Dendreon receives FDA approval for Los Angeles cancer immunotherapy manufacturing facility

Jun 30 2011

Dendreon Corporation (Nasdaq: DNDN) today announced that the U.S. Food and Drug Administration (FDA) approved its Los Angeles cancer immunotherapy manufacturing facility, allowing the company to continue to increase the availability of PROVENGE^® (sipuleucel-T) across the U.S. to help meet the needs of patients with asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.  

The Los Angeles facility includes 36 workstations, and Dendreon will bring these new workstations online in a staged approach. With this FDA approval and the fully approved New Jersey facility, Dendreon now has total of 84 workstations available to manufacture PROVENGE. Dendreon expects to continue to provide additional capacity through the anticipated licensure mid-year of one other manufacturing facility in the United States.  In April, Dendreon filed a post-approval supplement for its third facility in Atlanta, for which there is an FDA action date of August 28, 2011.

PROVENGE is designed to induce an immune response against prostatic acid phosphatase (PAP), an antigen expressed in most prostate cancers, and is the first in a new therapeutic class of drugs known as autologous cellular immunotherapies.

"As the foundation of care, PROVENGE is an important treatment option for men with metastatic castrate resistant prostate cancer," said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "The FDA approval of the Los Angeles facility will enhance our ability to provide PROVENGE to the many patients across the country who may benefit from it."  

In anticipation of the availability of the additional workstations, Dendreon expects to have approximately 225 active infusing sites by the end of the second quarter and approximately 500 by the end of 2011.

PROVENGE was approved based on three Phase 3 studies, including the pivotal, 512-patient Phase 3 IMPACT study, which showed that PROVENGE demonstrated a statistically significant improvement in overall survival compared to control in men with asymptomatic or minimally symptomatic metastatic castration resistant prostate cancer (CRPC). That trial showed PROVENGE extended median survival by 4.1 months compared to control.  Overall, PROVENGE reduced the risk of death by 22.5 percent compared to the control group.