Osiris Therapeutics Wins Title of European Orphan Drug Status for Prochymal

Osiris Therapeutics, Inc. (NASDAQ: OSIR), the leading stem cell companydeveloping and marketing products to treat medical conditions in inflammatory,cardiovascular, orthopedic and wound healing markets, announced today that theEuropean Medicines Agency (EMA) has designated Osiris as the Orphan Drug titleholder for Prochymal® (remestemcel-L).The EU Commission adopted the decision to transfer the designation ofProchymal (ex-vivo cultured adult human mesenchymal stem cells) as an orphanmedicinal product under Regulation (EC) No 141/2000 of the European Parliamentand of the Council. The Decision will appear in the EU Community Register ofOrphan Medicinal Products.In Europe, Orphan Drug designation provides a variety of incentives, includingmarket exclusivity for up to 10 years following approval, to companies thatdevelop drugs for underserved patient populations.In the EU, the Orphan Drug designation for Prochymal is for the treatment ofacute graft versus host disease (GvHD). Prochymal, a first-in-class allogeneicstem cell therapy, has already received approval in Canada and New Zealand forthe treatment of acute GvHD in children, and is currently available in sevenother countries including the United States under an Expanded Access Program(EAP). Recently, Swissmedic, the Swiss agency responsible for the evaluationof drugs, notified Osiris that Prochymal will be evaluated under its RapidAuthorization Procedure upon submission of the marketing application.