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Gilead Announces Presentation of Long-Term Data for Ambrisentan, a Potential Treatment for Patients With Pulmonary Arterial Hypertension



    Gilead Sciences, Inc. (Nasdaq:GILD) today announced results of two
    long-term studies evaluating ambrisentan, an investigational
    endothelin receptor antagonist (ERA) for the treatment of patients
    with pulmonary arterial hypertension (PAH). These long-term data are
    from patients who originally participated in the two pivotal Phase III
    ARIES studies and AMB-222, a Phase II study of patients who had
    previously discontinued other ERAs because of liver function
    abnormalities. These studies were selected for oral presentation at
    ATS 2007, the International Conference of the American Thoracic
    Society, taking place in San Francisco, California, May 18-23.

    "Pulmonary arterial hypertension is a progressive,
    life-threatening disease for which new therapies are clearly needed,"
    said Ronald J. Oudiz, MD, Associate Professor of Medicine, UCLA School
    of Medicine and Director, Liu Center for Pulmonary Hypertension, Los
    Angeles Biomedical Research Institute at Harbor-UCLA Medical Center.
    "The long-term clinical profile observed in these ambrisentan studies
    is very encouraging."

    About the Studies

    In the first presentation (Abstract #2307), Dr. Oudiz presented
    results from an integrated analysis of an ongoing, long-term extension
    study (ARIES-E) involving patients from the two 12-week Phase III
    placebo-controlled studies (ARIES-1 and ARIES-2). A total of 383
    patients with idiopathic PAH or PAH associated with connective tissue
    disease, HIV infection, or anorexigen use who received at least one
    dose of ambrisentan (2.5, 5 or 10 mg once-daily) in ARIES-1, ARIES-2
    or ARIES-E were included in the integrated analysis, which reflect
    data available as of February 2006 (mean exposure = 39 weeks; maximum
    exposure = 109 weeks).

    Improvements in the non placebo-corrected 6-minute walk distance
    observed during the first 12 weeks of ambrisentan treatment (+37.7
    meters) were sustained for at least 48 weeks (+36.4 meters).
    Improvements in WHO functional class and Borg dyspnea index were also
    maintained with long-term ambrisentan treatment. In addition, the
    one-year probability of survival was 95 percent for patients receiving
    ambrisentan.

    Ambrisentan adverse events were similar in nature to those
    reported in the previous 12-week placebo-controlled studies. The most
    common adverse event was peripheral edema which was generally reported
    to be mild or moderate and did not lead to discontinuation of
    ambrisentan.

    As of October 2006 (mean exposure = 1.4 years; maximum exposure =
    2.8 years), 2.1 percent of patients developed liver enzyme
    (aminotransferase) elevations greater than three times the upper limit
    of normal, which was similar to the incidence observed for the placebo
    groups (2.3 percent) in the 12-week ARIES-1 and ARIES-2 studies. One
    patient required discontinuation of ambrisentan due to liver enzyme
    abnormalities.

    Long-term results from the AMB-222 study (Abstract #2171) were
    presented by Michael McGoon, MD, Professor of Medicine, Mayo Clinic,
    Rochester, Minnesota. This open-label study evaluated 36 patients who
    had previously discontinued the ERAs bosentan (86 percent),
    sitaxsentan (6 percent), or both (8 percent) due to the development of
    liver function abnormalities. In this study, patients with idiopathic
    PAH or PAH associated with connective tissue disease, congenital heart
    defects, HIV infection, or anorexigen use received once-daily doses of
    ambrisentan -- 2.5 mg/day for four weeks, 5 mg/day for 20 weeks, and
    2.5, 5 or 10 mg/day thereafter -- for up to 18 months. Twenty-five of
    the 36 patients enrolled were also receiving concomitant sildenafil
    and/or prostanoid treatment. The primary endpoint of the study was the
    incidence of liver function abnormalities during 12 weeks of therapy
    that resulted in discontinuation of drug.

