(RTTNews) -  Medicines Co. (MDCO: News ) said Tuesday that it received extended European approval for its Angiox, or bivalirudin, as an anticoagulant in patients with heart attacks undergoing emergency heart procedure of primary percutaneous coronary intervention or PCI. Angiox has been indicated for intravenous use as an anticoagulant in patients undergoing coronary angioplasty. The company said Angiox in the new indication is set to hit the market in January 2010.

The commission's approval applicable to all member States of the European Union/European Economic Area comes in following a positive opinion from CHMP, or Committee for Medicinal Products for Human Use of the European Medicine agency, or EMEA in October.

Angiox is marketed as Angiomax in the U.S. and other territories. In its most recent quarterly filing, Angiomax U.S. Sales totaled $92.2 million, up 9% year-over-year. Internationally, Angiomax/Angiox net revenues surged 74% to $5.5 million.

ST-segment elevation myocardial infarction, or STEMI is the most severe type of heart attack and carries a substantial risk of death and disability. In the EU, an estimated 1 million percutaneous coronary intervention, or PCI procedures are performed each year, of which 150,000 are primary PCI's for the treatment of patients with STEMI. STEMI is part of a spectrum of acute coronary syndromes, or ACS caused by acute exacerbation of underlying coronary artery disease.
European Commission decision was based on landmark HORIZONS-AMI trial data, involving 3,602 patients, of which 57% were recruited in Europe, with the most severe form of heart attack, known as STEMI, undergoing a emergency or primary PCI. The study data showed a reduction in deaths from heart attacks in patients undergoing emergency PCI. The trial showed that patients treated with Angiox when compared with heparin plus a platelet glycoprotein IIb/IIIa inhibitor, or GPI were more likely to survive and had less frequent severe bleeds.

Clive Meanwell, chief executive officer of Medicines Company said, "The need for this drug is significant: 150000 primary PCIs are performed in Europe every year and appropriate cost-effective therapies like Angiox are increasingly important."

MDCO closed Monday's regular trading at $7.84, on the Nasdaq.

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by RTT Staff Writer

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