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 December 2019
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: December 12, 2019 |
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 Completion of Enrollment
for FABOLUS-FASTER, Phase 4 Clinical Trial of Aggrastat (Tirofiban Hydrochloride) Injection VS Kengreal (Cangrelor) in Patients
Undergoing Percutaneous Coronary Intervention (PCI)
WINNIPEG, Dec. 12, 2019 /CNW/ - Medicure
Inc. ("Medicure" or the "Company") (TSXV: MPH), (OTC: MCUJF), a cardiovascular pharmaceutical company, is pleased
to announce the completion of the FABOLUS-FASTER Phase 4 trial, a randomized, open-label, multi-center trial assessing different
regimens of intravenous platelet inhibitors, notably tirofiban (an IV GP IIb/IIIa inhibitor) and cangrelor (an IV P2Y12 inhibitor)
in the early phase of primary PCI. The study enrolled 120 patients. Medicure expects to release top-line data in Q1 of 2020.
"We are very pleased with the completion
of enrollment of FABOLUS-FASTER. Medicure is proud to support innovative and contemporary clinical research involving Aggrastat,
in particular sponsoring leading cardiologists such as Dr. Marco Valgimigli", said Albert Friesen, PhD, CEO of Medicure.
Marco Valgimigli, MD, PhD, Professor of Cardiology,
Director of Clinical Research at Bern University Hospital, and principle investigator for the trial, stated, "We are extremely
proud to have reached the completion of patient inclusion in this trial which, we believe, will be very informative for clinicians
as it will provide unique comparative data regarding the potency and consistency of platelet inhibition among STEMI patients across
available antiplatelet treatment options."
FABOLUS-FASTER was funded by a grant from
Medicure. This study does not imply comparable efficacy, safety, or product interchangeability. Please note that the use of Aggrastat
in STEMI patients 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 STEMI 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.2 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, ZYPITAMAGTM (pitavastatin) tablets and the ReDS™ device 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.
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, 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, 2018.
AGGRASTAT® (tirofiban hydrochloride)
is a registered trademark of Medicure International Inc.
Kengreal® is a registered trademark of Chiesi Farmaceutici S.p.A
References
1 https://clinicaltrials.gov/ct2/show/NCT02978040
2 Data on file
View
original content:http://www.prnewswire.com/news-releases/medicure-announces-completion-of-enrollment-for-fabolus-faster-phase-4-clinical-trial-of-aggrastat-tirofiban-hydrochloride-injection-vs-kengreal-cangrelor-in-patients-undergoing-percutaneous-coronary-intervention-pci-300974390.html
SOURCE Medicure Inc.
View original content: http://www.newswire.ca/en/releases/archive/December2019/12/c3179.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 18:00e 12-DEC-19
This regulatory filing also includes additional resources:
ex991.pdf
Medicure (PK) (USOTC:MCUJF)
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