Healthcare Industry News: MEND-CABG II
News Release - September 20, 2007
Medicure Announces Completion of Enrollment in Pivotal Phase 3 MEND-CABG II TrialTop-Line Results Expected in First Quarter 2008
WINNIPEG, MANITOBA--(Healthcare Sales & Marketing Network)--Sep 20, 2007 -- Medicure Inc. (Toronto:MPH.TO )(AMEX:MCU ), a cardiovascular focused biopharmaceutical company, today announced the completion of enrollment of 3,000 patients in its MEND-CABG II trial. This pivotal Phase 3 trial for registration is evaluating the Company's FDA Fast Tracked product MC-1's safety and cardioprotective efficacy in patients undergoing coronary artery bypass graft (CABG) surgery.
"The completion of patient enrollment in MEND-CABG II, which is two months ahead of schedule, is a testament to the support and confidence of the clinical investigators and patients participating in the trial," stated Medicure's President and CEO, Albert D. Friesen, PhD. "We believe MC-1 represents an important advancement in the care of CABG surgery patients, and could become the first cardioprotective therapy approved to reduce mortality and morbidity in this patient population. We therefore look forward to reporting top-line results from MEND-CABG II early next year."
About MEND-CABG II
The Phase 3 MEND-CABG II trial is a double-blind, randomized, placebo-controlled clinical trial that enrolled 3,000 patients undergoing CABG surgery at approximately 130 cardiac surgical centers throughout North America and Europe. Study patients were randomized to receive placebo or MC-1 250 mg prior to surgery and for 30 days post operatively (POD 30). The primary efficacy endpoint of MEND-CABG II is the incidence of cardiovascular death or non-fatal myocardial infarction up to and including POD 30. Study patients will be followed for 60 days after treatment (90 days post operatively) for additional safety and efficacy analysis. The study was initiated in November 2006 and is subject to a Special Protocol Assessment with the FDA.
About Medicure Inc.
Medicure is a biopharmaceutical company focused on the research, development and commercialization of novel compounds to treat cardiovascular disorders. The Company's solid position in this field is highlighted by the following:
- Lead compound MC-1 in pivotal Phase 3 study for FDA approval
- Four positive Phase 2 trials completed with MC-1
- FDA Fast Track designation for MC-1
- U.S. rights to AGGRASTAT® Injection (tirofiban hydrochloride)
- Combination of MC-1 and lisinopril (MC-4232) completed Phase 2
- 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, as defined under applicable securities legislation, 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. 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 except as required by law. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, among others, the Company's stage of development, lack of product revenues, additional capital requirements, risks associated with the completion of clinical trials and obtaining regulatory approval to market the Company's products, the ability to protect its intellectual property, dependence on collaborative partners and the ability to meet its debt obligations. These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. Additional risks and uncertainties relating to the Company and its business can be found in the "Risk Factors" section of its Form 20F for the year ended May 31, 2007.
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