Amarin Corporation plc (NASDAQ:AMRN), a pharmaceutical company
focused on improving cardiovascular health, in addition to its
previously announced data from scientific presentations at the
American College of Cardiology’s (ACC) 68th Annual Scientific
Session from March 16-18, 2019 in New Orleans, LA, announced data
from three presented scientific posters. These data highlight that
there is no medically established threshold for what constitutes
safe or “normal” triglyceride (TG) levels, and that higher TGs are
correlated with a higher lifetime risk of cardiovascular (CV)
events. Poster data also delved into potential mechanisms of action
for Vascepa® (icosapent ethyl) capsules.
In a poster titled, “Triglycerides as a Risk
Factor for Coronary Heart Disease: What Measure and What Cutoff?”,
research focused on triglyceride levels of people who had their
first cardiovascular event. The findings indicated that there was
no threshold below which increasing TG levels were not associated
with increased CV risk. In other words, increasing average TG
levels over time, even levels well below 100 mg/dL, are associated
with increased risk of CVD. The research was a collaborative effort
with Duke Clinical Research Institute and authored by Ann Marie
Navar, Neha Pagidipati, Hillary Mulder, Tsion Aberra, Sephy Philip,
Craig Granowitz, and Eric Peterson.
A poster titled, “Eicosapentaenoic Acid Inhibits
Membrane Lipid Oxidation in a Concentration-Dependent Manner at
Pharmacologic Doses In Vitro,” was presented which supports an
anti-oxidant effect for eicosapentanoic acid (EPA) in a pure
formulation and at pharmacologic concentrations. This research
builds on previously reported mechanism of action research with
respect to Vascepa and supports that a relatively high dose and
concentration of eicosapentaenoic acid (EPA) are needed to provide
sustained antioxidant effects and may provide a potential mechanism
for reduced cardiovascular risk. This research was authored by R.
Preston Mason and Samuel C. R. Sherratt.
A poster titled, ”Long-term Statin Persistence
Is Poor Among High-Risk Patients with Baseline Peripheral Artery
Disease: A Real-World Administrative Claims Analysis of the Optum
Research Database,” summarized data which concluded that statin
persistence is poor among patients with peripheral artery disease
(PAD) with or without hypertriglyceridemia. It supports that there
is an urgent need for patient education to address the medical risk
associated with premature statin discontinuation. This research was
authored by Peter P. Toth, Craig Granowitz, Michael Hull, and Sephy
“The risk of cardiovascular disease is high.
Efforts continue to be needed to increase patient education
regarding these risks, including communication about triglyceride
levels as an identifier of risk and the multifactorial effect of
Vascepa, including it anti-oxidant effects,” said Craig B.
Granowitz, M.D., Ph.D., senior vice president and chief medical
officer of Amarin. “Amarin continues to aggressively conduct
research to help the tens of millions of adults with cardiovascular
In a separate presentation yesterday at the ACC
68th Annual Scientific Session, additional data was reported from
the Amarin cardiovascular outcomes study of Vascepa, the REDUCE-IT
study, which demonstrated that Vascepa lowers both primary major
adverse cardiovascular events (MACE) and recurrent MACE in patients
with elevated triglyceride levels (≥135 mg/dL) and other
cardiovascular risk factors. While lowering triglyceride levels
alone have not been demonstrated to lower cardiovascular risk, the
REDUCE-IT study demonstrated that in patients with high levels of
cardiovascular risk despite statin therapy, as identified by having
elevated triglyceride levels and other risk factors, Vascepa
significantly lowered the first occurrence of primary MACE by 25%
and primary plus recurrent MACE by 30%, each compared to placebo.
This benefit appears to derive from the multifactorial effects of
Vascepa, a portion of which appears to be related to lowering
triglyceride levels with the balance of the effects likely
explained by other effects of Vascepa as separately evaluated. As
summarized below, in REDUCE-IT, Vascepa was well tolerated with a
safety profile generally consistent with clinical experience
associated with omega-3 fatty acids and current FDA-approved
labeling of such products.
In addition, at this same medical congress,
Amarin also supported a presentation of Veteran’s Administration
real-world data that showed significant risk increase in
cardiovascular events in people with elevated triglycerides. A
separate presentation of data and analysis concluded that over nine
million atherosclerotic cardiovascular disease (ASCVD) events are
projected to occur in the U.S. within the next ten years in adults
aged 40-79 for whom ASCVD is not established, and over three
million of these events are projected to occur in persons with
elevated TG levels of ≥150 mg/dL, including approximately one
million events in statin users. More information on this research
can be found at https://investor.amarincorp.com/press-releases.
