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Datum nieuwsfeit: 27-04-2006
Bristol-Myers Squibb en Gilead dienen aanvraag in bij FDA voor nieuwe 1-tablet-per-dag-medicatie bij HIV-behandeling
( BW)(CA-GILEAD/BRISTOL)(GILD)(BMY) Bristol-Myers Squibb and Gilead
Sciences Submit New Drug Application to U.S. FDA for a Once-Daily
Single Tablet Regimen of Sustiva(R) (Efavirenz) and Truvada(R)
(Emtricitabine and Tenofovir Disoproxil Fumarate) for HIV Treatment
Business Editors/Health/Medical Writers
BIOWIRE2K
PRINCETON, N.J. & FOSTER CITY, Calif.--(BUSINESS WIRE)--April 27,
2006--Bristol-Myers Squibb Company (NYSE:BMY) and Gilead Sciences,
Inc. (Nasdaq:GILD) today announced the submission of a New Drug
Application (NDA) to the U.S. Food and Drug Administration (FDA) for
approval of a product that combines the anti-HIV medications
Sustiva(R) (efavirenz), manufactured by Bristol-Myers Squibb, and
Truvada(R) (emtricitabine and tenofovir disoproxil fumarate),
manufactured by Gilead Sciences, in a once-daily single tablet
regimen. 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. If approved by the FDA, the new single tablet regimen would be
the first and only product that contains a complete Highly Active
Antiretroviral Therapy (HAART) regimen in a single once-daily tablet,
intended for the treatment of HIV-1 infection in adults as a complete
regimen or in combination with other antiretrovirals.
The collaboration between Bristol-Myers Squibb and Gilead is the
first of its kind in the field of HIV therapy. On December 20, 2004
the companies established a U.S. joint venture to develop and
commercialize the single tablet regimen in the United States. The work
necessary to file the NDA for the single tablet regimen, including
bioequivalence studies and the initiation of stability studies, has
since been completed.
"The partnership between Bristol-Myers Squibb and Gilead was
founded on the companies' shared commitment to addressing the needs of
people living with HIV," commented John C. Martin, PhD, President and
Chief Executive Officer, Gilead Sciences. "Significant progress in
science and medicine has been achieved since the advent of the first
combination regimens 10 years ago, but more work is needed and we view
this partnership to create the first-ever once-daily single tablet
regimen for HIV as an important step toward further simplifying dosing
of HIV therapy for physicians and patients."
"Bristol-Myers Squibb is pleased to partner with a company that,
like us, values scientific and commercial innovation to help
patients," said Anthony C. Hooper, President, U.S. Pharmaceuticals,
Bristol-Myers Squibb. "The collaboration between the companies is an
important milestone for patients living with HIV. Working together,
Bristol-Myers Squibb and Gilead Sciences are ushering in a new era of
collaboration driven by the need to deliver HIV therapies to patients
in need."
The proposed once-daily single tablet regimen contains 600 mg of
efavirenz, 200 mg of emtricitabine and 300 mg of tenofovir disoproxil
fumarate. All three active ingredients work by blocking reverse
transcriptase, an enzyme necessary for HIV replication. It is
important for patients to be aware that these medications do not cure
HIV infection or prevent passing HIV to others.
Subject to marketing approval of the once-daily single tablet
regimen, Bristol Myers-Squibb and Gilead will share responsibility for
commercializing the product in the United States. Both companies will
provide funding and field-based sales representatives in support of
promotional efforts for the combination product. Bristol-Myers Squibb
and Gilead will receive revenues from future net sales at percentages
relative to the contribution represented by their individual products
that comprise the once-daily single tablet regimen. Sustiva, Truvada,
Viread and Emtriva will continue to be sold by the respective
companies as individual products.
Guidelines issued by the U.S. Department of Health and Human
Services (DHHS) list the combination of efavirenz, emtricitabine and
tenofovir disoproxil fumarate as one of the preferred non-nucleoside
reverse transcriptase inhibitor (NNRTI)-based treatment regimens for
use in appropriate patients who have never taken anti-HIV medicines
before. Efavirenz should not be used during the first trimester of
pregnancy due to the potential harm to the fetus. Pregnancy should be
avoided in women receiving efavirenz.
