PARIS--(BUSINESS WIRE)--Regulatory News: Ipsen (Paris:IPN) (Euronext: IPN; ADR: IPSEY) announced today that the European Commission has granted orphan drug status for OBI-1 for the treatment of hemophilia. Expected to enter pivotal clinical trials before the end of this year, OBI-1 is designed to treat individuals with hemophilia who have developed inhibitory antibodies (inhibitors) against human Factor VIII (hFVIII). The orphan drug status would trigger a 10-year market exclusivity for OBI-1 in the European Union after its marketing approval. The U.S. Food & Drug Administration (FDA) issued an Orphan Drug Designation for OBI-1 in March 2004.
