FDA approves Dendreon's second manufacturing facility Print E-mail
By Staff and Wire Reports   
Thursday, 30 June 2011 05:58
Penny stockAfter hours on Wednesday, Dendreon Corporation (Nasdaq:DNDN) announced that the FDA approved its Los Angeles cancer immunotherapy manufacturing facility, allowing the company to continue to increase the availability of PROVENGEĀ® across the country to help meet the needs of patients with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer.

On Tuesday, we told our premium subscribers via a research note that analyst George Farmer fully expected DNDN would win FDA approval for its California Provenge manufacturing facility, adding 36 West Coast workstations to support the 48 in NJ.

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.

"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."  

According to the company, 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.

Canaccord is reiterating a BUY rating on Dendreon witha $65 price target.


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