Gilead Submits New Drug Application To U.S. FDA for Ambrisentan for the Treatment of Pulmonary Arterial Hypertension



    Gilead Sciences, Inc. (Nasdaq:GILD) today announced the submission
    of a New Drug Application (NDA) to the U.S. Food and Drug
    Administration (FDA) for marketing approval of ambrisentan (5 mg and
    10 mg) for the once-daily treatment of pulmonary arterial hypertension
    (PAH). The application is supported by data from two Phase III
    clinical studies (ARIES-1 and ARIES-2) and three Phase II studies in
    patients with PAH.

    "Current therapeutic options are limited, and there remains an
    urgent need for safe and effective treatments for patients with PAH,"
    said John C. Martin, PhD, President and CEO, Gilead Sciences. "The
    achievement of today's milestone reflects the tremendous dedication of
    numerous clinical investigators and other research collaborators, all
    of whom share our goal of advancing new treatment options for patients
    suffering from PAH. This is also a testament to our Colorado-based
    team, who designed and managed the clinical development program for
    ambrisentan and whose efforts led to the completion of this new drug
    application."

    About ARIES Pivotal Trials

    In the two ARIES clinical trials, patients were randomized in a
    blinded fashion to receive placebo or one of two doses of ambrisentan.
    The trials were of identical design except for the doses of
    ambrisentan studied and the geographic locations of the investigative
    sites. Both trials were designed to enroll 186 patients (62 patients
    per dose group). ARIES-1 evaluated once-daily doses of 5 mg and 10 mg
    of ambrisentan. ARIES-2 evaluated once-daily doses of 2.5 mg and 5 mg
    of ambrisentan. ARIES-1 enrolled 202 patients primarily in the United
    States while ARIES-2 enrolled 192 patients primarily in Europe.

    Approximately 400 patients from these and other studies are
    continuing ambrisentan treatment in long-term clinical trials.

    About Ambrisentan

    Ambrisentan is a non-sulfonamide, propanoic acid-class, endothelin
    receptor antagonist that is selective for the endothelin type-A (ETa)
    receptor. Endothelin is a small peptide hormone that plays a critical
    role in the control of blood flow and cell growth. Elevated endothelin
    blood levels are associated with PAH. Ambrisentan has been granted
    orphan drug designation for the treatment of PAH in both the United
    States and European Union.

    Ambrisentan is an investigational compound and has not yet been
    determined safe or efficacious in humans.

    Gilead acquired the U.S. rights to ambrisentan when it completed
    its acquisition of Myogen, Inc. on November 17, 2006. GlaxoSmithKline
    holds rights to commercialize ambrisentan outside of the United
    States.

    About Pulmonary Arterial Hypertension

    PAH is a debilitating disease characterized by constriction of the
    blood vessels in the lungs leading to high pulmonary arterial
    pressures. These high pressures make it difficult for the heart to
    pump blood through the lungs to be oxygenated. Patients with PAH
    suffer from shortness of breath as the heart struggles to pump against
    these high pressures causing such patients to ultimately die of heart
    failure. PAH can occur with no known underlying cause, or it can occur
    secondary to diseases such as connective tissue disease, congenital
    heart defects, cirrhosis of the liver and HIV infection. PAH afflicts
    approximately 200,000 patients worldwide.

    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. 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.

    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 develop and commercialize this product.
    For example, ambrisentan may not be approved for the doses Gilead is
    seeking, 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. 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 Annual Report on Form 10-K for the year ended
    December 31, 2005, 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.