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Bristol-Myers Squibb and Gilead Sciences Establish Agreement to Commercialize ATRIPLA(TM) (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) in Canada



    Bristol-Myers Squibb Company (NYSE:BMY) and Gilead Sciences, Inc.
    (Nasdaq:GILD) today announced an agreement to commercialize
    ATRIPLA(TM) (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir
    disoproxil fumarate 300 mg) in Canada for the treatment of HIV-1
    infection in adults, subject to the approval of the product by Health
    Canada. ATRIPLA is the first once-daily single tablet regimen (STR)
    for HIV intended as a stand-alone therapy or in combination with other
    antiretrovirals. ATRIPLA received approval from the U.S. Food & Drug
    Administration on July 12, 2006.

    The agreement is the result of negotiations between Bristol-Myers
    Squibb and Gilead Sciences and expands the companies' U.S. joint
    venture established in December 2004. The companies will work together
    to complete regulatory filings in Canada and will share responsibility
    for commercializing ATRIPLA in Canada, subject to regulatory approval
    of the product. As in the United States, both companies will provide
    funding and field-based sales representatives in support of
    promotional efforts for ATRIPLA. Gilead will record revenues from
    future net sales of ATRIPLA, while Bristol-Myers Squibb will record
    revenues at percentages relative to the contribution represented by
    its individual product.

    "We are pleased to have finalized our agreement for Canada, and
    are working expeditiously to complete the regulatory filing for
    ATRIPLA with Health Canada," said John C. Martin, PhD, President and
    CEO, Gilead Sciences. "We recognize the need for access to ATRIPLA,
    the first once-daily single tablet regimen, and are working to make it
    available to all patients who need it as quickly as possible."

    "This agreement with Gilead Sciences marks an important step
    forward in our efforts to deliver effective HIV therapies," said
    Lamberto Andreotti, president, Worldwide Pharmaceuticals,
    Bristol-Myers Squibb. "We look forward to working with Gilead Sciences
    and Health Canada to make available another effective treatment option
    for Canadian adult patients living with HIV/AIDS."

    ATRIPLA combines SUSTIVA(R) (efavirenz), manufactured by
    Bristol-Myers Squibb, and Truvada(R) (emtricitabine and tenofovir
    disoproxil fumarate), manufactured by Gilead Sciences. Truvada itself
    is a fixed-dose product that contains two of Gilead's anti-HIV
    medications, Viread(R) (tenofovir disoproxil fumarate) and Emtriva(R)
    (emtricitabine), in a single once-daily tablet for use as part of
    combination therapy.

    Important Safety Information About ATRIPLA, Truvada, Viread and
    Emtriva

    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. ATRIPLA, Truvada,
    Viread and Emtriva are not indicated for the treatment of chronic
    hepatitis B virus (HBV) infection and the safety and efficacy of these
    drugs 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 Emtriva or Viread (components of
    ATRIPLA and Truvada). Hepatic function should be monitored closely
    with both clinical and laboratory follow-up for at least several
    months in patients who discontinue ATRIPLA, Truvada, Emtriva or Viread
    and are co-infected with HIV and HBV. If appropriate, initiation of
    anti-hepatitis B therapy may be warranted.

    Additional Important Information About ATRIPLA

    In the United States, ATRIPLA 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.

    It is important for patients to be aware that ATRIPLA does not
    cure HIV infection or AIDS. ATRIPLA has not been shown to reduce the
    risk of transmission of HIV to others through sexual contact or blood
    contamination.

    ATRIPLA is contraindicated for use with astemizole, cisapride,
    midazolam, triazolam, ergot derivatives, or voriconazole. Concomitant
    use of ATRIPLA and St. John's wort (Hypericum perforatum) or St.
    John's wort-containing products is not recommended. Since ATRIPLA
    contains efavirenz, emtricitabine and tenofovir disoproxil fumarate,
    it should not be coadministered with SUSTIVA, Emtriva, Viread, or
    Truvada. Due to similarities between emtricitabine and lamivudine,
    ATRIPLA should not be coadministered with drugs containing lamivudine,
    including Combivir(R), Epivir(R), Epivir-HBV(R), Epzicom(TM), or
    Trizivir(R).

