Dr. Michael Har-Noy, founder and CEO of Immunovative Therapies, Ltd., says that the hostile environment for immune cancer treatment development changed on April 29, 2010. On this date, Dendreon’s (DNDN) Provenge® [sipuleucel-T] became FDA approved for the treatment of metastatic castrate-resistant prostate cancer [CRPC]. A randomized clinical trial involving Provenge® demonstrated a 4.1 month survival increase compared to placebo. Dr. Michael Har-Noy says that these positive results rekindled enthusiasm for cancer vaccine research.
The stock shares of Dendreon, which traded below five dollars in March 2009, subsequently rocketed to a value greater than $57 and Dendreon reached a market capitalization of over $7.8 billion. This remarkable achievement, says Dr. Michael Har-Noy, showed the capital markets that the FDA would approve a living cell immunotherapy if a randomized trial showed that it had statistically significant efficacy, even if that efficacy was marginal. Also, Dendreon showed that Medicare would pay for novel and expensive therapies. Medicare approved a $93,000 of reimbursement for Provenge®.
However, Dr. Michael Har-Noy says that Provenge®’s commercialization proved to be much more difficult than predicted. On August 3, 2011, Dendreon lowered its revenue guidance for 2011 and predicted only modest growth. Dendreon’s revised estimates not only caused a dramatic drop in its stock price but also put a damper on other companies trying to bring their own cancer vaccines to market.
Finally, said Dr. Michael Har-Noy, Dendreon applied for Chapter 11 bankruptcy on November 10, 2014. The poor market performance of Dendreons’s cancer vaccine treatment again raised fear in the investment community. Dr. Michael Har-Noy says that Dendreon’s failure was likely caused by Provenge®’s inscalablilty rather by its marginal effectiveness. Provenge® cannot be mass produced – it must be made dose-by-dose using a complex process involving the patient’s individual tumor.