Montreal, Canada, July 24, 2003 – H3 Pharma Inc., a Montreal-based pharmaceutical Product Development Company, today announced that it has received written confirmation from the U.S. Food & Drug Administration (FDA) that the dossier for SANVAR® (vapreotide), which has already been awarded Orphan Drug designation, is fileable for registration in the United States for the treatment of esophageal variceal bleeding (EBV). The SANVAR® IR (immediate release) formulation is expected to enter the US market by late 2004.
Unlike other somatostatin analogues, SANVAR® IR has demonstrated success versus placebo in the early treatment of EVB, both in stopping acute hemorrhage prior to endoscopic intervention, and a positive impact on survival during the critical three-five days following treatment. The multi-center Phase III clinical study involved 227 patients at 21 sites (Calès et al. (2001)) was published in the New England Journal of Medicine. The study also demonstrated that this benefit maintained a positive trend in survival up to 42 days after acute intervention. EVB is a complex medical emergency with a high mortality rate. Patients with esophageal varices have a 30% lifetime risk of bleeding; one-third of those who bleed will die; patients who have bled once have a 70% chance of recurrent bleeding; and rebleeding results in a further 30% fatality in these patients. EVB accounts for about 7% of episodes of all gastrointestinal bleeding in western countries.
“The FDA’s fileable letter marks another important step in bringing our range of SANVAR® products to market around the world,” said Dr. Loïc Maurel, M.D., President and CEO of H3 Pharma. “We are planning to sign agreements for all indications in the core markets of North America, Europe and in non-core geographic regions, this year. We will seek to obtain registration and early market entry in non-core countries together with partners with regulatory expertise in these regions.”
H3 Pharma also expects its SANVAR® 3-month sustained release (SR) formulation, to begin Phase III clinical trials in the fall of 2003 in acromegaly, as well as in the treatment of chronic symptoms caused by other diseases. The 3-month sustained release formulation brings significant therapeutic advantages over other somatostatin analogues in acromegaly and neuroendocrine tumors. Encouraging preliminary data in the reduction of diarrhea induced by chronic disease or cytostatic treatment also provide a platform for the development of a Phase III program to address these critical medical conditions. H3 Pharma plans to license out the commercialization rights to SANVAR® SR at the same time as SANVAR® IR.
About H3 Pharma
H3 Pharma is a pharmaceutical product development company that focuses on oncology and gastrointestinal diseases. Extensive internal expertise and world-renowned advisory panels allow H3 Pharma to effectively bridge the gap between innovative products and the global pharmaceutical marketplace. H3 Pharma licenses in the most promising therapeutic discoveries (post proof-of-concept in humans) and manages the clinical development, intellectual property, global registration and manufacturing logistics prior to out-licensing the products for global commercialization. H3 Pharma is an international joint venture between SGF, one of Canada’s largest venture funds, and Debiopharm S.A., a privately owned company based in Lausanne, Switzerland.
All of the statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, are forward-looking statements. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown. Some examples of known risks are: the impact of general economic conditions, general conditions in the pharmaceutical industry, changes in the regulatory environment in the jurisdictions in which H3 Pharma does business, stock market volatility, fluctuations in costs, and changes to the competitive environment due to consolidation or otherwise. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements.