SECURITIES AND EXCHANGE
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT
For the month of January 2021
Commission File Number: 001-31995
(Translation of registrant's name into English)
2-1250 Waverley Street
Winnipeg, MB Canada R3T 6C6
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file
annual reports under cover of Form 20-F or Form 40-F.
Form 20-F x Form 40-F
Indicate by check mark if the registrant is submitting the Form 6-K
in paper as permitted by Regulation S-T Rule 101(b)(1):
Indicate by check mark if the registrant is submitting the Form 6-K
in paper as permitted by Regulation S-T Rule 101(b)(7):
Indicate by check mark whether the registrant by furnishing the
information contained in this Form is also thereby furnishing the
information to the Commission pursuant to Rule 12g3-2(b) under the
Securities Exchange Act of 1934.
Yes o No x
If “Yes” is marked, indicate below the file number assigned to the
registrant in connection with Rule 12g3-2(b): 8a72____.
Pursuant to the requirements of the Securities Exchange Act of
1934, the registrant has duly caused this report to be signed on
its behalf by the undersigned, thereunto duly authorized.
|Date: January 27,
||/s/ Dr. Albert D.
||Dr. Albert D. Friesen
Medicure Announces Early Completion of Enrollment for iSPASM, a
Phase 1/2a Exploratory Clinical Trial of AGGRASTAT® (tirofiban
hydrochloride) Injection vs. Placebo for Induced Suppression of
Platelets Activity in Aneurysmal Subarachnoid Hemorrhage
WINNIPEG, MB, Jan. 27, 2021 /CNW/ - Medicure Inc. ("Medicure"
or the "Company") (TSXV: MPH) (OTC: MCUJF), a cardiovascular
pharmaceutical company, is pleased to announce the early completion
of iSPASM, a randomized, double-blind, single-center, Phase 1/2a
trial aimed at assessing the safety of long-term (7-day) use
of AGGRASTAT® (tirofiban hydrochloride) injection
(an intravenous GP IIb/IIIa inhibitor) vs. placebo in patients with
aneurysmal subarachnoid hemorrhage (aSAH) (NCT03691727). The
primary endpoint in the 30 patient study was hemorrhagic changes
evident on head CT and/or MRI assessed by the rates of symptomatic
and asymptomatic bleeding.
"Medicure is gratified and encouraged by the results of the trial
led Dr. David Hasan, MD, Professor of Neurosurgery at University of
Iowa Hospitals and Clinics, and the trial's principal investigator.
His work is an important step in the exploration of the use of
parenteral IV antiplatelet therapy in the management of aSAH in
stroke patients.", said Albert D. Friesen, PhD, CEO of Medicure and
Chair of its Board of Directors. Dr. Hasan expects to release
top-line data and present the results at an upcoming conference
with a manuscript to follow.
Dr. Hasan states, "The results of iSPASM are very promising. The
trial is the first of its kind as it showed in a well-designed,
randomized controlled trial that using continuous IV infusion of
AGGRASTAT® appears to be safe in patients with
ruptured intracranial aneurysms (stroke). Results from this study
pave the way for a Phase 2 trial which will be focused on efficacy.
A positive outcome will be groundbreaking in the management of
these patients. Interventionalists who treat patients with this
condition using stents or flow diverters could use
AGGRASTAT® as the choice of antiplatelet therapy to
prevent clotting and further ischemic stroke. We are very grateful
for the sponsorship and partnership with Medicure for making this
trial happen to benefit our patients."
iSPASM was funded by an unrestricted educational grant from
Medicure. This study does not imply efficacy of
AGGRASTAT® in patients with aSAH. Please note that
the use of AGGRASTAT® in neurointerventions has not
been approved by the FDA. As of this time, neither
AGGRASTAT® nor any of the GP IIb/IIIa inhibitors
are indicated for the use in stroke patients.
AGGRASTAT® is approved for use in NSTE-ACS
patients. Refer to Important Safety Information below and
the U.S. Prescribing Information for complete product
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.1 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
ZYPITAMAG® (pitavastatin) tablets in the United
States, where they are sold through the Company's U.S. subsidiary,
Medicure Pharma Inc. Medicure also operates Marley Drug, Inc.
("Marley"), a pharmacy located in North Carolina that offers an
Extended Supply mail order drug program serving all 50 states,
Washington D.C. and Puerto Rico. Marley is committed to improving
the health status of their patients and the communities they serve
while reducing overall health care costs for employers and other
health care consumers. For more information visit
http://www.marleydrug.com. To learn more about The Extended Supply
Generic Drug Program call 800.286.6781 or email
email@example.com. For more information on Medicure please
visit www.medicure.com. For additional information about
AGGRASTAT®, refer to the full Prescribing Information.
For additional information about ZYPITAMAG®, refer to
the full Prescribing Information.
Important Safety Information for AGGRASTAT®
Indications and Usage
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.
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.
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
Bleeding is the most commonly reported
For more information on AGGRASTAT®, please refer to Full
Prescribing Information available
To be added to Medicure's e-mail list, please
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
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, expected
results, including future revenue from P5P, the likelihood of
receiving a PRV, 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,
AGGRASTAT® (tirofiban hydrochloride) injection is a
registered trademark of Medicure International Inc.
Data on file
SOURCE Medicure Inc.
View original content:
For further information: James Kinley, Chief Financial
Officer, Tel. 888-435-2220, Fax 204-488-9823, E-mail:
CO: Medicure Inc.
CNW 17:30e 27-JAN-21
This regulatory filing also includes additional resources: