Medivir gains on Phase III HCV data for TMC435

Medivir AB (SSE:MVIR B) gained SEK5.25 to SEK68 on Thursday after reporting data from a trio of Phase III trials of its simeprevir in combination with interferon and ribavirin for chronic HCV genotype 1 infection. Partner Johnson & Johnson (NYSE:JNJ) plans to submit regulatory applications for simeprevir ( TMC435) in the U.S., EU and Japan in 1H13. J&J's Janssen R&D Ireland has ex-Nordic rights from Medivir to develop and commercialize the second-generation HCV NS3/4A protease inhibitor.

Once-daily oral simeprevir for 12 weeks met the primary endpoint of a greater proportion of patients achieving an sustained virologic response (SVR) 12 weeks after the end of treatment vs. placebo in treatment-naive patients in the Phase III QUEST-1 trial (80% vs. 50%, p<0.001) and in the Phase III QUEST-2 trial (81% vs. 50%, p<0.001). Additionally, in the Phase III PROMISE trial in patients who relapsed after previous interferon-based therapy, once-daily oral simeprevir for 12 weeks met the primary endpoint of a greater proportion of patients achieving an SVR12 vs. placebo (79% vs. 37%, p<0.001). SVR24 data from all three trials, which each enrolled about 400 patients, are expected in 1H13. ...