About HIV/AIDS
2006 marks the 25th anniversary of the start of the AIDS epidemic.
The first cases of HIV/AIDS were reported by the U.S. Centers for
Disease Control and Prevention (CDC) in the June 5, 1981 issue of the
Morbidity and Mortality Weekly Report (MMWR). Today, the CDC estimates
that more than one million Americans are infected with HIV, the virus
that causes AIDS. Of these, approximately 25 percent are unaware of
their infection. Although HIV treatment options have expanded rapidly
in recent years, the CDC estimates that 216,000 Americans who are HIV
infected and eligible for antiretroviral treatment are currently not
receiving it.
Important Information About SUSTIVA(R) (efavirenz)
SUSTIVA is a prescription medicine used in combination with other
medicines to treat people who are infected with the human
immunodeficiency virus type 1 (HIV-1). SUSTIVA does not cure HIV or
help prevent passing HIV to others. SUSTIVA should not be taken with
Hismanal(R) (astemizole), Propulsid(R) (cisapride), Versed(R)
(midazolam), Halcion(R) (triazolam), ergot medicines (for example,
Wigraine(R) and Cafergot(R)), or Vfend(R) (voriconazole). This list of
medicines is not complete. Patients should discuss all prescription
and non-prescription medicines, vitamin and herbal supplements, or
other health preparations (particularly St. John's wort) they are
taking or plan to take with their healthcare provider.
Patients taking SUSTIVA (efavirenz) should tell their doctor right
away if they have any side effects or conditions including: severe
depression, strange thoughts, or angry behavior, which have been
reported in a small number of patients. A few reports of suicide have
been made, but it is not known if SUSTIVA was the cause. Dizziness,
trouble sleeping, drowsiness, trouble concentrating, and/or unusual
dreams are common. These feelings tend to go away after taking SUSTIVA
for a few weeks.
Women should not become pregnant or breastfeed while taking
SUSTIVA. Serious birth defects have been seen in children of women
treated with SUSTIVA during pregnancy. Women must use a reliable form
of barrier contraception, such as a condom, even if they also use
other methods of birth control. Patients should tell their doctor if
they have a history of mental illness or are using drugs or alcohol.
Rash is a common side effect that usually goes away without any change
in treatment. Rash may be a serious problem in some children. If a
child develops a rash, their doctor should be contacted right away.
Patients with liver disease, a history of seizures, or taking medicine
for seizures, may require the healthcare provider to check the liver
or check drug levels in the blood.
Changes in body fat have been seen in some patients taking HIV
medicines, however, the cause and long-term effects of these changes
are not known at this time. Other common side effects include:
tiredness, upset stomach, vomiting and diarrhea. SUSTIVA should be
taken on an empty stomach, preferably at bedtime, which may make some
side effects less bothersome. SUSTIVA and other anti-HIV medicines
should be taken exactly as instructed by healthcare providers.
SUSTIVA is marketed in the United States, Canada and certain
European countries by Bristol-Myers Squibb. Elsewhere in the world,
efavirenz is marketed by Merck & Co., Inc., under the brand name
Stocrin(R).
Important Safety Information for Truvada(R) (emtricitabine and
tenofovir disoproxil fumarate), Viread(R) (tenofovir disoproxil
fumarate) and Emtriva(R) (emtricitabine)
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. 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 Viread or Emtriva. Hepatic function should be
monitored closely with both clinical and laboratory follow-up for at
least several months in patients who discontinue Truvada, Viread or
Emtriva and are co-infected with HIV and HBV. If appropriate,
initiation of anti-hepatitis B therapy may be warranted.
Changes in body fat have been observed in patients taking Truvada,
Viread and Emtriva and other anti-HIV medicines. 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.
Truvada, Viread, and Emtriva do not cure HIV and do not prevent
infection or passing HIV to others.
About Truvada(R) (emtricitabine and tenofovir disoproxil fumarate)
Truvada is a fixed-dose combination product that combines Emtriva
(200 mg of emtricitabine) and Viread (300 mg of tenofovir disoproxil
fumarate) in one tablet, taken once a day, as part of combination
therapy. 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 (emtricitabine and tenofovir
disoproxil fumarate) 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 and 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.
Renal impairment, including cases of acute renal failure and
Fanconi syndrome (renal tubular injury with severe hypophosphatemia),
has been reported among patients taking Viread. 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 fracture risk are unknown.
