Bristol-Myers Squibb Announces Worldwide Collaboration with Janssen to Develop and Commercialize Next-Generation Cardiovascular Therapy

  • Factor XIa inhibitor moving into Phase 2 Trials for Secondary
    Stroke Prevention
  • Bristol-Myers Squibb to receive upfront payment and companies to
    share development and commercialization costs, and global profits

NEW YORK–(BUSINESS WIRE)–$BMYBristol-Myers
Squibb Company
(NYSE: BMY) today announced a worldwide collaboration
with Janssen
Pharmaceuticals, Inc
. (Janssen) on a Factor XIa (FXIa) inhibitor
program that includes the development and commercialization of
Bristol-Myers Squibb’s Factor XIa (FXIa) inhibitor, BMS-986177, an
investigational anticoagulant compound being studied for prevention and
treatment of major thrombotic conditions. The companies are expected to
advance BMS-986177 into Phase 2 clinical trials in the second half of
2018 for the study of secondary stroke prevention.

Thrombotic disorders include cardiovascular conditions such as coronary
artery disease, stroke and peripheral artery disease. BMS-986177 is an
inhibitor of Factor XIa, and is being explored for its potential to
improve upon the standard of care by reducing the risk of vascular
events – without increasing the risk of bleeding – in patients with
thrombotic disorders.

At Bristol-Myers Squibb, we are rooted in our commitment to patients
with cardiovascular disease. We are proud to partner with Janssen on our
shared vision for advancing cutting-edge science to develop potential
new treatments such as BMS-986177 for serious cardiovascular disease,”
said Tom
Lynch, M.D
., executive vice president and chief scientific officer,
Bristol-Myers Squibb. “By combining the strength of our companies’
extensive expertise in the development and commercialization of
cardiovascular treatments, we can maximize the potential of FXIa
inhibition.”

Bristol-Myers Squibb has a strong heritage of pioneering research and
advancing the development of novel compounds to address areas of high
unmet need for patients with serious cardiovascular conditions. The
collaboration will leverage both companies’ resources and expertise to
establish a broad development program across multiple indications.

Janssen will pay Bristol-Myers Squibb an upfront sum along with
potential development and regulatory milestone payments. The companies
will share development costs and commercial profits and losses.
Additional terms of the agreement were not disclosed.

About Factor XIa

Factor XIa (FXIa) plays a key role in the activation and amplification
of the coagulation cascade via the intrinsic pathway.i It was
first noticed as a potential approach to thrombosis because people with
little or no FXIa (Hemophilia C) show virtually no untoward bleeding in
the absence of a major injury or surgery. Further, a small study of
Hemophilia C patients showed a lower risk of stroke. Conversely,
elevated levels of FXI /FXIa are a risk factor for stroke and venous
thromboembolism.

Preclinical and early clinical studies suggest that selectively
inhibiting the intrinsic branch of the coagulation cascade at an
upstream protease such as FXIa could be a key strategy to reducing the
risk of vascular events without increasing the risk of bleeding.

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 about
Bristol-Myers Squibb, visit us at BMS.com or
follow us on LinkedInTwitter,
YouTube
and Facebook.

Forward-Looking Statements

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.
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, 2017 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.

____________

i R. Al-Horani, et al. Factor XIa inhibitors: A review of
patent literature. Expert Opin Ther Pat. 2016; 26(3): 323-345.

Contacts

Bristol-Myers Squibb
Media:
Lisa McCormick Lavery,
609-252-7602
lisa.mccormicklavery@bms.com
or
Ken
Dominski, 609-252-5251
ken.dominski@bms.com
or
Investors:
Tim
Power, 609-252-7509
timothy.power@bms.com
or
Bill
Szablewski, 609-252-5894
william.szablewski@bms.com