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Medicure Reports Positive Results From Phase II MEND-CABG Study.


NEW YORK New York, state, United States
New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of
 -- MC-1 Demonstrates Statistically Significant Reduction in Post-CABG Heart Attacks

Conference Call Today at 8:00 AM Eastern

Medicure Inc. (TSX TSX Toronto Stock Exchange (TSE before April, 2002)
TSX Transfer from Stack Pointer to Index
TSX True Space Extension
:MPH)(AMEX AMEX

See: American Stock Exchange
:MCU (1) (MicroController Unit) A computer on a single chip. See microcontroller.

(2) (Multipoint Control Unit) A device that is used to moderate a videoconference of three or more end points (users at computers or groups of users
), a cardiovascular drug discovery and development company is pleased to report positive results with its FDA Fast Tracked cardioprotective product, MC-1, in the Phase II MEND-CABG study. The MEND-CABG study is a double blind, parallel group, randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
, placebo-controlled study in 901 patients who underwent coronary artery bypass graft coronary artery bypass graft
n. Abbr. CABG
A surgical procedure in which a section of vein or other conduit is grafted between the aorta and a coronary artery below the region of an obstruction in that artery.
 (CABG CABG coronary artery bypass graft.

CABG
abbr.
coronary artery bypass graft


CABG Coronary artery bypass graft, see there
) surgery. Based on the positive results, the Company plans to move forward with a pivotal Phase III clinical development program for MC-1.

The MEND-CABG Study Results:

The MEND-CABG results demonstrate the positive clinical effects of MC-1:

- The 250 mg dose of MC-1 had a 37.2% reduction in the composite of death, non-fatal myocardial infarction myocardial infarction: see under infarction.  (peak CK-MB CK-MB Creatine phosphokinase MB isoenzyme Cardiology A CK isoenzyme usually ↑ in acute MI; CK-MB may be ↑ in muscular dystrophy, polymyositis, myoglobinuria, malignancy–eg, lung CA. Cf Troponin I, Troponin T.  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 substantial decrease in the incidence of non-fatal myocardial infarction, most notably a 46.9% reduction in non-fatal myocardial infarction (peak CK-MB greater than or equal to 100ng/ml) with the 250 mg of MC-1 versus placebo (p equals 0.008).

- The 250 mg dose of MC-1 had a 14.0% reduction in the primary endpoint composite of death, non-fatal myocardial infarction (peak CK-MB greater than or equal to 50ng/ml), and non-fatal stroke versus placebo (p equals 0.312).

-The 250 mg dose of MC-1 had a 78.7% reduction in physician diagnosed myocardial infarctions versus placebo (p equals 0.0065).

- Greater efficacy was demonstrated with the 250 mg dose than the 750 mg dose of MC-1.

The study protocol definition of myocardial infarction included peak CK-MB greater than or equal to 50ng/ml. This conservative measure of myocardial infarction was selected to increase the powering of the study. An analysis was also performed with a definition of myocardial infarction as peak CK-MB greater than or equal to 100ng/ml. This definition of myocardial infarction has been used in recent Phase III clinical studies in CABG patients.

The Principal Investigator for MEND-CABG, Dr. Jean-Claude Tardif, Director of the Research Centre, Montreal Heart Institute The Montreal Heart Institute (French: Institut de Cardiologie de Montréal), in Montreal, Quebec, is a specialty hospital dedicated to the development of cardiology. Founded in 1954, it is currently affiliated with the Université de Montréal. , commented, "The statistically significant reduction in myocardial infarctions defined as peak CK-MB greater than or equal to 100ng/ml of 46.9% with MC-1 is impressive for this high risk patient population. The results clearly suggest that patients treated with MC-1 experienced clinically meaningful reductions in the composite endpoint, driven by a pronounced reduction in non-fatal myocardial infarctions, which comprise the majority of events after CABG surgery."

"The strong efficacy signal observed with MC-1 in MEND-CABG, highlighted by the statistically significant reduction in heart attacks, have exceeded our expectations, and clearly warrant advancing MC-1 into pivotal Phase III development," commented Medicure's President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , Albert D. Friesen, PhD. "The recent FDA Fast Track designation for MC-1 combined with the positive results in MEND-CABG, have positioned Medicure at the forefront of cardioprotective therapeutic development. The results also provide us with the necessary information to design the Phase III study, including the dosing and endpoints. We now plan on meeting with the FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 to discuss these results and develop the Phase III program. Furthermore, we expect these results to accelerate our ongoing discussions with potential partners."

