Dendreon shares rise on plans to gain EU marketing approval for Provenge and US commercialization

US biotech firm Dendreon (Nasdaq: DNDN) saw its shares rise 4.2% to $36.90 in early trading last Friday, after the company outlined its European approval strategy for its prostate cancer drug Provenge (sipuleucel-T) and gave several updates on the US commercialization of the drug, which was cleared by the US Food and Drug Administration last spring (The Pharma Letter April 30, 2010).

Analysts predict that the product will reach blockbuster sales status - over $1 billion - by 2016, as the company expands production capacity for Provenge, therapy with which will cost some $93,000 per patient course of treatment. Provenge will largely be used in castration-resistant prostate cancer. The current standard of care is Taxotere (docetaxel)-based chemotherapy, from French drug major Sanofi-Aventis, which is comparatively easier to manufacture and administer, but is associated with significant toxicity.

"Last year was foundational for Dendreon with the successful introduction of Provenge as the world's first autologous cellular immunotherapy," said Mitchell Gold, president and chief executive of the Seattle-based company. "As we look to 2011 and beyond, we are positioned for significant growth with our increased capacity in the USA, our European strategy for filing now set, and our progress in advancing our ACI pipeline in bladder cancer. Most importantly, we are proud to deliver on our commitment to transform the lives of patients with cancer by making Provenge more broadly available in the USA and abroad."