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Toyama Chemical Submits IND for Its Anti-Influenza Compound ''T-705''



    Toyama Chemical Co., Ltd., (TOKYO:4518) (Headquarters: Tokyo,
    Japan; President: Katsuhiko Nakano) submitted an IND (Investigational
    New Drug) application to the United States FDA (Food and Drug
    Administration) on January 17, 2007 for its anti-influenza virus
    compound "T-705."

    T-705 is a unique viral RNA polymerase inhibitor discovered by
    Toyama Chemical. In 2005, Utah State University (US) carried out
    various studies under its contract with the NIAID (National Institute
    of Allergy and Infectious Disease), and demonstrated that T-705 has
    exceptionally potent activity in mouse infection models of H5N1 avian
    influenza, a highly pathogenic infection that cannot be treated with
    established therapies. Toyama is currently developing T-705 as a
    treatment for influenza infections including infections with H5N1
    strains.

    The WHO (World Health Organization) has stated that in the event
    of a pandemic outbreak, the pandemic virus will spread rapidly, and is
    likely to cause high death rates.

    Currently, the only antiviral agents approved to treat influenza
    infection are neuraminidase inhibitors. However, there are concerns
    over the emergence of resistant virus strains to these drugs and there
    is no demonstrated utility for these drugs in treating H5N1 avian
    influenza. Under such circumstances, the development of T-705, which
    has a different mechanism of action, would provide physicians and
    patients with alternative treatment options to the current therapies,
    and would be highly beneficial.

    In Japan, the Phase 1 clinical studies began on January 24 under a
    Japanese IND. As an influenza pandemic resulting from the emergence of
    a 'new' virus is of great concern worldwide, Toyama Chemical considers
    it its social responsibility to rapidly develop T-705, and will give
    the project top priority. Development in Japan and the US will be
    carried out in parallel. Toyama will keep in close contact with
    regulatory agencies in both Japan and the US, and with the NIH in
    order to discuss and quickly resolve any issues that might arise.

    Toyama Chemical specializes in research and development, and
    strives to "contribute to the further development of global health
    care by providing new medicines for unmet medical needs."

    Reference: WHO

    http://www.who.int/csr/disease/influenza/pandemic/en/