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

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

10-Feb-2010 - Switzerland

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 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.

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 patients1. 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.

https://www.bionity.com/en/news/113132/novartis-gains-exclusive-rights-to-debio-025-an-antiviral-agent-as-potential-first-in-class-hepatitis-c-therapy.html