Gentium Provides Update on the Review of Defibrotide Marketing Authorization Application

Gentium S.p.A. GENT today announced that, following the Company's presentation of Oral Explanations to the European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP") on September 19, 2012, the CHMP has decided to adopt a second List of Outstanding Issues ("LoOI") relating to the Company's Marketing Authorization Application ("MAA") for Defibrotide to treat and prevent hepatic veno-occlusive disease (VOD) in adults and children undergoing haematopoietic stem cell transplantation therapy. Defibrotide was designated as an orphan drug product in the European Union on July 29, 2004 for the treatment and prevention of VOD. Dr. Khalid Islam, Chairman and CEO of the Company, commented that "Gentium is committed to obtaining approval of this potentially life-saving treatment for VOD, a condition with a mortality rate of greater than 80% and for which there is currently no approved treatment." The Company continues to engage in an ongoing dialogue with the rapporteurs in the final stages of the application review process. The Company expects the CHMP to render a final decision on the Defibrotide MAA in the coming months.