AND EXCHANGE COMMISSION
FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
SECURITIES EXCHANGE ACT OF 1934
For the month of October 2019
Commission File Number: 001-31995
(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.
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Form 40-F o
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Pursuant to the requirements of the Securities Exchange Act of 1934,
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|Date: October 3, 2019
||/s/ Dr. Albert D. Friesen |
||Dr. Albert D. Friesen|
||Title: President & CEO|
Medicure Announces Preferred Pricing Agreement
for Zypitamag™ with the AIDS Drug Assistance Program ("ADAP") Crisis Task Force
WINNIPEG, Oct. 3, 2019 /CNW/ - Medicure
Inc. ("Medicure" or the "Company") (TSXV:MPH, OTC:MCUJD.PK), a cardiovascular pharmaceutical
company, is pleased to announce that it has reached a preferred pricing agreement with the AIDS Drug Assistance Program (ADAP)
Crisis Task Force for ZYPITAMAGTM (pitavastatin) tablets. The agreement will open access to ZYPITAMAGTM tablets
to low income, underinsured and uninsured Americans who qualify for ADAP coverage in states where ZYPITAMAG has been adopted onto
the ADAP formulary.
The advent of antiretroviral therapy has led
to increased life expectancy in persons living with HIV.1 The rates of various age and therapy-related co-morbidities
that were previously not experienced by this population are now increasing.2 Of note, persons living with HIV are at
increased risk of developing heart and vascular diseases* and may benefit from treatment of primary hyperlipidemia or mixed dyslipidemia
ZYPITAMAG™ may be an advantageous choice
for statin therapy in persons living with HIV and dyslipidemia. Unlike some other statins, ZYPITAMAG™ has no contraindications
or dose limitations when prescribed in combination with HIV protease inhibitors.3 ZYPITAMAG™ differs from most
other statins in that it is only minimally metabolized by the CYP450 family of enzymes. As a result, ZYPITAMAG™ has less
likelihood for certain drug-drug interactions and may be particularly suited for patients taking multiple medications.2-4
For more information, please visit https://patient.zypitamag.com/patients-who-may-benefit. Please refer to Important Safety Information
below and the full Prescribing Information.
"I am very pleased with the agreement
we have reached with the ADAP Crisis Task Force. We launched ZYPITAMAG™, with the goal of increasing patient access to this
statin. For many living with HIV, ZYPITAMAG™ may be an appropriate statin of choice in managing their dyslipidemia, and we
look forward to the results of the ongoing REPRIEVE study, which is evaluating if the use of pitavastatin can reduce the risk of
cardiovascular disease* in adults living with HIV. Overall, this agreement allows our statin therapy greater access to a population
who may benefit from it." said Dr. Albert Friesen, Chief Executive Officer for Medicure.
The ADAP Crisis Task Force negotiates reduced
drug prices for all ADAP formularies. ADAP formularies provide HIV treatment to low income, uninsured, and underinsured individuals
living with HIV/AIDS in all 50 states and the US territories. The ADAP Crisis Task Force was formed in 2002, and is currently comprised
of representatives from Arizona, California, Florida, Illinois, Massachusetts, New York, North Carolina, Tennessee, Texas, Virginia,
and Washington state HIV/AIDS divisions.
* The effect of ZYPITAMAG™ on
cardiovascular morbidity and mortality has not been determined.
Important Safety Information for ZYPITAMAGTM
Indications and Usage
Drug therapy should be one component of multiple-risk-factor
intervention in individuals who require modifications of their lipid profile. Lipid-altering agents should be used in addition
to a diet restricted in saturated fat and cholesterol only when the response to diet and other nonpharmacological measures has
Primary Hyperlipidemia and Mixed Dyslipidemia: Zypitamag™
is indicated as an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C),
apolipoprotein B (Apo B), triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with
primary hyperlipidemia or mixed dyslipidemia.
