MEDICURE ANNOUNCES SPA AGREEMENT FOR CABG STUDY

Medicure has reached a Special Protocol Assessment (SPA) agreement with the FDA for the Phase III MEND-CABG II study. This single confirmatory Phase III study for registration will evaluate the cardioprotective effects of the company's fast-track product, MC-1, in approximately 3,000 patients undergoing coronary artery bypass graft (CABG) surgery. The SPA provides official confirmation from the FDA that the Phase III protocol is appropriately designed to form the basis of a new drug application (NDA) submission.

The SPA process creates a binding written agreement between the sponsoring company and the FDA concerning the design of pivotal clinical trials, including clinical endpoints, study conduct, data analysis and other clinical trial issues. The final approval of a product by the FDA requires demonstration of statistically significant efficacy and acceptable safety.

MEND-CABG II is a double-blind, randomized, placebo-controlled clinical trial that will take place at approximately 120 cardiac surgical centers throughout North America and Europe. Study patients will be randomized to receive placebo or MC-1 250 mg prior to surgery and for 30 days post operatively. The primary efficacy endpoint of MEND-CABG II is the reduction in the composite of cardiovascular death and non-fatal myocardial infarction up to day 30. Study patients will be followed for 60 days after treatment (90 days post operatively) for additional safety and efficacy analysis.

MC-1 is a novel cardioprotective compound that prevents cardiac damage via inhibition of the purinergic receptors on cardiomyocytes. Medicure has completed two Phase II studies with MC-1 demonstrating its cardioprotective efficacy. The drug has received fast-track designation from the FDA as a treatment to reduce cardiovascular and cerebrovascular events associated with ischemic and/or ischemic reperfusion injury in patients experiencing percutaneous coronary interventions, coronary artery bypass graft surgery and acute coronary syndrome.