A Dramatic Day for Dendreon

Shares surged Friday after an FDA panel voted in favor its Provenge treatment for prostate cancer

Dendreon's (DNDN) stock price surged nearly 150% on Mar. 30 after news that the U.S. Food and Drug Administration advisory committee vouched for the company's Provenge compound - even though the prostate cancer treatment may not kill tumors. Studies suggest, however, that the drug extends peoples' lives.

The panel of outside experts voted 17 to 0 in favor of Provenge's safety and 13 to 4 on its efficacy. Now Dendreon expects an FDA decision on Provenge by May 15, 2007. "If approved, Provenge could become a breakthrough treatment for patients with advanced prostate cancer who currently have few treatment options," Dendreon CEO Mitchell H. Gold, M.D. said in a press release Mar. 29. After the news Dendreon's stock soared 148% to $12.93 per share on the Nasdaq March 30.

Provenge is designed to stimulate a patient's immune system against prostate cancer. Although researchers failed in their efforts to prove that the treatment can slow cancer, Dendreon had announced in February, 2005, that a four-month study of 127 men showed patients on Provenge had a 4.5 month improvement in their median survival and a greater than 3-fold increase in survival at 36 months when compared to patients on a placebo.

Questions were raised at the panel meeting about problems such as the small number of patients involved in the trial, according to Needham & Co. Several committee members, including Maha Hussain, M.D., Professor of Medicine and Urology at the University of Michigan, pointed out that a larger trial with 500 to 700 patients is needed to more adequately address the efficacy of Provenge. But panel members in large part agreed that Provenge is safe and relatively well tolerated compared to chemotherapy treatments, with the most common side effects including things like chills, fever, fatigue, and nausea. "Although the agency is not bound to follow the panel's recommendation, we believe that it is increasingly likely that the drug will be approved by the FDA," Needham analyst Mark Monane said in a research note.

While the FDA grapples with whether it can safely make the drug available yet, men suffering from prostate cancer are watching the clock tick. Around 30,000 men die from prostate cancer each year, making it the second largest cancer killer for men after lung cancer. But some common methods to help such patients have raised eyebrows during recent years. The PSA test, for example, is wildly inaccurate -- it carries a 75% false-positive rating -- and there's little or no evidence that widespread use correlates with lower mortality rates (see BusinessWeek.com, 6/20/04, "Bad Marks for a Prostate Cancer Test").

"We think there's nothing better than survival -- and the patients made that clear in the meeting that this is all they care about is living longer and better lives," said Monique Greer, senior director of corporate communications at Dendreon.

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