Amarin Corporation plc (NASDAQ:AMRN) today announced the acceptance
of funded research for presentation at the European Society of
Cardiology (ESC) Congress, both onsite and online in Amsterdam,
August 25-28, 2023. This new research includes, along with other
topics, the review of the contribution of eicosapentaenoic acid
(EPA) and other biomarkers to MACE reduction by icosapent ethyl
(IPE).
The accepted abstracts will be presented by
international academic collaborators, including Dr. Deepak L. Bhatt
MD, MPH, Director of Mount Sinai Heart and the Dr. Valentin Fuster
Professor of Cardiovascular Medicine, based on research or analyses
sponsored by Amarin.
Featured Amarin-supported abstracts to be
presented at ESC Congress 2023 include:
Abstract Sessions Oral
Presentation
- Session: Remnant
cholesterol and triglyceride-rich lipoproteins in atherosclerosis
progression and cardiovascular disease
Eicosapentaenoic Acid, Arachidonic Acid, and Triglyceride
Levels Mediate Most of the Benefit of Icosapent Ethyl in
REDUCE-IT
Michael Szarek PhD,
Deepak L. Bhatt, MD, MPH, Michael Miller, MD, et al.
-Available: August 26
at 9:24 CET (3:24 a.m. EST) in Lisbon Room
- Session: What's
new in lipid lowering?
Effects of
Icosapent Ethyl On Residual Cardiovascular Risk According To
Predicted Baseline Risk: Results From REDUCE-IT
Pascal M. Burger,
Deepak L. Bhatt, Jannick A.N. Dorresteijn, Ph. Gabriel Steg, et
al.
-Available: August 27
at 11:05 CET (5:05 a.m. EST) in Science Box 2
Moderated Poster Presentation
- Session:
Hypertriglyceridemia treatment: CEPT, icosapent ethyl, and
fibrates
Cross-Sectional Analysis of Demographic and Clinical
Characteristics of Patients Using Icosapent Ethyl
John R. Nelson, MD,
Peter P. Toth, MD, PhD, Handrean Soren, MSc, MD, et al.
-Available: August 27
at 16:15 CET (10:14 a.m. EST) in Station 9
“We continue to be encouraged by new data
generated and presented at ESC 2023 which continues to validate and
underscore the clinical and therapeutic value of IPE and
VASCEPA/VAZKEPA for clinicians and tens of millions of patients
globally,” said Nabil Abadir, MB. CH.B., SVP, Chief Medical Officer
and Head of Global Medical Affairs, Amarin. “These data provide
additional evidence for clinicians to make the best therapeutic
choice possible for their patients and should bolster confidence in
VASCEPA/VAZKEPA as a proven treatment option on top of statins to
reduce CV risk and to help optimize treatment in appropriate
high-risk patients. We are proud of the continued work that is
being done to enhance the proven efficacy of VASCEPA/VAZKEPA in
cardiovascular risk reduction while providing support to
investigators to explore other ways in which VASCEPA can
potentially help patients and impact public health.”
About AmarinAmarin is an innovative
pharmaceutical company leading a new paradigm in cardiovascular
disease management. We are committed to increasing the scientific
understanding of the cardiovascular risk that persists beyond
traditional therapies and advancing the treatment of that risk for
patients worldwide. Amarin has offices in Bridgewater, New Jersey
in the United States, Dublin in Ireland, Zug in Switzerland, and
other countries in Europe as well as commercial partners and
suppliers around the world.
About Cardiovascular RiskCardiovascular disease
is the number one cause of death in the world. In the United States
alone, cardiovascular disease results in 859,000 deaths per year.i
and the number of deaths in the United States attributed to
cardiovascular disease continues to rise. In addition, in the
United States there are 605,000 new and 200,000 recurrent heart
attacks per year (approximately 1 every 40 seconds). Stroke rates
are 795,000 per year (approximately 1 every 40 seconds), accounting
for 1 of every 19 U.S. deaths. In aggregate, in the United States
alone, there are more than 2.4 million major adverse cardiovascular
events per year from cardiovascular disease or, on average, 1 every
13 seconds.
