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Jazz Pharmaceuticals And Gentium S.p.A. Announce Agreement For Jazz Pharmaceuticals To Acquire Gentium For $57.00 Per Share
Date:12/19/2013

for the treatment of VOD and Fast Track Designation by the U.S. FDA to treat VOD. In October 2013, the European Commission granted Marketing Authorization for Defitelio™ (defibrotide) for the treatment of severe VOD in adults and children undergoing hematopoietic stem cell transplantation therapy.  In November 2013, the EU granted Orphan Drug Designation for defibrotide for the prevention of Graft versus Host Disease (GvHD).  For additional info and to sign up for email alerts, please visit www.gentium.com.

About Defitelio™
Defitelio obtained a Marketing Authorization by the European Commission for the treatment of severe hepatic VOD in hematopoietic stem cell transplantation (HSCT) therapy.  A Phase 3 randomized controlled study of defibrotide in the prevention of hepatic VOD in pediatric HSCT patients has also been completed.  Defitelio has generally been well-tolerated; the most frequent adverse reactions observed during the treatment of hepatic VOD in pre-marketing use were hemorrhage, hypotension and coagulopathy.

About VOD
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 for hematologic cancers and other conditions in both adults and children.

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This press release contains forward-looking statements regarding Jazz Pharmaceuticals and Gentium, including, but not limited to, statements rel
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