Seattle-based Dendreon said today it has completed all the necessary paperwork for its lead drug candidate, and handed over the amended application for approval to the FDA. The company had told investors to expect this milestone by “mid-November,” so this application came in a few days or even a few weeks ahead of schedule.
Investors have been antsy for months about Dendreon (NASDAQ: DNDN) turning in its amended application to start marketing sipuleucel-T (Provenge) as the first treatment of its kind to actively stimulate the immune system to fight prostate cancer like a virus. That’s because Dendreon reached its goal in a 512-patient study, known as Impact, back in April, generating the sort of evidence of safety and effectiveness that it will need to pass muster.
The FDA will now have a deadline of 180 days to finish its review of the application, although the FDA has to formally accept the application for review before it assigns itself a deadline, says Dendreon spokeswoman Katherine Stueland. Dendreon has said it expects to win approval by mid-2010.
This deadline matters a lot to Dendreon and prostate cancer patients. Dendreon’s stock has boomed this year from as low as $2.55 to as much as $30 on the assumption that its drug is a slam dunk with the FDA because of the results from the Impact study, and it has raised $221 million from investors to build up the manufacturing and marketing muscle it needs to make it a success. The company has also gone on a hiring binge this year as it seeks to make sure it has the talent to make the most of this drug, recently saying it plans to double in size to about 600 employees. If approved, the drug would be the first option of its kind for a disease that kills about 30,000 men in the U.S. each year, and an alternative to Sanofi-Aventis’ docetaxel (Taxotere) a chemotherapy that has been shown to extend lives, but also to cause nasty side effects.
Shares of Dendreon climbed 5 percent at the opening bell to $26.60 on the news.
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