Montreal, Canada, March 17, 2003 – H3 Pharma Inc., a Montreal based Pharmaceutical Development Company, announced today that it has finalized a licensing and an investment undertaking with OncoMab™ GmbH, a start-up biotech drug discovery company based in Würzburg, Germany. The deal is a multimillion-dollar transaction including an exclusive royalty-bearing license for the first product and its molecular target, an exclusive option for a license on three other products targeting other forms of cancer and the purchase of an equity stake in the company. H3 Pharma will take charge of the clinical development and worldwide registration for the four products.
The first product, SC-1, is a fully human monoclonal IgM antibody targeting a specific isoform of CD55 present in 60% of stomach carcinomas. In a prospective study, the antibody was administered prior to surgery in 51 patients and was shown to specifically induce tumour apoptosis. Moreover, two-year survival after SC-1 treatment and curative resection was 75% versus less than 60% in a comparable patient population. This statistically significant survival benefit was further increased after three years.
“Most patients diagnosed with stomach cancer fail to be cured by gastric resection, and most trials of pre- or post-surgery chemotherapy show no improvement in survival rates. Preliminary clinical results with SC-1 suggest a remarkable increase in survival with SC-1 administration being extremely well tolerated,” stated Dr. Didier Coquoz, Vice President Research and Development at H3 Pharma. Coquoz further added, “SC-1 will likely be the first human antibody of the IgM class to be registered. IgM antibodies like SC-1 directly induce cell death; these antibodies could, therefore, be more potent than IgGs in classical oncology settings in addition they could be effective in more aggressive cancers.”
The company envisages a fast track designation for SC-1 given the considerable unmet medical need and the positive preliminary results. Orphan Drug status will also be pursued in the United States where there are 25,000 new cases of stomach cancer out of the 300,000 occurring every year worldwide.
“OncoMab™ products are the result of more than 15 years of research at the University of Würzburg, Germany to harness the innate immune response of cancer patients to their tumours. The founders, Professor Heinz-Peter Vollmers, Professor Hans-Konrad Müller-Hermelink, and myself are extremely happy to partner with H3 Pharma for the development of our products, and to have H3 Pharma actively taking part as investors in building our company,” said Dr. Frank Hensel, CEO of OncoMab™ GmbH.
Dr. Loïc Maurel, President and CEO of H3 Pharma commented on today’s announcement with enthusiasm, “We are delighted with this deal. H3 Pharma has screened a very large number of projects since its inception. We have been extremely strict in our choice of products. Many projects have not survived our due diligence process including critical criteria based on product development and commercial potential. I am very happy to join forces with OncoMab™, they have superb science which no doubt will mark the beginning of a new era of both well-tolerated and life saving oncology treatments.”
OncoMab™ GmbH is a spinout of the Institute of Pathology, University of Würzburg. The company is a drug discovery company based on a technology platform, which enables the company to isolate potent IgM antibodies involved in the cancer patient’s immediate, innate immune response to malignant cell transformation. The company has a large bank of proprietary antibodies and potential targets ready to be validated and intends to raise more venture capital to build internal resources to further develop the OncoMab™ pipeline.
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.