Limitations of Use: Doses of Zypitamag™
greater than 4 mg once daily were associated with an increased risk for severe myopathy in premarketing clinical studies. Do not
exceed 4 mg once daily dosing of Zypitamag™. The effect of Zypitamag™ on cardiovascular morbidity and mortality has
not been determined. Zypitamag™ has not been studied in Fredrickson Type I, III, and V dyslipidemias.
Zypitamag™ is contraindicated in
patients with a known hypersensitivity to product components, in patients with active liver disease (which may include unexplained
persistent elevations in hepatic transaminase levels), in women who are pregnant or may become pregnant, in nursing mothers or
in coadministration with cyclosporine.
WARNINGS & PRECAUTIONS
Skeletal Muscle Effects: Cases of myopathy
and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with HMG-CoA reductase inhibitors, including
- These risks can occur
at any dose level, but increase in a dose-dependent manner, with advanced age (≥ 65 years), renal impairment, and inadequately
treated hypothyroidism; administer with caution in these patients, or when used concomitantly with fibrates or lipid-modifying
doses of niacin, or colchicine. Avoid concomitant administration with gemfibrozil.
- Advise patients to promptly
report unexplained and/or persistent muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever; discontinue Zypitamag™.
- If muscle signs and symptoms
persist after discontinuation, this may be a sign of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy associated
with statin use, requiring immediate medical attention. IMNM is characterized by proximal muscle weakness and elevated serum creatine
kinase, which persist despite discontinuation of statin treatment; muscle biopsy showing necrotizing myopathy without significant
inflammation; improvement with immunosuppressive agents.
- Zypitamag™ should
be discontinued if markedly elevated creatine kinase levels occur or myopathy is diagnosed or suspected.
- Zypitamag™ should
also be temporarily withheld in any patient with an acute, serious condition suggestive of myopathy or predisposing to the development
of renal failure secondary to rhabdomyolysis (e.g., sepsis, hypotension, dehydration, major surgery, trauma, severe metabolic,
endocrine, and electrolyte disorders, or uncontrolled seizures).
- Persistent elevation in
hepatic transaminases can occur. Check liver enzymes before initiating therapy and if signs or symptoms of liver injury occur;
advise patients to report fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice.
- Fatal and non-fatal hepatic
failure can occur. Interrupt Zypitamag™ if serious liver injury with clinical symptoms and/or hyperbilirubinemia
or jaundice occurs. If an alternate etiology is not found do not restart Zypitamag™.
- Use Zypitamag™ with
caution in patients who consume substantial quantities of alcohol and/or have a history of chronic liver disease. Do not use Zypitamag™ if
patient has active liver disease, which may include unexplained persistent transaminase elevations.
- Increases in HbA1c and
fasting serum glucose levels have been reported.
COMMON ADVERSE REACTIONS
Myalgia, back pain, diarrhea, constipation
and pain in extremity (rate ≥ 2% in at least one marketed dose). This is not a complete list of all reported adverse events.
For additional information,
refer to full Prescribing Information.
You are encouraged to
report negative side effects of prescription drugs to the FDA.
or call 1-800-FDA-1088
||Smit M et al. Lancet Infect Dis. 2015;15(7):810-818|
||Feinstein MJ et al. Circulation. 2019;Jun 3:CIR0000000000000695|
||FDA Drug Safety Communication: Interactions between certain HIV or hepatitis C drugs and cholesterol-lowering statin drugs can increase the risk of muscle injury. https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-interactions-between-certain-hiv-or-hepatitis-c-drugs-and-cholesterol. Accessed May 9, 2019|
||Jacobson TA et al. J Clin Lipid. 2016;10(1):211-227|
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.
To be added to Medicure's e-mail list, please
Neither the TSX Venture Exchange nor its Regulation
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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.
SOURCE Medicure Inc.
View original content: http://www.newswire.ca/en/releases/archive/October2019/03/c6669.html
For further information: James Kinley, Chief Financial Officer,
Tel. 888-435-2220, Fax 204-488-9823, E-mail: email@example.com, www.medicure.com
CO: Medicure Inc.
CNW 18:00e 03-OCT-19
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