- CCS dyslipidemia management guidelines published in the
Canadian Journal of Cardiology (CJC) on March 26, 2021
- Strong recommendation for the use of icosapent ethyl for
Primary Prevention (diabetes and ≥1 cardiovascular disease (CVD)
risk factors) and Secondary Prevention (atherosclerotic
cardiovascular disease (ASCVD))
- Guidelines do not recommend the use of over-the-counter
omega-3 polyunsaturated fatty acids supplements to reduce CVD
risk
TORONTO, March 29, 2021 /CNW/ - HLS Therapeutics Inc.
("HLS" or the "Company") (TSX: HLS), a specialty pharmaceutical
company focusing on central nervous system and cardiovascular
markets, announces that the Canadian Cardiovascular Society ("CCS")
has included icosapent ethyl (Vascepa) in its 2021 Canadian
Cardiovascular Society Guidelines for the Management of
Dyslipidemia for the Prevention of Cardiovascular Disease in the
Adult, published in the Canadian Journal of Cardiology. The
guideline authors recommend the use of icosapent ethyl to lower the
risk of cardiovascular ("CV") events in patients with ASCVD, or
with diabetes and ≥1 CVD risk factors, who have an elevated fasting
triglyceride level between 1.5-5.6 mmol/L despite treatment with
maximally tolerated statin therapy. The Guidelines
specifically do not recommend the use of over-the-counter omega-3
polyunsaturated fatty acids supplements (marketed as natural health
products in Canada) and specified
the lack of CV benefit of omega-3 fatty acids from dietary sources
or other formulations/supplements.
"By including Vascepa in the guidelines, the CCS is indicating
its focus on improving patient care by reducing the risk of
atherosclerotic cardiovascular disease," said Gilbert Godin, CEO of HLS. "To have this highly
credible medical society recognize the benefit of Vascepa as a new
treatment option for Canadians on statins with elevated
triglycerides who are at risk of cardiovascular events such as
Heart Attack, Stroke, Revascularization or Death is a tremendous
development for those eligible patients."
In Canada, up to two million
people have triglycerides ≥ 1.5 mmol/L and established
cardiovascular disease, or diabetes with risk factors despite
statin treatment.1,2,3
"These updated guidelines from the Canadian Cardiovascular
Society reaffirm the importance of the REDUCE-IT trial findings to
Canadian patients, not only in enhancing care, but also in
broadening awareness of the need for an icosapent ethyl treatment
among patients who may have their cholesterol controlled with a
statin, but still face a residual risk of major cardiac events,"
said Dr Jean-Claude Tardif, Director
of the Research Center at the Montreal Heart Institute and
professor of medicine at University of
Montreal. "Based on what we have learned on icosapent ethyl,
I foresee the beginning of a change in clinical practice in how
best to treat patients with multifactorial risks of cardiovascular
events beyond cholesterol management."
Added Mr. Godin: "With this new recommendation, Vascepa is now
included in the treatment guidelines or otherwise recommended for
use by 14 major medical associations internationally, solidifying
its role as an important treatment option beyond cholesterol
management for millions of patients worldwide at risk for a
cardiovascular event."
The icosapent ethyl recommendation was classified as 'Strong
Recommendation; High-Quality Evidence' and supported by
the results of the REDUCE-IT cardiovascular outcomes study. The
Guidelines state: "As icosapent ethyl is a purified form of ethyl
EPA, the results of REDUCE-IT cannot be extrapolated to other
non-prescription omega-3 fatty acids, which typically contain a
mixture of EPA and docosahexaenoic acid ("DHA")".
The CCS does not provide endorsements or any form of
certification for brand name commercial products. Accordingly, the
inclusion of icosapent ethyl in the CCS Guidelines should not be
understood as an endorsement by CCS of Vascepa.
The complete 2021 Canadian Cardiovascular Society Guidelines
for the Management of Dyslipidemia for the Prevention of
Cardiovascular Disease in the Adult addressing Primary and
Secondary Prevention of Cardiovascular Diseases with icosapent
ethyl published in the Canadian Journal of Cardiology can be
accessed online here
https://www.onlinecjc.ca/article/S0828-282X(21)00165-3/fulltext (payment/subscription
may be needed).
ABOUT VASCEPA (ICOSAPENT ETHYL) CAPSULES
VASCEPA
(icosapent ethyl) capsules are the first-and-only prescription
treatment comprised solely of the active ingredient, icosapent
ethyl (IPE), a unique form of eicosapentaenoic acid.
VASCEPA was approved by Health Canada, was added to Health
Canada's Register of Innovative Drugs and benefits from data
protection for a term of eight years, as well as being the subject
of multiple issued and pending patents based on its unique
clinical profile. HLS in-licensed the exclusive rights to VASCEPA
for the Canadian market from Amarin Corporation (NASDAQ:AMRN).
ABOUT HLS THERAPEUTICS INC.
Formed in 2015, HLS is a
specialty pharmaceutical company focused on the acquisition and
commercialization of late-stage development, commercial stage
promoted and established branded pharmaceutical products in the
North American markets. HLS's focus is on products targeting the
central nervous system and cardiovascular therapeutic areas. HLS's
management team is composed of seasoned pharmaceutical executives
with a strong track record of success in these therapeutic areas
and at managing products in each of these lifecycle stages. For
more information, please visit: www.hlstherapeutics.com
REFERENCES
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1https://www150.statcan.gc.ca/n1/pub/82-003-x/2016001/article/14305/tbl/tbl02-eng.htm
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2https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2989357/
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3https://www150.statcan.gc.ca/n1/pub/82-625-x/2018001/article/54982-eng.htm
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FORWARD LOOKING INFORMATION
This release includes
forward-looking statements regarding HLS and its business. Such
statements are based on the current expectations and views of
future events of HLS's management. In some cases the
forward-looking statements can be identified by words or phrases
such as "may", "will", "expect", "plan", "anticipate", "intend",
"potential", "estimate", "believe" or the negative of these terms,
or other similar expressions intended to identify forward-looking
statements, including, among others, statements with respect to
HLS's pursuit of additional product and pipeline opportunities in
certain therapeutic markets, statements regarding growth
opportunities and expectations regarding financial performance. The
forward-looking events and circumstances discussed in this release
may not occur and could differ materially as a result of known and
unknown risk factors and uncertainties affecting HLS, including
risks relating to the specialty pharmaceutical industry, risks
related to the regulatory approval process, economic factors and
many other factors beyond the control of HLS. Forward-looking
statements and information by their nature are based on assumptions
and involve known and unknown risks, uncertainties and other
factors which may cause HLS's actual results, performance or
achievements, or industry results, to be materially different from
any future results, performance or achievements expressed or
implied by such forward-looking statement or information.
Accordingly, readers should not place undue reliance on any
forward-looking statements or information. A discussion of the
material risks and assumptions associated with this release can be
found in the Company's Annual Information Form dated March 17, 2021 and Management's Discussion and
Analysis dated March 17, 2021, both
of which have been filed on SEDAR and can be accessed at
www.sedar.com. Accordingly, readers should not place undue reliance
on any forward-looking statements or information. Except as
required by applicable securities laws, forward-looking statements
speak only as of the date on which they are made and HLS undertakes
no obligation to publicly update or revise any forward-looking
statement, whether as a result of new information, future events,
or otherwise.
SOURCE HLS Therapeutics Inc.