Roche, one of the world’s largest biotech companies, and Ascletis, an emerging biotechnology company, have entered into a collaboration to develop and commercialise Roche’s investigational drug danoprevir in China for the treatment of hepatitis-C virus (HCV). Danoprevir is an investigational protease inhibitor which is active against HCV genotypes 1 and 4.
Under the terms of the agreement, Ascletis will fund and be responsible for the development, regulatory affairs and manufacturing of danoprevir in greater China, including Taiwan, Hong Kong and Macau and receive payments upon reaching certain development and commercial milestones from Roche. Ascletis and Roche will collaborate for the clinical development and the commercialisation. The contract also involves royalties.
It is estimated that over 10 million patients in China are chronically infected with HCV. The majority of these are genotype 1b, which has proven highly responsive to danoprevir. Roche and Ascletis are joining forces to develop a therapy with the potential to address a serious public health problem and to provide an effective new treatment option for Chinese patients with HCV. Protease inhibitors have become a core component of highly effective future HCV treatments.
Commenting on the agreement, Luke Miels, head of Roche Pharmaceuticals Asia Pacific, 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, and to do this via collaboration with our partner Ascletis represents another example of this strategy in action.”
Jinzi J Wu, president and CEO at Ascletis added, “No marketed direct antiviral agents (DAAs) are currently available for hepatitis C in China. Roche is a global leader in the development of innovative Hepatitis C therapies, and we are pleased to be collaborating with Roche to develop and eventually commercialize this much needed medicine for Chinese patients. Furthermore, we are very encouraged by the clinical data that have emerged to date and looking forward to bringing this novel DAA to patients in need.”
Ascletis is dedicated to discovering, developing and commercializing important new treatments for cancer and infectious diseases. Ascletis is focused on clinical development of innovative medicines and commercialization for the growing Chinese pharmaceutical marketplace.