Gentium Provides Update on MAA Process for Defibrotide in Europe

Gentium S.p.A. GENT today provided an update on the European Marketing Authorization Application for Defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing haematopoietic stem-cell transplantation therapy. Following a clarification meeting recently held with the Company's Rapporteurs, Gentium anticipates submitting a response to the Day 120 List of Questions (LoQs) from the European Medicines Agency's Committee for Medical Products for Human Use in the first quarter of 2012. Gentium submitted the MAA for Defibrotide to the EMA in May 2011 and the CHMP issued the LoQs at the end of September, 2011. The CHMP review of the MAA will resume with Day 121 upon submission of Gentium's response.