Gentium Gets EMA Orphan Drug Designation For Defibrotide For Prevention Of GvHD

(RTTNews) - Italy-based biopharma Gentium S.p.A. (GENT) said it received Orphan Drug Designation from European Commission for Defibrotide for the prevention of Graft versus Host Disease or GvHD. This follows a positive opinion released by the Committee for Orphan Medicinal Products, or COMP, of the European Medicines Agency, on October 10, 2013.

The EMA grants orphan medicinal product designations to advance the development of drugs intended to treat, prevent or diagnose life-threatening or very serious conditions that are rare and affect not more than 5 in 10,000 persons in EU.

Orphan Drug Designation will entitle Defibrotide to ten years of market exclusivity in European Union and will provide the Company with development and commercial incentive, access to a centralized review process, protocol assistance and scientific advice during product development, waiving or reduction of certain fees and eligibility for grants and research support initiatives.

"We are pleased to receive Orphan Drug Designation for this second indication by the EMA for Defibrotide for the prevention of GvHD," said Khalid Islam, Gentium's Chairman and Chief Executive Officer.