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Dendreon and the Prostate Cancer Battle


Promising treatments for the disease are gaining traction.

Now that Dendreon (DNDN) has overcome the confusion about whether or not it's going to require an advisory panel for its prostate cancer drug Provenge, the company is reinforcing shareholders' hope that the drug will be a major blockbuster as it moves one step closer to May 1, when it will hear final word on the FDA's approval.

(See Dendreon Drama Subsides; More Data to Come)

The drama-prone biotech released results Wednesday night providing more support for its late-stage Impact study showing that Provenge extends the overall survival of men with metastatic, castrate-resistant prostate cancer. The study showed that Provenge increased three-year survival by 40% compared to a placebo, extending median survival by 4.1 months and reducing risk of death by 24.1%. The full results of the study will be released on Friday at the American Society of Clinical Oncology 2010 Genitourinary Cancers Symposium.

"This is the first therapeutic vaccine to demonstrate a survival benefit in cancer," said Philip Kantoff, M.D., director of the Lank Center for Genitourinary Oncology and principal investigator of the Impact study. "Furthermore, the results of this study validate cancer immunotherapy as an entirely new treatment paradigm that can provide patients with a clinically meaningful survival benefit coupled with a well-tolerated safety profile."

The Seattle biotech's stock edged up almost 4% to linger near $35 per share on Thursday. "We continue to believe that the statistical results of Impact remain key to FDA approval and to this end we view the consistency from multiple analyses to be encouraging," wrote Leerink Swann analyst Howard Liang.

Liang believes that the new results quiet any fears that the positive data on survival rates from Provenge was impacted by use of the chemotherapy drug Taxotere.

Analysts believe that Provenge has the potential to break the $1 billion sales mark in its first year on the market and to surpass $5 billion in sales within a few years of that. The drug is also being tested for treatment of other types of cancer including bladder, colon, colorectal, and breast.

Hopefully for Dendreon, the second time is the charm. The company has been battling bears in the stock market and problems with FDA management over the past few years as the stock has gone from $30.90 to $2.55 and back again.

(See Dendreon Placing Its Final Bets on Provenge)

Meanwhile, Sanofi-Aventis (SNY) is making progress in the fight against prostate cancer as well. The French pharmaceutical company also announced results from a late-stage study on Wednesday night. The study showed that Sanofi's drug Jevtana reduced the risk of death by 30% in second-line prostate cancer patients, extending median overall survival to 15.1 months compared with 12.7 months on placebo.

"Jevtana delivered results in line with our predicted 30% reduction in the risk of death versus control, which supports the potential for significant pricing leverage versus our initial assumption that assumed pricing in line with Taxotere of $2,500 per dose," said Leerink Swann analyst Seamus Fernandez.

Prostate cancer is the second leading cause of cancer death in men in the US. In 2010, almost 200,000 new cases of the disease are expected to be diagnosed and 28,000 men will die from the disease. On Thursday the House Committee on Oversight and Government Reform will be holding a hearing to discuss prostate cancer screening and treatment.
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