WINNIPEG, MB, Jan. 7, 2021 /CNW/ - Medicure Inc.
("Medicure" or the "Company") (TSXV: MPH) (OTC:
MCUJF), a cardiovascular pharmaceutical company, today announced
that through its Barbados
subsidiary, Medicure International Inc., it intends to file an
Investigational New Drug ("IND") application with the U.S. Food and
Drug Administration ("FDA") pertaining to its legacy product
Pyridoxal 5′-phosphate ("P5P", also referred to as "MC-1") for the
treatment of seizures associated with pyridox(am)ine 5'-phosphate
oxidase ("PNPO") deficiency. The majority of patients with
PNPO deficiency have mutations in the PNPO gene, which is required
for the production of normal levels of P5P. In connection with the
IND, the Company will proceed with a Phase 3 clinical trial to
treat PNPO deficient patients with a daily dose of MC-1.
The FDA and the European Medicines Agency ("EMA") have both
granted a Rare Pediatric Disease Designation to MC-1 for the
treatment of seizures associated with PNPO deficiency.
Additionally, the FDA has granted Orphan Drug Status and a Rare
Pediatric Disease Designation to MC-1 for the treatment of PNPO
deficiency.
Under the Creating Hope Act passed into federal law in 2012, the
FDA grants a Rare Pediatric Disease Designation for serious and
life-threatening diseases that primarily affect children ages 18
years or younger and fewer than 200,000 people in the United
States. If a new drug application ("NDA") for MC-1 for
patients with PNPO deficiency is approved, the Company may be
eligible to receive a priority review voucher ("PRV") from the FDA,
which can be redeemed to obtain priority review for any subsequent
marketing application.
"MC-1 has the potential to become the first FDA-approved therapy
for patients with PNPO deficiency. Receiving Orphan Drug
Status and a Rare Pediatric Disease Designation from the FDA is a
significant milestone for this program and underscores the critical
value of our work," said Dr. Albert D.
Friesen, CEO of Medicure and Chair of its Board of
Directors. "With this designation, we will work diligently towards
FDA approval and the issuance of a PRV in order to expedite
realization of the value of MC-1. We are grateful to the FDA
and Congress for having enacted this law which helps
Medicure and all companies develop innovative drugs for rare
pediatric conditions."
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
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.
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.
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SOURCE Medicure Inc.
