Dendreon Awaits Provenge Approval

Dendreon Corporation (DNDN - Analyst Report) is likely to become the first company to receive approval from the US Food and Drug  Administration (FDA) for an anti-cancer, immunotherapy based vaccine, as it released phase III IMPACT (IMmunotherapy for Prostrate AdenoCarcinoma Treatment) trial results for its key product candidate, Provenge, in April 2009. Provenge boosted survival rates in men with advanced prostate cancer beyond any currently available treatments.

Dendreon intends to file an amendment to its existing Biologic License Application (BLA) in the fourth quarter of 2009. We believe that the FDA will approve Provenge in the first half of 2010 based on the positive late-stage study results. 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. We believe Provenge could have blockbuster potential if it is approved by the regulators.

Prostate cancer is the most common non-skin cancer in the U.S. and the third most common cancer worldwide. The American Cancer Society estimates that in this decade about 190,000 new cases have been diagnosed each year, and almost 30,000 men die every year from it.

We believe the approval of Provenge is critical for the financial performance of the company since the product has blockbuster potential and the successful commercialization of the drug can drive a company of Dendreon’s size to strong profitability.

The positive IMPACT results caused a significant rise in the company’s stock price. Taking advantage of its high stock price the company raised more than $200 million to support the manufacture and marketing of Provenge.