Debiopharm announces import approval from Elplat® (Oxaliplatin) in Japan

Lausanne, Switzerland, March 21, 2005 – Debiopharm S.A., the independent drug-development company specialising in oncology, endocrinology and niche products, announced today that Elplat® (oxaliplatin), a new generation of platinum derivatives licensed-in and developed by Debiopharm for the treatment of advanced colorectal cancer, was granted marketing approval in Japan by the Ministry of Health, Labor and Welfare for the treatment of inoperable advanced and recurrent carcinoma of the colon and the rectum. Elplat®, licensed-out to Yakult Honsha Co., Ltd. (Yakult), is one of the few oncology products to have received a priority review in Japan.

Oxaliplatin has been approved as an anticancer agent in over 60 countries worldwide and is currently marketed as Eloxatin® in Europe and the US by sanofi-aventis, Debiopharm’s other major licensee. Eloxatin® is the leading therapy for the treatment of advanced colorectal cancer worldwide.

“We are delighted to have obtained marketing approval for oxaliplatin in Japan,” said Rolland-Yves Mauvernay, President and CEO of Debiopharm. “This opens up an important new market for our life-saving therapy. Yakult is an excellent commercial company and we look forward to providing Japanese patients with a valuable therapy.”

The incidence of colorectal cancer in Japan is constantly growing and should represent 115’000 cases in 2005. This number is expected to reach 140’000 by 2010.

About Debiopharm
Debio is an established group of four complementary companies, Debiopharm, Debioinnovation, Debio R.P. and Debioclinic. Debiopharm, founded in 1979 in Lausanne, Switzerland, focuses on evaluating compounds with promising in-vivo results in animals to in-license, develop for global registration, and out-license to sales and marketing pharmaceutical partners. Debiopharm has proven expertise in drug development, having registered three products: Eloxatin®, one of sanofi-aventis’ leading marketed products, Decapeptyl®, the leading product of Ipsen, and Trelstar® (1-and 3-month). Together, their combined sales were in excess of $ 1.8 bn in 2004. Debioinnovation was set up to complement the core business objectives of Debiopharm through addressing the financing and partnering needs of biotechnology, pharmaceutical start-up companies and life science incubators. Debio R.P. is a leader in polymer-based controlled release technologies that allow certain drugs like proteins, peptides and anti-cancers to be delivered in customized, sustained-release formulation. From its FDA-inspected manufacturing facility in Martigny, Switzerland, Debio R.P. also conducts feasibility studies, formulation selection, optimization, scale-up and cGMP manufacturing from clinical trial supplies to commercial scale. Debioclinic is a contract research organization, specialized in oncology and dedicated to clinical development, providing regulatory, biometric and clinical support in line with cGCP.