Market Overview

FDA Grants Orphan Drug Designation to Biodel's Glucagon for Prevention of Hypoglycemia in Congenital Hyperinsulinism Population


Biodel (Nasdaq: BIOD) today announced that the FDA has granted orphan drug designation for Biodel's 'glucagon' for the prevention of hypoglycemia in the congenital hyperinsulinism (CHI) population.

The FDA grants orphan designation to promote development of therapies to treat rare diseases. Once this designation is granted, the sponsor may be eligible for a range of incentives including FDA grant funding for clinical trial costs, tax credits related to development expenses, waiver of FDA user fees, and a seven-year period of marketing exclusivity in the U.S. following FDA approval.

Dr. Errol De Souza, President and Chief Executive Officer of Biodel, stated: "We welcome the FDA's recognition of the important contribution a stable formulation of glucagon could bring to the lives of children suffering from CHI. While our primary glucagon program is a rescue product for the treatment of severe hypoglycemia in patients with diabetes, this designation represents an important component of our strategy to maximize the value of our product candidates to patients and shareholders in both our glucagon and ultra-rapid-acting prandial insulin programs."

Biodel previously received a positive opinion for orphan drug designation from the European Medicines Agency's Committee for Orphan Medicinal Products (EMA's COMP) on January 17, 2012, and orphan designation by the European Commission (EC) on March 5, 2012.

Posted-In: News FDA


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