Bristol-Myers Squibb and Gilead Sciences Establish U.S. Joint
Venture to Develop and Commercialize Fixed-Dose Combination of
Three HIV Medicines First Collaboration to Develop a Once-Daily
Antiretroviral Fixed-Dose Regimen NEW YORK and FOSTER CITY, Calif.,
Dec. 20 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company
(NYSE:BMY) and Gilead Sciences, Inc. (NASDAQ: GILD) today announced
details of a joint venture to develop and commercialize the
fixed-dose combination of Bristol-Myers Squibb's Sustiva(R)
(efavirenz) and Gilead's Truvada(TM) (emtricitabine and tenofovir
disoproxil fumarate) in the United States. If approved, the new
product would be the first complete Highly Active Antiretroviral
Therapy (HAART) treatment regimen for HIV available in a fixed-dose
combination taken once daily. Fixed-dose combinations contain
multiple medicines formulated together and may help simplify HIV
therapy for patients and providers. The joint venture established
by the two companies is the first of its kind in the field of HIV
therapy. The work necessary to co-formulate Sustiva and Truvada
into a once-daily combination product has been ongoing throughout
most of 2004 and will continue into 2005. Through the joint venture
-- Bristol-Myers Squibb & Gilead Sciences, LLC -- the companies
will work in partnership to complete development and U.S.
regulatory filings for this fixed-dose regimen. Subject to
receiving marketing approval of the fixed-dose regimen, the
companies would 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 fixed-dose combination. Guidelines
issued by the U.S. Department of Health and Human Services (DHHS)
list the combination of emtricitabine, tenofovir disoproxil
fumarate and efavirenz as one of the preferred non-nucleoside
reverse transcriptase inhibitor (NNRTI)-based treatments for use in
appropriate patients that have never taken anti-HIV medicines
before. It is important that patients be aware that individual HIV
medications must be taken as part of combination regimens, and that
they do not cure HIV infection or prevent passing HIV to others.
"Gilead and Bristol-Myers Squibb share a steadfast commitment to
addressing the needs of people living with HIV/AIDS around the
world, and today's announcement signals significant progress toward
our common goal," commented John C. Martin, PhD, president and
chief executive officer, Gilead Sciences. "This landmark
partnership reflects the dedication Gilead and Bristol-Myers Squibb
bring to delivering simplified therapy to physicians and patients.
We look forward to working with the Bristol-Myers Squibb team to
ensure this novel therapeutic advancement reaches physicians and
people living with HIV/AIDS as rapidly as possible." "For more than
a decade, Bristol-Myers Squibb has been a leader in the field of
HIV with significant investments in innovative scientific research
and an unwavering commitment to finding new and better treatment
options to help improve the lives of people with HIV," said Peter
R. Dolan, chairman and chief executive officer, Bristol-Myers
Squibb Company. "We are pleased to be leveraging our leadership in
HIV through this collaboration with Gilead to help advance the
management of the disease through the development of potentially
more convenient treatment options." Earlier in 2004, U.S. Secretary
of Health and Human Services Tommy Thompson addressed the need for
new products to help advance and simplify treatment for people with
HIV/AIDS, encouraging members of industry to work together to
create fixed-dose combinations that would help achieve these goals.
Additionally, earlier this year the U.S. Food and Drug
Administration issued new guidelines to expedite the approval of
new combination products for HIV. "The availability of simplified
treatment regimens for HIV/AIDS is important to our ability to make
progress in the fight against the disease," Secretary Thompson
said. "I am pleased to see the collaboration and efforts of
Bristol-Myers Squibb and Gilead. This partnership to create a
fixed-dose combination of three HIV medications represents an
important advance in our collective effort to deliver simplified
therapy for people living with HIV." Important Safety Information
About Sustiva 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 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. Patients should tell their doctor if they have a
history of mental illness or are using drugs or alcohol. 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. 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 should tell their
doctor if they have liver disease, have ever had seizures, or are
taking medicine for seizures as tests to check the liver or drug
levels in the blood may be needed. 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. Taking Sustiva with food increases the
amount of medicine in the body, which may increase the frequency of
side effects. Sustiva should be taken on an empty stomach,
preferably at bedtime, which may make some side effects less
bothersome. United States Full Prescribing Information is available
at http://www.sustiva.com/. Sustiva (efavirenz) 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). About
Truvada Truvada combines Emtriva(R) (emtricitabine) and Viread(R)
(tenofovir disoproxil fumarate) in one tablet taken once a day in
combination with other antiretroviral agents. 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. Safety and efficacy studies using Truvada tablets or using
Emtriva and Viread in combination are ongoing. Both components of
Truvada have been studied individually, as part of multi-drug
regimens and have been found to be safe and effective. Since
Emtriva and lamivudine (3TC) are comparable in their structure,
