Debiopharm signed four exclusive license agreements to market Sanvar®. Ranbaxy Laboratories will take the drug to India, Bangladesh, and Nepal, EMS Sigma Farma will market it in Brazil, Tzamal Bio-Pharma in Israel, and LG Life Sciences in Korea.
Sanvar (vapreotide acetate) has orphan drug status and currently is in Phase III trials for acute esophageal variceal bleeding (EVB). It is a synthetic octapeptide analogue of the naturally occurring somatostatin hormone. Debiopharm reports that 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 trials.
Debiopharm says that it continues to seek partnerships in other territories, including Europe, where the first international filing of a regulatory dossier was submitted in July in France. Salix Pharmaceuticals has already licensed the exclusive rights to Sanvar for the U.S., where Debiopharm expects to file for marketing approval in the first quarter of 2007.