Janssen Announces Collaboration With Vertex On Phase 2 Study To Investigate An All-Oral Regimen Of Simeprevir (TMC435) And VX-135 For Treatment Of Hepatitis C

Janssen Announces Collaboration With Vertex On Phase 2 Study To Investigate An All-Oral Regimen Of Simeprevir (TMC435) And VX-135 For Treatment Of Hepatitis C PR Newswire TITUSVILLE, New Jersey, Nov. 1, 2012 TITUSVILLE, New Jersey, Nov. 1, 2012 /PRNewswire/ -- Janssen Pharmaceuticals, Inc. today announced that it has entered into a non-exclusive collaboration with Vertex Pharmaceuticals Incorporated to evaluate in a Phase 2 study the safety and efficacy of an all-oral regimen for the treatment of hepatitis C (HCV). The regimen will include Janssen's investigational protease inhibitor simeprevir (TMC435) and Vertex's investigational nucleotide analogue HCV polymerase inhibitor VX-135. As a first step, Janssen will conduct a drug-drug interaction (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. Simeprevir is an investigational NS3/4A protease inhibitor currently in Phase 3 trials, developed in collaboration with and licensed from Medivir AB.