DNDN: Shares of Dendreon (
DNDN) traded higher by nearly eight percent during early trading on Monday after it became apparent that the company had recently appointed two new members to its Board of Directors, one being the Chief Executive of Genentech, Ian Clark and the other being Pedro Granadillo, a one time executive for Eli Lilly & Co.
The appointment of Clark has fueled speculation that a partnership deal (with Roche) is imminent since Genentech is wholly-owned by Roche after a recent merger between the two companies. The
DNDN stock price has now approached the thirty dollar level, most likely the result of speculation after the board appointments - in my opinion.
Dendreon, for those not familiar with the situation, is looking to have the company's prostate cancer immunotherapy treatment (Provenge) approved by the US FDA sometime in 2010. Barring any unforeseen delays, the FDA decision should come at sometime in the first half of next year since Dendreon intends to file for Provenge approval in November of this year, according to previously released reports. In a recent Phase III trial, Provenge proved to extend the survivability of patients who received the treatment.
While a US partner is a possibility, Dendreon has previously indicated that they would rather 'go it alone' in marketing Provenge in the United States, but would be open to a 'Rest of World' partner - that's where Roche would come into play.
If Provenge is approved by the FDA next year, then I would expect a pretty significant run in the 'cancer immunotherapy' sector. Stocks such as
AGEN and
ONTY, both also working on their own immunotherapy treatments, would be sure to benefit from such a run - among many others.
Provenge, if approved, would also become the first approved cancer vaccine in the United States. Antigenics' Oncophage claims the title as the the world's first approved cancer vaccine after the Russian medical authorities approved the vaccine for the treatment of kidney cancer in April of last year.
The Provenge story has been long and marred with protest, controversy and conflicts of interests - namely by two Doctors who served on the FDA's advisory committee for Provenge in 2007 - but it looks like Dendreon and and the thousands of prostate cancer patients who have lobbied for the vaccine's approval will finally have their day in the sun.
As always, it's important to keep in mind that the FDA is a fickle and unpredictable bunch, so only time will tell what the final outcome for Provenge will be.
That being said, things have never looked brighter for the company after bringing two big time heavyweights on board to help bring Provenge to market.
Disclosure: No position in DNDN, long AGEN and ONTY.