
| Anti-virals | | | | | |
| 204937(MIV210)** | nucleoside reverse transcriptase inhibitor | HIV infections | I | | |
| 873140(Ono4128)** | CCR5拮抗剤 | HIV infections | I | | |
| Valtrex XR | nucleoside analogue | Management of genital herpes -modified rlease | I | | |
| Ziagen/Epivir** | reverse transcriptase inhibitors | HIV infection - combination tablet | 申請 | S:Nov03 | S:Oct03 |
| Lexiva(433908)** | protease inhibitor; amprenavir pro-drug | HIV infection | 承認 | S:Dec02 | S:Dec02
A:Oct03 |
| Valtrex | nucleoside analogue | Herpes Simplex Virus (HSV) suppression in immunocompromised patients | 承認 | N/A | S:Sep02
A:Apr03 |
| Valtrex/Zelitrex | nucleoside analogue | prevention of HSV transmission | 承認 | S:Nov02
A:Aug03 | S:Oct02
A:Aug03 |
| ●Therapeutic area: Neurology & Gastrointestinal |
| talnetant (223412) | tachykinin (NK3) antagonist | IBS (also schizophrenia &過活動膀胱) | II | | |
| Lamictal | sodium channel inhibitor | neuropathic pain | III | N/A | 2004 |
| ReQuip CR** | non-ergot dopamine agonist | Parkinson's disease - controlled release formulation | III | 2005 | 2005 |
| ReQuip | non-ergot dopamine agonist | restless leg syndrome | 申請 | S:Jul03 | S:Jul03 |
| Imigran/Imitrex | 5HT1 agonist | adolescent migraine - nasal formulation | 承認 | S:Sep02
A:Apr03 | AL:Dec00 |
| Imigran/Imitrex | 5HT1 agonist | migraine - fast dissolving tablet | 承認 | A:Jul03 | A:Jul03 |
| ●Therapeutic area: Oncology, Musculoskeletal & Inflammation |
| elacridar(120918) | oral bioenhancer | cancer | I | | |
| ethynylcytidine (596168)** | selective RNA polymerase inhibitor | solid tumours | II | | |
| Hycamtin | topo-isomerase I inhibitor | small cell lung cancer first line therapy | III | 2004 | 2004 |
| Hycamtin | topo-isomerase I inhibitor | non-small cell lung cancer second line therapy | III | 2004 | N/A |
| Hycamtin | topo-isomerase I inhibitor | small cell lung cancer second line therapy - oral formulation | III | 2004 | 2004 |
| Hycamtin | topo-isomerase I inhibitor | ovarian cancer first line therapy | III | 2004 | 2004 |
| Boniva/Bonviva(ibandronate)** | bisphosphonate | treatment & prevention of postmenopausal osteoporosis - monthly oral dosing | III | 2004 | 2004 |
| Boniva/Bonviva(ibandronate)** | bisphosphonate | treatment & prevention of postmenopausal osteoporosis - intermittent i.v. dosing | III | 2004 | 2004 |
| Navelbine** | vinca alkaloid | non-small cell lung cancer & breast cancer | III | N/A | 2006 |
| Avandia | PPAR gamma agonist | psoriasis | III | 2006 | 2005 |
| Bexxar** | I131 radiolabelled anti-B1 monoclonal antibody | non-Hodgkin's lymphoma | 承認 | N/A | S:Sep00
A:Jun03 |
| Boniva/Bonviva(ibandronate)** | bisphosphonate | treatment & prevention of postmenopausal osteoporosis - daily oral regimen | 承認 | S:Jun02 | S:Jul02
A:May03 |
| Hycamtin | topo-isomerase I inhibitor | small cell lung cancer second line therapy | 承認 | S:Nov02 | A:Nov98 |
| ●Therapeutic area: Psychiatry |
| talnetant (223412) | tachykinin (NK3) antagonist | schizophrenia (also for IBS) | II | | |
| Lamictal | sodium channel inhibitor | bipolar disorder - acute treatment | III | N/A | 2006 |
| Wellbutrin XL (bupropion)** | noradrenaline / dopamine re-uptake inhibitor | seasonal affective disorder | III | | 2004 |
| Paxil CR** | SSRI | premenstrual dysphoric disorder (PMDD), intermittent treatment - controlled release formulation | 申請 | N/A | S:Mar03 |
| Lamictal | sodium channel inhibitor | bipolar disorder - long-term prophylaxis | 承認 | S:Aug02
A:Mar03 | S:Jun02
A:Jun03 |
| Paxil CR** | SSRI | PMDD, continuous treatment - controlled release formulation | 承認 | N/A | S:Jun02
A:Aug03 |
| Paxil CR** | SSRI | social anxiety disorder | 承認 | N/A | S:Dec02
A:Oct03 |
| Wellbutrin XL (bupropion)** | noradrenaline / dopamine re-uptake inhibitor | depression - controlled release formulation, once daily dosing | 承認 | 2006 | S:Aug02
A:Aug03 |
| ●Therapeutic area: Respiratory |
| mepolizumab (240563) | anti-IL5 monoclonal antibody | asthma (also hypereosinophillic syndrome) | II | | |
| Serevent | beta2 agonist | asthma & COPD -non-CFC inhaler | III | 2004 | N/A |
| Ariflo | PDE IV inhibitor | COPD | Approvable | 2004 | S:Dec02
AL:Oct03 |
| ●Non-CFC Metered Dose Inhaler propellants (106642) |
| Flixotide/Flovent | inhaled corticosteroid | asthma | Approved | A:Apr97 | AL:Dec02 |
| Seretide/Advair | beta2 agonist/inhaled corticosteroid | asthma | Approved | A:Jun00 | AL:Oct01 & Oct02 |
| ●Diskus/Accuhaler (dry powder inhaler) |
| Seretide/Advair | beta2 agonist/inhaled corticosteroid | COPD | 承認 | S:Sep01
A:May03 | AL:Mar02 & Dec02
A:Nov03 |
| ●Therapeutic area: Hepatitis Vaccines |
| Hepatitis E | recombinant | hepatitis E prophylaxis | II | | |
| Fendrix Extra strength hepatitis B | recombinant | extra strength hepatitis B prophylaxis (poor/non-responders) | 申請 | S:May03 | TBD |
| ●Therapeutic area: Paediatric Vaccines |
| N. meningitidis | conjugated | meningitis prophylaxis | II | 2005 | |
| Priorix-Tetra(MMR-varicella) | live attenuated | measles, mumps, rubella and varicella prophylaxis | III | 2004 | |
| Rotarix | live attenuated - oral | rotavirus prophylaxis | III | 2004 | |
| Streptorix | conjugated | S. pneumoniae disease prophylaxis for children | III | | |
| ●Therapeutic area: Other Vaccines |
| Dengue fever | attenuated tetravalent vaccine | prophylactic use | I | | |
| HIV | recombinant | HIV prophylaxis | I | | |
| New influenza | subunit | influenza prophylaxis � new delivery | I | | |
| S. pneumoniae elderly | conjugated | S. pneumoniae disease prophylaxis | I | | |
| Varicella zoster | recombinant | varicella zoster prevention | I | | |
| Cervarix | recombinant | prophylaxis of Human papillomavirus(HPV) infections | II | | |
| Epstein-Barr virus (EBV) | recombinant | EBV prophylaxis | II | | |
| Mosquirix | recombinant | malaria prophylaxis | II | | |
| Staphylococcal antibodies** | monoclonal antibody | prevention of staphylococcal infections | II | | |
| Simplirix | recombinant | genital herpes prophylaxis | III | | |
| Boostrix Polio | subunit | adolescent/adult booster for diphtheria, tetanus, pertussis and inactivated polio | 申請 | S:Jul03 | |
| Boostrix | subunit | adolescent/adult booster for diphtheria, tetanus and pertussis | 承認 | A:Oct00 | 2004 |
| ●Therapeutic area: Pharmaccines |
| Breast cancer therapeutic(Her 2 Neu) | recombinant | 乳癌ワクチン | I | | |
| mage 3(249553) | recombinant | treatment of lung cancer/melanoma | II | | |
KEY
** In-license or other alliance relationship with third party
S: Date of first submission
A: Date of first Regulatory approval (for MAA, this is the first EU approval letter)
AL: Approvable letter
All product names in italics are trademarks of the GlaxoSmithKline Group of comp
anies except Bexxar, which is a trademark of Corixa Corporation, Navelbine, a tr
ademark of Pierre Fabre Medicament and Levitra, a trademark of Bayer AG. For com
petitive reasons, new projects in pre-clinical development have not been disclos
ed and some project types may not have been identified.
■リスト除外品目
| Compound | Type | Indication | Phase | 承認
予定 | 申請
予定 |
843362
(NIN-058)** | oral insulin analogue | type 2 diabetes | I | | |
| 876167 (BVT933)** | 5HT2c agonist | obesity | II | | |
| Augmentin (granules)** | beta lactam antibiotic | respiratory tract infections (incl. penicillin-resistant S. pneumoniae) - modified release granule formulation | II | 2004 | N/A |
| Augmentin XR | beta lactam antibiotic | Treatment of acute exacerbation of chronic bronchitis (AECB), including complicated AECB | III | 2003 | 2003 |
| oxibendazole | polymerase inhibitor | treatment of adult & paediatric helminth intestinal infections | III | 2004 | N/A |
810781
(S-1360)* | HIV integrase inhibitor | HIV infections | II | | | 塩野義より |
| Imigran/Imitrex | 5HT1 agonist | migraine - needle-free injection | II | 2005 | 2005 |
683699
(T-0047)** | dual alpha4 integrin antagonist (VLA4) | multiple sclerosis (MS) & inflammatory bowel disease (IBD) (also asthma & rheumatoid arthritis (RA)) | I | | |
| carabersat (204269) | benzopyran | migraine prophylaxis & epilepsy | II | | |
737004
(S-0139)* | endothelin A antagonist | stroke | II | | |
737552
(S-8510)* | benzodiazepine inverse agonist | Alzheimer's disease & vascular dementia | II | | |
| repifermin** | keratinocyte Growth Factor-2 | mucositis (also wound care & IBD) | II | | |
| vilazodone 659746A (EMD 68843)** | selective serotonin re-uptake inhibitor (SSRI) + 5HT1a partial agonist | depression | II | 2005 | 2004 |
| 159797 (TD-3327)** | beta2 agonist | asthma & COPD | I | | |
683699
(T-0047)** | dual alpha4 integrin antagonist (VLA4) | asthma & RA (also MS & IBD) | I | | |
| 842470 (AWD 12-281)** | PDE IV inhibitor | asthma, COPD & allergic rhinitis | II | | |
| Seretide/Advair | beta2 agonist/inhaled corticosteroid | adult & paediatric asthma - once daily dosing | III | 2005 | 2005 |
| Serevent | beta2 agonist | COPD | Approved | 2003 | A:Mar02 |
| Twinrix 2 doses | recombinant | combined hepatitis A and B prophylaxis (child/adolescent) | Approved | A:Sep02 | 2003 |
| Meningitis B (Cuba) | subunit | meningitis B prophylaxis | II | | TBD |
| Infanrix /Pediarix PeNta-HepB-IPV | recombinant | diphtheria, tetanus, pertussis, hepatitis B and inactivated polio prophylaxis | Approved | A:Oct00 | A:Dec02 |
| Infanrix HeXa-Hep B- IPV/Hib | conjugated/ recombinant | diphtheria, tetanus, pertussis, hepatitis B and inactivated polio prophylaxis and haemophilus influenzae type B prophylaxis | Approved | A:Oct00 | TBD |
| GSK/PowderJect**vaccin | recombinant | hepatitis B treatment | I | | |
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グラクソ・スミスクライン 2009年度業績発表[2010.2.12]
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★業績情報
●医療関係者
●開発品目
更新日：2003/07/11
| 治験薬記号(一般名)および剤型 | 予定される効能又は効果、対象疾患名および症状名 | 開発段階 | その他 |
| 国内 | 海外(地域) |
| SN408(サルメテロール） ドライパウダー | 持続型β2受容体作動薬(気管支拡張薬)。気管支喘息、慢性閉塞性肺疾患（COPD） | 申請中 | 発売中 | 自社品 |
| BW430C(ラモトギン） 錠剤 | てんかん | 申請中 | 発売中 | 自社品 |
| SK&F-101468(ロピニロール) 錠剤 | ドパミンD2受容体作動薬。パーキンソン病 | 申請中 | 発売中 | 自社品 |
| GG167(ザナミビル) ドライパウダー | ノイラミニダーゼ阻害剤。A･B型インフルエンザ（小児） | 申請中 | 発売中 | 導入品 |
| BRL-49653C（ロシグリタゾン) 錠剤 | インスリン抵抗性改善薬。2型糖尿病(単独療法およびSU剤との併用療法） | 申請中 | 発売中 | 自社品 |
| 4UA76(エポステノール・ナトリウム）注射剤 | 肺動脈性肺高血圧症 | 申請中 | 発売中 | 自社品 |
| ラミブジン 錠剤 | ＨＩＶ | 申請中 | 発売中 | 自社品 |
| アザチオプリン 錠剤 | 炎症性腸疾患 | 申請中 | 発売中 | 自社品 |
| BRL29060A(パロキセチン) 錠剤 | 選択的セロトニン再取り込み阻害（SSRI）、強迫性障害 | 申請中 | 発売中 | 自社品 |
| GG714（ラミブジン） 錠剤 | 抗ウイルス剤。B型肝硬変 | 第Ⅲ相 | 発売中 | 自社品 |
| GW284873X（Adefovir dipivoxil) 錠剤 | 抗ウイルス剤。B型慢性肝炎/肝硬変 | 第Ⅲ相 | 発売中 | 導入品 |
| GW815SF(サルメテロール/フルチカゾン配合剤）ドライパウダー | 持続性β2受容体作動薬（気管支拡張薬）/合成副腎皮質ホルモン剤。気管支喘息 | 第Ⅲ相 | 発売中 | 自社品 |
| BRL29060A(パロキセチン) 錠剤 | 選択的セロトニン再取り込み阻害(SSRI)。外傷後ストレス障害 | 第Ⅲ相 | 発売中 | 自社品 |
| BRL29060A(パロキセチン) 錠剤 | 選択的セロトニン再取り込み阻害（SSRI）。社会不安障害 | 第Ⅲ相 | 発売中 | 自社品 |
| BRL29060A(パロキセチン) 錠剤 | 選択的セロトニン再取り込み阻害（SSRI）。全般性不安障害 | 第Ⅲ相 | 発売中 | 自社品 |
| BRL-49653C（ロシグリタゾン) 錠剤 | インスリン抵抗性改善薬。2型糖尿病(α-グルコシターゼ阻害薬との併用） | 第Ⅲ相 | 発売中 | 自社品 |
| SB207499(シロミラスト）錠剤 | PDE-IV阻害。慢性閉塞性肺疾患（COPD） | 第Ⅱ相 | 申請中 | 自社品 |
| GI198745（デュタステリド） ソフトゼラチンカプセル4UA76(エポステノール・ナトリウム）注射剤 | 抗前立腺肥大薬 | 第Ⅱ相 | 発売中 | 自社品 |
| GG548(ナラトリプタン） 錠剤 | 5HT1受容体作動薬。片頭痛 | 第Ⅱ相準備中 | 発売中 | 共同開発 |
| GR68755(アロセトロン）錠剤 | 5HT1受容体阻害薬/女性の重度の下痢型-過敏性腸症候群 | 第Ⅱ相準備中 | | |
★２００３年の業績「売上げ６％増と順調」 グラクソ・スミスクライン [薬事日報2004.3.24]
グラクソ・スミスクライン（日本法人）の２００３年の業績は、売上高は薬価ベースで１８００億円、前年比６・３％増となった。主力製品の抗うつ剤や喘息薬（吸入ステロイド剤）などの伸長が売り上げに寄与した。国内医薬品市場での売り上げランキングは、前年と同様１３位であった。
売り上げに最も大きく寄与した薬剤は、抗うつ剤の「パキシル」で薬価ベースで３３０億円、前年比５０％増となった。同剤の抗うつ剤市場でのシェアは４６～４７％。
喘息薬で吸入ステロイド剤「フルタイド」の売上高は約１８０億円で、前年比１０％強の伸び。同剤は吸入ステロイド市場で約７０％を占めるが、中山夏樹取締役営業本部長は「新しい製品が参入してきたが、フルタイドのシェアはほとんど変わっていない」という。同じく喘息薬で長時間作動型吸入β2刺激剤「セレベント」は、前年に比べ約３倍強伸長し、売上高は５０億円弱となった。中山氏は、セレベントの伸長率が高かった理由を「欧米ではＩＣＳ（吸入ステロイド薬）とＬＡＢＡ（長期間作動型吸入β2刺激剤）の併用療法が標準療法となっており、欧州では喘息療法の７０％、米国では５０％を占める。日本での普及率は１０％強に過ぎないが、現在、世界の標準治療に移行している段階。その背景の中でＩＣＳと共に伸びている」と説明する。
片頭痛薬「イミグラン」の売上高は約４０億円で、伸長率は約１％。中山氏は伸長率が約１％にとどまった理由として「片頭痛市場では新製品が参入してきて競合が激しくなった」と話す。
抗ヘルペス薬「ゾビラックス」と同剤の後継薬で経口吸収性を改善した「バルトレックス」の両剤合わせた売上高は約３００億円。同社は、ゾビラックスからバルトレックスへの切り替えを進めているが、中山氏によると「１００％切り替えることは難しいかもしれないが、最終的には、今年度か来年度までほぼ終了してくると思う」と言う。
★呼吸器専任ＭＲを増員 グラクソ・スミスクライン [薬事日報2004.3.17]
グラクソ・スミスクライン（ＧＳＫ）は、早期に呼吸器領域の専任ＭＲを現在の１５０人から５０人増員して２００人体制に増強する方針を固めた。
喘息薬で吸入剤の「セレベント」と「フルタイド」の併用療法の普及率の向上を目指し、中でも浸透率の低い内科医や小児科医など喘息非専門医に対する情報提供活動を強化する。将来、同社が上市を見込む「セレタイド」（セレベントとフルタイドの配合剤）についても、上市後に市場での早期浸透も図りたい考え。欧米では吸入剤の普及に伴い、喘息死が減少したとの報告があるため、同社では、国内で年間４０００人弱（２００２年）いる喘息死を、０８年までに１０００人台までに減らすことが目標という。
セレベントの薬効分類はＬＡＢＡ（長期間作動型吸入β2刺激薬）、フルタイドはＩＳＣ（吸入ステロイド剤）だが、欧米ではＩＣＳとＬＡＢＡの併用療法が標準療法となっており、欧州では喘息療法の７０％、米国では５０％を占めているという。日本での普及率は１０％強に過ぎない。 中山氏は「現在、日本は世界標準の治療に移行している段階。その背景の中でＩＣＳとＬＡＢＡのシェアも伸びていくだろう」との見方を示した。
呼吸器系領域では、これら２剤のほかに、将来大型化が期待される「セレタイド」（現在フェーズⅢ試験）の上市が控えており、セレベントとフルタイドの浸透により、セレタイドの市場での早期浸透にもつなげたい考え。
中山氏によると、０３年の「フルタイド」の売上高（薬価ベース）は約１８０億円で、対前年約１０％の伸び。同剤の国内でのシェアは、吸入ステロイド市場では７０％を占める。新製品が参入してきたが、同剤のシェア自体は前年度から変わっていない。「セレベント」は対前年６５％増で３倍強伸長し、売上高は５０億円弱となった。
★ＧＳＫの営業戦略 －上－ グラクソ・スミスクライン [薬事日報03.4.28]
グラクソ・スミスクライン（ＧＳＫ）取締役営業本部長の中山夏樹氏は本紙の取材に応じ、「２００４年に日本での医療用医薬品売上高でトップ１０入りを、さらにできるだけ早期にトップ５入りを目指す」と抱負を語った。
合併等による変動を考慮しなければ、国内１０位は薬価ベースで１９００億円程度となる。ＧＳＫの０２年売上高は１６８０億円（前年比３・５％増、１～１２月期、薬価ベース）。薬価引き下げの影響を受けつつも増収を維持。国内医療用医薬品のシェアは２・５％（自社推計）、売り上げランキングは１３位だった。
【パキシル絶好調、２３０億円に】
昨年の成長を支えたのは、いくつかの戦略品である。特にＳＳＲＩパキシルが絶好調。三環系・四環系抗うつ剤からの切り替えが進まないといわれている抗うつ剤市場で、売上高を約２３０億円（８５％増、薬価ベース）に伸ばした。同市場のシェアは昨年末時点で約４０％だったが、４月には４５％に届く勢い。
成功の要因は２点挙げられる。一つは新規患者の発掘であり、第二は吉富薬品との提携である。ＧＳＫが昨年９月から１２月まで、テレビと新聞で展開した“うつ病啓発キャンペーン”は大きな反響を呼んだ。「相当数のうつ病潜在患者が受診機会を持った」（中山氏）と好感触を得ている。
また昨年７月には、精神科領域に特化する吉富薬品とコ・プロモーション契約を締結。吉富薬品のＭＲ（１７０人）とＧＳＫのパキシル専任ＭＲ（９０人）を含む全ＭＲで、全国の精神科医約１６００人にダブル訪問し、処方を獲得した。今年の販売目標は３００億円以上。
片頭痛治療薬イミグランの売り上げ実績は約４０億円（８６％増）。新たに創設されたトリプタン市場では３剤が混戦状態にあるが、イミグランのシェアは約５０％でトップ。錠剤はアストラゼネカのゾーミッグと同時発売された（０１年８月）が、注射剤で先行していたため、ブランド認知度で優った。昨年は片頭痛の疾患啓発活動にも注力した。全国２６カ所で市民公開講座を、２００カ所で医療従事者向け講演を実施したほか、片頭痛啓発サイトも開設している。今年は速効性がポイントの点鼻液を投入し、製品ラインアップを強化する。
喘息治療薬フルタイドの売り上げは約１６０億円（２６％増）。吸入ステロイド市場におけるシェアは、単剤で約７０％、ベコタイドと合算で約８０％に達する。喘息・ＣＯＰＤ治療薬セレベントは約１３億円（昨年６月発売）。まだＣＯＰＤに対する認識が低いため、今年は疾患啓発活動に取り組む。「将来の市場規模はまだ不明だが、大化けする可能性を秘めた分野」と中山氏。
呼吸器領域ＭＲ１５０人が全国の呼吸器専門医に情報伝達し、治療法を認知させていく。セレベントとフルタイドの合剤として、海外で発売されている気管支喘息治療薬セレタイド（国内フェーズⅢ）は、ＧＳＫグローバルで最も成長著しい薬剤なだけに、呼吸器領域の強化がＧＳＫの将来を左右すると言っても過言ではない。
抗ヘルペス薬ゾビラックスの売上高は約２２０億円（１９％減）、そのプロドラッグであるバルトレックスは約１００億円（２３％増）だった。シェアは両剤合わせて約８０％。ＧＳＫはバルトレックスへの切り替えを進めている。また今年４月には、感染症領域に強い塩野義製薬と、両剤のコ・プロモーション契約を結んだ。１００床未満医療機関への情報提供を両社で行い、製品の早期最大化を図る。
★「来年に国内トップ１０入りを」カギ握る中枢系の成長
グラクソ・スミスクライン[薬事日報02.6.17]
--- ＧＳＫの2001年度売上高は決算ベースで1396億円。医療用医薬品の売り上げは薬価
ベースで1630億円（並売先の売り上げ含む）。統合の影響でタガメットとカイトリルを導
出したため、単純計算で250億円以上のマイナススタートとなったが、製品導出を考慮し
なければ前年比9％の販売増だった。
★売上～日本
(億円)（薬価ベース） 2003 2002 2001
売上高 1800(+6.3) 1680(+3.5) 1630
(決算ベース) 1396
ゾビラックス 180 220(-19) 270 [aciclovir]
バルトレックス 120 100(+23) 80 [valacyclovir]
ゼフィックス - ? 20 [lamivudine]
ザンタック - ? 200 [ranitidine]
ザイロリック - ? 150 [allopurinol]痛風
フルタイド・ロタディスク 180(+10) 160(+26) 130 [fluticasone]喘息 *シェア(2003&2002)70%
セレベント 50 13 - [salmeterol xinafoate]喘息;発売2002.6
イミグラン 40(+1) 40(+86) 32 [sumatriptan][01.8-02.4]片頭痛 *シェア50%
パキシル 330(+50) 230(+85) 120 [paroxetine]抗うつ剤*シェア[2003]46-47%[2002]40%
※発売中止
2004.3.5 フロン対策で「ベコタイド」の販売中止へ
2003.12 フロン対策でアレルギー性鼻炎治療薬「ベコナーゼ」の販売中止
「欧米ではＩＣＳ（吸入ステロイド薬）とＬＡＢＡ（長期間作動型吸入β2刺激剤）の併
用療法が標準療法となっており、欧州では喘息療法の７０％、米国では５０％を占める。
日本での普及率は１０％強に過ぎないが、現在、世界の標準治療に移行している段階。そ
の背景の中でＩＣＳと共に伸びている」(2003)
このほか次世代の成長を担う新薬としては、アバンディアとセレタイドを挙げた。
アバンディアは２型糖尿病のインスリン抵抗性改善剤。昨年12月に申請済みで、早期の
発売を目指す。昨年の全世界売り上げは約1340億円で、年率50%の伸びを示している。
セレタイドはセレベントとフルタイドの合剤（フェーズⅡ）。
昨年四月の米国発売以来、全世界で約1610億円を売り上げ、年率400%と大きく成長した。
気道の炎症と症状改善の両方に効果を示す。
●グラクソ・スミスクライン、提携戦略を強化-国内の開発パイプラインも増強-[2002.6.12]
2002年4月以降新たに発表されたGSKグループでの製品導入に関する提携のうち、日本国
内ではグラクソ・スミスクライン株式会社は以下の製品の開発を検討しています。
アデフォビル:B型慢性肝炎治療用の抗ウイルス薬。米国ギリアド・サイエンス社より導入。
現在、米国及び欧州にて承認申請中。GSKは既に、世界で唯一のB型慢性肝炎に対する経口
抗ウイルス薬である「ゼフィックス」(一般名:ラミブジン)を販売しています。アデフォ
ビルがGSKの開発品目に加わることにより、GSKは今まで以上に充実したB型慢性肝炎治療
領域のラインアップを得ることができ、またB型肝炎に苦しむ患者さんに、「ゼフィック
ス」に加えて新たな治療の選択肢を提供できると考えられます。
経口インスリン製剤:糖尿病治療薬。米国ノベックス社より導入。現在、海外ではフェー
ズI/IIの開発段階。GSKは、2型糖尿病治療用のインスリン抵抗性改善剤「アバンディア」
(一般名:ロシグリタゾン)を各国で発売しており、日本では現在承認申請中です。新たに
開発する予定の経口インスリン製剤は、インスリン製剤の中で最も革新的でニーズの高い
剤型であり、糖尿病治療領域において患者さんのQOL改善にさらに貢献できるものと期待しています。
アルビモパン:術後の腸閉塞管理、オピオイド鎮痛薬による便秘の治療薬。米国アドロー
ル社より導入。現在海外ではフェーズIIIの開発段階。アルビモパンはこの領域における
国内初めての経口治療薬となることが期待されます。アルビモパンにより、入院日数の短
縮につながり、医療経済的にもメリットがもたらされる可能性が期待されます。
経口副甲状腺ホルモン(PTH):骨粗鬆症治療薬。米国ユニジーン社より導入。現在海外では
前臨床の後期段階。骨粗鬆症領域は、日本ではGSKにとって新たな領域です。高齢化が進
む中、骨粗鬆症患者数も増加傾向にあり、社会問題となりつつあります。患者数の非常に
多いこの領域で、患者さんの福音となる薬剤を提供することを目指します。
FRAMINGHAM, MA
(NASDAQ: GTCB)
●会社決算
| ($ 000) | 2008/12 | 2007/12 | 2006/12 | 2006/1 | 2005/1 |
| 収入 | 16,656 | 13,896 | 6,128 | 4,152 | 6,626 |
| 原価 | 8,624 | 11,564 | 6,651 | 4,344 | 6,107 |
| 研究開発費 | 21,031 | 28,925 | 25,401 | 21,145 | 20,002 |
| 販売・一般管理費 | 10,208 | 9,834 | 9,723 | 8,428 | 9,710 |
| (原価・経費 計) | 39,863 | 50,320 | 41,775 | 33,917 | 35,819 |
| 営業利益 | (23,207) | (36,424) | (35,647) | (29,765) | (29,193) |
| 当期純利益 | (22,665) | (36,321) | (35,345) | (30,112) | (29,493) |
| 従業員数[連結] | 159 | | | | |
| | | | | |
Revenue. During 2008, we derived approximately $11.6 million of revenue from our external development programs, of which $6.6 million related to our work with PharmAthene, $3.8 million related to the Merrimack program, which was completed in the third quarter of 2008, $4.2 million from sales to LEO as well as $626,000 from the CD137 program. During 2007, we derived $9 million of our revenue from external programs, primarily with Merrimack and PharmAthene, as a result of the timing of milestones met on the programs during 2007, and $4.2 million from sales to LEO. We expect revenue from external programs and product shipments relating to ATryn@� to continue to vary due to the nature, timing and specific requirements for these development activities.
