Debiopharm extends its collaboration with Sanofi-Synthélabo on Eloxatin®

Lausanne, Switzerland, August 27, 2002 – The Swiss-based pharmaceutical development company Debiopharm announced today that it has renewed and extended its patent and know-how agreement on Eloxatin® (oxaliplatin), currently indicated for advanced colorectal cancer, with multinational Sanofi-Synthélabo (Paris, France). The new agreement will expire in 2016. Under the terms of this new agreement, Debiopharm and Sanofi-Synthélabo will share development costs on improvements to the currently available formulations for Eloxatin®, new indications and new methods of use for Eloxatin®. Sanofi-Synthélabo holds the marketing rights for Eloxatin® worldwide, excluding Japan, Argentina, Paraguay, Uruguay and India. Sanofi-Synthélabo pays royalties to Debiopharm on sales of Eloxatin® .

“The agreement confirms our long-standing partnership with Sanofi-Synthélabo and Debio’s successful track record in developing and commercialising oncology products. Eloxatin® is Debio’s third oncology product that has received FDA approval in the last two years.” states Dr. Rolland-Yves Mauvernay, founder and President of Debiopharm. “This agreement will provide for further joint development efforts on Eloxatin®, allowing for further innovation in Debio’s advanced drug delivery systems, particularly novel oral platforms and biodegradable and biocompatible parenteral delivery systems. Debiopharm’s Galenic Unit in Gland, with facilities specially dedicated to formulation research for oncology products, will build on existing knowledge, develop new projects and offer value-added research to our future partners.”

Oxaliplatin is a DACH-platinum (di-amino-cyclo-hexane) compound, or platinum derivative, that was discovered by Prof. Y. Kidani of Nagoya University, Japan. Debiopharm pursued the development of the compound and obtained marketing approval in Europe for the drug in the indication of advanced colorectal cancer. Oxaliplatin is currently marketed in a lyophilised formulation in over 60 countries by Sanofi-Synthélabo under the name Eloxatin®.

Today, Eloxatin® is indicated in first line treatment of advanced colorectal cancer in most major European countries. In the United States, oxaliplatin has recently been granted an FDA marketing authorisation in a record time of just seven weeks, after having been granted a fast track review. Eloxatin® is also being investigated for the treatment of ovarian cancer, pancreas cancer, breast cancer and other solid tumours. In 2001, sales of Eloxatin® reached EUR 196 million.

Debiopharm, Debio R.P. and Debioclinic are an established and proven group of three synergistic and complementary companies, that has a successful track record in developing, registering and bringing to the market new chemical entities 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. Debio Recherche Pharmaceutique (Debio R.P.), Debiopharm’s sister company, is a leading world player in the research, development and manufacturing of polymer-based controlled release injectable formulations for peptides and proteins, including proprietary technologies suitable for other therapeutic modalities such as soluble polymer drug conjugates for parenteral administration. Debio R.P. also carries out scale-up under current good manufacturing practice (cGMP) and has an FDA-inspected plant. Debioclinic, the third Debio company, is fully dedicated to clinical development.