|Dendreon Files Prostate Cancer Vaccine's Biologic License Application|
|By Staff and Wire Reports|
|Monday, 02 November 2009 10:41|
Dendreon Corp (Nasdaq:DNDN) has completed its U.S. regulatory submission for its closely watched experimental prostate cancer vaccine, the company said on Monday, sending its shares up in early trading.
If approved by the U.S. Food and Drug administration, PROVENGE would be the first drug in a new therapeutic class known as active cellular immunotherapies.
"ACI works by enhancing or encouraging immune response to cancerous cells," writes Dr. Theresa Phillips, About.com's Guide to Biotech
"In contrast to Passive Cellular Immunotherapy, where effector cells are infused into the patient but not induced or expanded within the patient, ACI involves inducing an effective response to tumor cells within patients whose immune systems have failed to do so on their own. These methods generally involve introducing tumor antigens to the host effector cells."
"With the BLA submission complete, we have taken an important step towards reaching our goal of bringing a new therapy to men with advanced prostate cancer," said Mitchell H. Gold, MD, president and chief executive officer of Dendreon. "We look forward to working with the FDA to potentially make PROVENGE the first active cellular immunotherapy to be licensed in the United States."
Dendreon in September said it will be able to make enough Provenge to generate potential sales of $60 million to $125 million in the second half of next year.
The company plans to ramp up production until full capacity is achieved by late 2011 at plants in New Jersey, Atlanta and Los Angeles, together able to support potential annual sales of $1.2 billion to $2.5 billion, according to published reports.