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

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
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SOURCE The Medicines Company
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