    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 treated with
    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 postmarketing
    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 the first or second day of therapy and generally resolve
    after the first two to four weeks of therapy. After four weeks of
    therapy, the prevalence of central 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.

    ATRIPLA should not be given to patients with creatinine clearance
    below 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 disoproxil fumarate, most often in patients with underlying
    systemic or renal disease, or in patients taking concomitant
    nephrotoxic agents. Some cases have occurred in patients with no
    identified risk factors. 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
    breastfeed while taking ATRIPLA. Barrier contraception must always be
    used in combination with other methods of contraception such as 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. Skin discoloration, associated with emtricitabine,
    may also occur. ATRIPLA should be discontinued in patients developing
    severe rash associated with blistering, desquamation, mucosal
    involvement, or fever. 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 have been seen with
    tenofovir disoproxil fumarate. 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 and/or accumulation of body fat
    have 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.

    Coadministration of ATRIPLA and atazanavir is not recommended due
    to concerns regarding decreased atazanavir concentrations. Patients on
    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 and didanosine should be undertaken with
    caution. Patients receiving this combination should be monitored
    closely for didanosine-associated adverse events. See full prescribing
    information for complete list of drug-drug interactions.

    In a large controlled clinical trial (Study 934), adverse events
    observed in greater than or equal to 5% of patients in the
    Viread/Emtriva/SUSTIVA group include dizziness, nausea, diarrhea,
    fatigue, headache, and rash.

    The dose of ATRIPLA is one tablet once daily taken orally on an
    empty stomach. Dosing at bedtime may improve the tolerability of
    nervous system symptoms.

    Important Information About SUSTIVA

    SUSTIVA (efavirenz) in combination with other antiretroviral
    agents is indicated for the treatment of HIV-1 infection. This
    indication is based on two clinical trials of at least one year
    duration that demonstrated prolonged suppression of HIV RNA.

    Coadministration with astemizole, cisapride, midazolam, triazolam,
    ergot derivatives, or voriconazole is contraindicated. Concomitant use
    of SUSTIVA and St. John's wort (Hypericum perforatum) or St. John's
    wort-containing products is not recommended. This list of medications
    is not complete.

    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 treated with
    SUSTIVA. In addition to SUSTIVA, factors identified in a clinical
    study that were associated with an increase in psychiatric symptoms
    included 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 SUSTIVA 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 SUSTIVA 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. After four weeks of therapy, the prevalence of central
    nervous system symptoms of at least moderate severity ranged from 5%
    to 9% in patients treated with regimens containing SUSTIVA. Nervous
    system symptoms are not predictive of the less frequent serious
    psychiatric symptoms.

    SUSTIVA may cause fetal harm when administered during the first
    trimester to a pregnant woman. Women should not become pregnant or
    breastfeed while taking SUSTIVA. 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 SUSTIVA, she should be apprised of the potential harm to the
    fetus.

    Mild to moderate rash is a common side effect of SUSTIVA. In
    controlled clinical trials, 26% of patients treated with SUSTIVA
    experienced new-onset skin rash compared with 17% of patients treated
    in control groups. SUSTIVA should be discontinued in patients
    developing severe rash associated with blistering, desquamation,
    mucosal involvement, or fever. Rash is more common and often more
    severe in pediatric patients.

    Liver enzymes should be monitored in patients with known or
    suspected hepatitis B or C, in patients treated with other medications
    associated with liver toxicity, and when SUSTIVA is administered with
    ritonavir. Use SUSTIVA 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 and/or accumulation of body fat have been
    seen in patients receiving antiretroviral therapy. A causal
    relationship has not been established. Immune reconstitution syndrome
    has been reported in patients treated with combination antiretroviral
    therapy, including SUSTIVA.

    It is recommended that SUSTIVA be taken on an empty stomach,
    preferably at bedtime. The increased concentrations following
    administration of SUSTIVA with food may lead to an increase in
    frequency of adverse events. Dosing at bedtime may improve the
    tolerability of nervous system symptoms.

