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Centocor Ortho Biotech Inc. Announces NDA Submission for Abiraterone Acetate for the Treatment of Metastatic Advanced Prostate Cancer
Date:12/20/2010

HORSHAM, Pa., Dec. 20, 2010 /PRNewswire/ -- 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.

Abiraterone 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.  

Both 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.  

Data 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.

"These regulatory file submissions are an important milestone for men with metastatic advanced prostate cancer and for our company,
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SOURCE Centocor Ortho Biotech Inc.
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