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Sanvar(R) (Debio 8609) for Esophageal Variceal Bleeding
Date:11/4/2008

l five days following the onset of bleeding. EVB is a life threatening condition and the mortality rate is high (about 15% to 25%) in the first six weeks following the haemorrhage. EVB is the cause of about 70% of gastro-intestinal bleeding in patients suffering from liver cirrhosis.

Sanvar(R) (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 analogue to have demonstrated 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). Control of bleeding with survival at five days was achieved more often with Sanvar(R) (p=0.021) than with placebo. Additional Phase III trials have been completed in Europe in this indication. Sanvar(R) can be stored at room temperature, an advantage over other products requiring refrigeration, allowing immediate administration, a key benefit in a life-threatening situation. The product has been granted orphan drug status in the U.S., where there is currently no FDA approved treatment for this indication.

About Debiopharm Group

Debiopharm Group is a global biopharmaceutical development specialist that in-licenses promising biologics and small molecule drug candidates. It 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 $2.65 billion in 2
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SOURCE The Debiopharm Group
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