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Salix, Debiopharm sign Sanvar license agreement
By Elaine Rigoli
Tampa, Fla., Sept. 5 - Salix Pharmaceuticals, Ltd. and the Debiopharm Group signed an exclusive license agreement granting Salix the right to sell, market and distribute Sanvar IR (600 ug vials vapreotide acetate powder) in the United States.
Debiopharm, the pharmaceutical company in Lausanne, Switzerland, developed Sanvar for the treatment of acute esophageal variceal bleeding. The product is undergoing a confirmatory phase 3 trial in the United States for the treatment of esophageal variceal bleeding secondary to portal hypertension.
Under the agreement, Raleigh, N.C.-based pharmaceutical company Salix is required to make an up-front payment and regulatory and sales performance milestone payments to Debiovision that could total up to $14 million.
The Food and Drug Administration has reviewed the protocol for this study under the Special Protocol Assessment process.
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