Amarin Corporation plc. is a rapidly growing,
innovative pharmaceutical company focused on developing
therapeutics to improve cardiovascular health. Amarin’s product
development program leverages its extensive experience in
polyunsaturated fatty acids and lipid science. Vascepa® (icosapent
ethyl) is Amarin's first FDA-approved drug and is available by
prescription in the United States, Lebanon and the United Arab
Emirates. Amarin’s commercial partners are pursuing
additional regulatory approvals for Vascepa in Canada, China and
the Middle East. For more information about Amarin, visit
REDUCE-IT1, 2, an 8,179-patient cardiovascular
outcomes study, was completed in 2018. REDUCE-IT was a
multinational cardiovascular outcomes study that evaluated the
effect of prescription pure EPA therapy as an add-on to statins in
patients with high cardiovascular risk who, despite stable statin
therapy, had elevated triglyceride levels (at least 135 mg/dL). A
large portion of the male and female patients enrolled in this
outcomes study were diagnosed with type 2 diabetes.
More information on the REDUCE-IT study results
can be found at www.amarincorp.com.
Worldwide, cardiovascular disease (CVD) remains
the #1 killer of men and women. In the United States CVD leads to
one in every three deaths – one death approximately every 38
seconds – with annual treatment cost in excess of $500 billion.3,
Multiple primary and secondary
prevention trials have shown a significant reduction of 25% to
35% in the risk of cardiovascular
events with statin therapy, leaving significant
persistent residual risk despite the achievement of target LDL-C
Beyond the cardiovascular risk associated with
LDL-C, genetic, epidemiologic, clinical and real-world data suggest
that patients with elevated triglycerides (TG) (fats in the blood),
and TG-rich lipoproteins, are at increased risk for cardiovascular
disease.6, 7, 8, 9
About VASCEPA (icosapent ethyl)
Vascepa (icosapent ethyl) capsules are a
single-molecule prescription product consisting of the omega-3 acid
commonly known as EPA in ethyl-ester form. Vascepa is not fish oil,
but is derived from fish through a stringent and complex
FDA-regulated manufacturing process designed to effectively
eliminate impurities and isolate and protect the single molecule
active ingredient from degradation. Vascepa, known in scientific
literature as AMR101, has been designated a new chemical entity by
the FDA. Amarin has been issued multiple patents
internationally based on the unique clinical profile of Vascepa,
including the drug’s ability to lower triglyceride levels in
relevant patient populations without raising LDL-cholesterol
Indication and Usage Based on Current
FDA-Approved Label (not including REDUCE-IT results)
- Vascepa (icosapent ethyl) is
indicated as an adjunct to diet to reduce triglyceride (TG) levels
in adult patients with severe (≥500 mg/dL)
- The effect of Vascepa on the risk
for pancreatitis and cardiovascular mortality and morbidity in
patients with severe hypertriglyceridemia has not been
Important Safety Information for Vascepa Based
on Current FDA-Approved Label (not including REDUCE-IT results)
(Includes Data from Two 12-Week Studies (n=622) (MARINE and ANCHOR)
of Patients with Triglycerides Values of 200 to 2000 mg/dL)
- Vascepa is contraindicated in
patients with known hypersensitivity (e.g., anaphylactic reaction)
to Vascepa or any of its components.
- In patients with hepatic
impairment, monitor ALT and AST levels periodically during
- Use with caution in patients with
known hypersensitivity to fish and/or shellfish.
- The most common reported adverse
reaction (incidence >2% and greater than placebo) was arthralgia
(2.3% for Vascepa, 1.0% for placebo). There was no reported adverse
reaction >3% and greater than placebo.
- Adverse events and product
complaints may be reported by calling 1-855-VASCEPA or the FDA at
- Patients receiving treatment with
Vascepa and other drugs affecting coagulation (e.g., anti-platelet
agents) should be monitored periodically.
- Patients should be advised to
swallow Vascepa capsules whole; not to break open, crush, dissolve,
or chew Vascepa.
FULL VASCEPA PRESCRIBING INFORMATION CAN BE
FOUND AT WWW.VASCEPA.COM.
Important Safety Information for Vascepa based on REDUCE-IT, as
previously reported in The New England Journal of Medicine2
publication of the primary results of the REDUCE-IT study:
- Excluding the major adverse CV events (MACE) results described
above, overall adverse event rates in REDUCE-IT were similar across
the statin plus Vascepa and the statin plus placebo treatment
- There were no significant differences between treatments in the
overall rate of treatment emergent adverse events or serious
adverse events leading to withdrawal of study drug.
- There was no serious adverse event (SAE) occurring at a
frequency of >2% which occurred at a numerically higher rate in
the statin plus Vascepa treatment group than in the statin plus
placebo treatment group.