| ●ATryn@�: (Recombinant Human Antithrombin) |
| 【2008】 Our first product ATryn@�, is a recombinant form of human antithrombin, a blood protein with anticoagulation and anti-inflammatory properties. In 2006, ATryn@� became the first transgenically produced therapeutic protein to be approved anywhere in the world when we obtained European Commission approval of the use of ATryn@� as a prophylactic treatment for patients with hereditary antithrombin deficiency, or HD, undergoing surgical procedures. On February 6, 2009, we received United States Food and Drug Administration, or FDA, approval for ATryn@� for HD patients undergoing surgery or childbirth in the United States, making ATryn@� the first transgenically derived therapeutic protein approved by the FDA. The FDA has also designated ATryn@� an Orphan Drug in this indication. Along with the approval of ATryn@�, the FDA’s Center for Veterinary Medicine also approved our New Animal Drug Application, the first of its kind to regulate genetically engineered animals. This is now required for a recombinant technology used to develop transgenic animals, such as the goats that produce recombinant antithrombin. We believe that the regulatory approval of ATryn@� in Europe and the U.S. achieved an important validation of our production technology, which will assist in obtaining approvals for other compounds and in other countries.
We plan to develop our portfolio of recombinant proteins through strategic collaborations: kﾎ In June 2008, we entered into a collaboration agreement with OVATION Pharmaceuticals to develop and market ATryn@� in the United States. The collaboration agreement includes the commercialization of ATryn@� in the HD indication and the further development of ATryn@� in acquired antithrombin deficiency indications, or AD.
ATryn@�: Our first product, ATryn@�, is approved in the U.S. for the treatment of HD patients undergoing surgery or childbirth. The FDA has designated ATryn@� an Orphan Drug, providing seven years of market exclusivity in this indication. OVATION, our partner for ATryn@� in the U.S., is planning for commercial launch in the second quarter of 2009. While the initial HD indication is expected to be a modest market, our collaboration with OVATION provides for the further clinical development of ATryn@� for larger AD indications in the U.S. The first of these indications is expected to be heparin resistance in cardiopulmonary bypass surgery where we believe our existing clinical data in this indication will allow us to proceed to a Phase III study. We estimate the market opportunity for the heparin resistance indication in the U.S. is approximately $100 million to $150 million. We estimate that the existing worldwide annual sales for plasma-sourced antithrombin is approximately $250 million, split principally between Japan and Europe, with $12 - $15 million being sold in the U.S. as Thrombate III@� by Talecris. Historically there has been limited availability of plasma-derived antithrombin in the U.S., and this product has not been developed in the broader AD indications. Antithrombin products from European-sourced plasma cannot be sold in the U.S.
We have a collaboration agreement with OVATION to develop and market ATryn@� in the United States. The collaboration agreement includes the commercialization of ATryn@� in the HD indication and the further development of ATryn@� in AD indications. The milestone payments to us under this agreement include a total of $9 million through approval of ATryn@� for HD in the U.S., $5 million of which was received in 2008 and $4 million is expected to be received in the first quarter of 2009. The collaboration anticipates further development of ATryn@� in larger market acquired deficiencies such as the treatment of heparin resistance in patients undergoing cardiopulmonary bypass surgery and the treatment of DIC associated with severe sepsis.
Under our agreement with OVATION, we are developing ATryn@� for the treatment of heparin resistance in patients undergoing coronary artery bypass graft (CABG) surgery that requires the use of a cardio pulmonary bypass (CPB) machine. Patients undergoing this surgery require anticoagulation with heparin to prevent clotting, which can occur when blood comes into contact with the tubing of the CPB machine performing the heart’s function during surgery. Patients with heparin resistance generally do not respond adequately to the dose of heparin normally required to achieve sufficient anticoagulation for them to go on to the CPB machine. The overall incidence of heparin resistance has been reported to range from 10% to over 22% of CABG patients. Treatment of heparin resistant patients with fresh frozen plasma, which contains low concentrations of antithrombin, is one option to restore heparin sensitivity and achieve adequate anticoagulation to permit initiation of CPB. We previously completed two Phase III studies in the heparin resistance indication, and we are planning to conduct one additional Phase III study to determine the safety and efficacy of ATryn@� in restoring heparin sensitivity in heparin resistant CABG patients as a basis for marketing approval in this indication.
We also have a collaboration agreement with LEO Pharma A/S, or LEO, for the commercialization of ATryn@� in HD in Europe, Canada, and the Middle East and for its further development in AD indications. LEO selected disseminated intravascular coagulation associated with severe sepsis, or DIC, as the first AD indication in which to conduct additional clinical studies under this collaboration. In the third quarter of 2008, LEO advised us that, as a result of an internal re-assessment of their strategic priorities, they wished to enter in to negotiations to transfer the ATryn@� program to us or an alternate partner. Pending any such transfer, further patients are not being enrolled in the study at this time. LEO has made it clear that their decision was not based on any safety or efficacy issues. We are currently engaged in a dispute resolution process with LEO, as described under Item 3 in this Annual Report. We estimate that the annual market opportunity for DIC in the U.S. alone is $2 - 3 billion.
Antithrombin is a protein found in the plasma of human blood that has anticoagulant and anti-inflammatory properties. Antithrombin, as is typical of many plasma proteins, is difficult to express in commercially viable quantities using traditional recombinant production methods. Scientists estimate that approximately 1 in 2,000 to 5,000 people have HD, which suggests that approximately 60,000 to 150,000 people in the U.S. have HD.
Patients with HD have low levels of antithrombin in their blood stream and are prone to spontaneously develop thromboses from puberty onwards. Once patients are aware that they have this disorder, they can normally be treated prophylactically with blood thinners such as warfarin or Coumadin@�. When these HD patients are undergoing high risk procedures, such as surgery or childbirth, the preferred course of treatment is to take them off their blood thinners and give them antithrombin to bring their antithrombin to normal levels in order to prevent the occurrence of thromboembolisms during the course of such procedures. The use of antithrombin in this indication, therefore, is an acute treatment for a chronic disorder.
We have developed a transgenically produced recombinant form of antithrombin, known as ATryn@�. ATryn@� has been approved in the U.S. for patients undergoing surgery or childbirth and in the EU for patients undergoing surgical procedures. Our intention is to file for label expansion in the EU for patients undergoing childbirth. As part of the FDA approval we are required to conduct a post-marketing surveillance study to continue gathering data on this rare patient population.
Our strategy is to leverage the availability of ATryn@� with readily scalable production capacity to support the development of additional clinical indications and the creation of markets significantly in excess of those supported by today’s plasma-sourced products. We also plan to seek approval for AD indications in the U.S. and Europe, and to develop ATryn@� in Japan and the rest of the world through further partnering arrangements.
We estimate that the existing worldwide annual sales for plasma-sourced antithrombin is approximately $250 million, split principally between Japan and Europe, with $12 - $15 million being sold in the U.S. as Thrombate III@� by Talecris. Historically there has been limited availability of plasma-derived antithrombin in the U.S., and this product has not been developed in the broader AD indications. Antithrombin products from European-sourced plasma cannot be sold in the U.S.
We have a collaboration agreement with OVATION to develop and market ATryn@� in the United States. The collaboration agreement includes the commercialization of ATryn@� in the HD indication and the further development of ATryn@� in AD indications. The milestone payments to us under this agreement include a total of $9 million through approval of ATryn@� for HD in the U.S. The collaboration anticipates further development of ATryn@� in larger market acquired deficiencies such as the treatment of heparin resistance in patients undergoing cardiopulmonary bypass surgery and the treatment of DIC associated with severe sepsis, or DIC. These deficiencies result when a medical condition leads to consumption or loss of native antithrombin in a patient’s bloodstream at a rate significantly in excess of the body’s ability to replace it. The AD indications may lead to subsequent complications that increase patient risk for morbidity and mortality. Other examples of AD conditions include severe burns and bone marrow transplant procedures.
Under our agreement with OVATION, we are planning to develop ATryn@� for the treatment of heparin resistance in patients undergoing coronary artery bypass graft (CABG) surgery that requires the use of a cardio pulmonary bypass (CPB) machine. Patients undergoing this surgery require anticoagulation with heparin to prevent clotting, which can occur when blood comes into contact with the tubing of the CPB machine performing the heart’s function during surgery. Patients with heparin resistance generally do not respond adequately to the dose of heparin normally required to achieve sufficient anticoagulation for them to go on to the CPB machine. The overall incidence of heparin resistance has been reported to range from 10% to over 22% of CABG patients. Treatment of heparin resistant patients with fresh frozen plasma, which contains low concentrations of antithrombin, is one option to restore heparin sensitivity and achieve adequate anticoagulation to permit initiation of CPB. We previously completed two studies in the heparin resistance indication, and we are planning to conduct one additional Phase III study to determine the safety and efficacy of ATryn@� in restoring heparin sensitivity in heparin resistant CABG patients as a basis for marketing approval in this indication.
Under our OVATION collaboration, we are responsible for production of ATryn@� and will receive a transfer price, including a margin, for commercial product, a royalty on net sales, $257 million in potential clinical, regulatory and sales milestone payments, including those already received, and payment for product used in clinical trials. Our agreement provides for OVATION to further develop ATryn@� in AD and fund our anticipated costs of clinical development. OVATION will be responsible for sales and marketing of ATryn@� in the U.S., including all launch activities, which are scheduled to commence in the second quarter of 2009.
We also have a collaboration agreement with LEO Pharma A/S, or LEO, for the commercialization of ATryn@� in HD in Europe, Canada, and the Middle East and for its further development in AD indications. LEO selected DIC associated with severe sepsis as the first AD indication in which to conduct additional clinical studies under this collaboration. In DIC, the septic infection consumes the patient’s native antithrombin faster than the body can replace it, leading to clotting and inflammation problems that can cause death. Of the approximately 220,000 patients in the European Union and 250,000 patients in the U.S. with DIC in severe sepsis annually, approximately 50% die from the condition. We estimate that the annual market potential for DIC in the U.S. alone is $2 - 3 billion.
LEO initiated a Phase II dose-ranging study in the DIC indication in 2007. In the third quarter of 2008, LEO advised us that, as a result of an internal re-assessment of their strategic priorities, they wished to enter into negotiations to transfer the ATryn@� program to us or an alternate partner. Pending any such transfer, further patients are not being enrolled in the study at this time. LEO has made it clear to us that their decision was not based on any safety or efficacy issues. We are currently engaged in a dispute resolution process with LEO, as described under Item 3 in this Annual Report.
OVATION Pharmaceuticals
In June 2008, we entered into a collaboration agreement with OVATION Pharmaceuticals to develop and market ATryn@� in the United States. The collaboration agreement includes the commercialization of ATryn@� in the HD indication and the further development of ATryn@� in AD indications. Under the terms of our agreement, OVATION is obligated to make milestone payments to us for a total of $9 million through approval of ATryn@� for HD in the U.S., $ 5 million of which was received in 2008 and $4 million is expected to be received in the first quarter of 2009. The collaboration anticipates further development of ATryn@� in larger market acquired deficiencies of antithrombin, such as the treatment of heparin resistance in patients undergoing surgery requiring cardiopulmonary bypass and the treatment of DIC associated with severe sepsis.
We are responsible for production of ATryn@� and will receive a transfer price, including a margin, for commercial product, a royalty on net sales, $257 million in potential clinical, regulatory and sales milestone payments, including those already received, and payment for product used in clinical trials. Our agreement provides for OVATION to further develop ATryn@� in AD and fund our anticipated costs of clinical development. OVATION will be responsible for sales and marketing of ATryn@� in the U.S., including all launch activities, which are scheduled to commence in the second quarter of 2009.
Competition
Competition for our lead product candidate ATryn@� comes from a number of companies internationally producing and marketing human antithrombin sourced from the fractionation of human plasma. CSL Behring’s antithrombin has a significant share of this market worldwide, but is not approved in the U.S. Talecris, which has a pending agreement to merge with CSL, is the only company that has commercially available fractionated antithrombin that is approved for sale in the U.S. Talecris’ U.S. sales are a small portion of the worldwide antithrombin market. There are many providers of plasma-derived antithrombin in Europe, including Octopharma, Grifols, Baxter International, Pfizer, Inc., CSL Behring and LFB. A Grifols plasma-derived antithrombin product is in clinical studies to support a planned request for approval with the FDA. As part of the orphan drug designation of ATryn@�, we have been granted market exclusivity for seven years for the treatment of patients in the HD indication.
For ATryn@�, a number of companies internationally produce and market antithrombin derived from human plasma. CSL Behring’s product has a significant share of the worldwide market, but is not approved for sale in the U.S. Talecris, which purchased Bayer’s plasma business and is being acquired by CSL, has a commercially available fractionated antithrombin product that is approved for sale in the U.S. Other companies, including Octapharma, CSL Behring, Grifols, Kedrion, Baxter International and LFB supply the European market with plasma-derived antithrombin products, none of which have been approved throughout the European Union.
Like antithrombin, the alpha-1 antitrypsin sold today is derived from human plasma. Talecris has a significant presence in the U.S. with an alpha-1 antitrypsin product called Prolastin@� which is approved for chronic use in patients with a genetic deficiency of alpha-1 antitrypsin who are prone to pulmonary disorders such as emphysema. |
|
| ● |
| 【】 |
●Products & Partnering
ATryn(R) - Recombinant Human Antithrombin
●Science & Technology
●News & Events
★Press Releases
May 6, 2009 - GTC Biotherapeutics Reports Launch of ATryn@� in the U.S. by Lundbeck Inc.
May 6, 2009 - ATryn Available for Patients with Hereditary Antithrombin Deficiency, a Rare Blood Clotting Disorder
March 30, 2009 - GTC Biotherapeutics Reports Progress in Preparations to Launch ATryn@� in the U.S.
March 13, 2009 - GTC Biotherapeutics Provides Update on Agreement with LEO Pharma A/S
March 9, 2009 - GTC Biotherapeutics Reports Progress in ATryn@� Program in U.S.
February 6, 2009 - ATryn@� (Antithrombin [Recombinant]) Approved by the FDA - Only recombinant option for patients with hereditary antithrombin deficiency, a rare and potentially life-threatening condition
January 9, 2009 - FDA Advisory Committee Recommends GTC Biotherapeutics' ATryn* (antithrombin [Recombinant]) - If approved, ATryn will be first recombinant human antithrombin available in the U.S.1
October 6, 2008 - FDA Accepts ATryn@� BLA Filing - GTC Receives $2 Million in Additional Milestone Payments
September 4, 2008 - FDA Assigns Priority Review to GTC Biotherapeutics’ATryn@�
August 14, 2008 - GTC Biotherapeutics and Ovation Pharmaceuticals Close Agreement to Market and Develop ATryn@� in the U.S.
August 7, 2008 - GTC Biotherapeutics Completes BLA Submission for Atryn@�
GTC Biotherapeutics Enters into $257 Million Agreement with OVATION Pharmaceuticals to Develop and Market ATryn@� in the U.S.
