Amarin Corporation plc (NASDAQ:AMRN) today announced the launch of
True To Your Heart, an educational campaign to help people learn
more about cardiovascular disease and how to better protect against
persistent cardiovascular risk. On truetoyourheart.com, people can
learn about the impact of and risk factors for cardiovascular
disease, as well as ways to reduce cardiovascular risk, including
lifestyle choices and medical therapies.
Despite the use of current standard-of-care treatments, such as
statin medications, and positive lifestyle choices, many patients
with cardiovascular disease may still face persistent
cardiovascular risk for life-threatening cardiovascular events such
as heart attacks or stroke. However, a recent survey of nearly 500
healthcare professionals (HCPs) revealed that a majority (60%) of
HCPs believe that less than half of their patients with persistent
cardiovascular disease who are treated with statins realize they
are still at risk for a cardiovascular event.
While most (93%) of the HCPs surveyed typically recommend
prescription medications as part of their management approach for
patients with persistent cardiovascular risk, only half believe
available treatment options (both prescription and
non-prescription) adequately protect patients from future
cardiovascular events. The survey also showed that many HCPs are
not up to date on the latest scientific evidence in terms of
treating beyond cholesterol management, with many recommending or
prescribing outdated, unproven, non-FDA approved and potentially
risky treatment approaches for their patients, such as fenofibrates
and fish oil dietary supplements. Notably, 55% of the HCPs surveyed
admitted to prescribing fenofibrates; and 47% recommended fish oil
dietary supplements, on top of statin therapy for their patients
with persistent cardiovascular risk.
Dietary fish oil supplements are not intended to treat disease
and have not been clinically proven to be safe or effective in the
treatment or prevention of cardiovascular risk. In fact, all
studies evaluating the use of fish oil supplements as an add-on to
statin therapy have failed to show any significant clinical
benefits beyond the use of statins alone.1 While there may be
appropriate uses for dietary supplements, they should not be used
for treating disease.2 Separately, the FDA withdrew approval to use
fenofibrates in combination with statins in 2016 because, in its
analysis, the benefits did not outweigh the risks.3 Fenofibrates
are not proven to reduce cardiovascular risk when paired with a
statin.
“The survey points to both a need and opportunity for more
healthcare provider and patient education,” said Craig Granowitz,
M.D., Ph.D., senior vice president and chief medical officer,
Amarin. “Patients with cardiovascular disease who take statins are
only lowering their risk of a life-threatening cardiovascular event
by 25-35%,4 so while they have taken an important first step, they
aren’t fully protected against persistent cardiovascular risk.
Unfortunately, some patients then turn to, or are being prescribed,
unproven therapeutic options. Through True To Your Heart, we aim to
increase consumer awareness that they may be missing out on
important cardiovascular risk protection, and hope to encourage
everyone, from patients to doctors, to educate themselves so people
can make the best health decisions to protect their hearts.”
For more information, visit truetoyourheart.com. And watch the
new True To Your Heart commercial, which begins airing nationally
on January 16, at truetoyourheart.com/commercial.
Survey MethodologyThe survey among physicians
was conducted by APCO Insight between December 27, 2019 – January
2, 2020, including n=255 primary care physicians and n=243
cardiologists who treat patients with persistent cardiovascular
disease. The sampling margin of error for this survey is
±4.4%.
About Cardiovascular DiseaseCardiovascular
disease is a large and growing problem. Approximately 92.1 million
American adults are living with some form of cardiovascular disease
or the debilitating effects of stroke. It is estimated that 45% of
the U.S. population will have cardiovascular disease by 2035.
Cardiovascular disease is the number one cause of death for men and
women in the United States, leading to 1 in 3 deaths. It is also
the nation’s costliest disease, with annual costs in excess of $500
billion each year. These costs are expected to increase to 1.1
trillion by 2035.5,[6],[7]
About AmarinAmarin Corporation plc. is a
rapidly growing, innovative pharmaceutical company focused on
developing and commercializing therapeutics to cost-effectively
improve cardiovascular health. Amarin’s lead product, VASCEPA®
(icosapent ethyl), is available by prescription in the United
States, Lebanon and the United Arab Emirates, and is expected to be
available in Canada through an anticipated February 2020 commercial
launch. Amarin, together with its commercial partners in select
geographies, is pursuing additional regulatory approvals for
VASCEPA in China, the European Union and the Middle East. For more
information about Amarin, visit www.amarincorp.com.
