The Medicines Company´s Angiox(R) Receives European Authorization for Expanded Use in Patients with Acute Coronary Syndromes (ACS)



    The Medicines Company (NASDAQ: MDCO) today announced the receipt
    of the European Commission Decision authorizing an expanded use for
    Angiox(R) (bivalirudin) in adult patients with acute coronary
    syndromes (ACS), specifically patients with unstable angina (UA) or
    non-ST segment elevation myocardial infarction (NSTEMI) planned for
    urgent or early intervention, when used with aspirin and clopidogrel.

    "With this new indication, Angiox can be used in patients
    experiencing ACS throughout the treatment paradigm, from arrival in
    the emergency department to the cardiac catheterization laboratory,"
    said Walter Desmet, MD, PhD, Department of Cardiology, University
    Hospital Gasthuisberg (Leuven, Belgium). "Angiox is a simple and
    effective option to meet the needs of ACS patients who require urgent
    or early."

    The approval is based on results from the ACUITY trial of 13,819
    patients with ACS.(1) ACUITY demonstrated 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(2) compared to
    standard therapy. Of the patients enrolled in ACUITY, 35% were treated
    at European hospitals.

    "With the European Commission decision, the benefits of Angiox can
    now be extended to the ACS patient population," said John Kelley,
    President and COO of The Medicines Company.

    In the United States, an sNDA for Angiomax in ACS is being
    reviewed by the U.S. Food and Drug Administration (FDA). The Company
    expects FDA action in mid-2008.

    About Angiox(R)/Angiomax(R)

    Angiox is approved in Europe for the treatment of adult patients
    with acute coronary syndromes (unstable angina/non-ST segment
    elevation myocardial infarction (UA/NSTEMI)) planned for urgent or
    early intervention when used with aspirin clopidogrel. Full
    prescribing information for Angiox is available at
    http://www.angiox.com.

    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 non-bleeding 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.
    Please see full prescribing information available at
    http://www.angiomax.com.

    About ACS

    ACS is a term given to a group of symptoms including chest pain at
    rest or during mild exertion. ACS also refers to certain types of
    heart attack and unstable angina. ACS is caused by insufficient blood
    supply to the heart. This typically results from years of plaque
    build-up in an artery. Patients with ACS symptoms are at significant
    risk for heart attack or death.

    The European Society of Cardiology (ESC) in June 2007 published
    guidelines for the treatment of ACS that state that anticoagulation
    should be selected according to the risk of both bleeding and ischemic
    events and recommend using Angiox, unfractionated heparin or
    enoxaparin for the treatment of NSTEMI patients undergoing an urgent
    invasive strategy.

    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.

    MDCO-G

    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. The Company
    re-acquired the commercial rights to Angiox in Europe in July 2007,
    and assumed the marketing rights January 1, 2008 from Nycomed. 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 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.

    (1) Stone, G., et al. Bivalirudin for Patients with Acute Coronary
    Syndromes, N Engl J Med 2006; 355;21

    (2) Reduced bleeding measured on both the ACUITY and TIMI scales