Bristol-Myers Squibb and Gilead Sciences Expand Their Alliance to Include Commercialization of ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) in Europe



    Bristol-Myers Squibb Company (NYSE:BMY) and Gilead Sciences, Inc.
    (Nasdaq:GILD) today announced an agreement to commercialize ATRIPLA(R)
    (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate
    300 mg) in Europe for the treatment of virologically suppressed adults
    with HIV-1 infection, subject to the product´s approval by the
    European Commission. If approved, ATRIPLA would represent the first
    and only once-daily single tablet regimen for HIV-1 infection in the
    European Union. The companies expect the European Commission to issue
    its decision by the end of the year.

    Under this agreement, Bristol-Myers Squibb and Gilead share
    responsibility for commercializing ATRIPLA throughout the European
    Union and certain other European countries. Gilead will record
    revenues from future net sales of ATRIPLA in most of the European
    countries, while Bristol-Myers Squibb will record revenues in most of
    the European countries at percentages relative to the contribution
    represented by its individual product.

    Bristol-Myers Squibb recently concluded an agreement with Merck &
    Co., Inc. under which Merck granted Bristol-Myers Squibb rights to
    co-commercialize ATRIPLA with Gilead in all of the European Union and
    certain other European countries. Previously, Merck had the exclusive
    right to market any product containing efavirenz (a component of
    ATRIPLA) in all European countries other than the United Kingdom,
    Germany, France, Italy, Spain and the Republic of Ireland.

    Efavirenz is marketed by Bristol-Myers Squibb under the tradename
    SUSTIVA(R) in the United States, Canada and six major countries of the
    European Union. Efavirenz will continue to be commercialized by Merck
    & Co, Inc, through its affiliate Merck Sharp & Dohme (MSD) Limited
    under the tradename STOCRIN(R) in all other countries within the
    European Union and many countries outside of the United States.
    Emtricitabine and tenofovir disoproxil fumarate are commercialized by
    Gilead under the tradenames Emtriva(R) and Viread(R), respectively,
    and are commonly prescribed together as a once-daily, fixed-dose
    tablet, marketed under the tradename Truvada(R) for use as part of
    combination therapy.

    ATRIPLA is currently sold in the United States and Canada through
    a joint venture between Bristol-Myers Squibb and Gilead. ATRIPLA was
    approved by the U.S. Food and Drug Administration (FDA) in July 2006
    and by Health Canada in October 2007. Gilead and Merck previously
    announced a collaboration to distribute ATRIPLA in developing
    countries.

    Important Product Safety Information (including Boxed WARNINGS)
    About ATRIPLA (efavirenz 600 mg/emtricitabine 200 mg/tenofovir
    disoproxil fumarate 300 mg), Emtriva (emtricitabine), Viread
    (tenofovir disoproxil fumarate (DF)) and Truvada
    (emtricitabine/tenofovir DF) in the United States

    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.

    Emtriva, Viread, Truvada and ATRIPLA are not approved for the
    treatment of chronic hepatitis B virus (HBV) infection and their
    safety and efficacy have not been established in patients co-infected
    with HBV and HIV. Severe acute exacerbations of hepatitis B have been
    reported in patients who have discontinued Viread or Emtriva, which
    are components of Truvada and ATRIPLA. In some of these patients
    treated with Emtriva, the exacerbations of hepatitis B were associated
    with liver decompensation and liver failure. 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 Truvada or ATRIPLA. If appropriate, initiation of
    anti-hepatitis B treatment may be warranted.

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

    Additional Important Information About ATRIPLA in the United
    States

    ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir
    disoproxil fumarate 300 mg) is indicated for use alone as a complete
    regimen or in combination with other antiretroviral agents for the
    treatment of HIV-1 infection in adults.

    Coadministration of ATRIPLA with astemizole, bepridil, cisapride,
    midazolam, pimozide, triazolam, ergot derivatives, or voriconazole is
    contraindicated. Concomitant use of ATRIPLA with St. John´s wort
    (Hypericum perforatum) or St. John´s wort-containing products is not
    recommended.

