Roche has enlisted the aid of Chinese-American biotech company Ascletis to help bring its hepatitis C virus (HCV) therapy danoprevir to the market in China.
Under the terms of the deal, Ascletis will have responsibility for funding the development, registration and manufacturing of danoprevir in greater China – including Taiwan, Hong Kong and Macau – in return for payments on development and commercial milestones.
The two companies will share responsibility for clinical development and commercialisation of the drug under the deal, which also includes a royalty stream.
China is one of the largest markets for HCV infections worldwide, with 10 million people chronically infected with the virus. Many of these are infected with HCV genotype 1b, a strain which has proved “highly responsive” to danoprevir, according to Ascletis.
Danoprevir is a small-molecule NS3/4A protease inhibitor with a similar mode of action to two other directly-acting HCV drugs – Merck & Co’s Victrelis (boceprevir) and Vertex Pharma/Janssen’s Incivek (telaprevir) – which reached the market in 2011 but are not yet available in China.
Therapy for HCV relies on the use of interferon-alpha in combination – such as Roche’s own Pegasys (peginterferon alfa-2a) – given alongside the oral drug ribavirin. Adding directly-acting antiviral agents to that background therapy has been shown to provide a significant boost to treatment efficacy in terms of achieving sustained virologic responses.
Commenting on the link-up with Ascletis, Luke Miels, head of Roche’s Asia-Pacific pharma operations, said: “our strategy is based on bringing innovative, differentiated medicines to patients.
“The decision to develop danoprevir based on its promising profile in HCV genotype 1b patients, and to do this via a collaboration with our partner Ascletis represents another example of this strategy in action.”
The agreement comes against a backdrop of increasing concern about HCV, particularly given that worldwide as few as 10 per cent of infected people receive treatment for the disease.
Last year, Roche said it had decided to focus the development of danoprevir as an add-on therapy to Pegasys in emerging markets after conceding it was lagging behind its rival in the protease inhibitor class.