Bristol-Myers Squibb to Present New Data on Hepatitis C and Hepatitis B Compounds at The International Liver CongressTM (ILC)

  Bristol-Myers Squibb to Present New Data on Hepatitis C and Hepatitis B
  Compounds at The International Liver CongressTM (ILC) 2013

  *New data on an investigational, all-oral, triple DAA regimen of
    daclatasvir, asunaprevir and BMS-791325 to be included in official ILC
    Press Conference on April 24
  *New ALT flare data further characterize profile of peginterferon lambda-1a
    (Lambda) as investigational treatment for Chronic Hepatitis B (CHB)
  *Breadth of data underscores Company’s commitment to advancing the
    treatment of liver disease

Business Wire

PRINCETON, N.J. -- April 8, 2013

Bristol-Myers Squibb Company (NYSE:BMY) announced today that 14 abstracts on
the Company’s research in liver disease have been accepted for presentation at
The International Liver Congress^TM 2013, the 48th annual meeting of the
European Association for the Study of the Liver (EASL), in Amsterdam, April 24
– 28.

Key presentations include:

  *New Phase 2 data on an investigational triple direct-acting antiviral
    (DAA) regimen of daclatasvir (NS5A replication complex inhibitor),
    asunaprevir (NS3 protease inhibitor) and BMS-791325 (NS5B non-nucleotide
    polymerase inhibitor) in patients with hepatitis C (HCV) genotypes 1a and
    1b. The regimen is being studied as a potential interferon alfa-,
    ribavirin- and ritonavir-free treatment option to avoid the tolerability
    and drug-drug interaction profiles of these medicines. These triple DAA
    data will be highlighted in the official ILC Press Conference on April 24.
  *An analysis of all available safety data on 1,100 patients who received
    daclatasvir plus interferon alfa and ribavirin in Phase 2 studies. These
    data support the ongoing Phase 3 development program for daclatasvir and
    further studies of daclatasvir as a component of DAA-based HCV treatment
    regimens.
  *A characterization of ALT flares observed in hepatitis B (HBV) treatment
    with the investigational interferon Lambda vs. alfa interferon, reflecting
    differing profiles for the two compounds. Lambda is being developed as a
    potential alternative for alfa wherever interferon is used in the
    treatment of either HCV or HBV.
  *An analysis of sustained virologic response with daclatasvir plus
    sofosbuvir, with or without ribavirin, in patients with HCV genotype 1 who
    previously failed telaprevir or boceprevir.

“Bristol-Myers Squibb has a longstanding commitment to viral hepatitis and has
been at the forefront of the evolving science in both hepatitis B and C,” said
Brian Daniels, MD, senior vice president, Global Development and Medical
Affairs, Research and Development, Bristol-Myers Squibb. “The data we are
presenting at the International Liver Congress demonstrate our continued
advancement of research to address unmet medical needs, through the
development of regimens for personalized hepatitis C treatment and increasing
options to treat hepatitis B.”

Bristol-Myers Squibb is studying a portfolio of compounds that has the
potential to address unmet medical needs for patients with liver disease,
including the investigational compounds daclatasvir, asunaprevir and
BMS-791325 for HCV, and Lambda for HCV and HBV. In addition to these
compounds, the Company’s medicine BARACLUDE^® (entecavir) is approved for the
treatment of chronic hepatitis B (CHB) in adults with evidence of active viral
replication and either evidence of persistent elevations in aminotransferases
(ALT or AST), or histologically active disease.

The complete list of Bristol-Myers Squibb data presentations is below.
Abstracts can be accessed on the ILC/EASL website at
http://www.easl.eu/_the-international-liver-congress/general-information.

Title                                                       Date/Time
Hepatitis C: Direct-Acting Antiviral Data
                                                           