    Additional Important Information About Truvada

    Truvada is a fixed-dose combination product that combines 200 mg
    of Emtriva(R) (emtricitabine) and 300 mg of Viread(R) (tenofovir
    disoproxil fumarate) in one tablet, taken once a day. In the United
    States, Truvada is indicated in combination with other antiretroviral
    agents (such as non-nucleoside reverse transcriptase inhibitors or
    protease inhibitors) for the treatment of HIV-1 infection in adults.
    Truvada should not be coadministered with Emtriva, Viread or
    lamivudine-containing products and it is not recommended that Truvada
    be used as a component of a triple nucleoside regimen. In
    treatment-experienced patients, the use of Truvada should be guided by
    laboratory testing and treatment history.

    Clinical Study 934 supports the use of Truvada tablets for the
    treatment of HIV-1 infection. Additional data in support of the use of
    Truvada are derived from Study 903, in which Viread and lamivudine
    were used in combination in treatment-naive adults, and clinical Study
    303, in which Emtriva and lamivudine demonstrated comparable efficacy,
    safety and resistance patterns as part of multidrug regimens.

    No drug interaction studies have been conducted using Truvada.
    Drug interactions have been observed when didanosine, atazanavir, or
    lopinavir/ritonavir are co-administered with Viread, a component of
    Truvada, and dose adjustments may be necessary. Data are not available
    to recommend a dose adjustment of didanosine for patients weighing
    less than 60 kg. Patients on atazanavir or lopinavir/ritonavir plus
    Truvada should be monitored for Truvada-associated adverse events that
    may require discontinuation. When co-administered with Truvada, it is
    recommended that atazanavir 300 mg be given with ritonavir 100 mg.
    Atazanavir without ritonavir should not be co-administered with
    Truvada.

    Four-hundred and forty-seven HIV-1 infected patients have received
    combination therapy with Emtriva and Viread with either a
    non-nucleoside reverse transcriptase inhibitor (Study 934) or protease
    inhibitor for 48 weeks in clinical studies. Adverse events observed in
    Study 934 were generally consistent with those seen in other studies
    in treatment-experienced or treatment-naive patients receiving Viread
    and/or Emtriva. Adverse events observed in more than 5% of patients in
    the Viread/Emtriva group in Study 934 include diarrhea, nausea,
    fatigue, headache, dizziness and rash.

    Renal impairment, including cases of acute renal failure and
    Fanconi syndrome (renal tubular injury with severe hypophosphatemia),
    has been reported among patients taking Viread, a component of Truvada
    (emtricitabine and tenofovir disoproxil fumarate). Renal impairment
    occurred most often in patients with underlying systemic or renal
    disease or in patients taking concomitant nephrotoxic agents, though
    some cases have appeared in patients without identified risk factors.
    Decreases in bone mineral density (BMD) at the lumbar spine and hip
    have been seen with the use of Viread. Redistribution and/or
    accumulation of body fat have been observed in patients receiving
    antiretroviral therapy. Immune reconstitution syndrome has been
    reported in patients treated with combination antiretroviral therapy
    including Truvada, Viread and Emtriva.

    The effects of Viread-associated changes in BMD and biochemical
    markers on long-term bone health and future fracture risk are unknown.
    Skin discoloration, manifested by hyperpigmentation on the palms
    and/or soles, has been reported with the use of Emtriva, a component
    of Truvada. Skin discoloration was generally mild and asymptomatic and
    its mechanism and clinical significance are unknown.

    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 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 the
    combination product will receive regulatory approval in Canada or
    other geographies, or, if approved, will be commercially successful.
    Forward-looking statements in this press release should be evaluated
    together with the many uncertainties that affect Bristol-Myers
    Squibb's business, particularly those identified in the cautionary
    factors discussion in Bristol-Myers Squibb's Annual Report on Form
    10-K for the year ended December 31, 2005 and in our Quarterly Reports
    on Form 10-Q. 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 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 that
    the combination product receive regulatory approval in Canada or other
    geographies, or, if approved, that physicians may not see advantages
    of ATRIPLA over other antiretrovirals and may therefore be reluctant
    to prescribe the product. 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.

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

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

    U.S. full prescribing information for Truvada, Viread and Emtriva
    is available at www.gilead.com.

    ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences,
    LLC.

    SUSTIVA is a registered trademark of Bristol-Myers Squibb Pharma
    Company.

    Truvada, Viread and Emtriva are registered trademarks of Gilead
    Sciences, Inc.