VILLA GUARDIA (COMO), Italy, Oct. 4, 2012 (GLOBE NEWSWIRE) -- Gentium S.p.A. (Nasdaq:GENT) announced today the appointment of Biologix FZCo as the exclusive distributor of Defibrotide in the Middle East and North Africa (MENA).
Under the terms of the agreement, which is valid for 10 years, Biologix will be responsible for managing named-patient requests and obtaining price and reimbursement approvals in the MENA region. Following regulatory approval to market Defibrotide, if any, Biologix will be responsible for sales, marketing and local medical affairs activities in this region.
"We are pleased to have established a long-term relationship with Biologix for the distribution of Defibrotide in the Middle East and North Africa, consistent with our overall commercial strategy to partner with strong local distributors," said Adrian Haigh, Senior Vice President of Commercial Operations at Gentium. "Local distribution partners with strong experience in hematology and well-established local relationships, such as Biologix, help to facilitate access to Defibrotide."
"We look forward to working with Gentium and are pleased with the addition of Defibrotide to our specialty distribution portfolio. The partnership with Gentium will allow us to provide MENA patients access to this potentially life-saving treatment," said Selim Ghorayeb, Managing Partner at Biologix.
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. Food and Drug Administration (FDA) and Orphan Medicinal Product Designation by the European Medicines Agency both to treat and to prevent veno-occlusive disease (VOD) and Fast Track Designation by the U.S. FDA to treat VOD.
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Biologix FZCo, a company established under the laws of UAE in 2003, provides for the distribution and marketing of biotech products in the MENA region. Equipped with a logistics hub based in Dubai Airport Free Zone and supported by a qualified workforce, it offers effective Regulatory, Medical, Marketing, Sales and Distribution support to its partners with a direct and adequate presence in 17 countries of the Middle East and North Africa including Saudi Arabia, UAE, Kuwait, Bahrain, Oman, Qatar, Yemen, Iran, Iraq, Lebanon, Syria, Jordan, Egypt, Libya, Tunisia, Algeria, and Morocco. Biologix' main therapeutic focuses are Oncology-Hematology, Central Nervous System and Rare Diseases.
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.
Defibrotide has the potential to become the first drug approved for the prevention and treatment of hepatic veno-occlusive disease (VOD) a serious and potentially fatal complication of hematopoietic stem-cell transplantation (HSCT). The efficacy of Defibrotide to treat hepatic VOD in HSCT patients is supported by data from a multi-center Phase 3 historically controlled trial, evaluating Defibrotide for the treatment of severe VOD (patients with VOD and multi-organ failure), a Phase 2 dose finding study, and interim data reported from the ongoing Phase 3 expanded access U.S. Treatment IND program in patients with severe hepatic VOD. Additional data include a Phase 3 randomized controlled study of Defibrotide in the prevention of hepatic VOD in pediatric HSCT patients. Defibrotide has generally been well-tolerated in the clinical setting, and results in more than 1,300 patients to date have generally shown that Defibrotide does not appear to increase the risk of complications in HSCT patients.
Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" that involve a number of risks and uncertainties the outcome of which could materially and/or adversely affect actual future results and the market price of Gentium's securities. 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. Specifically, the risks and uncertainties that could affect the development of Defibrotide include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general, and with Defibrotide in particular, including, without limitation, the potential failure of Defibrotide to prove safe and effective for treatment and prevention of hepatic veno-occlusive disease (VOD) in adults and children undergoing haematopoietic stem cell transplantation, that Gentium may not receive an opinion regarding approval of Defibrotide from the CHMP in the fourth quarter of 2012, that the CHMP may request additional information from Gentium regarding Defibrotide, that Gentium may not receive a positive opinion from the CHMP, and the risk factors listed or described from time to time in Gentium's filings with the Securities and Exchange Commission including, without limitation, Gentium's most recent filings on Forms 20-F.
CONTACT: Gentium S.p.A. Salvatore Calabrese SVP Finance & CFO +39 031 5373 260 firstname.lastname@example.org or The Trout Group Tricia Swanson, +1 646 378 2953 email@example.com Biologix FZCo Nabil Ghorayeb Human Health Lead & Managing Partner Tel.: +961 9 222050