Roche, Ascletis partner on Chinese development of experimental hepatitis C drug danoprevir

Roche announced Monday a deal with Ascletis to develop and commercialise the investigational protease inhibitor danoprevir in China for the treatment of hepatitis C. Roche noted that the majority of the more than 10 million patients in China chronically infected with HCV have genotype 1b, which the Swiss company indicated "has proven highly responsive to danoprevir."

Luke Miels, head of Roche's pharmaceuticals unit in Asia Pacific, said "the decision to develop danoprevir [is] based on its promising profile in HCV genotype 1b." Roche reported results last year from two mid-stage trials of danoprevir, showing that the drug was associated with high rates of viral clearance and good tolerability in patients with HCV, including SVR12 rates of up to 97 percent in genotype 1b patients.

Under the agreed terms, Roche said that Ascletis will fund and assume responsibility for the development, regulatory affairs and manufacturing of danoprevir in China, including Taiwan, Hong Kong and Macau. In return, Roche will pay the biotechnology company milestones linked to certain development and commercial targets, while the deal also includes royalties.

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