Debiopharm has initiated a confirmatory Phase III study of the somatostatin analog Sanvar (vapreotide acetate) for the treatment of acute esophageal variceal bleeding.

The Swiss Debiopharm Group - an in-licensor of promising biologics and small drug candidates for out-licensing to potential pharmaceutical partners - gained Sanvar through the acquisition of H3 Pharma in May 2005. The Sanvar NDA is currently "approvable" at FDA.

The confirmatory Phase III design was reviewed by FDA under a Special Protocol Assessment. In the multi-center, single-arm open label study, 85 patients with acute EVB due to portal hypertension will be treated with Sanvar for five days.

Debiopharm said the trial aims to confirm in U.S. patients the results of earlier trials demonstrating that early use of Sanvar with endoscopic treatment "improves the control of bleeding and prevents re-bleeding episodes."

EVB is a frequent complication of late-stage liver cirrhosis, with survival directly linked to an ability to control bleeding early, the company said. If Debiopharm gains marketing approval for Sanvar, it will be the first EVB treatment approved in the U.S.

Sanvar has been granted orphan drug status and was deemed approvable by FDA in December 2004, when it was owned by H3 Pharma.

In the approvable letter from FDA, the agency requested further data to address efficacy and manufacturing questions. At the time, H3 Pharma said it would address the questions but expected that the results of a completed Phase III study conducted in Eastern Europe would satisfy the request (¹ Also see "H3 Pharma Plans First Quarter Response To Sanvar IR "Approvable" Letter" - Pink Sheet, 4 January, 2005..

-Shirley Haley

Debiopharm Takes Up Confirmatory Phase III Trial Of Sanvar

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