●Investor Information
★SEC Filings
10-K Annual report [2009.2.27]
- http://www.gracewaypharma.com/ ; headquartered in Bristol, Tennessee
設立 2006
Graceway Pharmaceuticals to Acquire 3M Pharmaceuticals[2006.11.9]
- 北米・中南米事業を買収。 欧州はMeda ABが買収。
- http://www.gracewaypharma.com/
●Our Products
★外用剤
Aldara(R) (imiquimod) Cream, 5%
Atopiclair(R) Nonsteroidal Cream
Benziq(TM) Gel
★呼吸器
Maxair(R) Autohaler(R)(pirbuterol acetate inhalation aerosol)
★女性保健
Estrasorb(R)(estradiol topical emulsion)
★その他
MetroGel-Vaginal(R)(metronidazole vaginal gel) 0.75% Vaginal Gel
Minitran(TM) (nitroglycerin) Transdermal Delivery System
Tambocor(TM) Tablets (flecainide acetate)
Norflex(R) (orphenadrine) Injectable
Calcium Disodium Versenate(edetate calcium disodium injection, USP)
●News
Graceway Pharmaceuticals to Acquire 3M Pharmaceuticals[2006.11.9]
- 北米・中南米事業を買収。 欧州はMeda ABが買収。
- http://www.grunenthal.com/ ;
創立1946; 80カ国で販売；従業員総数5000人。
私企業につき。決算内容は非公開。
●経営指標(2005.3.29)
(Euro million) 2002 2001 2000 1999
売上高 666 776 716 647
欧州 551 570 525 480
国際 115 90 82 81
Takeda Pharm - 116 109 86 (50%合弁)
★分野別売上高比(2002)
痛み48%、感染・呼吸17%、婦人科10%、中枢神経系3%、消化器4%、その他18%
- http://www.grunenthal.com/ ;
●Products
●R & D
●About US
★KeyData - 経営データ
●Press
- http://www.helsinn.com/; スイスの私有企業。
●Products
★Aloxi -http://www.palonosetron.net/ 制吐剤
- Palonosetron Information
- Press Room
- Trademarks & Companies～世界地図で各国の商品名と会社を表示
- Medical Area[要登録]
- Link
-
●Commercial
●関連会社
Helsinn Birex Therapeutics Ltd[HBT]
Ergha Healthcare Ltd[EHC]～ジェネリック医薬品
[Manufacturing]Company Profiles
－Helsinn Chemicals Biasca SA (HCB)
－Helsinn Advanced Synthesis SA (HAS)
－Helsinn Chemicals Ireland Ltd(HCI)
－Helsinn Birex Pharmaceuticals Ltd (HBP)
●News
- http://www.hollisterstier.com/ ;3525 N. Regal Street, PO Box 3145 ,Spokane,WA 99207-5788
従業員 約300人。 株式非公開。 売上規模US $ 55 million (2006)
1921年設立 アレルゲン・エキスで世界のリーダー
1974年 Bayer Corporationの一部門Allergy Products unitとなった。
1999.3 Bayer社Allergy Products unitの上級マネージャーグループがスピンアウトしHollister-Stier Labsを設立復活。
2007.4 研究製造業務受託サービス（CRAM）分野のインド最大手であるJubilant Organosys がHollister-Stier Labs を$123 millionで買収
●Corporate
●Allergy
ComforTen(TM)(New)
Instructions and Dosage
OptiHaler(R)
Personal Best(R)
Positive Histamine Control
Prick Lancetter(R) - 皮膚テスト用具
QUINTEST(R)
QUINTIP(R)
●Contract Manufacturing
●News
-http://www.hospira.com/default.aspx
2003.9.16 Abbott Laboratoriesの100%子会社として病院向け製品事業部が分社化。
2004.4.30 Abbott株主に普通株を販売。
2004.5.3 株式公開、NY市場に上場。
2006.9.20 Mayne Pharma Limited(Australia上場)を買収。
●会社決算
| ($ 000) | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 |
| 売上高 | 2,688,505 | 2,626,696 | 2,645,036 | 2,623,737 | 2,602,550 | |
| 営業利益 | 339,584 | 336,615 | 427,650 | 360,375 | 378,197 | |
| 経常利益 | 324,697 | 322,075 | 411,520 | 359,121 | 352,426 | |
| 当期純利益 | 237,679 | 235,638 | 301,552 | 260,363 | 246,698 | |
| 研究開発費 | 161,621 | 138,834 | 119,583 | 109,720 | | |
| 取得研究開発費 | 10,000 | - | - | - | | |
| 従業員数[連結] | 13,000 | 13,000 | 14,000 | | | |
| | | | | | |
| | | | | | |
●事業別セグメント
| ($ 000) | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 |
| ●米国 |
| 注射用医薬品 | 807,557(-4.5) | 845,291(-5.5) | 894,190(+4.3) | 858,000(-1.5) | 871,000 | |
| Medication Delivery Systems | 855,483(+7.4) | 796,360(+1.7) | 782,703(+5.2) | 744,000(+2.8) | 724,000 | |
| 注射用医薬受託製造 | 183,266(+2.5) | 178,777(+0.0) | 178,719(+13.3) | 158,000(+2.2) | 154,000 | |
| Abbott社向け販売 | 90,464(-13.6) | 104,747(-12.6) | 119,814(-34.3) | 182,000(+14.4) | 160,000 | |
| その他 | 283,731(+8.0) | 262,600(+7.3) | 244,644(-8.3) | 267,000(-9.5) | 296,000 | |
| 米国 計 | 2,220,501(+1.5) | 2,187,775(-1.5) | 2,220,070(+0.35) | 2,209,000(+0.2) | 2,205,000 | |
| ●国外 |
| Third Parties向け販売 | 397,677(+6.2) | 374,560(+2.7) | 364,796(-2.5) | 374,000(+4.0) | 360,000 | |
| Abbott社向け販売 | 70,327(+9.3) | 64,361(+7.0) | 60,170(+46.6) | 41,000(+7.9) | 38,000 | |
| 国外 計 | 468,004(+6.6) | 438,921(+3.3) | 424,966(+2.4) | 415,000(+4.3) | 398,000 | |
| | 売上高 合計 | 2,688,505(+2.4) | 2,626,696(-0.7) | 2,645,036(+0.8) | 2,624,000(+0.8) | 2,603,000 | |
| | | | | | | |
| | | | | | |
- http://www.hospira.com/default.aspx
■Products
■Investor Relations
●Annual Reports/Proxies
●Quarterly Reports/Supplemental Tables
●SEC Filings
10-K Annual report[2011.2.16] - [pdf]
10-K Annual report[2010.2.18] - [pdf]
10-K Annual report[2009.2.25] - [pdf]
10-K Annual report[2008.2.28] - [pdf]
10-K Annual report[2007.2.28] - [pdf,446p]
●Financial Press Releases
■Press Releases
- http://www.hospira.co.jp/japanese/default.aspx
●製品
★医薬品
先発医薬品
プレセデックス(R)（塩酸デクスメデトミジン）静注液
後発医薬品 （ジェネリック医薬品）
プロポフォール /イオベリンR /インダストR /セフロニックR /フルコナゾール /プリンクR
ブイペルR /モベンゾシンR /ラスカルトンR /ロゼクラートR /オキリコンR
★医療機器
クリティカルケア
トランスデューサーR ディスポーサブル圧トランスデューサー
セーフセット? 血液サンプリングシステム
リセプタルR 廃液吸引システム
●医療関係者向け情報
●ニュース＆メディア
- http://www.hra-pharma.com/
1996 設立。
1999 第一号製品 緊急避妊薬NorLevo(levonorgestrel)フランス発売、1999.5
フランスで処方箋不要避妊薬第一号となる。2002年末までに世界５０か国で登録
2004 Gymiso(misoprostol, 200 mcg tablets)をフランスで発売。適応症－mifepristone
との併用で４９日以内のamenorrhea(無月経)の早期妊娠の終了
EUでのLysodren (orphan drug for adrenal carcinoma)発売
プレスリリースの発表もないので、詳細不明。
日本とは、そーせい と提携。
●Product Portfolio
NorLevo(錠75mcg norgestrel)緊急避妊薬
Lysodren(錠mitotane 500mg)副腎癌 －BMSからLicense
KPH(臀部骨折プロテクター)
Gymiso(錠misoprostol, 200 mcg)amenorrhea(無月経)の早期妊娠の終了
●Product Pipeline
●Links
●会社決算
| ($ 000) | 2010 | 2009 | 2008 | 2007 | 2006 |
| 製品売上 | 47,159 | 154,074 | - | - | - |
| 製造・開発サービス | 22,695 | 50653 | - | - | - |
| 研究開発提携収入 | 87,497 | 71,022 | 48,422 | 41,851 | 25,755 |
| 収入合計 | 157,351 | 275,749 | 48,,422 | 41,851 | 25,755 |
| 営業利益 | (190,773) | 6,188 | (255,700) | (256,643) | (266,371) |
| 経常利益 | (233,231) | 4,385 | (268,891) | (284,371) | (264,087) |
| 当期純利益 | (233,231) | 5,659 | (268,891) | (284,371) | (264,087) |
| 研究開発費 | 196,370 | 173,709 | 243,257 | 246,293 | 209,515 |
| 従業員数[連結] | 11,100 | | | | |
| | | | | |
| ■BENLYSTA® (belimumab) |
【2010】
BENLYSTA is a human monoclonal antibody and the first in a new class of drugs called BLYS-specific inhibitors. BENLYSTA inhibits the biological activity of a naturally occurring protein known as B-lymphocyte stimulator (BLyS), which was first discovered by HGS in 1996. In lupus and certain other autoimmune diseases, elevated levels of BLyS are believed to contribute to the production of autoantibodies kﾀ antibodies that attack and destroy the body’s own healthy tissues. BENLYSTA is being developed by HGS and GSK as a potential treatment for systemic lupus under a co-development and commercialization agreement entered into in 2006 (described below under “Lead Commercial Collaborations”).
On November 16, 2010, the FDA Arthritis Advisory Committee voted 13-2 to recommend that the FDA approve BENLYSTA for the treatment of autoantibody-positive patients with active SLE who are receiving standard therapy. In December 2010, the FDA extended the PDUFA target date for the priority review of BENLYSTA to March 10, 2011. In June 2010, GSK submitted an application to EMA seeking approval to market BENLYSTA in Europe. We expect to have the EMA decision in the second half of 2011. GSK has also submitted regulatory applications in Canada, Australia, Switzerland, Russia, Brazil and The Philippines. Regulatory submissions in other countries are planned in 2011.
BENLYSTA continues to progress toward commercialization. On November 16, 2010, the U.S. Food and Drug Administration (“FDA”) Arthritis Advisory Committee voted 13-2 to recommend that the FDA approve BENLYSTA for the treatment of autoantibody-positive patients with active SLE who are receiving standard therapy. The Advisory Committee provides non-binding recommendations for consideration by the FDA, which then makes the final decision on approval. In December 2010, the FDA extended the Prescription Drug User Fee Act (“PDUFA”) target date for its priority review of BENLYSTA from December 9, 2010 to March 10, 2011.
In June 2010, GlaxoSmithKline (“GSK”), our partner in the co-development and commercialization of BENLYSTA, submitted a Marketing Authorization Application (“MAA”) to the European Medicines Agency (“EMA”) for approval to market BENLYSTA in Europe. We expect to have the EMA decision in the second half of 2011. GSK has also submitted regulatory applications in Canada, Australia, Switzerland, Russia, Brazil and The Philippines. Regulatory submissions in other countries are planned in 2011.
In preparation for the anticipated launch and commercialization of BENLYSTA, we have hired and trained a specialized commercial team including sales, marketing and medical affairs. We are also building our own HGS commercial team to work alongside GSK in Europe. We believe we have produced sufficient BENLYSTA inventory to meet the anticipated global market need for at least one year, and are increasing our capacity to meet long-term demand.
Execute the successful launch and commercialization of BENLYSTA assuming regulatory approval.
Over the last year, we have taken steps to prepare for the approval and successful launch of BENLYSTA. We have hired and trained a specialized commercial team, including sales, marketing and medical affairs, that understands how to communicate effectively with rheumatologists and other stakeholders. The combined HGS and GSK team, including a U.S. sales force of approximately 150, will work closely together following approval to communicate effectively and appropriately with rheumatologists and other stakeholders and work to ensure that appropriate patients with systemic lupus who need BENLYSTA will have access to it. HGS and GSK also plan to support physicians and patients with reimbursement and access programs.
Under the terms of the 2006 co-development and co-commercialization agreement with GSK, and assuming regulatory approval, HGS will have responsibility for the global supply of BENLYSTA. We believe we have produced sufficient BENLYSTA inventory to meet anticipated global market needs for at least one year, and we believe our large-scale manufacturing facility has sufficient capacity to provide worldwide supply for the first two to three years following launch. However, HGS and GSK also anticipate that additional capacity will be required. In July 2010, HGS announced an agreement with Lonza that will provide for the future manufacture of BENLYSTA, eventually tripling capacity with production starting in 2012.
Make BENLYSTA globally available so patients with need will have access.
HGS and GSK expect a decision on the European approval of BENLYSTA in the second half of 2011. GSK has also submitted regulatory applications in Canada, Australia, Switzerland, Russia, Brazil and The Philippines. Regulatory submissions in other countries are planned in 2011. HGS is building its own commercialization team to work alongside GSK in Europe, with HGS headquarters in Switzerland and local organizations in Germany, France and Spain. Elsewhere, GSK will lead local implementation, with HGS sharing costs and profits equally with GSK.
BENLYSTA. In 2006, we entered into an agreement with GSK for the co-development and commercialization of BENLYSTA. GSK is a world leader that brings global pharmaceutical development and marketing capabilities to the BENLYSTA program. Under the BENLYSTA agreement, we and GSK share Phase 3 and 4 development costs, sales and marketing expenses, and profits equally. HGS has primary responsibility for bulk manufacturing. We have received an execution fee of $24.0 million under this agreement and have recognized this payment ratably over the development period. We recognized revenues of $3.4 million in 2010 and $4.7 million in 2009. The BENLYSTA agreement includes cost-sharing provisions under which we and GSK share clinical development costs. We recorded cost reimbursement from GSK under this provision of $62.0 million in 2010 and $43.1 million in 2009, which was reflected as a reduction in expenses. This agreement will expire three years after the later of (i) the expiration date of certain patent rights related to BENLYSTA and (ii) a period of 10 years after the first commercial sale of BENLYSTA. These certain patent rights are expected to expire by 2023, with the potential for later expiration that may result from any issuance of additional patent and/or patent term extensions. GSK may terminate the agreement if (i) upon the basis of competent scientific evidence or data regarding commercial potential, GSK determines BENLYSTA does not merit incurring additional development or marketing expenses or (ii) BENLYSTA is not approved by the FDA or EMA. In addition, either party may terminate if the other party commits a material breach of the agreement or if the other party is bankrupt or insolvent.
|
|
| ■BENLYSTA® (belimumab)追加適応 |
【2010】
We and GSK are examining a range of potential additional indications for BENLYSTA that might be explored in new clinical trials. In 2011, we are considering initiating Phase 2 trials of BENLYSTA in vasculitis and post-renal transplant. We also plan to initiate a Phase 3 trial of BENLYSTA in a subcutaneous formulation that may improve convenience for some patients. In addition, a number of exploratory studies are currently planned in SjAzgren’s syndrome, Waldenstrom’s disease, pre-transplant, idiopathic thrombocytopenic purpura (ITP) and others.
We are also working to expand and advance our mid- and early-stage pipeline beyond potential additional indications for BENLYSTA, with a primary focus on immunology and oncology. We continue to develop our oncology portfolio around our expertise in the apoptosis, or programmed cell death, pathway and we plan to initiate Phase 2 development of our human monoclonal antibody to the CCR5 receptor for the treatment of ulcerative colitis.
Work to achieve the full therapeutic and commercial potential of BENLYSTA by developing it for other B-cell mediated diseases.
Where patients with B-cell mediated autoimmune or other diseases need new treatment options and we have scientific evidence supporting the therapeutic potential and commercial viability, we are committed to continuing the development of BENLYSTA. In 2011, we are considering initiating Phase 2 trials of BENLYSTA in vasculitis and post-renal transplant. We also plan to initiate a Phase 3 trial of BENLYSTA in a subcutaneous formulation that may improve convenience for some patients. In addition, a number of exploratory studies are currently planned in SjAzgren’s syndrome, Waldenstrom’s disease, pre-transplant, idiopathic thrombocytopenic purpura (ITP) and others. |
|
| ■raxibacumab |
【2010】
Raxibacumab is a human monoclonal antibody that targets and blocks Bacillus anthracis protective antigen, which research has shown to be the key facilitator of the deadly toxicity of anthrax infection. Raxibacumab represents a new way to address the anthrax threat. While antibiotics can kill the anthrax bacteria, they are not effective against the deadly toxins the bacteria produce. Raxibacumab targets anthrax toxins after they are released by the bacteria into the blood and tissues. In an inhalation anthrax attack, people may not know they are infected with anthrax until the toxins already are circulating in their blood, and it may be too late for antibiotics alone to be effective.
We are developing raxibacumab under a contract entered into in 2006 with BARDA. The U.S. Government is currently our only customer for raxibacumab and has the right to terminate our contract for convenience at any time. In 2010, HGS continued delivery of raxibacumab to the U.S. Strategic National Stockpile. In July 2009, the U.S. Government exercised its option to purchase 45,000 additional doses of raxibacumab for the Stockpile for emergency use in treating inhalation anthrax, with delivery to be completed over a three-year period. HGS expects to receive approximately $142.0 million from this second order as deliveries are completed. In 2010, we recognized $47.2 million in raxibacumab product sales revenue. Also under our contract, HGS submitted a BLA to the FDA for raxibacumab for the treatment of inhalation anthrax in May 2009. We received a Complete Response Letter in November 2009, and we will continue to work closely with the FDA to obtain approval. HGS will receive approximately $20.0 million from the U.S. Government upon FDA licensure of raxibacumab. Raxibacumab revenue accounted for 31% and 65% of our total revenue for 2010 and 2009, respectively.
Raxibacumab. In September 2005, we entered into a two-phase contract with BARDA to supply raxibacumab for inhalation anthrax. HHS is the lead agency for public health and medical response to man-made or natural disasters, including acts of bioterrorism. Under the first phase of the contract, we supplied 10 grams of raxibacumab to HHS for comparative in vitro and in vivo testing. In June 2006, under the second phase of the contract, the USG exercised its option to purchase raxibacumab and we agreed to manufacture and deliver 20,001 doses to the SNS. In 2009, we achieved our company’s first product sales by completing these deliveries and recognized $162.5 million in product sales and manufacturing and development services revenue. In July 2009, the USG exercised its option to purchase 45,000 additional doses of raxibacumab for the SNS for emergency use in treating inhalation anthrax, with delivery to be completed over a three-year period. HGS expects to receive approximately $142.0 million from this second order as deliveries are completed, including approximately $47.2 million and $17.7 million recognized as product sales revenue in 2010 and 2009, respectively. Also under our contract, HGS submitted a BLA to the FDA for raxibacumab for the treatment of inhalation anthrax in May 2009. We received a Complete Response Letter in November 2009, and we will continue to work closely with the FDA to obtain approval. HGS will receive approximately $20.0 million from the USG upon FDA licensure of raxibacumab. Our raxibacumab agreement can be terminated by the USG if it determines that a termination is in its interest.
|
|
| ■ZALBIN™ (albinterferon alfa-2b) (Novartis) |
【2010】
In April 2010, we announced that Novartis withdrew its MAA seeking authorization to market ZALBIN in Europe for the treatment of chronic hepatitis C. The decision was based on feedback from European regulatory authorities including questions regarding whether the therapeutic benefit of JOULFERON® (known in the U.S. as ZALBIN) was sufficient relative to risk. In October 2010, as expected, HGS received a Complete Response Letter from the FDA regarding the Company’s BLA for 900-mcg ZALBIN. HGS and Novartis have decided not to develop ZALBIN further.
ZALBIN. In 2006, we entered into an exclusive worldwide agreement for the co-development and commercialization of albinterferon alfa-2b with Novartis, a global leader in the pharmaceutical industry. In October 2010, as expected, HGS received a Complete Response Letter from the FDA regarding the Company’s BLA for 900-mcg ZALBIN (albinterferon alfa-2b, known in Europe as JOULFERON) dosed every two weeks for the treatment of chronic hepatitis C. HGS and Novartis decided not to develop ZALBIN further. Based on this decision, in September 2010, HGS recognized all remaining deferred revenue relating to payments previously received under the ZALBIN agreement with Novartis, an amount totaling $34.1 million. There will, however, be certain additional costs incurred by both parties in the near future as activities are concluded.
|
|
| ■Mapatumumab |
【2010】
HGS has pioneered the development of highly targeted agonistic antibody therapies for cancer based on the TRAIL receptor apoptotic pathway. Mapatumumab is a human monoclonal antibody that specifically binds to TRAIL receptor 1 and causes it to induce apoptosis in cancer cells. The safety lead-in to a randomized Phase 2 trial of mapatumumab in combination with Nexavar (sorafenib) is ongoing in patients with advanced hepatocellular cancer, which accounts for 80%-90% of all liver cancers. We expect to initiate the randomization stage of this study in 2011.
The results of two Phase 2 trials of mapatumumab in combination with other therapeutic agents were announced in 2010. In March 2010, we announced the results of a randomized Phase 2 trial of mapatumumab in combination with paclitaxel and carboplatin as first-line therapy in advanced non-small cell lung cancer. In June 2010, we announced the results of a randomized Phase 2 trial of mapatumumab in combination with bortezomib (Velcade) in patients with advanced multiple myeloma. In both studies, the results showed no difference in disease response or progression-free survival for patients treated with the combination that included mapatumumab vs. the control group. Mapatumumab was well tolerated in both studies.
|
|
| ■darapladib(GSK共同) |
【2010】
Darapladib was discovered by GSK based on our technology. It is a small-molecule inhibitor of lipoprotein-associated phospholipase-A2 (Lp-PLA2), an enzyme associated with the formation of atherosclerotic plaques and identified in clinical trials as an independent risk factor for coronary heart disease and ischemic stroke. In two pivotal Phase 3 trials, GSK is evaluating whether darapladib can reduce the risk of adverse cardiovascular events, such as heart attack or stroke, in patients with chronic coronary heart disease and acute coronary syndrome, respectively. With a planned enrollment of more than 27,000 patients in the two trials, the Phase 3 clinical program for darapladib is among the largest ever conducted to evaluate the safety and efficacy of any cardiovascular medication. Darapladib was discovered by GSK based on HGS technology. HGS will receive 10% royalties on worldwide sales if darapladib is commercialized, and has a 20% co-promotion option in North America and Europe.
In addition to these products in our internal pipeline, we have substantial financial rights to two novel drugs that GSK has advanced to late-stage development. The first of these is darapladib, which was discovered by GSK using HGS technology. In two pivotal Phase 3 trials, GSK is currently evaluating whether darapladib can reduce the risk of adverse cardiovascular events such as heart attack or stroke in patients with chronic coronary heart disease and acute coronary syndrome, respectively. With a planned enrollment of more than 27,000 patients in the two trials, the Phase 3 clinical program for darapladib is among the largest ever conducted to evaluate the safety and efficacy of any cardiovascular medication. The second is albiglutide. GSK has eight Phase 3 trials in progress to evaluate the long-term efficacy, safety and tolerability of albiglutide as monotherapy and add-on therapy for patients with type 2 diabetes mellitus. Albiglutide was created by HGS using its proprietary albumin-fusion technology, and the product was licensed to GSK in 2004.
Darapladib. In December 2008, GSK initiated Phase 3 development of darapladib, a small-molecule Lp-PLA2 inhibitor discovered by GSK based on HGS technology. We will receive a 10% royalty on worldwide sales of darapladib if it is commercialized, and we have a 20% co-promotion option in North America and Europe. We are also entitled to receive a milestone payment if darapladib moves through clinical development into registration. |
|
| ■Albiglutide (formerly Syncria®) (GSK共同) |
【2010】
Albiglutide is a biological product generated from the fusion of human albumin and modified human GLP-1 peptide, and is designed to act throughout the body to help maintain normal blood-sugar levels and to control appetite. GSK currently has eight Phase 3 trials in progress to evaluate the long-term efficacy, safety and tolerability of albiglutide as monotherapy and add-on therapy for patients with type 2 diabetes mellitus. Albiglutide was created by HGS using its proprietary albumin-fusion technology, and the product was licensed to GSK in 2004. We are entitled to fees and milestone payments that could amount to as much as $183.0 million kﾀ including $33.0 million received to date kﾀ in addition to single-digit royalties on worldwide sales if albiglutide is commercialized.
Albiglutide. In February 2009, GSK initiated a Phase 3 clinical trial program to evaluate the efficacy, safety and tolerability of albiglutide in the long-term treatment of type 2 diabetes mellitus. Albiglutide was created by HGS using its proprietary albumin-fusion technology, and the product was licensed to GSK in 2004. HGS is entitled to fees and milestone payments that could amount to as much as $183.0 million kﾀ including $33.0 million received to date. We are also entitled to single-digit royalties on worldwide sales if albiglutide is commercialized.
|
| ■ |
【2010】
|
|
- 14200 Shady Grove Road, Rockville, MD 20850
●CLINICAL DEVELOPMENT PIPELINE
■Investors
●Annual Reports
Annual Report 2010[pdf,116p]
●SEC Filings
10-K Annual Report[2011-02-24]
●News Releases
HUMAN GENOME SCIENCES ANNOUNCES SECOND QUARTER 2011 FINANCIAL RESULTS AND KEY DEVELOPMENTS[2011.7.21] - BENLYSTA売上2011Q2=$7.8 million
GLAXOSMITHKLINE AND HUMAN GENOME SCIENCES RECEIVE EUROPEAN AUTHORIZATION FOR BENLYSTA® (BELIMUMAB)[2011.7.14]
GLAXOSMITHKLINE AND HUMAN GENOME SCIENCES RECEIVE POSITIVE OPINION IN EUROPE FROM THE CHMP FOR BENLYSTA® (BELIMUMAB)[2011.5.20]
HUMAN GENOME SCIENCES AND GLAXOSMITHKLINE ANNOUNCE FDA APPROVAL OF BENLYSTA® (BELIMUMAB) FOR TREATMENT OF SYSTEMIC LUPUS ERYTHEMATOSUS[2011.3.9]
HUMAN GENOME SCIENCES AND GLAXOSMITHKLINE ANNOUNCE PUBLICATION OF BLISS-52 PHASE 3 STUDY RESULTS FOR BENLYSTA® IN THE LANCET[2011.2.7]
HUMAN GENOME SCIENCES AND GLAXOSMITHKLINE ANNOUNCE FDA EXTENSION OF BENLYSTA® PDUFA TARGET DATE TO MARCH 10, 2011[2010.12.3]
HUMAN GENOME SCIENCES AND GLAXOSMITHKLINE ANNOUNCE VOTE OF FDA ADVISORY COMMITTEE TO RECOMMEND APPROVAL OF BENLYSTA® FOR SYSTEMIC LUPUS ERYTHEMATOSUS[2010.11.16]
HUMAN GENOME SCIENCES AND GLAXOSMITHKLINE ANNOUNCE FDA PRIORITY REVIEW DESIGNATION FOR BENLYSTA® (BELIMUMAB) AS A POTENTIAL TREATMENT FOR SYSTEMIC LUPUS ERYTHEMATOSUS[2010.8.19]
HUMAN GENOME SCIENCES AND LONZA ENTER COMMERCIAL MANUFACTURING AGREEMENT FOR BENLYSTA®, A POTENTIAL NEW TREATMENT FOR SYSTEMIC LUPUS ERYTHEMATOSUS[2010.7.13]
HUMAN GENOME SCIENCES ANNOUNCES PRESENTATION OF ADDITIONAL PHASE 3 SLE STUDY RESULTS FOR BENLYSTA® (BELIMUMAB) AT INTERNATIONAL CONGRESS ON SLE[2010.6.25]
HUMAN GENOME SCIENCES AND GLAXOSMITHKLINE ANNOUNCE FULL PRESENTATION AT EULAR OF BLISS-76 PHASE 3 STUDY RESULTS FOR BENLYSTA® IN SYSTEMIC LUPUS ERYTHEMATOSUS[2010.6.17]
HUMAN GENOME SCIENCES AND GLAXOSMITHKLINE ANNOUNCE PRESENTATION AT EULAR OF BLISS-52 PHASE 3 SLE STUDY RESULTS FOR BENLYSTA® (BELIMUMAB) [2010.6.17]
HUMAN GENOME SCIENCES ANNOUNCES SUBMISSION OF BIOLOGICS LICENSE APPLICATION TO FDA FOR BENLYSTA® (BELIMUMAB)[2010.6.10]
HUMAN GENOME SCIENCES ANNOUNCES SUBMISSION OF MARKETING AUTHORIZATION APPLICATION TO EMA FOR BENLYSTA® (BELIMUMAB)[2010.6.7]
HUMAN GENOME SCIENCES AND GLAXOSMITHKLINE ANNOUNCE TOPLINE 76-WEEK RESULTS OF PHASE 3 TRIAL OF BENLYSTAmV IN SYSTEMIC LUPUS ERYTHEMATOSUS[2010.4.20]
- http://www.ibsa.ch/welcome-intl.htm
スイスの株式非公開
●Products
★Human Reproduction
Fostimon
Merional
Choriomon
★Osteoarthritis
Chondrosulf
Sinovial
★Pain & Inflammation
Flector Tissugel
Flector Granulate
★Dermatology
Ialuset
Betesil
Ialugen Hydro
●News
Flector(R) Patch and Tirosint(R) licensed for the US market[2007.8.24]
- IBSA announces the signature of the licensing agreement with Alpharma Inc. for
the marketing of Flector(R) Patch and Tirosint(R) in the US market.
