Lausanne, Switzerland, July 24, 2006 – 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 Sanvar® 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 Sanvar®.
In Mexico, Sanvar® is registered under the name Docrised®. In the US, approval is expected for mid 2007 and the product is already partnered in several countries throughout the World.
“The submission of Sanvar® 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 Loïc Maurel, CEO of The Debiopharm Group Canadian subsidiary.
In June 2006, Debiopharm initiated a US confirmatory Phase III study for Sanvar® following review of the protocol by the US Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process.
Sanvar® (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 (Calès et al. New England Journal of Medicine, 2001). Survival with hemostasis at 5 days was achieved significantly (p=0.021) more often with Sanvar® than with placebo. In patients with control of bleeding at day 5, Sanvar® significantly (p=0.006) increased hemostasis and survival through day 42. Sanvar® has been granted orphan drug status in the US and received an approvable letter from the FDA in 2004. Sanvar® 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.