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Medivir Announces TMC435 in an Expanded Clinical Collaboration
Date:4/18/2012

pcoming phase II study the companies will evaluate the potential to achieve sustained viral response 12 and 24 weeks post treatment in null responder and interferon intolerant patients with HCV genotype 1. This study is planned to start later in 2012.

TMC435 and BMS-986094 (INX-189)

The expanded clinical agreement also includes clinical evaluation of a combination of TMC435 and the nucleotide polymerase NS5B inhibitor BMS-986094, formerly known as INX-189. A drug-drug interaction (DDI) study with TMC435 and BMS-986094 will be conducted. Results from the DDI study will guide the further evaluation of the use of TMC435 and BMS-986094 in HCV patients.

Charlotte Edenius, Executive VP Research & Development, of Medivir commented: "We are very excited to see this expanded collaboration between Janssen and Bristol-Myers Squibb and to be investigating TMC435 with the nucleotide BMS-986094 and to expand the clinical collaboration evaluating TMC435 with daclatasvir. This represents one of several strategies to explore TMC435 in interferon free regimens; a development we believe will be an important advancement in the HCV field for patients."

About TMC435

TMC435 is a highly potent once-daily (q.d.) investigational drug that is being jointly developed by Janssen R&D Ireland and Medivir to treat chronic hepatitis C virus infections in genotype 1 patients.

TMC435 - On-going global phase III program in brief:

  • TMC435-C208 or QUEST-1 in 375 treatment-naïve genotype-1 patients
  • TMC435-C216 or QUEST-2 in 375 treatment-naïve genotype-1 patients
  • TMC435-C3007 or PROMISE in 375 genotype-1 patients who have relapsed after prior interferon-based treatment
  • Phase III program in Japan, includes 417 genotype-1 treatment naïve and treatment experienced patients
  • TMC435-C3001 is a phase III efficacy, safety and tolerability
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