Janssen files abiraterone acetate NDS with Health Canada for metastatic, advanced prostate cancer

Janssen Inc. has filed a New Drug Submission (NDS) to Health Canada 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. Submissions for abiraterone acetate have also been filed with health authorities in the United States and Europe.

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 tumour.

The submission to Health Canada follows 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, including 12 centres in Canada, were presented at the 35^th Annual European Society for Medical Oncology (ESMO) Congress in October 2010. The study included 154 Canadian patients. Additional ongoing studies are currently underway for abiraterone acetate.

"These submissions are important milestones 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 tumour 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."