Flector Tissugel(R) approved by the FDA[2007.1.31]
- Flector Tissuegel(R), IBSA's patch containing 1.3% epolamine salt of diclofenac
, has been approved by the FDA for the treatment of acute pain due to minor strains
, sprains and contusion. The USA marketing authorisation enlightens another major
achievement and a further confirmation of the expansion trend of the company.
- http://www.idenix.com/ ;Cambridge, MA 02139; (NasdaqGM:IDIX)
抗ウイルス剤の開発・販売。
2002.5.31 Novirio Pharmaceuticals Limited を Idenix Pharmaceuticals , Inc.に社名変更。
★Novartisとの契約
2003.5 当社はNovartisと開発候補品全体の包括契約を締結。 同時にNovartisは当社発行株式の54%を
$255 million で取得。 現在56%をNovartis BioVentures Ltdが保有。
2003.5 NovartisはTyzeka(R)/Sebivo(R) and valtorcitabineのライセンス料として$75 million 支払った。
2006.3 valopicitabine(NM283), our lead HCV product candidateをライセンス。対価$25 million license payment
(開発進行に伴い最大$500 million)
★Tyzeka(R)/Sebivo(R)
米英独伊仏・スペインではNovartisと共同販売。残り全世界の販売権はNovartisに許諾。
●会社決算
| ($ 000) | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 |
| 売上高 | 67,377 | 64,718 | 95,389 | 29,570 | 3,465 | |
| (単体) | | | | | | |
| 営業利益 | (85,719) | (55,529) | (8,193) | (42,100) | (38,573) | |
| 経常利益 | () | () | () | () | () | |
| 当期純利益 | (75,087) | (50,777) | (6,244) | (41,880) | (38,356) | |
| 研究開発費 | 96,080 | 86,590 | 79,979 | 51,477 | 29,317 | |
| 従業員数[連結] | 277
(研開・製造160、管理117) | | | | | |
| | | | | | |
| | | | | | |
★Hepatitis B Patent Portfolio and Licenses
Our hepatitis B patent portfolio was initiated with two provisional applications filed on the use of telbivudine, L-deoxycytidine, or LdC, and generically valtorcitabine, for the treatment of HBV in the United States in August 1998 and April 1999. Subsequent U.S. patent applications were filed in 1999 and 2001 with four patents issued in 2002 and 2003 for the treatment of HBV. These patents, which expire in 2019, are set forth below:
・U.S. Patent No. 6,395,716 entitled “s-L-2’-Deoxy-Nucleosides for the Treatment of Hepatitis B”;
・U.S. Patent No. 6,569,837 entitled “s-L-2’-Deoxy Pyrimidine Nucleosides for the Treatment of Hepatitis B”;
・U.S. Patent No. 6,444,652 entitled “s-L-2’-Deoxy-Nucleosides for the Treatment of Hepatitis B”; and
・U.S. Patent No. 6,566,344, entitled “s-L-2’-Deoxy-Nucleosides for the Treatment of Hepatitis B”.
Applications for patent term extensions to extend the term of one of U.S. Patent No. 6,395,716 or 6,569,837, but not both, were filed in the U.S. Patent Office. Although there is no guarantee either application will be granted by the U.S. Patent Office, if one of the applications for term extension were granted, it could extend the term of U.S. Patent No. 6,395,716 or 6,569,837, but not both, to October 25, 2020.（以下略）
★Sumitomo ,p65
In March 2003, we entered into a final settlement agreement with Sumitomo Pharmaceuticals Corporation or Sumitomo, under which the rights to develop and commercialize telbivudine in Japan, China, South Korea and Taiwan previously granted to Sumitomo were returned to us. This agreement with Sumitomo became effective upon consummation of our collaboration with Novartis in May 2003. The settlement agreement which we entered into with Sumitomo provides for a $5.0 million milestone payment to Sumitomo if and when the first commercial sale of telbivudine occurs in Japan.
from 10-K Annual Filings[03/14/07] - [pdf,117p]
●About Idenix
★Product Pipeline
★Media Center～会社概要、Ｂ型肝炎・Ｃ型肝炎概要
●Products
★TYZEKA(telbivudine)Ｂ型肝炎
●Hepatitis B
●Hepatitis C
●HIV
■Investor Centor
●SEC filings
★10-K Annual Filings[03/14/07] - [pdf,117p]
●annual reports
★2005 Annual Report
●news releases
Idenix Pharmaceuticals Reports Fourth Quarter and Year End Financial Results[2007.3.2]
SEBIVO(R) (telbivudine) Recommended for Approval in European Union as a new Treatment for Patients with Chronic Hepatitis B[2007.2.23]
TYZEKA(TM) (telbivudine) Approved by U.S. Food and Drug Administration (FDA) as a New Treatment for Patients with Chronic Hepatitis B[2006.10.25]
癌免疫療法薬開発に特化した会社。 本社Irvine, California
設立 1987
2008.1 UVIDEMへのSanofi-Aventis契約打ち切りにともない、米国の多数の人員解雇、仏子会社の事業中止。
Takeda to acquire IDM Pharma[2009.5.18]
●会社決算
| ($ 000) | 2008 | 2007 | 2006 | 2005 | 2004 |
| 関連Party収入 | 2,401 | 14,246 | 11,147 | | |
| 研究Grant/契約収入 | 400 | 55 | 96 | | |
| ライセンス収入 | 346 | 329 | 43 | | |
| 売上高 | 3,147 | 14,630 | 11,286 | 8,500 | 5,800 |
| 営業利益 | (15,920) | (21,360) | (21,642) | | |
| 経常利益 | (18,361) | (18,044) | (23,698) | | |
| 当期純利益 | (18,606) | (18,350) | (23,455) | (39,200) | (31,700) |
| 研究開発費 | 11,161 | 22,339 | 22,921 | | |
| 従業員数[連結] | 15 | | | | |
| | | | | |
■パイプライン /2009.8.26
| ●MEPACT(R)(mifamurtide, or L-MTP-PE) 骨肉腫 |
| 【2008】We are developing our lead product candidate, mifamurtide, or L-MTP-PE, known as MEPACT(R) in Europe, for the treatment in combination with chemotherapy following surgery of patients with non-metastatic resectable osteosarcoma, or bone cancer. We have received orphan drug designation for mifamurtide in the United States, or U.S., and the European Union, or EU, for the treatment of osteosarcoma. A Phase 3 clinical trial for the treatment of osteosarcoma was completed by the Children’s Oncology Group, or COG, before the product candidate was acquired by us in 2003. In October 2006, we submitted a New Drug Application, or NDA, in electronic Common Technical Document, or eCTD format, to the U.S. Food and Drug Administration, or the FDA, for mifamurtide, requesting approval for its use in the treatment of patients with newly diagnosed resectable high-grade osteosarcoma following surgical resection in combination with multiple agent chemotherapy. The FDA accepted the NDA for substantive review, on a standard review basis, contingent upon our commitment to provide pharmacokinetic data for the to-be-marketed mifamurtide product.
In November 2006, we submitted a Marketing Authorization Application, or MAA, for MEPACT to the European Medicines Agency, or EMEA. The EMEA determined the application was valid and the review procedure was started in late November 2006.
We attended an oral explanation hearing before the Committee for Medicinal Products for Human Use, or CHMP, the scientific committee of the EMEA, regarding the MAA on January 23, 2008. The CHMP considered, in a non-binding opinion, that the data presented by us suggested a possible clinical benefit of MEPACT in terms of survival. As a result of the CHMP’s non-binding opinion, we were granted a clock stop, or time extension, to allow us additional time to respond to all the remaining questions regarding the MEPACT MAA. On November 17, 2008, the CHMP issued a positive opinion, recommending grant of a centralized marketing authorization for MEPACT. The CHMP recommendation was formally adopted by the CHMP on December 18, 2008, and final European Commission, or EC, approval was received on March 6, 2009. The centralized marketing authorization allows MEPACT to be marketed in the 27 Member States of the EU, as well as in Iceland, Liechtenstein and Norway. MEPACT was granted orphan medicinal product status in Europe in 2004 and under European pharmaceutical legislation is entitled to a period of 10 years market exclusivity in respect of the approved indication.
In the U.S., the FDA’s Oncologic Drugs Advisory Committee, or ODAC, met on May 9, 2007 and voted 12 to 2 that the submitted results of the Phase 3 trial did not provide substantial evidence of effectiveness of mifamurtide in the treatment of patients with non-metastatic, resectable osteosarcoma receiving combination chemotherapy. On July 23, 2007, following a meeting with the FDA, we announced that we would collect, analyze and submit additional data for mifamurtide to the FDA, in an amendment to the NDA. On August 27, 2007, the FDA issued a not approvable letter to us after completing the review of the NDA for mifamurtide. The FDA requested data from additional clinical trials to demonstrate the benefit of mifamurtide, as well as information or clarification with respect to other sections of the NDA. We do not believe that additional clinical trials are necessary to gain approval of the mifamurtide NDA. While we believe that the existing clinical trial data justifies approval of mifamurtide in the U.S., there are no assurances that the FDA will accept our amended NDA as supportive for approval. We do not have sufficient resources to conduct additional clinical trials of mifamurtide in the U.S. In order to focus on those areas we believe can provide the most near term value to our stockholders and to ensure we have adequate cash to complete our review of strategic options for the Company, we are concentrating our near-term efforts on certain MEPACT pre-launch commercial activities in Europe and review of such strategic options, including merger or acquisition opportunities, which may involve a change in control of our company. Consequently, we have placed the U.S. mifamurtide NDA amendment submission on hold until we complete our strategic review, which will allow us to operate into the third quarter of 2009. We have engaged JMP Securities, an investment bank, to advise us in exploring alternatives available to us with respect to a possible merger or acquisition transaction.
The timing of potential marketing approval of mifamurtide in the U.S. is subject to risks and uncertainties beyond our control. These risks and uncertainties regarding product approval and commercialization include the timing of submission and FDA review of the amendment to the NDA, our ability to respond to questions and concerns raised by the FDA in a satisfactory manner, the time needed to respond to any issues raised by the FDA during the review of our amended NDA for mifamurtide and the possibility that the FDA may not consider existing safety and efficacy data, the Phase 3 study design, conduct and analysis, available nonclinical studies, or the existing drug comparability studies between the drug used in the Phase 3 study and the drug manufactured by us as adequate or valid for their assessment of the marketing approval of mifamurtide. These factors may cause delays in submission or review of the NDA amendment, may result in the FDA requiring us to conduct or complete additional clinical trials, nonclinical and drug comparability studies, or may result in a determination by the FDA that the data in the to be submitted NDA amendment do not support marketing approval. As a result, we may not receive approval from the FDA for the marketing and commercialization of mifamurtide in the U.S. when expected or at all.
In addition, we currently do not have operational sales and marketing infrastructure for mifamurtide and do not currently have plans or sufficient funds to secure this capability. We would need to complete a strategic collaboration or other transaction with a strategic partner that has EU and/or U.S. commercialization abilities or otherwise arrange for the commercialization ourselves. If we are unable to commercialize mifamurtide ourselves or with or through a partner, any delay would materially adversely affect our business and financial position due to reduced or delayed revenues from mifamurtide sales.
We have an agreement with Novartis granting us an exclusive, worldwide license to intellectual property rights relating to mifamurtide. We have exclusive worldwide sales and marketing rights for mifamurtide, except in Israel and South East Europe where we licensed distribution rights to third parties.
Osteosarcoma
About 3% of all childhood cancers are osteosarcoma. Because osteosarcoma usually develops from osteoblasts, it most commonly develops in teenagers who are experiencing their adolescent growth spurt. Osteosarcoma is an orphan disease and there are approximately 1,000 new cases of osteosarcoma in the United States each year. A similar incidence of the disease exists in Europe. According to the Children’s Oncology Group, the survival of children with osteosarcoma has remained at 60-65% since the mid-1980s. The standard treatment for osteosarcoma is tumor resection with combination chemotherapy before and after surgery.
|
| 【2008】The Immune System and Our Therapeutic Approaches
The human immune system plays a crucial role in the body’s defense against cancer and infectious diseases. The immune system has multiple mechanisms for combating diseases, including macrophage-based and lymphocyte-based immune responses. Our products are designed to enhance the body’s natural immune defenses against cancer by stimulating these two response mechanisms, as described below.
Macrophages are large white blood cells capable of ingesting microbes and diseased cells, including cancer cells. They begin their life in the bone marrow, enter the blood where they are known as monocytes and then mature into macrophages upon entering tissues. Some macrophages are naturally attracted by tumors, where they can either facilitate tumor growth or destroy tumor cells. Macrophage activators can be used to manipulate this dual function of macrophages. The ability of macrophages to destroy tumor cells can be harnessed by activating macrophages inside the patient’s body or outside the body and reinjecting them into the patient.
Our lead product candidate, mifamurtide, L-MTP-PE, known as MEPACTR in Europe, is one of a family of macrophage activators, or immune system stimulants, that activate macrophages inside the body. Mifamurtide is a fully synthetic chemical entity based on immunostimulatory components and designed to activate macrophages. It is administered in an intravenous formulation that promotes delivery to tissue macrophages prominent in the lung and liver. Extensive development of mifamurtide has been completed, including a large randomized Phase 3 study in patients with osteosarcoma. We have submitted regulatory filings in the U.S. and the EU requesting approval to market mifamurtide for use in the treatment of patients with newly diagnosed resectable high-grade osteosarcoma in combination with multiple agent chemotherapy. On November 17, 2008, the CHMP issued a positive opinion, recommending grant of a centralized marketing authorization for MEPACT. The CHMP recommendation was formally adopted by the CHMP on December 18, 2008 and final European Commission approval was received on March 6, 2009. We received a not approvable letter from the FDA with respect to mifamurtide in August 2007. In order to focus existing resources on certain MEPACT pre-launch commercial activities in Europe and to conserve cash while we complete our review of strategic options for the Company, we have placed the U.S. mifamurtide NDA amendment submission on hold until we complete our review. Mifamurtide has received orphan drug designation in the U.S. and the EU for use in this cancer indication.
|
| 【2008】Mifamurtide for Treatment of Osteosarcoma. Mifamurtide is an immune system stimulant for the treatment of osteosarcoma, which is a rare aggressive bone tumor that occurs primarily in adolescents and young adults. Between two and three percent of all childhood cancers are osteosarcoma. Because osteosarcoma usually develops from osteoblasts, it most commonly affects children and young adults experiencing their adolescent growth spurt. Boys and girls have a similar incidence rate until later in their adolescence, when boys are more commonly affected. While most tumors occur in larger bones, such as the femur, tibia, and humerus, and in the area of the bone that has the fastest growth rate, they can occur in any bone. The most common symptom is pain, but swelling and limited movement can occur as the tumor grows. Current standard therapy includes surgical removal of the primary tumor and systemic chemotherapy prior to and after surgery. Long-term disease-free survival can be achieved in approximately 60-65% of patients diagnosed without metastases. The others will relapse, typically with metastases to the lungs. When the lung nodules can be completely removed, the 5-year survival rate is between 20% and 45%, but is reduced to less than 5% for those patients that are inoperable. The incidence of osteosarcoma is approximately 1,200 new cases per year in the U.S., mostly among children and adolescents, allowing mifamurtide to qualify for orphan drug designation in the U.S. for this disease in 2001. We also received orphan drug designation for mifamurtide for treatment of osteosarcoma in the EU in 2004. This designation allows us to benefit from certain advantages during product development and defined years of market exclusivity after marketing approval in both geographies. Financial advantages include reduced or waived fees associated with the filing of an MAA and we can also benefit from tax incentives for as much as 50% of clinical development costs.
A randomized Phase 3 study of mifamurtide for the treatment of newly diagnosed osteosarcoma in combination with a three-or four-drug chemotherapy regimen was conducted by the COG under an investigational new drug application, or IND, granted by the FDA and held by the National Cancer Institute, prior to our purchase of mifamurtide in 2003. Results of the Phase 3 study demonstrated that the use of mifamurtide showed a 30% reduction in the risk of death in patients with osteosarcoma.
Six hundred and seventy-eight patients with newly diagnosed non-metastatic resectable high grade osteosarcoma were treated with mifamurtide in combination with chemotherapy following surgery at a dose between 2 mg/m2 and 2 mg/m2 + 2 mg twice a week for 12 weeks and then once a week for 24 weeks. With a median follow up of almost 5 years, patients receiving mifamurtide had a significant improvement in Overall Survival, or OS, (p=0.0183). There was an approximately 30% reduction in the risk of death for patients who received mifamurtide in combination with chemotherapy, a clinically meaningful finding in pediatric population where the longer the survival, the greater the chance that the patient is cured of cancer. At 6 years, the probability of survival when mifamurtide is combined with adjuvant chemotherapy is 77% (95% CI: 72-83%) compared to 66% (95% CI: 59-73%) without mifamurtide, a 15 percent improvement. Additional survival data from the COG (median follow-up 7.7 years) support the survival benefit of mifamurtide in the treatment of non-metastatic osteosarcoma. Mifamurtide was generally well tolerated with the most common adverse events being anemia, anorexia, headache, dizziness, tachycardia, hypertension, hypotension, dypenea, tachypnea, cough, vomiting, diarrhea, constipation, abdominal pain, nausea, hyperhidrosis, myalgia, arthralgia, back pain, pain in extremity, fever, chills fatigue, hypothermia, pain, malaise, asthenis, and chest pain. These findings were generally mild to moderate in nature and consistent with the activation of monocytes and macrophages by mifamurtide.
Overall, almost 400 patients with advanced malignancies have been treated in Phase 1/2 trials with mifamurtide, of whom more than half were under an IND and for whom we have detailed data. In general, mifamurtide demonstrated acceptable tolerability, even when administered once weekly up to six months. These studies, conducted in the U.S., Canada, Belgium, Germany and France, established the safety profile and provided information for the dosing schedule of mifamurtide.
Preclinical studies with mifamurtide demonstrated tumor regression in mice with lung and lymph node disease and 36% long-term survival (greater than one year) in dogs with spontaneous osteosarcoma treated with a combination of surgery, chemotherapy and mifamurtide. This preclinical data suggests mifamurtide may have potential for treatment of other types of cancer, because it targets pulmonary macrophages. In the future, the Company may explore its use in the treatment of cancers that are prone to lung or liver metastases, such as breast, gastrointestinal and renal cancers.
In October 2006, we submitted an NDA in eCTD format to the FDA for mifamurtide, requesting approval for its use in the treatment of patients with newly diagnosed resectable high-grade osteosarcoma patients in combination with multiple agent chemotherapy. The FDA accepted the NDA file for substantive review, on a standard review basis. In November 2006, we submitted an MAA for mifamurtide to the EMEA.
We attended an oral explanation hearing before the CHMP regarding the MAA on January 23, 2008. The CHMP considered, in a non-binding opinion, that the data presented by us suggested a possible clinical benefit in terms of survival. As a result of the CHMP’s non-binding opinion, we were granted a clock stop, or time extension, to allow us additional time to respond to all the remaining questions regarding the MAA. On November 17, 2008, the CHMP issued a positive opinion, recommending grant of a centralized marketing authorization in the EU for MEPACT. The CHMP recommendation was formally adopted by the CHMP on December 18, 2008 and final European Commission approval was received on March 6, 2009. The centralized marketing authorization allows MEPACT to be marketed in the 27 Member States of the EU, as well as in Iceland, Liechtenstein and Norway.
MEPACT was granted orphan medicinal product status in Europe in 2004 and under European pharmaceutical legislation is entitled to a period of 10 years market exclusivity in respect of the approved indication.
In the U.S., the FDA’s ODAC, met on May 9, 2007 and voted 12 to 2 that the submitted results of the Phase 3 trial did not provide substantial evidence of effectiveness of mifamurtide in the treatment of patients with non-metastatic, resectable osteosarcoma receiving combination chemotherapy. On July 23, 2007, following a meeting with the FDA, we announced that we would collect, analyze and submit additional data for mifamurtide in an amendment to the NDA. On August 27, 2007, the FDA issued a not approvable letter to us after completing the review of the NDA for mifamurtide. The FDA requested data from additional clinical trials to demonstrate the benefit of mifamurtide, as well as information or clarification with respect to other sections of the NDA. We do not believe that additional clinical trials are necessary to gain approval of the mifamurtide NDA. While we believe that the existing clinical trial data justifies approval of mifamurtide in the U.S., there are no assurances that FDA will accept our amended NDA as supportive for approval. We do not have sufficient resources to conduct additional clinical trials of mifamurtide in the U.S. In order to focus existing resources on certain MEPACT pre-launch commercial activities in Europe and to conserve cash while we complete our review of strategic options for the Company, we have placed the U.S. mifamurtide NDA amendment submission on hold until we complete our review.
The timing of marketing approval of mifamurtide in the U.S. is subject to risks and uncertainties beyond our control. These risks and uncertainties regarding product approval and commercialization include the timing of submission and FDA review of the amendment to the NDA, our ability to respond to questions and concerns raised by the FDA in a satisfactory manner, the time needed to respond to any issues raised by the FDA during the review of our amended NDA for mifamurtide and the possibility that the FDA may not consider existing safety and efficacy data, the Phase 3 study design, conduct and analysis, available nonclinical studies, or the existing drug comparability studies between the drug used in the Phase 3 study and the drug manufactured by us as adequate or valid for their assessment of marketing approval of mifamurtide. These factors may cause delays in submission or review of the NDA amendment, may result in the FDA requiring us to conduct or complete additional clinical trials, nonclinical and drug comparability studies, or may result in a determination by the FDA that the data in the to be submitted NDA amendment do not support marketing approval. As a result, we may not receive approval from the FDA for the marketing and commercialization of mifamurtide in the U.S. when expected or at all.
