Empresas y finanzas

Gilead Announces Completion of Phase II Clinical Trial of Novel Investigational HIV Integrase Inhibitor GS 9137



    Gilead Sciences, Inc. (Nasdaq:GILD) today announced the completion
    of a Phase II clinical trial of GS 9137, a novel oral HIV integrase
    inhibitor. The clinical study met its primary endpoint of
    non-inferiority in viral load reduction in HIV-positive patients
    receiving 50 mg or 125 mg of GS 9137 once daily, each boosted with 100
    mg of ritonavir, in combination with an optimized background
    antiretroviral regimen compared to a boosted comparator protease
    inhibitor regimen (p=0.02 for the 125 mg arm).

    This ongoing Phase II study is a partially-blinded, randomized,
    active-controlled, 48-week clinical trial to evaluate the
    non-inferiority of once-daily GS 9137 versus boosted comparator
    protease inhibitors (CPI/r) in highly treatment-experienced
    HIV-infected patients. After week eight, the GS 9137 20 mg arm was
    closed due to a high rate of virologic failure. At this time, the
    addition of darunavir or tipranavir to the GS 9137 study arms was
    permitted, following the availability of data demonstrating a lack of
    drug interactions between both protease inhibitors and GS 9137. The
    primary endpoint of the study was DAVG24, a measure of viral load
    reduction over 24 weeks.

    Integrase inhibitors are an investigational class of
    antiretrovirals that interfere with HIV replication by blocking the
    ability of the virus to integrate into the genetic material of human
    cells. Novel classes of HIV-fighting drugs are needed as patients live
    longer and exhaust currently available treatment options.

    About GS 9137

    GS 9137, also known as JTK-303, was licensed by Gilead from Japan
    Tobacco Inc. (JT) in March 2005. Under the terms of the company's
    agreement with JT, Gilead has exclusive rights to develop and
    commercialize GS 9137 in all countries of the world, excluding Japan
    where JT retains rights. As an investigational compound, GS 9137 has
    not yet been determined safe or efficacious in humans for its ultimate
    intended use.

    About Gilead Sciences

    Gilead Sciences is a biopharmaceutical company that discovers,
    develops and commercializes innovative therapeutics in areas of unmet
    medical need. The company's mission is to advance the care of patients
    suffering from life-threatening diseases worldwide. Headquartered in
    Foster City, California, Gilead has operations in North America,
    Europe and Australia.

    This press release includes forward-looking statements, within the
    meaning of the Private Securities Litigation Reform Act of 1995, that
    are subject to risks, uncertainties and other factors, including risks
    related to Gilead's ability to successfully develop and commercialize
    GS 9137. For example, the safety and efficacy data from additional
    clinical studies may not warrant further development of this compound,
    and initiating and completing clinical trials may take longer or cost
    more than expected. Future discussions with the FDA may impact the
    amount of data needed and timelines for review, and Gilead's clinical
    trial protocol design, clinical endpoint and statistical analyses for
    any additional trials will be subject to FDA review and approval. In
    addition, integrase inhibitors represent a relatively new class of
    compounds that has not had a long history of clinical research and
    development. Therefore, Gilead may face challenges in clinical trial
    protocol design and trial enrollment, and the results of clinical
    trials involving integrase inhibitors may be less predictable than
    with other drug candidates for the treatment of HIV. These risks,
    uncertainties and other factors could cause actual results to differ
    materially from those referred to in the forward-looking statements.
    The reader is cautioned not to rely on these forward-looking
    statements. These and other risks are described in detail in the
    Gilead's Annual Report on Form 10-K for the year ended December 31,
    2005 and Reports on Form 10-Q for the first three quarters of 2006,
    filed with the U.S. Securities and Exchange Commission. All
    forward-looking statements are based on information currently
    available to Gilead, and Gilead assumes no obligation to update any
    such forward-looking statements.

    For more information on Gilead Sciences, please visit the
    company's website at www.gilead.com or call Gilead Public Affairs at
    1-800-GILEAD-5 or 1-650-574-3000.