Accelerating Cancer R&D

For Bill Hait, the most compelling science is that which holds the greatest promise for developing medicines that address high unmet needs. “A network that allows you to have insights into what is going on in the world of science is essential,” says Hait, M.D., Ph.D., Global Head, Janssen Research & Development, LLC. “It takes an understanding of both the medical need and the most compelling science to get meaningful innovations to patients quickly.”

One example is ZYTIGA^® (abiraterone acetate), an oral, once-daily medication for use in combination with prednisone for the treatment of men with metastatic castration-resistant prostate cancer (CRPC) who have received prior chemotherapy containing docetaxel. The U.S. Food and Drug Administration granted marketing approval for ZYTIGA^® in April 2011 after an expedited six-month review. An accelerated regulatory review process granted by the European Medicines Agency led to marketing authorization by the European Commission in September 2011.

Prostate cancer is the second most frequently diagnosed cancer among men and the fifth most common cancer overall.

How this transformative prostate cancer treatment came to market exemplifies a fundamental shift in the approach to research and development that is being applied across Janssen Research & Development.

TRANSFORMING PROSTATE CANCER TREATMENT

Globally, prostate cancer is the second most frequently diagnosed cancer in men and the fifth most common cancer overall. According to estimates by the National Cancer Institute, more than 240,000 new cases of prostate cancer were diagnosed in the U.S. in 2011, while nearly 34,000 men died from the disease.

Androgen hormones, such as testosterone, are known to fuel prostate cancer tumors, and despite chemical or surgical reduction of hormones, some cancers continue to rely on them. Before the approval of ZYTIGA^®, treatment options to extend life for men with this kind of metastatic castration-resistant prostate cancer were limited to chemotherapy. When this was no longer effective, patients were out of treatment options.

Abiraterone acetate was discovered by Imperial Cancer Research at Royal Marsden Hospital in London. It was licensed to Cougar Biotechnology, Inc., which began testing the compound in men with CRPC who were taking androgen deprivation therapy.

“This breakthrough research hinged on scientific understanding of the tumor micro-environment—specifically, the idea that the tumor itself could be the source of the remaining testosterone,” says compound leader for abiraterone acetate Michael L. Meyers, M.D., Ph.D., Janssen Research & Development, LLC.

“By identifying the key science for these patients and the fact that this drug was already being developed, the way to accelerate the process was to try to collaborate or acquire the drug,” says Hait, who recognized the value of abiraterone acetate and championed the acquisition of Cougar Biotechnology. “The fact that it worked so well shortened the timeline between the start of the Phase III trial and registration of the drug.”

Johnson & Johnson acquired Cougar Biotechnology in July 2009. Based on positive results from a completed Phase III study, marketing applications were filed with regulatory authorities in the U.S., Europe and other countries in 2010. The entire development program proceeded very rapidly: It was less than six years from the time the first patient was treated to marketing approvals in the U.S., Canada, the European Union and Switzerland.