Amarin Corporation plc (NASDAQ:AMRN), a pharmaceutical company
focused on improving cardiovascular health, announced today
that John F. Thero, president and chief executive officer of
Amarin, has been named EY’s 2019 Entrepreneur of The Year National
Award® for Life Sciences. The global business leader awards
program, founded in 1986, recognizes entrepreneurs who are
excelling in areas such as innovation, financial performance and
personal commitment to their businesses and communities. Mr. Thero
was named EY’s Entrepreneur of The Year 2019 Award for Life
Sciences in the New Jersey Region in June 2019, thus placing him in
the running for the national award.
“This award is a great honor, especially in
light of the many outstanding people, and the achievements of their
companies, that were considered,” stated Mr. Thero. “The
award is a tribute to the significant pioneering progress made by
Amarin’s dedicated employees in advancing cost-effective
preventative care solutions for reducing the risk of cardiovascular
disease, which is on the rise in the United States. Breakthroughs
in preventative cardiovascular care are rare and greatly needed.
Hopefully this award will bring added attention to Amarin’s efforts
in developing an innovative treatment option for high risk patients
that reduces cardiovascular risk beyond cholesterol
management.”
Mr. Thero was presented with this award
Saturday, Nov. 16, at Ernst & Young’s annual Strategic Growth
Forum. The selection of Mr. Thero for this award was made 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, Mr.
Thero led, together with Amarin’s employees, consultants and
advisors, 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. Mr. Thero credits
Amarin’s diverse and talented team of employees and believes that
Amarin is just getting started on a path to helping improve health
for millions of people.
Investor Webcast on November 18, 4:30
p.m., Eastern U.S. Time Recapping Data
Presented at the American Heart Association 2019 Scientific
Sessions
Amarin will host a webcast at 4:30 p.m. Eastern
U.S. Time, November 18, 2019. The webcast will be accessible
through the investor relations section of the company’s website at
www.amarincorp.com. The webcast can also be heard via telephone by
dialing 877-407-8033. A replay of the webcast will be available for
two weeks following the webcast. To hear a replay of the webcast,
dial 877-481-4010 (inside the United States) or 919-882-2331
(outside the United States). A replay of the webcast will also be
available through the company's website shortly after the webcast.
For both dial-in numbers please use conference ID 55923.
About Amarin
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 www.amarincorp.com.
REDUCE-IT Study
REDUCE-IT, an 8,179-patient cardiovascular
outcomes study, was completed in 2018.1 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
The number of deaths in the United States
attributed to cardiovascular disease continues to
rise.1,2 There are 605,000 new and 200,000 recurrent heart
attacks per year (approximately 1 every 40 seconds), in the United
States. Stroke rates are similar, accounting for 1 of every 19 U.S.
deaths (approximately 1 every 40 seconds).3
Controlling bad cholesterol, also known as
LDL-C, is one way to reduce a patient’s risk for cardiovascular
events. 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 high
triglycerides, a type of fat in the blood. Statin therapy has been
shown to control LDL-C, thereby reducing the risk of cardiovascular
events by 25-35% – but that still leaves a 65-75% risk remaining.4
People with high triglycerides have 35% more cardiovascular events
compared to people with normal (in range) triglycerides taking
stains.5,6,7,8
About VASCEPA (icosapent ethyl)
Capsules
Vascepa (icosapent ethyl) capsules are a
single-molecule prescription product consisting of the omega-3 acid
commonly known as EPA in ethyl-ester form (known as icosapent ethyl
or IPE). 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.
The FDA has not reviewed the information herein
or determined whether to approve Vascepa for use to reduce the risk
of major adverse cardiovascular events as studied in REDUCE-IT.
Indication and Usage Based on Current FDA-Approved Label (not
including REDUCE-IT results) |
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Vascepa (icosapent ethyl) is indicated as an adjunct to diet to
reduce triglyceride (TG) levels in adult patients with severe (≥500
mg/dL) hypertriglyceridemia. |
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The effect of Vascepa on the risk for pancreatitis and
cardiovascular mortality and morbidity in patients with severe
hypertriglyceridemia has not been determined. |
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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) |
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Vascepa is contraindicated in patients with known hypersensitivity
(e.g., anaphylactic reaction) to Vascepa or any of its
components. |
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In patients with hepatic impairment, monitor ALT and AST levels
periodically during therapy. |
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Use with caution in patients with known hypersensitivity to fish
and/or shellfish. |
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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. |
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Adverse events and product complaints may be reported by calling
1-855-VASCEPA or the FDA at 1-800-FDA-1088. Patients receiving
treatment with Vascepa and other drugs affecting coagulation (e.g.,
anti-platelet agents) should be monitored periodically. |
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Patients should be advised to swallow Vascepa capsules whole; not
to break open, crush, dissolve, or chew Vascepa. |
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FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT
WWW.VASCEPA.COM. |
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Important Safety Information for Vascepa based on REDUCE-IT, as
previously reported in The New England Journal of Medicine
publication of the primary results of the REDUCE-IT study: |
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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. |
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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. |
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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. |
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Adverse events (AEs) occurring in 5% or greater of patients and
more frequently with Vascepa than placebo were: |
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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 |
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constipation (5.4% Vascepa patients versus 3.6% placebo patients),
although mineral oil, as used as placebo, is known to lower
constipation, and |
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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 |
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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
treatments. |
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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
products. |
Forward-Looking
Statements
This press release contains forward-looking
statements, including statements related to the potential for
improving patient care and creating future company growth. 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 research and development, clinical trials
and related regulatory submissions, reviews and approvals;
the risk that data interpretations or other information from third
parties, the regulatory review process, regulatory authorities and
in connection with an advisory committee could be made public that
are negative or may delay approval or limit Vascepa’s
marketability; the risk that special protocol assessment (SPA)
agreements with the FDA are not a guarantee that FDA will approve a
product candidate; the risk associated with the FDA's rescinding
the REDUCE-IT SPA agreement; the risk related to FDA advisory
committee meetings; and the risk that the FDA may not complete its
review of the REDUCE-IT sNDA within the timing expected. 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
Amarin
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 1933.
Amarin Contact Information
Investor Inquiries:Elisabeth SchwartzInvestor
RelationsAmarin Corporation plcIn U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com
Lee M. SternSolebury TroutIn U.S.: +1 (646) 378-2992
lstern@soleburytrout.com
Media Inquiries:Gwen FisherCorporate
Communications Amarin Corporation plcIn U.S.: +1 (908) 325-0735
pr@amarincorp.com
References
1 American Heart Association. Heart Disease and Stroke
Statistics – 2019 Update: A Report from the American Heart
Association. Published January 31, 2019.
2 American Heart Association / American Stroke Association..
2017. Cardiovascular disease: A costly burden for America
projections through 2035.
3 American Heart Association: Heart Disease and Stroke
Statistics -- 2019 At-a-Glance.
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. 2014;384:626–635.
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