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Provenge

Generic name: sipuleucel-T
Treatment for: Prostate Cancer

Update: Provenge Now FDA Approved - April 29, 2010

Dendreon Completes Submission of Biologics License Application to FDA for Provenge in Hormone Refractory Prostate Cancer

SEATTLE, November 13, 2006 -- Dendreon Corporation today announced that the final portion of the Biologics License Application (BLA) for Provenge (sipuleucel-T) has been electronically submitted to the U.S. Food and Drug Administration (FDA), which completes its rolling submission that began in August 2006.

Dendreon is seeking marketing approval for Provenge for the treatment of asymptomatic, metastatic, androgen-independent (also known as hormone-refractory) prostate cancer. As part of the Provenge BLA submission, Dendreon has requested a Priority Review designation from the FDA, which, if granted, would give the FDA six months from the Agency's receipt of the submission to take action on the application.

"The submission of the BLA for the first active cellular immunotherapy for cancer is a major milestone for the Company and the prostate cancer community, and I would like to congratulate our dedicated employees who have worked tirelessly in helping us to reach this historic goal," said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "This application is the culmination of 10 years of rigorous clinical study and the dedication and involvement of hundreds of patients and physicians. The survival benefit we observed in our clinical program, combined with the favorable safety profile of Provenge form the basis of our submission, and we look forward to working with the FDA to make Provenge available to the many men with advanced prostate cancer who currently have few appealing treatment options."

Prostate cancer is the most common non-skin cancer in the United States and the third most common cancer worldwide. More than one million men in the United States have prostate cancer, with an estimated 232,000 new cases of prostate cancer diagnosed each year. More than 30,000 men die each year of the disease.

The BLA submission is based primarily on a double-blind, placebo-controlled Phase 3 Study known as D9901 that was published in the July issue of the Journal of Clinical Oncology. The study showed that the group of men with asymptomatic, metastatic, androgen-independent prostate cancer who received Provenge had a median survival time 4.5 months longer than the median survival seen in the group that had been assigned to receive placebo. For the men who received Provenge, there was a 41 percent overall reduction in the risk of death (p-value = 0.010; HR = 1.7). In addition, 34 percent of patients receiving Provenge were alive 36 months after treatment compared to 11 percent of patients randomized to receive placebo.

About Provenge

Provenge (sipuleucel-T) is an investigational product that may represent the first in a new class of active cellular immunotherapies (ACIs) that are uniquely designed to stimulate a patient's own immune system. Provenge is in late-stage clinical development for the treatment of patients with advanced prostate cancer. In clinical studies, patients typically received three infusions over a one-month period as a complete course of therapy.

Treatment with Provenge was generally well tolerated. In controlled clinical trials, the most common adverse reactions associated with Provenge were chills, fever, headache, fatigue, shortness of breath, vomiting and tremor. These events were primarily low grade events, with a short duration lasting 1 to 2 days following infusion.

Source: Dendreon Corporation

Posted: November 2006

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