Bristol-Myers Squibb Presents Phase III Data Demonstrating that Investigational All-oral Daclatasvir and Asunaprevir Therapy

  Bristol-Myers Squibb Presents Phase III Data Demonstrating that
  Investigational All-oral Daclatasvir and Asunaprevir Therapy Achieved SVR12
  Rates of up to 90% Among Broad Range of Genotype 1b Hepatitis C Patients

  *Results of the HALLMARK-Dual study include data among genotype 1b
    cirrhotic and non-cirrhotic, treatment-naïve, non-responder, and
    peginterferon/ribavirin ineligible and intolerant patients
  *Study reinforces the potential of daclatasvir-based regimens to treat HCV
    patients with high unmet needs
  *Data to be presented during late-breaker session at EASL The International
    Liver Congress^TM

Business Wire

PRINCETON, N.J. -- April 10, 2014

Bristol-Myers Squibb Company (NYSE:BMY) today announced Phase III results from
the global HALLMARK-Dual study investigating the all-oral, interferon- and
ribavirin-free regimen of daclatasvir (DCV), a NS5A inhibitor, and asunaprevir
(ASV), a NS3 inhibitor, among genotype 1b hepatitis C virus (HCV) infected
patients. Results showed that the 24-week regimen achieved an overall
sustained virologic response (a functional cure) 12 weeks after the end of
treatment (SVR[12]) among treatment-naïve (90%), peginterferon/ribavirin
non-responder (82%), and peginterferon/ribavirin ineligible/intolerant (82%)
patients, including cirrhotic and non-cirrhotic patients (84% and 85%). In the
study the DCV+ASV regimen was generally well tolerated. These data will be
presented this week at the 49th annual meeting of the European Association for
the Study of the Liver (EASL) The International Liver Congress^TM in London,
April 9-13.

Globally, there are 170 million people infected with HCV, with genotype 1
being the most prevalent. There are 9 million people infected in Europe, where
there is a high prevalence of HCV genotype 1b.

“Not only was the daclatasvir and asunaprevir regimen highly effective among
study participants, it was also very well tolerated, even among sicker
patients with more advanced liver disease and higher unmet needs,” said lead
study investigator Professor Michael P. Manns, director of the Department of
Gastroenterology, Hepatology and Endocrinology at Hannover Medical School,
Germany. “Despite a rapidly evolving HCV treatment paradigm, physicians and
patients remain in need of new all-oral, interferon- and ribavirin-free
regimens that have the potential to achieve virologic cure across a broad
range of patients, including those with advanced liver disease and cirrhosis.”

These data were part of the company’s recent DCV and ASV new drug application
(NDA) submissions to the U.S. Food and Drug Administration (FDA), and helped
support the validated marketing authorization application to the European
Medicines Agency for the use of DCV in combination with other agents for the
treatment of adults with HCV with compensated liver disease, including
genotypes 1, 2, 3, and 4. These data are comparable to a similar Phase III
study of this regimen in Japanese patients, which led to the submission of a
New Drug Application with Japan’s Pharmaceutical and Medical Devices Agency.

“Daclatasvir has unique scientific characteristics that support ongoing
research for its use in multiple all-oral HCV regimens,” said Brian Daniels,
MD, senior vice president, Global Development and Medical Affairs, Research
and Development, Bristol-Myers Squibb. “In addition to the HALLMARK-Dual
study, we are pleased to be presenting data at EASL on our investigational
3DAA fixed-dose-combination, as well as daclatasvir in combination with other
HCV compounds.”

Study Design and Results

This Phase III multinational clinical trial involved 116 sites in 18
countries, including countries that have a high prevalence of genotype 1b such
as Korea and Taiwan. In the study, treatment-naïve patients (n=205) received
DCV 60 mg once daily plus ASV 100 mg twice daily for 12 weeks, and 102
patients received matching placebo for 12 weeks. The DCV+ASV treatment-naïve
group continued treatment through week 24; placebo recipients entered another
DCV+ASV study. The peginterferon/ribavirin-ineligible/intolerant (n=235) and
non-responder patients (n=205) received the same doses of DCV and ASV for 24
weeks. The primary endpoint was the percentage of patients with a sustained
virologic response at 12 weeks after the end of treatment (SVR[12]).

