WINNIPEG, Manitoba - (June 4, 2003) - Medicure
Inc. (TSE:MPH), a cardiovascular drug discovery and development
company, announced today that it is moving forward with a submission
for the commencement of the Phase II/III clinical development program
for its second product, MC-4232, for use in the treatment of hypertension.
In a pre-IND meeting to consider Medicure's proposed development
of MC-4232, the United States Food and Drug Administration (FDA)
agreed in principle with Medicure's plan with regard to the proposed
Phase II/III clinical program. Based on the plan presented to the
FDA, Medicure expects to commence the initial study in the third
quarter of calendar 2003.
This second clinical candidate follows the successful results from
a recently completed Phase II clinical trial, which showed that
the Company's lead product, MC-1, reduces ischemic heart damage
following angioplasty. The results demonstrated the cardioprotective
effects and safety of MC-1 in high-risk patients undergoing angioplasty.
Ischemia and ischemic reperfusion injury remain a major inadequately
treated area of cardiovascular medicine.
Albert D. Friesen, Ph.D, Medicure President and CEO said this clearly
was another milestone achieved by the Company this year: "We
are excited about the unique characteristics of MC-4232, along with
the large commercial market for this drug and the impact it could
have on one of the larger cardiovascular markets.
"This represents a major advancement for Medicure and further
demonstrates the depth of our product pipeline and development capabilities;"
he added. "Based on the discussions we have had with the FDA,
we believe it is possible to develop MC-4232 within a relatively
short timeframe."
Hypertension is a common disorder in which blood pressure remains
abnormally high. Approximately 50 million adult Americans have high
blood pressure. Of those, 73% are not adequately controlled and
therefore have an increased risk of heart attack, stroke, kidney
failure, damage to the eyes, heart failure, and atherosclerosis.
Control of hypertension for certain subsets of this population has
remained inadequate despite the availability of several key classes
of compounds.
Further details concerning the development plan of MC-4232 will
be made available upon receipt of regulatory approval to commence
clinical trials.
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 lead drug, MC-1, is
focused on the prevention and treatment of ischemia, ischemic reperfusion
injury, and stroke. The cardiovascular and stroke markets are the
largest pharmaceutical markets with annual global sales of over
US $70 billion. In the United States alone, more than 7 million
patients suffer some form of Acute Myocardial Infarction (heart
attack) annually, 6.2 million suffer from angina and 3.0 million
undergo bypass surgery or angioplasty procedure.
MC-1, has shown strong potential for treating various forms of
cardiovascular diseases and stroke The traditional classes of cardiovascular
drugs, such as beta-blockers, ACE inhibitors, and calcium channel
blockers have not filled the gap in effectiveness required to stem
the increase in cardiovascular disease. MC-1 has demonstrated the
ability to become a key therapeutic agent in the fight against cardiovascular
diseases and stroke as a new class of drug. Additionally, the naturally
occurring lead drug is used as a scaffold to developing a new class
of therapeutics, which focus on cardioprotection against ischemic
reperfusion injury and stroke.
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.
For more information, please contact:
Derek Reimer
Chief Financial Officer
Don Bain
Director of Investor & Public Relations
Medicure Inc.
888-435-2220
204-488-9823 fax
info@medicure.com
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