Manufacturer of Provenge Files for Bankruptcy Protection

Zosia Chustecka

November 11, 2014

Dendreon, the Seattle-based company behind the prostate cancer vaccine sipuleucel-T (Provenge) has filed for bankruptcy protection (under Chapter 11 of the Bankruptcy Code) after smaller than anticipated sales of its only product.

The company is working on a financial restructuring, and says the product will remain available. "Whether the restructuring takes the form of a standalone recapitalization or a sale of the company or its assets, we are confident that this process will allow [sipuleucel-T] to remain commercially available to the patients and providers who have come to rely on this revolutionary personalized cancer immunotherapy," said W. Thomas Amick, president and chief executive officer of Dendreon.

Sipuleucel-T was approved by the US Food and Drug Administration in April 2010 for the treatment of asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC).

Often referred to as a vaccine, the product is an autologous active cellular immunotherapy, made from the patient's own white blood cells, which are collected and then reprogrammed to attack cancer cells. It needs to be manufactured individually for each patient.

This individual manufacture of the product and its high cost ($93,000 for a course of treatment) resulted in slower sales than had been predicted. In addition, competition appeared within months; when sipuleucel-T was launched, docetaxel was the only other approved treatment for men with mCRPC, but 2 other drugs were soon approved for the same indication: cabazitaxel (Jevtana, sanofi-aventis) in June 2010 and abiraterone (Zytiga, Johnson & Johnson) in April 2011.

The company has been in trouble for some time. In September 2011, the smaller than anticipated revenues led to 500 workers being laid off and company executives being sued for stock fraud.

Since 2011, Dendreon has changed chief executives twice and reduced its staff to about 700, about half the peak level, reports the New York Times. The company lost $22 million in the most recent quarter, it adds.

At one stage, analysts were estimating sales of $4 billion a year, but actual sales were more modest – an estimated $300 million in 2014, up slightly on last year, the newspaper reports. Dendreon said such a sales level would not be enough to allow the company to pay off $620 million in convertible debt, due early in 2016.

The company's stock is down about 70%, the newspaper reports; shares are now trading at around 30 cents a share. When the drug was approved in April 2010, they were around $50 per share.

Dendreon said it has about $100 million in cash and investments to support operations through the bankruptcy process, so it does not expect to raise any additional money until the restructuring is worked out, according to the Seattle Times.

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