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Oct 8, 2013

J&J's Janssen Buys Rights to Hepatitis C Compound from GSK

  • Johnson & Johnson’s Janssen Pharmaceuticals unit said today it acquired GSK2336805, an investigational once-daily NS5a replication complex inhibitor for chronic hepatitis C, from an affiliate of GlaxoSmithKline (GSK).  The price was not disclosed.

    Janssen said it acquired from GSK all rights to develop and commercialize GSK2336805, including GSK2336805 used in combination with other drugs.

    "This addition will broaden our clinical development program as we continue to look for new investigational interferon-free treatment combinations to combat the hepatitis C virus," Gaston Picchio, hepatitis disease area leader with Janssen, said in a statement. "We're excited to add GSK2336805 to our existing portfolio of direct-acting antivirals (DAAs).”

    He said Janssen is dedicated to working with the hepatitis C community to investigate its DAA portfolio in "numerous treatment combinations and patient populations."

    Janssen said it plans to launch Phase II studies evaluating GSK2336805 in interferon-free combinations with the investigational protease inhibitor simeprevir (TMC435) and TMC647055, Janssen's once-daily, non-nucleoside polymerase inhibitor, for chronic hepatitis C in adults with compensated liver disease.

    Simeprevir is an investigational NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir for genotype 1 and genotype 4 chronic hepatitis C in adult patients with compensated liver disease, including all stages of liver fibrosis.

    Janssen is responsible for the global clinical development of simeprevir and has acquired exclusive near-worldwide marketing rights to the drug candidate, except in Nordic countries, where Medivir retains those rights. Simeprevir was approved in Japan last month and has been submitted for regulatory approval in the United States, Canada, and Europe.

    Simeprevir remains in Phase II studies  in combination with several DAAs, with and without ribavirin, as part of interferon-free regimens, Janssen said.



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