Gilead Submits Marketing Applications in the United States and European Union for Viread(R) (Tenofovir Disoproxil Fumarate) for the Treatment of Chronic Hepatitis B



    Gilead Sciences, Inc. (Nasdaq: GILD) today announced that it has
    submitted a supplemental New Drug Application (sNDA) to the U.S. Food
    and Drug Administration (FDA) and a Type II variation to the European
    Medicines Agency (EMEA) for marketing approval of Viread(R) (tenofovir
    disoproxil fumarate) for the treatment of chronic hepatitis B in
    adults. Viread is already approved in the United States and European
    Union for the treatment of HIV as part of combination antiretroviral
    therapy.

    "New treatments are critically important in the fight against
    chronic hepatitis B, a potentially life-threatening infection that
    impacts millions of people worldwide," said Eugene Schiff, MD, Chief
    of the Division of Hepatology and Director of the Center for Liver
    Diseases at the University of Miami School of Medicine. "We've made
    great progress in our ability to diagnose and treat the disease, but a
    significant unmet medical need remains and ongoing efforts in research
    and development are essential."

    The submissions contain data from two Phase III pivotal clinical
    trials, Studies 102 and 103, in patients chronically infected with the
    hepatitis B virus (HBV). These studies evaluate the efficacy, safety
    and tolerability of Viread compared to Gilead's Hepsera(R) (adefovir
    dipivoxil). Gilead announced the primary results from Study 102 and
    103 on June 6 and June 25, 2007, respectively. Detailed data from both
    studies will be described in late-breaker presentations at the annual
    meeting of the American Association for the Study of Liver Diseases
    (The Liver Meeting 2007) in Boston, Massachusetts, November 2-6.

    "The active ingredient in Viread -- tenofovir disoproxil fumarate
    -- is the most widely prescribed molecule for the treatment of HIV in
    the United States," said Franck Rousseau, MD, Vice President, Clinical
    Research, Gilead Sciences. "With positive data from two pivotal
    studies now available, we look forward to extending the use of this
    important therapy to patients with chronic hepatitis B."

    Chronic hepatitis B affects more than 400 million people
    worldwide. The complications of chronic hepatitis B, which include
    liver cancer and cirrhosis, kill up to 1.2 million people each year,
    making it one of the world's top 10 causes of death. In the United
    States, an estimated 1.3 million people are currently living with
    chronic hepatitis B, of whom more than half are Asian American. In the
    European region, one million people are estimated to become infected
    with HBV each year and approximately 90,000 go on to develop chronic
    hepatitis B.

    While there is no cure for the disease, anti-HBV medications can
    have beneficial effects on chronic hepatitis B throughout the course
    of infection, potentially preventing fatal liver damage and liver
    cancer. In many cases, this requires prolonged treatment over the
    course of many months or years.

    About Viread (tenofovir disoproxil fumarate) for HIV

    In the United States, Viread is indicated in combination with
    other antiretroviral agents for the treatment of HIV-1 infection.

    Lactic acidosis and severe hepatomegaly with steatosis, including
    fatal cases, have been reported with the use of nucleoside analogues
    alone or in combination with other antiretrovirals. Viread is not
    approved for the treatment of chronic hepatitis B virus (HBV)
    infection and the safety and efficacy of Viread have not been
    established in patients coinfected with HBV and HIV. Severe acute
    exacerbations of hepatitis B have been reported in patients who have
    discontinued Viread. Hepatic function should be monitored closely with
    both clinical and laboratory follow-up for at least several months in
    patients who are co-infected with HIV and HBV and discontinue Viread.
    If appropriate, initiation of anti-hepatitis B treatment may be
    warranted.

    It is important for patients to be aware that anti-HIV medicines
    including Viread do not cure HIV infection or AIDS, and do not reduce
    the risk of transmitting HIV to others.

    Renal impairment, including cases of acute renal failure and
    Fanconi syndrome (renal tubular injury with severe hypophosphatemia),
    has been reported in association with the use of Viread. It is
    recommended that creatinine clearance be calculated in all patients
    prior to initiating therapy with Viread and as clinically appropriate
    during therapy. Routine monitoring of calculated creatinine clearance
    and serum phosphorous should be performed in patients at risk for
    renal impairment. Dosing interval adjustment and close monitoring of
    renal function are recommended in all patients with creatinine
    clearance less than 50mL/min. Viread should be avoided with concurrent
    or recent use of a nephrotoxic agent.

