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

December 07, 2015

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.