Debiopharm Group Grants an Exclusive Licence for the Development, Manufacture and Commercialisation of Debio 025

Tuesday, February 9, 2010 Corporate News
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LAUSANNE, Switzerland, February 9 Debiopharm Group(Debiopharm), a Swiss-based global biopharmaceutical group of companies witha focus on the development of prescription drugs that target unmet medicalneeds, today announced the signature of an exclusive licence agreement withNovartis for the development, manufacture and commercialisation of Debio 025(alisporivir), a selective, first-in-class cyclophilin (Cyp) inhibitor with apotent anti-hepatitis C virus (HCV) effect. The product is currently in phase2b clinical development for the treatment of hepatitis C. Debiopharm grantedNovartis worldwide commercialisation rights to Debio 025 except for Japan.

Under the terms of the agreement, Novartis will pay Debiopharm anupfront, development and sales milestones as well as royalties. Thistransaction is subject to customary regulatory approvals.

According to the World Health Organization 170 million people suffer fromHCV in the world. "Sadly only 20% of those patients are treated adequately,"said Rolland-Yves Mauvernay, President and Founder of Debiopharm Group. "AtDebiopharm, we have a strong commitment to providing HCV sufferers with anefficacious cure and are confident about the potential of an innovative,first-in-class compound such as Debio 025, which may represent a breakthroughin the treatment of Hepatitis C. We are very happy to be working alongsideNovartis, a partner with a strong dedication to HCV."

About Debio 025

Debio 025 is an oligopeptide that has some chemical features in commonwith cyclosporine A, but is devoid of its immunosuppressive pharmacologicaleffects. It has a very potent inhibitory effect on HCV replication both invitro and in vivo. Debio 025 has excellent antiviral activity against a broadrange of genotypes (1, 2, 3 and 4); a high barrier to the development ofresistance; and the possibility for once daily dosing. It is expected to havea superior safety and efficacy profile to standard of care, and to beefficacious in patients not responding to the standard treatment.

Its potent inhibitory activity on the HCV replication was shown in thefollowing clinical studies. Results of a phase Ib study demonstrate thatDebio 025 monotherapy for 15 days induced a strong anti-HCV effect (3.6 log10reduction) in HIV-1/HCV co-infected patients (Hepatology, 47:817-26). Resultsof a phase IIa study with Debio 025 indicate that Debio 025 shows animportant additive anti-HCV effect (4.6 log10 reduction) when co-administeredwith peg-IFN-alpha-2a for four weeks to treatment-naive HCV patients(Hepatology, 2009 May;49(5):1460-8).

About HCV

HCV, in combination with hepatitis B, now accounts for 75% of all casesof liver disease around the world. HCV is considered by the World HealthOrganization as an epidemic. Because HCV can infect a patient for decadesbefore being discovered, it is often called the "silent" epidemic. Studiessuggest that in the US alone, nearly 4 million people are or have beeninfected with HCV and of these, 2.7 million have an ongoing chronicinfection, the majority being between 40 to 60 years old.

About Debiopharm Group

Debiopharm Group is a Swiss-based global biopharmaceutical group ofcompanies with a focus on the development of prescription drugs that targetunmet medical needs. The group in-licenses and co-develops promisingbiological and small molecule drug candidates having reached clinicaldevelopment phases I, II or III. It develops its products for globalregistration and maximum commercial potential. The products are out-licensedto pharmaceutical partners for sales and marketing.

Debiopharm independently funds the worldwide development of all of itsproducts 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, Debiopharmhas developed four products with global combined sales of $2.6 billion in2008.

For more information on Debiopharm Group, please visit:http://www.debiopharm.comDebiopharm S.A. Contact Maurice Wagner Director Corporate Affairs & communication Tel.: +41-(0)21-321-01-11 Fax: +41-(0)21-321-01-69 Additional Media Contacts In London Maitland Brian Hudspith Tel: +44-(0)20-7379-5151 In New York Russo Partners, LLC Martina Schwarzkopf, Ph.D. Account Executive Tel: +1-212-845-4292 Fax: +1-212-845-4260

SOURCE Debiopharm Group

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