Controlling bad cholesterol, also known as
LDL-C, is one way to reduce a patient’s risk for cardiovascular
events, such as heart attack, stroke or death. However, even with
the achievement of target LDL-C levels, millions of patients still
have significant and persistent risk of cardiovascular events,
especially those patients with elevated triglycerides. Statin
therapy has been shown to control LDL-C, thereby reducing the risk
of cardiovascular events by 25-35%.iiSignificant cardiovascular
risk remains after statin therapy. People with elevated
triglycerides have 35% more cardiovascular events compared to
people with normal (in range) triglycerides taking
statins.iii,iv,v
About REDUCE-IT®REDUCE-IT was
a global cardiovascular outcomes study designed to evaluate the
effect of VASCEPA in adult patients with LDL-C controlled to
between 41-100 mg/dL (median baseline 75 mg/dL) by statin therapy
and various cardiovascular risk factors including persistent
elevated triglycerides between 135-499 mg/dL (median baseline 216
mg/dL) and either established cardiovascular disease (secondary
prevention cohort) or diabetes mellitus and at least one other
cardiovascular risk factor (primary prevention cohort).
REDUCE-IT, conducted over seven years and
completed in 2018, followed 8,179 patients at over 400 clinical
sites in 11 countries with the largest number of sites located
within the United States. REDUCE-IT was conducted based on a
special protocol assessment agreement with FDA. The design of the
REDUCE-IT study was published in March 2017 in Clinical
Cardiology.vi The primary results of REDUCE-IT were published
in The New England Journal of Medicine in November 2018.vii The
total events results of REDUCE-IT were published in the Journal of
the American College of Cardiology in March 2019.viii These and
other publications can be found in the R&D section on the
company’s website at www.amarincorp.com.
About
VASCEPA®/VAZKEPA®
(icosapent ethyl) CapsulesVASCEPA capsules are the
first prescription treatment approved by the U.S. Food and Drug
Administration (FDA) comprised solely of the active ingredient,
icosapent ethyl, a unique form of eicosapentaenoic acid. VASCEPA
was launched in the United States in January 2020 as the first and
only drug approved by the U.S. FDA for treatment of the studied
high-risk patients with persistent cardiovascular risk after statin
therapy. VASCEPA was initially launched in the United States in
2013 based on the drug’s initial FDA approved indication for use as
an adjunct therapy to diet to reduce triglyceride levels in adult
patients with severe (≥500 mg/dL) hypertriglyceridemia. Since
launch, VASCEPA has been prescribed more than 20 million times.
VASCEPA is covered by most major medical insurance plans. In
addition to the United States, icosapent ethyl is approved and sold
in Canada, Lebanon, and the United Arab Emirates. In Europe, in
March 2021 marketing authorization was granted to icosapent ethyl
in the European Union for the reduction of risk of cardiovascular
events in patients at high cardiovascular risk, under the brand
name VAZKEPA. VAZKEPA is being commercialized in multiple European
countries, including England, Wales, Sweden and Finland.
United States Indications and Limitation of Use VASCEPA is
indicated:
- As an adjunct to maximally
tolerated statin therapy to reduce the risk of myocardial
infarction, stroke, coronary revascularization and unstable angina
requiring hospitalization in adult patients with elevated
triglyceride (TG) levels (≥ 150 mg/dL) and
- established cardiovascular disease
or
- diabetes mellitus and two or more
additional risk factors for cardiovascular disease.
- As an adjunct to diet to reduce TG
levels in adult patients with severe (≥ 500 mg/dL)
hypertriglyceridemia.
The effect of VASCEPA on the risk for
pancreatitis in patients with severe hypertriglyceridemia has not
been determined. Important Safety Information
- VASCEPA is contraindicated in
patients with known hypersensitivity (e.g., anaphylactic reaction)
to VASCEPA or any of its components.
- VASCEPA was associated with an
increased risk (3% vs 2%) of atrial fibrillation or atrial flutter
requiring hospitalization in a double-blind, placebo-controlled
trial. The incidence of atrial fibrillation was greater in patients
with a previous history of atrial fibrillation or atrial
flutter.
- It is not known whether patients
with allergies to fish and/or shellfish are at an increased risk of
an allergic reaction to VASCEPA. Patients with such allergies
should discontinue VASCEPA if any reactions occur.
