Osiris Therapeutics, Inc. Receives Second Approval for Life-Saving Stem Cell Drug; Prochymal Granted Marketing Consent By New Zealand

Osiris Therapeutics, Inc. announced that it has received consent from New Zealand to market its first-in-class stem cell therapy Prochymal (remestemcel-L), for the treatment of acute graft-vs-host disease (GvHD) in children. Osiris submitted a New Medicine Application (NMA) to Medsafe (New Zealand's medical regulatory agency) in May of 2011, and was granted Priority Review in June of 2011. Priority review provides expedited review for new drugs which offer a significant clinical advantage over current treatment options. Prochymal was granted provisional consent under Section 23 of the Medicines Act 1981. Clinical trials have shown that Prochymal is able to induce an objective, clinically meaningful response in 61-64% of children with GvHD that is otherwise refractory to treatment. Furthermore, treatment response with Prochymal resulted in a statistically significant improvement in survival. It is expected that Prochymal will be commercially available in New Zealand later this year.