David Kandzari, MD, Assistant Professor of Interventional Cardiology interventional cardiology Cardiology The subspecialty of cardiology dedicated to the diagnosis, medical and mechanical therapy, pre- and post-procedure management of adult patients with acute and chronic forms of cardiovascular disease amenable to catheter-based  and Genomic Sciences, Duke Clinical Research Institute, and Principal Investigator for the US MEND-CABG sites added, "While bypass surgery Bypass surgery
A surgical procedure that grafts blood vessels onto arteries to reroute the blood flow around blockages in the arteries (arteriosclerosis).
 has brought a significant improvement in the management of coronary artery disease coronary artery disease, condition that results when the coronary arteries are narrowed or occluded, most commonly by atherosclerotic deposits of fibrous and fatty tissue. , post operative mortality operative mortality The percentage of Pts who die while hospitalized during or after a surgical procedure  and morbidity remain significant complications of this procedure. To date cardiologists and surgeons have had limited therapeutic options to mitigate this risk. The promising clinical results seen with MC-1, first in the angioplasty setting of the MEND-1 study and now in the setting of bypass surgery, suggest that MC-1 could represent a major therapeutic breakthrough in the treatment of acute ischemia and ischemic reperfusion ischemic reperfusion,
n the restoration of blood flow to an area that had previously experienced deficient blood flow. Oxidative stresses associated with this situation may cause damage to the affected tissues or organs.
 injury."

About the MEND-CABG Study

The MEND-CABG trial was designed to evaluate the cardioprotective and neuroprotective effects of MC-1 in high-risk coronary artery disease patients undergoing CABG surgery. The trial enrolled 901 patients at 42 investigational sites throughout Canada and the United States The United States and Canada share a unique legal relationship. U.S. law looks northward with a mixture of optimism and cooperation, viewing Canada as an integral part of U.S. economic and environmental policy. . The study is a double blind, parallel group, randomized, placebo-controlled study in 901 patients who underwent coronary artery bypass graft (CABG) surgery. The primary endpoint of MEND-CABG is a reduction in the composite of death, non-fatal myocardial infarction (heart attacks), and non-fatal stroke up to post operative day (POD) 30. To assess the efficacy, the event incidence in each of two dose groups - 250 mg and 750 mg per day - was compared to the incidence level in the placebo group.

Secondary efficacy endpoints include evaluating the effect of MC-1 at postoperative day 90 (POD 90) on the same composite of events, as well as the individual components of the composite (i.e. death, non-fatal heart attack and stroke) at POD 4, 30, and 90. Other secondary endpoints being measured during the trial include; cardiac tissue damage as determined by CK-MB and neurological function. Safety and tolerability will also be assessed and reported at the end of the study. Upon completion of POD 90, the Company plans to present the complete MEND-CABG results in future scientific publications and presentations.

About MC-1

MC-1 is a naturally occurring 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 Ischemic
An inadequate supply of blood to a part of the body, caused by partial or total blockage of an artery.

Mentioned in: Antiangiogenic Therapy, Subarachnoid Hemorrhage, Ventricular Fibrillation


ischemic
 event, their preservation is key to minimizing ischemic damage and maintaining proper heart function. MC-1's cardioprotective properties have now 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.

Notification of Conference Call:

Medicure will host a live conference call and webcast to discuss the POD 30 MEND-CABG study results:
Date:       Monday, December 5, 2005
Time:       8:00 am Eastern Time
Telephone:  1-800-591-6923 or 1-617-614-4907
Passcode:   Medicure
Location:   The New York Palace Hotel
            455 Madison Avenue
            New York, New York
Webcast:    Available at the Medicure website at www.medicure.com



Archive of Conference Call:

An archive of the POD 30 MEND-CABG study results conference call will be available starting at 10:30 am Eastern December 5, 2005:
Telephone:  1-888-286-8010 or 1-617-801-6888
Passcode:   11090767
Webcast:    Available at the Medicure website at www.medicure.com



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 - advancing to Phase III 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 Safe Harbor

1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated.

2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive.
  provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  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.

Medicure Inc. (TSX:MPH) (AMEX:MCU)
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Date:Dec 5, 2005
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