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CHMP Recommends Expanded Use of Angiox(R) (Bivalirudin) in Europe for Patients With Acute Coronary Syndromes
Date:11/19/2007

Positive Opinion Coincides with Expansion of The Medicines Company into

Europe

PARSIPPANY, N.J. and ZURICH, Switzerland, Nov. 19 /PRNewswire/ -- The Medicines Company (Nasdaq: MDCO) today 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,
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SOURCE The Medicines Company
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