Healthcare Industry News: Esophageal Variceal Bleeding
News Release - July 24, 2006
Debiopharm Applies for First European Marketing Authorisation for Sanvar(R) in FranceLAUSANNE, Switzerland, July 24 (HSMN NewsFeed) -- The Debiopharm Group (Debiopharm), a global independent biopharmaceutical development company specialising in oncology and serious medical conditions filed a French marketing authorisation application (MAA) for SanvarŽ in the treatment of patients with Esophageal Variceal Bleeding (EVB). Debiopharm intends to apply for wider European approval through the Mutual Recognition Procedure (MRP), in which France will serve as Reference Member State. Debiopharm is seeking partners for the European commercialisation of SanvarŽ.
In Mexico, SanvarŽ is registered under the name DocrisedŽ. In the US, approval is expected for mid 2007 and the product is already partnered in several countries throughout the World.
"The submission of SanvarŽ to the AFSSAPS, the French equivalent of the US Food and Drug Administration, is an important step for Debiopharm. We are committed to rapidly providing a highly effective therapy for patients suffering from EVB in Europe," said Loic Maurel, CEO of The Debiopharm Group Canadian subsidiary.
In June 2006, Debiopharm initiated a US confirmatory Phase III study for SanvarŽ following review of the protocol by the US Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process.
SanvarŽ (vapreotide acetate) is a synthetic octapeptide analogue of the naturally occurring somatostatin hormone. It has similar pharmacological properties to native somatostatin but exhibits a longer duration of action. 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). Survival with hemostasis at 5 days was achieved significantly (p=0.021) more often with SanvarŽ than with placebo. In patients with control of bleeding at day 5, SanvarŽ significantly (p=0.006) increased hemostasis and survival through day 42. SanvarŽ has been granted orphan drug status in the US and received an approvable letter from the FDA in 2004. SanvarŽ can be stored at room temperature, an advantage over other products that require refrigeration, allowing immediate administration, which is a key benefit in a life-threatening situation.
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: The Debiopharm Group
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