Amarin Corporation plc (NASDAQ:AMRN), today announced the
company’s plans to undertake its own focused commercial launch of
VASCEPA® (icosapent ethyl) in Europe. Amarin’s plan is subject to
review and approval of its Marketing Authorization Application
(MAA) by the European Medicines Agency and the European Commission,
respectively. The application is in the late stages of review for
the reduction of cardiovascular (CV) risk in high-risk patients
based on the REDUCE-IT® cardiovascular outcomes study.
“With more than 80 million people in Europe with
cardiovascular disease1, there is a significant and untapped market
opportunity for a safe and effective treatment beyond conventional
therapies for cardiovascular risk reduction for appropriate
patients based on the REDUCE-IT study,” said John Thero, president
and chief executive officer, Amarin. “In anticipation of approval,
we conducted an extensive evaluation of the commercial options for
VASCEPA in Europe. Based on that analysis, we determined that a
commercialization team within Amarin and dedicated to VASCEPA is
the best choice to maximize the blockbuster potential of the drug
in Europe. Amarin’s plan will allow the company to retain
substantially all of the economic benefits of this sizeable market
opportunity in key regions within Europe and is expected to result
in select partnering transactions in certain smaller countries.
Amarin has the passion, commitment and in-depth understanding of
the product and its unique cardiovascular benefits necessary for a
commercial launch. We look forward to advancing VASCEPA through the
regulatory process and maximizing the blockbuster potential of
VASCEPA in Europe to help millions of patients in need.”
Ten to eleven years of market protection is
anticipated from regulatory exclusivity in connection with VASCEPA
approval based on REDUCE-IT in Europe. Amarin has filed for
additional patent protection, which has the potential to extend
exclusivity into 2039.
Over the past year, Amarin has made considerable
progress laying the foundation for a successful commercial launch
in Europe. While not yet approved for sale in Europe, VASCEPA is
already included in the medical treatment guidelines of the
European Society of Cardiology (ESC) and the European
Atherosclerosis Society. Amarin is also looking forward to
supporting a series of robust clinical data presentations
highlighting the role of VASCEPA in CV risk reduction at the ESC
annual meeting later this month. In addition, Amarin has been
conducting market analysis and payor access research in order to
size the market opportunity and prepare for the reimbursement
negotiations in the various countries.
To enable Amarin to deliver on its vision in
Europe, the company announces its recent hiring of Karim Mikhail as
senior vice president, commercial head Europe. Mr. Mikhail joins
Amarin from THEODON, a global commercial strategy consultancy that
he founded in 2018 and where he served as chief executive officer.
Prior to that, he was with Merck for 22 years, in a career spanning
seven different countries across three continents. His most recent
role was global commercial leader for Merck’s $4 billion lipid
franchise, where he led the global launch of ezetimibe with the
IMPROVE-IT study indication. Prior to that Mr. Mikhail was also
chief marketing officer for Europe, Middle East and Africa and
chief operating officer for emerging markets. While at Merck, Mr.
Mikhail led the successful commercial launch of dozens of products,
including ezetimibe and various molecules in diabetes,
hypertension, immunology, and oncology.
At Amarin, Karim plans on selecting a team of
highly talented professionals to fill key positions while
leveraging third-party relationships to focus further on product
reimbursement and launch plans. Reimbursement, which needs to be
sought for VASCEPA on a country-by-country basis, should be
supported by the drug’ s demonstrated effectiveness and support
from leaders in the medical community.
Based on its current plans and expectations,
Amarin believes that its current capital resources are sufficient
to achieve sustained positive cash flows from VASCEPA, including
commercial launch of VASCEPA in Europe. Physician targets to be
educated about VASCEPA in Europe tend to be more concentrated than
in the United States. In addition, the efficiency of launching a
product and educating physicians in Europe should be aided by
innovations in digital communication and other forms of education
and promotion.
“We are delighted to welcome Karim to the Amarin
team,” continued Mr. Thero. “He is an accomplished professional
with a successful track record in building organizations and
commercializing numerous products in Europe and internationally.
Karim brings to Amarin extensive European regulatory experience,
market access expertise and the commercial innovation needed to
successfully launch VASCEPA in Europe. Importantly, Karim shares
our vision and excitement for VASCEPA and its potential
multi-billion-dollar market opportunity in Europe.”
