Dr. Albert Friesen reports

MEDICURE RECEIVES US FDA FAST TRACK DESIGNATION FOR MC-1 FOR PNPO DEFICIENCY

Through Medicure Inc.'s subsidiary, Medicure International Inc., the U.S. Food and Drug Administration has granted fast-track designation for MC-1, an investigational product for the prevention or treatment of seizures associated with pyridox(am)ine 5'-phosphate oxidase (PNPO) deficiency. Fast-track designation is intended to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need.

The designation was requested based on the potential for MC-1 to address an unmet medical need for PNPO deficiency, a serious and life-threatening condition. Medicure is in the launch phase of its phase 3 clinical trial to treat approximately 10 PNPO deficient patients at sites in the United States and Australia with daily doses of MC-1.

PNPO deficiency is a rare neurometabolic disorder, often leading to neonatal onset seizures that are resistant to other anti-seizure medications, resulting in severe neurological dysfunction and ultimately death, if untreated.

The FDA has granted both a rare pediatric disease designation and an orphan drug designation to MC-1 for the treatment of seizures associated with PNPO deficiency. Additionally, the European Medicines Agency has granted an orphan drug designation to MC-1 for the treatment of PNPO deficiency.

If a new drug application for MC-1 for patients with PNPO deficiency is approved, Medicure is eligible to receive a priority review voucher from the FDA, which can be redeemed or sold, and provides significant value.

About Medicure Inc.

Medicure is a pharmaceutical company focused on the development and commercialization of pharmaceuticals and health care products for patients and prescribers in the U.S. market. The present focus of the company is the marketing and distribution of Aggrastat (tirofiban hydrochloride) injection and Zypitamag (pitavastatin) tablets in the United States, where they are sold through the company's U.S. subsidiary, Medicure Pharma Inc. Medicure also operates Marley Drug Inc., a pharmacy located in North Carolina that offers an extended supply drug program serving all 50 states, Washington, D.C., and Puerto Rico. Marley Drug is committed to improving the health status of its patients and the communities it serves while reducing overall health care costs for employers and other health care consumers.

We seek Safe Harbor.