Wachovia Cautious on Interim Data from Dendreon's (DNDN) Provenge Trial; Says Rally Will Be 'Short-Lived'
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Wachovia is out with a research note giving its thoughts on interim data from the IMPACT trial Dendreon (Nasdaq: DNDN) released this morning. The firm maintains its Market Perform rating and $5-$6 valuation range on shares of Dendreon.
The firm says its remains cautious on expectations that Dendreon's Provenge will be successful in the final analysis. Wachovia mentions several concerning points:
- the firm said it needs to see a confidence interval for this analysis as management reported that the interim analysis showed a confidence interval at the upper range that was greater than 1.0, but the integrated analysis of 9901 and 9902a demonstrated an adjusted-Cox HR at 24 months of 0.78.
- on prior occasions, management had indicated it designed the IMPACT study to measure a 31% decrease in the of death in the Provenge arm, meaning that a 22% reduction (as reported by Dendreon earlier) may not be sufficient to meet the primary endpoint in the final analysis.
- there was no futility analysis in this interim analysis nor was there a p-value given thus, there are few conclusions that can be derived from the data presented.
- the only covariates used in the Cox model are PSA and LDH; Wachovia said this is surprising "given that an analysis based on this specific criteria was not presented in the FDA briefing docs."
Dendreon Corporation, a biotechnology company, engages in the discovery, development, and commercialization of novel therapeutics that harness the immune system to fight cancer.
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