Amarin Corporation plc (NASDAQ:AMRN) today announced the first
European launch of VAZKEPA (icosapent ethyl) in Germany. VAZKEPA
received marketing authorization from the European Commission in
March 2021 and the Medicines and Healthcare Products Regulatory
Agency (MHRA) in Great Britain in April 2021. VAZKEPA is indicated
as a treatment to reduce the risk of cardiovascular events in
statin-treated adult patients at high cardiovascular risk who have
elevated triglycerides (≥ 150 mg/dL [≥ 1.7 mmol/L]) and either
established cardiovascular disease or diabetes and at least one
additional cardiovascular risk factor.1
The European launch of VAZKEPA, beginning in
Germany, is supported by more than a decade of evidence-based
cardiovascular clinical outcomes research including the landmark
REDUCE-IT® study, a groundbreaking study2 which established that
VASCEPA®/VAZKEPA lowers the risk of a life-threatening heart attack
or stroke by 25% when added to a statin in the targeted population.
Importantly, VASCEPA/VAZKEPA has been included in the treatment
guidelines for cardiovascular disease (CVD) prevention by the
European Society of Cardiology, the European Association of
Preventive Cardiology and the European Atherosclerosis Society, in
addition to 17 other medical guidelines around the world.
The launch of VAZKEPA in Germany featured a
scientific conference in Berlin titled, “New therapeutic strategies
for residual CV risk management,” which highlighted the scientific
underpinnings and clinical benefits of VASCEPA/VAZKEPA in reducing
cardiovascular risk. The symposium was led by eleven
internationally renowned cardiovascular specialists, was attended
by more than 200 healthcare professionals from Germany and was live
streamed to many more physicians across the continent. The event
has been archived and is available to thousands of physicians
across Europe.
Amarin’s president and chief executive officer,
Karim Mikhail, stated, “The German launch is a historic moment for
Amarin, as it is the first European country where VAZKEPA’s proven
cardioprotective benefits are available to healthcare providers and
patients. This is particularly important as CVD is the number one
cause of death in Europe.” Mr. Mikhail added, “Our European launch
marks a key milestone in our corporate growth strategy to bring the
cardiovascular risk reduction benefits of VASCEPA/VAZKEPA to
at-risk patients around the world. As Germany is the fourth largest
global economy and there are more than 300,000 deaths due to CVD in
Germany every year3, it represents both a significant market need
and opportunity.”
Laurent Abuaf, recently appointed as senior vice
president and president of Europe, further noted, “Throughout last
year Amarin made great progress building the commercial
infrastructure in Europe and has recruited and trained a talented
team of nearly 200 professionals to execute VAZKEPA’s launch. We
are especially pleased with our successful German launch event and
look forward to executing our plans to launch VAZKEPA across
multiple European countries before the end of 2022.” Mr. Abuaf
continued, “Cardiovascular disease (CVD) is one of Europe’s biggest
health crises, costing the European Union €210 billion a year,4 and
resulting in 3.9 million deaths.5 Amarin has ambitious plans to
tackle this growing healthcare burden by working in partnership
with healthcare professionals across the continent to challenge the
conventions surrounding CVD care.”
Amarin has already filed market access dossiers
in five out of the ten planned “first wave” European country
submissions. The dossiers were filed in Germany, the United
Kingdom, France, Italy and Denmark and, over the next quarter,
Amarin plans to submit the remaining five dossiers. The company is
committed to bringing the benefits of VAZKEPA to as many patients
in Europe as quickly as possible.
With its global headquarters in Ireland and a
new commercial hub in Zug, Switzerland, Amarin has strong European
roots and the infrastructure necessary to support the company’s
plans to build a local commercial presence in all major European
markets for a series of successful launches across the
continent.
About AmarinAmarin 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 advancing the
scientific understanding of cardiovascular risk and its impact on
society, in particular, the 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 and one of Europe’s biggest health crises,
costing the European Union €210 billion a year,6 and resulting in
3.9 million deaths.7 In the United States, cardiovascular disease
results in 859,000 deaths per year.8 And the number of deaths
in the United States attributed to cardiovascular disease continues
to rise.
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%.9 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.10,11,12
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.13 The primary results of REDUCE-IT were published
in The New England Journal of Medicine in November
2018.14 The total events results of REDUCE-IT were published
in the Journal of the American College of Cardiology in
March 2019.15 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.
FOR FURTHER INFORMATION ABOUT THE SUMMARY OF PRODUCT
CHARACTERISTICS (SMPC) FOR VAZKEPA® IN EUROPE,
PLEASE click here.
