Phase 3 study results of simeprevir in hepatitis C patients to be presented at EASL Congress

Janssen Pharmaceuticals, Inc.Apr 8 2013

Janssen R&D Ireland (Janssen) announces that data will be presented on the investigational protease inhibitor simeprevir (TMC435) for the treatment of hepatitis C at The International Liver Congress 2013 of the European Association for the Study of the Liver (EASL), which will take place April 24 to 28 in Amsterdam, The Netherlands. These data presentations will include primary efficacy and safety results from the Phase 3 QUEST-1 study of simeprevir administered once daily in combination with pegylated interferon and ribavirin in treatment-naive genotype 1 chronic hepatitis C patients.

"The presentation of this primary efficacy Phase 3 data in a peer-reviewed setting such as The International Liver Congress represents a significant milestone for simeprevir," said Maria Beumont , M.D., medical leader for simeprevir, Janssen. "These data show the potential utility of simeprevir for people living with hepatitis C."

Janssen recently announced the submission of new drug applications in Japan and the United States for simeprevir administered once daily in combination with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients and anticipates submitting simeprevir for regulatory authorization in the EU in the first half of 2013. Simeprevir is also being studied in combination with pegylated interferon and ribavirin for the treatment of genotype 4 HCV infection and in several interferon-free regimens using selected combinations of direct-acting antiviral agents with different mechanisms of action.

Additional simeprevir data from the QUEST-2 study have been accepted by The International Liver Congress, but are subject to EASL's embargo policy until April 23. The data to be presented at The International Liver Congress 2013 include:

• Simeprevir (TMC435) with peginterferon/ribavirin for chronic HCV genotype-1 infection in treatment-naive patients: results from QUEST-1, a Phase III trial
  • Available Thursday, April 25 – Saturday, April 27
  • Lead Author: Ira Jacobson , chief of the Division of Gastroenterology and Hepatology, Vincent Astor Distinguished Professor of Medicine, Weill Cornell Medical College, and attending physician, New York-Presbyterian Hospital/Weill Cornell Medical Center
• Pharmacokinetics of simeprevir (TMC435) in volunteers with moderate or severe hepatic impairment
  • Available Friday, April 26
  • Lead Author: Sivi Ouwerkerk-Mahadevan , scientific director, Clinical Pharmacology, Janssen
• Improved SVR with simeprevir (TMC435) associated with reduced time with patient-reported fatigue in treatment-naive, HCV-infected patients in the PILLAR Phase IIb trial
  • Available Friday, April 26
  • Lead Author: Jane Scott , director, Patient Reported Outcomes, Janssen
• Adding simeprevir (TMC435) to pegylated interferon/ribavirin does not increase patient reported fatigue in treatment-experienced patients with chronic HCV infection: results from the ASPIRE trial
  • Available Friday, April 26
  • Lead Author: Jane Scott , director, Patient Reported Outcomes, Janssen
• Combination therapy of TMC647055 with simeprevir (TMC435) in genotype 1 HCV patients
  • Lead Author: Stefan Bourgeois , gastroenterologist, ZNA Stuivenbergziekenhuis