MEDICURE
REITERATES ITS COMMITMENT TO PROVIDING EXCEPTIONAL ACCESS TO ITS
BRANDED PITAVASTATIN (ZYPITAMAG) TO PEOPLE LIVING WITH
HIV
WINNIPEG, CANADA – August 30, 2023
-- InvestorsHub NewsWire -- Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH, OTC:MCUJF), a company focused on the development
and commercialization of pharmaceuticals and healthcare products
for patients and prescribers in the United States market, reaffirms
its commitment to providing affordable and straightforward access
to its branded pitavastatin, ZYPITAMAG®, to people living with HIV
through two important channels: its pharmacy subsidiary Marley
Drug® and through the AIDS Drug Assistance Program (ADAP) Crisis
Task Force formulary. Access to branded medications can be
challenging, however Medicure recognizes that access to
pitavastatin is more important than ever in light of the recently
published REPREIVE study (Randomized Trial to Prevent Vascular
Events in HIV)1,
which reported the benefits of pitavastatin for people living with
HIV who are at increased risk of developing heart and vascular
diseases. The effect of ZYPITAMAG on cardiovascular morbidity and
mortality has not been determined.
The progressive advancements in
antiretroviral therapy have significantly enhanced the life
expectancy in individuals with HIV, leading to a surge in age- and
therapy-related co-morbidities2,3.
It is now recognized that people living with HIV have an escalated
risk of heart and vascular diseases, and the treatment of primary
hyperlipidemia or mixed dyslipidemia with pitavastatin may be
beneficial3.
Unlike most statins, pitavastatin
(ZYPITAMAG) is minimally metabolized by the CYP450 family of
enzymes, reducing the likelihood of certain drug-drug
interactions4.
This makes pitavastatin particularly suitable for patients taking
multiple medications, such as those living with
HIV2-5.
"I am pleased to emphasize
Medicure's steadfast commitment to making ZYPITAMAG both accessible
and affordable for those who may benefit from it, especially
persons living with HIV. Our collaboration with the ADAP Crisis
Task Force over the past years further reflects our dedication to
affordability and accessibility, ensuring that this vital
medication is within reach of those who need it. Also through our
subsidiary Marley Drug, we can offer ZYPITAMAG at an affordable
cash price to all Americans, without the need for insurance, prior
authorizations or step through therapy," said Dr. Albert Friesen,
Chief Executive Officer for Medicure.
The ADAP Crisis Task Force
continues to negotiate drug prices for all ADAP formularies,
providing essential HIV treatment to low-income, uninsured, and
underinsured individuals across the U.S. Medicure's engagement with
the Task Force amplifies its mission to offer effective and
reasonably priced statin therapy to those who may benefit
significantly.
Please refer to
Important Safety Information below and the full
Prescribing Information for ZYPITAMAG (pitavastatin)
tablets.
Important
Safety Information for ZYPITAMAG® (pitavastatin)
tablets
Indications
& Usage
ZYPITAMAG is indicated as an
adjunctive therapy to diet in adult patients with primary
hyperlipidemia or mixed dyslipidemia 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). Limitations of Use:
The effect of ZYPITAMAG on
cardiovascular morbidity and mortality has not been
determined.
Contraindications:
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
co-administration with cyclosporine.
Warnings &
Precautions
-
Myopathy and
Rhabdomyolysis: Risk
factors include age 65 and greater, renal impairment, inadequately
treated hypothyroidism, concomitant use of certain drugs, and
higher doses of ZYPITAMAG. ZYPITAMAG is contraindicated in patients
taking cyclosporine and not recommended in patients taking
gemfibrozil. The following drugs when used concomitantly with
ZYPITAMAG may also increase the risk of myopathy and
rhabdomyolysis: lipid-modifying dosages of niacin (>1 g/day),
fibrates, and colchicine. Discontinue ZYPITAMAG if markedly
elevated CK levels occur or myopathy is diagnosed or suspected.
Temporarily discontinue ZYPITAMAG in patients experiencing an acute
or serious condition at high risk of developing renal failure
secondary to rhabdomyolysis; e.g., sepsis; shock; severe
hypovolemia; major surgery; trauma; severe metabolic, endocrine, or
electrolyte disorders; or uncontrolled epilepsy. Inform patients of
the risk of myopathy and rhabdomyolysis when starting or increasing
the ZYPITAMAG dosage. Instruct patients to promptly report any
unexplained muscle pain, tenderness or weakness particularly if
accompanied by malaise or fever.
-
Immune-Mediated
Necrotizing Myopathy (IMNM): There have been rare reports of IMNM, an
autoimmune myopathy, associated with statin use. IMNM is
characterized by: proximal muscle weakness and elevated serum
creatine kinase, which persist despite discontinuation of statin
treatment; positive anti-HMG CoA reductase antibody;
muscle biopsy showing necrotizing
myopathy; and improvement with immunosuppressive
agents.
-
Hepatic
Dysfunction: Increases in
serum transaminases can occur. Rare postmarketing reports of fatal
and non-fatal hepatic failure have occurred. Consider liver enzyme
testing before initiating therapy and as clinically indicated
thereafter. If serious hepatic injury with clinical symptoms and/or
hyperbilirubinemia or jaundice occurs, promptly discontinue
ZYPITAMAG.
-
Increases in
HbA1c and Fasting Serum Glucose Levels: Increases of each have been reported with
statins, including ZYPITAMAG. Optimize lifestyle measures,
including regular exercise, maintaining a healthy body weight, and
making healthy food choices.
Adverse
Reactions: The most
frequent adverse reactions (rate = 2%) are myalgia, back pain,
diarrhea, constipation and pain in extremity. 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. Visit
www.FDA.gov/medwatch
or call
1-800-FDA-1088.
References
1
Grinspoon SK et al.
N Engl J
Med.
2023;389:687-699
2
Smit M et al. Lancet Infect
Dis.
2015;15(7):810-818
3
Feinstein MJ et al.
Circulation. 2019;Jun
3:CIR0000000000000695
4
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
5 Jacobson TA et
al. J
Clin Lipid.
2016;10(1):211-227
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 Drug"), a pharmacy located in
North Carolina that offers an Extended Supply drug program serving
all 50 states, Washington D.C. and Puerto Rico. Marley
Drug®
is committed to
improving the health status of its 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
info@marleydrug.com. For more information on
Medicure please visit
www.medicure.com. For additional information
about AGGRASTAT®,
please visit
www.aggrastathdb.com or refer to the full
Prescribing Information. For additional information
about ZYPITAMAG®,
please visit
www.zypitamag.com or refer to the full
Prescribing Information.
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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 priority review voucher from the United State Food and
Drug Administration, 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 current Form 20F.
AGGRASTAT®
(tirofiban hydrochloride)
injection, ZYPITAMAG®
(pitavastatin) tablets, and Marley
Drug®
are registered
trademarks.
For more
information, please contact:
Dr. Albert D. Friesen
Chief Executive Officer
Tel. 888-435-2220
Fax 204-488-9823
E-mail:
info@medicure.com
www.medicure.com