Janssen, Medivir and Idenix partner for clinical development of HCV combination therapy
Published on January 29, 2013 at 12:52 AM
Medivir AB (STO:MVIR-B) today announced a non-exclusive collaboration between Janssen Pharmaceuticals Inc. (Janssen) and Idenix Pharmaceuticals for the clinical development of an all-oral (interferon-free) direct-acting antiviral (DAA) hepatitis C (HCV) combination therapy. The collaboration will evaluate combinations including simeprevir (TMC435), a once-daily protease inhibitor jointly developed by Janssen R&D Ireland and Medivir, TMC647055, a potent once-daily NNI (non-nucleoside inhibitor) of the HCV polymerase, boosted with low dose ritonavir, being developed by Janssen and IDX719, Idenix's once-daily pan-genotypic NS5A inhibitor.
Clinical development plans include an initial drug-drug interaction study to begin in the first quarter of 2013, followed by phase II studies as agreed between the companies, and pending approval from regulatory authorities. The phase II program is expected to first evaluate the two-DAA combination of IDX719 and simeprevir plus ribavirin for 12 weeks in treatment-naïve HCV-infected patients. Subsequently, the companies plan to evaluate a three-DAA combination of IDX719, simeprevir, TMC647055/r, with or without ribavirin. The clinical trials will be conducted by Idenix. Both companies retain all rights to their respective compounds under this agreement.
"This collaboration agreement underscores our strong commitment to develop interferon-free treatment options with simeprevir as a base for hepatitis C patients", says Charlotte Edenius, EVP of Research and Development, Medivir AB. "We are committed to develop these new treatments, where already four different interferon-free combinations with simeprevir are under investigation, with the potential to achieve high viral cure rates after only 12 weeks of total treatment, and we look forward to start this new collaboration with Idenix."