In addition, we currently do not have operational sales and marketing infrastructure for mifamurtide and do not currently have plans or sufficient funds to secure this capability. We would need to complete a strategic collaboration or other transaction with a strategic partner that has EU and U.S. commercialization abilities or otherwise arrange for the commercialization ourselves. If we are unable to commercialize mifamurtide ourselves or with or through a partner, any delay would materially adversely affect our business and financial position due to reduced or delayed revenues from mifamurtide sales.
|
| 【2008】Product Manufacturing
Mifamurtide and IDM-2101 are product candidates for which we rely on outsourced manufacturing.
MTP-PE is the active pharmaceutical ingredient, or API, in mifamurtide. MTP-PE is a fully synthetic analogue of muramyldipeptide, a naturally occurring component of bacterial cell walls that is synthesized in a multi-step process. Mifamurtide is a liposomal formulation of MTP-PE combined with two synthetic lipids, a type of organic compound. When saline is added to the final product, the lipids form liposomes, which are spherical vessels used to deliver MTP-PE to macrophages and monocytes. In seeking regulatory approval for mifamurtide, we have established outsourcing arrangements with third parties to provide us with our supply and manufacturing needs for commercialization of mifamurtide.
The manufacture of mifamurtide involves the acquisition of the API and excipients, which are then dissolved in a specialized solvent, mixed, filtered and finally lyophilized in vials. Currently we have contracts with third-party suppliers for the manufacture of the API and final product formulation, fill and finish for mifamurtide. We also have agreements with several other suppliers that perform the key analytical and quality control tests necessary for the release of mifamurtide. The excipients are obtained via purchase orders.
While we have identified alternate suppliers that could provide these products and services, should the ability of our current contractors to manufacture and test MTP-PE and/or mifamurtide be impaired or otherwise limited, we do not have any agreements or current arrangements with these alternate suppliers. Delays or impairment of our ability to continue manufacturing mifamurtide could be caused by physical damage or impairment of our supplier facilities, failure to renew manufacturing agreements with them or other unforeseen circumstances. Such impairment could significantly impact our ability to commercialize mifamurtide. Despite our having already identified potential alternative suppliers, it would take a significant amount of time and resources to initiate and validate all of the required processes and activities to bring any new supplier on-line, resulting in interruptions in the availability of mifamurtide. |
| 【2008】License Agreement with Novartis
In March 2003, we entered into an asset purchase agreement with Jenner Biotherapies, Inc., or Jenner. Pursuant to the terms of the agreement, we purchased certain of Jenner’s assets, which included our lead product candidate, mifamurtide, and an exclusive worldwide license from Ciba-Geigy Ltd., now known as Novartis, covering patent rights to compounds that we use in the production of mifamurtide. These assets were acquired by issuing IDM Pharma S.A. shares with a fair value of $3.1 million. The asset purchase was consummated in April 2003. The purchase consideration was allocated to the mifamrutide license, which was determined to have alternative future use and is included in Patents, Trademarks and Other Licenses (see Note 4 in the notes to the consolidated financial statements). Under the license agreement, we are required to make certain milestone payments with respect to mifamurtide totaling $2.75 million, which is triggered by the achievement of gross profit related to mifamurtide. We achieved two of the milestones totaling $750,000 in 2006 and prior years although no amounts had been previously recorded in our financial statements because ultimate payment was not determined to be probable. In the second quarter of 2008, based on the status of the EMEA review of the MAA and the assessed probability of European approval, we determined that the payment of $750,000 was probable in the event mifamurtide is successfully commercialized in Europe. As such, we capitalized this additional amount as Patents, Trademarks and Other Licenses and recorded a corresponding liability. Pursuant to the license agreement, the total milestones payable in any year with respect to all such milestones shall not exceed 25% of the gross profit of mifamurtide in any year, with the balance being carried forward to later years without incurring interest. We also agreed to pay royalties with respect to net sales of mfiamurtide, which royalties will be reduced by an established percentage upon the expiration of certain patent protection in accordance with the terms of the license. A portion of the milestone payments will be credited against these royalty obligations. Unless earlier terminated, the license agreement shall continue on a country-by-country and product-by-product basis until there are no remaining royalty payments in each country covered by the patents obtained under the agreement. In most countries the remaining patents expired in 2007 and, under the terms of the agreement, the royalties payable will be reduced. In addition to certain standard termination clauses, we may terminate the agreement with respect to any patent upon 60 days’ written notice. |
| 【2008】Acquisition of Certain Assets from Jenner Biotherapies
In March 2003, we entered into an Asset Purchase Agreement with Jenner Biotherapies, Inc., a biotechnology company, now dissolved, that was devoted to the development of cancer vaccines and macrophage activators. Pursuant to the terms of the agreement, we purchased certain assets of Jenner Biotherapies, including its lead product candidate, mifamurtide, and various agreements, patents, licenses and other intellectual property rights associated with Jenner Biotherapies’ cancer vaccine programs. The assets were acquired for shares in our subsidiary, IDM Pharma S.A. |
| 【2008】Patents
Patents and other proprietary rights are critical to our business. We maintain a policy of filing patent applications to protect our technology and products, including our Cell Drugs and other product candidates, processes for preparing our product candidates, pharmaceutical compositions containing such products and, in the United States, methods of treatment of the human body. Some of our patent applications cover key technologies underlying the products in our developmental pipeline and are issued or pending in jurisdictions that are key to our business. We classify our patents and proprietary rights into four groups: dendritic cells, macrophages, cellular technology and immuno-designed molecules. The dendritic cell group contains patents and applications related to Dendritophages. The macrophage group of patents focuses on monocyte-derived macrophages and protects methods for their preparation and their use, including combinations with antibodies. The cellular technology group of patents contains patents and applications protecting different methods or kits usable for preparation of dendritic cells as well as for macrophages. The immuno-designed molecules family of patents represents immune system stimulants and new complexes allowing for efficient modification of cells. It also includes the patents acquired from Jenner Biotherapies, in particular those covering mifamurtide, Jenact and certain tumor antigens, such as prostate specific antigen, or PSA, and KSA. Certain of these have been abandoned and the rest will expire between November 2012 and April 2024.
Our policy is to extend patent coverage to countries that represent market opportunities for our products and/or our technology, in order to be able to sell licenses or form partnering alliances for joint development of our technologies in related fields. We also rely on trade secrets, confidentiality agreements and other measures to protect our technology and products.
The original patents covering mifamurtide have expired and the one U.S. patent relating specifically to liposomal formulation of mifamurtide was set to expire in November 2007. However, we were granted an interim patent extension that extended the expiration until November 2009. We expect to be able to extend this U.S. patent an additional three years to November 2012. If we receive regulatory approval for mifamurtide and choose to commercialize it, we will have a seven-year period of marketing exclusivity for mifamurtide for the treatment of osteosarcoma in the U.S. as a result of mifamurtide’s designation as an orphan drug for osteosarcoma by the FDA. This seven-year period would begin on the date that our marketing application for mifamurtide is approved by the FDA. During this period, the FDA would be barred from approving a third-party’s marketing application for the same drug for the same application. The FDA would not, however, be barred from approving a third-party’s marketing application for mifamurtide for a type of cancer other than osteosarcoma or for a drug other than mifamurtide for the treatment of osteosarcoma, if it is shown to be more effective. Similarly, we will have a 10-year marketing exclusivity in Europe as a result of mifamurtide’s designation as an orphan drug for osteosarcoma by the EMEA. The orphan drug designation in the U.S. and Europe for mfiamurtide and the manufacturing process patent may not provide us with adequate protection from competitive products.
Most issued patents granted, or deemed to be granted, by the European Patent Office, or EPO, can be validated as individual patents in eight key countries within Europe. As a result of multi-country validation of our EPO patents (coupled with our issued patents and patent applications in non-European countries), our patent portfolio comprised, as of January 2009, a total of 27 issued patents and 7 patent applications.
In addition, we have been granted licenses to patents covering several products by our collaboration partners. We have exclusive or non-exclusive rights to 135 licensed patents (109 issued, 26 pending) covering loading and dendritic cell differentiation/maturation technologies as well as tumor antigens. We also have two licenses covering tumor epitopes, one from the National Institutes of Health, or NIH, and one from the Ludwig Institute for Cancer Research.
With respect to our technology, know-how and data, we have chosen to protect our interests by relying on confidentiality agreements with our employees, consultants and certain contractors. In addition, we have a policy of entering into confidentiality agreements with our collaborators and licensees. |
| 【2008】Our lead product candidate, mifamurtide, may never obtain regulatory approval in the U.S.
Even though we have received marketing authorization for mifamurtide in Europe, we may never obtain regulatory approval in the U.S. We submitted an NDA to the FDA for mifamurtide, requesting approval for its use in the treatment of newly diagnosed resectable high grade osteosarcoma patients following surgical resection in combination with multiple agent chemotherapy. In August 2007, the FDA issued a not approvable letter to us after completing the review of the NDA for mifamurtide. In this letter, the FDA requested data from additional clinical trials to demonstrate the benefit of mifamurtide, as well as information or clarification with respect to other sections of the NDA. In order to focus existing resources on certain MEPACT pre-launch commercial activities in Europe and to conserve cash while we complete our review of strategic options for the Company, we have placed the U.S. mifamurtide NDA amendment submission on hold until we complete our review.
If a single randomized trial is intended to support a marketing application, the trial should be well designed, well conducted, internally consistent and provide statistically persuasive efficacy findings, and a second trial would be ethically or practically impossible to perform. The mifamurtide marketing applications include efficacy and safety data from one Phase 3 clinical trial conducted by the COG sponsored by the NCI completed prior to our purchase of mifamurtide from Jenner in 2003 and data from preclinical, Phase 1 and Phase 2 studies. The FDA may not consider preclinical and clinical development work conducted by Ciba-Geigy, or safety and efficacy data and analyses from several Phase 1/2 and Phase 3 clinical trials, or the Phase 3 study design, conduct and analysis to be adequate or valid for their assessment of mifamurtide. These factors may cause significant delays in review, may result in the FDA requiring us to conduct additional pre-clinical or clinical trials, or may result in a determination by the FDA that the quality, safety and/or efficacy data do not support marketing approval.
We may not be able to collect, analyze and submit additional data in an amendment to the NDA for mifamurtide, if at all. Further, it is possible that the additional data will not support the benefit of mifamurtide in the treatment of non-metastatic osteosarcoma, will not allow a more robust analysis of mifamurtide, will not continue to support the overall survival benefit of mifamurtide in osteosarcoma, and may not provide substantial evidence for the potential regulatory approval of mifamurtide.
Other risks relating to regulatory approval of mifamurtide include our ability and time needed to respond to questions raised during review with regard to regulatory submissions for mifamurtide. In addition, FDA staffing issues could delay critical FDA meetings that are needed to file our amended NDA. We may not be able to address outstanding issues of the FDA. For instance, the FDA’s not approvable letter related to the NDA for mifamurtide requested data from additional clinical trials to demonstrate the benefit of mifamurtide, and we do not have sufficient financial, operational and other resources necessary to complete additional clinical trials. If we are not able to address these issues to the satisfaction of the FDA, we may not receive necessary approvals for the marketing and commercialization of mifamurtide in the U.S. when expected or at all.
Manufacturing of mifamurtide and mifamurtide components for IDM Pharma by third party suppliers is based in part on the specifications and processes established before the Phase 3 trial. We have produced mifamurtide materials that meet the same specifications as the product used in pivotal clinical trials. We submitted data showing comparability of the new (IDM Pharma) and the old (Ciba-Geigy) materials in the NDA and MAA so that the data generated during preclinical and clinical development can be used to support regulatory marketing approval. If the FDA does not accept our assessment of the comparability results, the approval in the U.S. would be delayed.
Manufacturing of mifamurtide and mifamurtide components for IDM Pharma is also a complex process involving a number of suppliers and steps, and is carried out in numerous locations and countries. Managing this manufacturing process is intricate and also involves issues created by time zone and language differences as well as knowledge of local and territorial regulations. We rely on our employees, local manufacturer representatives and consultants with knowledge of the local and territorial regulations to manufacture mifamurtide and its components to meet all of the required manufacturing and regulatory specifications. If we are unable to manufacture mifamurtide and its components in accordance with application requirements, our ability to obtain regulatory approval for mifamurtide would be adversely affected.
The development of mifamurtide suitable for commercial distribution, the review of our NDA by the FDA and stringent regulatory requirements to manufacture commercial products in various geographies have required and will continue to require significant investments of time and money, as well as the focus and attention of key personnel. If we fail to receive or are delayed in receiving regulatory approval for mifamurtide in the U.S., our financial condition and results of operations will be significantly and adversely affected. |
|
|
| ● 骨肉腫 |
| 【2008】 |
|
●Pipeline
■Investors
●News Releases
IDM Pharma Reports 2008 Financial Results[2009.3.31]
IDM Pharma's MEPACT(R) (Mifamurtide, L-MTP-PE) Receives Approval in Europe for Treatment of Patients with Non-Metastatic, Resectable Osteosarcoma[2009.3.9]
IDM Pharma Receives Recommendation for Approval of Mifamurtide (MEPACT(R), L-MTP-PE) for the Treatment of Patients with Non-Metastatic, Resectable Osteosarcoma in Europe from the Committee for Medicinal Products for Human Use (CHMP)[2008.11.18]
IDM Pharma Receives Not Approvable Letter for Mifamurtide (L-MTP-PE) for the Treatment of Osteosarcoma[2007.8.27]
IDM Pharma Announces Plans to Amend New Drug Application for Mifamurtide (L-MTP-PE) for the Treatment of Patients with Osteosarcoma[2007.7.23]
FDA Advisory Committee Reviews Data on IDM Pharma's Junovan(TM) (mifamurtide) for Treatment of Osteosarcoma[2007.5.9]
IDM Pharma Submits Filing for European Market Approval of Mepact(TM) (mifamurtide, Junovan(TM) in the US) in the Treatment of Osteosarcoma[2006.11.7]
IDM Pharma Submits New Drug Application to the FDA for Junovan(TM) (mifamurtide) in the Treatment of Osteosarcoma[2006.10.26]
●SEC Filings
10-K Annual report[2009.3.31] - [pdf] - [doc] - [xls]
●Annual Reports
- http://www.imclone.com/; (Nasdaq: IMCL); 米国New York City
1984年 設立。 免疫診断薬とワクチン研究でスタート
従業員数 582人(2004.2.1現在)
●決算
($000) 2003 2002 2001 2000 1999
Revenues $ 80,830 60,005 50,237 6,253 8,726
Operating loss (108,851) (154,849) (127,360) (72,720) (37,336)
Net loss (112,502) (157,949) (127,607) (70,469) (34,739)
★ERBITUX
University of California からライセンスを受けている。
★Bristol-Myers Squibb Company - ERBITUX
2001.9.19 BMSの100%子会社BMS Biologics の買収契約。
★Merck KGaA - ERBITUX
1998.12 ライセンス契約。米・カナダ・日本以外の全世界。
2003年末迄に5500万ドル受領。
頭頚部squamous cell carcinoma に対するERBITUX plus radiotherapy の拡大研究
に関して、共同開発を実施してきた。
●Investor Relations
★Annual Reports
★SEC Filings
10-K Annual Financials[2004.3.15] -[pdf]
★Press Releases
●News
ERBITUX -Cetuximab- Receives FDA Approval to Treat Irinotecan Refractory or
Intolerant Metastatic Colorectal Cancer[2004.2.12]
- www.erbitux.com
米国で大腸癌・直腸癌の新患は毎年14.8万人。診断時には半数が転移。
EGFRは大腸癌・直腸癌の77%にあらわれる。
●2001年売り上げ
IMMUNEX CORP Annual Report (SEC form 10-K)[2002.3.8]
Revenues (in millions)
2001 2000 1999
------ ------ ------
Enbrel $761.9 $652.4 $366.9 etanercept
Leukine 108.4 88.3 69.1
Novantrone 71.2 59.9 44.5
Other product sales 18.1 28.2 38.8
------ ------ ------
Total product sales 959.6 828.8 519.3
Royalty and contract revenue 27.2 33.0 22.4
------ ------ ------
Total revenues $986.8 $861.8 $541.7
====== ====== ======
★2001.12 Amgenによる買収に合意。
- http://www.impaxlabs.com/ ; (Nasdaq:IPXL), a Delaware corporation,
is headquartered in Hayward, California
1999.12.14 Global Pharmaceutical Corporationと私企業IMPAX Pharmaceuticals, Inc.
が合併し、Impax Laboratories, Inc.を新設。
6-8品目の新薬を開発中。
●会社決算[12月]
($000) 2003 2002 2001 2000 1999
純収入 58,818 24,515 6,591 10,170 1,240
研究開発費 16,938 15,549 10,972 11,096 7,858
営業経費 計 28,584 26,817 22,252 25,546 9,648
営業損失 -13,178 -20,794 -25,330 -25,092 -9,333
純損失 -14,207 -20,040 -25,111 -24,961 -8,949
従業員数 453 273
Operations 214 96
研究開発 95 80
品質 94 49
管理 41 38
販売 9 10
(2003) 2004.2.27常用従業員 別に臨時98人(operations 91)
(2002) 2003.2.28常用従業員
- http://www.impaxlabs.com/
●Products
- 中枢神経系医薬品の銘柄品部門とジェネリック部門(Global Pharmaceuticals)
●Investor Relations
★Financial Reports - Annual Reports | Quarterly & Other Reports
- Annual Report 2003[pdf,96p]
★SEC Filings
NT 10-K[2005.3.16] - [Word] |[pdf] |
★Press Releases
★
Rilutek Tablets
2001.5 FDAはANDA申請を受け付け。
2002.7 FDAからこのANDAのtentative FDA approvalを受け取った。
(due to the Orphan Drug Exclusivity (ODE) for Rilutek that extended through
December 2002.)
2002.6 当社はa declaratory judgment action seeking a Judicial Declaration of
Invalidity against Aventis regarding patent #US 5,527,814
( FDA "Orange Book"収録)
2002.12.12 the District Court of Wilmington, Delaware, granted the Preliminary
Injunction Notice brought by Aventis in October 2002 to forestall our
entry into this market.
2003.1 当社はfinal FDA approval of this ANDAを受け取った。
A trial was held in October 2003 and we are currently awaiting a decision from
the court.
Total U.S. sales for Rilutek were
approximately $34.8 million for the twelve months ended
December 31, 2002.
IMPAX v. Aventis Pharmaceuticals, Inc.: The Riluzole Case
In June 2002, IMPAX filed suit against Aventis Pharmaceuticals, Inc. in the U.S. District Court in Wilmington, Delaware,
seeking a declaration that the filing of an ANDA to engage in a commercial manufacture and/or sale of Riluzole 50 mg
Tablets for treatment of patients with amyotrophic lateral scleroses (ALS) does not infringe claims of Aventis’ U.S. Patent
No. 5,527,814 (‘814 patent) and a declaration that this patent is invalid.
In response to IMPAX’s complaint, Aventis filed counterclaims for direct infringement and inducement of infringement of
the ‘814 patent. In December 2002, the district court granted Aventis’ Motion for Preliminary Injunction and enjoined
IMPAX from infringing, contributory infringing, or inducing any other person to infringe Claims 1, 4 or 5 of the ‘814 patent
by selling, offering for sale, distributing, marketing or exporting from the United States any pharmaceutical product or
compound containing riluzole or salt thereof for the treatment of ALS.
The trial was completed on October 30, 2003, and post-trial briefing was completed in December 2003. IMPAX is pursuing
its assertions that claims of the ‘814 patent are invalid in view of prior art and are unenforceable in view of inequitable
conduct committed during the prosecution of the patent before the USPTO.
On January 30, 2004, the court denied IMPAX’s Motion for Summary Judgment on inequitable conduct and, on February 5,
2004, the court denied IMPAX’s Motion for Summary Judgment on non-infringement of certain claims. As of February 27,
2004, the court did not issue its trial rulings and did not rule on the third pre-trial Motion for Summary Judgment based on
invalidity of the patent-in-suit.
If IMPAX is not ultimately successful in proving invalidity or unenforceability, there is a substantial likelihood that the court
will enter a Permanent Injunction enjoining IMPAX from marketing Riluzole 50 mg Tablets for the treatment of ALS in the
United States until the expiration of the ‘814 patent (June 18, 2013). If IMPAX is ultimately successful in proving either
defense, the Preliminary Injunction would be set aside and IMPAX would be permitted to market its Riluzole 50 mg Tablet
product for the treatment of ALS in the United States.
