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Gentium Provides Update On The Review Of Defibrotide Marketing Authorization Application

VILLA GUARDIA, Italy, Sept. 26, 2012 (GLOBE NEWSWIRE) -- Gentium S.p.A. (Nasdaq:GENT) (the "Company") 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. 

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 following high-dose chemotherapy and radiation therapy for hematologic cancers and other conditions in both adults and children. At present there is no approved agent for the treatment or prevention of VOD in the United States or the European Union.

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