WINNIPEG, Manitoba -(October 14, 2004). Medicure
Inc. (TSX: MPH; Amex: MCU), a cardiovascular drug discovery and
development company, today reported the results of operations for
the first quarter ended August 31, 2004. All amounts referenced
herein are in Canadian dollars unless otherwise noted.
Research and development expenditures during the quarter ended
August 31, 2004 were $2,191,000 as compared to $755,000 for the
same quarter in fiscal 2004. This increase is primarily due to the
costs incurred to the ongoing Phase II/III Coronary Artery Bypass
Graft (CABG) trial, MEND-CABG, which is evaluating the ischemic
reperfusion and neuro-protective effects of the Company's lead drug,
MC-1. The Phase II portion of the study will enroll up to 900 patients.
The study will evaluate the ischemic reperfusion and neuro-protective
effects of MC-1 in patients undergoing high-risk CABG surgery. The
trial is being conducted at approximately 40 cardiac centres throughout
Canada and the US and is managed by Montreal Heart Institute and
Duke Clinical Research Institute (DCRI). For the three months ended
August 31, 2004, total expenditures for the MEND-CABG study were
$1,429,000 as compared to nil for the three months ended August
31, 2003. In addition, the increase in expenditures was also due
to the costs associated with the start of the MATCHED Study (MC-1
and ACE Therapeutic Combination for Hypertensive Diabetics) as part
of the Company's expanded Phase II/III clinical development program
for MC-4232. This study is assessing effects on a variety of important
parameters in patients with diabetes and hypertension.
Medicure anticipates research and development expenditures for
the remainder of fiscal 2005 will be significantly higher than fiscal
2004, with a majority of the increase attributed to the expected
acceleration of both the MEND-CABG and MATCHED studies.
"The quarter was highlighted by the start of enrolment of
patients in our phase II trial to evaluate the effects of MC-4232
in the treatment of diabetic patients with hypertension," stated
Albert D. Friesen, PhD, Medicure's President & CEO. "MC-4232,
is a unique combination drug for the treatment of diabetic patients
with hypertension. The co-existing conditions of diabetes and hypertension
present a major increase in risk of cardiovascular complications,
including coronary artery disease, peripheral artery disease, retinopathy,
nephropathy and stroke. 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."
The MATCHED study is part of Medicure's expanded Phase II/III clinical
development program for MC-4232, and 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. 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.
General and administrative expenditures for the current quarter
totaled $518,000 compared to $417,000 for the same quarter in fiscal
2004. The increase is attributable to an increase in stock based
compensation, which totaled $86,000 for the first three months of
fiscal 2005, compared to $33,000 for the same period a year ago.
The Company expects slightly higher levels of general and administrative
activities for the remainder of fiscal 2005.
Interest and other income for the first quarter ended August 31,
2004 was $107,000 compared to $70,000 for the first quarter ended
August 31, 2003. The primary reason for the increase in interest
revenue in the first quarter is due to the higher cash and short-term
investment balances of the Company.
As a result of the above noted items the financial results for
the first quarter ended August 31, 2004 include a consolidated net
loss from operations of $2,615,000 or $0.04 per share, compared
to a net loss of $1,107,000 or $0.02 per share for the three-month
period ended August 31, 2003. The increased loss is attributable
mainly to the expansion in research and development activities associated
with the clinical development of both MC-1 and MC-4232.
The Company continues to maintain a solid cash position with cash
and cash equivalents totaling $16.9 million as of August 31, 2004
as compared to $20.0 million as of May 31, 2004. The cash position
is sufficient to fund completion of both the Phase II portion of
the MEND-CABG study and the MATCHED study.
Corporate Highlights
Subsequent to the end of the first quarter, Medicure announced the
development of an intravenous (I.V.) formulation of the Company's
lead drug MC-1 after successful completion of a Phase I clinical
trial to assess its safety and tolerability in healthy volunteers.
This new product presentation, which complements the existing oral
dosage form, broadens MC-1's use as a cardioprotective agent in
the management of cardiovascular emergencies.
"Medicure's proprietary I.V. formulation will now permit cardiovascular
patients to receive MC-1 where oral administration is not viable,
or the rapid attainment of the target drug levels in the blood is
desirable," Dr. Friesen stated. Hospitalized patients treated
for stroke or acute coronary syndrome (ACS) will benefit most from
this product line extension. It also complements our oral form of
MC-1, and permits the broadest possible range of alternatives to
the physician for initiation and maintenance of cardioprotective
therapy in patients experiencing acute cardiovascular events."
Also subsequent to the end of the first quarter, based on the positive
preclinical results of its novel antithrombotic drug candidate,
MC-45308, Medicure entered into a development agreement with Dr.
Jawed Fareed, Professor, Departments of Pathology and Pharmacology,
Loyola University Medical School, Chicago. This collaboration will
advance the development of MC-45308, Medicure's novel and composition
of matter-patented drug from the Company's antithrombotic library.
Antithrombotics are drugs that prevent blood clots, which lead to
heart attacks and stroke.
"This has the potential to be a major discovery in the field
of antithrombotic therapy. Dr. Fareed's preliminary biochemical
results showed the significant potential of Medicure's antithrombotic
drug candidate, which has the unique property that demonstrates
a dual anti-platelet and anti-coagulant effect. MC-45308, which
is structurally different from Medicure's lead compound MC-1, has
the potential to be more effective at providing improved prevention
of coronary events as compared to other known clinical agents as
a result of its dual effects," Dr. Friesen stated.
Download First Quarter Financials (948 K PDF)
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. In its successful Phase
II clinical trial, MEND-1, the Company's lead drug, MC-1, demonstrated
cardioprotective effects and safety in high-risk patients undergoing
angioplasty. The results from this clinical trial showed that MC-1
significantly reduces ischemic heart damage associated with the
angioplasty procedure. Proceeding from this positive outcome, Medicure's
ongoing Phase II/III MEND-CABG clinical trial is evaluating the
cardioprotective and neuroprotective effects of MC-1 in patients
undergoing high-risk Coronary Artery Bypass Graft (CABG) surgery.
The cardiovascular market is the largest pharmaceutical sector with
annual global sales of over US $70 billion.
The Company's second product candidate, MC-4232, is a unique combination
drug for the treatment of diabetic patients with hypertension. The
co-existing conditions of diabetes and hypertension present a major
increase in risk of cardiovascular complications, including coronary
artery disease, peripheral artery disease, retinopathy, nephropathy
and stroke. MC-4232 is a novel combination product that combines
MC-1's cardioprotective properties with an ACE Inhibitor, the most
common form of hypertensive therapy. In addition to cardioprotection,
this product has also demonstrated potential to provide further
blood pressure lowering effects and reduction in glycated hemoglobin
(HbA1c), the primary measure of blood glucose control. The Company
is currently enrolling patients in the Phase II MATCHED study (MC-1
and ACE Therapeutic Combination for Hypertensive Diabetics), evaluating
the effects of MC-1 alone and in combination with an ACE Inhibitor
in control of blood pressure, metabolism and other endpoints in
diabetic patients with hypertension.
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
Medicure Inc.
888-435-2220
204-488-9823 fax
info@medicure.com
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