Recently, Dendreon Corp. (DNDN) announced that the U.S. Food and Drug Administration (FDA) has accepted the amended Biologics License Application (BLA) for Provenge, a therapeutic vaccine for the treatment of prostate cancer in men. The agency is expected to decide on whether to approve the drug by May 1, 2010.
The BLA, submitted on Nov 2, 2009, is based on the positive phase III IMPACT (IMmunotherapy for Prostrate AdenoCarcinoma Treatment) trial results announced in Apr. 2009.The multi-center, randomized, double-blind, placebo-controlled study, which enrolled 512 patients with metastatic androgen-independent prostate cancer, met its primary endpoint of improving overall survival compared to a placebo control.
If approved, Provenge would be the first product in the new therapeutic class known as active cellular immunotherapies. In development studies, Provenge boosted survival rates in men with advanced prostate cancer beyond any currently available treatments. Unlike traditional vaccines that prevent diseases, Provenge treats it by stimulating the body’s own immune system to attack cancer cells. Dendreon plans to market Provenge in the U.S. on its own and is seeking partners for ex-U.S territories.
Prostate cancer is the most common non-skin cancer in the United States and the third most common cancer globally as per data from the American Cancer Society. The disease affects more than one million men in the United States .
We believe that approval of Provenge is critical for the financial performance of the company because the product has blockbuster potential and its successful commercialization could drive a company of Dendreon’s size to strong profitability.
The company plans to manufacture Provenge in its New Jersey facility. Furthermore, additional manufacturing facilities in Los Angeles and Atlanta will begin producing the drug in the second half of 2011.
Currently, we have an Outperform rating on Dendreon.
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