BioCentury
ARTICLE | Clinical News

MDCO gains on Phase III data for cangrelor

January 9, 2013 1:24 AM UTC

The Medicines Co. (NASDAQ:MDCO) jumped $3.01 (12%) to $28.83 on Tuesday after reporting that IV cangrelor met the primary composite endpoint in the Phase III CHAMPION PHOENIX trial to prevent platelet activation and aggregation in patients undergoing percutaneous coronary intervention (PCI). Specifically, cangrelor followed by Plavix clopidogrel after discontinuation of cangrelor significantly reduced all-cause mortality, MI, ischemia-driven revascularization and stent thrombosis at 48 hours vs. placebo plus Plavix. The Medicines Co., which declined to disclose details, said it plans to submit the CHAMPION PHOENIX data, along with data from the Phase II BRIDGE trial, in an NDA to FDA and an MAA to EMA this year.

In 2009, The Medicines Co. discontinued the cangrelor Phase III program after the product missed the primary composite endpoints in both the Phase III CHAMPION PLATFORM and CHAMPION PCI trials in the indication. After discussions with experts and FDA, the company restarted the program with the CHAMPION PHEONIX trial using a different definition of MI than the previous failed trials "to ensure that only the MIs which occurred after randomization were counted" for the primary endpoint. ...