Gentium Receives EMA Orphan Drug Designation for Defibrotide

Gentium S.p.A.

announced today that the European Commission ("EC") has granted Orphan Drug Designation to Defibrotide for the prevention of Graft versus Host Disease ("GvHD"). The designation follows a positive opinion released by the Committee for Orphan Medicinal Products ("COMP") of the European Medicines Agency ("EMA"), on October 10, 2013. Orphan Drug Designation will entitle Defibrotide to ten years of market exclusivity in EU 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. 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. "We are pleased to receive Orphan Drug Designation for this second indication by the EMA for Defibrotide for the prevention of GvHD," said Dr. Khalid Islam, Gentium's Chairman and Chief Executive Officer. The granting of this Orphan Drug Designation is another important milestone for Defibrotide as we continue our