Bristol-Myers Squibb’s Investigational Hepatitis C Compounds Lambda and Daclatasvir Plus Ribavirin Achieved SVR12 in 93% of

  Bristol-Myers Squibb’s Investigational Hepatitis C Compounds Lambda and
  Daclatasvir Plus Ribavirin Achieved SVR12 in 93% of Genotype 1b
  Treatment-Naive Patients In Phase IIb Study

  *First presentation of interim data on Lambda in combination with the
    direct-acting antiviral (DAA) daclatasvir, from the global D-LITE study of
    genotype 1 patients
  *Data from a separate Phase IIb study, EMERGE, continue to demonstrate
    comparable SVR24 rates and further illustrate the safety and tolerability
    profile of Lambda vs. alfa interferon in genotype 1 and 4 patients
  *Phase III development of Lambda in combination with other antivirals
    underway, and in combination with daclatasvir and ribavirin to initiate in
    2013

Business Wire

BOSTON -- November 12, 2012

Bristol-Myers Squibb Company (NYSE: BMY) today announced for the first time
interim results from the global, D-LITE Phase IIb study, in which a 24-week
regimen combining the investigational compound Peginterferon lambda-1a
(Lambda) with the investigational direct-acting antiviral (DAA) daclatasvir
(DCV) and ribavirin (RBV), achieved sustained virologic response 12 weeks
post-treatment (SVR[12]) in 93% (13/14) of treatment-naïve, genotype 1b
chronic hepatitis C patients who achieved a protocol-defined response (PDR)^1.
The SVR12 rate for all genotype 1 infected patients in the Lambda/RBV/DCV
group was 76% (28/37). These study findings were presented in a late breaker
presentation at the American Association for the Study of Liver Diseases
(AASLD) congress in Boston. The Company also presented SVR[4] results from the
D-LITE Japanese sub-study, where all subjects were infected with HCV genotype
1b and SVR[12 ]was 100%. SVR results from the EMERGE Phase IIb study of Lambda
versus alfa interferon (alfa) in treatment-naïve genotype 1 or 4 patients were
also presented.

In the D-LITE study, adverse events were mostly low grade and self-limiting.
In the Lambda/RBV/DCV treatment group, only one of 37 patients experienced a
serious adverse event (breast cancer), which was unrelated to study drug.

“Despite the desire for all-oral regimens without alfa interferons for the
treatment of chronic hepatitis C, it is likely that certain patient
populations will require interferon-based therapies to eradicate hepatitis C.
Development of lambda interferon is an important goal for such patients,
especially those who cannot tolerate or refuse to use alfa interferon,” said
D-LITE lead investigator John M. Vierling, M.D., FACP, Professor of Medicine
and Surgery, Director of Baylor Liver Health, and Chief of Hepatology at the
Baylor College of Medicine in Houston, TX. “Treatment with lambda interferon
combined with daclatasvir and ribavirin achieved high rates of sustained
virologic response, and the data support further study of regimens using
lambda interferon to address the medical needs of hepatitis C patients who
cannot use alfa interferons.”

PEGinterferon lambda-1a is the first investigational type III interferon in
Phase III development for the treatment of hepatitis C. Daclatasvir is the
first NS5A replication complex inhibitor to be investigated in HCV clinical
trials and is currently in Phase III development

D-LITE Study Results

D-LITE is a randomized, double-blind, global phase IIb study designed to
evaluate for the first time the safety and efficacy of Lambda 180 μg s.c.
weekly in combination with an investigational direct-acting antiviral
daclatasvir (DCV) dosed 60 mg orally once daily or asunaprevir (ASV) dosed 200
mg orally twice daily plus ribavirin (RBV), compared to alfa 180 μg s.c.
weekly plus RBV in 119 treatment-naïve patients with chronic HCV genotype 1
infection. RBV was dosed based on weight twice daily in all three treatment
groups. The primary endpoint of the study is the proportion of patients who
achieve SVR[24]. The interim SVR[12] results in patients who achieved a PDR
(protocol defined response, based on viral suppression at weeks 4 and 12,
qualified patients to complete therapy at 24 weeks), were presented.