- http://www.indevus.com/; (NASD: IDEV)
設立 1988
社名変更 2002.4 Interneuron Pharmaceuticals, Inc.からIndevus Pharmaceuticals, Inc.ヘ
Indevus Pharmaceuticals, Inc. -http://www.interneuron.com/
2007.4.18 Valera Pharmaceuticals, Inc.を買収。
2009.3.23 Endo Pharmaceuticalsに買収された。
●決算(決算期９月)
| ($ 000) | 2008 | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 備考 |
|
| 収入 |
| 製品収入 | 32,642 | 25,033 | 26,738 | 14,269 | 9,740 | 4,316 | 3,439 | 1,952 | - | *Sarafem分 |
| うちSANCTURA | | 4,100 | 14,975 | 5,839 | | | | | | [trospium Cl]過活動膀胱;Allerganへの売上 |
| うちDELATESTRYL | | | 2,709 | | | | | | | [testosterone enanthate]Hypogonadism(性腺機能低下症) |
| 契約・ライセンス | 45,149 | 41,034 | 23,714 | 19,067 | 8,986 | 929 | 968 | 13,281 | 27,754 | |
| うちSANCTURA | 42,317 | 19,939 | 7,734 | 6,742 | | | | | | [trospium Cl]過活動膀胱 |
| うちSarafem Lilly収入 | | | 1,318 | 1,687 | | | | | | [fluoxetine]PDD(月経前不安障害) |
| 総収入 計 | 77,791 | 66,067 | 50,452 | 33,336 | 18,726 | 5,245 | 4,407 | 15,233 | 27,754 | |
| 営業利益 | (59,109) | (101,595) | (48,452) | (47,837) | (64,443) | (31,399) | (18,030) | 7,655 | 16,506 | |
| 純利益 | (65,551) | (103,826) | (50,554) | (53,218) | (68,212) | (31,812) | (17,586) | (1,491) | 19,956 | |
|
| 研究開発費 | 24,964 | 41,927 | 43,203 | 30,597 | 23,303 | 24,466 | | | | |
| 取得研究開発費 | - | 50,000 | - | - | - | | | | | x |
| 従業員数 | 246 | | 158 | | | 27 | | | | |
|
| | | | | | | | | | x |
●製品
| 薬剤名 | 薬効 | 段階 | 備考 |
| SANCTURA™(trospium Cl) | 過活動膀胱 | ＠米発売2004.8.23 | Madausから米国ライセンス,1999.11。米国市場規模(2006)$1.5 billion |
| VANTAS(R)(histrelin) | 前立腺癌 | 米発売2004.11 | 12-month hydrogel implant LHRH agonist |
| DELATESTRYL(R)(testosterone enanthate) | Hypogonadism(性腺機能低下症) | 発売 | 米国市場規模(2005)$490 million |
| SANCTURA(R) XR(trospium chloride) | 過活動膀胱 | 申請2006.10.12 | |
| SUPPRELIN(R) LA(histrelin) | Central precocious puberty(CPP) | 発売/米国承認2006.6 | １２ヵ月長期持続性 |
| VALSTAR(R)(valrubicin) | Bladder cancer | 承認1998.9.25
再申請2007.4.19
Approvable Letter 2007.8.17 | 2000年に市場回収していたのを再申請 |
| NEBIDO(R)(３ヵ月持続testosterone) | Hypogonadism | P3 | Schering AGから米国開発販売権をライセンス;EU発売2005.7;米国市場規模(2005)$490 million |
| PRO 2000() | HIV/STD予防 | P3 | Paligent, Inc.(旧HeavenlyDoor.com and Procept, Inc.)から全世界ライセンス,2000.6。 |
| Octreotide Implant | Acromegaly | P2 | |
| Ureteral Stent | 腎臓結石 | P2 | |
| Sarafem®(fluoxetine) | PDD(月経前不安障害) | 発売 | Lillyに全世界サブライセンス,1997.6。 Galen Holdings PLCは2003.1にSarafemの販売権をLillyから取得。 |
| Pagoclone | 不安症
Stuttering | P3
P2 | Aventisから全世界ライセンス,1994.2。 1999.12,Pfizerに全世界販売権を許諾。 |
| ALKS 27 | COPD | P2 | Alkermesと共同開発 |
| IP 751 | 消炎鎮痛 | P1完了 | 2002.6,Manhattan Pharmaceuticals, Inc.(旧Atlantic Technology Ventures, Inc.)から全世界ライセンス |
| Naltrexone Implant | 薬物依存 | P1完了 | |
| Aminocandin | 重篤な真菌症 | P1完了 | Aventisから全世界ライセンス,2003.4。2006.12.5全世界ライセンスをNovexel SAにライセンスアウト |
| Hydron Implant Technology | | P1 | |
| Citicoline | 脳卒中 | P3 | Ferrer Internacional, S.Aから,米国・カナダ,1993.1。元はMITがFerrerにライセンス。 1998.6,脳卒中に関してIndevusがFerrerに米加を除く全世界ライセンス。 1999.12武田薬工に米加販売権を許諾。 |
| | | |
- http://www.indevus.com/; (NASD: IDEV)
●Products|
SANCTURA® - www.sanctura.com(trospium chloride) - SANCTURA Product Label Information[pdf]
SANCTURA XR™(trospium chloride extended release capsules) - www.sancturaxr.com - Full prescribing information
VANTAS®(histrelin implant)前立腺癌 - www.vantasimplant.com - Full prescribing information
DELATESTRYL®(testosterone enanthate)男性性腺機能低下症
SUPPRELIN® LA(histrelin mplant)中枢性思春期早発症 - www.supprelinla.com - Full prescribing information
VALSTAR™(valrubicin)膀胱癌 - www.valstarsolution.com - Full prescribing information
NEBIDO®(estosterone)男性性腺機能低下症
-
■Investors
●SEC Filings
10-K Annual Filings[2009.12.19] - [pdf]
10-K Annual Filings[2008.12.11] - [pdf]
●News|
August 26, 2004★New Data Presented at International Continence Society Show SANCTURATM Improves All Classic Symptoms of Overactive Bladder and is Well Tolerated by Hepatically Impaired Subjects
August 26, 2004★Data on SANCTURATM Show Treated Patients do not Experience Daytime Sleepiness
August 23, 2004★SANCTURATM Launched for Overactive Bladder★OAB患者数は米国で33 millionと多いが、従来治療法は効果も乏しく、患者側も病気として医師にかかる率が少ない。 両社のSR(sales representatives)は480人で、全国35,000薬局での供給体制を整えている。
August 16, 2004★Indevus Pharmaceuticals, Inc. Announces Third Quarter Fiscal 2004 Results
August 12, 2004★Indevus to Release Third Quarter Fiscal 2004 Results and Hold Conference Call on August 16, 2004, 10 A.M. Eastern Time
August 11, 2004★Indevus and Odyssey Announce Initiation of U.S. Distribution of SANCTURATM★OAB市場規模は、$1.13 billion(2003)
July 29, 2004★Indevus Announces Favorable Results of Long-term Use of SANCTURATM
July 1, 2004★Indevus Pharmaceuticals Authorizes Stock Repurchase of up to 2,500,000 Shares
June 9, 2004★Indevus Announces Favorable Results of Phase I Clinical Trial of Aminocandin for Systemic Fungal Infections
June 2, 2004★Indevus Receives $120 Million Milestone Payment from PLIVA for FDA Approval of SANCTURATM
May 28, 2004★Indevus Announces FDA Approval Of SANCTURA™
Investor Conference Call Planned for May 28, 2004, 1 P.M. Eastern Time
May 11, 2004★Indevus Pharmaceuticals Announces Second Quarter Fiscal 2004 Results
April 7, 2004★Indevus And Pliva Sign Co-Promotion And Licensing Agreement For SANCTURA� (Trospium Chloride)
February 25, 2004★Indevus Initiates Phase I Clinical Trial of Aminocandin for Systemic Fungal Infections
February 13, 2004★Indevus Pharmaceuticals Announces First Quarter Fiscal 2004 Results
February 12, 2004★Indevus To Release First Quarter Fiscal 2004 Financial Results And Hold Conference Call On February 13, 2004, 9 a.m. EST
December 18, 2003★Indevus Pharmaceuticals Announces Fiscal 2003 Year End And Fourth Quarter Results
November 21, 2003★Incara and Indevus Outlicense Bucindolol Interest for Development
November 14, 2003★Indevus Added to Nasdaq Biotechnology Index
October 14, 2003★Early Patient Response Predicts Long-Term Sucess of Therapy with Indevus' Trospium For Overactive Bladder
October 9, 2003★Presentations at International Continence Society Highlight Onset of Action, Urodynamic Data with Trospium, Under Development by Indevus for Overactive Bladder
October 7, 2003★Indevus' Trospium Shown to Reduce Urgency Severity Among Patients with Overactive Bladder
－http://www.valerapharma.com/
2007.4.18 Indevus Pharmaceuticals, Inc.はValera Pharmaceuticals, Inc.を買収。
Valera Pharmaceuticals (VLRX) Acquires Rights To VALSTAR [2006.4.3]
- VALSTARは既に2002年半ばに市場から姿を消し、FDA's Drug Shortage Programにリスト
されていた。
●Valera Press Releases
■VALSTAR (valrubicin )
Paladin Acquires the Canadian Distribution Rights for Valstar^(TM) from Anthra Pharmaceuticals, Inc.[1999.6.11]
- 2002Q2 Anthra社から生産中止連絡。
- http://www.inotech.ch/index.php?en_home
1980年創立
- http://www.inotech.ch/index.php?en_home
●NEWS
●About us
Morbus Morquio
- http://www.ikaria.com/home.htm
創立 2005 by Arch Venture Partners, the Fred Hutchinson Cancer Research Center (FHCRC)
and Mark Roth, Ph.D., a member of the center’s Basic Sciences Division,
to commercial research conducted in Dr. Roth’s laboratory at the FHCRC.
IKARIA\INVESTOR GROUP TO AQCUIRE INO THERAPEUTICS[2007.4]
- Ikaria Holdings, a newly formed investment company, has announced the signing of
a definitive agreement to combine Ikaria Inc., a biotechnology company, and
INO Therapeutics, the world leader in gaseous drugs including inhaled nitric oxide
for treatment of hypoxic respiratory failure in newborns.
●Press Releases
IKARIA AND INVESTOR GROUP CLOSE TRANSACTION TO ACQUIRE INO THERAPEUTICS FROM LINDE IN
$670 MILLION CASH AND STOCK MERGER, CREATING A WORLD LEADER IN CRITICAL CARE THERAPEUTICS[2007.3.28]
●Investors
- http://www.inotherapeutics.com/home.htm
●Products
★INOmax(R) (nitric oxide) for inhalation
●Research & Development
●Medical Information
●News
IKARIA AND INVESTOR GROUP CLOSE TRANSACTION TO ACQUIRE INO THERAPEUTICS[2007.3.28]
●関連データ
日本における PPHN の NO 吸入療法
米国FDA は1999 年12 月にNO ガスを医薬品として承認しているが、2000 年には早くも米国小児科学会がNO 吸入療
法実施における指針を公表している。欧州でも2000年１月に吸入用NOガスの販売許可申請が欧州医薬品庁に対し
てなされ、同年８月に異例のスピードで承認されている。一方、我が国の動向として注目すべきは、2000 年11 月
の「日刊薬業」に掲載されたように、「エア・ウォーターと住友精化はINO Therapeutics 社とライセンス契約を結
び、日本国内でのNOガスの医薬品化と輸入・製造ならびに販売を行うと発表。米国および我が国での臨床試験成
績を利用した、ブリッジングコンセプトに基づいた承認申請への動きとなった」ことである。さらに、同じ「日刊
薬業」2002年７月８日付けの記事には、「厚生労働省の薬事・食品衛生審議会医薬品第一部会では、アイノセラピュ
ウティックス社の「一酸化窒素」を希少疾病用医薬品として指定することを決めた。肺高血圧症における低酸素性
呼吸不全の改善（新生児に限る）が効能・効果。推定患者数は年間1600 ～ 1700 人で、今後承認されればこの分野
で初めての医薬品となる」とある。その後、NO 供給装置であるINOvent が我が国で未使用であるとの判断から、
現在、INOmax およびINOvent の両者を使用しての臨床試験が限られた施設で実施されている。本臨床試験の終了
を待って再度申請がなされ、2005年度中には我が国でも承認されることが期待されるが、現時点で広く臨床の現場
で研究目的として汎用されている現状を鑑みるに、一日でも早い承認が、今後、臨床現場での安全な使用を保障す
るためにも不可欠である。
- http://www.insitevision.com/ ;
1987年設立。 眼科専門。 65 Atlantic Avenue,Alameda, CA 94501
Telephone: 510.865.8800 Fax: 510.865.5700
DuraSiteというDDR技術を持つ。
子会社：Azithromycin Royalty Sub LLC,
●会社決算
| ($ 000) | 2007 | 2006 | 2005 | 2004 | 2003 |
| 総収入 | 23,761 | 2 | 4 | 542 | 134 |
| 当期純利益 | 5,535 | (16,611) | (15,215) | (5,514) | (6,751) |
| 研究開発費 | 11,384 | 8,890 | 10,690 | 6,788 | 4,007 |
| 従業員数[連結] | 45 | | | | |
| | | | | |
●[Ophthalmic Anti-Infective Market](2007)
We have concentrated most recently on the need for differentiated topical anti-infectives. In the ocular market we have concentrated on eye and eye-lid infections. Today, eye infections are treated with antibiotics as well as antibiotic/corticosteroid combination products. This ocular anti-infective market represented global sales of $1.5 billion in 2006 according to Navigant Consulting IMS-based data. The market is comprised of two separate product segments: Ocular antibiotic products and Ocular antibiotic/corticosteroid combination products.
★Otic Anti-Infective Market
Direct application of a topical anti-infective to the site of an infection will be an improvement over systemic dosing if an appropriate biocompatible vehicle can deliver high concentrations of drug to infected sites and sustain the release of the antibiotic to minimize dosing frequency. Therefore we are expanding our azithromycin-DuraSite platform outside of ocular anti-infectives to those markets where azithromycin has proven itself as an effective systemic drug agent, but a topical azithromycin format has been unavailable.
For our first opportunity outside of the ocular market space, we are focusing on ear infections. According to Hygea Strategies 2007 IMS-based data, the topical otological drugs category is valued at approximately $600 million globally, with the U.S. accounting for 67% of this market.
The worldwide otological market is fragmented. Companies engaged in the otic market include Alcon Laboratories, Inc., Daiichi Sankyo Co. Ltd., and Monarch Pharmaceuticals Inc. In the U.S., Alcon’s Ciprodex, which requires a total of 56 drops per ear infection therapy, is approximately 9% of the U.S. market and neomycin/steroid combination, which requires approximately 200 drops, is approximately 18%, while in Japan Daiichi Sankyo’s Floxin, which requires approximately 100 drops per therapy, is 29% of the market and in Italy the neomycin/steroid combination is more than 60%. Ciprodex and Floxin are not yet widely approved in international markets.
●Product Pipeline
★AzaSite
★パイプライン
| 製品 | 組成 | 適応 | 段階 | 備考 |
| AzaSite Plus (ISV-502) | 1.0% azithromycinと0.1% dexamethasone配合剤 | 細菌感染と炎症によるBlepharitis(眼瞼炎)等 | P3 | |
| AzaSite Xtra (ISV-405) | | 眼科感染症 | 前臨床 | |
| AzaSite Otic (ISV-016) | | 耳鼻科感染症 | 前臨床 | |
●DuraSite Core Technology
●Ophthalmic Diseases
●Press Releases
■Investors
●SEC Filing
10-K Annual Filings[2008.3.17] - [pdf] - [xls] - [word]
●Annual Reports
InSite Vision Initiates Pivotal Phase 3 Trials for AzaSite Plus(TM)[2007.12.20]
InSite Vision Announces U.S. Launch of AzaSite(TM) for Ocular Infections[2007.8.13]
InSite Vision Announces FDA Approval for AzaSite(TM) Approval Triggers $19 Million Milestone Payment[2007.4.30]
InSite Vision Announces License Agreement With Inspire Pharmaceuticals[2007.2.16]
- AzaSite(TM) (1% azithromycin)を米国・カナダに関してライセンス
InSite Vision Announces Patent Agreement With Pfizer[2007.2.15]
- Pfizer社の特許"Method of Treating Eye Infections with Azithromycin"の全世界独占実施権についてのライセンス契約
InSite Vision Announces Submission of AzaSite(TM) NDA[2006.6.29]
- AzaSite(TM)をNDA申請。
InSite Vision Announces the Issuance of an Additional US Patent on Azalide Ophthalmic Products[2006.6.7]
- azalide drug products 関連特許を追加発行した。
InSite Vision Signs Commercial Supply Agreement for Active Drug in AzaSite[2005.5.18]
- http://www.insmed.com/
2000.6 NASDAQ上場-INSM
2000.6 Celtrixを買収。
★子会社
Insmed Therapeutic Proteins, Insmed Pharmaceuticals, Inc.
and Celtrix Pharmaceuticals, Inc. (“Celtrix”).
●会社決算 12月
| ($ 000) | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 備考 |
| 販売高 | 423 | 263
旧834 | - | - | | | | Iplex |
| ロイヤリティ | 121 | 157 | 131 | 137 | | | |
| ライセンス | 1,607 | - | - | - | - | - | - | (2007)Napa社INSM-18 $1.5m |
| 他の拡張アクセスプログラム | 5,378 | 571 | - | - | - | - | - | IPLEX-ALS(伊政府) |
| 収入 計 | 7,529 | 991 | 131 | 137 | 150 | 1,955 | |
| 原価経費 |
| 研究開発費 | 18,937 | 21,089
旧18,077 | 21,835
旧7,140 | 23,320 | 7,140 | 18,077 | |
| 一般管理費 | 8,455 | 25,682 | 5,730 | 4,242 | 3,477 | 2,984 | |
| restructuring | - | - | - | - | - | 2,533 | |
| Goodwill impairment | - | - | - | - | - | 15,385 | |
| 計 | 27,968 | 55,364 | 27,565 | 27,502 | 10,736 | 38,979 | |
| 営業損失 | (20,439) | (54,373) | (27,434) | (27,365) | (10,586) | (37,024) | |
| 純損失 | (19,962) | (56,139) | (40,929) | (27,203) | (10,298) | (36,417) | |
| 従業員数 | 94 | | | | | | | |
| | | | | | | | |
|
★開発品目
mecasermin rinfabate(rhIGF-I/rhIGFBP-3)は別記
HIV-Associated Lipodystrophy P2開始(2005.4.20)
Type A Extreme Insulin Resistance P2開始(2005.4.26)
rhIGFBP-3 腫瘍領域でP1/前臨床
Masoprocal(INSM-18) 2005年に臨床試験開始予定
2007.1.5 NAPO Pharmaceuticalsに開発権をライセンス
(diabetes, cardiac disease, vascular disease, metabolic disease and Syndrome X)
| ★mecasermin rinfabate(IPLEX) 成長障害
a recombinant complex of insulin-like growth factor-I (rhIGF-I) and binding pro
tein-3 (rhIGFBP-3) [insulin-like growth factor-I/insulin-like growth factor bind
ing protein-3, rhIGF-I/rhIGFBP-3, SomatoKine],
Celtrix社が創製。 同社をInsmed Pharmaceuticalsが2000.6.1に買収。
Insmed社と英国Avecia社がmecasermin rinfabateとその構成成分のrhIGF-I,rhIGFBP-3を
製造する契約。
2004.4 Insmed社は、Baxter社のSomatoKine製造設備のリース契約。
本物質は、当初ウェルファイドにライセンスされ、現在田辺三菱製薬に。
FDAにはまずonce-daily IGF-I therapy for the treatment of growth hormone insensit
ivity syndrome (GHIS).として申請中
IGF-1 Therapyの対象患者数は米国で２０万人。
rhIGF-I/rhIGFBP-3 2005年 GHISでP3開始。
(商品名iPlex(TM))2005.1.3 FDA申請,2005.4.13 FDAが優先審査を許諾。
2005.9.25 SomatoKineから国際ブランドiPlexに商品名変更
同時に 申請適応症をGrowth Hormone Insensitivity Syndrome (GHIS)から
for the treatment of children with growth failure who suffer from Severe Prima
ry IGF-1 deficiency (Primary IGFD)に変更。 FDAからApprovable Letterを受領/2005.9.27。
追加要求データはChemistry, Manufacturing and Controls (CMC) sectionのみ。
FDA承認2005.12.12(重症Primary IGFD)～初の１日１回療法剤。 米国発売2006.5.25
EMEA申請2006.7.5(Primary IGFD)
Insmed Provides Update on IPLEX(TM) Programs[2008.7.21]
[適応追加]myotonic muscular dystrophy[MMD] ; P2(2007.12開始)
～MMD市場評価を発表[2008.1.22]
筋緊張性筋ジストロフィー,筋強直性筋ジストロフィー
[適応追加]HIV Associated Adipose Redistribution Syndrome (HARS)/HIVに伴う脂肪再分布症候群
[適応追加]amyotrophic lateral sclerosis (ALS) ;InsmedがALS全世界権利を保持[2008.11.10] /筋萎縮性側索硬化症
- Ipsen/Tercica との協議の結果、Royalty-freeにて権利獲得。
[適応追加]Retinopathy of Prematurity (ROP) ;P1[2008.9.23 Premacure ABと共同]
尚本剤に関してTercica and Genentech が2004.12.23 特許侵害で提訴。
Tercica and GenentechとのIPLEX特許係争決着[2007.3.5]により、Insmedは米国販売中止、
EMEA申請取り下げ。但し適応開発は継続。
【2007】
Our proprietary protein product, IPLEX (mecasermin rinfabate, recombinant DNA origin, injection), which is a complex of recombinant human IGF-1 and its binding protein IGFBP-3 (rhIGF-1/rhIGFBP-3), is being studied as a treatment for several serious medical conditions.
IPLEX is typically administered as a once-daily subcutaneous injection, which can restore and maintain IGF-1 at physiologically relevant levels. The binding protein, rhIGFBP-3, extends the residence time of IGF-1 in the blood. In the bound state, we believe IGF-1 is inactive and remains so until delivered to target tissues in the body where it is released and becomes biologically active.
Following an external review of the markets for the various indications which could be served by IPLEX^(TM) we have prioritized our targets and have selected MMD as our initial primary indication for IPLEX^(TM). We are also evaluating IPLEX^(TM) as a treatment for ALS in Italy as part of our EAP. Other areas where IPLEX^(TM) has also shown potential such as HIV-associated Adipose Redistribution Syndrome (“HARS”), , and Retinopathy of Prematurity (“ROP”) will be considered in the future when our primary indications have been fully pursued.
Development of IPLEX in Myotonic Muscular Dystrophy
MMD is the most common type of adult muscular dystrophy and affects approximately 1 in 8,000 individuals. MMD causes progressive muscle wasting and weakness in the hands, forearms, legs, neck and face. It often involves many other systemic effects, including endocrine abnormalities, neurological changes, cataracts, gastrointestinal problems, and cardiac rhythm abnormalities. In extreme cases, these patients can eventually become totally disabled, dying usually from respiratory or cardiac failure. At present, there is no treatment to reverse most of these symptoms. Previous preclinical and clinical studies have demonstrated that IGF-1 therapy may be an effective treatment for MMD.
Based on information published by the Muscular Dystrophy Association (the “MDA”), we believe that there are approximately 40,000 patients that suffer from MMD in the United States. At present, there is no approved treatment for this disease.
Ongoing Clinical Study
A Phase III enabling clinical trial investigating IPLEX as a treatment for MMD has been initiated, with the help of a $2.1 million grant from the MDA. This expanded Phase II program is a 24 week, 60 patient, placebo controlled trial using a dose of 1.0 mg/kg/day of IPLEX. This study is ongoing and is evaluating the effects of IPLEX on endurance, cognitive function, GI function, muscle function, lean body mass and insulin sensitivity. A final report is expected in 2009.
Expanded Access Program for Patients in Italy with ALS
ALS is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord. Motor neurons reach from the brain to the spinal cord and from the spinal cord to the muscles throughout the body. The progressive degeneration of the motor neurons in ALS eventually leads to their death. When the motor neurons die, the ability of the brain to initiate and control muscle movement is lost. With voluntary muscle action progressively affected, patients in the later stages of the disease may become totally paralyzed. Yet, through it all, for the vast majority of people, their minds remain unaffected.
At the request of the Italian Ministry of Health, we established an Expanded Access Program in Italy to provide IPLEX to physicians for use in their patients with ALS. The request came as a result of several Italian Court rulings ordering the Italian National Health System to provide IPLEX to specific ALS patients who have petitioned the Court. Through an agreement with Cephalon, which holds patent rights in the European Union to IGF-1 as it relates to the treatment of ALS, we are able to provide IPLEX to physicians in Italy and receive payment for the drug, on a cost recovery basis, from the Italian Health Authorities. We plan to evaluate the patient outcomes to determine if a clinical trial is warranted. There are an estimated 1,000 new cases of ALS per year in Italy.
IPLEX and Short-Stature Market
In the past, we were focused on development and commercialization of IPLEX for the treatment of growth failure in children with severe primary IGF-1 deficiency. IPLEX was approved by the FDA for treatment of severe primary IGF-1 deficiency in December 2005 and was commercially launched in the second quarter of 2006. As a result of our recent settlement agreement with Tercica, Inc. and Genentech, Inc., discussed below, we have withdrawn IPLEX from this market.
Settlement of Litigation with Tercica and Genentech
In December 2004, Tercica and Genentech filed patent infringement suits against us in the U.S. District Court for the Northern District of California and in the United Kingdom at the High Court of Justice, Chancery Division, Patents Court. In these cases, Tercica and Genentech alleged that production and use of IPLEX infringed claims in certain U.S. and European patents, owned by Genentech and licensed to Tercica, directed to methods of using rhIGF-1/rhIGFBP-3 and methods of producing rhIGF-1 and IGFBP-3. In June 2006, Tercica also filed an unfair competition suit against us in the U.S. District Court of the Eastern District of Virginia, claiming that we disseminated misleading statements to the market in connection with our marketing of IPLEX.
On December 6, 2006, a jury in the U.S. District Court for the Northern District of California found that we infringed patents held by Tercica and Genentech and awarded damages of $7.5 million as an upfront payment and a royalty of 15% on past sales of IPLEX below $100 million and 20% for past sales of IPLEX above $100 million.
On March 5, 2007, we reached a settlement agreement ending all litigation with Tercica and Genentech. Pursuant to the agreement, we agreed to cease sales and marketing of IPLEX in the United States and agreed to withdraw our European Marketing Authorization Application for IPLEX. We will continue to provide IPLEX to named patients with ALS in Italy under our Expanded Access Program. The agreement also gives us the right, through a worldwide development partnership with Tercica and Genentech, to market IPLEX for conditions not related to short-stature. These indications include severe insulin resistance, MMD and HARS, among others. The development partnership includes provisions that give us a 50% share of profits and reimbursement for 50% of development costs if either Tercica or Genentech exercises opt-in rights for marketing of IPLEX in any of these new indications that we develop. In addition, as part of the settlement agreement, Tercica and Genentech waived the damages awarded by the jury in the patent infringement suit from the U.S. District Court for the Northern District of California.
