Biotech Values

[DewDiligence]

NVS Licenses Debio 025 Cyclophilin Inhibitor for HCV

[Debiopharm’s Debio 025, in phase-2b, has the same MoA as NVS’ own drug candidate called NIM811, so it’s reasonable to surmise that NVS has discontinued development of NIM811. (I previously questioned NVS’ commitment to NIM811 in #msg-36507550.) Debiopharm is a private biotech company based in Switzerland that is well known to NVS; financial terms of this deal have not been disclosed. The phase-2a data for Debio 025 are in #msg-37359213.

Although NVS’ financial commitment in this deal may be small, the deal does show that NVS remains interested in HCV in spite of the likelihood that Albuferon will be a commercial flop. This makes it somewhat puzzling that NVS opted not to license IDIX’s IDX184 last year.]

http://www.novartis.com/newsroom/media-releases/en/2010/1381968.shtml

›February 09, 2010 07:15 CET

Novartis gains exclusive rights to Debio 025, an antiviral agent in Phase IIb development as potential first-in-class hepatitis C therapy

• Phase II results demonstrate efficacy of Debio 025, a cyclophilin inhibitor, against hepatitis C virus when used alone or in combination with current standard therapy

• Cyclophilin inhibitors evolving as new class of medicines with potential to become part of future standard of care for treating hepatitis C

• Hepatitis C is one of the world's most common liver diseases, current therapies may only be effective in around 50% of patients2

• Novartis to make upfront payment to Debiopharm Group, with Debiopharm eligible for milestones and royalties on future sales

Basel, February 9, 2010 - Novartis has gained exclusive 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 is the first in a new class of drugs called cyclophilin inhibitors which could become part of the future standard of care for the disease.

Debio 025 has been in-licensed from Debiopharm Group, an independent biopharmaceuticals company based in Switzerland, under an agreement which gives Novartis exclusive worldwide development and marketing rights (excluding Japan). Under the terms of the agreement, Novartis will make an upfront payment to Debiopharm, and Debiopharm will 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.

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

More than 170 million people worldwide are infected with hepatitis C virus (HCV)3, and this can cause serious liver disease leading to cirrhosis or liver cancer which may result in death. There is an urgent need for more effective medications, often used in combination, as current therapy is only effective in around 50% of patients with the most prevalent form of the virus, called genotype 12.

Cyclophilin inhibitors such as Debio 025 provide a novel approach to treatment by targeting host proteins that are involved in the growth of the hepatitis C virus. Results of a Phase II study show that Debio 025 significantly 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-naïve patients. No significant safety issues have been identified so far.

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-naïve 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.‹