BioSante Pharmaceuticals receives receipt of Orphan Drug designation for GVAX Pancreas Vaccine

Mar 15 2010

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced BioSante’s receipt of Orphan Drug designation from the FDA’s Office of Orphan Products Development for GVAX Pancreas Vaccine in the treatment of pancreatic cancer.

“The Orphan Drug designation of GVAX Pancreas Vaccine for the treatment of pancreatic cancer is BioSante’s first GVAX regulatory submission and response from the FDA since acquiring this portfolio of cancer vaccines last October”

“The Orphan Drug designation of GVAX Pancreas Vaccine for the treatment of pancreatic cancer is BioSante’s first GVAX regulatory submission and response from the FDA since acquiring this portfolio of cancer vaccines last October,” said Stephen M. Simes, BioSante’s president & CEO. “It is our intention to find ways to continue the development of our GVAX Pancreas Vaccine using the benefits conferred by gaining Orphan Drug designation. Further, this designation alerts the FDA that we are dedicated to bringing better cancer therapy to patients in need. Currently, GVAX Pancreas Vaccine clinical trials are ongoing at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center. In addition, clinical trials of GVAX vaccines against many different cancer types are being conducted, including leukemia and breast cancer. We value our collaborative relationship with the researchers at the Cancer Center and intend to work with them to advance the development of these potentially life-saving therapies.”

Patients with pancreatic cancer have one of the poorest 5-year survival rates for any form of cancer. Median survival after diagnosis is around 3 to 6 months. Pancreatic cancer is sometimes called a “silent killer” because generally it does not cause symptoms, and when symptoms do arise, they are usually non-specific and varied. Consequently, pancreatic cancer often is not diagnosed until the disease is advanced. In view of this poor patient prognosis, the need for new, effective pancreatic cancer treatment regimens is urgent.

The ongoing GVAX Pancreas Vaccine trials are designed to determine the safety, overall survival and response to GVAX Pancreas Vaccine combined with various anti-cancer agents, as compared to those agents on their own or in combination with other agents.

The Orphan Drug Act (ODA) provides for granting special status to a product to treat a rare disease or condition upon request of a sponsor. The combination of the product to treat the rare disease or condition must meet certain criteria. This status is referred to as orphan designation. Orphan designation qualifies the sponsor of the product for a tax credit and seven years of marketing exclusivity of the ODA. A marketing application for a prescription drug product that has been designated as a drug for a rare disease or condition is not subject to a prescription drug user fee unless the application includes an indication for other than a rare disease or condition. The disease or condition for which the drug is intended affects fewer than 200,000 people in the United States or, if the drug is a vaccine, diagnostic drug, or preventive drug, the persons to whom the drug will be administered in the United States are fewer than 200,000 per year.

SOURCE BioSante Pharmaceuticals, Inc.