Synergistic Interactions of HCV NS5A replication Complex     April 25
Inhibitors Sensitize Resistant Variants and Enhance the    
Efficacy of Daclatasvir (DCV, BMS-790052) In Vitro and In    12:15 – 1:30 pm
Vivo
Asunaprevir with Peginterferon and Ribavirin in              April 25
Treatment-Naïve Patients with Genotype –1 or -4 Chronic    
Hepatitis C: SVR24 Results From a Randomized Phase 2b        12:15 – 1:30 pm
Study (AI447016)
Evaluation of Pharmacokinetic Drug-Drug Interaction (DDI)    April 25
Between BMS-791325, an NS5B Non-Nucleotide Polymerase      
Inhibitor, Daclatasvir and Asunaprevir in Triple             12:15 – 1:30 pm
Combination in HCV Genotype 1-Infected Patients
The Effect of Coadministration of the Proton-Pump            April 26
Inhibitor Omeprazole on the Pharmacokinetics of            
Daclatasvir in Healthy Subjects                              12:30 – 2:00 pm
Exposure-Response Analyses of Asunaprevir in Combination
with Daclatasvir ± Peginterferon / Ribavirin Among
Patients with Genotype 1 Chronic HCV Infection: Dose         April 26
Selection for Phase 3 Clinical Trials                      
                                                             12:30 – 2:00 pm
-Response Analyses of Asunaprevir in Patients with
Genotype 1, Chronic HCV Infection: Dose Selection for
Phase 3 Clinical Trials
                                                             April 27
Daclatasvir Combined With Peginterferon Alfa and Ribavirin
for 12 or 16 Weeks in Patients With HCV Genotype 2 or 3     3:30 – 5:30 pm
Infection: COMMAND GT2/3 Study
                                                             Oral presentation
Sustained Virologic Response with Daclatasvir Plus           April 27
Sofosbuvir ± Ribavirin (RBV) In Chronic HCV Genotype (GT)
1-Infected Patients who Previously Failed Telaprevir (TVR)  3:30 – 5:30 pm
or Boceprevir (BOC)
                                                             Oral presentation
Safety Profile of Daclatasvir in Combination with            April 27
Peginterferon Alfa and Ribavirin in 1100 Patients with     
Chronic HCV Infection Treated in Phase 2 Studies             12:30 – 1:30 pm
Pre-Existence, Emergence and Persistence of HCV Genotype 4   April 27
NS5A Resistance Variants from the Phase 2b COMMAND-1       
Study: Daclatasvir Plus Peginterferon-Alfa/Ribavirin in      12:30 – 1:30 pm
Treatment-Naïve Patients
Hepatitis C: Outcomes Research Data
Host Genetic Variants Around IL28A/IL28B Associated with     April 25
HCV-Related Outcomes Based on R.E.V.E.A.L.-HCV Cohort      
                                                             12:15 – 1:30 pm
Genome-Wide Association Study to Identify Potential Single   April 25
Nucleotide Polymorphisms Associated with Spontaneous       
Hepatitis C Virus Clearance Among Chronic Hepatitis C        12:15 – 1:30 pm
Patients
Hepatitis B: Peginterferon Lambda-1a Data
ALT Flares During Treatment With Peginterferon Lambda or     April 26
Peginterferon Alfa in Patients with HBeAg-Positive Chronic 
Hepatitis B Infection (CHB)                                  12:30 – 2:00 pm
Hepatitis B: BARACLUDE^® (entecavir) Data
Impact of Entecavir Versus Lamivudine on Hepatic             April 26
Covalently Closed-Circular DNA and Total Hepatic HBV DNA   
in Nucleoside-Naïve HBeAg Positive Chronic Hepatitis B       12:30 – 2:00 pm
Patients
                                                           

INDICATION and IMPORTANT SAFETY INFORMATION about BARACLUDE^® (entecavir)
Tablets:

INDICATION

BARACLUDE is indicated for the treatment of chronic hepatitis B virus (HBV)
infection in adults with evidence of active viral replication and either
evidence of persistent elevations in serum aminotransferases (ALT or AST) or
histologically active disease.

The following points should be considered when initiating BARACLUDE:

  *This indication is based on histologic, virologic, biochemical, and
    serologic responses in nucleoside-treatment-naïve and lamivudine-resistant
    adult subjects with HBeAg-positive or HBeAg-negative chronic HBV infection
    and compensated liver disease.
  *Virologic, biochemical, serologic, and safety data are available from a
    controlled study in adult subjects with chronic HBV infection and
    decompensated liver disease.
  *Virologic, biochemical, serologic, and safety data are available for a
    limited number of adult subjects with HIV/HBV co-infection who have
    received prior lamivudine therapy.

IMPORTANT SAFETY INFORMATION

WARNINGS: SEVERE ACUTE EXACERBATIONS OF HEPATITIS B, PATIENTS CO-INFECTED WITH
HIV AND HBV, and LACTIC ACIDOSIS AND HEPATOMEGALY

  *Severe acute exacerbations of hepatitis B have been reported in patients
    who have discontinued anti-hepatitis B therapy, including entecavir.
    Hepatic function should be monitored closely with both clinical and
    laboratory follow-up for at least several months in patients who
    discontinue anti-hepatitis B therapy. If appropriate, initiation of
    anti-hepatitis B therapy may be warranted.
  *Limited clinical experience suggests there is a potential for the
    development of resistance to HIV (human immunodeficiency virus) nucleoside
    reverse transcriptase inhibitors if BARACLUDE (entecavir) is used to treat
    chronic HBV infection in patients with HIV infection that is not being
    treated. Therapy with BARACLUDE is not recommended for HIV/HBV co-infected
    patients who are not also receiving highly active antiretroviral therapy
    (HAART).
  *Lactic acidosis and severe hepatomegaly with steatosis, including fatal
    cases, have been reported with the use of nucleoside analogues, alone or
    in combination with antiretrovirals.