Forward-Looking StatementsThis press release
contains forward-looking statements which are made pursuant to the
safe harbor provisions of the Private Securities Litigation Reform
Act of 1995, including beliefs about the world-wide market
potential for VASCEPA/VAZKEPA; expectations regarding financial
metrics and performance such as prescription growth, revenue
growth, operating expenses, inventory purchases, and managed care
coverage for VASCEPA/VAZKEPA, including the impact of the COVID-19
pandemic, the disappointing outcome of patent litigation and the
launch of generic competition on these metrics; beliefs that Amarin
is well positioned to deliver on its goals to grow VASCEPA in the
U.S. and beyond; beliefs about patient needs for VASCEPA/VAZKEPA;
effects of the COVID-19 pandemic on Amarin's operations and on the
healthcare industry more broadly, which effects continue to be
fluid; beliefs that Amarin's strategy for reducing the effects of
cardiovascular disease is sound and that Amarin is efficiently
reaching physicians, payors, pharmacists and patients; plans for
Amarin's go-to-market model; the timing and outcome of regulatory
reviews, recommendations and approvals and related reimbursement
decisions and commercial launches in Europe, the China region and
elsewhere; plans for Amarin's expected launch of VASCEPA/VAZKEPA
directly in major markets in Europe, directly and indirectly;
beliefs about the cardioprotective and other benefits of
VASCEPA/VAZKEPA; beliefs about the strength of data in market
access dossiers and other reports; expectations for the timing,
effectiveness and outcome of promotional activities, including
patient-oriented campaigns, conference and posted presentations and
education of healthcare professionals; commercial and international
expansion, prescription growth and revenue growth and future
revenue levels, including the contributions of sales
representatives and the new leadership team; beliefs that Amarin's
current resources are sufficient to fund projected operations;
ongoing patent litigation efforts; and the impact of the COVID-19
pandemic on all of the forgoing. These forward-looking statements
are not promises or guarantees and involve substantial risks and
uncertainties. Amarin's ability to effectively commercialize
VASCEPA/VAZKEPA and maintain or grow market share will depend in
part on Amarin’s ability to continue to effectively finance its
business, VASCEPA/VAZKEPA approval in geographies outside the U.S.,
efforts of third parties, Amarin’s ability to create and increase
market demand for VASCEPA/VAZKEPA through education, marketing and
sales activities, to achieve broad market acceptance of
VASCEPA/VAZKEPA, to receive adequate levels of reimbursement from
third-party payers, 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/VAZKEPA and to secure, maintain and defend its patent
protection for VASCEPA/VAZKEPA. Among the factors that could cause
actual results to differ materially from those described or
projected herein include the following: the possibility that
VASCEPA/VAZKEPA may not receive regulatory approval in the China
region or other geographies on the expected timelines or at all,
the risk that additional generic versions of VASCEPA/VAZKEPA will
enter the market and that generic versions of VASCEPA/VAZKEPA will
achieve greater market share and more commercial supply than
anticipated, particularly in light of the recent and disappointing
outcome of Amarin's litigation against two generic drug companies
and subsequent requests for appeal; the risk that the scope and
duration of the COVID-19 pandemic will continue to impact access to
and sales of VASCEPA/VAZKEPA; the risk that Amarin has
overestimated the market potential for VASCEPA/VAZKEPA in the U.S.,
Europe and other geographies; risks associated with Amarin's
expanded enterprise; 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/VAZKEPA 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
Amarin’s quarterly report on Form 10-Q for the quarter ended June
30, 2021, filed on or about the date hereof. Existing and
prospective investors are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date
they are made. Amarin undertakes no obligation to update or revise
the information contained in its forward looking statements,
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)
719-1315IR@amarincorp.com (investor inquiries)Solebury
Troutamarinir@troutgroup.com
Media Inquiries:CommunicationsAmarin Corporation plcIn U.S.: +1
(908) 892-2028PR@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 Summary of Product Characteristics Vazkepa – April 2021
https://ec.europa.eu/health/documents/community-register/2021/20210326150935/anx_150935_en.pdf.
Accessed August 20212 REDUCE-IT® study N Engl J
Med. 2019;380(1):11-22.3 Destatis: Federal Statistical Office:
Causes of death - the number of deaths fell by 1.6% in
2019. (last accessed on January 6, 2021)4 European Society of
Cardiology. ESC Cardiovascular Realities 2020.
https://www.flipsnack.com/Escardio/esc-cardiovascular-realities-2020/full-view.html.
Accessed August 20215 European Heart Network. European
Cardiovascular Disease Statistics 2017.
https://ehnheart.org/cvd-statistics/cvd-statistics-2017.html.
Accessed August 20216 European Society of Cardiology. ESC
Cardiovascular Realities 2020.
https://www.flipsnack.com/Escardio/esc-cardiovascular-realities-2020/full-view.html.
Accessed August 20217 European Heart Network. European
Cardiovascular Disease Statistics 2017.
https://ehnheart.org/cvd-statistics/cvd-statistics-2017.html.
Accessed August 20218 American Heart Association. Heart Disease and
Stroke Statistics—2020 Update: A Report From the American Heart
Association. Circulation. 2020;141:e139-e596.9 Ganda OP, Bhatt DL,
Mason RP, et al. Unmet need for adjunctive dyslipidemia therapy in
hypertriglyceridemia management. J Am Coll Cardiol.
2018;72(3):330-343.10 Budoff M. Triglycerides and triglyceride-rich
lipoproteins in the causal pathway of cardiovascular disease. Am J
Cardiol. 2016;118:138-145.11 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):e008740.12 Nordestgaard BG. Triglyceride-rich
lipoproteins and atherosclerotic cardiovascular disease - New
insights from epidemiology, genetics, and biology. Circ Res.
2016;118:547-563.13 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;40:138-148.14 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;380:11-22.15 Bhatt DL,
Steg PG, Miller M, et al., on behalf of the REDUCE-IT
investigators. Effects of Icosapent Ethyl on Total Ischemic Events:
From REDUCE-IT. J Am Coll Cardiol. 2019;73:2791-2802.
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