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 March 2017
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
Exhibit |
Title |
|
|
99.1 |
News Release Dated March 23, 2017 - Medicure Announces FDA Approval for Apicore's Generic Tetrabenazine |
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.
|
Medicure Inc. |
|
(Registrant) |
|
|
|
|
|
Date: March 23, 2017 |
By: |
/s/ Dr. Albert D. Friesen |
|
Dr. Albert D. Friesen |
|
Title: President & CEO |
Exhibit 99.1
Medicure Announces FDA Approval for Apicore's Generic
Tetrabenazine
WINNIPEG, March 23, 2017 /CNW/ - Medicure Inc. ("Medicure"
or the "Company") (TSXV:MPH, OTC:MCUJF), a leading Canadian specialty pharmaceutical company, is pleased to announce
that its majority-owned subsidiary, Apicore Inc., has received final approval from the U.S. Food and Drug Administration (FDA)
for the Company's abbreviated new drug application ("ANDA") for tetrabenazine tablets in the 12.5 mg and 25 mg strengths.
The newly approved product is a generic equivalent of the branded product Xenazine® sold in the United States by
Valeant Pharmaceuticals. Xenazine is indicated to treat the involuntary movements (chorea) of Huntington's disease.
Development of tetrabenazine was done in partnership with TAGI Pharma Inc., which recently launched the product commercially.
Medicure currently owns approximately 61% of Apicore on a
fully diluted basis, and continues to have option rights until July 3, 2017 to acquire additional shares in Apicore.
About Apicore
Apicore is a private, New Jersey based developer and manufacturer
of specialty Active Pharmaceutical Ingredients ("APIs") and pharmaceuticals, including over 15 Abbreviated New Drug Applications
("ANDAs"), one of which, is partnered with Medicure. Apicore manufactures over 100 different API's, including over
35 for which Drug Master Files have been submitted to the FDA and 16 that are approved for commercial sale in the U.S. by customers
of Apicore. Apicore specializes in the manufacture of difficult to synthesize, high value and other niche API's for many
U.S. and international generic and branded pharmaceutical companies. Apicore has two FDA-approved facilities. In the U.S.,
the Somerset, New Jersey facility can produce a few grams up to 200 kg volumes and in India, the Vadodara, Gujarat facility can
produce a few kilograms up to 60 metric tons yearly. Both facilities are equipped with state-of-the-art analytical and research
capabilities. For more information, please visit Apicore online at www.apicore.com.
About Medicure
Medicure is a specialty pharmaceutical company focused on
the development and commercialization of therapeutics for the U.S. hospital market. The primary focus of the Company and its subsidiaries
is the marketing and distribution of AGGRASTAT (tirofiban hydrochloride) in the United States, where it is sold through the Company's
U.S. subsidiary, Medicure Pharma, Inc. For more information on Medicure please visit www.medicure.com.
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, including the potential for Apicore's revenue
and value to increase, and Medicure to secure and advance new products are based on the current assumptions, 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, 2015.
AGGRASTAT® (tirofiban hydrochloride) is
a registered trademark of Medicure International, Inc
SOURCE Medicure Inc.
To view the original version on PR Newswire, visit: http://www.newswire.ca/en/releases/archive/March2017/23/c5920.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 07:30e 23-MAR-17
This regulatory filing also includes additional resources:
ex991.pdf
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