Healthcare Industry News: liver failure
News Release - May 2, 2012
Gentium Appoints PharmaSwiss, S.A. as Exclusive Distributor of Defibrotide in Central and Eastern European CountriesVILLA GUARDIA (COMO), Italy, May 2, 2012 -- (Healthcare Sales & Marketing Network) -- Gentium S.p.A. (GENT ) today announced the appointment of PharmaSwiss S.A., a division of Valeant Pharmaceuticals International, Inc., as the exclusive distributor of Defibrotide in the following territories: Albania, Bosnia, Bulgaria, Croatia, Cyprus, Czech Republic, Greece, Hungary, Macedonia, Montenegro, Poland, Romania, Serbia, Slovenia and Slovakia. Under the terms of the agreement, which is valid for 10 years, PharmaSwiss will be responsible for managing named-patient requests and achieving price and reimbursement approvals in these territories. Following regulatory approval to market Defibrotide, if any, PharmaSwiss will be responsible for sales, marketing and local medical affairs activities in these countries.
Commenting on the partnership with PharmaSwiss, Adrian Haigh, Senior Vice President of Commercial Operations at Gentium GmbH. said, "We are pleased to have established a long-term relationship with PharmaSwiss for the distribution of Defibrotide in various Central, Southern and Eastern European countries, which is consistent with our overall commercial strategy to partner with strong local distributors. By entering into this agreement, we now have local distribution channels for Defibrotide in all European territories including Nordics, South, Central, East and Western Europe. Our experience has shown that local distribution partners facilitate earlier and easier access to defibrotide, this is very important for this potentially life-saving treatment."
"We are looking forward to the partnership with Gentium and the growth potential that Defibrotide will add to our specialty distribution portfolio." said Pavel Mirovsky, President of Valeant Europe.
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.
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 VOD and Fast Track Designation by the U.S. FDA to treat VOD. Gentium submitted the MAA for Defibrotide to the EMA in May 2011 and the CHMP issued the 120 day List of Questions in September 2011. Gentium responded to these questions in February 2012. The CHMP will continue its review of the MAA and will either issue an opinion on the MAA or submit a List of Outstanding Issues (LoOIs) requiring further clarification, the latter of which will stop the review clock to permit the Company time to respond. The CHMP is expected to reach its final opinion no later than day 210 calculated based on the EMA review process timeline.
PharmaSwiss, S.A., a division of Valeant Pharmaceuticals International, Inc., has a broad product portfolio in various therapeutic areas and operations in 21 countries throughout Central and Eastern Europe, including Poland, Hungary, the Czech Republic and Serbia. It is the largest distributor in Central and Eastern Europe and conducts operations in Greece as well. PharmaSwiss is an existing partner to several large pharmaceutical and biotech companies offering regional expertise with respect to regulatory, compliance, sales, marketing and distribution functions. In March 2011, PharmaSwiss was acquired by Valeant Pharmaceuticals International, Inc. For further information, please visit the website www.pharmaswiss.com.
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