Warnings and Precautions

  *Before initiating BARACLUDE^® (entecavir) therapy, HIV antibody testing
    should be offered to all patients. BARACLUDE has not been studied as a
    treatment for HIV infection and is not recommended for this use.
  *Lactic acidosis with BARACLUDE use has been reported, often in association
    with hepatic decompensation, other serious medical conditions, or drug
    exposures. Patients with decompensated liver disease may be at higher risk
    for lactic acidosis. BARACLUDE should be suspended in any patient who
    develops clinical or laboratory findings suggestive of lactic acidosis or
    pronounced hepatotoxicity.

Adverse Reactions

  *In clinical trials in patients with compensated liver disease, the most
    common (≥3%) adverse reactions of any severity with at least a possible
    relation to study drug for BARACLUDE-treated subjects were headache,
    fatigue, dizziness, and nausea. In these trials, the most common adverse
    reactions of moderate to severe intensity (grades 2-4) were diarrhea,
    dyspepsia, nausea, vomiting, fatigue, headache, dizziness, somnolence, and
    insomnia.
  *In the decompensated liver disease trial, the most common adverse
    reactions of any severity among patients treated with BARACLUDE,
    regardless of causality, included: peripheral edema (16%), ascites (15%),
    pyrexia (14%), hepatic encephalopathy (10%), and upper respiratory
    infection (10%). In this trial, 18% (18/102) of BARACLUDE (entecavir)
    patients and 20% (18/89) of adefovir patients died during the first 48
    weeks of therapy. The majority of those deaths were due to liver related
    causes.

Drug Interactions

BARACLUDE is primarily eliminated by the kidneys, therefore coadministration
of BARACLUDE with drugs that reduce renal function or compete for active
tubular secretion may increase serum concentrations of either entecavir or the
coadministered drug. Patients should be monitored closely when receiving
BARACLUDE^® (entecavir) with other renally-eliminated drugs.

Pregnancy and Nursing Mothers

  *There are no adequate and well-controlled studies of BARACLUDE in pregnant
    women. BARACLUDE should be used during pregnancy only if clearly needed
    and after careful consideration of the risks and benefits.
  *There are no studies on the effect of BARACLUDE on transmission of HBV
    from mother to infant. Therefore, appropriate interventions should be used
    to prevent neonatal acquisition of HBV.
  *It is not known whether BARACLUDE is excreted into human milk; however,
    many drugs are excreted into breast milk. Due to the potential for serious
    adverse reactions in nursing infants from BARACLUDE, risks and benefits
    should be considered when deciding whether to discontinue breast-feeding
    or discontinue BARACLUDE in nursing women.

Pediatric Use

  *Safety and effectiveness of BARACLUDE in pediatric patients below the age
    of 16 years have not been established.

Renal Impairment

  *Dosage adjustment of BARACLUDE is recommended for patients with a
    creatinine clearance <50 mL/min, including those on hemodialysis or
    continuous ambulatory peritoneal dialysis.

Liver Transplant Recipients

  *Renal function must be carefully monitored both before and during
    treatment with BARACLUDE in a liver transplant recipient who has received
    or is receiving an immunosuppressant that may affect renal function, such
    as cyclosporine or tacrolimus.

Dosage and Administration

BARACLUDE^® (entecavir) should be administered on an empty stomach (at least 2
hours after a meal and at least 2 hours before the next meal).

The recommended dose of BARACLUDE:

  *in nucleoside-naïve adults and adolescents (16+ yrs) with compensated
    liver disease is 0.5 mg once daily
  *in adults and adolescents (16+ yrs) with compensated liver disease, and
    refractory to lamivudine or with known lamivudine or telbivudine
    resistance mutations (rtM204I/V with or without rtL180M, rtL80I/V, or
    rtV173L) is 1 mg once daily
  *in adults with decompensated liver disease is 1 mg once daily

The optimal duration of treatment with BARACLUDE for patients with chronic HBV
infection and the relationship between treatment and long-term outcomes such
as cirrhosis and hepatocellular carcinoma are unknown.

Additional Information

BARACLUDE is not a cure for HBV. Patients should be advised that treatment
with BARACLUDE has not been shown to reduce the risk of transmission of HBV to
others through sexual contact or blood contamination.

Please see accompanying Full Prescribing Information, including Boxed
WARNINGS, or click here.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to
discover, develop and deliver innovative medicines that help patients prevail
over serious diseases. For more information, please visit http://www.bms.com
or follow us on Twitter at http://twitter.com/bmsnews.

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 clinical trials of these compounds will support
regulatory filings, or that the compounds will receive regulatory approvals
or, if approved, that they will become commercially successful products.
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, 2012, in our Quarterly Reports on Form 10-Q and our Current Reports on
Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information, future
events or otherwise.

BARACLUDE^® (entecavir) is a registered trademark of Bristol-Myers Squibb.

Contact:

Media:
Sonia Choi, 609-252-5132
sonia.choi@bms.com
or
Carrie Fernandez, 609-252-4831
carrie.fernandez@bms.com
or
Investors:
John Elicker, 609-252-4611
john.elicker@bms.com
or
Ranya Dajani, 609-252-5330
ranya.dajani@bms.com
or
Ryan Asay, 609-252-5020
ryan.asay@bms.com
 
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