“Assuming market authorization is granted in
early 2021, we look forward to the successful launch of VASCEPA as
the first and only non-LDL lowering agent approved in Europe with a
cardiovascular disease risk reduction indication as an adjunct to
statin therapy in dyslipidemic patients,” concluded Mr. Thero.
About Amarin
Amarin Corporation plc is a rapidly growing,
innovative pharmaceutical company focused on developing and
commercializing therapeutics to cost-effectively improve
cardiovascular health. Amarin’s lead product, VASCEPA (icosapent
ethyl), is available by prescription in the United States, Canada,
Lebanon, and the United Arab Emirates. Amarin, together with its
commercial partners in select geographies, is pursuing additional
regulatory approvals for VASCEPA in China, Europe, and the Middle
East. For more information about Amarin, visit
www.amarincorp.com.
About Cardiovascular Risk
The number of deaths in the United States
attributed to cardiovascular disease continues to rise. 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 795,000 per year (approximately 1 every 40 seconds),
accounting for 1 of every 19 U.S. deaths. Cardiovascular disease
results in 859,000 deaths per year in the United States.2 In
aggregate, this is more than 2.4 million major adverse
cardiovascular events per year from cardiovascular disease or, on
average, 1 every 13 seconds in the United States alone.
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%.3 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.4,5,6
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 U.S. FDA. The design of
the REDUCE-IT study was published in March 2017 in Clinical
Cardiology.7 The primary results of REDUCE-IT were published in The
New England Journal of Medicine in November 2018.8 The total events
results of REDUCE-IT were published in the Journal of the American
College of Cardiology in March 2019.9 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.
FDA comprised solely of the active ingredient, icosapent
ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was
initially launched in the United States in 2013 based on the drug’s
initial U.S. 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 in the U.S.,
VASCEPA has been prescribed over eight million times. VASCEPA is
covered by most major medical insurance plans. The new,
cardiovascular risk indication for VASCEPA was approved by the U.S.
FDA in December 2019.
U.S. FDA Indications and Limitation of Use
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 = 4089 n (%) |
Incidence Rate (per 100 patient years) |
N = 4090 n (%) |
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 VASCEPA
PRESCRIBING INFORMATION CAN BE FOUND
AT WWW.VASCEPA.COM.
Forward-Looking Statements
This press release contains forward-looking
statements, including expectations regarding commercialization
plans and anticipated regulatory approvals and pricing
determinations in Europe and expectations related to exclusivity in
various jurisdictions and associated business plans in various
scenarios. These forward-looking statements are not promises or
guarantees and involve substantial risks and uncertainties.
Amarin's ability to effectively commercialize VASCEPA will depend
in part on its ability to continue to effectively finance its
business, efforts of third parties, its ability to create market
demand for VASCEPA through education, marketing and sales
activities, to achieve broad market acceptance of VASCEPA, to
receive adequate levels of reimbursement from relevant
third-parties, 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 and maintain exclusivity and patent
protection for VASCEPA. 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 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
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.
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
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.
Amarin Contact Information
Investor Inquiries:Elisabeth SchwartzInvestor
RelationsAmarin Corporation plcIn U.S.: +1 (908)
719-1315IR@amarincorp.com (Investor inquiries)
Lee M. SternSolebury TroutIn U.S.: +1 (646)
378-2992lstern@soleburytrout.com
Media Inquiries:Alina
KolomeyerCommunicationsAmarin Corporation plcIn U.S.: +1 (908)
892-2028PR@amarincorp.com (media inquiries)
References
1 http://www.ehnheart.org/cvd-statistics.html2 American Heart
Association. Heart Disease and Stroke Statistics—2020 Update: A
Report From the American Heart Association. Circulation.
2020;141:e139–e596.3 Ganda OP, Bhatt DL, Mason RP, et al. Unmet
need for adjunctive dyslipidemia therapy in hypertriglyceridemia
management. J Am Coll Cardiol. 2018;72(3):330-343.4 Budoff M.
Triglycerides and triglyceride-rich lipoproteins in the causal
pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.5
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):e008740.6 Nordestgaard BG.
Triglyceride-rich lipoproteins and atherosclerotic cardiovascular
disease - New insights from epidemiology, genetics, and biology.
Circ Res. 2016;118:547-563.7 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;40:138-148.8 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;380:11-22.9 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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