The
Medicines Company (Nasdaq: MDCO) announced that the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines Agency
(EMEA) adopted a positive opinion to extend the indication for Angiox(R)
(bivalirudin) to adult patients with acute coronary syndromes (ACS) planned
for urgent or early intervention, specifically patients with unstable
angina (UA) or non-ST segment elevation myocardial infarction (NSTEMI).
Angiox should be administered with aspirin and clopidogrel. Angiox is an
anticoagulant currently approved in Europe for use in patients undergoing
percutaneous coronary interventions (PCI), commonly referred to as
angioplasty.
The positive opinion is based on results from the ACUITY trial of
13,819 patients with ACS, which found that Angiox with or without a
glycoprotein IIb/IIIa inhibitor (GPI) resulted in similar rates of ischemic
clinical outcomes compared to standard therapy of heparin (unfractionated
or enoxaparin) plus a GPI. Importantly, Angiox monotherapy was associated
with 47% less major bleeding compared to standard therapy. Of the patients
enrolled in ACUITY, 35% were treated at European hospitals.
"The CHMP recommendation will accelerate our efforts to establish
Angiox as the preferred anti-thrombotic strategy for patients who require
PCI for coronary artery disease in Europe," noted John Kelley, President
and Chief Operating Officer of The Medicines Company. "We believe the
European Commission will approve expanded use of Angiox in ACS patients
during the first quarter of 2008, which coincides with the expansion of our
commercial operations into major European markets."
The Medicines Company re-acquired rights to Angiox in Europe in July
2007. Since then, the Company has been expanding its European presence and
developing clinical and commercial plans for Angiox with input from
European thought leaders in cardiology, thrombosis and health economics.
The Company also has been working on clinical trials and expert advisory
activities in Europe for the Company's Phase III development compounds,
cangrelor and Cleviprex(TM) (clevidipine butyrate injectable emulsion). The
Company is creating the legal infrastructure to support operations in
Europe, is establishing supply chain capabilities for the territory, and
has set up a central office in Zurich, Switzerland. The Medicines Company
markets bivalirudin as Angiomax(R) in the United States.
The European Society of Cardiology (ESC) in June 2007 published
guidelines for the treatment of ACS that recommend using Angiox in ACS
patients undergoing PCI. The Company estimates that more than one million
PCI procedures are performed annually in Europe.
The CHMP is the scientific committee of EMEA. The opinions of the CHMP
generally serve as the basis for the European Commission approvals, which
are valid in all Member States of the European Union and the European
Economic Area.
In the United States, a similar Angiomax ACS filing is being reviewed
by the U.S. Food and Drug Administration (FDA). The Company expects FDA
action in mid-2008.
About ACUITY
ACUITY was one of the largest ACS clinical trials ever conducted to
evaluate anti-thrombotic therapies and enrolled 13,819 high-risk patients
in 450 centers worldwide. The trial design employed an early invasive
strategy (angiography within 72 hours), starting anti-clotting therapy when
ACS patients arrived at the emergency department and randomly assigning
them to treatment with standard therapy of heparin (unfractionated or
enoxaparin) plus GPI, Angiox plus GPI, or Angiox monotherapy. In the Angiox
monotherapy group, selective use of GPI was permitted in limited
circumstances and occurred in less than 10% of patients. Then, based on an
evaluation in the cardiac catheterization laboratory, patients were treated
for ACS through medical management, bypass surgery or PCI.
About Angiox(R)/Angiomax(R)
Angiox/Angiomax is currently approved in the European Union and the
United States as well as several other territories. It is a direct thrombin
inhibitor with a naturally reversible mechanism of action. In clinical
trials, Angiox has demonstrated efficacy plus reductions in bleeding
complications compared to heparin as the foundation anticoagulant in the
contemporary catheterization lab setting. These reductions in bleeding
complications remain evident across the spectrum of patients undergoing
interventional therapy.
In Europe, Angiox currently is indicated as an anticoagulant for
patients undergoing PCI. Please see full prescribing information available
at angiox.
In the United States, Angiomax is indicated for use as an anticoagulant
in patients with unstable angina undergoing percutaneous transluminal
coronary angioplasty (PTCA) and with provisional GPI in patients undergoing
PCI. The most common adverse events for Angiomax in clinical trials
comparing Angiomax and heparin were back pain, pain, nausea, headache, and
hypotension. The incidence of these adverse events was comparable in both
the Angiomax and heparin groups in these trials. 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 is contraindicated in patients with active major
bleeding or hypersensitivity to Angiomax or its components.
About The Medicines Company
The Medicines Company (Nasdaq: MDCO) is committed to delivering
innovative, cost-effective acute care products in the worldwide hospital
marketplace. The Company markets Angiomax(R) / Angiox(R) (bivalirudin) in
the United States and other countries for use in patients undergoing
coronary angioplasty, a procedure to clear restricted blood flow in
arteries around the heart. The Company also has two products in late-stage
development, CleviprexTM (clevidipine butyrate injectable emulsion) and
cangrelor. The Company's website is themedicinescompany.
Statements contained in this press release about The Medicines Company
and Angiomax(R)/Angiox(R) 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," "estimates,"
"projects" 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 the forward-looking statements. Important
factors that may cause or contribute to such differences include the extent
of the commercial success of Angiomax/Angiox; the Company's success in
taking over the commercial functions previously performed by Nycomed in
Europe; whether clinical trial results of the Company's product candidates
will warrant submission of applications for regulatory approval on a timely
basis or at all; whether the Company's product candidates will receive
approvals from regulatory agencies on a timely basis or at all; whether
physicians and other key decision-makers will accept clinical trial
results; and the effects of exchange rate fluctuations and other
international economic, political and other. Such factors and others 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 on November
8, 2007, which are incorporated herein by reference. The Company
specifically disclaims any obligation to update these forward-looking
statements in the future. These forward-looking statements should not be
relied upon as representing the Company's estimates or views as of any date
subsequent to the date of this press release.
The Medicines Company
themedicinescompany
View drug information on Angiomax.