Dendreon Corp has unveiled its regulatory and commercialisation plans for its eagerly-anticipated investigational prostate cancer vaccine Provenge which the US firm is hoping to launch in mid-2010.

Speaking to analysts, chief executive Mitchell Gold said the Seattle-based group is on track to complete the submission of a Biologics License Application amendment to the US Food and Drug Administration by the middle of November, If approved, the firm will implement “a deliberate, stepwise launch” of Provenge (sipuleucel-T), which represents a “completely new approach that could change the way prostate cancer and eventually other cancers are treated”.

Dendreon believes that Provenge represents the first in a new class of active cellular immunotherapies that are uniquely designed to stimulate a patient's own immune system. The route to approval has been a controversial one as the FDA asked for more information on the vaccine in May 2007 despite one of its advisory committees voting 17-0 in favour of the safety of the drug and 13 to 4 for its efficacy.

That decision, based on data that featured a study which only showed a trend toward improvement in overall survival, led to protests from prostate cancer patients and the FDA was sued by a group called Care to Live. That lawsuit was dismissed because the agency has still not made a final decision that could be challenged.

However Dendreon’s stock soared in April after the firm unveiled data from a 512-patient Phase III study of men with advanced prostate cancer which showed that Provenge met its primary endpoint of improving overall survival compared to placebo. The company now says its New Jersey manufacturing plant would be at 25% capacity next year and up to full capacity in the first half of 2011. This will be supplemented by manufacturing at facilities which have been leased in Atlanta and Los Angeles.

Dendreon also noted that its headcount is currently 290 and this is expected to more than double by the anticipated time of Provenge’s launch. Analysts’ peak sales estimates for Provenge vary wildly from $1 billion to over $2.5 billion and the firm confirmed that it is looking for a partner to sell the vaccine outside the USA.

Dendreon also told the analysts that it plans to start a clinical trial of Neuvenge (lapuleucel-T) targeting the Her2-Neu pathway in bladder cancer in late 2010 or early 2011. The company added that the latter immunotherapy could also be effective in breast and colorectal cancers.