CHMP Gives Negative Opinion on Gentium's Defibrotide for VOD; Shares to Resume at 9AM EST


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Gentium S.p.A.(Nasdaq: GENT) (the "Company") announced today that it has been informed by theEuropean Medicines Agency's ("EMA") Committee for Medicinal Products for HumanUse ("CHMP") that it has adopted a negative opinion, recommending the refusalof the marketing authorization for Defibrotide to treat and prevent hepaticveno-occlusive disease ("VOD") in adults and children undergoing hematopoieticstem cell transplantation therapy.Gentium remains convinced of the favourable benefit/risk profile ofDefibrotide, which is the only option recommended by the European Group forBlood and Marrow Transplantation for the treatment VOD, an unmet medical needwhere no agents are currently approved. In accordance with Europeanregulations, the Company plans to appeal the EMA's decision and request are-examination of the CHMP opinion.EU patients will continue to have access to Defibrotide, under a named patientprogram ("NPP") where available.

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