Virologic Response

In the Lambda/RBV/DCV treatment group, 90% (37/41) of patients achieved a
protocol-defined response (PDR). Of these patients, 76% (28/37) achieved
SVR[12] after 24 weeks of treatment. Response rates were higher in genotype 1b
patients, with 93% (13/14) of genotype 1b patients achieving SVR[12 ]and [
]65% (15/23) of genotype 1a patients achieving SVR[12].

The Company also presented SVR[12] data from the D-LITE study Japanese cohort
of genotype 1b patients in an oral presentation. In the Japanese cohort, 100%
of patients in the Lambda/RBV/DCV arm (8/8) achieved a PDR and went on to
achieve SVR[4] and SVR[12].

Based on these study results, the combination regimen of Lambda/RBV/DCV will
move into Phase III development.

Safety Data

In the Lambda/RBV/DCV treatment group, one of 37 patients experienced a
serious adverse event (breast cancer), which was unrelated to study drug, and
six patients experienced grade 3-4 adverse events. There were no adverse
event-related treatment discontinuations. No patients in this treatment group
experienced ALT elevation and two patients experienced AST elevation that were
manageable. One patient who received Lambda/RBV/DCV experienced elevated total
bilirubin, manageable with dose modification.

In the D-LITE study Japanese cohort, one patient experienced a grade 3-4 AE
(transient leukopenia).

Safety and efficacy data for the Lambda/RBV/ASV treatment group were also
presented at the AASLD annual meeting.

EMERGE Study Results

The EMERGE 2B study is a randomized, controlled, multicenter, Phase IIb study
designed to evaluate the safety, efficacy, and pharmacokinetics of Lambda/RBV
versus alfa/RBV, in 526 non-cirrhotic, treatment-naïve patients with chronic
hepatitis C genotype 1, 2, 3 or 4 with 407 patients with genotype 1 or 4
chronic hepatitis C randomized into four dose groups: Lambda 240 µg (n=104),
Lambda 180 µg (n=102), Lambda 120 µg (n=98) and alfa 180 µg (n=103), each
administered weekly 48 weeks in combination with daily oral RBV. As of April
2011, all subjects who remained on 240 µg Lambda were reduced to 180 µg, the
dose selected for further development. The primary endpoint of the study is
the proportion of patients who achieved complete early virologic response
(cEVR). HCV viral load and safety were assessed through 72 weeks (48-weeks
on-treatment and 24-weeks post-treatment or to SVR[24]). Results in patients
with HCV genotype 2 or 3 were previously reported.

Virologic Response

In this study, at the dose selected for further development (180µg),
Lambda/RBV achieved SVR[24] rates that were comparable to alfa/RBV, with a
greater early virologic response as demonstrated by RVR and cEVR rates.

                                                Lambda 180 µg  Alfa 180 µg
RVR                                               14.7%
                                                                  5.8%
(undetectable viral load at week 4 on             (p<0.05)
treatment)
cEVR                                              55.9%
                                                                  36.9%
(undetectable viral load at week 12 on            (p<0.05)
treatment)
EOT
                                                  57.8%           56.3%
(undetectable viral load at end of 48 weeks of
treatment)
SVR[24 ]
                                                  37.3%           36.9%
(undetectable viral load 24 weeks
post-treatment)

Safety Data

Treatment-related serious adverse events were reported in three patients who
received Lambda at the 180 µg dose (one case each of hyperbilirubinemia,
nausea/vomiting and anemia) and seven patients who received alfa (two cases of
sarcoidosis and one case each of hyperbilirubinemia, depression/suicidal
ideation, pneumonia, appendicitis and neutropenia). Compared to alfa, Lambda
was associated with a reduced rate of interferon dose reductions (Lambda:
7.8%, 8/102 vs. alfa: 28.2%, 29/103) and ribavirin dose reductions (Lambda:
10.8%, 11/102 vs. alfa: 33.0%, 34/103 patients).

