Amarin Corporation plc (NASDAQ:AMRN) today announced that data
adding to the growing body of knowledge on VASCEPA®/VAZKEPA
(icosapent ethyl) in patients with prior heart attack, known as
myocardial infarction (MI), at risk for major adverse
cardiovascular events were delivered in a Late Breaking Science
Presentation at ESC Congress 2021, organized by the European
Society of Cardiology (ESC), taking place virtually from August 27
– August 30, 2021.
The presentation titled, “Reduction in Ischemic
Events, Including Cardiovascular Mortality, with Icosapent Ethyl in
Patients with Prior Myocardial Infarction: REDUCE-IT PRIOR MI,” was
presented on behalf of all authors by Deepak L. Bhatt, M.D.,
M.P.H., Executive Director of Interventional Cardiovascular
Programs at Brigham and Women’s Hospital, Professor of Medicine at
Harvard Medical School, and principal investigator of REDUCE-IT®
and is available On-Demand beginning today at 3:00 am ET (9:00 am
CEST) through the completion of the Congress.
The Late Breaking Science Presentation included
both prespecified and post hoc analyses of patients who had prior
MI from the REDUCE-IT study (prior to trial randomization) to
determine if treatment with VASCEPA (icosapent ethyl) reduced
further ischemic events in those subjects.
“The REDUCE-IT PRIOR MI analyses provide
valuable data supporting an effective new approach to prevent
ischemic events using prescription icosapent ethyl in patients who
have had previous heart attacks,” commented Dr. Bhatt. “The
benefits in these heart attack patients at-risk for another
cardiovascular event are particularly important given these
patients are at elevated risk for recurrent cardiovascular
problems. These results further strengthen the case for pure
eicosapentaenoic acid (EPA) in the form of prescription icosapent
ethyl as a key intervention beyond statins for meaningful risk
reduction by physicians caring for this high-risk population.”
The investigators concluded that, “Icosapent
ethyl 4 g/day significantly reduced first and total primary
endpoints of 5-point major adverse cardiovascular event (MACE),
comprised of CV death, MI, stroke, coronary revascularization, and
hospitalization for unstable angina by 26% and 35%, respectively,
in patients with prior MI (P=0.00001 and P=0.0000001,
respectively). Icosapent ethyl led to generally robust reductions
across the prespecified hierarchy of secondary endpoints, and in
sudden cardiac death and cardiac arrest. The benefits of icosapent
ethyl in patients with prior MI were consistent in those with or
without a history or prior revascularization.”
“The global burden of cardiovascular disease is
a growing problem worldwide. For patients with prior MI, the risk
of ischemic events is even greater. We are delighted to have these
analyses presented at this year’s ESC as they show our prescription
icosapent ethyl provides substantial cardiovascular risk reduction
in the high-risk REDUCE-IT population, with consistent and
significant benefits in patients who have experienced a prior MI,”
stated Steven Ketchum, Ph.D., executive vice president and
president, research & development and chief scientific officer,
Amarin.
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).
Dr. Bhatt receives research funding paid to
Brigham and Women’s Hospital from Amarin for his role as the Chair
of REDUCE-IT.
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 (%) |
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;
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 June 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
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.
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. Effects of Icosapent Ethyl on Total Ischemic Events:
From REDUCE-IT. J Am Coll Cardiol. 2019;73:2791-2802.
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