Angiox Label Expanded - Analyst Blog

The Medicines Company (MDCO) recently received positive news in the form of a label expansion for Angiox in the EU. The European Commission granted approval for the use of Angiox as an anticoagulant in patients with heart attacks [ST-segment elevation myocardial infarction (STEMI)] undergoing emergency heart procedures called primary percutaneous coronary intervention (PCI). 

The approval was expected as Angiox received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) in Oct 2009. The approval was based on the landmark HORIZONS-AMI study which demonstrated a reduction in deaths from heart attacks in patients undergoing emergency PCI. 

The trial showed that patients treated with Angiox compared with heparin plus a platelet glycoprotein IIb/IIIa inhibitor (GPI) were more likely to survive and had less frequent severe bleeds. The new indication should expand the market for Angiox significantly. According to the company, about 150,000 primary PCIs are performed in Europe every year. We believe data from the HORIZONS-AMI study will help Angiox gain share and acceptance. 

The Medicines Company intends to launch Angiox for the new indication in Jan 2010. 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 PCI procedures are performed each year, of which 150,000 are primary PCIs for the treatment of patients with STEMI. 

Although the approval of the new indication for Angiox is a positive for the company, we remain concerned about the company facing generic versions of Angiomax (Angiox’ trade name) in the U.S. Angiomax will most likely lose patent exclusivity in the U.S. in Sep 2010 and the entry of generics would be devastating for the company. 

Angiomax is the company’s lead product, accounting for almost 96% of total revenues in 2008. We currently have an Underperform recommendation on The Medicines Co based on its dependence on Angiomax for growth and the lack of any pipeline candidate that can contribute significantly to revenues once Angiomax loses exclusivity.
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