Bristol-Myers Squibb to Acquire Cardioxyl Pharmaceuticals, Inc.

  • Gains full rights to Cardioxyl’s novel nitroxyl (HNO) donor in
    Phase 2 development for acute decompensated heart failure
  • Strengthens Bristol-Myers Squibb’s pipeline and strategic focus
    on heart failure

NEW YORK & CHAPEL HILL, N.C.–(BUSINESS WIRE)–Bristol-Myers
Squibb Company
(NYSE:BMY) and Cardioxyl
Pharmaceuticals, Inc.
announced today that the companies have signed
a definitive agreement under which Bristol-Myers Squibb will acquire all
of the issued and outstanding capital stock of Cardioxyl, a private
biotechnology company focused on the discovery and development of novel
therapeutic agents for the treatment of cardiovascular disease. The
acquisition will give Bristol-Myers Squibb full rights to Cardioxyl’s
lead asset CXL-1427, a novel nitroxyl (HNO) donor (prodrug) in Phase 2
clinical development as an intravenous treatment for acute decompensated
heart failure (ADHF). The transaction includes upfront and near-term
milestone payments of up to $300 million and potential additional
consideration of up to $1.775 billion upon the achievement of certain
development, regulatory and sales milestones. The transaction, which is
expected to be dilutive to 2015 GAAP EPS by approximately $0.12, with
minimal dilution to non-GAAP EPS in both 2015 and 2016, has been
approved by the boards of directors of both companies.

CXL-1427 releases nitroxyl, a molecule that has demonstrated beneficial
effects on heart muscle and vascular function. Pre-clinical and early
clinical data indicate that CXL-1427 improves how the heart muscle
contracts and relaxes without increasing heart rate or the demand for
oxygen. Current therapies for ADHF that improve heart muscle function
produce an increase in heart rate and/or oxygen consumption, and are
associated with an increased risk for ischemia, arrhythmias and
increased mortality.

“The acquisition of Cardioxyl strengthens Bristol-Myers Squibb’s heart
failure pipeline with a Phase 2 asset that has the potential to change
the course of the disease rather than simply treating the symptoms,”
said Francis
Cuss
, MB BChir, FRCP, executive vice president and chief scientific
officer, Bristol-Myers Squibb. “Bristol-Myers Squibb is uniquely
positioned, with our understanding of patient needs in the hospital
setting and our heritage in cardiovascular diseases, to continue
development of CXL-1427 as a potential new therapy to address the
clinical and economic burden of heart failure.”

“We are excited about the breadth of drug development capabilities and
cardiovascular expertise that Bristol-Myers Squibb will bring to the
nitroxyl donor program,” said Christopher A. Kroeger, M.D., President
and Chief Executive Officer, Cardioxyl. “Heart failure is an important
and under-served therapeutic area and we believe Bristol-Myers Squibb is
the optimal partner to bring new therapeutic options to the patients who
need them.”

Bristol-Myers Squibb and Cardioxyl anticipate the transaction will close
during the fourth quarter of 2015. Closing of the transaction is subject
to customary closing conditions, including clearance under the
Hart-Scott-Rodino Antitrust Improvements Act.

About ADHF

Heart failure is the leading diagnosis for patients at the time of
discharge from U.S. hospitals and the most common cause of
hospitalization for patients over 65 years of age. ADHF is the sudden or
gradual onset of symptoms, such as shortness
of breath
, edema,
and fatigue,
in patients with heart failure leading to hospitalization. Despite the
prevalence and severity of the condition, the treatment options
available for patients with ADHF remain limited. In the U.S., the
treatment of HF has a direct cost of over $34 billion per year, most of
which results from hospitalization.

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 www.bms.com
or follow us on Twitter at http://twitter.com/bmsnews.

About Cardioxyl Pharmaceutical, Inc.

Cardioxyl Pharmaceuticals is focused on the discovery and development of
new classes of safe and effective therapeutic agents for the treatment
of cardiovascular disease. Cardioxyl has developed industry-leading
expertise in the chemistry, biology and clinical applications of
nitroxyl (HNO) technology. The company’s core HNO platform has generated
several pre-clinical and clinical candidates. Cardioxyl is a privately
held company financed by life science venture investors, including New
Enterprise Associates, OrbiMed, Aurora Funds and Osage University
Partners.

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 the acquisition will
be completed, or if it is completed, that it will close within the
anticipated time period or that the expected benefits of the acquisition
will be realized.
In addition, the compounds described in this
release are subject to all the risks inherent in the drug development
process, and there can be no assurance that the development of these
compounds will be successful. Forward-looking statements in the 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, 2014, its Quarterly
Reports on Form 10-Q, and 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.

Contacts

Bristol-Myers Squibb
Media:
Ken Dominski, 609-252-5251
ken.dominski@bms.com
or
Sarah
Koenig, 609-252-4145
sarah.koenig@bms.com
or
Investors:
Ranya
Dajani, 609-252-5330
ranya.dajani@bms.com
or
Bill
Szablewski, 609-252-5894
william.szablewski@bms.com
or
for
Cardioxyl Pharmaceuticals, Inc.

PressComm PR, LLC
Jamie
Lacey-Moreira, 443-212-5260
jamielacey@presscommpr.com