Dendreon to Seek FDA Approval

Recently, Dendreon Corp. (DNDN - Analyst Report) announced that it intends to file an amendment to its existing Biologic License Application (BLA) for its prostate cancer vaccine Provenge in Nov. 2009. We believe that the US Food and Drug Administration (FDA) will approve Provenge in the first half of 2010 based on the positive phase III IMPACT (IMmunotherapy for Prostrate AdenoCarcinoma Treatment) trial results announced in Apr. 2009.
 
If approved, Dendreon will become the first company to receive approval for an anti-cancer immunotherapy based vaccine. 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. We also expect the company to announce a partner for Provenge in Europe soon while Dendreon itself will market the drug in the U.S.
 
Prostate cancer is the most common non-skin cancer in the U.S., affecting more than one million men.
 
We believe that approval of Provenge is critical for the financial performance of the company because the product has blockbuster potential and a successful commercialization can drive a company of Dendreon’s size to strong profitability.

However, sales of the drug for six months following its launch are expected to be low due to supply constraints. The company intends to more than double its current workforce by the time Provenge is launched.
 
Apart from Provenge, the company also intends to initiate a clinical trial for its therapeutic vaccine - Neuvenge - against bladder cancer in late 2010 or early 2011.