Ranbaxy Laboratories Limited has signed an exclusive licensing agreement with The Debiopharm Group (Debiopharm), a Swiss biopharmaceutical development company, to market its New Chemical Entity (NCE), Sanvar (vapreotide acetate). The injectable molecule will be used for the treatment of acute variceal bleeding and prevention of rebleeding related to portal hypertension. Sanvar can be used in combination with specific treatment such as sclerotherapy or band ligation. Ranbaxy will have exclusive marketing rights in the territories of India, Bangladesh and Nepal, a Ranbaxy release said.
Sanvar has been granted orphan drug status in the US where it is presently undergoing phase III clinical trials. Debiopharm expects to file Sanvar for approval in the US in Q1 2007.
Commenting on the agreement, Sanjeev Dani, regional director, India and Middle East, Ranbaxy, said, "We are glad to partner with Debiopharm in the Gastroenterology area and shall work towards creating a productive relationship by complementing each others strengths. The agreement will enable Ranbaxy to increase its focus in this segment".
"Debiopharm is pleased to sign agreements with recognised industry leader like Ranbaxy. These partnerships demonstrate the value that Sanvar can add to a growing portfolio of late-stage compounds and we look forward to developing these, and future relationships, to maximize the potential of the product," said Loic Maurel, president and CEO of the Canadian affiliate of Debiopharm.
Sanvar (vapreotide acetate) is a synthetic octapeptide analogue of the naturally occurring somatostatin hormone. It is the only somatostatin analog to demonstrate statistically significant benefits in the early treatment of esophageal variceal bleeding (EVB) in association with endoscopic therapy in a placebo-controlled clinical study (Calèes et al, New England Journal of Medicine, 2001). Sanvar 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 Debiopharm Group is a global independent biopharmaceutical development company specialising in oncology and serious medical conditions. The company 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.