The most commonly reported adverse events at the Lambda 180 µg dose were
fatigue (46.1%), headache (27.5%) and nausea (21.6%). Certain adverse events
commonly associated with interferon alfa treatment were less frequently seen
with Lambda than with alfa in this study. There was a greater than 2-fold
difference in frequency between Lambda and alfa in the rate of flu-like
symptoms and musculoskeletal symptoms.

                                     Lambda 180 µg   Alfa 180 µg
Adverse Events of Special Interest                
                                     n=102           n=103

Musculoskeletal symptoms             15.7%           46.6%
Flu-like symptoms                    12.7%           45.6%
Neurologic                           33.3%           45.6%
Constitutional                       46.1%           42.7%
Psychiatric                          32.4 %          40.8%

Lambda was also associated with fewer hematologic abnormalities than alfa, and
similar rates of elevated liver enzyme and total bilirubin levels.

                                                  Lambda 180 µg   Alfa 180 µg
Laboratory Abnormalities                                       
                                                  n=102           n=103
Hematologics
Anemia (hemoglobin <9 g/dL or Δ ≥4.5 g/dL)        5.9%            31.1%
Hemoglobin-associated ribavirin reduction         0.0%            23.3%
Neutropenia (neutrophils <750/mm^3)               1.0%            20.4%
Thrombocytopenia (platelets <50,000/ mm^3)        0.0%            1.9%
Hematologic abnormality-associated interferon     0.0%            20.4%
reduction
Liver-Related
AST and/or ALT > 5.0-10 x ULN                     3.0%            6.8%
AST and/or ALT > 10 x ULN                         0.0%            1.0%
Total bilirubin 2.6 - 5.0 x ULN                   5.0%            3.9%
Total bilirubin > 5.0 x ULN                       2.0%            1.0%

Efficacy and safety results for the Lambda 120 µg and 240 µg treatment groups
were also presented at the AASLD annual meeting.

About Bristol-Myers Squibb’s Commitment to Liver Disease

Bristol-Myers Squibb is researching a portfolio of compounds that aim to
address unmet medical needs across the liver disease continuum, including
hepatitis C, hepatitis B and liver cancer. The Company’s hepatitis C pipeline
includes compounds with different mechanisms of action, pursuing both
biologics as well as small molecule direct-acting antivirals. These compounds
are being studied as part of multiple treatment regimens with the goal of
increasing SVR rates across diverse patient types and geographies.

Peginterferon lambda-1a is the first investigational type III interferon in
Phase III development for the treatment of hepatitis C. Native human
interferon lambda proteins are generated by the immune system in response to
viral infection, and signal through a different receptor than native human
interferon alfa proteins. Lambda receptors are present on fewer cell types
within the human body than alfa receptors. This restricted distribution of the
interferon lambda receptor offers the potential for more targeted delivery of
interferon therapy. Lambda is in Phase III development for the treatment of
chronic hepatitis C and in Phase II development for the treatment of chronic
hepatitis B. The Company has studied Lambda in more than 950 people for the
treatment of chronic hepatitis C and B.

About Hepatitis C

Hepatitis C is a virus that infects the liver and is transmitted through
direct contact with infected blood and blood products. An estimated 170
million people worldwide are infected with hepatitis C. Up to 90 percent of
those infected with hepatitis C will not clear the virus and will become
chronically infected. Twenty percent of people with chronic hepatitis C will
develop cirrhosis and, of those, up to 25 percent may progress to liver
cancer. Although there is no vaccine to prevent hepatitis C, it is a
potentially curable disease.

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 the
research, development and commercialization of pharmaceutical products. 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 compounds
described in this release will move from exploratory development into full
product development, 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, 2011, 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.

^1 Defined as viral load below the lower limit of quantitation (HCV RNA < 25
IU/mL) at week 4 and undetectable viral load (HCV RNA <10 IU/mL) at week 12.

Contact:

Bristol-Myers Squibb Company
Media:
Cristi Barnett, 609-252-6028, cristi.barnett@bms.com
Sonia Choi, 609-252-5132, sonia.choi@bms.com
or
Investors:
John Elicker, 609-252-4611, john.elicker@bms.com
Ranya Dajani, 609-252-5330, ranya.dajani@bms.com
Ryan Asay, 609-252-5020, ryan.asay@bms.com
 
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