Amarin Corporation plc (NASDAQ:AMRN) today announced that John F.
Thero, 60, has informed the board of directors of his plan to
retire as president and chief executive officer, effective August
1, 2021. He will also step down from the board at that time. The
board has appointed Karim Mikhail, 50, Amarin’s senior vice
president and head of commercial for Europe, to succeed Mr. Thero
as the company’s next president and chief executive officer. Mr.
Mikhail will join the board upon his effective date. Mr. Thero will
continue to provide his guidance and expertise to the company in an
advisory capacity through the end of 2021.
Mr. Mikhail joined Amarin in 2020 from THEODON,
a global commercial strategy consultancy he founded in 2018. Prior
to this, Mr. Mikhail spent more than 20 years at Merck, where from
2014 to 2018 he served as global commercial leader for Merck’s $4
billion lipid franchise, overseeing P&L and leading the
worldwide launch of ezetimibe with the IMPROVE-IT study indication.
In this role, he was responsible for reversing the business’
decline in the U.S. market and globally, accelerating revenue by an
additional $380 million through the launch of ATOZET and driving
EBITDA growth through international expansion. Prior to that, Mr.
Mikhail led the successful commercial launch of dozens of products,
including ezetimibe and various molecules in diabetes,
hypertension, immunology, and oncology, and served as Merck’s chief
marketing officer for Europe, Middle East and Africa and chief
operating officer for emerging markets. At Amarin, Mr. Mikhail has
been responsible for preparing commercialization of the company’s
lead product in Europe, for which regulatory approval was received
on March 30, 2021.
Dr. Lars Ekman, Chairman of Amarin’s Board of
Directors, commented, “After 12 years at Amarin, and the last seven
as CEO, John has decided now is the right time to announce his
retirement. We owe enormous gratitude to John as under his
leadership roles, with the support of the entire Amarin team, the
company has completed multiple successful clinical trials, launched
its lead product VASCEPA® (icosapent ethyl) in the United States,
and has initiated its international expansion plans, including
commercialization in Europe following the recent marketing
authorization of VAZKEPA from the European Commission. John and the
entire board have taken a thoughtful approach to succession
planning designed to ensure that Amarin is best positioned to both
continue its progress in the United States and accelerate its
growth trajectory globally. The board has been increasingly
impressed with Karim’s strategic and operational capabilities, and
his clear passion for VASCEPA and vision for continuing Amarin’s
progress worldwide make him the clear choice to succeed John. We
look forward to an exciting new chapter for the highly capable
Amarin team under Karim’s leadership.”
“While announcing my retirement is a bittersweet
moment for me, I have every confidence in Amarin and its
outstanding employees who are dedicated to the patients and
shareholders we serve,” said Mr. Thero. “2021 is a pivotal year for
Amarin as we continue to develop markets for our important drug,
VASCEPA. As the first-and-only drug approved by
each of the U.S. FDA, European Commission, and Health Canada for
treatment of the studied high-risk patients with persistent
cardiovascular risk after statin therapy, we are proud of our role
in ushering in a new era in cardiovascular care. With our unique
therapeutic solution and deep bench of internal talent, I believe
that now is an ideal time to transition leadership to Karim as we
work to realize Amarin’s full potential. Since Karim joined Amarin
last year, he has proven himself to be an invaluable member of the
leadership team and a true partner to me as we prepare for the
commercialization of VAZKEPA in Europe. I am excited to continue
working closely with him and the board to facilitate a successful
transition over the coming months.”
Mr. Mikhail stated, “I joined Amarin last year
because I was inspired by the company’s entrepreneurial spirit in
addressing such a large unmet medical need and the potential to set
a new standard of cardiovascular care. I am honored to take on this
new role. We have an unparalleled product with outstanding
evidence, positive efficacy and safety profile, and tremendous
momentum with our near-term European launch plans and expected
commercial approval in China near the end of 2021. Amarin’s team is
first rate and I am excited to build upon the strong commercial
progress in the United States. I look forward to working with John,
the board and the entire Amarin team as we capture the significant
growth opportunities ahead.”
About Karim Mikhail Mr.
Mikhail, 50, joined Amarin in July 2020, and currently serves as
senior vice president and head of commercial for Europe where he
has responsibility for the company’s commercialization of VAZKEPA
in Europe. He was previously with Merck for 22 years, in seven
different countries, spanning three continents, where he held
positions of increasing responsibility, including as global
commercial leader for Merck’s $4 billion lipid franchise and chief
marketing officer for Europe, Middle East and Africa and chief
operating officer for emerging markets. Mr. Mikhail led THEODON, a
global commercial strategy consultancy he founded in 2018.
Mr. Mikhail is a pharmacist by training and
holds a master’s degree in biopharmaceutical marketing and
management from the graduate school of business in Paris, École
Supérieure de Commerce de Paris (ESCP).
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
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.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)
CapsulesVASCEPA (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 StatementsThis
press release contains forward-looking statements, including
statements about expectations for continued company progress in the
United States and accelerated growth trajectory globally,
anticipated regulatory approvals and related timing and a smooth
management transition. These forward-looking statements are not
promises or guarantees and involve substantial risks and
uncertainties that may individually or together impact the matters
herein and cause actual results, events and performance to differ
materially from such forward looking statements. Among the factors
that could cause actual results to differ materially from those
described or projected herein include the following: events that
could impact future regulatory assessment, such as delays due to
COVID-19 restrictions, later arising data, regulatory reviews and
pricing assessments, and the successful implementation of
commercialization plans or other information, uncertainties
associated with litigation generally and patent litigation
specifically; Amarin's ability generally to maintain adequate
patent protection and successfully enforce patent claims against
third parties; and uncertainties associated generally with research
and development and regulatory submissions, reviews, action dates
and approvals. 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 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. 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
AmarinInvestors 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) 719-1315 IR@amarincorp.com
(investor inquiries)
Solebury Troutamarinir@troutgroup.com
Media Inquiries:CommunicationsAmarin Corporation
plcIn U.S.: +1 (908) 892-2028 PR@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
HeartAssociation. Circulation. 2020;141:e139–e596. 2 Ganda OP,
Bhatt DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia
therapy in hypertriglyceridemiamanagement. 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
cardiovascularrisk. J Am Heart Assoc. 2018;7(15):e008740.5
Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic
cardiovascular disease - New insights fromepidemiology, 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.
Cardiovascular Risk Reduction with Icosapent Ethyl for
Hypertriglyceridemia. N Engl J Med. 2019;380(1):11-22.8 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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