Dr. Steven Manoukian reports

MEDICURE ANNOUNCES Aggrastat CLINICAL TRIAL: SAVI-PCI

Medicure Inc. has released its plans for a new clinical trial of Aggrastat (tirofiban HCl) entitled "Shortened Aggrastat Versus Integrilin in Percutaneous Coronary Intervention" (SAVI-PCI).

SAVI-PCI (pronounced savvy) will be a randomized, open-label study enrolling approximately 600 patients undergoing percutaneous coronary intervention (PCI) at sites across the United States. The study is designed to evaluate whether patients receiving the investigational, high-dose bolus (HDB) regimen of Aggrastat (25 micrograms per kilogram bolus over three minutes) followed by an infusion of 0.15 microgram per kilogram per minute for a shortened duration of two hours will have outcomes that are similar, or "non-inferior," to patients receiving an 18-hour infusion of Integrilin (eptifibatide) (Merck & Co. Inc.) at its U.S. Food and Drug Administration-approved dosing regimen. The primary objective of SAVI-PCI is to demonstrate Aggrastat is non-inferior to Integrilin with respect to the composite end point of death, PCI-related myocardial infarction, urgent target vessel revascularization or major bleeding within 48 hours following PCI or hospital discharge. The secondary objectives of this study include the assessment of safety as measured by the incidence of major bleeding. The first patient is anticipated to be enrolled in spring 2012. The principal investigator for the study is Dr. Steven V. Manoukian, MD, director of cardiovascular research at the Sarah Cannon Research Institute (SCRI).

"SAVI-PCI has the potential to advance a promising new treatment strategy for PCI by validating that a short regimen of tirofiban provides similar efficacy compared to the standard regimen of eptifibatide. Furthermore, it is hoped this regimen will be associated with lower bleeding risk, more efficient throughput and lower cost. This is also a major milestone in SCRI's cardiovascular research initiative, and we are excited to be a part of it," commented Dr. Manoukian.

Both Aggrastat and Integrilin are reversible, small-molecule glycoprotein IIb/IIIa (GP IIb/IIIa) inhibitors that have been shown in clinical trials to reduce the combined incidence of death and myocardial infarction in patients with unstable angina (UA) or non-ST elevation myocardial infarction (NSTEMI) undergoing cardiac catheterization when compared with heparin. These agents work by preventing the ability of platelets to aggregate together. These platelet aggregates -- commonly known as blood clots -- can result in a partial or complete blockage of the coronary artery if left untreated.

Bleeding is a common adverse reaction associated with the use of GP IIb/IIIa inhibitors due to their unique ability to prevent and disaggregate blood clots. A patient's risk of bleeding is an important factor when determining an optimal treatment approach, and, in some cases, complicates or limits the use of these agents. With the SAVI-PCI study, the investigators will explore whether Aggrastat HDB plus a shortened infusion can reduce the risk of bleeding while maintaining comparable ischemic protection relative to the currently practiced 18-hour infusion of Integrilin. Other studies have indicated that shortening the infusion duration of GP IIb/IIIa inhibitors can potentially lead to a reduction in bleeding complications for patients undergoing PCI. It is important to note that bleeding complications have been linked to increased rates of other major complications and mortality, as well as increased overall cost of care. A goal of the SAVI-PCI study is to further optimize the safety, efficacy and efficiency of treatment used in the setting of PCI.

Dawson Reimer, president and chief operating officer of Medicure, said, "Medicure's return to cardiovascular clinical research and the exploration of this contemporary dosing regimen is an important step forward in the company's long-term growth and in the clinical advancement of Aggrastat."

To assist in completion of the study, Medicure International Inc. has partnered with SCRI and GVI Clinical Development Solutions (CDS). SCRI is one of the largest community-based research programs in the United States, conducting cardiology and oncology clinical trials through its affiliation with a network of hundreds of physicians. CDS is a full-service contract research organization with extensive clinical development experience across a multitude of therapeutic areas and a record of delivering quality data on time at competitive costs.

About Aggrastat

Aggrastat (tirofiban HCl), in combination with heparin, is indicated for the treatment of acute coronary syndrome, including patients who are to be managed medically and those undergoing PTCA or atherectomy. In this setting, Aggrastat has been shown to decrease the rate of a combined end point of death, new myocardial infarction or refractory ischemia/repeat cardiac procedure. Aggrastat has been studied in a setting that included aspirin and heparin.

Bleeding is the most common complication encountered during therapy with Aggrastat. Administration of Aggrastat is associated with an increase in bleeding events classified as both major and minor bleeding events by criteria developed by the thrombolysis in myocardial infarction study group (TIMI). Most major bleeding associated with Aggrastat occurs at the arterial access site for cardiac catheterization. Fatal bleedings have been reported. Aggrastat should be used with caution in patients with platelet count less than 150,000 per cubic millimetre, in patients with hemorrhagic retinopathy and in chronic hemodialysis patients. Because Aggrastat inhibits platelet aggregation, caution should be employed when it is used with other drugs that affect hemostasis. The safety of Aggrastat when used in combination with thrombolytic agents has not been established. During therapy with Aggrastat, patients should be monitored for potential bleeding. When bleeding cannot be controlled with pressure, infusion of Aggrastat and heparin should be discontinued.

Aggrastat is a parenteral non-peptide, reversible GP IIb/IIIa receptor antagonist that is marketed in the United States by Medicure Pharma Inc. Medicure does not promote unapproved use of Aggrastat. Please see the Aggrastat prescribing information for approved indications, dosage regimens and safety-related information.

The Aggrastat dosing regimen and the treatment setting studied in the SAVI-PCI study have not been approved by the FDA.

We seek Safe Harbor.