MATCHED
Study to Evaluate MC-1 in Combination With ACE InhibitorWINNIPEG, Manitoba - (August 11, 2004) - Medicure
Inc. (TSX: MPH / Amex: MCU), a cardiovascular drug discovery and
development company, is pleased to announce the enrollment of patients
in the Company's new Phase II trial to evaluate the effects of MC-4232
in the treatment of diabetic patients with hypertension. MC-4232
is a combination of MC-1 and an ACE Inhibitor.
The MATCHED study (MC-1 and ACE Therapeutic
Combination for Hypertensive Diabetics), part
of the expanded Phase II/III clinical development program for MC-4232,
will evaluate MC-1 alone and in combination with an ACE inhibitor.
The study is a randomized, double-blinded, placebo controlled, double-crossover
trial encompassing 120 patients with co-existing diabetes and hypertension.
MC-1 at doses of 100, 300 or 1000 mg or placebo will be given alone
and in combination with an ACE Inhibitor, at a dose of 20 mg. This
study will assess effects on a variety of important parameters in
diabetic hypertensive patients, including blood pressure and metabolic
function. The study, guided for completion in the spring of 2005,
will also provide information on product safety and tolerability.
This trial is being conducted under the guidance and direction
of an internationally recognized hypertension expert, Yves Lacourcière,
MD, FRCP, FACP, director of the hypertension research unit, Centre
Hospitalier de l'Universite Laval Sainte-Foy, Québec. Dr.
Lacourcière, one of North America's foremost experts in management
of hypertension in difficult to treat patient groups, will be leading
a group of 14 specialist investigators enrolling patients at sites
across Canada. Dr. Lacourcière has led numerous important
hypertension studies and he serves as a scientific advisor to several
leading pharmaceutical companies.
Commenting on the start of this new trial, Dr. Lacourcière
stated: "The cardiovascular risk of hypertensive patients is
greatly increased with the presence of diabetes. Additionally, physicians
find it extremely difficult to control patients multiple conditions
and therefore there is a real need for new products that provide
tissue protection while addressing a variety of other factors at
once."
"The MATCHED study is an important first evaluation of the
combination of the cardioprotective agent MC-1 and one of the most
commonly prescribed anti-hypertensive agents, and serves as a prelude
to more extensive Phase III evaluation in coexistent hypertension
and diabetes mellitus," added Dr. Lacourcière.
Albert D. Friesen, Ph.D, Medicure's President & CEO stated:
"Given the high risk of serious cardiovascular incidents presented
by the deadly combination of hypertension and diabetes, we believe
this patient population is ideal to be the first to receive MC-4232.
Data from our MEND-1 Phase II trial last year provided significantly
positive results of MC-1's cardioprotective effects. While these
effects alone would be sufficient to differentiate our product,
the MATCHED study, led by one of the world's leaders in this field
of medicine, will provide us with information on further benefits
of MC-4232, such as improving control of hypertension, blood glucose,
or improving upon the many other medical challenges facing these
patients."
"There is no drug on the market today that specifically targets
the numerous problems associated diabetic hypertension. MC-4232
is a very promising therapy that could dramatically improve the
quality of life within this patient group. Success in this program
would be a major advancement for Medicure and would serve to further
demonstrate our innovative strength and the depth of our development
capabilities," Dr. Friesen added.
Study Design
The cross-over study design will provide information on MC-1 alone
and in combination with an ACE Inhibitor for 8 weeks in each treatment
regimen, for a total treatment period of 16 weeks per patient. While
MC-1's cardioprotective properties are being confirmed in other
clinical programs, this study will evaluate effects on a variety
of other important parameters, each of which could add important
differentiation of the product. The primary blood pressure data
will be provided by ambulatory blood pressure measurements, with
standard blood pressure readings also being taken. Metabolic function
measurements will include, among others, fasting serum glucose,
glycated hemoglobin (HbA1c) and triglycerides.
This study is a key part of Medicure's plans for a Phase III registration
study of MC-4232 under the United States FDA's 505 B2 regulations
for combination products.
Huge Market Potential
MC-4232, Medicure's first combination product, addresses the major
need for cardioprotection and improved therapeutic control of patients
with diabetes and hypertension. As it incorporates an ACE inhibitor,
an established first line therapy for blood pressure control in
diabetic patients, the product will tap into the existing large
market for this class of drugs, which in 2003 exceeded USD$2.8 billion
in sales within the USA.
Hypertension is a common disorder in which blood pressure remains
abnormally high. Approximately 73% of the more than 50 million adult
Americans, who have hypertension, are not adequately treated. Recent
studies have shown that despite substantial clinical research and
refinements to existing pharmacological therapy, the ability to
control hypertension remains at the same level as in the 1980s and
it is now well accepted that most patients require multiple treatment
approaches in order to achieve blood pressure goals. Diabetes, a
condition where the patient has impaired ability to utilize blood
glucose for energy, is a major complicating factor for the approximately
12 million Americans who also have hypertension. These coexisting
conditions present a major increase in risk of macrovascular and
microvascular complications, including stroke, coronary artery disease,
peripheral artery disease, retinopathy, nephropathy and possible
neuropathy.
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 Company's lead drug,
MC-1, is focused on reduction of damage associated with acute coronary
syndromes/acute myocardial infarction and cardiovascular interventions
such as angioplasty and Coronary Artery Bypass Graft (CABG). Medicure
is currently enrolling patients in its MEND-CABG clinical trial,
which will evaluate the cardioprotective and neuroprotective effects
of MC-1 in up to 900 patients undergoing high-risk CABG.
This news 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:
Don Bain
Director of Investor & Public Relations
Derek Reimer
Chief Financial Officer
Medicure Inc.
888-435-2220
204-488-9823 fax
info@medicure.com
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