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Bristol-Myers Squibb, Tibotec partner for TMC435 Phase II combination study in HCV

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    Medivir AB (OMX:MVIR), the research-based speciality pharmaceutical company focused on the development of high-value treatments for infectious diseases, announces that its development partner, Tibotec Pharmaceuticals, has entered into an agreement with Bristol-Myers Squibb Company (NYSE:BMY). TMC435, a once daily NS3/4A protease inhibitor (PI) for the treatment of genotype-1 chronic hepatitis C virus (HCV) infection will be investigated in combination with Bristol-Myers Squibb´s investigational NS5A replication complex inhibitor, daclatasvir. Charlotte Edenius, Executive VP Research & Development, of Medivir commented, "We are very excited to work with Bristol-Myers Squibb to investigate our protease inhibitor, TMC435, in combination with an NS5A replication complex inhibitor to enable the advancement of novel treatment options for people chronically infected with HCV. We believe that an all oral, treatment regimen for HCV would represent a major step towards improved HCV treatments." Bristol-Myers Squibb released the following statement on 2nd December 2011: Bristol-Myers Squibb Enters Clinical Collaboration Agreement with Tibotec Pharmaceuticals for Phase II Combination Study in Patients Chronically Infected with Hepatitis C Bristol-Myers Squibb Company (NYSE:BMY) announced today that it has entered into a clinical collaboration agreement with Tibotec Pharmaceuticals, one of the Janssen Pharmaceutical Companies, to evaluate the utility of daclatasvir (BMS-790052), Bristol-Myers Squibb's investigational NS5A replication complex inhibitor, in combination with Tibotec Pharmaceuticals' investigational NS3 protease inhibitor, TMC435, for the treatment of chronic hepatitis C virus (HCV). Under the agreement the companies will evaluate the potential to achieve sustained viral response 12 and 24 weeks post treatment in patients with HCV genotype 1 in a study with three treatment regimens: an oral, once-daily treatment regimen of daclatasvir and TMC435 with pegylated-interferon alpha plus ribavirin; an oral, once-daily treatment regimen of daclatasvir and TMC435 with ribavirin and an oral, once-daily treatment regimen of daclatasvir and TMC435 alone. The study is planned to start in the first half of 2012. "Bristol-Myers Squibb is dedicated to developing innovative treatment options for patients with serious diseases like HCV," said Brian Daniels, senior vice president, Development. "We are pleased to work with Tibotec to advance the scientific understanding for the potential for an all-oral regimen of direct acting antivirals, which would be an important advancement for patients with HCV. This is a continuation of our leadership in forging partnerships to advance combination antiviral therapy."

 

 

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