SEATTLE, Aug. 1 /PRNewswire-FirstCall/ -- Dendreon Corporation announced today that the Company has completed the initial build-out of its New Jersey manufacturing facility.
This state-of-the art facility has the capacity to support clinical processes and future anticipated commercial needs for PROVENGE(R) (sipuleucel-T), the Company’s investigational active cellular immunotherapy for advanced prostate cancer.
“The completion of the initial build-out of our New Jersey manufacturing facility is an important milestone on the path to our PROVENGE license application for marketing approval, which we plan to submit to the FDA later this year,” said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. “We are committed to bringing PROVENGE to the market to help the many men with late-stage prostate cancer and believe this achievement brings us one step closer to this goal.”
PROVENGE has Fast Track designation and the Company plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) as a rolling submission this year for approval to market PROVENGE. The Company will apply for Priority Review upon completion of its BLA submission. If approved, PROVENGE would become the first commercially available active cellular immunotherapy designed to stimulate a man’s own immune system to treat advanced hormone-refractory prostate cancer.
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 232,000 new cases of prostate cancer diagnosed each year. More than 30,000 men die each year of the disease.
About PROVENGE
PROVENGE 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. ACIs hold promise because they may provide patients with a meaningful survival benefit with low toxicity. PROVENGE targets the prostate cancer antigen, prostatic acid phosphatase (PAP), which is found in approximately 95% of prostate cancers. PROVENGE is in clinical development for the treatment of patients with early-stage and advanced prostate cancer. In clinical studies, patients typically are randomized to receive three infusions of PROVENGE or placebo over a one-month period as a complete course of therapy.
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 uses its experience in antigen identification, antigen engineering and antigen-presenting cell processing to produce active immunotherapy product candidates to potentially stimulate a cell-mediated immune response. PROVENGE (sipuleucel-T) is Dendreon’s lead active cellular immunotherapy in Phase 3 development for prostate cancer. The Company also discovered Trp-p8, a cold receptor and transmembrane ion channel in pre-clinical development, which is over-expressed in breast, prostate, lung and colon cancers. For more information about the Company and its programs, visit 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 www.sec.gov.
Dendreon Corporation
CONTACT: Monique M. Greer, Sr. Director, Corporate Communications ofDendreon Corporation, +1-206-829-1500
Web site: http://www.dendreon.com//
