Lausanne, Switzerland – February 7, 2005 – Debiopharm S.A., the independent drug-development company specialising in oncology, endocrinology, CNS and niche diseases announced that sanofi-aventis has received marketing approval from the United States Food and Drug Administration (FDA) for a new formulation of Eloxatin® (oxaliplatin for injection).
Eloxatin® INJECTION is a clear, preservative-free, ready for use solution. It offers additional benefit and convenience to physicians and nurses for the administration of Eloxatin®. It is available in two different presentations of 50mg and 100mg.
Eloxatin® INJECTION used in combination with infusional 5-FU/LV, is indicated for adjuvant treatment of stage III colon cancer patients who have undergone complete resection of the primary tumor, and for the treatment of advanced carcinoma of the colon or rectum.
Pioneered by Debiopharm shortly after the approval of the lyophilised formulation of Eloxatin®, the aqueous solution was then jointly developed with sanofi-aventis.
“We are happy to have worked with sanofi-aventis to be able to offer health care providers a more convenient form of Eloxatin® that has benefited many patients around the world,” said Rolland-Yves Mauvernay, President and CEO of Debiopharm. “We strive to continue to look for ways to further innovate and improve the standard of care to patients.”
Eloxatin® was developed in association with sanofi-aventis and is currently marketed by sanofi-aventis in more than 60 countries.
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 a 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.
For more information on Debiopharm, please visit our website at www.debio.com