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Medicure Announces Special Protocol Assessment With the FDA For Phase III MEND-CABG II Study
Tuesday December 12, 7:32 am ET


WINNIPEG, MANITOBA--(MARKET WIRE)--Dec 12, 2006 -- Medicure Inc. (TSX:MPH.TO - News)(AMEX:MCU - News), 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.
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"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.





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