PARSIPPANY, N.J.–(BUSINESS WIRE)–
The Medicines Company (MDCO) today announced the approval of
KENGREAL™ (cangrelor) by the U.S. Food and Drug
Administration (FDA) as an adjunctive therapy to percutaneous coronary
intervention (PCI) for reducing periprocedural thrombotic events in
patients who have not been treated with a P2Y12 inhibitor and
are not being given a glycoprotein IIb/IIIa inhibitor (GPI).
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The Medicines Company expects KENGREAL to be available in the U.S. in
July.
KENGREAL is the first and only intravenous, reversible P2Y12
platelet inhibitor with an immediate onset of action for patients
undergoing PCI that, in clinical trials, has been shown to reduce the
risk of periprocedural thrombotic events, including myocardial
infarction, stent thrombosis, and repeat coronary revascularization.
“The approval of KENGREAL provides a new option for PCI,” said Clive A.
Meanwell, MD, PhD, Chairman and Chief Executive Officer, The Medicines
Company. “This novel drug will potentially decrease thrombotic risk in
the acute care setting, deliver value to the healthcare system alongside
Angiomax®, and help us to increase our commercial offerings in the cath
lab.”
The CHAMPION PHOENIX study provided the primary evidence of efficacy for
the approval of KENGREAL™. The results of this trial, an 11,145 patient
Phase 3 randomized, double-blind clinical trial comparing KENGREAL to
oral clopidogrel in patients undergoing PCI, were published in The
New England Journal of Medicine. Co-principal investigators for the
CHAMPION clinical program were Robert A. Harrington, MD, Professor and
Chair of the Department of Medicine, Stanford University Medical School,
Stanford, CA and Deepak L. Bhatt, M.D., M.P.H., Executive Director of
Interventional Cardiovascular Programs, Brigham and Women’s Hospital,
Boston, MA and Professor, Harvard Medical School, Boston, MA.
“In the U.S., the vast majority of PCI procedures are done on an ad hoc
basis because clinicians want to define the coronary anatomy prior to
making a treatment decision,” said J. Jeffrey Marshall, MD, FACC, FSCAI,
Director, Cardiac Catheterization Lab, Northeast Georgia Medical Center
and Past President, Society for Cardiovascular Angiography and
Interventions (SCAI). “Cangrelor provides a benefit because it allows
for antiplatelet therapy to be initiated just after the decision for PCI
has been made.”
PCI, commonly known as coronary angioplasty, is a non-surgical procedure
used to treat narrowed arteries found in coronary heart disease. More
than 700,000 PCI procedures each year in the U.S. require effective
antithrombin and antiplatelet therapy. KENGREAL has the potential to
address the unmet needs of these patients and is well-suited for
contemporary U.S. practice in the cath lab.
“I believe that intravenous cangrelor has the potential to substantially
improve outcomes for patients with cardiovascular disease because of its
immediate onset of near complete platelet inhibition with rapid
reversibility,” said Gregg Stone, MD, Director of Cardiovascular
Research and Education, Columbia University Medical Center, New
York-Presbyterian Hospital. “With decreasing door-to-procedure times and
the limitations of all oral anti platelet agents, I believe cangrelor
will be widely embraced by the interventional community.”
Conference Call
The Company will discuss this approval during a call on June 23rd
at 8:30 am ET. The conference call will be available via phone and
webcast. Dial-in information is listed below:
Domestic Dial-in: +1 (877) 359-9508
International Dial-in: +1 (224)
357-2393
Passcode for both Dial-in numbers: 69887586
Replay is available from 11:30 am Eastern time following the conference
call through July 1, 2015. To hear a replay of the call, dial +1 (855)
859-2056 (domestic) and +1 (404) 537-3406 (international). Passcode for
both dial-in numbers is 69887586.
This call is being webcast and can be accessed via The Medicines Company
website at www.themedicinescompany.com.
In addition, the slides that will be used during the call can found on
the event page of the Investor Relations section of our website at www.themedicinescompany.com.
