Janssen Inc. Announces New Drug Submission for Abiraterone Acetate for the
Treatment of Metastatic Advanced Prostate Cancer

TORONTO, Dec. 23 /CNW/ - 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. ¹   

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."

About Metastatic Advanced Prostate Cancer
Prostate cancer is considered to be advanced when metastases beyond the prostate occur and when resistance emerges to conventional hormonal therapies.^{2 3}  Metastatic advanced prostate cancer is also referred to as castration-resistant prostate cancer, or CRPC, when disease progresses despite conventional hormone therapies as manifested by a continuous rise in serum prostate-specific antigen (PSA), progression of pre-existing measurable disease, or appearance of new metastases.⁴

Prostate cancer occurs when cancer cells form in the tissues of the prostate.  The prostate is a gland in men located around the urethra (under the bladder) that produces part of the seminal fluid.³  In some cases, cancer of the prostate can grow slowly compared with other cancers.  However, depending on factors including characteristics specific to the patient and the tumor, prostate cancer can also grow very quickly and spread widely.⁵ 

Prostate cancer is the most common cancer among men in Canada (excluding non-melanoma skin cancer).  It is estimated that approximately 24,600 men will be diagnosed with prostate cancer in Canada in 2010, and one in seven Canadian men will develop prostate cancer during his lifetime.⁶ 

About Janssen Inc.
As a member of the Janssen Pharmaceutical Companies, Janssen Inc. is dedicated to addressing and solving the most important unmet medical needs in pain management, psychiatry, oncology, psoriasis, virology, anemia, attention deficit hyperactivity disorder, dementia, gastroenterology and women's health. Driven by our commitment to the passionate pursuit of science for the benefit of patients, we work together to bring innovative ideas, products and services to patients around the world.

About Johnson & Johnson Pharmaceutical Research & Development
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) is a subsidiary of Johnson & Johnson, the world's most broadly based producer of health care products. J&JPRD is headquartered in Raritan, N.J., and has facilities throughout the United States, Europe and Asia. J&JPRD is focusing its drug discovery and drug development efforts to address unmet medical needs worldwide in a variety of therapeutic areas including cardiovascular and metabolic diseases, oncology, immunology, central nervous system disorders and virology. More information can be found at http://www.jnjpharmarnd.com.

About Ortho Biotech Oncology Research & Development, a Unit of Cougar Biotechnology, Inc.
Ortho Biotech Oncology Research & Development, a unit of Cougar Biotechnology, Inc., partners with affiliated units and companies in the Janssen Pharmaceutical Companies of Johnson & Johnson, such as Centocor Ortho Biotech, Inc. and J&JPRD, in the research and development of oncology and supportive care treatments. 

References
_______________________

¹ Danila DC, Morris MJ, de Bono JS, et al. Phase II Multicenter Study of Abiraterone Acetate Plus Prednisone Therapy in Patients with Docetaxel-Treated Castration-Resisitant Prostate Cancer. J Clin Oncol. 2010 Mar 20;28(9):1447-9.

² Moul, Judith.  The Evolving Definition of Advanced Prostate Cancer.  Rev Urol. 2004; 6(Suppl 8): S10-S17.

³ National Cancer Institute.  "What You Need to Know About Prostate Cancer." http://www.cancer.gov/cancertopics/wyntk/prostate/page1.  Accessed September 10, 2010 at. 

⁴ Hotte SJ, Saad F. Current management of castrate-resistant prostate cancer. Curr Oncol. 2010 September; 17(Supplement 2): S72-S79.

⁵ Mayo Clinic.  "Prostate Cancer."  http://www.mayoclinic.com/health/prostate-cancer/DS00043. Accessed September 10, 2010. 

⁶ Prostate Cancer Statistics.  Canadian Cancer Society.  Available at:  http://www.cancer.ca/Canada-wide/About%20cancer/Cancer%20statistics/Stats%20at%20a%20glance/Prostate%20cancer.aspx?sc_lang=en.  Accessed August 2010. 

For further information: