Medicure Announces Top-Line Results From Pivotal Phase 3 MEND-CABG II Clinical Trial
February 22 2008 - 4:32PM
Marketwired
WINNIPEG, MANITOBA (AMEX: MCU), a cardiovascular-focused
biopharmaceutical company, today announced that an analysis of the
data from its pivotal phase 3 MEND-CABG II clinical trial showed
that it did not meet the primary endpoint. The trial was designed
to evaluate the effect of Medicure's lead product MC-1, versus
placebo, on the incidence of cardiovascular death or nonfatal
myocardial infarction up to and including 30 days following
coronary artery bypass graft (CABG) surgery.
Based on the results, the Company does not plan on submitting an
application for MC-1 marketing approval to the U.S. Food and Drug
Administration for the CABG indication at this time.
The study results will be presented at the Late-Breaking
Clinical Trial session on April 1, 2008 at 1 p.m. Central Time
during the American College of Cardiology (ACC) 57th Annual
Scientific Session in Chicago.
Trial Design
The pivotal Phase 3 MEND-CABG II trial was a double-blind,
randomized, placebo-controlled clinical trial that enrolled over
3,000 patients undergoing CABG surgery at more than 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 was the incidence of
cardiovascular death or non-fatal myocardial infarction up to and
including POD 30. Study patients were 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.
Medicure conducted the MEND-CABG II study in conjunction with
Duke Clinical Research Institute (DCRI) and Montreal Heart
Institute (MHI). Principal investigators for the study are Dr.
Robert Harrington, Director of the DCRI, and Dr. Michel Carrier,
Director of Cardiovascular Surgery Program at MHI.
Dr. Jean-Claude Tardif, Director of the Research Centre, MHI,
and Dr. Robert W. Emery, Jr., Medical Director of Cardiovascular
Services, St Joseph's Hospital, served as co-chairs of the
MEND-CABG II steering committee.
About CABG
CABG is performed to improve blood flow to the heart by
re-routing blood around blocked arteries. CABG surgery is one of
the 10 most frequently performed procedures in North America. More
than 400,000 CABG procedures are performed each year in the U.S.
alone. Coronary artery disease incidence is increasing dramatically
worldwide, creating a major demand for products that make CABG
surgery safer for patients.
Notification of Conference Call
Medicure has scheduled a conference call and webcast to
reiterate Medicure's Phase 3 MEND-CABG II top-line results.
Date: February 25, 2008
Time: 8:00 AM Eastern Time
Telephone: 1- 416-340-8010 or 1- 866-540-8136
Webcast: Available at the Medicure website at www.medicure.com
Archive of Conference Call:
Telephone: 1- 416-695-5800 or 1- 800-408-3053
Passcode: 3253708
Webcast: Available at the Medicure website at www.medicure.com
Expires: March 10, 2008
About Medicure Inc.
Medicure Inc is a fully integrated biopharmaceutical company
focused on the research, development and commercialization of novel
compounds to treat cardiovascular disorders.
Cardiovascular medicine represents the largest pharmaceutical
sector, with annual global sales of over US $70 billion. Medicure
aims to make a global impact on cardiovascular disease and stroke
by reducing deaths, improving the quality of life and serving the
unmet needs of people who suffer from cardiovascular disease and
stroke.
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.
Contacts: Medicure Inc. Derek Reimer Chief Financial Officer
1-888-435-2220 Medicure Inc. Adam Peeler Manager of Investor &
Public Relations 1-888-435-2220 (204) 488-9823 (FAX) Email:
info@medicure.com Website: www.medicure.com
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