UNITED STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM 6-K
REPORT OF
FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE
SECURITIES EXCHANGE ACT OF 1934
For the month of January
2021
Commission File Number: 001-31995
MEDICURE
INC.
(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 o
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): o
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): o
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____.
EXHIBIT
LIST
SIGNATURES
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.
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Medicure Inc. |
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(Registrant) |
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| Date: January 27, 2021 |
By: |
/s/ Dr. Albert D. Friesen |
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Dr. Albert D. Friesen |
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Title: CEO |
Exhibit 99.1
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 Management
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 information.
About AGGRASTAT®
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.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 marleydrug@bellsouth.net. 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®
(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, 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, 2019.
AGGRASTAT® (tirofiban hydrochloride)
injection is a registered trademark of Medicure International Inc.
| References: |
| 1. Data on file |
View original content:http://www.prnewswire.com/news-releases/medicure-announces-early-completion-of-enrollment-for-ispasm-a-phase-12a-exploratory-clinical-trial-of-aggrastat-tirofiban-hydrochloride-injection-vs-placebo-for-induced-suppression-of-platelets-activity-in-aneurysmal-subara-301216718.html
SOURCE Medicure Inc.
View original content: http://www.newswire.ca/en/releases/archive/January2021/27/c4778.html
%CIK: 0001133519
For further information: James Kinley, Chief Financial Officer,
Tel. 888-435-2220, Fax 204-488-9823, E-mail: info@medicure.com, www.medicure.com
CO: Medicure Inc.
CNW 17:30e 27-JAN-21
This regulatory filing also includes additional resources:
ex991.pdf
Medicure (PK) (USOTC:MCUJF)
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