Novartis Gains Rights To Debio 025

Published: 09-Feb-2010

Novartis has gained rights to develop and market Debio 025 (alisporivir), a potential first-in-class antiviral agent, currently in phase IIb development for the treatment of hepatitis C. Debio 025 has been in-licensed from Debiopharm, under an agreement which gives Novartis worldwide development and marketing rights (excluding Japan).

As per the agreement, Novartis will make an upfront payment to Debiopharm, and the latter will be eligible for milestone payments and royalties on future sales of Debio 025, if approved. The transaction is subject to customary regulatory approvals.

David Epstein, CEO of Novartis, said: "Hepatitis C is sometimes referred to as a 'silent epidemic' because the virus can lie dormant in the body for years or even decades before the symptoms become apparent. Novartis is dedicated to developing medicines that will reduce the impact of this disease on patients, and we believe that Debio 025 could prove an important step forward by significantly enhancing the efficacy of existing therapy that forms the standard of care for hepatitis C."

Cyclophilin inhibitors, such as Debio 025, provide a new approach to treatment by targeting host proteins that are involved in the growth of the hepatitis C virus. Results of a phase II study showed that Debio 025 reduced HCV replication when used alone, and had an important additive anti-HCV effect (4.6 log10 reduction) in combination with pegylated interferon alfa-2a in treatment-naive patients.

A double-blind, placebo-controlled phase IIb study is now under way to assess the efficacy and safety of Debio 025, in combination with the current standard of care for hepatitis C - peginterferon alfa-2a plus ribavirin - in treatment-naive patients. The study is being conducted in patients with the most common genotype 1. Debio 025 is also effective against other genotypes of the virus.

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