Healthcare Industry News: esophageal variceal bleeding
News Release - October 23, 2006
Debiopharm Signs International License Agreements for Sanvar(R)LAUSANNE, Switzerland, October 23 (HSMN NewsFeed) -- The Debiopharm Group (Debiopharm), a global independent biopharmaceutical development company specialising in oncology and serious medical conditions, today announced the signing of four exclusive license agreements for the marketing of SanvarŪ in key territories throughout the world. SanvarŪ is developed by Debiopharm for the treatment of acute esophageal variceal bleeding (EVB). The agreements include Ranbaxy Laboratories Ltd (Ranbaxy) for India, Bangladesh and Nepal; EMS Sigma Farma (EMS) for Brazil; Tzamal Bio-Pharma Ltd (Tzamal) for Israel; and LG Life Sciences (LG) for the Korean market. Debiopharm continues to seek partnerships in other territories, including Europe where the first international filing of a regulatory dossier was submitted in July in France. Salix Pharmaceuticals licensed the exclusive rights to SanvarŪ for the US, where Debiopharm expects to file for marketing approval in the first quarter of 2007, after completion of a Phase III clinical trial.
"Debiopharm is thrilled to sign agreements with recognized gastroenterology market leaders. These partnerships demonstrate the value that SanvarŪ can add to a growing portfolio of late-stage compounds and we look forward to building them, as well as future relationships, to maximize the potential of the product," said Loic Maurel, President and CEO of the Debiopharm Group Canadian subsidiary.
SanvarŪ (vapreotide acetate) is a synthetic octapeptide analogue of the naturally-occurring somatostatin hormone. It is the only somatostatin analog to demonstrate statistically significant benefits in the early treatment of EVB in association with endoscopic therapy in a placebo-controlled clinical study (Cales et al. New England Journal of Medicine, 2001). SanvarŪ can be stored at room temperature, an advantage over other products requiring refrigeration, allowing immediate administration, a key benefit in a life-threatening situation. It has been granted orphan drug status in the US, where a Phase III clinical trial was initiated in Q2 of 2006.
About The Debiopharm Group
The Debiopharm Group is a global biopharmaceutical development company that in-licenses promising biologics and small molecule drug candidates. Debiopharm develops its products for global registration and maximum commercial potential for out-licensing to pharmaceutical partners for sales and marketing.
Debiopharm independently funds the worldwide development of all of its products while providing expertise in pre-clinical and clinical trials, manufacturing, drug delivery and formulation, and regulatory affairs.
Founded in 1979 and headquartered in Lausanne, Switzerland, Debiopharm has developed three products with global combined sales in excess of $2.3 billion in 2005.
For more information on the Debiopharm Group, please visit: www.debiopharm.com
Source: Debiopharm Group
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