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Dendreon Receives European Patent Covering PROVENGE and Company’s ACI Platform Technology
Tuesday, January 15, 2008
Seattle, WA -- Dendreon Corporation today announced that the company has been granted a broad European patent covering the company's lead product candidate PROVENGE (sipuleucel-T), the Company's investigational active cellular immunotherapy for the treatment of advanced prostate cancer. European patent No. 0 870 022 B1 covers the composition of matter of PROVENGE as well as the company's other active cellular immunotherapy (ACI) product candidates, such as NEUVENGE (lapuleucel-T), which utilize Dendreon's Antigen Delivery Cassette technology. The patent also covers methods of activating antigen presenting cells in vitro with certain fusion proteins developed by Dendreon, including the fusion protein that is used in PROVENGE.
"The approval of this broad patent covering PROVENGE and our other active cellular immunotherapies in Europe is an important milestone for the company," stated Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "While our priority is to obtain the approval of PROVENGE in the United States, the issuance of this key patent solidifies the commercial potential of PROVENGE and our ACI platform on a more international basis. Prostate cancer is a global unmet need with, according to Cancer Research UK, approximately 670,000 men diagnosed with the disease each year, and we believe that PROVENGE could have a worldwide impact on the treatment of prostate cancer."
About Active Cellular Immunotherapy with PROVENGE
PROVENGE may represent the first product in a new class of active cellular immunotherapies (ACIs) that are uniquely designed to use live human cells to engage the patient's own immune system with the goal of eliciting a specific long-lasting response against cancer. In clinical studies, patients typically received three doses of PROVENGE over a one-month period as a complete course of therapy. Following a positive assessment of safety and efficacy from an outside panel of experts on the Cell, Tissue and Gene Therapies Advisory committee to the FDA, Dendreon received a complete response letter from the U.S. Food and Drug Administration (FDA) that asked for additional evidence that would support the efficacy of PROVENGE. Subsequently, Dendreon received confirmation that the FDA will accept either a positive interim or positive final analysis of overall survival from the IMPACT study to amend the Biologics License Application (BLA) and support the efficacy claim for PROVENGE. Interim data from the fully-enrolled IMPACT study are expected in the second half of 2008.
About Prostate Cancer
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 218,890 new cases expected to be diagnosed in 2007, and more than 27,000 men expected to die this year from the disease. Currently, there are limited treatment options for men with advanced, metastatic prostate cancer.
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 an 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 its headquarters in Seattle, Washington and is traded on the Nasdaq Global Market 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 existing clinical trials or from additional clinical trials for PROVENGE will not support approval 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.
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