Dendreon Corporation, a biotechnology 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 (sipuleucel-T), the company's investigational active cellular immunotherapy for advanced prostate cancer, a company release said.

"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.

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.

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 per cent 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.