VILLA GUARDIA (COMO), Italy, June 21, 2011 (GLOBE NEWSWIRE) -- Gentium S.p.A. (Nasdaq:GENT) (the "Company") announced that the Company has signed a ten-year exclusive license and distribution agreement with Medison Pharma Ltd. for defibrotide in Israel and the Palestinian Authority. Under the terms of the agreement, Medison will be responsible for managing the named-patient sales program and for local registration, authorization, marketing, reimbursement, and medical affairs in Israel and the Palestinian Authority region. Following approval to market defibrotide, if any, Medison will have the exclusive right to promote, purchase, market and sell defibrotide in these territories.
Commenting on the appointment of Medison, Adrian Haigh, Senior Vice President of Commercial Operations said, "I am delighted that Gentium has entered into a long-term partnership with Medison, a company with a very strong presence in Oncology and Hematology and a track record of success in the Israeli market."
Medison Pharma's President & CEO Meir Jakobsohn commented, "Medison's mission is to deliver the most innovative and unique healthcare solutions to our patients and we are very pleased to expand our Oncology & Hematology portfolio with defibrotide. Defibrotide is a unique product that addresses an unmet medical need, the treatment and prevention of veno-occlusive disease. It offers the real possibility to save lives where no alternative treatment exists."
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.
Medison Pharma Ltd, headquartered in Petach Tikva, Israel, is Israel's leading marketing group representing innovative pharmaceuticals, medical devices and diagnostics products. Medison provides a complete spectrum of integrated services for international companies looking to enter or expand their presence in the Israeli, Romanian and Slovakian healthcare markets. Medison has a long-term collaboration with many companies including Amgen, Biogen Idec, Shire, Ipsen and Boston Scientific.Medison employs a comprehensive approach to sales and service, supplying HMOs, medical centers and physicians. Aligned with the growing trend toward integrating pharmaceuticals, medical devices and diagnostics, Medison is taking a leading role in advancing personalized medicine and healthcare toward a more focused practice and treatment paradigms.
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."
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