Dendreon Corporation (DNDN) recently announced the presentation of Provenge (sipuleucel-T) data at the American Urological Association (AUA) annual meeting.
At the AUA meeting, two topics were presented by Dendreon on Provenge. A subgroup analysis of three phase III trials of Provenge in metastatic castrate resistant prostate cancer patients was presented on May 21, 2012. In this analysis, survival benefit in African American men who participated in the three Provenge phase III studies, including the IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) trial, was evaluated. We note that in the U.S., among African American, Caucasian and other races, African American men are at the highest risk of prostate cancer. The results showed median overall survival difference of 30.7 months between the Provenge (median overall survival of 45.3 months) and control arms (median overall survival of 14.6 months).
The second presentation, held on May 20, 2012, analyzed the overall survival benefit of Provenge in patients crossing over from the IMPACT trial to an open label phase II study in which they received APC8015F, an investigational therapy.
Provenge is Dendreon’s sole marketed product. In the U.S., Provenge is approved for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. Dendreon reported net Provenge revenue of $82.0 million in the first quarter, up from $27.0 million in the comparable quarter of 2011. Dendreon expects low single-digit quarter-over-quarter growth for Provenge in the second quarter of 2012.
Our Recommendation
We currently have a Neutral recommendation on Dendreon. The stock carries a Zacks #3 Rank (Hold rating) in the short run. The successful commercialization of Provenge is crucial for the financial performance of Dendreon as it can drive the company to profitability. Though we are encouraged by the growth of Provenge in the first quarter of 2012, we prefer to remain on the sidelines until we get better visibility on whether the improvement in Provenge’s sales is sustainable.
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