Positive Aggrastat Results Versus Integrilinr Featured in American Heart Journal
WINNIPEG, Manitoba - (July 27, 2007) Medicure Inc. (TSX:MPH; Amex:MCU), a cardiovascular focused, biopharmaceutical company, today announced that data from MR PCI (Multicenter Registry of High-Risk Percutaneous Coronary Intervention and Adequate Platelet Inhibition), a head-to-head study comparing the platelet inhibition effects of AGGRASTATR (tirofiban hydrochloride) and INTEGRILINR (eptifibatide), will be published in the August edition of the American Heart Journal.
The article, titled, "Optimal platelet inhibition in patients undergoing PCI: Data from the Multicenter Registry of High-Risk Percutaneous Coronary Intervention and Adequate Platelet Inhibition (MR PCI) study", outlines a higher degree of platelet inhibition with high-dose AGGRASTATR versus double-bolus INTEGRILINR at 10 minutes (p@003) and at 6 to 8 hours (p<0.001) in patients undergoing elective high-risk PCI. In addition the study demonstrated that significantly more patients achieved >95% inhibition of platelet aggregation (IPA) with the high-dose AGGRASTATR regimen.
"The MR PCI trial results indicate that high-dose AGGRASTATR
effectively inhibits platelet aggregation at 10 minutes and 6 to 8
hours and compares favorably with double-dose INTEGRILINR,"
commented Dr. David Moliterno, Chief of Cardiovascular Medicine at
the University of Kentucky and the study's senior author. "These
findings add to the existing data favoring the potential use of
high-dose AGGRASTATR during elective high-risk PCI in acute
coronary syndrome patients."
"Positive data now exists comparing AGGRASTATR with both
INTEGRILINR and REOPROR in new investigational uses, such as
high-risk PCI," commented Medicure's President and CEO, Albert D.
Friesen, PhD. "We look forward to further data presentations and
publications on AGGRASTATR later this year."
Medicure acquired the exclusive U.S. rights to AGGRASTATR in August
2006.
Important Information About AGGRASTATR AGGRASTATR was approved by
the Food and Drug Administration on May 14, 1998.
AGGRASTATR, in combination with heparin, is indicated for the treatment of acute coronary syndrome, including patients who are to be medically managed and those undergoing percutaneous transluminal coronary angioplasty (PTCA) or atherectomy. In this setting AGGRASTATR has been shown to decrease the rate of a combined endpoint of death, new myocardial infarction or refractory ischemia/repeat cardiac procedure. AGGRASTATR has been studied in a setting that included aspirin and heparin.
AGGRASTATR is contraindicated in patients with known hypersensitivity to any component of the product; active internal bleeding or a history of bleeding diathesis within the previous 30 days; or a history of intracranial hemorrhage, intracranial neoplasm, arteriovenous malformation, or aneurysm. Other contraindications to AGGRASTATR include: a history of thrombocytopenia following prior exposure to AGGRASTATR; history of stroke within 30 days or any history of hemorrhagic stroke; major surgical procedure or severe physical trauma within the previous month; history, symptoms, or findings suggestive of aortic dissection. AGGRASTATR is also contraindicated in patients with: severe hypertension (systolic blood pressure greater than 180 mmHg and/or diastolic blood pressure greater than 110 mmHg); concomitant use of another parenteral GP IIb/IIIa inhibitor; or acute pericarditis.
Bleeding is the most common complication encountered during therapy with AGGRASTATR. Administration of AGGRASTATR is associated with an increase in bleeding events classified as both major and minor bleeding events, by criteria developed by the Thrombolysis in Myocardial Infarction Study group (TIMI). Most major bleeding associated with AGGRASTATR occurs at the arterial access site for cardiac catherterization. Fatal bleedings have been reported. AGGRASTATR should be used with caution in patients with platelet count less than 150,000/mm3, in patients with hemorrhagic retinopathy and in patients in chronic hemodialysis. Because AGGRASTATR inhibits platelet aggregation, caution should be employed when it is used with other drugs that affect hemostasis. The safety of AGGRASTATR when used in combination with thrombolytic agents has not been established. During therapy with AGGRASTATR, patients should be monitored for potential bleeding. When bleeding cannot be controlled with pressure, infusion of AGGRASTATR and heparin should be discontinued.
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 AGGRASTATR 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, 2006.
For more information, please contact:
Derek Reimer Adam Peeler
Chief Financial Officer Manager of Investor & Public Relations
Tel. 888-435-2220
Fax 204-488-9823
E-mail: info@medicure.com Web: www.medicure.com
Posted: July 2007
