DNDN Trading Dendreon FDA has approved PROVENGE Stock Trading Video
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DNDN Trading Dendreon FDA has approved PROVENGE Stock Trading Video
DNDN Trading Dendreon FDA has approved PROVENGE Stock Trading Video
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Co also confirms that the FDA has approved PROVENGE (sipuleucel-T) for the treatment of asymptomatic or minimally symptomatic metastatic, castrate-resistant (hormone-refractory) prostate cancer. Co intends to make PROVENGE available through ~50 centers, all of which were approved PROVENGE clinical trial sites, and expects to increase capacity over the next year. The increased capacity will be a result of the anticipated licensure of its expanded New Jersey, Atlanta, Georgia and Orange County, Calif. facilities in mid-2011.
Dendreon Provenge Approval Call Summary (45.50 +5.88) -Update : During the call, the co said that it will provide Provenge to 2000 patients in next 12 months. Co said that demand for Provenge will exceed co's ability to provide it in the first 12 months; will continue build out of manufacturing capabilities. Mgmt said that 1 infusion will cost $31k; complete course will cost $93k. Mgmt said market is large - Europe alone is 1-2x the size of US market. Provenge to be used prior to chemotherapy.
DNDN said that the initial challenge will be meeting demand of marketplace - additional capacity comes online in 1H of next year in New Jersey and then the other two facilities come online in mid-2011. Mgmt said that once all facilities are online, co will be able to market $1.2 bln to 2.5 bln in revenue of product into the market.
Co said that it has started to train physicians already and will treat first patient within the first week. Mgmt noted that it is working with a non for profit organization that will provide financial assitance to patients who can't meet payments. DNDN said that the company is ready for launch - everything is ready with FDA. Co expects to treat first patient next week. Mgmt said that it will release financial results in the next couple of weeks.
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DNDN Trading Dendreon FDA has approved PROVENGE Stock Trading Video