Amarin Corporation plc (NASDAQ:AMRN) today reported an overview of
new data relating to VASCEPA®/VAZKEPA (icosapent ethyl) presented
at the American Heart Association (AHA) Scientific Sessions 2021,
which took place virtually from November 13-15, 2021.
“We are committed to serving patients with
cardiovascular (CV) disease and the data presented at this year’s
AHA annual meeting provide further evidence of the CV benefits of
VASCEPA/ VAZKEPA in specified high-risk patients, potentially
including those with peripheral artery disease,” said Karim
Mikhail, Amarin’s president and chief executive officer. “We also
continue to back investigator-led studies as they support the
exploration of further potential mechanisms and clinical benefits
of VASCEPA/VAZKEPA.”
Key data presented at AHA 2021:
Rapid Fire Oral Session
Presentation
- “Benefits of Icosapent
Ethyl in Patients with Prior Peripheral Artery Disease: REDUCE-IT
PAD,”– presented on behalf of all authors by Deepak L.
Bhatt, M.D., M.P.H., Brigham and Women’s Hospital
Highlights: The investigators
concluded that, “Icosapent ethyl 4 g/day significantly reduced
total (first and subsequent) primary endpoints by 32%, and trended
toward a 22% reduction in first events, in patients with PAD.
Icosapent ethyl provides substantial cardiovascular risk reduction
in the high-risk REDUCE-IT population, with consistent benefits in
patients with a history of PAD. Safety was generally consistent
with the overall study. Overall tolerability and adverse events
were generally similar between icosapent ethyl and placebo in
patients with prior PAD. More atrial fibrillation/flutter occurred
with icosapent ethyl versus placebo in patients with prior PAD
(5.2% versus 2.6%, respectively; P=0.07). No differences in
bleeding were observed between icosapent ethyl and placebo in
patients with prior PAD, likely due to the sample size.”
For more information on this presentation, see
Amarin’s previously issued press release, available here.
e-Poster Presentation
- Eicosapentaenoic Acid (EPA)
Restores Pulmonary Endothelial Nitric Oxide Bioavailability
Following Exposure to Urban Air Pollution Small
Particles”– presented on behalf of all authors by R.
Preston Mason, Ph.D., Brigham and Women’s Hospital
Highlights: This study examined
the effects of EPA on pulmonary endothelial cell (PEC) function and
inflammatory state when challenged with air pollution particulate
matter isolated from an urban environment. In this study, primary
PECs were pre-treated with EPA (40 µM) for two hours in 2%
FBS-containing medium and then challenged with urban particulate
matter (50 µg/mL) for two hours. After two hours, media was washed
out and HBSS buffer was added. Cells were then stimulated with a
calcium ionophore and concurrent measurements of nitric oxide and
ONOO- were performed using tandem electrochemical nanosensors. In
parallel with the endothelial function analysis, soluble
intracellular adhesion molecule-1 (sICAM-1) was detected i.
The study authors concluded that, “EPA
significantly improved pulmonary endothelial cell function under
conditions of inflammation caused by air pollution particles,
including reductions in nitroxidative stress and the soluble
adhesion molecule ICAM-1. These effects of EPA in pulmonary tissue
challenged with air particulate matter indicate a novel potential
benefit for further exploration in people exposed to air
pollution.”
Late-Breaking Science
Presentation
- “Icosapent Ethyl Versus
Placebo In Outpatients With COVID-19: The Main Results Of
PREPARE-IT 2” – presented on behalf of all authors
and the PREPARE-IT 2 Trial Investigators by Rafael Diaz, M.D.,
Estudios Cardiologicos Latinoamerica (ECLA), Rosario,
Argentina
Highlights: These data
represent the first presentation of the topline results from the
PREPARE-IT 2 study, which was an investigator-initiated trial (IIT)
to evaluate the efficacy of icosapent ethyl (IPE) to reduce
hospitalizations or death in approximately 2000 patients in
Argentina with a positive diagnosis for the COVID-19 virus. In this
study, subjects were randomized 1:1 to receive IPE or placebo and
received a loading dose of 8g per day of IPE for the first three
days followed by 4g per day of IPE thereafter from days 4-28. The
primary endpoint is COVID-19 related hospitalizations or death
assessed through day 28.
While the results of the PREPARE-IT 2 study in
Argentina did not meet the primary and/or other endpoints studied,
we believe it is valuable for Amarin to support pilot IITs of this
nature to determine the safety and potential efficacy of
VASCEPA/VAZKEPA in a diverse group of at-risk populations.
Importantly, the study supports the safety and tolerability of
VASCEPA/VAZKEPA at varying doses.
PREPARE-IT 1 and 2 are part of a series of IITs
evaluating VASCEPA/VAZKEPA’s potential benefit in preventing and/or
treating COVID-19. Amarin continues to support MITIGATE, another
IIT study of IPE’s potential efficacy in the prevention of
COVID-19.
The results of this study have no relationship
to or bearing on any approved indications for VASCEPA/VAZKEPA.
All analyses highlighted above were supported or
funded by Amarin.
Additional REDUCE-IT and icosapent ethyl-related
topics presented at AHA Scientific Sessions 2021 can be found
here.
