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Tibotec to Present Final Safety and Efficacy Results From Phase 2b PILLAR Study of Once-Daily TMC435 in Late-Breaker at AASLD
Date:11/5/2011

SAN FRANCISCO, Nov. 5, 2011 /PRNewswire/ -- Tibotec Pharmaceuticals (Tibotec), one of the Janssen (Janssen) Pharmaceutical Companies, today will present results of the final analysis of PILLAR, a phase 2b study of the investigational hepatitis C virus (HCV) NS3/4A protease inhibitor TMC435 in treatment-naive patients with chronic genotype 1 HCV, as part of a late-breaker oral presentation at the 62nd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco, CA, USA.  

Results from the final PILLAR analysis showed that TMC435 administered in combination with peginterferon alpha-2a and ribavirin (PR) resulted in significantly higher sustained virologic response (SVR) rates compared to placebo plus PR. In the two TMC435 treatment groups who received TMC435 75mg, between 75 and 82 percent of patients achieved SVR24, and in the two TMC435 treatment groups who received TMC435 150mg, between 81 and 86 percent of patients achieved SVR24. This is compared to 65 percent of patients in the placebo arm who achieved SVR24. In addition, 79 to 86 percent of patients in the TMC435 treatment arms had a shortened treatment duration of 24 weeks, compared to a 48 weeks treatment duration for patients who received placebo plus P/R. In TMC435 arms, 68 to 76 percent of patients achieved rapid virologic response [RVR; HCV RNA<25 (undetectable)], of whom 88 to 95 percent achieved SVR24. There were no significant differences for adverse events between TMC435 treatment groups and placebo. TMC435 150mg administered once daily (q.d.) is being investigated in phase 3 trials in treatment-naive patients and in patients who experienced a viral relapse after being treated with interferon-based therapy. TMC435 is being developed by Tibotec Pharmaceuticals. Medivir AB has commercialization rights for TMC435 for the Nordic countries, Janssen has commercialization rights for TMC435 in the rest of the world.

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SOURCE Tibotec Pharmaceuticals
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