WINNIPEG, Manitoba -(April 7, 2004) Medicure
Inc. (TSX: MPH/Amex: MCU), a cardiovascular drug discovery and development
company, is pleased to announce that the preliminary results from
its Phase II study showed a positive trend in diabetic hypertensive
patients. The data from this trial supports the Company proceeding
with expansion of its MC-4232 clinical development program. MC-4232,
a combination product incorporating MC-1 and an ACE Inhibitor is
being developed for the treatment of patients with diabetes and
hypertension, in addition to patients with essential hypertension.
The initial 15-patient Phase II trial tested MC-1 alone in diabetic
hypertensive patients. The results from this trial support the Company's
plans to proceed with additional Phase II clinical trials as a prelude
to MC-4232's Phase III clinical study. The expanded program will
include a broadening of the patient study group and an extension
of the dose range.
Analysis of the data indicates that there is a trend towards the
reduction in glycated hemoglobin (HbA1c), the primary measure of
blood glucose control used by the FDA to determine the efficacy
of drug candidates in diabetics. Of the 11 patients that have completed
the 14-week study, the group showed a 4.9% reduction compared to
baseline HbA1c.
HbA1c is a commonly used clinical measure that reflects glycemic
control (average blood glucose fluctuations) over a 60- to 90-day
period. Glucose is carried in the blood stream and becomes attached
to the hemoglobin molecule. As a result of this attachment, changes
occur, which can be measured to estimate the average glucose level
for the life of the hemoglobin molecule.
"This finding would add value to the use of MC-1 in combination
products directed at diabetic hypertensives, and potentially to
the diabetic population at large," stated Dr. Albert D. Friesen,
PhD, Medicure's President and Chief Executive Officer. "This
and other related endpoints will be important components of the
newly expanded clinical program.
In preparation for the Phase III combination study, Medicure tested
MC-1 alone in this initial trial, as it is generally well known
that the ACE Inhibitor is an effective treatment for hypertension.
This study was designed to look at complementary therapeutic effects
of MC-1 and dosing regimens.
"We believe it is this complementary effect that will distinguish
our product as a valued therapy within this class," added Dr.
Friesen. "Based on the encouraging results thus far, we are
pleased to be expanding our hypertension and diabetes program to
include further studies encompassing a wider patient population
and additional measurement parameters."
The expanded program, which will incorporate information gathered
from the current pilot study and other exploratory trials, will
be key in determining MC-4232's effectiveness as a therapy in treating
patients with hypertension.
All safety related endpoints of the ongoing study have been met,
thus confirming safety and tolerability of this drug candidate.
Full clinical results on hypertension and other markers will be
released when the expanded Phase II program is completed and an
announcement is made on the initiation of the pivotal Phase III
trial.
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.
Hypertension is twice as common in people with diabetes than the
rest of the population. Approximately 18 million Americans have
diabetes, and 12 million of them have hypertension as well.
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 the prevention and treatment of ischemia, ischemic
reperfusion injury, and stroke. The cardiovascular and stroke market
is the largest pharmaceutical sector with annual global sales of
over US $70 billion.
The Company's second product candidate, MC-4232, is being targeted
for the treatment of hypertension, 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.
Medicure also has a medicinal chemistry based Drug Discovery program
focused on discovery and advancement of novel small molecule, anti-ischemics
and anti-thrombotics towards human clinical studies.
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:
Derek Reimer
Chief Financial Officer
Don Bain
Director of Investor & Public Relations
