Gentium Requests Re-Examination of Negative Opinion of Defibrotide MAA by EMA

Gentium S.p.A. GENT (the "Company") announced today that, the Company has filed the documentation requesting a Re-examination of the negative opinion given by the European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP"), regarding the Marketing Authorisation (MAA) for Defibrotide to treat and prevent hepatic veno-occlusive disease ("VOD") in adults and children undergoing hematopoietic stem cell transplantation therapy. In accordance with European regulations, the CHMP has 60 days to consider a revision of the initial opinion and consequently a final recommendation may be made by the end of July. About the EMA Review Process: More information can be obtained from the EMA website www.ema.europa.eu. About VOD Veno-occlusive disease (VOD) is a potentially life-threatening condition, which typically occurs as a significant complication of stem cell transplantation. Certain high-dose conditioning regimens used as part of stem cell transplantation can damage the lining cells of hepatic blood vessels and result in VOD, a blockage of the small veins in the liver that leads to liver failure and can result in significant dysfunction in other organs such as the kidneys and lungs (so-called severe VOD). Stem cell transplantation is a frequently used treatment modality See full press release