- VASCEPA was associated with an
increased risk (12% vs 10%) of bleeding in a double-blind,
placebo-controlled trial. The incidence of bleeding was greater in
patients receiving concomitant antithrombotic medications, such as
aspirin, clopidogrel or warfarin.
- Common adverse reactions in the
cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent
than placebo): musculoskeletal pain (4% vs 3%), peripheral edema
(7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial
fibrillation (5% vs 4%).
- Common adverse reactions in the
hypertriglyceridemia trials (incidence >1% more frequent than
placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs
0.3%).
- Adverse events may be reported by
calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
- Patients receiving VASCEPA and
concomitant anticoagulants and/or anti-platelet agents should be
monitored for bleeding.
FULL U.S. FDA-APPROVED VASCEPA PRESCRIBING
INFORMATION CAN BE FOUND AT
WWW.VASCEPA.COM.
Europe For further information about the Summary of Product
Characteristics (SmPC) for VAZKEPA® in Europe,
please click here.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
Forward-Looking StatementsThis press release
contains forward-looking statements which are made pursuant to the
safe harbor provisions of the Private Securities Litigation Reform
Act of 1995, including beliefs about how the data generated and
presented at ESC 2023 helps validate and underscore the clinical
and therapeutic value of icosapent etyhl (IPE) and VASCEPA/VAZKEPA
for clinicians and millions of patients globally; and the overall
potential and future success of VASCEPA/VAZKEPA and Amarin
generally. These forward-looking statements are not promises or
guarantees and involve substantial risks and uncertainties. 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 Amarin’s annual report on Form 10-K for the full year
ended 2021. Existing and prospective investors are cautioned not to
place undue reliance on these forward-looking statements, which
speak only as of the date they are made. Amarin undertakes no
obligation to update or revise the information contained in its
forward-looking statements, whether as a result of new information,
future events or circumstances or otherwise. Amarin’s
forward-looking statements do not reflect the potential impact of
significant transactions the company may enter into, such as
mergers, acquisitions, dispositions, joint ventures or any material
agreements that Amarin may enter into, amend or
terminate.
Availability of Other Information About
Amarin Amarin communicates with its investors and the
public using the company website (www.amarincorp.com) and the
investor relations website (amarincorp.gcs-web.com), including but
not limited to investor presentations and 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:Jordan ZwickAmarin
Corporation plcIR@amarincorp.com
Media Inquiries:Mark MarmurCorporate Communications, Amarin
Corporation plcPR@amarincorp.com
AMARIN, REDUCE-IT, VASCEPA and VAZKEPA are trademarks of Amarin
Pharmaceuticals Ireland Limited. VAZKEPA is a registered trademark
in Europe and other countries and regions and is pending
registration in the United States.
i American Heart Association. Heart Disease and Stroke
Statistics—2020 Update: A Report From the American Heart
Association. Circulation. 2020;141:e139-e596.ii 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.iii Budoff M. Triglycerides and
triglyceride-rich lipoproteins in the causal pathway of
cardiovascular disease. Am J Cardiol. 2016;118:138-145.iv Toth PP,
Granowitz C, Hull M, et al. High triglycerides are associated with
increased cardiovascular events, medical costs, and resource use: A
real-world administrative claims analysis of statin-treated
patients with high residual cardiovascular risk. J Am Heart Assoc.
2018;7(15):e008740.v Nordestgaard BG. Triglyceride-rich
lipoproteins and atherosclerotic cardiovascular disease - New
insights from epidemiology, genetics, and biology. Circ Res.
2016;118:547-563.vi Bhatt DL, Steg PG, Brinton E, et al., on behalf
of the REDUCE-IT Investigators. Rationale and Design of REDUCE‐IT:
Reduction of Cardiovascular Events with Icosapent
Ethyl–Intervention Trial. Clin Cardiol. 2017;40:138-148.vii Bhatt
DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT
Investigators. Cardiovascular Risk Reduction with Icosapent Ethyl
for Hypertriglyceridemia. N Engl J Med. 2019;380:11-22.viii Bhatt
DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT
Investigators. Effects of Icosapent Ethyl on Total Ischemic Events:
From REDUCE-IT. J Am Coll Cardiol. 2019;73:2791-2802.
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