|
April 12, 2006
MEDICURE REPORTS ON MEND-CABG END OF PHASE II MEETING WITH THE FDA
WINNIPEG, ManitobaÐ (April 12, 2006)
WINNIPEG, Manitoba– (April 12, 2006) Medicure Inc. (TSX:MPH; Amex: MCU), a cardiovascular drug discovery and development company, today announced that based on the positive Phase II MEND-CABG study and a recent End of Phase II meeting with the U.S. Food and Drug Administration (FDA), the Company plans to proceed with a single confirmatory Phase III study to gain approval for MC-1 in the reduction of cardiovascular events in patients undergoing coronary artery bypass graft (CABG) surgery. MC-1 has received a Fast Track designation from the FDA.
Based on the End of Phase II meeting, Medicure plans to use a composite of cardiovascular death and non-fatal myocardial infarction (primary definition peak CK-MB ≥ 100ng/ml) at post operative day (POD) 30 as the primary endpoint for the Phase III study. Initiation of this study is targeted for the second half of calendar 2006.
“We are extremely pleased with the outcome of the End of Phase II meeting with the FDA. A single confirmatory study provides Medicure the most efficient and affordable path for MC-1’s Phase III development, and is a valuable asset in our partnership negotiations,” commented Medicure’s President and CEO, Albert D. Friesen, PhD. “MC-1 has the opportunity to be the first product indicated to reduce cardiovascular events associated with ischemia and/or ischemic reperfusion injury in CABG patients, targeting a significant unmet medical need. We look forward to working with the FDA in expediting the development of MC-1.”
MC-1 is a small molecule that reduces the amount of damage to the heart following ischemia and/or ischemic reperfusion injury. Studies with MC-1 suggest that it does this by protecting cardiomyocytes (heart muscle cells). Since cardiomyocytes are essential for normal heart function and do not regenerate themselves following an ischemic event, their preservation is key to minimizing ischemic damage and maintaining proper heart function. MC-1’s cardioprotective properties have been demonstrated in the Phase II MEND-1 study in patients undergoing percutaneous coronary interventions and the Phase II MEND-CABG study in patients undergoing CABG surgery.
About Medicure Inc.
Medicure Inc. is a cardiovascular drug discovery and development Company focused on developing effective therapeutics for unmet needs in the field of cardiovascular medicine, the largest pharmaceutical market sector. The Company's solid position in this field is supported by the following attributes:
- Cardiovascular focused pipeline: a global market of over US $70 billion
- Two drugs - MC-1 & MC-4232 - in late stage clinical development
- Four positive Phase II trials completed
- FDA Fast Track designation for MC-1
- Unique products addressing major, inadequately served markets
- Dual action antithrombotic, MC-45308, with positive preclinical results
Medicure also has a medicinal chemistry based Drug Discovery program focused on discovery and advancement of novel small molecule, anti-ischemics, and antithrombotics towards human clinical studies.
This press release contains forward-looking statements that involve risks, which may cause actual results to differ materially from the statements made, and accordingly may be deemed to be forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such risks, include among others, those described in the Company’s annual return on Form 20-F. The forward-looking statements are made as of the date hereof, and the Company disclaims any intention and has no obligation or responsibility to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
For more information, please contact:
Derek Reimer
Chief Financial Officer
Hogan Mullally
Manager of Investor & Public Relations
Medicure Inc.
888-435-2220
204-488-9823 fax
info@medicure.com
Back to News Releases
|
