Amarin Corporation plc (NASDAQ:AMRN) today announced that new data
that add to the growing body of knowledge on VASCEPA® (icosapent
ethyl) in patients at risk for major adverse cardiovascular events
will be presented at ESC Congress 2020, the annual meeting of the
European Society of Cardiology (ESC), being held virtually from
August 29 - September 1, 2020. These new findings will be presented
in one Late-Breaking Science presentation and four rapid fire
abstract and e-poster presentations from a variety of academic
collaborators based on research or analyses supported by
Amarin.
“Cardiovascular disease is an ever-increasing
global challenge commanding both attention and action,” said Craig
Granowitz, M.D., Ph.D., Amarin’s senior vice president and chief
medical officer. “Often devastating, cardiovascular disease demands
new research to increase our understanding of how to address
residual cardiovascular risk. Several scheduled presentations at
ESC provide new data on VASCEPA and its potential to address heart
health in at-risk patients.”
Featured Amarin-supported abstracts to be
presented at ESC Congress 2020 include:
Late-Breaking Science
Presentation
- Session: Late-Breaking Science in
Lipids“Effect of Icosapent Ethyl on Progression of
Coronary Atherosclerosis in Patients with Elevated Triglycerides on
Statin Therapy: Final results of the EVAPORATE Study” – presented
on behalf of all authors by Matthew Budoff, M.D., The Lundquist
Institute – August 29, 8:50-9:20 a.m. CEST (Central European Summer
Time)
Rapid Fire Abstracts and e-Poster
Presentations
- Session: Rapid Fire Abstracts“REDUCE-IT:
Accumulation of Data Across Prespecified Interim Analyses to Final
Results” – presented on behalf of all authors by Brian Olshansky,
M.D., University of Iowa – Available from August
30
- Session: Rapid Fire Abstracts“REDUCE-IT: Total
Ischemic Events Reduced Across the Full Range of Baseline LDL
Cholesterol and Other Key Subgroups” – presented on behalf of all
authors by Deepak L. Bhatt, M.D., M.P.H., Brigham and Women’s
Hospital – Available from August 30
- Session: Rapid Fire Abstracts“Are the Results
of Clinical Trials Relevant in The Real World? The Applicability of
REDUCE-IT to the FAST-MI Registry.” – presented on behalf of all
authors by Jean Ferrières, M.D., M.Sc., FESC, Toulouse Rangueil
University Hospital – Available from August 30
- Session: e-Poster“REDUCE-IT: Outcomes by
Baseline Statin Type” – presented on behalf of all authors by
Deepak L. Bhatt, M.D., M.P.H., Brigham and Women’s Hospital –
Available from August 28
Additional REDUCE-IT® and icosapent ethyl
(EPA)-related topics will be presented at ESC Congress 2020 and can
be found at
https://www.escardio.org/Congresses-&-Events/ESC-Congress.
About Amarin Amarin 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, Canada, Lebanon and the United Arab Emirates. Amarin,
together with its commercial partners in select geographies, is
pursuing additional regulatory approvals for VASCEPA in China,
Europe and the Middle East. For more information about Amarin,
visit www.amarincorp.com.
About Cardiovascular RiskThe
number of deaths in the United States attributed to cardiovascular
disease continues to rise. There are 605,000 new and 200,000
recurrent heart attacks per year (approximately 1 every 40
seconds), in the United States. Stroke rates are 795,000 per year
(approximately 1 every 40 seconds), accounting for 1 of every 19
U.S. deaths. Cardiovascular disease results in 859,000 deaths per
year in the United States.1 In aggregate, there are more than 2.4
million major adverse cardiovascular events per year from
cardiovascular disease or, on average, one every 13 seconds in the
United States alone.
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%.2 Significant 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.3,4,5
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.6 The primary results of REDUCE-IT were published in The
New England Journal of Medicine in November 2018.7 The total events
results of REDUCE-IT were published in the Journal of the American
College of Cardiology in March 2019.8 These and other publications
can be found in the R&D section on the company’s website at
www.amarincorp.com.
About VASCEPA®
(icosapent ethyl) CapsulesVASCEPA (icosapent
ethyl) capsules are the first-and-only prescription treatment
approved by the FDA comprised solely of the active ingredient,
icosapent ethyl (IPE), a unique form of eicosapentaenoic acid.
