WINNIPEG, MANITOBA (AMEX: MCU), a cardiovascular-focused
biopharmaceutical company, today commented on the positive results
of two large AGGRASTAT� (tirofiban) studies, MULTI-STRATEGY 2 and
ON-TIME 2, that were presented at the Late Breaking Sessions of the
American College of Cardiology 57th Annual Scientific Session.
The 745-patient MULTI-STRATEGY 2 study demonstrated that
high-dose tirofiban is non-inferior to REOPRO� (abciximab) during
primary percutaneous coronary intervention (PCI) for acute
myocardial infarction. The incidence of death/MI at 8 months was
5.9% vs. 7.5% (p equals 0.55) between tirofiban and abciximab.
The 984-patient ON-TIME 2 study showed that treatment with
tirofiban in addition to aspirin, heparin and clopidogrel,
significantly reduced the incidence of residual ST-segment
deviation after PCI in STEMI patients versus placebo (patients
treated with aspirin, unfractioned heparin and clopidogrel).
"We are very pleased with the positive data presented on
AGGRASTAT� at ACC," commented Medicure's President and CEO, Albert
D. Friesen, PhD. "Although, our marketing efforts have been focused
on the substantial upstream opportunity for the use of AGGRASTAT�
in patients with non-ST-segment elevation acute coronary syndromes,
the results from MULTI-STRATEGY 2 and ON-TIME 2 demonstrate the
potential for AGGRASTAT� in acute MI patients, while also
confirming that earlier, upstream administration of AGGRASTAT�
improves outcomes compared to later administration, at the time of
PCI."
AGGRASTAT� is not currently approved for use in STEMI patients
or as adjunctive therapy in patients undergoing PCI.
About MULTI-STRATEGY 2
The purpose of this 2x2 factorial study was to evaluate the
risks and benefits of administering tirofiban at high-bolus dose
(25 ug/Kg bolus) followed by a standard infusion rate vs abciximab,
and to assess the efficacy of drug-eluting stents in the setting of
ST-elevation MI. With respect to the comparison of tirofiban and
abciximab, the primary endpoint was the incidence of a equals 50%
resolution in ST-segment elevation following percutaneous coronary
intervention.
The investigators found no significant difference in % ST
segment resolution between the tirofiban and the abciximab groups
(n equals 722, 85.3% vs. 83.6%, (95% CI, 0.958-1.086)) following
percutaneous coronary intervention. Furthermore, there was no
significant difference in the incidence of MACE (p equals 0.85),
death/MI (p equals 0.98), urgent target vessel revascularization
(uTVR) (p equals 0.59), and stent thrombosis (definite, p equals
0.56) at 30 days. The incidence of death/MI at 8 months was 5.9%
vs. 7.5% (p equals 0.55) between tirofiban and abciximab (MACE 9.9%
vs. 12.4%, p equals 0.3). With respect to safety measures, there
was no significant difference in TIMI major and minor bleeding
between tirofiban and abciximab at 30 days. However, the occurrence
of thrombocytopenia was significantly greater among patients
treated with abciximab as compared to those treated with tirofiban
(4.0% vs. 0.8%, p equals 0.004).
About ON-TIME 2
This double-blind, randomized study enrolled 984 patients with
ST-segment elevation myocardial infarction. Patients were randomly
assigned to pre-hospital treatment with tirofiban 25 ug/kg bolus
and 0.15 ug/kg/min maintenance infusion for 18 hours post-PCI or
placebo (patients treated with aspirin, unfractioned heparin and
clopidogrel (600 mg)) with bailout tirofban as required at time of
PCI.
The study's primary end points evaluated the benefit of
pre-hospital initiation of high-bolus tirofiban, administered in
addition to aspirin, unfractioned heparin and 600 mg clopidogrel,
on the extent of residual ST-segment deviation (defined as
percentage of patients with greater than 3 mm deviation of ST
segment) at one hour after PCI in patients with STEMI. Secondary
endpoints evaluated the effect of this treatment regimen, as
compared with placebo and in addition to aspirin, unfractioned
heparin and clopidogrel, on the incidence of death, MI, uTVR or
thrombotic bailout combined at 30 days. Additionally, major
bleeding, as measured by the Thrombolysis in Myocardial Infarction
(TIMI) criteria, was also assessed.
The study results showed a significant reduction in the
percentage of patients with more than 3mm residual ST-segment
deviation one hour post-PCI in the tirofiban versus placebo-treated
group (33.6 percent versus 44.3 percent, respectively; p equals
0.026 (primary endpoint)). Additionally, a median of 60 minutes
pre-PCI administration of tirofiban in the ambulance or referral
center setting significantly reduced cumulative ST-segment
deviation before PCI as compared to placebo (10.9 mm versus 12.1
mm, respectively; p equals 0.028). Cumulative ST-segment deviation
as a continuous variable was also reduced with early tirofiban
administration (3.3 mm versus 4.8 mm, respectively; p equals
0.002).
Study results also showed that the combined incidence of death,
recurrent myocardial infarction (MI), urgent target vessel
revascularization (uTVR), and thrombotic bailout was significantly
reduced in the tirofiban group (26.0 percent) versus placebo (33.3
percent; p equals 0.013). Early intervention with tirofiban did not
result in a significant increase of major bleeding when compared to
placebo (4.0 percent versus 2.9 percent, respectively; p equals
0.363); results for minor bleeding were consistent with this trend
(6.1 percent of tirofiban-treated patients versus 4.4%; p equals
0.233).
About Medicure Inc.
Medicure Inc is a biopharmaceutical company focused on the
research, development and commercialization of novel compounds to
treat cardiovascular disorders.
Cardiovascular medicine represents the largest pharmaceutical
sector, with annual global sales of over US $70 billion. Medicure
aims to make a global impact on cardiovascular disease and stroke
by reducing deaths, improving the quality of life and serving the
unmet needs of people who suffer from cardiovascular disease and
stroke.
This press release contains forward-looking statements, as
defined under applicable securities legislation, 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
except as required by law. Such forward-looking statements involve
known and unknown risks, uncertainties and other factors that may
cause the actual results, events or developments to be materially
different from any future results, events or developments expressed
or implied by such forward-looking statements. Such factors
include, among others, the Company's stage of development, lack of
product revenues, additional capital requirements, risks associated
with the completion of clinical trials and obtaining regulatory
approval to market the Company's products, the ability to protect
its intellectual property, dependence on collaborative partners and
the ability to meet its debt obligations. These factors should be
considered carefully and readers are cautioned not to place undue
reliance on such forward-looking statements. Additional risks and
uncertainties relating to the Company and its business can be found
in the "Risk Factors" section of its Form 20F for the year ended
May 31, 2007.
Contacts: Medicure Inc. Derek Reimer Chief Financial Officer
1-888-435-2220 (204) 488-9823 (FAX) Email: info@medicure.com
Website: www.medicure.com
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