Please replace the release dated September 2, 2007 with the
following corrected version due to multiple revisions.
The corrected release reads:
ANGIOX(R) (BIVALIRUDIN) ALONE REDUCED EARLY BLEEDING AND RESULTED
IN SIMILAR ONE-YEAR MORTALITY COMPARED TO HEPARINS PLUS GP IIB/IIIA
COMBINATION THERAPY IN ACS PATIENTS UNDERGOING ANGIOPLASTY
Results Were Consistent in Patients Switched to Angiox from Other
Antithrombin Therapy
Patients with acute coronary syndromes (ACS) undergoing
percutaneous coronary intervention (PCI), or angioplasty, experienced
nearly 50 percent less bleeding at 30 days and comparable mortality at
one-year when treated with Angiox(R) (bivalirudin) alone compared to
unfractionated heparin or enoxaparin plus a glycoprotein IIb/IIIa
inhibitor (GPI), according to data from the ACUITY trial. These
findings were consistent in patients switched to Angiox monotherapy
from unfractionated heparin or enoxaparin. These data were presented
today at the European Society of Cardiology (ESC) Congress 2007. The
Medicines Company (NASDAQ: MDCO) recently re-acquired rights for
Angiox in Europe and currently markets the product as Angiomax(R) in
the United States.
"The ACUITY trial demonstrated that Angiox is the preferred
antithrombotic strategy in moderate and high risk ACS patients
undergoing PCI. The subgroup analysis presented today gives us
compelling new information on the benefits of switching ACS patients
to Angiox," said lead author of the study, Harvey D. White, MD,
Director of Coronary Care and Cardiovascular Research at Green
Lane Cardiovascular Service, Auckland City Hospital, Auckland, New
Zealand. "The reduction in early bleeding achieved with Angiox
monotherapy is particularly important, as bleeding events are commonly
linked to late mortality in these patients."
The ESC recently published guidelines for the treatment of ACS
that recommend using Angiox to replace heparins (unfractionated or
low-molecular weight) and GPIs in ACS patients undergoing PCI.
Study Details
The subgroup analysis of the ACUITY trial in ACS patients
undergoing PCI presented today are consistent with the overall ACUITY
results. As previously reported, in ACS patients undergoing PCI, the
risk of major bleeding at 30 days was significantly less - by nearly
50 percent - in patients who received Angiox alone compared to those
who received unfractionated heparin or enoxaparin plus GPI: 4% vs. 7%
(p less than 0.0001).(1) In his presentation at ESC, Dr. White showed
that the clinical benefits of Angiox monotherapy compared to
unfractionated heparin or enoxaparin plus GPI were consistent across
subgroups of patients, including those at high-risk, those who
received other previous antithrombin therapy and were switched to
Angiox, and those who did not receive prior antithrombin therapy.
Additionally, the new analysis showed that, after one year, there were
no significant differences in the incidence of composite ischemic
events or mortality between patients who had received Angiox
monotherapy and those who had received unfractionated heparin or
enoxaparin plus GPI. The mortality results observed at one-year with
Angiox monotherapy were not dependent on the timing of clopidogrel
administration. PCI patients experiencing a non-CABG (coronary artery
bypass graft) major bleed had a significantly longer length of
hospital stay, 5.0 days vs. 3.0 days (p less than 0.0001), compared
with those that did not bleed. Further, a strong association was
observed between bleeding events at 30 days and one-year mortality in
ACS patients undergoing PCI.
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/Angiomax
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 even in high-risk
patients.
In Europe, Angiox is indicated as an anticoagulant for patients
undergoing PCI. Please see full prescribing information available at
http://www.angiox.com.
European regulatory authorities are currently reviewing an
application to expand the use of Angiox to include the emergency use
of Angiox in ACS patients undergoing PCI.
MDCO-G
About The Medicines Company
The Medicines Company meets the demands of the world's most
advanced medical practitioners by developing products that improve
acute hospital care. The Company markets Angiomax(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. In July 2007 the Company terminated its
distribution arrangements with Nycomed and reacquired from Nycomed all
development, commercial and distribution rights held by Nycomed for
Angiox(R) (bivalirudin) in Europe. The Company also has two products
in late-stage development, Cleviprex(TM) (clevidipine) and cangrelor.
The Company's website is http://www.themedicinescompany.com.
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 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; and whether
physicians will accept clinical trial results. 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 August 9, 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.
(1) Stone GW, White HD, Ohman EM, Bertrand ME, Lincoff AM,
McLaurin BT, Cox DA, Pocock SJ, Ware JH, Feit F, Colombo A, Manoukian
SV, Lansky AJ, Mehran R, Moses JW; Acute Catheterization and Urgent
Intervention Triage strategy (ACUITY) trial investigators. Bivalirudin
in patients with acute coronary syndromes undergoing percutaneous
coronary intervention: a subgroup analysis from the Acute
Catheterization and Urgent Intervention Triage strategy (ACUITY)
trial. Lancet. 2007 Mar 17;369(9565):907-19.
