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Dendreon Placing Its Final Bets on Provenge


The potential blockbuster cancer drug races the last mile of its scandal-plagued marathon.

The next few months will be Dendreon's (DNDN) show as the company eagerly anticipates the potential approval of its prostate cancer drug Provenge by the FDA on May 1, marking its first product to make it to market.

The Seattle-based biotech has had a long, winding road trying to get Provenge approved, but the company is prepared to show investors that it has confidence in the cancer treatment that some interest groups have called a "miracle drug." Dendreon Chief Executive Mitchell Gold said Tuesday at the BIO CEO conference in New York that the company has prepared three plants to be in full manufacturing mode for Provenge by mid-2011 and that 125 sales people will be out in full force.

"Our plan is to commercialize this product ourselves in the United States," said Gold at the conference. "And we are currently evaluating potential structures for partnering outside the United States."

Provenge will target a patient population of about 103,000 men in the US. It has been shown in studies to prolong a patient's life by 4.5 months -- a huge period of time in the world of cancer treatments -- and to lower the risk of death by the cancer by 22.5%. Unlike chemotherapy, the drug works to boost a patient's own immune system, instead of introducing cell-killing toxins into the body. It is also more convenient than chemotherapy -- chemotherapy requires patients to get infusions every three weeks for several months, while Provenge only requires one infusion a month for three months.

"Within one year of potential approval, we will be in full capacity in terms of our manufacturing infrastructure that we will be able to supply to the marketplace," Gold added. "I do believe Dendreon offers a unique investment opportunity."

The company will begin manufacturing at its Morris Plains, New Jersey, plant, and then will expand production to plants in Atlanta, Georgia, and Orange County, California. At full capacity the New Jersey plant will be able to handle $500 million to $1 billion worth of sales. The other facilities will be able to handle $375 million to $750 million in sales.

Analysts believe that Provenge has the potential to break the $1 billion sales mark in its first year on the market and to surpass $5 billion in sales within a few years of that. The drug is also being tested for treatment of other types of cancer including bladder, colon, colorectal, and breast.

Yet, Provenge and Dendreon have had a rocky time over the last couple of years. Dendreon's stock has ranged between $2.55 and $30.90 over the last 52 weeks. The stock has been plagued by problems including a manipulated bear run on the stock last April, which caused the stock to lose 65% of its value in less than two minutes. The stock also took a hit in 2005 when CNBC's Jim Cramer told investors that Provenge had been rejected by the FDA when the company had yet to submit the drug for FDA approval. CNBC was forced to apologize for the mistake.

The SEC's Office of Inspector General is now investigating the bear run and other allegations that the stock has been subject to illegal naked short selling. "The OIG has opened an investigation into complaints from an investor alleging that the SEC failed to investigate instances of market manipulation and other misconduct in connection with the review, and eventual nonapproval, of a developmental drug," said the report by the OIG.

This hasn't been the only scandal surrounding Provenge. The FDA has been accused of ignoring conflicts of interest for two of the doctors that were on the original advisory panel by a group called Care To Live after the FDA rejected the approval of Provenge and asked for further data. The FDA has responded by saying the accusations are "baseless speculation" and "conspiracy theory." Check out Pharmalot for further details on this scandal.

Investors and patients will be waiting with bated breath because by May 1 the FDA will finally bring the Dendreon saga to a close with the approval of Provenge.
No positions in stocks mentioned.

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