Amarin Corporation plc (NASDAQ:AMRN) today announced that new data
that add to the growing body of knowledge on VASCEPA®/VAZKEPA
(icosapent ethyl) in patients at risk for major adverse
cardiovascular events will be presented at ESC Congress 2021,
organized by the European Society of Cardiology (ESC), being held
virtually from August 27 – August 30, 2021. These and other new
findings will be presented in two Late-Breaking Science
presentations and five e-Poster presentations from a variety of
international academic collaborators based on research or analyses
supported by Amarin.
“Given the growing global burden of
cardiovascular disease, we are pleased that new data is being
presented at this year’s ESC Congress in support of the clinical
efficacy and underlying scientific rationale for VASCEPA/VAZKEPA to
address residual cardiovascular risk. These presentations are
particularly timely as we will soon initiate our European launch,
starting in Germany, and these data amplify the potential for
VASCEPA/VAZKEPA to address heart health in at-risk patients,” said
Karim Mikhail, Amarin’s president and chief executive officer. “We
are also looking forward to the first readout from PREPARE-IT 1,
part of a larger investigator-initiated study program, looking at
the potential benefits of VASCEPA/VAZKEPA for the prevention of
COVID-19 in people at risk of exposure to the infection. With
COVID-19 continuing to spread due to variants as well as low
vaccine rates globally, these data could provide valuable insights
in the ongoing fight against this pandemic.”
Featured Amarin-supported abstracts to be
presented at ESC Congress 2021 include:
Late-Breaking Science
Presentations
- Session: Late-Breaking
Science“Reduction in Ischemic Events, Including
Cardiovascular Mortality, with Icosapent Ethyl in Patients with
Prior Myocardial Infarction: REDUCE-IT PRIOR MI” –
presented on behalf of all authors by Deepak L. Bhatt, M.D.,
M.P.H., Brigham and Women’s Hospital – Available On-Demand from
August 23, 9:00 a.m. CEST
- Session: Late-Breaking Trials-COVID-19“Icosapent Ethyl
Versus Placebo in People Exposed to COVID-19: The Main Results of
PREPARE-IT-1” – presented on behalf of all authors by
Rafael Diaz, M.D., Estudios Cardiologicos Latinoamerica (ECLA),
Rosario, Argentina – August 29, 2:00 p.m. CEST
e-Poster Presentations
- Session: Preventive Cardiology and
Special Populations“Cardiovascular benefits outweigh risks
in patients with atrial fibrillation in REDUCE-IT (Reduction of
Cardiovascular Events with Icosapent Ethyl-Intervention
Trial)” – presented on behalf of all authors by Brian
Olshansky, M.D., University of Iowa – Available On-Demand from
August 23, 9:00 a.m. CEST
- Session: e-Posters“Omega-3
Fatty Acids Differentially Alter the Expression of Detoxification
Enzymes and Nitric Oxide Bioavailability in Endothelial Cells
during IL-6 Exposure” – presented on behalf of all authors
by R. Preston Mason, Ph.D., Brigham and Women’s Hospital –
Available On-Demand from August 23, 9:00 am CEST
- Session: e-Posters“Omega-3
Fatty Acids Differentially Reduced Expression of Neutrophil
Degranulation-Associated Proteins in Endothelial Cells during IL-6
Exposure” – presented on behalf of all authors by R.
Preston Mason, Ph.D., Brigham and Women’s Hospital – Available
On-Demand from August 23, 9:00 am CEST
- Session:
e-Poster“Eicosapentaenoic Acid Inhibits Lipopolysaccharide
(LPS)-induced Nitrite Production and Cytokine Release from J774
Macrophages” presented on behalf of all authors by R.
Preston Mason, Ph.D., Brigham and Women’s Hospital – Available
On-Demand from August 23, 9:00 am CEST
- Session:
e-Poster“Characteristics and prognosis of patients with
elevated triglycerides in acute myocardial infarction:
observational data from a large database over a 17-years
period” – presented on behalf of all
authors by Michel Farnier, M.D., University of Bourgogne Franche
Comte - Dijon, France – Available On-Demand from August 23, 9:00 am
CEST
Additional REDUCE-IT® and icosapent ethyl
(EPA)-related topics will be presented at ESC Congress 2021 and can
be found at https://digital-congress.escardio.org/ESC-Congress (if
registered to ESC Congress).
About Amarin
Amarin is an innovative pharmaceutical company
leading a new paradigm in cardiovascular disease management. From
our scientific research foundation to our focus on clinical trials,
and now our commercial expansion, we are evolving and growing
rapidly. Amarin has offices in Bridgewater, New Jersey in the
United States, Dublin in Ireland, and Zug in Switzerland as well as
commercial partners and suppliers around the world. We are
committed to rethinking cardiovascular risk through the advancement
of scientific understanding of the impact on society of significant
residual risk that exists beyond traditional therapies, such as
statins for cholesterol management.
About Cardiovascular Risk
Cardiovascular 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.1 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%.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)
Capsules
VASCEPA (icosapent ethyl) capsules are the
first-and-only prescription treatment approved by the U.S. Food and
Drug Administration (FDA) comprised solely of the active
ingredient, icosapent ethyl (IPE), 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 over ten million times. VASCEPA is covered by most major
medical insurance plans. In addition to the United States, VASCEPA
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.
Indications and Limitation of Use (in the United States)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.
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 (%) |
IncidenceRate(per 100patient
years) |
N = 4090n (%) |
IncidenceRate(per 100patient
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 U.S. FDA-APPROVED
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
Amarin
Investors 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:Investor RelationsAmarin Corporation plcIn U.S.:
+1 (908) 719-1315IR@amarincorp.com (investor inquiries)
Solebury Troutamarinir@troutgroup.com
Media Inquiries:CommunicationsAmarin
Corporation plcIn U.S.: +1 (908)
892-2028PR@amarincorp.com (media inquiries)
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.
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