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Simeprevir Data in Hepatitis C Patients to be Presented at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD)
Date:10/1/2013

CORK, Ireland, Oct. 1, 2013 /PRNewswire/ -- Janssen R&D Ireland (Janssen) announced that data will be presented on the investigational protease inhibitor simeprevir (TMC435) for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease at the upcoming Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which will take place November 1 to 5 in Washington, D.C.

"Simeprevir's clinical profile has been characterized through a robust clinical development program including more than 3,700 patients," said Gaston Picchio, Disease Area Leader Hepatitis, Janssen. "The study results that will be presented at the AASLD Annual Meeting support the potential utility of simeprevir in a number of different hepatitis C patient populations."

Simeprevir was approved in Japan in September 2013 for the treatment of genotype 1 hepatitis C. In the U.S., the New Drug Application (NDA) filed by Janssen for simeprevir administered once daily in combination with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients was granted Priority Review designation by the Food and Drug Administration (FDA) in May. Simeprevir is also being studied in several interferon-free regimens using selected combinations of direct-acting antiviral agents with different mechanisms of action.

The data to be presented at the 2013 AASLD Annual Meeting include:

Poster Presentations: HCV Therapeutics: New Agents, Poster Hall, November 3, 8:00 a.m. - 5:30 p.m. (EST)

  • Simeprevir (TMC435) with peg-interferon alpha-2a/ribavirin for treatment of chronic HCV genotype 1 infection in patients who relapsed after previous interferon-based therapy: Efficacy and safety in patient sub-populations in the PROMIS
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SOURCE Janssen R&D Ireland
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1. 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
2. Efficacy and Safety Data from Phase 2B Trials of Janssens Simeprevir in Hepatitis C Patients with Advanced Fibrosis of the Liver Presented at Annual Meeting of the American Association for the Study of Liver Diseases
3. Janssen Submits New Drug Application to U.S. FDA for Simeprevir (TMC435) for Combination Treatment of Adult Patients with Genotype 1 Chronic Hepatitis C
4. Findings from Two Phase 3 Studies of Janssens Simeprevir Administered Once Daily Demonstrate Sustained Virologic Response in Genotype 1 Chronic Hepatitis C Patients
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7. Primary Efficacy and Safety Findings from Phase 3 Study of Janssens Simeprevir Administered Once Daily Demonstrate Sustained Virologic Response in Treatment-Experienced Genotype 1 Chronic Hepatitis C Adult Patients
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