SEATTLE and NEW YORK, Sept. 24, 2009 - At its analyst event today, Dendreon Corporation (Nasdaq: DNDN) provided updates on its regulatory and commercialization progress for PROVENGE® (sipuleucel-T), the Company's investigational product candidate for men with advanced prostate cancer.
"2009 has been a transformational year for the company as we prepare to commercialize PROVENGE by the middle of next year and make it available to the many men with metastatic castrate-resistant prostate cancer who currently have few appealing treatment options. We are on track to complete the submission of our Biologics License Application (BLA) amendment to the U.S. Food and Drug Administration (FDA) by the middle of November," said Mitchell H. Gold, M.D., president and chief executive officer. "After FDA approval we will implement a deliberate, stepwise launch to ensure the highest quality standards, patient delivery and experience with this completely new approach that could change the way prostate cancer and eventually other cancers are treated."
In addition to this regulatory progress, Dendreon provided the following updates today during its Analyst Day meeting in New York:
Manufacturing and Commercialization Preparation
PROVENGE is Dendreon's investigational product candidate for men with advanced prostate cancer and may represent the first in a new class of ACIs specifically designed to engage the patient's own immune system against cancer. PROVENGE and other ACIs 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. Dendreon recently announced that the pivotal Phase 3 IMPACT study of PROVENGE in men with advanced prostate cancer met its primary endpoint of improving overall survival compared to a placebo control.
Webcast Replay Information
If you are interested in listening to the replay of the analyst day webcast, you may access it from the Company's website at www.dendreon.com under the "Investor/Webcasts and Presentations" section.
Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics. The Company applies its expertise in antigen identification, engineering and cell processing to produce ACI product candidates designed to stimulate an immune response. Dendreon is also developing an orally-available small molecule that targets TRPM8 that could be applicable to multiple types of cancer as well as benign prostatic hyperplasia. 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 www.dendreon.com.
This news release contains forward-looking statements that are subject to risks and uncertainties. Factors that could affect these forward-looking statements include, but are not limited to, developments affecting Dendreon's business and prospects, including progress on the commercialization efforts for PROVENGE and requisite receipt of FDA licensure for marketing and the risk that additional capital could be needed in the future for the potential commercialization of PROVENGE. 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 www.sec.gov. Dendreon cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to Dendreon on the date hereof, and Dendreon undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.
Jennifer Cook Williams