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Apr 29, 2010

Dendreon Bags FDA Approval for Prostate Cancer Vaccine Provenge

Dendreon Bags FDA Approval for Prostate Cancer Vaccine Provenge

Provenge primes the patient's immune cells to elicit a stronger T-cell response against the prostatic acid phosphatase antigen.

  • FDA cleared the first therapeutic vaccine for cancer with sanction given to Dendreon's Provenge®. This individualized treatment is indicated for advanced prostate cancer. Provenge takes the patient's own immune cells and fuses them to a protein that functions as a prostate cancer-associated antigen. This primes the immune system to generate a T-cell response against the prostatic acid phosphatase antigen, which is expressed on most prostate cancers, according to Dendreon.

    The stock traded up 15% earlier today to $45.50 prior to being halted. The Spyder ETF with symbol XBI, up 3%, has not been halted and has a 4% exposure to Dendreon. After the conference call at 3:45 pm EDT, the stock traded in the $50 range, up 27% for the day. The company’s marketcap is $6.8 billion. One year ago the stock traded in the teens.

    In 2007, the FDA rejected Provenge despite a unanimous vote from its advisory panel in favor of treatment. The current approval comes with a post-marketing requirement to have a registry of about 1,500 patients to further evaluate a small potential safety signal of cerebrovascular events that were observed in 3.5% of patients in the Provenge arm of the study.

    The company has mobilized the Provenge product launch with three manufacturing facilities, 70 field sales and support staff, 50 clinics offering the product (all clinics involved in the clinical trial); 70 percent of these sites are for oncology and 30% for urology by specialty. Initial capability in the NJ facility will be for 2,000 patients, which is about 25% of plant capacity. Pricing will be a total of about $93,000 ($31,000 per infusion) per patient, with three infusions over one month. Treatment will begin almost immediately. The company has yet to meet with Centers for Medicare & Medicaid to coordinate reimbursement details.

    Dendreon does not yet have a major pharma partner, but it is expected that other major biotech companies like Celgene will collaborate with Dendreon on its other technology platform, active cellular therapies. A priority for the firm is to pursue regulatory approval for Provenge in major countries outside the U.S. The likelihood of generic competition will be more difficult due to intellectual property and the unique delivery system of autologous therapy, the company pointed out.

    Dendreon has been working on this product and technology for 15 years with an investment of close to $1 billion. In the fourth quarter of 2009, the company raised $409 million and had about $600 million in cash. Recently, the stock was upgraded from analysts at Canaccord Adams, JPMorgan, and Robert W. Baird. The stock was downgraded by Citigroup on April 14.

    Three Phase III studies were presented to the FDA to support approval. The pivotal study was the Phase III IMPACT trial, a 512-patient, multicenter, randomized, double-blind, placebo-controlled study that evaluated men with asymptomatic or minimally symptomatic, metastatic, hormone refractory prostate cancer.

    Provenge extended median survival beyond two years, demonstrating a median improvement of 4.1 months compared to the control group, Dendreon reported. Risk of death was reduced by 22.5%.


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