Dendreon CEO sees 2006 Provenge filing

By Julie Steenhuysen

LOS ANGELES (Reuters) - After a bumpy ride, Dendreon Corp. (DNDN.O: Quote, Profile, Research, Stock Buzz) is poised to submit its lead drug candidate for treating prostate cancer to U.S. regulators for approval later this year, according to Chief Executive Mitchell Gold.

Speaking at the Reuters Biotechnology Summit in Los Angeles on Tuesday, Gold said a launch in the United States could come by mid-2007.

Approval will hinge on how U.S. regulators view data from two clinical trials, both of which failed to reach their primary goal.

The trials did show the drug prolonged the lives of patients with advanced prostate cancer, however, and the Seattle-based biotechnology company believes that may be enough to win approval from the U.S. Food and Drug Administration.

"Survival in oncology is the gold standard. It is the one that carries the most weight," said Gold, explaining how the company can win approval for the treatment given U.S. regulators' inclination for trials that meet with clear-cut success.

"It is the first cancer immunotherapy to go before the FDA," said Gold. The treatment is designed to stimulate the body's immune system to attack cancer with minimal side effects.

Patients with advanced prostate cancer currently use Taxotere, a chemotherapy from Sanofi-Aventis (SASY.PA: Quote, Profile, Research, Stock Buzz) linked with severe toxic side effects.

"It remains to be seen whether the U.S. Food and Drug Administration will ultimately grant a full approval to Provenge," said Next Generation Equity Research analyst Liisa Bayko, in a research note.  Continued...