Dendreon Provides An Update On Provenge

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provenge.jpgIn an earnings call last night with Wall Street analysts, Dendreon reiterated its strategy for the controversial Provenge prostate cancer vaccine, which was recommended last spring by an FDA panel, but then unexpectedly issued an approvable letter after two panel members wrote the agency urging a delay in approval. That set off a firestorm among patients and investors, as well as charges of conflicts of interest, threats against the two panel members and a lawsuit against the FDA.

The key points made last night by Dendreon management include completing enrollment of a Phase III trial by the end of this year, reporting interim results in mid-2008, and an ongoing quest to find a marketing partner outside the US, according to an investor note written this morning by Needham’s Mark Monane, who adds Dendreon’s burn rate is about $100 million a year and has enough cash to last through 2009.

Here’s an excerpt from his note:

“The company indicated a possibility that the FDA might accept the interim survival data towards a modified (biologics license) application. The Impact trial is a randomized, double-blind, placebo control trial in patients with asymptomatic metastatic hormone refractory prostate cancer…

Under the amended special protocal assessment, 500 patients with all Gleason scores will be eligible for enrollment in the D9902B trial, as will patients with minimally symptomatic pain. The primary endpoint is overall survival while time to tumor progression (TTP) is the secondary endpoint. Final analysis will be triggered by the occurrence of 360 events…

To date, more than 400 patients are enrolled in the study, with enrollment expected to complete by year-end 2007. We expect the interim data in mid-2008 and final data analysis in 2009.”

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  1. Mr. Silverman,

    Thanks again for keeping the Dendreon/Provenge story out in the open for all readers to see….

  2. What is misleading from Monane’s statement is the fact that the cash burn will drop by half in 12 months to $50 million or thereabouts.

  3. Mr. Silverman,

    Thank you for your excellent coverage of Dendreon/ Provenge.

  4. tumor…

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