Daclatasvir Marketing Authorization Application for Treatment of Chronic Hepatitis C
Validated for Accelerated Regulatory Review by the European Medicines Agency
o Bristol-Myers Squibb application supports use of daclatasvir in combination with otheragents for treating HCV patients with genotypes 1, 2, 3 and 4o Submission includes EU’s first all-oral and ribavirin-free investigational regimen − foruse in treatment naïve genotype 1, 2, 3 patients and protease inhibitor treatment failureso Company is prepared to work with authorities across Europe to help ensure daclatasvir
is reimbursed for HCV patients with high unmet needs, if daclatasvir is approved(PRINCETON, N.J., January 8, 2014) – Bristol-Myers Squibb Company (NYSE: BMY) today
announced that the European Medicines Agency (EMA) has validated the company’s marketing
authorization application (MAA) for the use of daclatasvir (DCV), an investigational NS5A
complex inhibitor, for the treatment of adults with chronic hepatitis C (HCV) with compensatedliver disease, including genotypes 1, 2, 3, and 4. The application seeks the approval ofdaclatasvir for use in combination with other agents, including sofosbuvir, for the treatment ofchronic hepatitis C. The MAA validation marks the start of an accelerated regulatory review
process for DCV, which has the potential, when used in combination with other agents, toaddress a high unmet need in the European Union (EU) where an estimated 9 million people areliving with hepatitis C.i“Our extensive clinical trial program has demonstrated that daclatasvir has potential use
as a foundational agent for multiple HCV treatment regimens,” said Brian Daniels, MD, senior
vice president, Global Development and Medical Affairs, Research and Development, BristolMyers Squibb. “If daclatasvir is approved, we would focus on helping to ensure its availability topatients with limited treatment options and would work with EU health authorities to ensure
access is achieved as quickly as possible.”In the European Union, the burden of liver disease and other morbidities from HCV
infection is significant, with large numbers of patients in urgent need of new treatment options.ii
Because of the progressive nature of HCV, decades may pass before patients become
symptomatic. Many of these aging patients develop liver disease, making them more difficult totreat with the current standard of care of interferon plus ribavirin with or without a proteaseinhibitor.iii Viral hepatitis has also been cited as a cause for the increase in the incidence of HCC(hepatocellular carcinoma) in Europe.iv

The EMA submission is supported by data from multiple studies of daclatasvir with other
HCV therapies. To date, DCV has been studied in more than 5,500 patients in a variety of alloral regimens and with the current interferon-based standard of care. In addition todemonstrating pan-genotypic potency in vitro, DCV has shown a low drug-drug interaction
profile, supporting its potential use in multiple treatment regimens and in people with comorbidities. No clinically relevant safety signals have been observed thus far in DCV clinical
trials, and DCV has been generally well-tolerated in all investigational regimens and patient
types.
The EU submission follows the recent Bristol-Myers Squibb regulatory filing in Japanseeking approval of a DCV-based regimen for the treatment of patients infected with HCV
genotype 1b.
About Hepatitis CHepatitis C is a virus that infects the liver and is transmitted through direct contact withinfected blood and blood products.v An estimated 170 million people worldwide are infectedwith hepatitis C.vi Up to 90 percent of those infected with hepatitis C will not clear the virus andwill become chronically infected.viiAccording to the World Health Organization, 20 percent ofpeople with chronic hepatitis C will develop cirrhosis and, of those, up to 25 percent may
progress to liver cancer.viii,ix,
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, aninvestigational NS5A replication complex inhibitor that has been extensively studied as afoundational agent for multiple direct-acting antiviral (DAA) based combination therapies.
DCV is currently being studied in the ongoing Phase III UNITY Program, where it isbeing investigated as part of an all-oral 3DAA regimen with other Bristol-Myers Squibb
investigational agents. Study populations include non-cirrhotic naïve, cirrhotic naïve andpreviously treated patients. Additional Phase III clinical trials are planned to start in early 2014.
Other compounds in the pipeline include:Asunaprevir (ASV) is an investigational NS3 protease inhibitor for hepatitis C which has
been studied as a component of DCV-based treatment regimens

BMS-791325 is a non-nucleoside inhibitor of the NS5B polymerase, currently in Phase
III development for hepatitis C as a component of DCV-based treatment regimens

PegInterferon-Lambda is an investigational type III interferon that has the potential tooffer an alternative to alfa-interferon in patients for whom an interferon-based regimen isrequired or preferred

About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is todiscover, 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 andcommercialization 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. Amongother risks, there can be no guarantee that DCV will receive regulatory approval or, if approved,that it will become a commercially successful product. 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 BristolMyers 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 resultof new information, future events or otherwise.
###Contact:
Media:
Carrie Fernandez,
Office: 609-252-4831; Cell: 215-859-2605
carrie.fernandez@bms.com
Jeff Smith
Office: +33(0)1 58 83 83 21; Cell: +33(0) 6 03 99 40 18
JR.Smith@bms.com
Investors:
Ranya Dajani, 609-252-5330, ranya.dajani@bms.com
Ryan Asay, 609-252-5020, ryan.asay@bms.com

iVietri J, Prajapati G, El Khoury AC. “The burden of hepatitis C in Europe from the patients’ perspective” BMS
Gastroenterol. 2013 Jan 17; 13:16
ii
European Centre for Disease prevention and Control. Hepatitis B and C in the EU neighbourhood: prevalence,burden of disease and screening policies. 2010; 1-56. P17. Table 2iii
Poordad F, Dieterich D, Treating hepatitis C: current standard of care and emerging direct-acting antiviral agents,
Journal of Viral Hepatitis, Volume 19, Issue 7, pages 449–464, July 2012; http://refhub.elsevier.com/S01688278(13)00209-2/h0015
iv
Venookv
Centers for Disease Control and Prevention. “Hepatitis C Information for the Public,”
http://www.cdc.gov/hepatitis/c/. Accessed Dec. 21, 2013vi
Averhoff FM, et al. Clin Infect Dis 2012;55(S1):S10-S15
vii
World Health Organizations (WHO). “Hepatitis C: About HCV Infection.” Accessed at:
http://www.who.int/csr/disease/hepatitis/whocdscsrylo2003/en/index3.html.
viiiWorld Health Organization (WHO). “Hepatitis C.” Accessed at:
http://www.who.int/csr/disease/hepatitis/Hepc.pdf. Page 4.
ix
EASL International Consensus Conference on Hepatitis C. Consensus Statement. Journal ofHepatology, 1999, 31:3-8.