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Novartis gain rights to hepatitis C drug

Novartis has gained the exclusive rights to Debio 025, an antiviral agent for hepatitis C currently in phase IIb development

Novartis has gained the exclusive rights to Debio 025 (alisporivir), an antiviral agent for hepatitis C currently in phase IIb development.

The Swiss drugmakers will make an undisclosed upfront payment to Debiopharm Group, an independent biopharmaceuticals company based in Switzerland, with Novartis receiving exclusive worldwide development and marketing rights (excluding Japan).

Debiopharm will also be eligible for milestone payments, and for royalties on future sales of Debio 025, if it is approved. The transaction is subject to customary regulatory approvals.

Debio 025 is the first in a new class of drugs called cyclophilin inhibitors, which, according to a statement by Novartis 'could become part of the future standard of care for the disease' for which 'current therapies may only be effective in around 50 per cent of patients'.

Cyclophilin inhibitors tackle hepatitis C, which affects more than 170 million people worldwide, by targeting host proteins involved in the virus' growth. A recent phase II study showed Debio 025 significantly reduced virus replication when used alone, and had an important anti-virus effect in combination with current antiviral, pegylated interferon alfa-2a, in treatment-naïve patients.

A double-blind, placebo-controlled phase IIb study is now being carried out to assess the efficacy and safety of Debio 025 in combination with the current standard treatments for hepatitis C.

"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," said David Epstein, CEO of Novartis' pharmaceuticals division.

"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 an existing therapy that forms the standard of care for hepatitis C."

9th February 2010

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