COMPETITION
In the proprietary protein area, we are aware of several pharmaceutical companies that are developing drugs in various forms of muscular dystrophy including PTC Therapeutics, Asklepios Biopharmaceutical Inc., Wyeth and Schering-Plough/Key Pharmaceutical, AVI Biopharma, Cephalon and Transgene, however, we believe that IPLEX is the only drug that is in development for the treatment of MMD. We are also aware that rhIGF-1 has been shown in a small clinical study to have positive effects in patients with MMD and that Nifendipine, Coenzyme Q10, DHEA-S and low dose Metformin have all been investigated for the treatment of MMD, however we are unaware of any formal development programs to pursue this indication for these drugs. from INSMED 10-K annual report[2008.3.12] |
Mecasermin rinfabate: insulin-like growth factor-I/insulin-like growth factor
binding protein-3, mecaserimin rinfibate, rhIGF-I/rhIGFBP-3.
Drugs R D. 2005;6(2):120-7. Review.
PMID: 15777106 [PubMed - indexed for MEDLINE]
■Investors Relations
●Press Releases
Insmed Announces Restructure, Settlement Ending IPLEX(TM) Patent Dispute[2007.3.7]
- Insmed, Inc.はGenentech, Inc. and Tercica, Incとの間で、IPLEXの米国販売中止
とEMEA申請取り下げの合意に達した。
Insmed Patent Litigation Verdict Announced[2006.12.6]
- 米国地裁Northern District of California支部で、Genentech, Inc. and Tercica, Inc
により提訴された特許係争で、 Insmed, Inc.および子会社Insmed Therapeutic Proteins, Inc.
and Celtrix Pharmaceuticals, Incに対して次の条件の支払い判決を下した。
$7.5 million as an upfront payment and a royalty of 15% on sales of IPLEX below
$100 million and 20% on sales above $100 million
●SEC Filings
10-K Annual Report[2008.3.12] - [pdf]
10-K Annual Report[2007.3.16] - [pdf]
10-K Annual Report[2006.3.09] - [pdf]
10-K Annual Report[2005.3.16] - [pdf,97p]
●Product Pipeline
●Insmed Therapeutic Proteins
- http://www.inspirepharm.com/
1993 設立。 University of North Carolina (UNC)の技術をベース
最初の製品がElestat(アレルギー性結膜炎薬) and Restasis(ドライアイ)
2003 直接販売(MR 64名)。
●決算
| ($ 000) | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999 |
| 売上高 | 48,665 | 37,059 | 23,266 | 11,068 | 5,200 | 4,883 | 7,285 | 5,368 | 1,104 |
| ～製品売上高(Azasite) | 3,142 | - | - | | | | | | |
| ～共販収入Elestat | 21,01 | 20,284 | 16,790 | 9,600 | | | | | |
| ～共販収入Restasis | 24,442 | 15,525 | 6,476 | 1,500 | | | | | |
| ～共同開発収入 | - | 1,250 | - | | | | | | |
| 営業利益 | (65,877) | (46,623) | (35,527) | (45,519) | (32,271) | (25,497) | (26,790) | (14,716) | (9,001) |
| 当期純利益 | (63,740) | (42,115) | (31,847) | (44,069) | (31,395) | (24,693) | (23,135) | (13,990) | (8,934) |
| 研究開発費 | 53,391 | 42,537 | 23,566 | 25,698 | 27,631 | 25,229 | 28,193 | 16,354 | 7,694 |
| Cost of sales | 1,622 | - | - | - | - | - | | | |
| 販売費用 | 45,543 | 25,265 | 23,223 | 21,848 | 2,838 | 60 | 124 | - | - |
| 一般管理費 | 13,986 | 15,880 | 12,004 | 9,041 | 7,002 | 5,091 | 5,758 | 3,730 | 2,411 |
| 営業費用 計 | 114,542 | 83,682 | 58,793 | 56,587 | 37,471 | 30,380 | 34,075 | 20,084 | 10,105 |
| 従業員数[連結] | 250 | 170 | | 150 | | | | | |
| | | | | | | | | |
●Competition
★Allergic Conjunctivitis.(2007)
Allergic Conjunctivitis. There are multiple therapies available to treat or prevent allergic conjunctivitis. The primary products that Elestat competes with are Patanol(R) and Pataday(TM), both by Alcon, Inc.; Zaditor(R) by Novartis and its related generic; and Optivar(R) by Meda Pharmaceuticals. Patanol currently has the majority of the prescriptions in the allergic conjunctivitis market.
★Allergic Conjunctivitis.(2006)
There are multiple therapies available to treat or prevent allergic conjunctivitis. The primary products that Elestat competes with are Patanol(R) and Pataday(R), both by Alcon, Inc.; Zaditor(R) by Novartis and its related generic; and Optivar(R) by MedPointe Pharmaceuticals. Patanol currently has the majority of the prescriptions in the allergic conjunctivitis market.
For the year ended December 31, 2006, Elestat was the second most prescribed allergic conjunctivitis product in the United States, based upon prescription volume data as reported by IMS Health, and in our target universe, the top 200 highest prescribing ophthalmologists, optometrists, and allergists in each of our 64 sales territories. Based upon weekly national prescription data from IMS Health, Elestat had a market share of approximately 19% for total prescription volume in our target universe for the three and twelve months ended December 31, 2006, as compared to 19% and 17%, for the three and twelve months ended December 31, 2005, respectively. Based upon weekly data from IMS Health, the total U.S. allergic conjunctivitis market, in terms of prescriptions, increased approximately 5% and approximately 6% for the years ended December 31, 2006, and 2005, respectively, compared to the previous year. For the year ended December 31, 2006, Elestat represented approximately 10% of the total U.S. allergic conjunctivitis market, as compared to approximately 8% in 2005 and approximately 4% in 2004. Based on current trends in prescriptions for Elestat, we expect no market share growth or declining market share in future periods, unless we expand our commercial rights to Elestat.
★Allergic Rhinitis.(2007)
The current prescription nasal treatments for allergic rhinitis include Flonase(R), Beconase AQ(R), and Veramyst(TM), all by GlaxoSmithKline; Nasonex(R), by Schering-Plough; Nasacort AQ(R), by Sanofi-Aventis; Rhinocort Aqua(R), by AstraZeneca; Astelin(R), by Meda Pharmaceuticals; and OmnarisTM, by Nycomed. In addition, Alcon has submitted an amendment to their pending NDA for Patanase(R) for the treatment of symptoms of seasonal allergic rhinitis.
★Bacterial Conjunctivitis.(2007)
The current prescription ocular anti-infective treatments for bacterial conjunctivitis that compete with AzaSite include Vigamox(R) and Ciloxan(R), both by Alcon; Zymar(R) and Ocuflox(R), both by Allergan; Quixin(R) and Iquix(R), both by Vistakon Pharmaceuticals, LLC (single-entity); Zylet(R) by Bausch & Lomb, Inc.; and TobraDex(R) by Alcon (combination products). In addition, there are several generics used to treat bacterial conjunctivitis which include erythromycin, gentamycin and tobramycin.
★Cystic Fibrosis.(2007)
There are two products approved in the United States specifically for the treatment of complications of cystic fibrosis lung disease: Pulmozyme(R), by Genentech, Inc., an agent designed to break up thickened airway secretions, and TOBI(R), by Novartis, an inhaled antibiotic. Academic groups have completed at least one clinical trial that demonstrated clinical benefit of hypertonic saline. At least one clinical trial has been completed that demonstrated clinical benefit with Zithromax(R), by Pfizer, Inc., an oral antibiotic. Although Zithromax has not been officially approved by the FDA for use in cystic fibrosis, in some cases, it has been added to the treatment regimen in patients with evidence of airway infection. In addition, Gilead Sciences, Inc. has submitted an NDA for aztreonam lysine for inhalation, an antibiotic therapy for cystic fibrosis.
★Cystic Fibrosis.(2006)
There are two products approved in the United States specifically for the treatment of complications of cystic fibrosis lung disease: Pulmozyme(R), by Genentech, Inc., an agent designed to break up thickened airway secretions, and TOBI(R), by Novartis, an inhaled antibiotic. Academic groups have completed at least one clinical trial that demonstrated clinical benefit of hypertonic saline. At least one clinical trial has been completed that demonstrated clinical benefit with Zithromax(R), by Pfizer, Inc., an oral antibiotic. Although Zithromax has not been officially approved by the FDA for use in cystic fibrosis, in some cases, it has been added to the treatment regimen in patients with evidence of airway infection. In addition, Gilead Sciences, Inc. is developing and conducting Phase 3 trials of aztreonam lysine for inhalation, an antibiotic therapy for cystic fibrosis. Pharmaxis is developing and conducting Phase 3 clinical trials of BronchitolTM, an agent designed to increase mucus clearance in cystic fibrosis patients. Vertex Pharmaceuticals is developing and conducting a Phase 1 clinical trial of VX-770, a potentiator compound that may act to restore the function of the cystic fibrosis transmembrane conductance regulator (CFTR) protein. Predix Pharmaceuticals has preclinical programs related to cystic fibrosis but no compounds in clinical development.
★Dry Eye Disease.(2006)
The current prescription and non-prescription treatments for dry eye disease include Restasis by Allergan; artificial tear solutions and lubricant eye drops. In addition to our development program for Prolacria, several other companies are attempting to develop dry eye therapies. Candidates in various phases of clinical development include: rimexolone by Alcon, Inc.; OPC-12759 (rebamipide), by Novartis, licensed from Otsuka Pharmaceuticals; ecabet sodium by ISTA Pharmaceuticals, licensed from Senju; VISMED(R) (sodium hyaluronate) by Lantibio, Inc., licensed from TRB Chemedica; ProGraf/FK-506, by Fujisawa Healthcare, Inc.; pimecrolimus by Novartis; and NP50301 by Nascent Pharmaceuticals; ALTY-0501 (doxycycline 0.05%) by Alacrity Biosciences; and CF101 by Can-Fite BioPharma.
We began co-promotion activities related to Restasis in January 2004 and began receiving co-promotion revenue in April 2004. All of our revenue from Restasis is based on worldwide net sales of Restasis according to the terms of our collaborative agreement with Allergan. However, less than 2% of our co-promotion revenue from Restasis is derived from sales of Restasis outside of the United States. Our entitled percentage of net sales of Restasis increased in April 2006 and the last scheduled increase will occur in April 2007. Co-promotion revenue from Restasis is becoming a larger component of our total co-promotion revenue. For the year ended December 31, 2006, co-promotion revenue from Restasis represented approximately 43% of our total co-promotion revenue compared to approximately 28% in 2005. We expect that this trend will continue in 2007 and future reporting periods. For the year ended December 31, 2006, Allergan recorded approximately $270 million of revenue from net sales of Restasis, as compared to approximately $191 million in 2005 and approximately $100 million in 2004.
Restasis, in terms of prescription volume, has grown significantly since it was first launched in April 2003. Since we began co-promoting Restasis in January 2004, total prescriptions, as reported by IMS Health, have been approximately 2.9 million, 2.1 million and 1.3 million for the twelve months ended December 31, 2006, 2005 and 2004, respectively. This represents year-over-year prescription volume increases of 35% and 64% for the twelve months ended December 31, 2006 and 2005, respectively.
★Glaucoma.(2006)
The current prescription treatments for glaucoma include Xalatan(R), by Pfizer; Alphagan(R) and Lumigan(R), by Allergan; Cosopt(R), by Merck & Co., Inc. and Azopt(R) and Travatan(R) by Alcon.
●AzaSite (2007)
AzaSite (azithromycin ophthalmic solution) 1% is a topical anti-infective, in which azithromycin is formulated into an ophthalmic solution utilizing DuraSite(R), a novel ocular drug delivery system. Azithromycin is a semi-synthetic antibiotic that is derived from erythromycin and since 1992, has been available via oral administration by Pfizer Inc. under the trade name Zithromax(R). In April 2007, AzaSite was approved by the U.S. Food and Drug Administration, or FDA, for the treatment of bacterial conjunctivitis in adults and children one year of age and older. In August 2007, we launched AzaSite in the United States and are promoting it to select eye care professionals, pediatricians and primary care providers. The manufacture and sale of AzaSite is protected in the United States under use and formulation patents which expire in March 2019.
On February 15, 2007, we entered into a license agreement with InSite Vision pursuant to which we acquired exclusive rights to commercialize AzaSite, as well as other potential topical anti-infective products containing azithromycin for use in the treatment of human ocular or ophthalmic indications. The license agreement also grants us exclusive rights to develop, make, use, market, commercialize and sell the products in the United States and Canada and their respective territories. See “―Collaborative Agreements―InSite Vision Incorporated.”
Market Opportunity. The U.S. single-entity ocular antibiotic market was approximately $391 million for the 12 months ended December 31, 2007, according to data compiled from IMS Health. Total prescriptions in the ocular antibiotic market were approximately 14.9 million for the 12 months ended December 31, 2007, up approximately 2% from the prior year according to data compiled from IMS Health.
Market Opportunity. The current ocular antibiotic market is approximately $600 million in annual sales in the United States based on data compiled by IMS Health as of December 31, 2006. This includes approximately $360 million for the single-entity market and approximately $245 million in the combination products market. Total prescriptions in the ocular antibiotic market were approximately 15 million for the twelve months ended December 31, 2006, up 7% from the prior year according to data compiled from IMS Health.
- http://www.inspirepharm.com/
[参天製薬との契約 1998.12]
diquafosol tetrasodium for the therapeutic treatment of ocular surface diseases, such as dry eye disease, in Asia.
対象 Japan, China, South Korea, the Philippines, Thailand, Vietnam, Taiwan, Singapore, Malaysia and Indonesia
対価 (契約時)1998.12 INSPIRE社優先株と交換に$1.5 millionを参天から受領。
2000年にa milestone payment of $500,000 を参天から受領。
2006.3にa milestone payment of $1.25 millionを参天から受領。(参天のP2完了で) P3開始
●Products
Restasis(cyclosporine ophthalmic emulsion) - 2003.4発売、Allerganと共販
Elestat(epinastine HCl ophthalmic solution) - 2004.2発売、Allerganと共販
- 米国では眼アレルギー患者4000万人。その90%にアレルギー性結膜炎が発生。
眼アレルギー薬の米国市場規模は$604 million(IMS data; 2007.6末迄の)
AzaSite(azithromycin ophthalmic solution)
- Inspire licensed AzaSite from InSite Vision Incorporated.
Inspire employs a U.S. sales force for the promotion of AzaSite(TM) for bacterial conjunctivitis.
細菌性結膜炎の従来製剤に比べ60-75%低用量。
眼科用抗生物質製剤市場規模(単味剤)は米国で年間$379 million(IMS data; 2007.6末迄の)
●Pipeline
Prolacria(TM) (diquafosol tetrasodium) for dry eye P3
- 2001.6 Allerganと開発・販売契約。アジアを除く全世界。
Denufosol tetrasodium (INS37217 Respiratory) for cystic fibrosis (CF) P3
-
Epinastine nasal spray for allergic rhinitis P3
- Boehringer Ingelheimと共同
INS115644 for glaucoma P1
- Wisconsin Alumni Research Foundation と共同開発
■Investors Relations
●Financials Data～
●Annual Reports
Annual Report 2006 Editorial Only (956 KB)
Annual Report 2003
●SEC Filings
10-K Annual report[2008.3.14] - [pdf]
10-K Annual report[2007.3.16] - [pdf]
●Press Releases
Inspire Reports Fourth Quarter and Full Year 2007 Financial Results[2008.2.26]
Inspire Reports Fourth Quarter and Full Year 2006 Financial Results[2007.2.27]
Inspire Pharmaceuticals Launches AzaSite(TM) in the United States for Ocular Infections[2007.8.13]
Inspire Announces FDA Approval Of AzaSite(TM)[2007.4.27]
Inspire Licenses AzaSite(TM) For Ocular Infections[2007.2.16]
- InSite Vision Incorporated (AMEX: ISV) から米国・カナダに関する独占販売権を獲得。
本剤はazithromycinのDuraSite(R), InSite Vision's patented drug-delivery vehicle製剤化。
対価はan upfront license fee of $13 million and an additional $19 million milestone payment contingent
upon regulatory approval by the FDA
Inspire Pharmaceuticals Will Hold Conference Call on Recently Announced Collaboration with Allergan to Co-Promote Elestat(TM)[2003.12.8]
Allergan and Inspire Enter Into Collaboration to Co-Promote Elestat(TM) in the U.S.[2003.12.8]
- http://www.intermune.com/wt/home
1998 設立in California (pulmonology and hepatologyに特化) InterMune Pharmaceuticals, Inc.
2000 再設立in Delaware 株式公開
2001.4.26 InterMune, Inc. に社名変更。
●決算[連結]
| ($000) | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 備考 |
|
| 総収入 | 66,692 | 90,784 | 110,496 | 128,680
旧150,987(-2) | 144,862
旧154,138(+38) | 109,034
旧111,965(+180) | 39,183
旧39,951 | 11,201 | 556 | - | |
| Actimmune | 53,420 | 90,317 | 107,633 | 124,980(-12) | 141,402(+34) | 105,802(+191) | 36,320 | 11,201 | 556 | - | (interferon gamma-1b);骨粗鬆症、慢性肉芽腫症 |
| Infergen | - | - | - | 22,307(+141) | 9,276 | 2,931 | 768 | - | - | - | [interferon alfacon-1]慢性C型肝炎 |
| その他 | - | - | 2,863 | 3,700(+7) | 3,470 | 3,232 | 2,863 | - | - | - |
| Collaboration収入 | 13,272 | 467 | - | - | - | - | - | - | - | - | |
| 営業損失 | (106,904) | (114,989) | (61,665) | (36,017)
旧(50,452) | (81,457)
旧(90,988) | (131,904)
旧(141,881) | (114,873)
旧(124,672) | (32,539) | (6,403) | (6,127) |
| 営業損失[継続] | (94,596) | (105,962) | (57,648) | (45,043) | (87,470) | (134,332) | (108,392) | () | () | () | |
| 営業損失[中止] | 4,994 | (1,244) | (32,925) | (14,435) | (9,531) | (9,977) | (9,799) | () | () | () | |
| 純損失 | (89,602) | (107,206) | (5,235) | (59,478) | (97,001) | (144,309) | (118,191) | (24,246) | (6,349) | (6,072) |
| 純損失[中止] | 4,994 | (1,224) | 52,413 | (14,435) | (9,531) | (9,977) | (9,799) | () | () | () | |
|
| 研究開発費 | 105,939 | 103,849 | 82,736 | 75,683
旧81,319 | 118,771
旧119,858 | 128,326
旧129,500 | 49,718
旧52,049 | 20,821 | 2,969 | 1,235 |
| 取得研究開発費 | 13,725 | - | (10,000) | - | 12,150 | | | | | | |
| 従業員数 | | | 193 | 326 | 260 | 250 |
| うち研開発 | | | 115 | 108 | 153 | 106 |
| ★地域セグメント |
| 米国 | 53,321 | 90,185 | 110,017 | 148,594
旧126,288 | 151,373
旧142,109 | 109,537 | | | | | |
| その他 | 13,371 | 599 | 479 | 2,393
旧2,392 | 2,765
旧2,753 | 2,428 | | | | | |
| | | | | | | | | | | |
2005年度Infergen売却に伴う修整数値があるので、(旧)は修正前値。
2005.5 AmphotecをThree Rivers Pharmaceuticals, LLC に売却。
[Actimmune(interferon gamma-1b)]
・米国・カナダ・日本の独占販売権保有(1998年Genentech, Inc.よりライセンスを受けた)
２つの先天異常のFDA認可を受けている。
1990年 CGD=Chronic granulomatous diseaseに伴う重症感染
2000年 severe, malignant osteopetrosis
欧州含む他の地域はBoehringer Ingが独占販売権保有(Imukin)。
当社は2001年B-Iと契約し、B-I社の商品名で共同販売。
[Infergen(R) (interferon alfacon-1)] 成人慢性C型肝炎
・米国とカナダの独占販売権保有(Amgenから2001ライセンス); FDA承認1997
・2002.1 自前の販売員による再発売
・2005.11.28 本製品の一切の権利をValeant Pharmaceuticals Internationalに売却($122.1 million)。
[Amphotec(R) (amphotericin B cholesteryl sulfate complex for injection)] 侵襲性aspergillosis
・Amphotecは、米国外でAmphocilの名称で販売されているが、ALZAから世界全域の権利を取得(2001)。
・amphotericin B関連製品の世界売上高は$350 million (2002&2004)
・Amphotecは当社が2002.1に再発売した。 それ以前の３年間は殆ど販売活動は行われなかった。
・AmphotecはAmphocilの名称で世界４０か国で販売。
・本製品は2003年中に再検討の結果、当社戦略とマッチしないので、当社での積極販売は
行わずに、譲渡するパートナーを探すこととした。
2005.5 AmphotecをThree Rivers Pharmaceuticals, LLC に売却。
- http://www.intermune.com/wt/home
●Products & Pipeline
★Actimmune
★Infergen
★Amphotec
●Investors Relations
★Annual Report
★SEC Filings
Form 10-K[2008.3.14] - [pdf,358p]
Form 10-K[2006.3.13] - [pdf]
Form 10-K[2005.3.16] - [pdf]
Form 10-K[2004.3.12]
Form 10-K[2003.3.31]
●News
- http://www.ipsen.com/home.jsp
IPSENは1929年設立、30製品を販売。110ヶ国4000人。
1929 Laboratoires Beaufourが Dr Henri Beaufourにより設立。
1954 Citrate de Betaine発売
1969 仏にthe Institut Henri Beaufour設立
1978 Beaufour and 独Schwabeは２つの合弁会社を設立。
１)製薬会社(Intersan, Ettlingen,Germany) ２)銀杏エキスEGb 761の製造(Cork, Ireland).
1983 La Fondation Ipsenを設立。
1994 英国Speywood (当時Porton International)を買収
2003.5 Beaufour-Ipsen社はIpsenに社名変更。
*現在 IPSENはBeaufour家が85%を支配するLuxembourg企業Mayroyの傘下にある。
History ; Annual Report 2005[pdf,49p] P5
2005.12時点でMayroyは株式総数の82.1%、議決権のを保有89.5%。
●製品売上高
(Euro million) 2004
Decapeptyl(R) 198.9(+9.8) [triptorelin]前立腺癌、子宮内膜症、子宮筋腫;発売1986仏
Dysport(R) 82.5(+19.7)[botulinum neurotoxin type A complex]
Somatuline(R) 72.1(+21) [lanreotide] 神経内分泌腫瘍、末端肥大症;発売1994仏;帝人P1
その他製品 3.6
管理領域 計 357.1(+14.4%)
Tanakan(R) 116.7 [EGb 761]めまい
Smecta(R) 65.4 [diosmectite]下痢
Ginkor Fort(R) 59.1
その他製品 127.6
プライマリケア計368.8(+4.4%)
その他製品 14.8
医薬原料 29.5
合計売上高 770.2
研究開発費 147.4(+8.2)
●開発中の新薬
| 分野 | 製品 | 段階 | 適応 | 備考 |
| 腫瘍 | Decapeptyl(R) | P3 | Combined hormone therapy for premenopausal breast cancer | |
| Decapeptyl(R) | P2 | Combination therapy to alleviate the side effects of GnRH analogues | |
| Decapeptyl(R) | P2 | Prostate cancer (new formulation: 4 months) | |
| BN 83495 (STX 64) | P1 | Post-menopausal breast cancer, expressing oestrogen receptors | |
| BIM 46187 | 前臨床 | Cytostatic, solid tumours | |
| BN 2629 (SJG-136) | P1 | Advanced metastatic cancers refractory to chemotherapy | |
| Diflomotecan (BN 80915) | P2 | Advanced metastatic cancers: colon, breast and prostate | |
| Elomotecan (BN 80927) | P1 | Metastatic tumours | |
| 内分泌 | Somatuline(R) Autogel(R) | P3 | Acromegaly | |
| Somatuline(R) Autogel(R) | P3 | Neuroendocrine tumours | () |
| Somatuline(R) Autogel(R) | P1 | Acromegaly (new formulation: 3 months) | |
| BIM 51077 | P2 | Type 2 diabetes | |
| NutropinAq(R) | P3 | Idiopathic short stature | (somatropin)Pen; 2002.9 Genentechから |
| NutropinAq(R) | P2 | Prevention of the long-term effects of glucocorticoid treatments | |
| Sustained-release recombinant human growth hormone | 前臨床 | Long-term treatment of growth failure in children or adults | |
| 神経筋疾患 | Dysport(R) | P3 | Cervical dystonia | |
| Botulinum toxin type A | P3 | Aesthetic medicine | |
| Dysport(R) | P2 | Myofacial pain | |
| 認知症 | Tanakan(R) | P3 | Mild cognitive impairment related to age | (EGb 761) |
| 血液 | OBI-1 | P2 | Haemophilia | |
| リウマチ | Febuxostat (TMX-67) | P3 | Symptomatic hyperuricaemia | 帝人提携 |
| | | | |
FROM Annual Report 2005[pdf,49p]p31-32
28-30pに詳細説明。
・2003.7 帝人とIPSENのSomatuline Autogelを含む4製品の開発契約
Agreement between Teijin Limited and Ipsen...[2003.7.7]
The four products from Ipsen are a Glucagon-like peptide-1 analogue (GLP-1, code
name: BIM51077) for which Teijin has been granted co-exclusive rights in Japan,
a type 2-receptor selective somatostatin analogue (SSTR-2) code name: BIM23190
), a parathyroid hormone 1-34 fragment analogue (PTH, code name: BIM44058), and
a sustained-release formulation of a somatostatin analogue (SomatulineR Autogel
R), for which Teijin has been granted exclusive rights in Japan.
