Debiopharm in EVB agreement with H3 pharma
Gives H3 Pharma worldwide research, development and commercialisation rights to Sanvar (vapreotide)
H3 Pharma Inc, a Montreal-based pharmaceutical product development company, focusing on both oncology and endocrinology, and Swiss drug development company Debiopharm, based in Lausanne, have announced an agreement that gives H3 Pharma the worldwide research, development and commercialisation rights to Sanvar (vapreotide).
The agreement provides H3 Pharma with an advanced second product following the in-licensing agreement for SC-1 monoclonal antibody with OncoMab, of Wuerzburg, Germany in February 2003.
Sanvar immediate release (IR) formulation is the only somatostatin analogue that has demonstrated the benefits of the early use of the product in the treatment of acute esophageal variceal bleeding, (EVB) both in stopping acute haemorrhage prior to endoscopic intervention and in the prevention of recurring bleeding during the critical five days following treatment.
EVB is a complex medical emergency with a high mortality rate, and accounts for about 7% of episodes of gastrointestinal bleeding in North America and Europe.
Sanvar IR, which has successfully completed a Phase III clinical trial in Europe, has been awarded Orphan Drug status in the US. 'We are very pleased to have acquired the worldwide rights to this Phase III product from Debiopharm,' said Dr Loïc Maurel, president and ceo of H3 Pharma. 'This addition moves our product pipeline significantly closer to commercialisation. Moreover, the Sanvar products have important commercial potential and we look forward to their out-licensing in Latin America this year, with other market regions to follow thereafter.'
Dr R.-Y. Mauvernay, founder and ceo of Debiopharm, said: 'There is currently no product registered in the US for the treatment of EVB. This new direction will allow Debiopharm to focus on oncology, virology and our technology platforms and will allow H3 Pharma to build its product development pipeline.'
