Montreal, Canada, and Lausanne, Switzerland, July 2, 2003 – H3 Pharma Inc., a Montreal-based pharmaceutical product development company, focusing on both oncology and endocrinology, and Debiopharm S.A. (Debiopharm), a Lausanne, Switzerland-based drug development company, today announced an agreement, which gives H3 Pharma the worldwide research, development, and commercialization rights to SANVAR (vapreotide). The agreement provides H3 Pharma with an advanced second product in its pipeline following the in-licensing agreement for SC-1 monoclonal antibody with OncoMab™ GmbH, Würzburg, Germany in February 2003.
SANVAR® immediate release (IR) formulation is the only somatostatin analogue that has demonstrated, in a well conducted clinical study (Cales et al. New England Journal of Medicine, 2001), the benefits of the early use of the product in the treatment of acute esophageal variceal bleeding (EVB) both in stopping acute hemorrhage 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 U.S.A. H3 Pharma expects to file for Latin American registration for the indication of the treatment of esophageal variceal bleeding in the summer 2003, with registration in other regions to follow. H3 Pharma expects SANVAR sustained release (SR), the 3-month sustained release formulation that brings significant therapeutic advantages over other somatostatin analogues, to begin Phase III clinical trials in the fall of 2003 in acromegaly and neuroendocrine tumors. Encouraging preliminary data in the treatment of Crohn’s disease also provides the platform for the potential start of a Phase III program during 2004 to meet this critical condition.
“We are very pleased to have acquired the worldwide rights to this Phase III product from Debiopharm.” said Dr. Loïc Maurel, M.D., President and CEO of H3 Pharma; ”This product addition moves our product pipeline significantly closer to commercialization. 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.”
“Debiopharm, as a shareholder in H3 Pharma, is an active and committed partner in the Company,” said Dr. R.-Y. Mauvernay, founder and CEO of Debiopharm. “There is currently no product registered in the US for the treatment of esophageal variceal bleeding, which underscores Debiopharm’s confidence in the strong potential of SANVAR® products for acute and chronic patient care. This new direction will allow Debio to focus on oncology, virology and our technology platforms and will allow H3 Pharma to build its product development pipeline.”
“H3 Pharma’s objective is to become a leading international player in the pharmaceutical development arena,” said Dr. Francis Bellido, CEO of SGF Health., “This agreement brings the company one more step towards this realization.” Société Générale de Financement du Québec (SGF) is also a shareholder in H3 Pharma.
About H3 Pharma
H3 Pharma Inc. is a pharmaceutical Product Development Company with extensive internal expertise complemented by world-renowned advisory panels and that focuses on products in both Oncology and Endocrinology. H3 Pharma develops, registers and manufactures products for global market entry prior to licensing out to large Pharma for marketing and sales. Vital investment is provided together with development and commercial expertise at the crucial time following clinical proof of concept, adding value to the discovery. H3 Pharma Inc. is an international joint venture between SGF Health, a division of SGF, one of Canada’s largest venture funds, and Debiopharm S.A., a privately owned company based in Lausanne, Switzerland. To find out more about the company, visit www.h3pharma.com.
About Debiopharm S.A.
Debiopharm S.A., located in Lausanne, Switzerland, has an established successful track record in developing, registering and ensuring that new molecular entities are brought to market both in Europe and in the United States. Products successfully registered and launched include oxaliplatin for advanced colorectal cancer and triptorelin pamoate for prostate cancer, both market leaders in their therapeutic areas. Specialized in oncology, hormonal and niche products for serious medical conditions, Debiopharm is a partner of research institutions; pharmaceutical and biotechnology companies who seek to develop and register their drugs. To find out more about the company, visit www.debio.com.
An industrial and financial holding company, the Société Générale de Financement du Québec (SGF) provides businesses with development capital, and it does so based on profitability and performance. It invests in partnerships, assuming its share of risk. With a focus on Québec’s long-term economic development, the SGF chooses projects that promise high profitability – in ten industry sectors, from natural resources to high technology. In synergy with private partners the investment potential of the SGF is $2 billion over a five-year period. For more information about the company, visit www.sgfqc.com
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.