Bristol-Myers Squibb Receives U.S. FDA Breakthrough Therapy Designation for All-Oral Daclatasvir Dual Investigational Regimen

Bristol-Myers Squibb Receives U.S. FDA Breakthrough Therapy Designation for 
All-Oral Daclatasvir Dual Investigational Regimen for Chronic Hepatitis C 

        --  FDA grants Designation request for investigational daclatasvir
            (DCV) and asunaprevir (ASV) combination therapy for treatment
            of genotype 1b chronic hepatitis C (HCV) infection
        --  Marks second Breakthrough Therapy Designation for a
            daclatasvir-based regimen; 3DAA regimen granted Designation in

PRINCETON, NJ, Feb. 25, 2014 /CNW/ - Bristol-Myers Squibb Company (NYSE: BMY) 
today announced that the U.S. Food and Drug Administration (FDA) has granted 
its investigational DCV Dual Regimen (daclatasvir and asunaprevir) 
Breakthrough Therapy Designation for use as a combination therapy in the 
treatment of genotype 1b chronic hepatitis C infection (HCV). The designation 
is based on data from the company's ongoing Phase III clinical trial program 
evaluating the all-oral combination regimen of DCV, an investigational NS5A 
replication complex inhibitor, and ASV, an investigational NS3 protease 
inhibitor, without ribavirin.

According to the FDA, Breakthrough Therapy Designation is intended to expedite 
the development and review of drugs for serious or life-threatening 
conditions. The criteria for Breakthrough Therapy Designation require 
preliminary clinical evidence that demonstrates the drug may have substantial 
improvement on at least one clinically significant endpoint over available 

"The FDA's decision to grant Breakthrough Therapy Designation for our DCV Dual 
Regimen (daclatasvir and asunaprevir combination therapy) marks the second 
time that the FDA has granted the Designation to a daclatasvir-based regimen, 
further underscoring its potential to help address the high unmet needs of the 
HCV patient population," said Brian Daniels, MD, senior vice president, Global 
Development and Medical Affairs, Research and Development, Bristol-Myers 
Squibb. "This is an important milestone for Bristol-Myers Squibb as we 
continue our strategic focus on the development of innovative medicines to 
address areas of high unmet medical need, where potential expedited review can 
make a critical difference for patients."

Approximately 170 million people worldwide are infected with hepatitis C, with 
an estimated 2.7-3.9 million chronically infected in the U.S. Many of these 
people have been living with HCV for decades, putting them at heightened risk 
for developing serious, potentially life-threatening liver disease.

New data from Bristol-Myers Squibb's ongoing Phase III clinical program 
studying the DCV Dual Regimen is anticipated to be presented at an upcoming 
scientific forum. Data from a separate daclatasvir and asunaprevir Phase III 
trial in Japanese patients with HCV genotype 1b who were either 
interferon-ineligible/intolerant or non-responders (null and partial) to 
interferon-based therapies served as the basis for a regulatory filing in 
Japan in October 2013.

Bristol-Myers Squibb also recently announced that the European Medicines 
Agency (EMA) validated the company's marketing authorization application (MAA) 
for the use of daclatasvir for the treatment of adults with HCV with 
compensated liver disease, including genotypes 1, 2, 3, and 4. The application 
seeks the approval of daclatasvir for use in combination with other agents for 
the treatment of chronic hepatitis C and will be reviewed under an accelerated 
regulatory review.

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, 
20 percent of people with chronic hepatitis C will develop cirrhosis and, 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, an investigational NS5A replication complex 
inhibitor that has been studied in more than 5,500 patients as a foundational 
agent for multiple direct-acting antiviral (DAA) based combination therapies.

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

In addition, enrollment has begun for the Phase III ALLY Program, in which 
daclatasvir in combination with sofosbuvir, is being studied in high unmet 
need patients, such as pre- and post-transplant patients, HIV/HCV co-infected 
patients and patients infected with HCV genotype 3.

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 to offer an alternative to peginterferon
            alfa in patients for whom an interferon-based regimen is
            required or preferred

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 
or follow us on Twitter at

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 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.

SOURCE  Bristol-Myers Squibb 
Media: Carrie Fernandez, Office: 609-252-4831; Cell: 215-859-2605 
Investors: Ranya Dajani, 609-252-5330, Ryan Asay, 
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CO: Bristol-Myers Squibb
ST: New Jersey
-0- Feb/25/2014 10:59 GMT
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