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