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GEN News Highlights : Dec 1, 2009

The Medicines Company Receives Label Expansion for Anticoagulant

Latest approval covers use in STEMI patients undergoing percutaneous coronary intervention.

The Medicines Company received pan-EU clearance for the direct thrombin inhibitor, Angiox®, as an anticoagulant in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI).

The drug was previously approved in Europe for the treatment of adults with unstable angina/non-STEMI who were to undergo urgent or early intervention. Angiox is designed for use in combination with aspirin and clopidogrel.

The latest EU approval for the STEMI-PCI indication is based on data from a trial that showed Angiox to significantly reduce overall mortality, heart-related deaths, and the incidence of major bleeding in comparison to therapy involving heparin and a platelet glycoprotein IIb/IIIa inhibitor.

In the U.S. the drug is called Angiomax. The Medicines Company reported U.S. Angiomax sales of $194.3 million for the first six months of 2009, up 21% from sales of $161.3 million reported for the first six months of 2008. International net revenues from Angiomax/Angiox were $7.7 million in the first six months this year, compared with $4.2 million in the first six months of 2008.