Dendreon Revisited

(RTTNews) - Shares of Dendreon Corp. (DNDN: News ) have lost nearly 50% of their value since the company's initial public offering in June 2000. Blame it on Provenge, the company's much touted investigational therapeutic vaccine for prostate cancer that flunked the FDA muster, disappointing many patients and fraying the nerves of investors.

But Dendreon has not given up on Provenge, which according to the company is on the brink of commercialization. Dendreon has pinned its hopes on the ongoing IMPACT (Immunotherapy for Prostate AdenoCarcinoma Treatment) study designed to measure overall survival in men with late stage prostate cancer receiving Provenge compared to placebo. While interim results from the IMPACT study are expected to be available during the second half of this year, final results are anticipated to be presented during the second half of 2009.

The making of Provenge

Provenge, an investigational therapeutic cancer vaccine belongs to a new class of therapy known as Active Cellular Immunotherapy. It works by stimulating the immune system to recognize a protein known as the prostatic acid phosphatase or PAP, which is found in about 95% of all prostate cancer cells and mounts an attack on the cancer cells.

There are two types of vaccines namely therapeutic and prophylactic. While a therapeutic cancer vaccine is given to patients to treat existing cancers, a prophylactic cancer vaccine is given to healthy subjects to prevent infection with cancer-causing viruses. Merck & Co. Inc's (MRK) Gardasil and GlaxoSmithKline's (GSK) Cervarix, which are approved to prevent cervical cancer, are examples of prophylactic cancer vaccine.

Though Dendreon, which filed the Biologics License Application in 2006 seeking approval for Provenge was optimistic about the vaccine's approval, some analysts cautioned that Provenge was unlikely to get the green light from the FDA. Skepticism was such that when Dendreon announced on March 1, 2007 that Provenge has been taken up for review by the FDA panel, the company's stock shed 8.84% to close at $4.23.

Contrary to doomsday predictions of some analysts, on March 30, Provenge was voted 17 to 0 safe and 13 to 4 efficacious by an FDA panel of experts, giving Dendreon's stock price an unexpected lift. The share price, which nearly tripled in the first few minutes of trading on March 30, 2007 to $14.90 a share, closed the day's trade at $12.93. Buoyed by the FDA panel's positive vote, Dendreon's stock price continued its upward march and hit a 52-week high of $25.25 on April 10, 2007. But the joy was short lived for Dendreon. On May 9, 2007 the FDA issued an approvable letter, requesting Dendreon to furnish more clinical data related to Provenge. Reacting to the news, the stock took a whacking, losing over 64% to settle at $6.33 at the close of the trade.

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