Bristol-Myers Squibb, Gilead Sciences and Merck & Co. Submit Marketing Authorisation Application for ATRIPLA(TM) (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) to European Medicines Agency



    Bristol-Myers Squibb Company (NYSE:BMY), Gilead Sciences, Inc.
    (Nasdaq:GILD) and Merck & Co., Inc. (NYSE:MRK) today announced the
    submission of a Marketing Authorisation Application (MAA) for
    ATRIPLA(TM) (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir
    disoproxil fumarate 300 mg) in the European Union to the European
    Medicines Agency (EMEA). The MAA will be reviewed by the Committee for
    Medicinal Products for Human Use (CHMP), subject to validation by the
    EMEA.

    The MAA for ATRIPLA in the European Union was filed jointly by the
    three companies through a newly established three-way joint venture
    based in Ireland, Bristol-Myers Squibb Gilead Sciences And Merck Sharp
    & Dohme Limited. Review of the MAA will be conducted by the EMEA under
    the centralized licensing procedure, which, when finalized, provides
    one marketing authorization in all member states of the European
    Union. Discussions among the three companies regarding agreements for
    manufacturing, commercialization and distribution of ATRIPLA in the
    European Union are ongoing.

    ATRIPLA is a once-daily single tablet regimen approved in the
    United States for the treatment of HIV-1 infection in adults for use
    either as stand-alone therapy or in combination with other
    antiretroviral agents. The product contains 600 mg of efavirenz, a
    non-nucleoside reverse transcriptase inhibitor (NNRTI), 200 mg of
    emtricitabine and 300 mg of tenofovir disoproxil fumarate, both
    nucleoside reverse transcriptase inhibitors (NRTIs). Efavirenz is
    marketed by Bristol-Myers Squibb under the tradename SUSTIVA(R) in the
    United States, Canada and six European countries (France, Republic of
    Ireland, Germany, Italy, Spain and the United Kingdom). In other
    territories, including all other countries of the European Union,
    efavirenz is commercialized by Merck & Co., Inc., (also known as MSD
    outside of the United States and Canada) and is marketed in most of
    these countries under the tradename Stocrin(R). Emtricitabine and
    tenofovir disoproxil fumarate are commercialized by Gilead Sciences
    under the tradenames Emtriva(R) and Viread(R), respectively. The
    compounds 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 was approved by the U.S. Food and Drug Administration
    (FDA) on July 12, 2006. In the United States, the product is
    commercialized by Bristol-Myers Squibb and Gilead Sciences through a
    joint venture. The FDA also granted approval of an alternate
    tradedress of ATRIPLA for developing countries, where ATRIPLA will be
    made available as a white-colored tablet to distinguish it from the
    salmon-colored version currently available in the United States.
    Gilead and Merck established a separate agreement in August 2006 for
    distribution of the product in developing countries.

    "Bristol-Myers Squibb is committed to delivering effective HIV
    therapies to patients worldwide and is pleased to work with Gilead and
    Merck to realize this goal with ATRIPLA," said Lamberto Andreotti,
    president, Worldwide Pharmaceuticals, Bristol-Myers Squibb. "With the
    filing of ATRIPLA in Europe, we are one step closer to making
    available another effective treatment option for European adult
    patients living with HIV/AIDS."

    "As the first and only once-daily single tablet regimen, ATRIPLA
    may help to simplify therapy for many HIV-infected adults. Gilead is
    pleased to have established this partnership with Bristol-Myers Squibb
    and Merck, and we look forward to working with colleagues at both
    companies to make this product available to people living with HIV in
    Europe as quickly as possible," said Kevin Young, Executive Vice
    President, Commercial Operations, Gilead Sciences.

    "ATRIPLA has the potential to offer an important new tool to
    patients and physicians in Europe for treating HIV infection in
    adults," said Stefan J. Oschmann, President, Europe, Middle East,
    Africa, Canada, Merck & Co., Inc. "This new single tablet regimen
    exemplifies our commitment to putting patients first. We look forward
    to collaborating with BMS, Gilead and national health authorities to
    deliver ATRIPLA to those who need it as soon as possible."

    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.

    Antiretroviral therapies do not cure HIV infection or AIDS and
    have not been proven to prevent the risk of transmission of HIV to
    others through sexual contact or blood contamination.

