WINNIPEG, MB, Aug. 24, 2020 /CNW/ - Medicure Inc.
("Medicure" or the "Company") (TSXV:MPH, OTC:MCUJF),
a pharmaceutical company, is reporting that early investigator
sponsored clinical reports evaluating the efficacy of
AGGRASTAT® (tirofiban hydrochloride) show promise
for preventing and treating thrombotic complications due to
COVID-19. AGGRASTAT® is not currently indicated for
use in patients with COVID-19.
Notably, a non-randomized, case-controlled, investigator
sponsored proof of concept study (n=10) evaluating
AGGRASTAT® in combination with standard of care in
patients with severe COVID-19 and hypercoagulability found that
enhanced platelet inhibition improves hypoxemia
(https://clinicaltrials.gov/ct2/show/NCT04368377). Treated patients
experienced a mean reduction in alveolar-arterial oxygen gradient
and an increase in PaO2/FiO2 (ratio of
partial arterial pressure of oxygen to fraction of inspired oxygen)
at 24h, 48h and 7 days after treatment. Seven other small clinical
reports have recently been published exploring the clinical
efficacy of AGGRASTAT® in patients with
COVID-19.
Medicure is evaluating sponsorship of further US-based
randomized clinical studies to rapidly assess the efficacy and
safety of using AGGRASTAT® for preventing
thrombotic complications due to COVID-19.
"These initial results are sufficiently positive to warrant
further investigation to more clearly understand the potential role
of AGGRASTAT® to reduce thrombotic effects which
are observed in many COVID-19 patients", commented Medicure's CEO,
Dr. Albert D. Friesen. "We believe
there is reason to sponsor this type of clinical research due to
the emerging understanding of the role of thrombosis in the
pathophysiology of COVID-19."
The Company is not making any express or implied claims that its
product has the ability to eliminate, cure or contain COVID-19 (or
SARS-2 Coronavirus) at this time. A list of the reports referred to
can be provided upon request.
About
AGGRASTAT®
AGGRASTAT® is
not indicated for use in patients with COVID-19, nor has the safety
or efficacy been established in this patient population.
AGGRASTAT® is an IV antiplatelet medication
indicated to reduce the rate of thrombotic cardiovascular events
(combined endpoint of death, myocardial infarction, or refractory
ischemia/repeat cardiac procedure) in patients with non-ST
elevation acute coronary syndrome (NSTE-ACS).
AGGRASTAT® is currently the most widely used GP
IIb/IIIa inhibitor in the U.S. and has several administration
benefits including room temperature storage, a 3-year shelf life
and is available in pre-mixed formats. Please refer to the
IMPORTANT SAFETY INFORMATION below.
About Medicure Inc.
Medicure is a pharmaceutical
company focused on the development and commercialization of
therapies for the U.S. cardiovascular market. The present focus of
the Company is the marketing and distribution of
AGGRASTAT® (tirofiban hydrochloride) injection and
ZYPITAMAGTM (pitavastatin) tablets in the United States, where they are sold through
the Company's U.S. subsidiary, Medicure Pharma Inc. For more
information on Medicure please visit www.medicure.com. For
additional information about ZYPITAMAGTM, refer to the
full Prescribing Information.
Important Safety Information for AGGRASTAT® (tirofiban
hydrochloride)
Indications and Usage
AGGRASTAT® is
indicated to reduce the rate of thrombotic cardiovascular events
(combined endpoint of death, myocardial infarction, or refractory
ischemia/repeat cardiac procedure) in patients with non-ST
elevation acute coronary syndrome (NSTE-ACS).
Dosage and Administration
Administer intravenously 25
mcg/kg within 5 minutes and then 0.15 mcg/kg/min for up to 18
hours. In patients with creatinine clearance ≤60 mL/min, give 25
mcg/kg within 5 minutes and then 0.075 mcg/kg/min.
Contraindications
Known hypersensitivity to any
component of AGGRASTAT®, history of thrombocytopenia
with prior exposure to AGGRASTAT®, active internal
bleeding, or history of bleeding diathesis, major surgical
procedure or severe physical trauma within previous month.
Warnings and Precautions
AGGRASTAT® can cause serious bleeding. Most
bleeding associated with AGGRASTAT® occurs at the
arterial access site for cardiac catheterization. Minimize the use
of traumatic or potentially traumatic procedures such as arterial
and venous punctures, intramuscular injections, nasotracheal
intubation, etc. Concomitant use of fibrinolytics, anticoagulants
and antiplatelet drugs increases the risk of bleeding. If bleeding
cannot be controlled, discontinue AGGRASTAT®.
Thrombocytopenia: Discontinue AGGRASTAT® and
heparin.
Adverse Reactions
Bleeding is the most commonly
reported adverse reaction.
For more information on AGGRASTAT®, please refer to
Full Prescribing Information available
at www.aggrastatHDB.com.
To be added to Medicure's e-mail list, please
visit:
http://medicure.mediaroom.com/alerts
Neither the TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in policies of the TSX Venture
Exchange) accepts responsibility for the adequacy or accuracy of
this release.
Forward Looking Information: Statements contained in this
press release that are not statements of historical fact,
including, without limitation, statements containing the words
"believes", "may", "plans", "will", "estimates", "continues",
"anticipates", "intends", "expects" and similar expressions, may
constitute "forward-looking information" within the meaning of
applicable Canadian and U.S. federal securities laws (such
forward-looking information and forward-looking statements are
hereinafter collectively referred to as "forward-looking
statements"). Forward-looking statements, include estimates,
analysis and opinions of management of the Company made in light of
its experience and its perception of trends, current conditions and
expected developments, as well as other factors which the Company
believes to be relevant and reasonable in the circumstances.
Inherent in forward-looking statements are known and unknown risks,
uncertainties and other factors beyond the Company's ability to
predict or control 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, and as such, readers are cautioned not to place undue
reliance on forward-looking statements. Such risk factors include,
among others, the Company's future product revenues, the ability of
AGGRASTAT® to provide
benefits to COVID-19 patients, expected future growth
in revenues, stage of development, additional capital requirements,
risks associated with the completion and timing of clinical trials
and obtaining regulatory approval to market the Company's products,
the ability to protect its intellectual property, dependence upon
collaborative partners, changes in government regulation or
regulatory approval processes, and rapid technological change in
the industry. Such statements are based on a number of assumptions
which may prove to be incorrect, including, but not limited to,
assumptions about: general business and economic conditions; the
impact of changes in Canadian-US dollar and other foreign exchange
rates on the Company's revenues, costs and results; the timing of
the receipt of regulatory and governmental approvals for the
Company's research and development projects; the availability of
financing for the Company's commercial operations and/or research
and development projects, or the availability of financing on
reasonable terms; results of current and future clinical trials;
the uncertainties associated with the acceptance and demand for new
products and market competition. The foregoing list of important
factors and assumptions is not exhaustive. The Company undertakes
no obligation to update publicly or otherwise revise any
forward-looking statements or the foregoing list of factors, other
than as may be required by applicable legislation. Additional
discussion regarding the risks and uncertainties relating to the
Company and its business can be found in the Company's other
filings with the applicable Canadian securities regulatory
authorities or the US Securities and Exchange Commission, and in
the "Risk Factors" section of its Form 20F for the year ended
December 31, 2019.
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SOURCE Medicure Inc.