Biotech Values

[DewDiligence]

“The FDA has requested additional clinical data
in support of the efficacy claim contained in the BLA.”

So 9902b is the real pivotal trial after all. Comisserations
to DNDN longs. If investors are rational, the hype that has
surrounded this company should now immediately cease.

http://biz.yahoo.com/prnews/070509/aqw069.html?.v=8

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Dendreon Receives Complete Response Letter From FDA for Provenge(R) Biologics License Application

Wednesday May 9, 5:30 am ET

SEATTLE, May 9 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN - News) today announced that it received a Complete Response Letter, commonly referred to as an "approvable" letter, on May 8, 2007 from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for PROVENGE (sipuleucel-T) for the treatment of asymptomatic, metastatic, androgen-independent (also known as hormone refractory) prostate cancer.

The FDA has requested additional clinical data in support of the efficacy claim contained in the BLA. The Company is seeking a clarification from the FDA as to the nature of the data that is being requested. The FDA has also requested additional information with respect to the chemistry, manufacturing and controls (CMC) section of the BLA, which the Company believes it can supply to the FDA in a timely manner.

"Given our strong belief in the survival benefit and safety profile of PROVENGE, coupled with the positive outcome of the Advisory Committee meeting, we are disappointed that this decision will cause a delay in the availability of PROVENGE for patients who suffer from advanced prostate cancer," said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "We are committed to working closely with the FDA to resolve these questions in a timely and efficient manner to bring PROVENGE to patients with advanced prostate cancer who currently have few appealing treatment options."

On March 29, 2007, the FDA's Office of Cellular, Tissue and Gene Therapies Advisory Committee was asked if the submitted data established that PROVENGE is reasonably safe and whether there is substantial evidence that the product is efficacious. The Advisory Committee voted 17 to 0 in favor of the safety of PROVENGE and 13 to 4 in favor of the efficacy of PROVENGE.

PROVENGE Biologics License Application

Dendreon's BLA was submitted under a Fast Track designation and was accepted for filing by the FDA in January 2007. The BLA was based primarily on a multi-center, randomized, double-blind, placebo-controlled Phase 3 study (D9901) that showed that the group of men with asymptomatic, metastatic, androgen-independent prostate cancer who received PROVENGE had a median survival time 4.5 months longer than the median survival seen in the group that had been assigned to receive placebo. For the men who received PROVENGE, there was a 41 percent overall reduction in the risk of death (p-value = 0.010; HR = 1.7). In addition, 34 percent of patients receiving PROVENGE were alive 36 months after treatment compared to 11 percent of patients randomized to receive placebo.

Treatment with PROVENGE was generally well tolerated. The majority of side effects were mild, including infusion-related fever and chills that were usually of low grade and typically lasted for one to two days following infusion.

Ongoing Clinical Study

IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) also known as D9902B, is an ongoing Phase 3 clinical trial measuring overall survival in men with hormone-refractory prostate cancer receiving PROVENGE versus those receiving placebo.

In order to be eligible to participate in the IMPACT study, a person must meet certain criteria, such as having cancer that has spread outside the prostate (metastatic) or cancer that has worsened while on hormone therapy among other additional criteria. Interested patients should contact the Dendreon Prostate Cancer Information line at 1-866-4PROSTATE (1-866-477-6782).
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