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 five percent of
patients in the Viread/Emtriva group in Study 934 include diarrhea,
nausea, fatigue, headache, dizziness and rash.
For additional safety information about Viread or Emtriva in
combination with other antiretroviral agents, please see "About
Viread" and "About Emtriva" below.
About Viread(R) (tenofovir disoproxil fumarate)
In the United States, Viread is indicated in combination with
other antiretroviral agents for the treatment of HIV-1 infection.
Viread should not be used in combination with Truvada.
Drug interactions have been observed when didanosine, atazanavir
or lopinavir/ritonavir is co-administered with Viread 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 and lopinavir/ritonavir plus Viread should be
monitored for Viread-associated adverse events, which may require
discontinuation. When co-administered with Viread, it is recommended
that atazanavir 300 mg be given with ritonavir 100 mg. Atazanavir
without ritonavir should not be co-administered with Viread.
Renal impairment, including cases of acute renal failure and
Fanconi syndrome (renal tubular injury with severe hypophosphatemia),
has been reported among patients taking Viread. 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 fracture risk are unknown. The most common
adverse events among patients receiving Viread with other
antiretroviral agents in clinical trials were mild to moderate
gastrointestinal events and dizziness. Moderate to severe adverse
events occurring in more than 5 percent of patients receiving Viread
included rash (rash, pruritis, maculopapular rash, urticaria,
vesiculobullous rash and pustular rash), headache, pain, diarrhea,
depression, back pain, fever, nausea, abdominal pain, asthenia and
anxiety (Study 903). Less than 1 percent of patients discontinued
participation because of gastrointestinal events (Study 907).
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 Emtriva(R) (emtricitabine)
In the United States, Emtriva is indicated, in combination with
other antiretroviral agents, for the treatment of HIV-1 infection in
patients over three months of age. This indication is based on
analyses of plasma HIV-1 RNA levels and CD4 cell counts from
controlled studies of 48 weeks duration in antiretroviral-naive
patients and antiretroviral-treatment-experienced patients who were
virologically suppressed on an HIV treatment regimen. In
antiretroviral-treatment-experienced patients, the use of Emtriva may
be considered for adults with HIV strains that are expected to be
susceptible to Emtriva as assessed by genotypic or phenotypic testing.
Adverse events that occurred in more than 5 percent of patients
receiving Emtriva with other antiretroviral agents in clinical trials
include abdominal pain, asthenia (weakness), headache, diarrhea,
nausea, vomiting, dizziness and rash (rash, pruritis, maculopapular
rash, urticaria, vesiculobullous rash, pustular rash and allergic
reaction). Approximately 1 percent of patients discontinued
participation because of these events. All adverse events were
reported with similar frequency in Emtriva and control treatment
groups with the exception of skin discoloration, which was reported
with higher frequency in the Emtriva-treated group. Skin
discoloration, manifested by hyperpigmentation on the palms and/or
soles, was generally mild and asymptomatic. The mechanism and clinical
significance are unknown. For pediatric patients over three months of
age, the adverse event profile observed during clinical trials was
similar to that of adult patients, with the exception of anemia and a
higher frequency of hyperpigmentation.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global pharmaceutical and related
healthcare products company whose mission is to extend and enhance
human life. For more than a decade, Bristol-Myers Squibb Company has
been a global leader in the science of infectious diseases and has
invested consistently in innovative research leading to the
development of important treatments for people with HIV/AIDS. 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, 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 the
willingness of regulatory authorities to grant regulatory approval for
the combination product based on data from studies conducted to
support the NDA. 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.
Full prescribing information for Sustiva is available at
www.bms.com.
Full prescribing information for Truvada, Viread and Emtriva is
available at www.gilead.com
Sustiva is a registered trademark of Bristol-Myers Squibb Pharma
Company.
Truvada, Viread and Emtriva are registered trademarks of Gilead
Sciences, Inc.
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CONTACT: Gilead Sciences
James Loduca, 650-522-5908 (Media)
Susan Hubbard, 650-522-5715 (Investors)
or
Bristol-Myers Squibb
Eric Miller, 609-252-7981 (Media)
John Elicker, 212-546-3775 (Investors)