PRINCETON, N.J. and FOSTER CITY, Calif., Dec. 11 /PRNewswire-FirstCall/
-- 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 <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 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 <18 years
of age.
For complete U.S. prescribing information, including Boxed WARNINGS,
for ATRIPLA, visit http://www.atripla.com. For complete prescribing information
for SUSTIVA, visit http://www.bms.com. For complete U.S. prescribing information
for Truvada, Viread and Emtriva, including Boxed WARNINGS, visit
http://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
http://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 http://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 http://www.atripla.com.
Full U.S. prescribing information for SUSTIVA is available at http://www.bms.com.
Full U.S. prescribing information for Truvada, Viread and Emtriva, including
Boxed WARNINGS, are available at http://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.
SOURCE Bristol-Myers Squibb Company
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Related links:
http://www.bms.com
http://www.gilead.com http://www.atripla.com
http://www.emea.europa.eu/htms/human/epar/a.htm
CONTACT:
Sonia Choi, +1-609-252-5132, or for
Investors, John Elicker +1-212-546-3775, both of Bristol-Myers
Squibb; Cara Miller, +1-650-522-1616, or for Investors, Susan
Hubbard, +1-650-522-5715, both of Gilead Sciences, Inc.
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