Virologic Response

  *90% of treatment-naïve patients achieved SVR[12]
  *82% of patients with prior null or partial response to
    peginterferon/ribavirin (non-responders) achieved SVR[12]
  *82% of peginterferon/ribavirin ineligible/intolerant patients achieved
    SVR[12]

       *Among peginterferon/ribavirin ineligible/intolerant patients, SVR[12]
         was achieved by patients with anemia/neutropenia (91%); depression
         (80%) and compensated advanced fibrosis/cirrhosis with
         thrombocytopenia (73%).

Results among Cirrhotic Patients treated with DCV+ASV

  *At baseline, 33 treatment-naïve, 63 non-responders, and 111
    ineligible/intolerant patients had cirrhosis. Cirrhotic patients made up
    ~32% of the study population.

  *SVR rates were similar in cirrhotic (84%) and non-cirrhotic (85%)
    patients.

The regimen used in this Phase III study resulted in low rates of
discontinuation (1-3%) due to adverse events (AEs). In addition, the rate of
serious adverse events (SAEs) was low (5-7%). Headache was the most common AE
in the study (24-25%). No deaths occurred, and no clinically meaningful
differences were observed in frequencies of SAEs, AEs leading to
discontinuation, or grade 3/4 ALT/AST (liver enzymes) elevations in patients
with or without cirrhosis. Importantly, all grade 3/4 ALT/AST elevations
observed were reversible and resolved off-treatment.

About Hepatitis C

Hepatitis C is a virus that infects the liver and is transmitted through
direct contact with infected blood and blood products. Up to 90 percent of
those infected with hepatitis C will not spontaneously clear the virus and
will become chronically infected. According to the World Health Organization,
up to 20 percent of people with chronic hepatitis C will develop cirrhosis; of
those, up to 25 percent may progress to liver cancer.

About Bristol-Myers Squibb’s HCV Portfolio

Bristol-Myers Squibb’s research efforts are focused on advancing late-stage
compounds to deliver the most value to patients with hepatitis C. At the core
of our pipeline is daclatasvir (DCV), an investigational NS5A replication
complex inhibitor that has been studied in more than 5,500 patients as part of
multiple direct-acting antiviral (DAA) based combination therapies.DCV has
shown a low drug-drug interaction profile, supporting its potential use in
multiple treatment regimens and in people with co-morbidities.

Daclatasvir is being investigated in combination with sofosbuvir in high unmet
need patients, such as pre- and post-transplant patients, HIV/HCV co-infected
patients, and patients with genotype 3, as part of the ongoing Phase III ALLY
Program.

In 2014, the U.S. Food and Drug Administration (FDA) granted Bristol-Myers
Squibb’s investigational DCV Dual Regimen Breakthrough Therapy Designation for
use as a combination therapy in the treatment of genotype 1b HCV infection.

In 2013, Bristol-Myers Squibb’s investigational all-oral 3DAA Regimen
(daclatasvir/ asunaprevir/BMS-791325) also received Breakthrough Therapy
Designation, which helped to expedite the start of the ongoing Phase III UNITY
Program. Study populations include non-cirrhotic naïve, cirrhotic naïve and
previously treated patients. The daclatasvir 3DAA regimen is being studied as
a fixed-dose-combination treatment with twice daily dosing.

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 clinical trials
of these compounds will support regulatory filings, or that DCV or any other
compounds mentioned in this release will receive regulatory approval 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, 2013 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.

EASL The International Liver Congress is a registered trademark of European
Association for the Study of the Liver.

Contact:

Bristol-Myers Squibb
Media:
Jeff Smith,
Office: +33(0) 1 58 83 83 21
Cell: +33(0) 6 03 99 40 18
jr.smith.paeurope@bms.com
or
Carrie Fernandez
Office: +1-609-252-4831
Cell: +1-215-859-2605
carrie.fernandez@bms.com
or
Investors:
Ranya Dajani, +1-609-252-5330
ranya.dajani@bms.com
or
Ryan Asay, +1-609-252-5020
ryan.asay@bms.com
 
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