Forward-Looking Statements
This press release contains forward-looking statements,
including expectations regarding commercialization of VASCEPA in
Canada and regulatory submissions and approvals in other markets,
as well as timing related thereto. These forward-looking statements
are not promises or guarantees and involve substantial risks and
uncertainties. In addition, Amarin's ability, directly or through
licensees, to effectively commercialize VASCEPA in various
jurisdictions will depend in part on its ability to continue to
effectively finance its business, efforts of third parties, ability
to gain regulatory approvals, obtain favorable pricing, and create
market demand for VASCEPA to achieve market acceptance of VASCEPA,
to receive adequate levels of reimbursement from third-party
payers, to develop and maintain a consistent source of commercial
supply at a competitive price, to comply with legal and regulatory
requirements in connection with the sale and promotion of VASCEPA
and to maintain exclusivity through grant of regulatory exclusivity
and through patent protection for VASCEPA in various markets. Among
the factors that could cause actual results to differ materially
from those described or projected herein include the following:
uncertainties associated generally with acceptance of clinical
trial results and related regulatory approvals; risks related to
factors affecting pricing in various jurisdictions; the risk that
exclusivity may not be obtained from governing authorities and that
patents may not be upheld in patent litigation. A further list and
description of these risks, uncertainties and other risks
associated with an investment in Amarin can be found in Amarin's
filings with the U.S. Securities and Exchange Commission, including
its most recent quarterly report on Form 10-Q. Existing and
prospective investors are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date
hereof. Amarin undertakes no obligation to update or revise the
information contained in this press release, whether as a result of
new information, future events or circumstances or otherwise.
Availability of Other Information About
AmarinInvestors and others should note that Amarin
communicates with its investors and the public using the company
website (www.amarincorp.com), the investor relations website
(investor.amarincorp.com), including but not limited to investor
presentations and investor FAQs, Securities and Exchange Commission
filings, press releases, public conference calls and webcasts. The
information that Amarin posts on these channels and websites could
be deemed to be material information. As a result, Amarin
encourages investors, the media, and others interested in Amarin to
review the information that is posted on these channels, including
the investor relations website, on a regular basis. This list of
channels may be updated from time to time on Amarin’s investor
relations website and may include social media channels. The
contents of Amarin’s website or these channels, or any other
website that may be accessed from its website or these channels,
shall not be deemed incorporated by reference in any filing under
the Securities Act of 1933.
Amarin Contact InformationInvestor
Inquiries:Elisabeth SchwartzInvestor RelationsAmarin
Corporation plcIn U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com
Lee M. SternSolebury TroutIn U.S.: +1 (646) 378-2992
lstern@soleburytrout.com
Media Inquiries:Gwen Fisher Corporate
Communications Amarin Corporation plcIn U.S.: +1 (908) 325-0735
pr@amarincorp.com
References
1 Theingi Aung, et al., Associations of Omega-3 Fatty Acid
Supplement Use with Cardiovascular Disease Risks: Meta-analysis of
10 Trials Involving 77,917 Individuals, JAMA Cardiology, published
online January 31, 2018.
2
https://www.fda.gov/consumers/consumer-updates/fda-101-dietary-supplements
3
https://www.federalregister.gov/documents/2016/04/18/2016-08887/abbvie-inc-et-al-withdrawal-of-approval-of-indications-related-to-the-coadministration-with-statins
4 Ganda OP, Bhatt DL, Mason RP, et al. Unmet need for adjunctive
dyslipidemia therapy in hypertriglyceridemia management. J Am Coll
Cardiol. 2018;72(3):330-343.
5 American Heart Association: Heart Disease and Stroke
Statistics -- 2019 At-a-Glance.
6 American Heart Association. Heart Disease and Stroke
Statistics – 2019 Update: A Report from the American Heart
Association. Published January 31, 2019.
7 American Heart Association. 2017. Cardiovascular disease: A
costly burden for America projections through 2035.
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