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Provenge

Generic name: sipuleucel-T
Treatment for: Prostate Cancer

Update: Provenge Now FDA Approved - April 29, 2010

Dendreon Announces Plans to Submit BLA

SEATTLE, September 14, 2005 -- Dendreon Corporation today announced plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) to market Provenge, the Company's investigational immunotherapy for the treatment of advanced prostate cancer.

This decision follows a recent pre-BLA meeting in which the Company reviewed safety and efficacy data with the FDA from its two completed Phase 3 clinical trials of Provenge in patients with advanced prostate cancer. The outcome of these discussions determined that the survival benefit observed in the D9901 study in conjunction with the supportive data obtained from study D9902A and the absence of significant toxicity in both studies is sufficient to serve as the clinical basis of a BLA submission for Provenge.

"Our decision to move forward with a BLA submission is based on feedback we have received from the FDA in a recent pre-BLA meeting," said Mitchell H. Gold, M.D., Dendreon's president and chief executive officer. "We look forward to working closely with the FDA to bring what caould be the first cancer immunotherapy agent to market for the many men with advanced prostate cancer who have few appealing treatment options."

Prostate cancer is the number one non-skin cancer in the United States. More than one million men in the United States have prostate cancer, with an estimated 220,000 new cases of prostate cancer diagnosed each year. More than 30,000 men die each year from the disease.

D9901 and D9902A Phase 3 Study Results

As reported earlier this year, the final three-year follow up of the D9901 Phase 3 study of Provenge in 127 men with asymptomatic, metastatic, androgen- independent prostate cancer showed a median survival benefit of 21 percent or 4.5 months and a three-fold improvement in survival at 36 months (p-value = 0.01; hazard ratio = 1.7) for patients who were randomized to receive Provenge compared to placebo. This hazard ratio implies that patients who received placebo have a 70 percent greater relative risk of dying than patients who received Provenge.

Final three-year follow up of the D9902A Phase 3 study of Provenge in 98 men with asymptomatic, metastatic, androgen-independent prostate cancer showed a 20 percent improvement in median survival for patients who were randomized to receive Provenge compared to placebo. In addition, at the three-year final follow up, the percentage of patients alive in the Provenge-treated group was substantially greater than the percentage of patients alive who received placebo.

In both studies, as in previous studies, Provenge was well tolerated with the most common adverse events reported being fever and chills lasting for one to two days.

About Provenge

Provenge is designed to stimulate a patient's immune system against prostate cancer. It is developed through Dendreon's proprietary Antigen Delivery Cassette(TM) technology, which utilizes a recombinant form of an antigen found in 95 percent of prostate cancers, prostatic acid phosphatase (PAP).

Provenge is being further evaluated in an ongoing Phase 3 study in asymptomatic, metastatic, androgen-independent prostate cancer (D9902B). It is also being evaluated in a Phase 3 trial, known as PROTECT or P-11, in men with earlier stage prostate cancer.

Source: Dendreon Corporation

Click here for more information on Provenge from the manufacturer.

Posted: September 2005

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