( BW)(CA-GILEAD/BRISTOL-MYERS)(GILD)(BMY) Bristol-Myers Squibb and
Gilead Announce Data Supporting Bioequivalence for Single-Pill
Fixed-Dose Regimen of Sustiva and Truvada

    Pharmaceutical Writers/Business Editors/Health/Medical Writers
    BIOWIRE2K

    NEW YORK & FOSTER CITY, Calif.--(BUSINESS WIRE)--Jan. 9, 2006--

                 Companies Anticipate Filing New Drug
                 Application in Second Quarter of 2006

    Bristol-Myers Squibb Company (NYSE:BMY) and Gilead Sciences, Inc.
(Nasdaq:GILD) today announced they have obtained data supporting
bioequivalence of a new formulation of the fixed-dose combination of
Bristol-Myers Squibb's Sustiva(R) (efavirenz) and Gilead's Truvada(R)
(emtricitabine and tenofovir disoproxil fumarate) with the components
that make up the new combination. The new fixed-dose regimen is
intended for the treatment of HIV-1 infection in adults.
    The fixed-dose regimen was developed using a bi-layer technology
to co-formulate Sustiva and Truvada as individually formulated layers
combined in one tablet. In August of 2005, Gilead announced that the
companies were proceeding with the evaluation of three new
formulations in parallel, based on bi-layer technology.
    A bioequivalence study is required to demonstrate that a
co-formulated product results in the same levels of medication in the
blood as achieved when the individual products are dosed
simultaneously as separate pills. Gilead and Bristol-Myers Squibb
anticipate filing a New Drug Application with the U.S. Food and Drug
Administration (FDA) in the second quarter of 2006.
    "Tremendous progress has been made in the fight against HIV/AIDS,
yet there is still work that needs to be done," said Anthony C.
Hooper, President, U.S. Pharmaceuticals, Bristol-Myers Squibb.
"Together with our partner Gilead, Bristol-Myers Squibb will continue
advancing the development of this potential innovative treatment
option for HIV patients."
    "The advancement of our fixed-dose regimen represents an important
step forward in the further simplification of HIV treatment," said
John C. Martin, PhD, President and Chief Executive Officer, Gilead
Sciences. "Gilead and Bristol-Myers Squibb share a commitment to the
treatment of HIV, a disease for which significant unmet medical need
continues to exist, and we look forward to working with regulatory
authorities."
    In December 2004, Gilead and Bristol-Myers Squibb announced the
establishment of a U.S. joint venture to co-formulate the
antiretrovirals Truvada and Sustiva in a fixed-dose regimen. If
approved by the FDA, the new product would be the first complete
Highly Active Antiretroviral Therapy (HAART) treatment regimen for HIV
available in a fixed-dose combination tablet 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.
    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. 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. 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.

    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 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. United
States Full Prescribing Information for SUSTIVA is available at
www.SUSTIVA.com.

    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.
    Emtriva and Viread have each been studied as part of multi-drug
regimens and have been found to be safe and effective. In clinical
study 303 Emtriva and lamivudine (3TC) demonstrated comparable
efficacy, safety and resistance patterns as part of multidrug
regimens. These data, and those from study 903, in which lamivudine
and tenofovir were used in combination, support the use of Truvada for
the treatment of HIV-1 infection in treatment-naive adults. 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.
    Immune reconstitution syndrome has been reported in patients
treated with combination antiretroviral therapy, including Viread and
Emtriva. Changes in body fat have been observed in patients taking
anti-HIV medicines, including Viread and Emtriva. The cause and long
term health effect of these conditions are unknown.
    The parent compound of one of the component drugs in Truvada,
tenofovir disoproxil fumarate, 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. The inventors have
agreed to waive their right to a royalty on sales of products
containing tenofovir in the developing countries served by the Gilead
Access Program to ensure the product can be offered at a no-profit
price in parts of the world where the AIDS epidemic has hit the
hardest.

    About Emtriva

    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.
In pediatric patients over three months of age, the safety and
efficacy of emtricitabine is supported by data from three open-label,
non-randomized clinical studies in which emtricitabine was
administered to 169 HIV-1 infected treatment naive and experienced
patients between three months and 21 years of age.
    Adverse events that occurred in more than five 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 one 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 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-naive 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 and increases in biochemical markers
of bone metabolism 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 five 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 one percent of patients
discontinued participation because of gastrointestinal events.

    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.

    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, 2004 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 regulatory requirements to support approval of the
combination product, and the willingness of regulatory authorities to
grant regulatory approval for the combination product based on
available data. 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, 2004, and in
periodic reports on Form 10-Q and Form 8-K.

    Sustiva is a registered trademark of Bristol-Myers Squibb Pharma
Company.

    Truvada, Viread and Emtriva are registered trademarks of Gilead
Sciences, Inc.

    All other trademarks are the property of third parties.

    --30--MER/sf*

    CONTACT: Gilead
             Amy Flood, 650-522-5643 (Media)
             Susan Hubbard, 650-522-5715 (Investors)
                 or            
             Bristol-Myers Squibb                                  
             Kathy Baum, 609-252-4227 (Media)
             Blaine Davis, 212-546-4631 (Investors)