Dendreon Catches a Break From The FDA

Dendreon (DNDN-NASDAQ) is benefitting from something that become thought of as a low probability event: an FDA that buckled at least a little to peer pressure.   It has received confirmation that the FDA will accept either "a positive interim or final analysis of survival" from its ongoing IMPACT study to amend the Biologics License Application for PROVENGE as a late-stage prostate cancer treatment. This information was obtained in a recent follow up meeting with the FDA to discuss the additional clinical data required to support the licensure of PROVENGE requested by the FDA in the Complete Response Letter the Company received on May 8, 2007.

Mitchell H. Gold, President/CEO: "We anticipate completing enrollment in the IMPACT study this year and anticipate interim survival results in 2008. We are committed to making PROVENGE available as rapidly as possible to help the many men with late-stage prostate cancer who currently have few appealing treatment options."  So the translation here is that this won’t yield an immediate approval, but it could move up the date of an approval considerably.  The Company anticipates net cash for operating and capital expenditures for 2007 of approximately $95 million and expects spending levels to decrease substantially in 2008 to approximately $55 million because it has already incurred many of the third-party costs necessary to prepare for the commercialization of PROVENGE. These costs include items such as third party clinical trial costs, inventory purchases, capital expenditures related to New Jersey manufacturing and other outside infrastructure costs.

Shares are up more than 50% on this news to over $10.00, and this is much sooner than would have been expected by most.  It should also give the company some added oomph going into the ASCO meeting this weekend.  This one is still a long way from over, but this is at least a break for the company and should keep it from facing as soon of a cash crunch.

Jon C. Ogg
May 31, 2007

Jon Ogg can be reached at [email protected]; he does not own securities in the companies he covers.