Will The E.U. Save Dendreon If The U.S. Won't? (DNDN)

Dendreon Corp. (NASDAQ:DNDN) shares are trading up in early trading on a patent award, and that is after the fairly large gains yesterday.   Dendreon was granted a broad European patent covering what is still its lead product candidate PROVENGE, its investigational active cellular immunotherapy for the treatment of advanced prostate cancer.

• We did not take the E.U. into consideration at all when we named Dendreon as 1 of 10 stocks that could double in 2008 under the right circumstances. 

This patent grant is in the E.U. rather than in the U.S. and has been granted European patent No. 0 870 022 B1.  The patent covers the composition of matter of PROVENGE as well as the company’s other active cellular immunotherapy product candidates, such as NEUVENGE(TM) (lapuleucel-T). The patent also covers methods of activating antigen presenting cells in vitro with certain fusion proteins developed by Dendreon, including the fusion protein that is used in PROVENGE.

As previously noted, the FDA will accept either a positive interim or positive final analysis of overall survival from the IMPACT study to amend the Biologics License Application (BLA) and support the efficacy claim for PROVENGE. Interim data from the fully-enrolled IMPACT study are expected in the second half of 2008.

A patent grant is far from an approval to commence sales.  But this is good news in that the E.U. now has a chance to become a market for PROVENGE even if the FDA sticks it to the company again in late 2008.  With Congress involved and looking into potential conflicts of interest from FDA panel members that gave PROVENGE the thumbs down, this might be one more ray of hope for the company, its shareholders, and for those with prostate cancer.

Dendreon shares were up as much as 5% in early trading, but shares sit up about 3% at $6.67 at 10:00 AM EST and we’ve already seen a full average daily volume after only 30 minutes.

Jon C. Ogg
January 15, 2008