Healthcare Industry News: reperfusion injury
News Release - December 12, 2006
Medicure Announces Special Protocol Assessment With the FDA For Phase III MEND-CABG II StudyWINNIPEG, MANITOBA--(Healthcare Sales & Marketing Network)--Dec 12, 2006 -- Medicure Inc. (TSX:MPH.TO )(AMEX:MCU ), a cardiovascular focused biopharmaceutical company, today announced that it has completed a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (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 FDA Fast Tracked 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.
"We are pleased to have finalized the SPA agreement with the FDA on the design of the ongoing MEND-CABG II trial. This agreement provides Medicure with a well defined pathway towards regulatory approval for MC-1," commented Medicure's President and CEO, Albert D. Friesen, PhD. "We believe MC-1 will be an important therapeutic addition to the standard of care for patients undergoing CABG surgery."
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.
About MEND-CABG II
MEND-CABG II is a double-blind, randomized, placebo-controlled clinical trial that will enroll up to 3,000 patients undergoing CABG surgery 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 (POD 30). The primary efficacy endpoint of MEND-CABG II is the reduction in the composite of cardiovascular death and non-fatal myocardial infarction up to POD 30. Study patients will be followed for 60 days after treatment (90 days post operatively) for additional safety and efficacy analysis. Study enrollment was initiated in November 2006.
The study protocol and entry criteria for MEND-CABG II closely follow that of the Phase II MEND-CABG study. MEND-CABG was a Phase II study involving 901 patients that evaluated MC-1 versus placebo in patients undergoing CABG surgery. The 250 mg dose of MC-1 had a 37.2% reduction in the composite of cardiovascular death, non-fatal myocardial infarction (peak CK-MB greater than or equal to 100ng/ml), and non-fatal stroke versus placebo (p equals 0.028). The reduction in the composite endpoint was driven by a significant 46.9% decrease in the incidence of non-fatal myocardial infarction (peak CK-MB greater than or equal to 100ng/ml) with the 250 mg dose of MC-1 versus placebo (p equals 0.008). The clinical results reported at POD 30 were maintained throughout the 90 day follow up period (POD 90). Safety analysis included in the MEND-CABG study demonstrated MC-1 was safe and well tolerated. The incidence of adverse events in the study was comparable across both treatment and control groups.
MC-1 is a novel cardioprotective compound that prevents cardiac damage via inhibition of the purinergic receptors on cardiomyocytes (heart muscle cells). Medicure has completed two Phase II studies with MC-1 demonstrating its cardioprotective efficacy. In addition to the MEND-CABG study outlined above, the 60 patient MEND-1 study demonstrated that MC-1 had a statistically significant reduction in the cardiac enzyme CK-MB in patients undergoing percutaneous coronary intervention (PCI). MC-1 has received a 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 (ACS). Medicure intends to develop MC-1 for the CABG surgery and ACS markets, which have a combined annual incidence of approximately two million in the United States.
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:
- Two drugs, MC-1 & MC-4232, in late stage clinical development
- Four positive Phase II trials completed with MC-1
- FDA Fast Track designation for MC-1
- U.S. rights to AGGRASTAT® Injection (tirofiban hydrochloride)
- 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. 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. 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, 2006.
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