About KENGREAL™ (cangrelor)
KENGREAL, a synthetic, small molecule, is indicated as an adjunct to
percutaneous coronary intervention (PCI) to reduce the risk of
periprocedural myocardial infarction (MI), repeat coronary
revascularization, and stent thrombosis (ST) in patients who have not
been treated with a P2Y12 platelet inhibitor and are not
being given a glycoprotein IIb/IIIa inhibitor.
Important Safety Information
KENGREAL™ is contraindicated in patients with significant active
bleeding.
KENGREAL™ is contraindicated in patients with known hypersensitivity
(e.g., anaphylaxis) to cangrelor or any component of the product.
Drugs that inhibit platelet P2Y12 function, including
KENGREAL™, increase the risk of bleeding. In CHAMPION PHOENIX, bleeding
events of all severities were more common with KENGREAL™ than with
clopidogrel. Bleeding complications with KENGREAL™ were consistent
across a variety of clinically important subgroups. Once KENGREAL™ is
discontinued, there is no antiplatelet effect after an hour.
The most common adverse reaction is bleeding.
Please see full prescribing information for KENGREAL, available at http://www.kengreal.com.
About ANGIOMAX® (bivalirudin)
Angiomax® is indicated in patients undergoing PCI with provisional use
of GPI and in patients with, or at risk of, heparin-induced
thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI. In
addition, Angiomax is also indicated for use as an anticoagulant in
patients with unstable angina undergoing percutaneous transluminal
coronary angioplasty (PTCA). Angiomax is intended for use with aspirin.
Angiomax is not approved for use in patients with acute coronary
syndromes (ACS) not undergoing PCI or PTCA.
In clinical trials comparing Angiomax and heparin, the most common
adverse reaction for Angiomax was bleeding (28%). Other common adverse
reactions were headache, thrombocytopenia and fever. An unexplained fall
in blood pressure or hematocrit, or any unexplained symptom, should lead
to serious consideration of a hemorrhagic event and cessation of
Angiomax administration. Angiomax should be used with caution in
patients with disease states associated with an increased risk of
bleeding.
In gamma brachytherapy, an increased risk of thrombus formation,
including fatal outcomes, has been associated with the use of Angiomax.
Angiomax is contraindicated in patients with active major bleeding or
hypersensitivity to Angiomax or its components.
Please see full prescribing information for Angiomax, available at http://www.angiomax.com.
About The Medicines Company
The Medicines Company’s purpose is to save lives, alleviate suffering
and contribute to the economics of healthcare by focusing on 3000
leading acute/intensive care hospitals worldwide. Its vision is to be a
leading provider of solutions in three areas: serious infectious disease
care, acute cardiovascular care and surgery and perioperative care. The
company operates in the Americas, Europe and the Middle East, and Asia
Pacific regions with global centers today in Parsippany, NJ, USA
and Zurich, Switzerland.
Forward-Looking Statements
Statements contained in this press release about The Medicines Company
that are not purely historical, and all other statements that are not
purely historical, may be deemed to be forward-looking statements for
purposes of the safe harbor provisions under The Private Securities
Litigation Reform Act of 1995. Without limiting the foregoing, the words
“believes,” “anticipates,” “expects,” “hopes” and “potential” and
similar expressions, are intended to identify forward-looking
statements. These forward-looking statements involve known and unknown
risks and uncertainties that may cause the Company’s actual results,
levels of activity, performance or achievements to be materially
different from those expressed or implied by these forward-looking
statements. Important factors that may cause or contribute to such
differences include whether physicians, patients and other key decision
makers will accept clinical trial results, the Company’s ability to
successfully compete with potential competitors which may discover,
develop or commercialize competing products more successfully than we
do, whether third parties on whom the Company relies to manufacture and
support the development and commercialization of KENGREAL are able to
fulfill their obligations or the Company is able to establish or
maintain such arrangements; and such other factors as are set forth in
the risk factors detailed from time to time in the Company’s periodic
reports and registration statements filed with the Securities and
Exchange Commission including, without limitation, the risk factors
detailed in the Company’s Quarterly Report on Form 10-Q filed with the
SEC on March 5, 2015, which are incorporated herein by reference. The
Company specifically disclaims any obligation to update these
forward-looking statements.
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