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Gentium Appoints Gen Ilac as Exclusive Distributor of Defibrotide in Turkey

/ Source: GlobeNewswire

VILLA GUARDIA (COMO), Italy, June 16, 2011 (GLOBE NEWSWIRE) -- Gentium S.p.A. (Nasdaq:GENT) announced the appointment of Gen Ilac A.C. as exclusive distributor of Defibrotide in Turkey. Under the terms of the agreement, which is valid for 10 years, Gen Ilac will be responsible for managing named patient requests, achieving registration, marketing authorization and reimbursement within Turkey. Following regulatory approval, if any, Gen Ilac will be responsible for sales, marketing and local medical affairs activity as it relates to Defibrotide.

Commenting on the appointment of Gen Ilac, Adrian Haigh, Senior Vice President of Commercial Operations said, "Identifying and appointing experienced distribution partners with a strong presence in important markets is a key part of our commercialization strategy. After a thorough selection process, we chose Gen Ilac, a company with existing operations in hematology and a successful track record in managing the introduction of orphan drugs to the Turkish market."

Abidin Gulmus, CEO of Gen Ilac, added, "We are proud of our reputation as one of Turkey's leading specialty pharma companies, but even more important to us is the difference we make to the lives of people with life threatening conditions. We look forward to a successful partnership with Gentium, together providing Oncologists and Hematologists with the opportunity to treat and to prevent Veno Occlusive Disease, a serious complication of Stem Cell Transplantation treatment. We aspire to make Defibrotide available for Turkish patients as soon as possible."

About Gentium

Gentium S.p.A., located in Como, Italy, is a biopharmaceutical company focused on the development and manufacture of drugs to treat and prevent a variety of diseases and conditions, including vascular diseases related to cancer and cancer treatments. Defibrotide, the Company's lead product candidate, is an investigational drug that has been granted Orphan Drug status by the U.S. FDA and Orphan Medicinal Product Designation by the European Commission both to treat and to prevent VOD and Fast Track Designation by the U.S. FDA to treat VOD. Gentium's Marketing Authorization Application for Defibrotide was recently accepted by the European Medicines Agency and was granted an accelerated assessment. The company expects to file a New Drug Application with the U.S. FDA by the end of Q2 2011.

About Gen Ilac

Gen Ilac A.C, is a leading specialty pharmaceutical company headquartered in Ankara, Turkey. Gen Ilac represents innovative pharmaceutical and biotechnology companies, serving the medical community and patients in specific therapeutic areas of Neurology, Oncology, Hematology and Endocrinology. Gen Ilac has long term collaborations with a number of international companies including Biogen Idec, Cephalon and Ipsen. Gen Ilac is taking a leading role in Turkey bringing novel treatment options to patients with difficult to treat or rare conditions. 

Cautionary Note Regarding Forward-Looking Statements

This press release contains "forward-looking statements." In some cases, you can identify these statements by forward-looking words such as "may," "might," "will," "should," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential" or "continue," the negative of these terms and other comparable terminology. These statements are not historical facts but instead represent the Company's belief regarding future results, many of which, by their nature, are inherently uncertain and outside the Company's control. It is possible that actual results, including with respect to the possibility of any future regulatory approval, may differ materially from those anticipated in these forward-looking statements. For a discussion of some of the risks and important factors that could affect future results, see the discussion in our Form 20-F filed with the Securities and Exchange Commission under the caption "Risk Factors."

CONTACT: Gentium S.p.A. Salvatore Calabrese SVP Finance & CFO +39 031 385 287 or The Trout Group Marcy Nanus, +1 646 378 2927