Dendreon Completes Construction of New Jersey Manufacturing Facility
Dendreon Corporation 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® (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 is an investigational product that, according to the company, 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.
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