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 over eight million times. VASCEPA is
covered by most major medical insurance plans. The new,
cardiovascular risk indication for VASCEPA was approved by the FDA
in December 2019.
Indications and Limitation of UseVASCEPA 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.
Key clinical effects of VASCEPA on major adverse
cardiovascular events are included in the Clinical Studies section
of the prescribing information for VASCEPA, as set forth below:
Effect of VASCEPA on Time to First
Occurrence of Cardiovascular Events in Patients with
Elevated Triglyceride levels and Other Risk Factors for
Cardiovascular Disease in REDUCE-IT
|
VASCEPA |
Placebo |
VASCEPA vs Placebo |
N = 4089n (%) |
Incidence Rate (per 100 patient years) |
N = 4090n (%) |
Incidence Rate (per 100 patient years) |
Hazard Ratio(95% CI) |
Primary composite endpoint |
Cardiovascular death, myocardial infarction, stroke, coronary
revascularization, hospitalization for unstable angina (5-point
MACE) |
705(17.2) |
4.3 |
901(22.0) |
5.7 |
0.75(0.68, 0.83) |
Key secondary composite endpoint |
Cardiovascular death, myocardial infarction, stroke (3-point
MACE) |
459(11.2) |
2.7 |
606(14.8) |
3.7 |
0.74(0.65, 0.83) |
Other secondary endpoints |
Fatal or non-fatal myocardial infarction |
250(6.1) |
1.5 |
355(8.7) |
2.1 |
0.69(0.58, 0.81) |
Emergent or urgent coronary revascularization |
216(5.3) |
1.3 |
321(7.8) |
1.9 |
0.65(0.55, 0.78) |
Cardiovascular death [1] |
174(4.3) |
1.0 |
213(5.2) |
1.2 |
0.80(0.66, 0.98) |
Hospitalization for unstable angina [2] |
108(2.6) |
0.6 |
157(3.8) |
0.9 |
0.68(0.53, 0.87) |
Fatal or non-fatal stroke |
98(2.4) |
0.6 |
134(3.3) |
0.8 |
0.72(0.55, 0.93) |
[1] Includes adjudicated cardiovascular deaths and deaths of
undetermined causality.[2] Determined to be caused by myocardial
ischemia by invasive/non-invasive testing and requiring emergent
hospitalization. |
FULL VASCEPA
PRESCRIBING INFORMATION CAN BE FOUND
AT WWW.VASCEPA.COM.
Forward-Looking Statements This
press release contains forward-looking statements, including
statements regarding the potential impact of VASCEPA in various
clinical uses. These forward-looking statements are not promises or
guarantees and involve substantial risks and uncertainties. Among
the factors that could cause actual results to differ materially
from those described or projected herein include the following:
uncertainties associated generally with research and development
and clinical trials such as further clinical evaluations failing to
confirm earlier findings. 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. 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
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)
719-1315IR@amarincorp.com (investor inquiries)
Lee M. SternSolebury TroutIn U.S.: +1 (646)
378-2992lstern@soleburytrout.com
Media Inquiries:Alina
KolomeyerCommunicationsAmarin Corporation plcIn U.S.: +1 (908)
892-2028PR@amarincorp.com (media inquiries)
1 American Heart Association. Heart Disease and Stroke
Statistics—2020 Update: A Report From the American Heart
Association. Circulation. 2020;141:e139–e596.2 Ganda OP,
Bhatt DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia
therapy in hypertriglyceridemia management. J Am Coll Cardiol.
2018;72(3):330-343.3 Budoff M. Triglycerides and
triglyceride-rich lipoproteins in the causal pathway of
cardiovascular disease. Am J Cardiol. 2016;118:138-145.4
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):e008740.5 Nordestgaard BG.
Triglyceride-rich lipoproteins and atherosclerotic cardiovascular
disease - New insights from epidemiology, genetics, and biology.
Circ Res. 2016;118:547-563.6 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;40:138-148.7
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;380:11-22.8 Bhatt DL, Steg PG, Miller M, et al., on
behalf of the REDUCE-IT Investigators. Reduction in first and total
ischemic events with icosapent ethyl across baseline triglyceride
tertiles. J Am Coll Cardiol. 2019;74:1159-1161.
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