SEATTLE and ATLANTA, Aug. 10, 2009 - Dendreon Corporation (Nasdaq: DNDN) today announced it has signed a lease agreement with Majestic Realty Co. to build a 160,000 square-foot manufacturing facility in Union City, Ga., where it expects to manufacture PROVENGE® (sipuleucel-T) for patients with advanced prostate cancer. The state of Georgia will be hosting a ribbon-cutting ceremony on September 30.
If approved by the U.S. Food and Drug Administration (FDA), Dendreon would launch PROVENGE from its existing facility in Morris Plains, N.J. and would then ramp up additional manufacturing capacity of PROVENGE at its other facilities under development in Union City and Seal Beach, Calif. once they are completed. The Company expects to disclose more details relating to its manufacturing facilities at an upcoming analyst day in New York City.
"We are pleased to announce that we are expanding our manufacturing capacity with the addition of two new facilities in Atlanta and Los Angeles," said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "We have particularly enjoyed partnering with the state of Georgia, Fulton County officials and the local community during this process and are grateful for their partnership and support as we prepare to commercialize PROVENGE to help the many patients with advanced prostate cancer who currently have few appealing treatment options."
"Hosting the 2009 BIO International Convention in May introduced biotechnology companies like Dendreon to Georgia's business assets," said Sonny Perdue, Governor of the State of Georgia. "Our state's world-class healthcare institutions and hospitals enable companies like Dendreon to conduct clinical research and engage in product development while benefiting from the vast scientific resources that Georgia has to offer."
PROVENGE is Dendreon's investigational product candidate for men with advanced prostate cancer and may represent the first in a new class of active cellular immunotherapies (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 (IMmunotherapy for Prostate AdenoCarcinoma Treatment) study of PROVENGE in men with advanced prostate cancer met its primary endpoint of improving overall survival compared to a placebo control. The Company expects to complete its Biologics License Application (BLA) with the FDA in the fourth quarter of 2009.
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 active cellular immunotherapy 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.
Forward Looking Statements
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 presentation, except as required by law.
Jennifer Cook Williams