帝人株式会社と仏イプセン社とのライセンス契約について[2003.7.7]
●The Group
●Products
●Research & Development
●Partnership
●Media Center
★Annual Report
Annual Report 2005[pdf,49p]
Annual Report 2003[pdf,111p]
Annual Report 2002[pdf,108p]
Annual Report 2001[pdf,45p]
★All press releases
Agreement between Teijin Limited and Ipsen...[2003.7.7]
The four products from Ipsen are a Glucagon-like peptide-1 analogue (GLP-1, code
name: BIM51077) for which Teijin has been granted co-exclusive rights in Japan,
a type 2-receptor selective somatostatin analogue (SSTR-2) code name: BIM23190
), a parathyroid hormone 1-34 fragment analogue (PTH, code name: BIM44058), and
a sustained-release formulation of a somatostatin analogue (SomatulineR Autogel
R), for which Teijin has been granted exclusive rights in Japan.
- http://www.isispharm.com/index.html
設立 1989
世界最大1500以上の製薬系antisense/RNA関連特許資産を持つ。
従業員数 303(2005.3.3)
[Vitravene]
1998.8 FDA承認。
1997年 Novartis Ophthalmics AG[旧Ciba Vision Corporation]に全世界ライセンスを許
諾。同社は1998.11に発売。
2001.12.21迄に $20 Million受領。
エイズ患者のCMV網膜炎の発生率が極めて低いため、限定生産。
2002年度ISISのMilestone収入は$2.5million,2003&2004年度はなし。
但し出荷に伴う収入は$293,000。
●会社決算
($000) 2004 2003 2002 2001 2000
総収入 42,624 49,990 80,179 53,273 37,255
うち研究開発 32,617 49,467 67,820 契約収入
うちLicense 10,007 523 417 /&Royalty
うち系列会社 - - 11,942 からのR&D収入
経費 160,477 128,968 130,992
研究開発費118,474 116,963 124,074 83,741 57,014
営業損失 -117,853 -78,978 -50,813
純損失 -142,864 -95,690 -73,302 -75,131 -54,699
* 2004 Licensing&Royalty収入増($9.5million)中、$5.5millionはAlnylamとの戦略提携
残り$4.0millionはEyetech社のMacugen申請に伴うmilestones収入。
- http://www.isispharm.com/index.html
●Antisense Pipeline
Vitravene
Product Pipeline
●Investor Center
★Financials
★Annual Reports
★SEC Filings
10-K 2004 Annual(2005.3.16) [html] | [pdf,224p] |[word]
★Press Releases
- http://www.istavision.com/; 15295 Alton Parkway, Irvine, CA 92618; NASDAQ=ISTA
1992.02 Advanced Corneal Systemsとして設立
2000.03 ISTA Pharmaceuticals, Incに社名変更
2000.08 NASDAQ上場
2002.05 AcSentient, Inc.を買収。Istalol (Senju)/Xibrom (Senju)も獲得。
千寿製薬、田辺三菱製薬、大塚製薬から製品導入している。
●会社決算
| ($ 000) | 2009 | 2008 | 2007 | 2006 | 2005 | 備考 |
| 売上高 | 110,648 | 83,076 | 58,867 | 33,007 | 10,660 | |
| うち製品売上 | 107,593 | 82,798 | 58,589 | 32,729 | 10,382 | |
| うちライセンス収入 | 3,055 | 278 | 278 | 278 | 278 | |
| 売上原価 | 27,278 | 21,947 | 15,864 | 9,943 | 3,542 | |
| 営業利益 | 2,089 | (24,810) | (36,092) | (38,119) | (40,092) | |
| 当期純利益 | (57,754) | (34,667) | (41,817) | (40,216) | (38,480) | |
| 研究開発費 | 24,904 | 32,400 | 32,492 | 23,826 | 16,611 | |
| 従業員数[連結] | 315 | | | | | |
| | | | | | |
| ($ million) | 2009 | 2008 | 2007 | 2006 | 2005 | 備考 |
| Xibrom | 81.1 | 63.0 | 42.1 | | | [bromfenac点眼液]眼科用抗炎症剤;FDA承認2005.3、発売2005Q2 |
| Istalol | 18.8 | 14.6 | 11.3 | | | [timolol maleate点眼液]緑内障;FDA承認2004.6、発売2004Q3 |
| Vitrase | 5.9 | 5.2 | 5.2 | | | [hyaluronidase注];FDA承認2004.5、発売2005Q1 |
| Bepreve | 1.7 | -- | - | | | [bepotastine besilate点眼液]アレルギー性結膜炎;FDA承認2009.9、発売2009Q4 |
| | | | | | [] |
●個別製品
| ●Bepreve (bepotastine besilate ophthalmic solution) 1.5% |
| 【2009】Bepreve is a twice.daily prescription treatment for ocular itching associated with allergic conjunctivitis in patients two years of age and older. In September 2009, we received approval from the FDA for, and launched, Bepreve in the United States. We promote Bepreve through our own sales force to ophthalmologists, optometrists and allergists.
Bepreve was first approved in Japan for use as a systemic drug in the treatment of allergic rhinitis and urticaria/pruritus in July 2000 and January 2002, respectively, and is marketed by Mitsubishi Tanabe Pharma Corporation (formerly Tanabe Seiyaku Co., Ltd.) under the brand name TALION@� . TALION was co.developed by Tanabe Seiyaku and Ube Industries, Ltd., who discovered the utility of bepotastine. In 2001, Tanabe Seiyaku granted Senju exclusive worldwide rights, with the exception of certain Asian countries, to develop, manufacture and market bepotastine for ophthalmic use. In 2006, we licensed the exclusive North American rights from Senju to an eye drop formulation of bepotastine for the treatment of allergic conjunctivitis. In 2007, we licensed exclusive North American rights to nasal dosage forms of bepotastine from Tanabe Seiyaku and obtained a future right to negotiate for a North American license to oral dosage forms of bepotastine for allergy treatment.
Based upon 2009 data from IMS Health, we estimate that 2009 sales in the U.S. ocular allergy market were approximately $594 million, with total prescriptions of 6.6 million. From 2008 to 2009, the U.S. ocular allergy market grew approximately 6% in total dollars and remained flat in total prescriptions. |
|
| ● |
| 【2009】 |
|
- http://www.istavision.com/
●Products
★BEPREVE (bepotastine besilate ophthalmic solution) 1.5%/アレルギー性結膜炎
★Xibrom(bromfenac ophthalmic solution) 0.09% 眼科用抗炎症剤
★Vitrase (hyaluronidase for injection)
★Istalol(timolol maleate ophthalmic solution) 0.5%/緑内障治療薬
●Pipeline
■Investors
●SEC Filings
10-K Annual report[2010.2.24] - [pdf,95p] - [doc] - [xls]
●News Releases
ISTA Pharmaceuticals Reports Fourth Quarter and Full-Year 2009 Financial Results[2010.2.24]
ISTA Pharmaceuticals Highlights Bepreve(TM) Clinical Data at the 2009 Annual Meeting of the American College of Allergy, Asthma & Immunology (ACAAI)[2009.11.9]
ISTA Pharmaceuticals Highlights Bepreve(TM) Clinical Data at the American College of Clinical Pharmacy (ACCP) 2009 Annual Meeting[2009.10.21]
ISTA Pharmaceuticals' Bepreve(TM) Receives FDA Approval for the Treatment of Ocular Itching Due to Allergies[2009.9.8]
ISTA Pharmaceuticals Files New Drug Application with U.S. FDA for Bepreve(TM)[2008.11.13]
- http://www.ivax.com/jsps/index.jsp ; 本社Miami, Florida
３６カ国で事業展開。８０カ国で製品販売。 医薬品製造販売。
1987年設立。 従業員総数8,700人。
元はGeneric医薬品メーカーで急成長したが、最近は企業買収を含めて研究開発力を
増強し、新薬メーカーへと脱皮しつつある。
IVAX CORP (0000772197)
SIC: 2834 - Pharmaceutical Preparations
(AMEX: IVX, LSE: IVX.L WSE: IVX)
2000 米国・欧州でproprietary productsの販売を開始。
2002.04 3MのQVAR(beclomethasone dipropionate)の米国独占権を取得。
2003.10 3Mの欧州の呼吸器官系薬(Qvar等)事業を買収。欧州9か国の販売要員含む。
2004.12 ポーランド大手製薬会社Polfa SAを買収。
2005.07 TevaがIvaxを買収、基本合意。
●主なPipeline
Xorane(TM) 経口paclitaxel P2
*現在注射剤は販売。米国Onxol、米国外Paxene
Talampanel P2 (適応glioblastoma) AMPA receptor antagonist
*2001.2 Lillyより開発販売権取得。 本薬はIVAX Drug Research Institute(Budapest,Hungary)
により創製され、LillyがP2を実施していた。
etiprednol dicloacetate P2 気管支喘息
経口剤 P2 bronchial asthma, allergic rhinitis and inflammatory diseases of the large intestine
吸入剤 P2 気管支喘息
loteprednol etabonate P2(小児アレルギー鼻炎)
*2003.8 日本・アジア以外の全世界権利取得
HMN-214 抗がん剤
*2004.10 日本新薬とライセンス契約 A polo-like kinase inhibitor that targets
pancreatic, prostate and a number of other cancers
Cladribine P3 多発性硬化症 (経口)
*2002.8 Ares Trading, S.A., an affiliate of Serono, S.Aと全世界ライセンス契約締結。
*本剤は、日本ではロイスタチン注[ヤンセンファーマ]からヘアリーセル白血病、
非ホジキンリンパ腫，マントル細胞リンパ腫の適応症で販売。
●子会社
米国内33社(IVAX Pharmaceuticals等Ivaxを冠した会社の他、Baker Norton U.S.,Incなど)
また海外を含めると100社超。
see Subsidiaries
IVAX Pharmaceuticals Inc. (Formerly Zenith Goldline Pharmaceuticals, Inc. and Goldcaps Inc.)
IVAX Research Inc. (Formerly Baker Norton Pharmaceuticals)
Norton Healthcare Limited
Elvetium S.A.
Galena a.s.
Diamedix Corporation
DVM Pharmaceuticals, Inc.
Baker Norton Asia Ltd.
IVAX Laboratories Inc. (Formerly Wakefield Pharmaceuticals)
Laboratorios Fustery, S.A. DE C.V
●会社決算
| ($ 000) | 2004(1) | 2003(2) | 2002 | 2001(5) | 2000 |
|
| Net revenues | 1,837,418 | 1,420,339 | 1,197,244 | 1,215,377 | 793,405 |
| 粗利益 | 852,293 | 638,956 | 533,536 | 631,789 | 383,502 |
| 営業利益 | 251,867 | 172,578 | 149,727 | 267,889 | 136,732 |
| 経常利益 | 198,027 | 99,047 | 118,595 | 243,263 | 137,515 |
| 中止事業所得(3) - | 22,204 | - | - | - |
| 純利益 | 198,027 | 121,251 | 122,756 | 243,263 | 131,044 |
|
| 研究開発費 | 141,604 | 108,347 | 76,041 | 88,015 | 65,331 |
| | | | | |
(1) 買収企業の実績を含む。
2004.6.2 Corporacion Medco S.A.C. and Botica Torres de Limatambo S.A.C.
2004.12.15 Kutnowskie Zaklady Farmaceutyczne "POLFA" SA (98%)
(2) 買収企業の実績を含む。
2003.1.24 API Industries, Inc.
2003.10.1 a branded respiratory business in Europe
(3) 中止事業(2003)。
特許・製品の権利及びMcGaw,Inc.から B. Braun Melsungen AG.ヘノ当社の販売価格
に関する訴訟[litigation]問題(1997年)
(5) 買収企業の実績を含む。
Includes the post-acquisition results of companies acquired, primarily
2001.7.5 Laboratorio Chile S.A.
2001.3.13 IVAX Scandinavia AB
2001.2.9 IVAX Pharmaceuticals Mexico, S.A. de C.V.
●事業別セグメント
|
During 2007, the Company launched INVEGA(TM)(paliperidone) Extended-Release Tablets, in both the U.S. and Europe. Additionally, in 2007 the Company launched the antibacterial, DORIBAX(TM)(doripenem for injection) in the U.S. and the antiretroviral, PREZISTA(TM) (darunavir), in Europe. The Company submitted five new molecular entities for approval: paliperidone palmitate for schizophrenia in the U.S., ustekinumab, or CNTO 1275, for psoriasis in both the U.S. and Europe, dapoxetine for premature ejaculation in several countries in Europe, antibacterial ceftobiprole in the U.S. and Europe and anti-HIV medication, TMC 125 in the U.S. and Europe. TMC 125 was approved by the U.S. FDA in January 2008 and will be marketed as INTELENCE(TM) (etravirine).
EVRA R (norelgestromin/ethinyl estradiol), the first contraceptive patch approved by the FDA, experienced a significant decline in sales as a result of labeling changes and negative media coverage concerning product safety. The sales decline was also a result of continued generic competition in oral contraceptives. Growth in ORTHO TRI-CYCLEN R LO (norgestimate/ethinyl estradiol), a low dose oral contraceptive partially offset the sales decline in the hormonal contraceptive franchise.
CONCERTA R (methylphenidate HCl), a product for the treatment of attention deficit hyperactivity disorder, achieved sales of $0.9 billion in 2006, representing an increase of 20.2% over 2005. Although the original CONCERTA R patent expired in 2004, two new CONCERTA R patents have been issued which expire in 2017. At present, the FDA has not approved any generic version that is substitutable for CONCERTA R . Abbreviated New Drug Applications (ANDAs) for generic versions of CONCERTA R are pending and may be approved at any time.
NATRECOR R (nesiritide), a product for the treatment of patients with acutely decompensated congestive heart failure who have dyspnea at rest or with minimal activity, has experienced a significant decline in demand due to negative media coverage regarding a meta analysis of selected historical clinical trials. The Company believes that the data does not support the conclusions of these medical and consumer publications and the currently approved label for NATRECOR R reflects all available data to date.
NATRECOR R was purchased by the Company in 2003 and resulted in the recording of an intangible asset, which is being amortized over 12 years. The remaining unamortized intangible value associated with NATRECOR R was $1.0 billion at the end of the fiscal fourth quarter of 2006, and based on the current estimate of projected future cash flows, no adjustment to this intangible asset is required. The Company is currently conducting several clinical trials for NATRECOR R , the outcomes of which cannot be predicted and may impact the projections of future cash flows.
During 2006, the Company received FDA approval for PREZISTA TM (darunavir), an anti-HIV medication, and INVEGA TM (paliperidone) Extended-Release Tablets, a new atypical antipsychotic, for the treatment of schizophrenia. Additionally, IONSYS TM (fentanyl iontophoretic transdermal system), the first needle-free, patient-activated analgesic system received FDA and European Commission approval.
JURNISTA TM prolonged-release tablets (Hydromorphone HCl), a new prescription treatment for severe pain, received approval through the European Mutual Recognition Procedure in 2006.
During 2004, 2005 and 2006, DURAGESIC R /Fentanyl Transdermal (fentanyl transdermal system) lost its basic patent protection and is subject to generic competition in the United States and certain international markets and EPREX R (Epoetin alfa) lost its basic patent protection and is subject to generic competition in international markets. DURAGESIC R /Fentanyl Transdermal sales declined by 18.3% to $1.3 billion in 2006 as compared to 2005, due to the impact of generic competition. Regarding EPREX R , generic competition will be limited in the near term due to the lack of approved generic compounds. Combined sales of DURAGESIC R /Fentanyl Transdermal and EPREX R accounted for approximately 5% of Johnson & Johnson’s worldwide sales in 2006. The only material patents scheduled to expire within the next two years are related to RISPERDAL R , which is scheduled to expire in the United States in December 2007, and TOPAMAX R , which is scheduled to expire in the United States in September 2008. The Company has submitted data to the FDA in order to obtain a pediatric extension for RISPERDAL R , which, if approved, would grant exclusivity in the United States through June 2008. The TOPAMAX R patent also carries the possibility of a pediatric extension in the United States, which, if obtained, would grant exclusivity in the United States until March 2009.
- http://en.janssenpharmaceutica.be/
ヘルギー本社従業員数3700人。 Turnhoutseweg 30, B-2340 Beerse, Belgium
- 1953 Dr. Paul Janssenにより創立。 Turnhout, Belgium本社。
1961 Dr. Paul and Janssen Pharmaceutica はJohnson & Johnson グループの傘下。
2011.07 Janssen Pharmaceutica NVは動物薬事業をElanco, a Division of Eli Lillyに売却
●Our Products - 製品一覧
製品詳細は、欧州販売元Janssen-Cilag.com を参照。
●News & Media
On January 16, 2008, the Company entered into the Original Makena™ Agreement with Hologic. On January 8, 2010, the Company and Hologic entered into Amendment No. 1 to the Original Makena™ Agreement, which, among other things, included a $70 million cash payment for the exclusive rights to Makena™, which was recorded as purchased in-process research and development expense on the statement of operations for the fiscal year ended March 31, 2010. On February 4, 2011, the Company entered into Amendment No. 2 to the Original Makena™ Agreement. The amendments set forth in Amendment No. 2 reduced the payment to be made on the fifth business day following the day on which Hologic gave the Company notice that the FDA has approved Makena™ (the “Transfer Date”) to $12.5 million and revised the schedule for making the remaining payments of $107.5 million. Under these revised payment provisions, after the $12.5 million payment on the Transfer Date and a subsequent $12.5 million payment 12 months after the date the FDA approved Makena™ (the “Approval Date”), the Company has the right to elect between the two alternate payment schedules for the remaining payments, with royalties of 5% of the net sales of Makena™ payable for certain periods and under different circumstances, depending on when the Company elects to make the remaining payments. The Company may make any of the payments on or before their due dates, and the date on which the Company makes the final payment contemplated by the selected payment schedule will be the final payment date, after which royalties, if any, will cease to accrue.
On February 3, 2011, the Company was informed by Hologic that the FDA granted approval for Makena™. The Company shipped approximately 6,300 vials to its customers, specialty pharmacies and specialty distributors in March 2011. On February 14, 2011, the Company announced the initial list price at $7,500 per vial, or $1,500 per injection and on April 1, 2011 the list price was reduced to $3,450 per vial, or $690 per injection including for March 2011 shipments. Additionally, the Company announced on April 1, 2011 that it would expand its patient financial assistance program so that the majority of women who are clinically eligible for Makena™ would have a co-pay of no more than twenty dollars per injection.
Additionally, Ther-Rx established the MakenaTM Care Connection, a support program for patients and healthcare providers that provides administrative, financial assistance and treatment support for MakenaTM. Administrative and treatment support includes insurance benefit investigation, educational information and a compliance reminder program. Because specialty injectable products like MakenaTM are not typically carried by retail pharmacies, the process for facilitating prescriptions for MakenaTM is managed by this dedicated customer support center.
Ther-Rx has also established a Patient Assistance Program for MakenaTM that provides co-pay assistance (for insured patients), and financial assistance (for uninsured patients). Under the program, patients with a household income of up to $120,000 will pay $20 or less per injection for MakenaTM. This encompasses 85% of the U.S. based on 2009 U.S. census data. Clinically-eligible patients who are uninsured and whose financial need is greatest will receive MakenaTM at no cost. There are no upper-level income caps to qualify for the patient assistance program. Ther-Rx began shipping MakenaTM in March 2011.
Since the initial shipment of vials of MakenaTM in March 2011, Ther-Rx has tracked and accumulated the following key performance metrics (all information is cumulative through May 31, 2011):
kﾎ Approximately 6,500 vials have been shipped to Ther-Rx customers, including approximately 200 vials that shipped subsequent to March 31, 2011.
kﾎ Approximately 1,200 vials have been shipped to doctors and patients. Approximately 15% of these vials were provided at no cost to patients who have demonstrated financial need. Of the remaining 85%, approximately two thirds of the vials were shipped to patients covered by commercial insurance plans and one third were shipped to patients covered by a government insurance plan.
kﾎ Approximately 1,700 patient referrals have been made to the MakenaTM Care Connection, of which approximately:
kﾎ 900 patients have initiated treatment or are in the enrollment phase or are pending insurance approval and treatment initiation.
kﾎ The remaining balance of these referrals (approximately 800) did not lead to filled Makena prescriptions for a variety of reasons including; not meeting the labeled indication, some of which were because they were outside the treatment initiation window and others who did not have the proper obstetric history or were pregnant with multiples; cancellation prior to completion of the insurance benefits verification process either by prescribers or patients for unspecified reasons; or not receiving positive insurance coverage, most of which were referrals for Medicaid patients.
kﾎ The data that is available to us indicates that patient co-pays are averaging approximately, $12 per injection including more than 36% of insured patients that had a $0 co-pay. Further, of the patients that have had a co-pay assigned by their insurance plan, 90% of those patients have had an average co-pay of about $9 per injection. This data does not include patients who have benefitted from our financial assistance programs.
kﾎ Over 100 different payors (both commercial and Medicaid) have approved at least one Makena prescription.
Ther-Rx is continuing to work with commercial insurance programs and state Medicaid agencies to increase coverage of and access to MakenaTM. These on-going discussions include negotiations regarding rebates and patient coverage levels, none of which have been finalized as of May 31, 2011.
Following the July 2010 resubmission of the NDA by Hologic, the FDA assigned a Prescription Drug User Fee Act (“PDUFA”) action date of January 13, 2011. Hologic advised the Company that the FDA had recently requested additional information with respect to the Gestiva™ application. The requested information was provided to the FDA on January 10, 2011.
In order to provide for additional time to review the information that was solicited by the FDA and provided by Hologic, the FDA has extended the PDUFA date to April 13, 2011. Based on the information provided, the Company remains confident in the approval of Gestiva™ and believes a positive action by the FDA is likely on or before the new PDUFA date.
In light of this new information, the Company further stated that it is evaluating its liquidity outlook. When the Company completes its evaluation, it intends to furnish an update as appropriate.
Greg Divis, President of Ther-Rx Corporation, the Company’s branded subsidiary and Interim President and Chief Executive Officer of the Company, stated, "We believe this latest submission meets all the outstanding FDA requirements and marks an important milestone in the progression toward the potential approval and marketing of this product."
As previously announced, K-V has an agreement with Hologic, Inc. to secure the rights of Gestiva™ upon FDA approval.
David Van Vliet, interim CEO at KV Pharmaceutical Company, said, “While our highest priority is to demonstrate cGMP compliance so we can return our approved products to market, we believe Gestiva™ will be an important addition to our women’s health franchise and are pleased we could reach this agreement with Hologic. We will continue to assist Hologic in completing the steps to obtain FDA approval of this socially valuable product.”