    Since ATRIPLA contains efavirenz, emtricitabine, and tenofovir DF,
    ATRIPLA should not be coadministered with SUSTIVA(R) (efavirenz),
    Emtriva, Viread, or Truvada(R) (emtricitabine/tenofovir DF). Due to
    similarities between emtricitabine and lamivudine, ATRIPLA should not
    be coadministered with drugs containing lamivudine, including
    Combivir(R) (lamivudine/zidovudine), Epivir(R) or Epivir-HBV(R)
    (lamivudine), Epzicom(TM) (abacavir sulfate/lamivudine), or
    Trizivir(R) (abacavir sulfate/lamivudine/zidovudine).

    Serious psychiatric adverse experiences, including severe
    depression (2.4%), suicidal ideation (0.7%), nonfatal suicide attempts
    (0.5%), aggressive behavior (0.4%), paranoid reactions (0.4%), and
    manic reactions (0.2%), have been reported in patients receiving
    efavirenz. In addition to efavirenz, factors identified in a clinical
    study that were associated with an increase in psychiatric symptoms
    included a history of injection drug use, psychiatric history, and use
    of psychiatric medication. There have been occasional reports of
    suicide, delusions, and psychosis-like behavior, but it could not be
    determined if efavirenz was the cause. Patients with serious
    psychiatric adverse experiences should be evaluated immediately to
    determine whether the risks of continued therapy outweigh the
    benefits.

    Fifty-three percent of patients reported central nervous system
    symptoms (including dizziness (28.1%), insomnia (16.3%), impaired
    concentration (8.3%), somnolence (7.0%), abnormal dreams (6.2%), and
    hallucinations (1.2%)) when taking efavirenz compared to 25% of
    patients receiving control regimens. These symptoms usually begin
    during Days 1-2 of therapy and generally resolve after the first 2-4
    weeks of therapy; they were severe in 2.0% of patients, and 2.1% of
    patients discontinued therapy.

    After 4 weeks of therapy, the prevalence of nervous system
    symptoms of at least moderate severity ranged from 5% to 9% in
    patients treated with regimens containing efavirenz. Nervous system
    symptoms are not predictive of the less frequent psychiatric symptoms.

    It is recommended that creatinine clearance (CrCl) be calculated
    in all patients prior to initiating therapy and as clinically
    appropriate during therapy with ATRIPLA(R) (efavirenz 600
    mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), and
    routine monitoring of CrCl and serum phosphorous be performed for
    patients at risk of renal impairment. ATRIPLA should not be given to
    patients with CrCl less than 50 mL/min. 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 tenofovir DF. ATRIPLA should be avoided with
    concurrent or recent use of a nephrotoxic agent.

    ATRIPLA may cause fetal harm when administered during the first
    trimester to a pregnant woman. Women should not become pregnant or
    breast-feed while taking ATRIPLA. Barrier contraception must always be
    used in combination with other methods of contraception (e.g., oral or
    other hormonal contraceptives). If the patient becomes pregnant while
    taking ATRIPLA, she should be apprised of the potential harm to the
    fetus.

    Mild-to-moderate rash is a common side effect of efavirenz. In
    controlled clinical trials, 26% of patients treated with efavirenz
    experienced new-onset skin rash compared with 17% of patients treated
    in control groups. ATRIPLA should be discontinued in patients
    developing severe rash associated with blistering, desquamation,
    mucosal involvement, or fever. Skin discoloration, associated with
    emtricitabine, may also occur.

    Liver enzymes should be monitored in patients with known or
    suspected hepatitis B or C and when ATRIPLA is administered with
    ritonavir or other medications associated with liver toxicity.

    Decreases in bone mineral density (BMD) have been seen with
    tenofovir DF. Cases of osteomalacia (associated with proximal renal
    tubulopathy) have been reported in association with the use of
    tenofovir DF.

    Use ATRIPLA with caution in patients with a history of seizures.
    Convulsions have been observed in patients receiving efavirenz,
    generally in the presence of known medical history of seizures.

    Redistribution/accumulation of body fat has been observed in
    patients receiving antiretroviral therapy.

    Immune reconstitution syndrome has been reported in patients
    treated with combination antiretroviral therapy, including the
    components of ATRIPLA.

    Saquinavir should not be used as the only protease inhibitor in
    combination with ATRIPLA.

