World's first stem cell drug, Osiris' Prochymal, approved in Canada

USA-based Osiris Therapeutics (Nasdaq: OSIR) has received market authorization from Health Canada to market its stem cell therapy Prochymal (remestemcel-L), for the treatment of acute graft-vs-host disease (GvHD) in children. The company's shares jumped 15% to $6.05 in after hours trading following the announcement on Thursday.

Prochymal is now authorized for the management of acute GvHD in children who fail to respond to steroids. The decision marks the world’s first regulatory approval of a manufactured stem cell product and the first therapy approved for GvHD - a devastating complication of bone marrow transplantation that kills up to 80 of children affected, many within just weeks of diagnosis.

Earlier this year French drug major Sanofi (Euronext: SAN) returned the rights to Prochymal outside the USA, Canada and Japan, which had been licensed to its now subsidiary Genzyme, to Osiris – freeing the latter  to commercialize or enter into commercialization agreements for Prochymal with other parties without restriction (The Pharma Letter February 13). The product is currently also in Phase III trials for refractory Crohn's disease and is being evaluated in clinical trials for the treatment of heart attacks and type 1 diabetes.