Amarin Corporation plc (NASDAQ:AMRN), a pharmaceutical company
focused on the commercialization and development of therapeutics to
improve cardiovascular health, announced today that John F. Thero,
president and chief executive officer of Amarin, has been named
EY’s Entrepreneur of The Year 2019 Award for Life Sciences in the
New Jersey Region. The global business leader awards program, which
was founded in 1986, recognizes entrepreneurs who are excelling in
areas such as innovation, financial performance and personal
commitment to their businesses and communities.
“I am pleased that Amarin’s significant progress
and innovative work is recognized by this award and thank the
judges and our employees for this honor,” commented Mr. Thero.
“This award reflects the high quality of Amarin’s employees and is
a testament to our company’s accomplishments in addressing the
enormous public health issue of cardiovascular disease. We are
privileged to have significant operations in New Jersey, a state
with high-caliber talent and resources.”
Thero was presented with this award last evening
following his selection by a panel of independent judges consisting
of prior award winners, and civic and community leaders not
affiliated with EY.
Becoming chief executive officer in 2014, Thero led
the transformation of Amarin from a company with its survival in
question to a company with robust compounded commercial business
growth and game-changing scientific achievement. For example, in
late 2018, Amarin completed the REDUCE-IT™ cardiovascular outcomes
study, which many leading physicians have characterized as one of
the most significant breakthroughs in decades for preventative
cardiovascular care. Thero credits Amarin’s success to its highly
engaged, diverse team of employees and believes that Amarin is just
getting started on a path to improve care for millions of
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, an 8,179-patient cardiovascular
outcomes study, was completed in 2018. REDUCE-IT was the first
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.
About Cardiovascular Disease
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.2,3
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
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 levels.
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
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
- Excluding the major adverse
cardiovascular 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 groups.
- 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.
This press release contains forward-looking
statements, including statements related to the potential impact of
Vascepa on patient care, cardiovascular risk in particular patient
groups and data suggesting the potential benefits of Vascepa. 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; the
risk that sales of Vascepa may not meet expectations and the risk
that patents may not be upheld 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 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.
Availability of Other Information About
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.
1 Bhatt DL, Steg PG, Miller M, et al.
Cardiovascular Risk Reduction with Icosapent Ethyl for
Hypertriglyceridemia. N Engl J Med
2019;380:11-22.2 American Heart Association. 2018.
Disease and Stroke Statistics-2018 Update.3 American
Heart Association. 2017. Cardiovascular disease: A costly burden
for America projections through 2035.4 Ganda OP, Bhatt
DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia therapy
in hypertriglyceridemia management. J Am Coll Cardiol.
2018;72(3):330-343.5 Budoff M. Triglycerides and
triglyceride-rich lipoproteins in the causal pathway of
cardiovascular disease. Am J Cardiol.
2016;118:138-145.6 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):e008740.7 Nordestgaard BG. Triglyceride-rich
lipoproteins and atherosclerotic cardiovascular disease - New
insights from epidemiology, genetics, and biology. Circ Res.
2016;118:547-563.8 Nordestgaard BG, Varbo A.
Triglycerides and cardiovascular disease. Lancet.
Amarin Contact Information
Investor Relations:Elisabeth SchwartzInvestor Relations Amarin
Corporation plcIn U.S.: +1 (908)
Lee M. SternTrout Group In U.S.: +1 (646)
Media Inquiries: Gwen Fisher Corporate CommunicationsAmarin
Corporation plcIn U.S.: +1 (908)
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