CepTor Corporation Receives Dual Orphan Drug Designation For Myodur (C101) For Duchenne And Becker Muscular Dystrophies

HUNT VALLEY, Md.--(BUSINESS WIRE)--Jan. 25, 2006--CepTor Corporation (OTCBB:CEPO), a development-stage biopharmaceutical company focusing on cell-targeted therapeutic products for neuromuscular and neurodegenerative diseases, announced that the Office of Orphan Products Development of the Food and Drug Administration (FDA) granted orphan drug designation for Myodur for both Duchenne and Becker muscular dystrophies. The Orphan Drug Act (ODA) of 1983 provides for the granting of orphan designation for products that address serious or life threatening disease that affect less than 200,000 people in the U.S. and where no other definitive therapy is currently available. The spirit of the ODA legislation is to provide incentives to promote research on orphan diseases. As such, compounds, like Myodur, that are granted orphan designation, provide their manufacturers tax breaks, potential regulatory expediency including accelerated reviews and seven years of market exclusivity after commercial approval. CepTor recently announced the submission of its Investigational New Drug application (IND) to initiate phase I/II clinical trials with Myodur in Duchenne boys.