Roche and InterMune have initiated a Phase IIb study evaluating the hepatitis C virus (HCV) protease inhibitor, RG7227/ ITMN-191, in combination with Pegasys (pegylated interferon alfa-2a) and Copegus (ribavirin). The study will be conducted at 45 sites globally and will further evaluate the safety and efficacy profile of the drug. Approximately 300 treatment-naive patients with chronic HCV genotype 1 infection will participate. The initiation of the Phase IIb trial triggered a $20 million payment to InterMune as per the companies’ collaboration agreement.

Frank Duff, M.D., head of Roche’s Clinical Development for Virology, said, “This trial represents an important step forward in the development of this oral direct-acting antiviral (DAA), and builds on the encouraging clinical safety and efficacy data generated to date.”

Dan Welch, chairman, chief executive officer and president of InterMune, added, “We are very pleased to announce with our colleagues, Roche, the start of the global Phase IIb program of RG7227/ ITMN-191 in treatment-naive HCV patients. This study will significantly expand the clinical efficacy and safety database for this treatment, and in the first quarter of next year provide our first look at the rapid virologic response (RVR) rates associated with this triple therapy.”

Read Roche’s profile in this year’s Top 20 Pharma Report!


Sign up today for Contracting & Outsourcing 2009!
contractpharma.com/2009conference