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 June 2020
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: June 29, 2020 |
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 Positive Results for
AGGRASTAT® in the FABOLUS-FASTER Trial and Publication in the Journal - Circulation
WINNIPEG, MB, June 29, 2020 /CNW/ - Medicure
Inc. ("Medicure" or the "Company") (TSXV: MPH) (OTC: MCUJF), a pharmaceutical company, today
announced that results from the investigator sponsored FABOLUS-FASTER Phase 4 clinical trial, using AGGRASTAT®, have
been published in Circulation, a peer-reviewed journal of the American Heart Association.
FABOLUS-FASTER studied different regimens of
intravenous platelet inhibitors, notably AGGRASTAT® (tirofiban hydrochloride) injection (an IV GP IIb/IIIa
inhibitor) and cangrelor (an IV P2Y12 inhibitor) in the early phase of primary PCI.
"The results published in Circulation
are the first to compare the pharmacodynamic effects of cangrelor, with AGGRASTAT®, as well as the pharmacodynamic
and pharmacokinetic effects of a chewed or integral pill of prasugrel," said Dr. Albert D. Friesen, CEO of Medicure. "We
are pleased with the performance of AGGRASTAT® in the FABOLUS-FASTER trial against cangrelor and look forward
to its continued growth as part of our portfolio of cardiovascular products."
The FABOLUS-FASTER study randomized 122 P2Y12-naive
STEMI patients to receive tirofiban (n=40), cangrelor (n=40), or a 60 mg loading dose of prasugrel (n=42). Those randomized to
prasugrel were sub-randomized to chewed (n=21) or integral (n=21) tablet administration. The study was powered to test the noninferiority
of cangrelor compared with tirofiban, the superiority of both tirofiban and cangrelor compared with chewed prasugrel, and superiority
of chewed prasugrel compared with integral prasugrel for the primary endpoint of 30-minute inhibition of platelet aggregation (IPA)
after stimulation with (20 µmol/L) ADP.
The results from the FABOLUS-FASTER trial showed
cangrelor did not reach non-inferiority with tirofiban; in fact, tirofiban achieved superior IPA over cangrelor at 30 minutes (95.0%±9.0%
vs 34.1%±22.5%; P <0.001). Cangrelor and tirofiban were both superior to chewed prasugrel (10.5%±11.0%, P<0.001
for both comparisons), which did not provide higher IPA over integral prasugrel (6.3%±11.4%; P=0.47).1
Results from FABOLUS-FASTER were recently presented
virtually at the PCR e-Course Scientific Sessions, due to the cancellation of EuroPCR 2020. Complete results from this study were
published on June 27, 2020 in Circulation, a peer-reviewed journal of the American Heart Association.
Additional Details About the Study
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™ PRO 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.
You are encouraged to report negative side
effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
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 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® is a registered
trademark of Medicure International Inc.
References
| 1. | Gargiulo G, Esposito G, Avvedimento M, et al. Cangrelor,
Tirofiban and Chewed or Standard Prasugrel Regimens in Patients with ST-Segment Elevation Myocardial Infarction: Primary Results
of the FABOLUS FASTER Trial. Circulation. 2020. doi:10.1161/circulationaha.120.046928 |
View original content:http://www.prnewswire.com/news-releases/medicure-announces-positive-results-for-aggrastat-in-the-fabolus-faster-trial-and-publication-in-the-journal---circulation-301085021.html
SOURCE Medicure Inc.
View original content: http://www.newswire.ca/en/releases/archive/June2020/29/c2253.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 09:06e 29-JUN-20
This regulatory filing also includes additional resources:
ex991.pdf
Medicure (PK) (USOTC:MCUJF)
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