Vapreotide

Vapreotide [Octastatin^®, Sanvar^®, RC 160, BMY 41606] is a somatostatin analogue developed at Tulane University School of Medicine, New Orleans, USA, which holds patent rights for vapreotide. Vapreotide provides a much higher metabolic stability than its parent compound.

Vapreotide was licensed to Debiopharm for development in Europe.

Vapreotide is usually administered SC although a slow-release IM formulation is also available. Other sustained-release formulations are under development.

H3 Pharma plans to sign agreements for all indications in the core markets of North America, Europe and in non-core geographic regions during 2003. H3 Pharma will also seek to obtain registration and early market entry in non-core countries with help from partners.

Sanvar^® Immediate Release (IR) has been submitted for approval within the European Union for the treatment of acute oesophageal variceal bleeding (EVB). Sanvar^® IR has been awarded orphan drug status in the US for EVB.

In July 2003, H3 Pharma received written confirmation from the US FDA that the dossier for Sanvar^® is fileable for registration in the United States for the treatment of esophageal variceal bleeding (EVB). The Sanvar^® IR (immediate-release) formulation is expected to enter the US market by late 2004.[1]

H3 Pharma expects to file for Latin American registration for this indication in the second half of 2003, with registrations in other regions to follow.

Sanvar^® SR has been submitted for Orphan Drug designation.