Roche is teaming up with Ascletis, a biotech company focused on new treatments for cancer and infectious diseases, to develop and commercialize Roche’s investigational drug and protease inhibitor danoprevir in China for the treatment of hepatitis C virus (HCV). Their mission: to develop a therapy with the potential to provide an effective new treatment option for Chinese patients with HCV.
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 on the clinical development and the commercialization. The contract also involves royalties.
"Our strategy is based on bringing innovative, differentiated medicines to patients," Luke Miels, head of Roche Pharmaceuticals Asia Pacific, said. "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."
"No marketed direct antiviral agents (DAAs) are currently available for hepatitis C in China," added Jinzi J. Wu, Ph.D., president and CEO of Ascletis. "We are very encouraged by the clinical data that has emerged to date and looking forward to bringing this novel DAA to patients in need."
Roche co-developed danoprevir with InterMune under an agreement signed in 2006 and paid InterMune $175 million to acquire full worldwide development and commercialization rights to the drug in October of 2010. At the time of the acquisition, danoprevir was in Phase II clinical development both as monotherapy and in combination with Pegasys (pegylated interferon alfa-2a) and Copegus (ribavirin).