    The U.S. package insert advises that co-administration of Viread
    and didanosine should be undertaken with caution. Patients should be
    monitored closely for didanosine-associated adverse events and
    didanosine should be discontinued if these occur. Patients on
    atazanavir and lopinavir/ritonavir plus Viread should be monitored for
    Viread-associated adverse events and Viread should be discontinued if
    these occur. When co-administered with Viread, it is recommended that
    atazanavir be given with ritonavir 100 mg. Atazanavir without
    ritonavir should not be co-administered with Viread.

    Decreases in bone mineral density (BMD) at the lumbar spine and
    hip have been seen with the use of Viread. The effect on long-term
    bone health and future fracture risk is unknown. Cases of osteomalacia
    (associated with proximal renal tubulopathy) have been reported in
    association with the use of Viread.

    Changes in body fat have been observed in patients taking anti-HIV
    medicines. The mechanism and long-term health effect of these changes
    are unknown. Immune Reconstitution Syndrome has been reported in
    patients treated with combination therapy, including Viread.

    The most common adverse events among patients receiving Viread
    with other antiretroviral agents in a pivotal clinical study (Study
    903) were mild to moderate gastrointestinal events and dizziness.
    Moderate to severe adverse events occurring in more than 5 percent of
    patients receiving Viread included rash (rash, pruritis, maculopapular
    rash, urticaria, vesiculobullous rash and pustular rash), headache,
    pain, diarrhea, depression, back pain, fever, nausea, abdominal pain,
    asthenia (weakness) and anxiety. In another pivotal study (Study 907),
    less than 1 percent of patients discontinued participation because of
    gastrointestinal events.

    For full prescribing information outside of the United States,
    physicians should consult their local product labeling.

    The parent compound of Viread was discovered through a
    collaborative research effort between Dr. Antonin Holy, Institute for
    Organic Chemistry and Biochemistry, Academy of Sciences of the Czech
    Republic (IOCB) in Prague and Dr. Erik DeClercq, Rega Institute for
    Medical Research, Katholic University in Leuven, Belgium.

    About Hepsera (adefovir dipivoxil)

    Hepsera, a nucleotide analogue, works by inhibiting HBV DNA
    polymerase, an enzyme involved in the replication of the virus in the
    body.

    In the United States, Hepsera is indicated for the treatment of
    chronic hepatitis B in adults with evidence of active viral
    replication and either evidence of persistent elevations in serum
    aminotransferases (ALT or AST) or histologically active disease.

    The U.S. package insert advises that the adverse reactions
    considered at least possibly related to treatment reported in 3
    percent or greater of patients in the first 48 weeks in Hepsera
    pivotal clinical studies were asthenia, headache, abdominal pain,
    nausea, flatulence, diarrhea and dyspepsia. With extended treatment,
    mild to moderate increases in serum creatinine were observed
    uncommonly in patients with chronic hepatitis B and compensated liver
    disease treated with Hepsera for a median of 49 weeks up to a maximum
    of 240 weeks. Changes in serum creatinine were observed very commonly
    in patients pre- and post-transplantation with lamivudine-resistant
    liver disease and multiple risk factors for changes in renal function
    who were treated with Hepsera for up to 129 weeks, with a median time
    on treatment of 19 and 56 weeks, respectively. Clinical and laboratory
    evidence of exacerbations of hepatitis have occurred after
    discontinuation of treatment with antiviral therapies for hepatitis B,
    including Hepsera. Special warnings and precautions for use are
    included in the U.S. package insert regarding monitoring of renal
    function, post-treatment exacerbations of hepatitis, and the
    occurrence of lactic acidosis and severe hepatomegaly with steatosis.
    For physicians in the United States, dosing instructions for patients
    with underlying renal impairment and for patients co-infected with HIV
    are also provided in the U.S. package insert, which is available for
    download online at www.hepsera.com.

    For full prescribing information outside of the United States,
    physicians should consult their local product labeling.

    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.

    Forward-Looking Statement

    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 Viread for
    chronic hepatitis B. For example, the FDA and EMEA may not approve
    Viread for the treatment of chronic hepatitis B, and marketing
    approval, if granted, may have significant limitations on its use and
    physicians may not see advantages of Viread over other treatment
    options and may therefore be reluctant to prescribe Viread for chronic
    hepatitis B. 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 Quarterly Report on Form 10-Q for the first
    and second quarters of 2007, as 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.

    U.S. full prescribing information for Viread is available at
    www.Viread.com

    U.S. full prescribing information for Hepsera is available at
    www.Hepsera.com

    Viread and Hepsera are registered trademarks of Gilead Sciences,
    Inc.

    For more information on Gilead, please call the Gilead Public
    Affairs Department at 1-800-GILEAD-5 (1-800-445-3235) or visit
    www.gilead.com.