Dendreon says FDA has approved a third Provenge manufacturing facility Print
By Staff and Wire Reports   
Sunday, 28 August 2011 05:24
biotech tradingAfter hours on Friday, Dendreon Corp. announced that the Food and Drug Administration approved a third facility where the company will make its prostate cancer therapy Provenge.

Dendreon said the FDA approved its facility in Atlanta. It previously approved manufacturing plans in New Jersey and Los Angeles. The Atlanta facility includes 36 workstations and Dendreon will bring the workstations online in stages.

Provenge is a therapy designed to train a patient's immune system to fight prostate cancer. Studies indicate it extended patients' lives by about four months. A round of treatment with Provenge costs $93,000, and earlier this month, Dendreon said concerns about reimbursement for the drug were hurting its sales. The company had expected $350 million to $400 million in Provenge revenue in 2011, but it has withdrawn that forecast.

Analysts have been saying that the demand for the drug may not be very strong and doctors and patients may not be very impressed with its results. This caused biotech executives and others involved in the cancer vaccine space to speak up about their own products.

Days ago, Dr. Manish Singh, President and CEO of ImmunoCellular Therapeutics (OTCBB:IMUC), shared his thoughts on the recent headlines which sent shockwaves through the entire biotechnology grouping on Wall Street.

"Analyst reports issued after last week’s earnings call indicate Dendreon’s setback was primarily due to slower-than-expected adoption of Provenge and the continued high cost of manufacturing," explained Singh. "It therefore appears that Dendreon’s current problems mainly relate to execution, and not to the technologies underlying its products. We know Provenge works based on data from multiple clinical trials demonstrating a clear survival benefit in treated patients. It was based on these data that the FDA approved Provenge last year, a decision that reinvigorated interest in the entire immunotherapy space. With the approval of BMS’ melanoma drug Yervoy earlier this year, immunotherapy companies gained even greater momentum, which we are confident will increase even further as these companies, including ImmunoCellular Therapeutics, continue advancing novel immunotherapy products in the clinic, and ultimately to the market.

Read the rest of his comments at:

According to the American Cancer Society, prostate cancer is the most common non-skin cancer in men in the United States and the third most common cancer worldwide. More than two million men in the United States have prostate cancer, with an estimated 240,890 new cases and approximately 33,720 men expected to die from the disease in 2011.


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