Janssen Pharmaceuticals, a Johnson & Johnson (JNJ) company, announced that it has entered into a non-exclusive collaboration with Vertex Pharmaceuticals (VRTX) Incorporated to evaluate in a Phase 2 study the safety and efficacy of an all-oral regimen for the treatment of hepatitis C, or HCV. The regimen will include Janssen's investigational protease inhibitor simeprevir, or TMC435, and Vertex's investigational nucleotide analogue HCV polymerase inhibitor, VX-135. As a first step, Janssen will conduct a drug-drug interaction, or DDI, study with simeprevir and VX-135. The DDI study will support the initiation of the Phase 2 study in early 2013 pending discussions with regulatory authorities. The goal of the Phase 2 study will be to evaluate the safety, tolerability and viral cure rates of a 12-week regimen of simeprevir and VX-135, administered with and without ribavirin, in treatment-naive patients who have chronic non-cirrhotic genotype 1 HCV. The companies will jointly fund development costs associated with the collaboration. There are no up-front or milestone payments associated with the agreement.
- Pharmaceuticals & Drug Trials
- Vertex Pharmaceuticals