Biodel (BIOD) Gets Orphan Designation Suggestion from EMA COMP for CHI Treatment Glucagon

Biodel Inc. (Nasdaq: BIOD) reports that the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) has recommended that Biodel's Stabilized Glucagon for the treatment of congenital hyperinsulinism (CHI) be granted Orphan Medicinal Product Designation. The COMP's recommendation to the European Commission generally results in a ratification of the COMP opinion by the European Commission one to two months following the announcement by the COMP. Orphan designation qualifies the sponsor of the product for fee reductions, protocol assistance, centralized application procedure and access to 10 years marketing exclusivity once authorized, according to the Orphan Drug Regulation.

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