Idenix Pharma, Janssen Collaborate to Begin Phase II All-Oral Combo Studies Which Include IDX719, TMC647055

Idenix Pharmaceuticals,Inc. (Nasdaq: IDIX), a biopharmaceutical company engaged in the discovery anddevelopment of drugs for the treatment of human viral diseases, todayannounced a non-exclusive collaboration with Janssen Pharmaceuticals, Inc. forthe clinical development of all-oral direct-acting antiviral (DAA) HCVcombination therapies. The collaboration will evaluate combinations includingIDX719, Idenix's once-daily pan-genotypic NS5A inhibitor, simeprevir (TMC435),a once-daily protease inhibitor jointly developed by Janssen and Medivir AB,and TMC647055, a once-daily non-nucleoside polymerase inhibitor, boosted withlow dose ritonavir, being developed by Janssen.Clinical development plans include an initial drug-drug interaction study tobegin in the first quarter of 2013, followed by phase II studies as agreedbetween the companies, and pending approval from regulatory authorities. Thephase II program is expected to first evaluate the two-DAA combination ofIDX719 and simeprevir plus ribavirin for 12 weeks in treatment-naïveHCV-infected patients. Subsequently, the companies plan to evaluate athree-DAA combination of IDX719, simeprevir and TMC647055/r, with and withoutribavirin. The clinical trials will be conducted by Idenix. Both companiesretain all rights to their respective compounds under this agreement.