    Additional Important Information About ATRIPLA in the United
    States

    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.

    Coadministration of ATRIPLA with astemizole, cisapride, midazolam,
    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 disoproxil
    fumarate, ATRIPLA 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 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 (CNS) 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 two days of therapy and generally resolve after
    the first two to four weeks of therapy; they were severe in 2.0% of
    patients and 2.1% of patients discontinued therapy. After four weeks
    of therapy, the prevalence of CNS 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
    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 disoproxil fumarate. Renal impairment occurred 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 (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. 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 (BMD) 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/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.

    Coadministration with 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 Full Prescribing
    Information for complete list of drug-drug interactions.

    In Study 934, the most frequently reported grades two to four
    adverse events through 48 weeks in patients receiving efavirenz,
    emtricitabine and tenofovir disoproxil fumarate 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 disoproxil fumarate)
    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 younger than 18 years of age.

    Important Information About Efavirenz

    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 efavirenz 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
    efavirenz. In addition to efavirenz, 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 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. 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
    serious psychiatric symptoms.

    Efavirenz may cause fetal harm when administered during the first
    trimester to a pregnant woman. Women should not become pregnant or
    breastfeed while taking efavirenz. 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 efavirenz, 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. Efavirenz 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 efavirenz is administered
    with ritonavir. Use efavirenz 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 efavirenz.

    It is recommended that efavirenz be taken on an empty stomach,
    preferably at bedtime. The increased concentrations following
    administration of efavirenz 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 and the European Union, 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 is 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. In the European Union, the co-administration of
    tenofovir disoproxil fumarate and didanosine is not recommended unless
    judged strictly necessary. 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. The effects of
    Viread-associated changes in BMD and biochemical markers on long-term
    bone health and future risk fracture are unknown. Redistribution
    and/or accumulation of body fat have been observed in patients
    receiving combination antiretroviral therapy. The cause and long term
    health effect of these conditions are unknown. Immune reconstitution
    syndrome has been reported in patients treated with combination
    antiretroviral therapy including Truvada, Viread and Emtriva.

    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.

    About Merck

    Merck & Co. Inc., which operates as Merck Sharp & Dohme (MSD) in
    countries outside of the United States, is a global research-driven
    pharmaceutical company dedicated to putting patients first.
    Established in 1891, Merck currently discovers, develops, manufactures
    and markets vaccines and medicines to address unmet medical needs. The
    Company devotes extensive efforts to increase access to medicines
    through far-reaching programs that not only donate Merck medicines but
    also help deliver them to the people who need them. Merck also
    publishes unbiased health information as a not-for-profit service. For
    more information, visit www.merck.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 the European
    Union or other geographies, or, if approved, will be commercially
    successful. Nor is there any guaranty that discussions among the three
    companies regarding agreements for manufacturing, commercialization
    and distribution of ATRIPLA in the European Union will be successfully
    concluded or implemented. 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 the
    risk that ATRIPLA may not be approved in the European Union or other
    markets and the risk that physicians and regulatory agencies 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.

    Merck Forward-Looking Statement

    This press release contains "forward-looking statements" as that
    term is defined in the Private Securities Litigation Reform Act of
    1995. These statements are based on management's current expectations
    and involve risks and uncertainties, which may cause results to differ
    materially from those set forth in the statements. The forward-looking
    statements may include statements regarding product development,
    product potential or financial performance. No forward-looking
    statement can be guaranteed, and actual results may differ materially
    from those projected. Merck undertakes no obligation to publicly
    update any forward-looking statement, whether as a result of new
    information, future events, or otherwise. Forward-looking statements
    in this press release should be evaluated together with the many
    uncertainties that affect Merck's business, particularly those
    mentioned in the cautionary statements in Item 1 of Merck's Form 10-K
    for the year ended Dec. 31, 2005, and in its periodic reports on Form
    10-Q and Form 8-K, which the company incorporates by reference.

    Full U.S. prescribing information 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
    is available at www.gilead.com.

    EU Summary of Product Characteristics for Truvada, Viread,
    Emtriva, SUSTIVA and Stocrin are available at
    http://www.emea.eu.int/humandocs/Humans/EPAR/a-zepar.htm.

    ATRIPLA is a 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 registered trademarks of Gilead
    Sciences, Inc.