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 2013

Business Wire

PRINCETON, N.J. -- February 24, 2014

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
therapy.

“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 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 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.

Contact:

Bristol-Myers Squibb Company
Media:
Carrie Fernandez
Office: 609-252-4831
Cell: 215-859-2605
carrie.fernandez@bms.com
or
Investors:
Ranya Dajani, 609-252-5330
ranya.dajani@bms.com
or
Ryan Asay, 609-252-5020
ryan.asay@bms.com
 
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