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Preclinical Update - Debio-0512 Therapeutic Vaccine for the Treatment of Chronic and Acute Inflammatory Conditions

Proof of Concept in Mice Transgenic for Human TNFa

LAUSANNE, Switzerland, March 12, 2007 /PRNewswire/ -- Debiopharm Group (Debiopharm), a global independent biopharmaceutical development company specialising in oncology and serious medical conditions, announces the presentation of preclinical results that validate the mechanism of action of Debio-0512 as an anti-TNFa therapeutic vaccine, that inhibits inflammatory processes in animal models of acute and chronic inflammation. Debio-0512 is a keyhole limpet hemocyanin (KLH)-human TNFa heterocomplex (hTNFa kinoid). The results of this study, published recently in the Proceedings of the National Academy of Sciences (PNAS), were presented on March 10 at the 4th International Conference on Tumor Microenvironment in Florence, Italy.

"These results confirm that therapeutic vaccination against human TNFa could represent in the future, an effective approach for the treatment of TNFa-dependent inflammatory pathologies including rheumatoid arthritis and Crohn's disease," said Professor Daniel Zagury of the University Pierre et Marie Curie (Paris) and co-author of the report. "Debiopharm's plan is for IND enabling clinical studies to be ready by the end of this year. We believe that active immunization may offer advantages over passive anti-TNFa monoclonal antibody therapy, by potentially limiting therapeutic failure related to the formation of anti-idiotypic antibodies. Moreover, the potential low frequency of boost immunizations would increase patient compliance."

TNFa is a well-established pro-inflammatory mediator. In hTNFa expressing transgenic mice (TTg mice), a mouse model of rheumatoid arthritis, animals receiving the Debio-0512 therapeutic vaccine developed high levels of anti-TNFa antibodies, neutralising both TNFa bioactivity and binding of TNFa to its receptor. This study shows that immunization with Debio-0512 effectively controls pathogenic effects triggered by TNFa in this mouse model of rheumatoid arthritis.

About Debiopharm Group

Debiopharm Group is a global biopharmaceutical development company that in-licenses promising biologics and small molecule drug candidates. Debiopharm develops its products for global registration and maximum commercial potential for out-licensing to pharmaceutical partners for sales and marketing.

Debiopharm independently funds the worldwide development of all of its products while providing expertise in pre-clinical and clinical trials, manufacturing, drug delivery and formulation, and regulatory affairs.

Founded in 1979 and headquartered in Lausanne, Switzerland, Debiopharm has developed three products with global combined sales in excess of $2.6 billion in 2006.

For more information on Debiopharm Group, please visit: www.debiopharm.com.

CONTACT: Debiopharm S.A. Contacts: Herve Porchet, VP, Medical Affairs,Tel.: +41-21-321-01-11, Fax: +41-21-321-01-69, . KimBill, VP, Business & Legal Affairs, . Additional MediaContacts: In London: Maitland, Brian Hudspith, Tel: +44-(0)20-7379-5151,. In New York: Noonan Russo, Wendy Lau, Tel:+1-212-845-4272, Fax: +1-212-845-4260, hporchet@debio.com kbill@debio.com bhudspith@maitland.co.uk wendy.lau1@eurorscg.com

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Posted: March 2007

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