- Adverse events (AEs) occurring in 5% or greater of patients and
more frequently with Vascepa than placebo were:– peripheral
edema (6.5% Vascepa patients versus 5.0% placebo patients),
although there was no increase in the rate of heart failure in
Vascepa patients– constipation (5.4% Vascepa patients versus
3.6% placebo patients), although mineral oil, as used as placebo,
is known to lower constipation, and– atrial fibrillation
(5.3% Vascepa patients versus 3.9% placebo patients), although
there were reductions in rates of cardiac arrest, sudden death and
myocardial infarctions observed in Vascepa patients
- There were numerically more SAEs related to bleeding in the
statin plus Vascepa treatment group although overall rates were low
with no fatal bleeding observed in either group and no significant
difference in adjudicated hemorrhagic stroke or serious central
nervous system or gastrointestinal bleeding events between
- In summary, Vascepa was well tolerated with a safety profile
generally consistent with clinical experience associated with
omega-3 fatty acids and current FDA-approved labeling of such
Vascepa has been approved for use by the United
States Food and Drug Administration (FDA) as an adjunct to diet to
reduce triglyceride levels in adult patients with severe (≥500
mg/dL) hypertriglyceridemia. FDA has not reviewed and opined on a
supplemental new drug application related to REDUCE-IT. FDA has not
reviewed the information herein or determined whether to approve
Vascepa for use to reduce the risk of MACE. Nothing in this press
release should be construed as promoting the use of Vascepa in any
indication that has not been approved by the FDA.
Important Cautionary Information About
Recurrent event analyses for the total primary
endpoint events and for the total key secondary endpoint in
REDUCE-IT as published in the Journal of the American College of
Cardiology1 were conducted using a series of statistical models.
These analyses were tertiary or exploratory endpoints; most of the
models used were prespecified and one was post hoc. Each
recurrent event statistical model has inherent strengths and
weaknesses, with no single model considered definitive or
outperforming the other models, and this is an evolving field of
science. Nonetheless, results from the total primary and
total key secondary endpoint events analyses are consistent across
the various recurrent event statistical models and are also
consistent with the original primary and secondary endpoint
results. Together, the REDUCE-IT recurrent event analyses and
the original primary and key secondary endpoint analyses support
the robustness of the clinical benefit of Vascepa therapy in
reducing cardiovascular risk.
Further REDUCE-IT data assessment and data
release could yield additional useful information to inform greater
understanding of the trial outcome. Further detailed data
assessment by Amarin and regulatory authorities will
continue and take several months to complete and record. The final
evaluation of the totality of the efficacy and safety data from
REDUCE-IT may include some or all of the following, as well as
other considerations: new information affecting the degree of
treatment benefit on studied endpoints; study conduct and data
robustness, quality, integrity and consistency; additional safety
data considerations and risk/benefit considerations; consideration
of REDUCE-IT results in the context of other clinical studies.
This press release contains forward-looking
statements, including statements related to cardiovascular risk in
patient groups and various purported effects of EPA. 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 data of this type, research and
development, clinical trials and related regulatory approvals.
A list and description of uncertainties and 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 annual report on Form 10-K. 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.
Availability of Other Information About
Investors and others should note that Amarin
communicates with its investors and the public using the company
website (http://www.amarincorp.com/), the investor relations
website (http://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
1 Bhatt DL, Steg PG, Miller M, et al.
Effects of Icosapent Ethyl on Total Ischemic Events –From
REDUCE-IT. J Am Coll Cardiol 2019. epub ahead of print.
2 Bhatt DL, Steg PG, Miller M, et al.
Cardiovascular Risk Reduction with Icosapent Ethyl for
Hypertriglyceridemia. N Engl J Med 2019;380:11-22.
3 American Heart Association. 2018.
Disease and Stroke Statistics-2018 Update.
4 American Heart Association. 2017.
Cardiovascular disease: A costly burden for America projections
5 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.
6 Budoff M. Triglycerides and triglyceride-rich
lipoproteins in the causal pathway of cardiovascular disease. Am J
7 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.
8 Nordestgaard BG. Triglyceride-rich
lipoproteins and atherosclerotic cardiovascular disease - New
insights from epidemiology, genetics, and biology. Circ Res.
9 Nordestgaard BG, Varbo A. Triglycerides and
cardiovascular disease. Lancet. 2014;384:626–635.
Amarin Contact Information
Investor Relations:Elisabeth SchwartzInvestor Relations and
Corporate CommunicationsAmarin Corporation plcIn U.S.: +1
(908) firstname.lastname@example.org (investor
inquiries)PR@amarincorp.com (media inquiries)
Lee M. Stern Trout Group In U.S.: +1 (646)
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