Medical Blogs

March 2, 2007

Dendreon Announces New Data Analyses Presented At Prostate Cancer Foundation Scientific Retreat

Dendreon Corporation (Nasdaq: DNDN) today announced that Eric J. Small, M.D., professor of medicine and urology at the University of California, San Francisco presented new exploratory analyses of the Phase 3 Study (D9901) that further support the results observed with the Company's investigational active cellular immunotherapy PROVENGE(R) (sipuleucel-T) in men with advanced androgen- independent (hormone refractory) prostate cancer.

These data were presented at the Prostate Cancer Foundation's 13th Annual Scientific Retreat held Oct. 19-21, 2006 in Scottsdale, Arizona. The Company plans to complete the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) prior to the end of this year to seek approval to market PROVENGE.

The analyses presented by Dr. Small showed:

-- The overall survival benefit does not appear to be due to any imbalances in the treatment arms or the subsequent use and timing of chemotherapy. As published in the July issue of the Journal of Clinical Oncology, the Phase 3 Study (D9901) demonstrated a median overall survival of 25.9 months in the PROVENGE arm compared with 21.4 months in the placebo arm, or a 4.5 month survival difference. For these men, there was a 41 percent overall reduction in the risk of death (p-value = 0.010; HR = 1.71); and

-- An analysis of prostate-cancer-specific survival showed a median survival of 35.2 months for patients randomized to PROVENGE compared to 23.5 months for patients randomized to placebo, a difference of 11.7 months and a 50 percent reduction in prostate cancer-specific mortality (p-value = 0.002; HR = 2.04).

A link to Dr. Small's presentation will be available via Dendreon's web site at http://www.dendreon.com.

"These and other analyses we have performed further support our BLA filing, which we intend to complete this year," said Mark Frohlich, M.D., vice president of clinical affairs at Dendreon. "We remain focused on the goal of making this active cellular immunotherapy available for the treatment of the many men with advanced prostate cancer who currently have few appealing treatment options available to them."

Prostate cancer is the most common non-skin cancer in the United States and the third most common cancer worldwide. More than one million men in the United States have prostate cancer, with an estimated 232,000 new cases of prostate cancer diagnosed each year. More than 30,000 men die each year of the disease.

About PROVENGE

PROVENGE (sipuleucel-T) is an investigational product that may represent the first in a new class of active cellular immunotherapies (ACIs) that are uniquely designed to stimulate a patient's own immune system. PROVENGE is in late-stage clinical development for the treatment of patients with early-stage and advanced prostate cancer. In clinical studies, patients typically received three infusions over a one-month period as a complete course of therapy.

Treatment with PROVENGE was generally well tolerated. In controlled clinical trials, the most common adverse reactions associated with PROVENGE were chills, fever, headache, fatigue, shortness of breath, vomiting and tremor. These events were primarily low grade events, with a short duration lasting 1 to 2 days following infusion.

Dendreon has submitted one of two portions of a rolling submission of a BLA with the FDA for PROVENGE as an active cellular immunotherapy treatment for asymptomatic men with metastatic, androgen-independent prostate cancer. The Company expects to submit the chemistry, manufacturing and controls (CMC) section prior to the end of 2006. If approved, PROVENGE would become the first commercially available active cellular immunotherapy for advanced hormone- refractory prostate cancer.

About Dendreon

Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics that harness the immune system to fight cancer. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy product candidates designed to stimulate a cell-mediated immune response. Active cellular immunotherapy holds promise because it may provide patients with a meaningful clinical benefit, such as survival, combined with low toxicity. The Company has headquarters in Seattle and is traded on The Nasdaq Stock Market(R) under the symbol DNDN. For more information about the Company and its programs, visit http://www.dendreon.com.

Except for historical information contained herein, this news release contains forward-looking statements that are subject to risks and uncertainties surrounding the efficacy of PROVENGE to treat men suffering from prostate cancer, risks and uncertainties surrounding the presentation of data to the FDA and approval of product applications by the FDA and risks and uncertainties inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Factors that may cause such differences include risks related to our limited operating history, risks associated with completing our clinical trials, the risk that the safety and/or efficacy results of a clinical trial for PROVENGE will not support an application for a biologics license, the risk that the FDA may interpret data differently than we do or require more data or a more rigorous analysis of data than expected, the risk that the FDA will not approve a product for which a biologics license has been applied, the risk that the results of a clinical trial for PROVENGE or other product may not be indicative of results obtained in a later clinical trial, risks that we may lack the financial resources and access to capital to fund required clinical trials or commercialization of PROVENGE, our dependence on the efforts of third parties, and our dependence on intellectual property. Further information on the factors and risks that could affect Dendreon's business, financial condition and results of operations are contained in Dendreon's public disclosure filings with the U.S. Securities and Exchange Commission, which are available at http://www.sec.gov.

Dendreon Corporation
http://www.dendreon.com

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