Medivir Announces Plans for a Phase II All-oral Study of Simeprevir (TMC435) and VX-135 for the Treatment of Hepatitis C to be Conducted by Janssen and Vertex

Medivir Announces Plans for a Phase II All-oral Study of Simeprevir (TMC435) and VX-135 for the Treatment of Hepatitis C to be Conducted by Janssen and Vertex PR Newswire STOCKHOLM, November 1, 2012 STOCKHOLM, November 1, 2012 /PRNewswire/ -- Companies to evaluate a two-drug combination of Medivir/Janssen's investigational protease inhibitor simeprevir (TMC435) and Vertex's investigational nucleotide analogue VX-135 Phase II proof-of-concept study to begin in early 2013 to evaluate safety, tolerability and viral cure rates of 12- week treatment regimen Medivir AB (OMX: MVIR), announced today plans for a phase II proof-of-concept study of an all-oral regimen for the treatment of hepatitis C containing of Medivir/Janssen's protease inhibitor simeprevir and Vertex's nucleotide analogue hepatitis C virus (HCV) polymerase inhibitor VX-135. Janssen will conduct a drug-drug interaction study with simeprevir and VX-135 to support the planned initiation of a phase II proof-of-concept study in early 2013, pending discussions with regulatory authorities. The phase II study is expected to evaluate safety, tolerability and viral cure rates using a 12-week combination of simeprevir and VX-135, with and without ribavirin. Janssen and Vertex will jointly fund development costs associated with the collaboration. There are no up-front or milestone payments associated with the agreement.