Biotech Values

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Results from abiraterone phase III in CRPC presented at ESMO abstract :

http://www.investor.jnj.com/releaseDetail.cfm?ReleaseID=516967&year=2010

A former AF piece on this:

J&J Prostate Cancer Drug Boosts Survival

http://www.thestreet.com/story/10857472/jj-prostate-cancer-drug-boosts-survival.html

Adam Feuerstein 9/10/10 - 09:38 AM EDT

NEW BRUNSWICK, N.J. (TheStreet) -- A Johnson & Johnson(JNJ) drug was found to prolong survival in men with advanced prostate cancer, but fear not Dendreon(DNDN) fans for Provenge is safe -- for now.

The J&J drug abiraterone prolonged survival in patients with advanced, metastatic prostate cancer whose tumors were no longer responding to treatment with chemotherapy, most notably the commonly used drug Taxotere, according to results from an interim look at a phase III study.

The early positive finding of a survival benefit prodded J&J to unblind the phase III study and allow all patients access to abiraterone, the company said Thursday night.

The phase III study had enrolled 1,195 prostate cancer patients, randomizing them to treatment with abiraterone plus the steroid prednisone or a placebo plus prednisone.

For now, abiraterone does not pose a competitive threat to Dendreon's Provenge because the patients treated with the newly launched prostate cancer immunotherapy have less advanced disease than those treated in the abiraterone study.

Doctors administer Provenge to patients who also have advanced prostate cancer but before chemotherapy drugs like Taxotere are used. In the J&J trial, abiraterone was used after chemotherapy.

Abiraterone could potentially compete immediately with Sanofi-Aventis'(SNY) new drug cabazitaxel, which also prolonged survival in prostate cancer patients previously treated with chemotherapy.

Earlier this year, Sanofi reported results from a phase III study showing a median overall survival of 15.1 months for patients treated with cabazitaxel compared to 12.7 months for patients treated with another chemotherapy drug mitoxantrone. The U.S. Food and Drug Administration approved cabazitaxel in June.

J&J has not yet disclosed the extent of the survival benefit derived from abiraterone. That data will come at the European Society for Medical Oncology (ESMO) meeting, being held Oct. 8-12.

J&J said it is evaluating its approval filing strategy for abiraterone in light of the new prostate cancer data.

Abiraterone works by interfering with the way prostate cancer cells feed from testosterone produced in the body. That's different from cabazitaxel, which interferes with cancer cell division.

J&J is conducting a second phase III study of abiraterone in "Provenge-eligible" prostate cancer patients i.e. in the pre-chemotherapy setting, but results are not expected until late in 2011 or early 2012.

Medivation(MDVN) and partner Astellas are developing MDV3100, a prostate cancer drug that works in a very similar way to abiraterone. Phase III studies are underway.