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Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV


    Bristol-Myers Squibb Company (NYSE:BMY) and Gilead Sciences, Inc.
    (Nasdaq:GILD) announced today that Health Canada has approved
    ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil
    fumarate 300 mg) for the treatment of HIV-1 infection in adults. With
    this Notice of Compliance, ATRIPLA becomes the first once-daily single
    tablet regimen for HIV approved in Canada for use as a stand-alone
    therapy or in combination with other antiretrovirals.

    ATRIPLA combines SUSTIVA(R) (efavirenz), manufactured by
    Bristol-Myers Squibb Company, and Truvada(R) (emtricitabine/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. All three medicines work by blocking reverse
    transcriptase, an enzyme necessary for HIV replication.

    "ATRIPLA represents a milestone in treatment for this disease,"
    said Mark Wainberg, MD, Director of the McGill AIDS Centre and
    Professor of Medicine and Microbiology at McGill University. "I
    commend the companies involved for joining forces to make ATRIPLA, the
    first complete three-drug regimen in a single once-daily pill."

    ATRIPLA was developed through a joint venture partnership between
    Bristol-Myers Squibb Company and Gilead Sciences. The product was
    approved by the U.S. Food and Drug Administration in July 2006 and has
    since become the most-prescribed treatment regimen for patients
    starting HIV therapy in the United States. In Canada, approximately
    60,000 people are living with HIV, and around 2,500 new HIV diagnoses
    are reported each year.

    Clinical data support the use of the three-drug regimen contained
    in ATRIPLA in HIV treatment-naive patients. A randomized, open label,
    active-controlled, multicenter, non-inferiority study, Study 934,
    compared a once-daily regimen of Viread, Emtriva and SUSTIVA, the
    components of ATRIPLA, with twice-daily Combivir(R)
    (lamivudine/zidovudine) and once-daily SUSTIVA in treatment-naive
    patients with HIV. Through 48 weeks, 84 percent of patients in the
    Viread/Emtriva/SUSTIVA group (n=244) compared to 73 percent of
    patients in the Combivir/SUSTIVA group (n=243) achieved and maintained
    a viral load of less than 400 copies/mL. This difference largely
    results from the higher number of discontinuations in the
    Combivir/SUSTIVA group due to adverse events (9 percent vs. 4 percent
    in the Viread/Emtriva/SUSTIVA group) and other reasons including loss
    to follow-up, patient withdrawal, non-compliance and protocol
    violation (14 percent vs. 10 percent in the Viread/Emtriva/SUSTIVA
    group).

    In addition, 80 percent and 70 percent of patients in the
    Viread/Emtriva/SUSTIVA group and the Combivir/SUSTIVA group,
    respectively, achieved and maintained a viral load less than 50
    copies/mL through 48 weeks. Selected treatment-emergent adverse events
    (Grades 2-4) reported in greater than or equal to 5 percent of
    patients in the Viread/Emtriva/SUSTIVA group through 48 weeks included
    dizziness, nausea, diarrhea, fatigue, headache and rash.

    Important Product Safety Information 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)

    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

    ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir
    disoproxil fumarate (DF) 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, 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 (eg, 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 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 prescribing information for ATRIPLA, visit
    www.atripla.com. For complete prescribing information for Sustiva,
    visit www.bms.com. For complete prescribing information for Truvada,
    Viread and Emtriva, 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 Canadian offices in Mississauga,
    Ontario and manufacturing facilities in Edmonton, Alberta. The company
    also has operations in 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 be made available on public formularies and private drug
    plans as a reimbursed medication. 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 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 physicians in Canada may not see advantages of ATRIPLA over
    other antiretrovirals and may therefore be reluctant to prescribe the
    product. In addition, Bristol-Myers Squibb Company and Gilead may be
    unsuccessful in listing ATRIPLA on federal and provincial formularies
    as a reimbursed medication. 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 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 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 registered 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.