About AmarinAmarin is an
innovative pharmaceutical company leading a new paradigm in
cardiovascular disease management. From our foundation in
scientific research 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, Zug in Switzerland, and other countries in Europe as
well as commercial partners and suppliers around the world. We are
committed to increasing the scientific understanding of the
cardiovascular risk that persists beyond traditional therapies and
advancing the treatment of that risk.
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.ii 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%.iii 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.
iv,v,vi
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.vii The primary results of REDUCE-IT were published in
The New England Journal of Medicine in November 2018.viii The total
events results of REDUCE-IT were published in the Journal of the
American College of Cardiology in March 2019.ix 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 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 (%) |
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 U.S. FDA-APPROVED VASCEPA
PRESCRIBING INFORMATION CAN BE FOUND
AT WWW.VASCEPA.COM.
Forward-Looking Statements
This 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 the world-wide market potential for VASCEPA (marketed
as VAZKEPA in Europe); expectations regarding financial metrics and
performance such as prescription growth, revenue growth, operating
expenses, inventory purchases, and managed care coverage for
VASCEPA, including the impact of the COVID-19 pandemic, the
disappointing outcome of patent litigation and the launch of
generic competition on these metrics; beliefs that Amarin is well
positioned to deliver on its goals to grow VASCEPA in the U.S. and
beyond; beliefs about patient needs for VASCEPA; effects of the
COVID-19 pandemic on Amarin's operations and on the healthcare
industry more broadly, which effects continue to be fluid; beliefs
that Amarin's strategy for reducing the effects of cardiovascular
disease is sound and that Amarin is efficiently reaching
physicians, payors, pharmacists and patients; plans for Amarin's
go-to-market model; the timing and outcome of regulatory reviews,
recommendations and approvals and related reimbursement decisions
and commercial launches in Europe, the China region and elsewhere;
plans for Amarin's expected launch of VASCEPA directly in major
markets in Europe, directly and indirectly; beliefs about the
cardioprotective and other benefits of VASCEPA; beliefs about the
strength of data in market access dossiers and other reports;
expectations for the timing, effectiveness and outcome of
promotional activities, including patient-oriented campaigns,
conference and posted presentations and education of healthcare
professionals; commercial and international expansion, prescription
growth and revenue growth and future revenue levels, including the
contributions of sales representatives and the new leadership team;
beliefs that Amarin's current resources are sufficient to fund
projected operations; ongoing patent litigation efforts; and the
impact of the COVID-19 pandemic on all of the forgoing. These
forward-looking statements are not promises or guarantees and
involve substantial risks and uncertainties. Amarin's ability to
effectively commercialize VASCEPA and maintain or grow market share
will depend in part on Amarin’s ability to continue to effectively
finance its business, VASCEPA approval in geographies outside the
U.S., efforts of third parties, Amarin’s ability to create and
increase market demand for VASCEPA through education, marketing and
sales activities, to achieve broad 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 secure, maintain and defend its patent protection for
VASCEPA. Among the factors that could cause actual results to
differ materially from those described or projected herein include
the following: the possibility that VASCEPA may not receive
regulatory approval in the China region or other geographies on the
expected timelines or at all, the risk that additional generic
versions of VASCEPA will enter the market and that generic versions
of VASCEPA will achieve greater market share and more commercial
supply than anticipated, particularly in light of the recent and
disappointing outcome of Amarin's litigation against two generic
drug companies and subsequent requests for appeal; the risk that
the scope and duration of the COVID-19 pandemic will continue to
impact access to and sales of VASCEPA; the risk that Amarin has
overestimated the market potential for VASCEPA in the U.S., Europe
and other geographies; risks associated with Amarin's expanded
enterprise; uncertainties associated generally with research and
development, clinical trials and related regulatory approvals; the
risk that sales may not meet expectations and related cost may
increase beyond expectations; the risk that patents may be
determined to not be infringed or not be valid in patent litigation
and applications may not result in issued patents sufficient to
protect the VASCEPA franchise. 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 quarterly
report on Form 10-Q for the quarter ended September 30, 2021,
filed on or about the date hereof. 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 (investor.amarincorp.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:Investor RelationsAmarin
Corporation plcIn U.S.: +1 (908)
719-1315IR@amarincorp.com (investor inquiries)
Solebury TroutIn U.S.: +1 (646)
378-2992amarinir@troutgroup.com
Media Inquiries:CommunicationsAmarin Corporation
plcIn U.S.: +1 (908) 892-2028PR@amarincorp.com (media
inquiries)
i Mason RP et al. Biomed Pharmacother.
2018;103:1231- 1237ii American Heart Association. Heart Disease and
Stroke Statistics—2020 Update: A Report From the American Heart
Association. Circulation. 2020;141:e139-e596.iii 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.iv Budoff M. Triglycerides
and triglyceride-rich lipoproteins in the causal pathway of
cardiovascular disease. Am J Cardiol. 2016;118:138-145.v
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.vi
Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic
cardiovascular disease - New insights from epidemiology, genetics,
and biology. Circ Res. 2016;118:547-563.vii 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.viii 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.ix 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.
Amarin (NASDAQ:AMRN)
Historical Stock Chart
From Feb 2024 to Mar 2024
Amarin (NASDAQ:AMRN)
Historical Stock Chart
From Mar 2023 to Mar 2024