    Coadministration of ATRIPLA and atazanavir is not recommended due
    to concerns regarding decreased atazanavir concentrations. Atazanavir
    and lopinavir/ritonavir have been shown to increase tenofovir
    concentrations. Patients on atazanavir or lopinavir/ritonavir plus
    ATRIPLA should be monitored for tenofovir-associated adverse events.
    ATRIPLA should be discontinued in patients who develop
    tenofovir-associated adverse events.

    Coadministration of ATRIPLA with didanosine should be undertaken
    with caution. Patients receiving this combination should be monitored
    closely for didanosine-associated adverse events. See U.S. Full
    Prescribing Information for complete list of drug-drug interactions.

    In Study 934, the most frequently reported grades 2-4 adverse
    events through 48 weeks in patients receiving efavirenz +
    emtricitabine + tenofovir DF were dizziness (8%), nausea (8%),
    diarrhea (7%), fatigue (7%), headache (5%), rash (5%), sinusitis (4%),
    depression (4%), insomnia (4%), and abnormal dreams (4%).

    The dose of ATRIPLA is one tablet (containing 600 mg of efavirenz,
    200 mg of emtricitabine, and 300 mg of tenofovir DF) once daily taken
    orally on an empty stomach. Dosing at bedtime may improve the
    tolerability of nervous system symptoms. ATRIPLA is not recommended
    for use in patients less than 18 years of age.

    For complete U.S. prescribing information, including Boxed
    WARNINGS, for ATRIPLA, visit www.atripla.com. For complete prescribing
    information for SUSTIVA, visit www.bms.com. For complete U.S.
    prescribing information for Truvada, Viread and Emtriva, including
    Boxed WARNINGS, visit www.gilead.com.

    About Bristol-Myers Squibb

    Bristol-Myers Squibb is a global pharmaceutical and related
    healthcare products company. Visit Bristol-Myers Squibb on the World
    Wide Web at www.bms.com.

    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. Visit Gilead on the World Wide Web at
    www.gilead.com.

    Forward-Looking Statements

    Bristol-Myers Squibb Forward-Looking Statement

    This press release contains "forward-looking statements" as that
    term is defined in the Private Securities Litigation Reform Act of
    1995 regarding product development. Such forward-looking statements
    are based on current expectations and involve inherent risks and
    uncertainties, including factors that could delay, divert or change
    any of them, and could cause actual outcomes and results to differ
    materially from current expectations. No forward-looking statement can
    be guaranteed. Among other risks, there can be no guarantee that
    ATRIPLA will receive regulatory approval in the European Union or
    other geographies. Forward-looking statements in this press release
    should be evaluated together with the many risks and uncertainties
    that affect Bristol-Myers Squibb´s business, including those
    identified in Bristol-Myers Squibb´s Annual Report on Form 10-K for
    the year ended December 31, 2006 and in our Quarterly Reports on Form
    10-Q, particularly under "Item 1A. Risk Factors". Bristol-Myers Squibb
    undertakes no obligation to publicly update any forward-looking
    statement, whether as a result of new information, future events or
    otherwise.

    Gilead Sciences 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 the
    risk that the European Commission will not formally approve ATRIPLA
    for marketing in the European Union prior to the end of the year or at
    all, and any marketing approval, if granted, may have significant
    limitations on its use. 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, 2006 and
    its Quarterly Reports on Form 10-Q for the first three quarters 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.

    Full U.S. prescribing information, including Boxed WARNINGS, for
    ATRIPLA is available at www.atripla.com. Full U.S. prescribing
    information for SUSTIVA is available at www.bms.com. Full U.S.
    prescribing information for Truvada, Viread and Emtriva, including
    Boxed WARNINGS, are available at www.gilead.com.

    EU Summary of Product Characteristics for Truvada, Viread,
    Emtriva, SUSTIVA and STOCRIN are available at
    http://www.emea.europa.eu/htms/human/epar/a.htm.

    ATRIPLA is a registered trademark of Bristol-Myers Squibb & Gilead
    Sciences, LLC. SUSTIVA is a registered trademark of Bristol-Myers
    Squibb Pharma Company. STOCRIN is a registered trademark of Merck &
    Co., Inc. Truvada, Viread and Emtriva are all registered trademarks of
    Gilead Sciences, Inc.