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Agreement

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Date: 2010-02-09
Biotech partner: Debiopharm (Switzerland)
Pharma Partner: Novartis (Switzerland)
Type of agreement: * licensing
* commercialization/ distribution
* development
* marketing/ promotion
Compound: Debio 025 (alisporivir - synthetic first-in-class cyclophilin inhibitor)
Disease area: hepatitis C
Development phase: 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. In April 2009, Debiopharm announced that the last patient has been randomised (See clinical_studies).
Nature of the agreement: 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. The agreement 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.
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. (See clinical_studies).
Financial terms of the agreement: Financial details were not disclosed.


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