LAGUNA NIGUEL, Calif., Oct. 19 /PRNewswire/ -- Inspiration Biopharmaceuticals, Inc. (Inspiration) 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 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.
Michael Griffith, Ph.D., President and CEO of Inspiration, commented, "OBI-1 provides a unique, alternative approach to treating individuals with hemophilia who develop an immune reaction to human FVIII. The orphan drug designation in Europe is another sign of the overall progress of our program to develop OBI-1 and address a clear, unmet medical need among individuals with hemophilia." According to a partnership agreement signed with Ipsen SA (Euronext: IPN; ADR: IPSEY) in January 2010, Inspiration licensed OBI-1 from Ipsen and is responsible for the OBI-1 clinical trial development and commercialization.
Hemophilia is a bleeding disorder caused by low levels or absence of a protein called a coagulation factor, essential for blood clotting. The two most common forms of hemophilia are types A and B. Hemophilia A is caused by a factor VIII deficiency and occurs in ~1 out of every 5,000 male births. Hemophilia B is caused by factor IX deficiency and occurs in ~1 out of every 30,000 male births. Approximately 60% of persons with hemophilia have a severe condition, which results in frequent spontaneous bleeding episodes in addition to serious bleeding after injuries. The annual market for hemophilia treatments is $7.5 billion worldwid