resistance profiles, and efficacy and safety as part of multi-drug
regimens, existing data from the use of lamivudine and Viread in
combination have been extrapolated to support use of Truvada
tablets for the treatment of HIV-1 infection in adults. Therefore,
in treatment-na�ve patients, Truvada should be considered as an
alternative to the combination of Viread and lamivudine for those
patients who might benefit from a once-daily regimen. In
treatment-experienced patients, the use of Truvada should be guided
by laboratory testing and treatment history. There are no study
results demonstrating the effect of Truvada on clinical progression
of HIV-1, and it is not recommended that Truvada be used as a
component of a triple nucleoside regimen. Truvada should not be
used with Emtriva or Viread, or other drugs containing lamivudine,
including Combivir(R), Epivir(R), Epivir-HBV(R), Epzicom(TM) or
Trizivir(R). Two-hundred eighty-three patients have received
combination therapy with Emtriva and Viread with either a
non-nucleoside reverse transcriptase inhibitor or protease
inhibitor for 24 to 48 weeks in ongoing clinical studies. Based on
these limited data, no new patterns of adverse events were
identified and there was no increased frequency of established
toxicities. For additional safety information about Emtriva or
Viread in combination with other antiretroviral agents, please see
"About Emtriva" and "About Viread," below. 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. Viread, Emtriva and Truvada
are not indicated for the treatment of chronic hepatitis B virus
(HBV) infection and the safety and efficacy of these drugs has 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 Viread, Emtriva
or Truvada 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 Viread, Emtriva,
Truvada and other anti-HIV medicines. The cause and long term
health effect of these conditions are unknown. About Viread In the
United States, Viread is indicated in combination with other
antiretroviral agents for the treatment of HIV-1 infection. This
indication is based on analyses of plasma HIV-1 RNA levels and CD4
cell counts in controlled studies of Viread in treatment-na�ve
adults and in treatment- experienced adults. There are no study
results demonstrating the effect of Viread on clinical progression
of HIV-1. The use of Viread should be considered for treating adult
patients with HIV-1 strains that are expected to be susceptible to
tenofovir as assessed by laboratory testing or treatment history.
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 or 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 serious cases, has been
reported. 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 clinical significance of changes in BMD and
biochemical markers is unknown and follow-up is continuing to
assess long-term impact. The most common adverse events and those
occurring in more than 5 percent of patients receiving Viread with
other antiretroviral agents in clinical trials include asthenia,
pain, abdominal pain, headache, nausea, diarrhea, vomiting, rash
(rash, pruritis, maculopapular rash, urticaria, vesiculobullous
rash and pustular rash), flatulence, dizziness and depression. Less
than 1 percent of patients discontinued participation because of
gastrointestinal events. About Emtriva In the United States,
Emtriva is indicated, in combination with other antiretroviral
agents, for the treatment of HIV-1 infection in adults. 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. 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 http://www.bms.com/. About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers,
develops and commercializes therapeutics to advance the care of
patients suffering from life-threatening diseases worldwide. The
company has seven marketed products and focuses its research and
clinical programs on anti-infectives. Headquartered in Foster City,
CA, 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. Among other risks,
there can be no guarantee that the combination product will be
submitted for regulatory approval, will receive regulatory
approval, or, if approved, will be commercially successful. No
forward-looking statement can be guaranteed. 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/A for the year
ended December 31, 2003 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 contains "forward-looking statements"
as that term is defined in the Private Securities Litigation Reform
Act of 1995. The forward-looking statements include statements
regarding approval and licensure of the combination product. These
statements involve risks and uncertainties, which may cause results
to differ materially from those set forth in the statements,
including the risks related to the ability of the companies to
successfully complete ongoing studies to support approval of the
combination product and the willingness of regulatory authorities
to grant regulatory approval for the combination product based on
data from those studies. No forward-looking statement can be
guaranteed, and actual results may differ materially from those
projected. Gilead 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 Gilead's business, particularly those
mentioned in the cautionary statements in the company's Form 10-K
for the year ended December 31, 2003, and in periodic reports on
Form 10-Q and Form 8-K. DATASOURCE: Bristol-Myers Squibb Company
CONTACT: Media: David Rosen of Bristol-Myers Squibb,
+1-609-252-5675; or Amy Flood of Gilead Sciences, +1-650-522-5643;
Investors: John Elicker of Bristol-Myers Squibb, +1-212-546-3775;
or Susan Hubbard of Gilead Sciences, +1-650-522-5715 Web site:
http://www.bms.com/ http://www.sustiva.com/ http://www.gilead.com/
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