    No patients had liver function abnormalities that required
    discontinuation of ambrisentan during the 12-week primary endpoint
    period. Of the 36 patients evaluated, two patients discontinued due to
    adverse events not related to liver toxicity. As of October 2006 (mean
    exposure = 1.1 years, maximum duration 1.4 years), one patient had
    developed a transient liver function abnormality that was greater than
    three times the upper limit of normal and this patient continued
    receiving treatment with ambrisentan. The long-term adverse event
    profile appeared similar to results from previous ambrisentan clinical
    studies and included peripheral edema, headache, dyspnea and flushing.

    "Endothelin receptor antagonism has well-established clinical
    benefits in patients with PAH, but liver toxicity, which frequently
    leads to discontinuation of treatment, has limited the usefulness of
    these drugs in some patients," said Dr. McGoon. "The results of this
    study support the potential of ambrisentan in newly diagnosed patients
    with PAH, as well as patients who have failed other ERA therapies due
    to liver function abnormalities."

    "PAH is a chronic disease and, as such, we recognize the
    importance of evaluating the long-term efficacy and safety profile of
    ambrisentan," said Michael J. Gerber, MD, Senior Vice President,
    Clinical Research at Gilead. "We will continue to work with the
    clinical investigators and follow patients from each of these studies
    so we can better understand the benefits and risks of ambrisentan with
    long-term treatment."

    In addition to these long-term ambrisentan data presentations, two
    posters describing an integrated analysis of 12-week ARIES-1 and
    ARIES-2 data are also being presented at ATS. The first poster
    (Abstract #3192) titled "Ambrisentan Therapy for Pulmonary Arterial
    Hypertension: An Integrated Analysis of the ARIES-1 and ARIES-2
    Studies" was presented today by Nazzareno Galie, MD, Professor of
    Cardiology at the University of Bologna in Bologna, Italy. The second
    poster (Abstract #2873) titled "Ambrisentan Improves Exercise Capacity
    and Dyspnea in WHO Functional Class II and Class III Patients with
    Pulmonary Arterial Hypertension" will be presented on Wednesday, May
    23 by Horst Olschewski, MD, Professor of Medicine in the Division of
    Pulmonology at the Medical University of Graz in Graz, Austria.

    About Ambrisentan

    Ambrisentan is a non-sulfonamide, propanoic acid-class, endothelin
    receptor antagonist that is selective for the endothelin type-A (ETA)
    receptor. Activation of the ETA receptor by endothelin, a small
    peptide hormone, leads to vasoconstriction (narrowing of blood
    vessels) and cell proliferation. PAH is associated with elevated
    endothelin blood levels. Ambrisentan has been granted orphan drug
    designation for the treatment of PAH in both the United States and
    European Union.

    The U.S. Food and Drug Administration (FDA) recently accepted for
    filing and granted a Priority Review for Gilead's New Drug Application
    (NDA) for marketing approval of ambrisentan (5 mg and 10 mg) for the
    once-daily treatment of PAH. The FDA has established a target review
    date, under the Prescription Drug User Fee Act (PDUFA), of June 18,
    2007.

    As an investigational compound, ambrisentan has not yet been
    determined safe or efficacious in humans.

    GlaxoSmithKline holds rights to commercialize ambrisentan for PAH
    in territories outside of the United States. A Marketing Authorisation
    Application (MAA) for ambrisentan was filed with the European
    Medicines Agency (EMEA) earlier this year.

    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 successfully commercialize ambrisentan
    for PAH. For example, the FDA may not approve ambrisentan for the
    treatment of PAH in the United States, and marketing approval, if
    granted, may have significant limitations on its use. In addition,
    future discussions with the FDA may impact the amount of data needed
    and timelines for review, which may differ materially from Gilead's
    current projections. Further, safety and efficacy data from additional
    clinical studies may not warrant further development of this compound
    and completing our clinical studies 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 Gilead's Annual Report on Form 10-K for the year ended
    December 31, 2006 and its Report on Form 10-Q for the first quarter of
    2007, 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.