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 peripheral artery disease
(PAD) at risk for major adverse cardiovascular events were
delivered in a Rapid Fire Oral Session Presentation at the American
Heart Association (AHA) Scientific Sessions 2021, which took place
virtually from November 13-15, 2021.
The presentation, titled, “Benefits of
Icosapent Ethyl in Patients with Prior Peripheral Artery Disease:
REDUCE-IT PAD,” 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 was available On-Demand beginning on November 13,
2021 at 8:00 am ET through the completion of AHA Scientific
Sessions 2021.
The Rapid Fire Oral Session presentation
included both prespecified and post hoc analyses of patients who
had PAD prior to randomization in the REDUCE-IT study to determine
if treatment with VASCEPA (icosapent ethyl) reduced further
ischemic events in those subjects.
“The REDUCE-IT prior PAD analyses provide
valuable data supporting a potentially effective new approach to
prevent ischemic events using prescription icosapent ethyl in
patients with prior PAD,” commented Dr. Bhatt. “The potential
benefits for patients with prior PAD are particularly important
given these patients are at significantly higher risk of
cardiovascular morbidity and mortality. These results strongly
support 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
their high-risk PAD patients.”
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.”
“Amarin is committed to serving patients at high
risk of cardiovascular events and these new data add to our growing
body of clinical evidence in support of its benefits to reduce that
risk in patients with prior PAD,” stated Steven Ketchum, Ph.D.,
executive vice president and president, research & development
and chief scientific officer, Amarin. “For these patients, the
demonstrated cardiovascular risk reduction of VASCEPA/VASKEPA could
be an important, and potentially life-saving, addition to their
treatment regimen.”
Additional REDUCE-IT and icosapent ethyl-related
topics to be presented at AHA Scientific Sessions 2021 can be found
here.
Dr. Bhatt receives research funding paid to
Brigham and Women’s Hospital from Amarin for his role as the Chair
of REDUCE-IT.
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.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%.ii 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.
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® (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 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 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 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. 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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