抗艾药阿比特龙的新药申请已被提交至FDA

Centocor Ortho Biotech Inc. Announces NDA Submission for Abiraterone Acetate for the Treatment of Metastic Advanced Prostate Cancer
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Marketing application also submitted to European Health Authorities

HORSHAM, Pa., December 20, 2010 – Centocor Ortho Biotech Inc. has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational drug abiraterone acetate administered with prednisone for the treatment of metastatic advanced prostate cancer in patients who have received prior chemotherapy containing a taxane. Janssen-Cilag International NV also filed a marketing authorization application (MAA) with the European Medicines Agency (EMA) for abiraterone acetate.

( n% a4 t, q3 H" [) k, W1 [% I( T8 LAbiraterone acetate was developed by Ortho Biotech Oncology Research & Development, Unit of Cougar Biotechnology, Inc.

Abiraterone acetate is an investigational oral androgen biosynthesis inhibitor being developed for the treatment of metastatic advanced prostate cancer that has developed resistance to conventional hormonal therapies. This is also known as castration-resistant prostate cancer (CRPC). It is believed that abiraterone acetate inhibits a key enzyme, CYP17, needed for androgen biosynthesis in the testes, adrenals and tumor.
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8 b: e* j, c: h& w( TBoth applications follow completion of a Phase 3, randomized, double-blind, placebo-controlled clinical study (COU-AA-301), which evaluated overall survival and tolerability in patients with metastatic advanced prostate cancer treated with abiraterone acetate plus prednisone compared to treatment with placebo plus prednisone. In September 2010, the company announced that the study was unblinded on the recommendation of an Independent Data Monitoring Committee.
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, p' X; d& B! u* TData from this 1,195 patient study conducted in 147 centers in 13 countries were presented at the 35th Annual European Society for Medical Oncology (ESMO) Congress in October 2010. Additional ongoing studies are currently underway for abiraterone acetate.
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; {, N0 R; l: |9 c* w“These regulatory file submissions are an important milestone for men with metastatic advanced prostate cancer and for our company,” said William N. Hait, M.D., Ph.D., Global Therapeutic Head, Oncology, Johnson & Johnson Pharmaceutical Research & Development, LLC. “We believe that we can develop important therapies to treat devastating diseases by focusing on the tumor microenvironment. Abiraterone acetate is a key part of this strategy, and we look forward to working with health authorities to provide a new therapeutic option for metastatic advanced prostate cancer patients.”

# ~' m' S& X% ]4 O' ]7 S4 \If approved, abiraterone acetate will be commercialized and distributed by Centocor Ortho Biotech Inc. in the U.S. and by Janssen Pharmaceutical Companies in all other countries around the world.

3 |  {/ w& P& rhttp://www.centocororthobiotech.com

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Centocor Ortho生物科技公司宣布已向FDA提交有关阿比特龙的新药申请
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——同时该药的上市申请也已被提交至欧洲健康管理机构
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2010年12月20日，美国宾夕法尼亚州HORSHAM消息——Centocor Ortho生物科技公司已向美国食品药品监督管理局（FDA）提交了一项有关研究性药物醋酸阿比特龙（abiraterone acetate）联用泼尼松以治疗之前已接受过含紫杉碱（taxane）化疗的转移性晚期乳腺癌患者的新药申请（NDA）。同时，Janssen-Cilag International NV公司也已向欧洲药管局（EMA）提交了一项有关醋酸阿比特龙的上市批准申请（MAA）。
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醋酸阿比特龙由Cougar生物科技公司下属的Ortho生物科技肿瘤产品研发公司负责研发。

5 }8 r! K  h- d醋酸阿比特龙是一种研究用口服雄激素生物合成抑制剂，用于治疗已发生对传统激素治疗耐药的转移性晚期前列腺癌，后者又名去势治疗失败的前列腺癌（CRPC）。据称，该药可抑制在睾丸、肾上腺和肿瘤中的雄激素生物合成所需的关键酶（CYP17）。
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! h. |8 s8 R& ]上述两项申请均是在一项3期、随机、双盲、有安慰剂对照的临床研究（COU-AA-301）完成后被提交的，该研究对接受醋酸阿比特龙+泼尼松治疗的转移性晚期前列腺癌患者的总体存活和耐受能力与接受安慰剂+泼尼松治疗者的进行了比较和评估。在2010年9月，该公司宣布，该研究是依照独立数据监察委员会的建议而进行的。

# s, \9 s3 s, _9 o6 I9 H( I+ \在2010年10月召开的第35届欧洲肿瘤医学学会（ESMO）的年会上，发布了来自在13个国家的147个中心进行的有1195名患者参与的该项研究的相关数据。其他有关醋酸阿比特龙的研究目前仍在进行中。

“这些规范文件的提交对于患有转移性晚期前列腺癌的男性和我们公司而言均是一个重要的里程碑，”全球肿瘤制剂巨头强生制药研发公司的William N. Hait医学和药学博士说。“我们相信，通过对肿瘤微环境的关注，我们能够研发出用于治疗严重疾病的重量级药物。醋酸阿比特龙是这一战略的关键部分，我们希望能够与相关的健康管理机构合作以提供一种新的用于转移性晚期前列腺癌患者的治疗选择。”

一旦获批，醋酸阿比特龙将由Centocor Ortho生物科技公司在美国进行商业运作和销售，而该药在全世界的所有其他国家的业务则由强生制药公司负责。