Medicure Inc.

Medicure Inc.

March 01, 2005 09:00 ET

Medicure Announces Full Patient Enrollment In Its Phase II Matched Clinical Trial




MARCH 1, 2005 - 09:00 ET

Medicure Announces Full Patient Enrollment In Its
Phase II Matched Clinical Trial

WINNIPEG, MANITOBA--(CCNMatthews - March 1, 2005) -

Trial Evaluating Effects of MC-4232 on Patients With Diabetes and

Medicure Inc. (TSX:MPH)(AMEX:MCU), a cardiovascular drug discovery and
development company, is pleased to announce that it has reached full
enrollment in its 120 patient advanced Phase II MATCHED trial evaluating
MC-4232, in patients with co-existing diabetes and hypertension. The
results of the study are expected to be announced in the summer of 2005.

Patients with co-existing diabetes and hypertension face a major
increase in risk of cardiovascular complications, including heart
attacks, stroke, heart failure and renal failure. MC-4232 is a novel
product that combines the cardioprotective properties of Medicure's lead
product, MC-1, with an ACE-Inhibitor, an established first line therapy
for blood pressure control.

"There is no one drug on the market today that specifically targets the
numerous problems facing a patient who suffers from both hypertension
and diabetes, so there is an urgent need to find a therapy that can
reduce the cardiovascular risks associated with this patient
population," stated Albert D. Friesen, Ph.D, Medicure President and CEO.
"The participation of the investigators and their patients highlights
the need for a new therapeutic such as MC-4232, to treat this
potentially deadly combination.

"We eagerly await the results from this trial, as the data will lay the
groundwork necessary for a larger Phase III study to support
registration of the product" added Dr. Friesen. "Success in this trial
would represent a major milestone for Medicure and would clearly serve
to further validate our combination product strategy."

The MATCHED study is a randomized, double-blinded, placebo controlled,
double-crossover trial encompassing up to 120 patients that will have
received MC-1 at doses of 100, 300 or 1000 mg or placebo, 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
and 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 Lacourciere, MD,
FRCP, FACP, Director of the Hypertension Research Unit, Centre
Hospitalier de l'Universite Laval Sainte-Foy, Quebec. Dr. Lacourciere,
one of North America's foremost experts in management of hypertension in
difficult to treat patient groups, is leading a group of 12 specialist
investigators enrolling patients at sites across Canada. Dr. Lacourciere
has led numerous important hypertension studies and he serves as a
scientific advisor to several leading pharmaceutical companies.

"As principal Investigator of the MATCHED Trial, I am pleased to be
involved in the development of a cardiovascular product like MC-4232,
which represents a novel approach in treating this patient population,"
said Dr. Lacourciere. "The clinical findings from the MATCHED Trial
should distinguish the drug as a valued therapeutic option, so we are
very excited about releasing results from this study as they will be
central in advancing the clinical development of MC-4232."


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

This study is a key part of Medicure's plans for a Phase III
registration study of MC-4232.


MC-4232, Medicure's first combination product, incorporates an ACE
inhibitor, the most common form of therapy for blood pressure control in
diabetic patients. As such, 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.


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 largest pharmaceutical market
sector. The Company's solid position in this field is supported by the
following attributes:

- Cardiovascular focused pipeline: a global market of over US $70 billion

- Two drugs - MC-1 & MC-4232 - in advanced Phase II trials

- Two positive Phase II trials completed

- Unique products addressing major markets not adequately served by
existing drugs

- Second combination product, MC-4262 is entering development stage

- Dual action antithrombotic, MC-45308, in preclinical testing

The Company's financial position remains solid, providing sufficient
resources to complete the ongoing Phase II studies, and to advance the
lead candidates up to pivotal Phase III studies.

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 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.


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