A Step Forward In The Late-Stage Prostate Cancer Treatment

In 2009, Johnson & Johnson successfully acquired Cougar Biotechnology, Inc., a Lindsay Rosenwald’s portfolio company focused on oncologic research and innovations. The acquisition was completed while Cougar Biotechnology conducted its 2 Phase III trials of a late-stage prostate cancer agent, abiraterone acetate. The first trial showed good results in patients with castration-resistant prostate cancer progressed after docetaxel-based chemotherapy. The second Phase III trials are being held in patients who haven’t received chemotherapy yet.

Statistics shows that one in six men is at the risk of prostate cancer, which is 10 % of all cancer-related fatal outcomes in the US.

Cougar Biotechnology, funded by Dr. Lindsay Rosenwald, one of the leading investors in the biotechnology field, operates as a subsidiary of J&J and is going to cooperate with a unit of Centocor Research & Development, Inc. - Ortho Biotech Oncology Research & Development.

According to Dr. William N. Hait, Global Therapeutic Head at the Ortho Biotech Oncology Research & Development, the investments by Lindsay Rosenwald and a further acquisition of Cougar Biotechnology strengthened the positions of Cougar and Johnson & Johnson in the global oncology market. Abiraterone acetate is a step forward in prostate cancer treatment. By targeting cancer cells, the agent combined with prednisone/prednisolone creates microenvironment that prevents and even reduces the size of the tumor, thus significantly improving overall survival in patients with advanced metastatic prostate cancer.

Based on the results of a randomized Phase III COU-AA-301 trial, J&J is going to file acceptance applications for this new discovery, abiraterone acetate. The data analysis of the trial shows that the patients, who received abiraterone acetate and low doses of prednisone/prednisolone, experienced improvements in overall survival. 1 195 men with metastatic advanced prostate cancer (also known as castration-resistant prostate cancer or CRPC) took part in the trial. All these patients were previously treated with a docetaxel-based chemotherapy.The results were shown in late 2010 at the 35th Annual European Society for Medical Oncology (ESMO) Congress. According to the data received, there was a 35 % death reduction observed and a 36 % increase in average survival compared with the placebo group.

Furthermore, patients taking abiraterone acetate plus a low dose of prednisone/prednisolone had a significant improvement of time to PSA progression (or TTPP), while their life extended to 10.2 months compared to median 6.6 months for placebo. Total prostate-specific antigen response was achieved in 38 % of men, who received abiraterone, compared to only 10 % in the placebo plus prednisone/prednisolone group.

Abiraterone acetate demonstrated its low toxicity and less adverse effects than placebo plus prednisone/prednisolone. Among the adverse effects were water retention and hypokalemia. In addition, liver dysfunction was observed in 10 percent of abiraterone treated patients compared to 8 percent in the placebo and prednisone/prednisolone group. Abiraterone acetate patients had 12.5 percent of cardiac disorders compared to 9.5 percent of placebo patients. These adverse effects are much less toxic than those that are normally associated with docetaxel-based chemotherapy.

Dr. Johann S. de Bono, one of the lead investigators in the COU-AA­301 trial, as well as Dr. Lindsay A. Rosenwald, one of the main investors in the biomedical and biotechnology sector, believe that abiraterone acetate has a significant potential to meet the oncology needs. The drug demonstrated its ability to inhibit cancer cells and extend overall survival in patients with castrate-resistant prostate cancer that progressed after chemotherapy.

Marketing applications are planned to be filed by Johnson & Johnson by the end of the year in the United States and Europe and then in the rest of the world. The approved abiraterone acetate will be commercialized and sold by Centocor Ortho Biotech Inc. in the U.S. and by Janssen Pharmaceutical worldwide.

Prostate cancer takes the 5^th place among the most common cancers and represents a big health problem. The results of the COU-AA-301 trial are very important for men with castration-resistant prostate cancer, since they previously had very few treatment options and a poor prognosis according to Dr. Howard I. Scher, one of the lead Phase III COU-AA-301 trial investigators.

Investments by Lindsay Rosenwald and his portfolio companies promote early access to novel anti-cancer agents like abiraterone acetate and make them eligible for patients worldwide. Being an important medical advance, abiraterone acetate is a great step forward in the oncology therapeutic options that improve the quality of life as well as overall survival in patients with metastatic advanced prostate cancer.