Amarin Corporation plc (NASDAQ: AMRN) today outlined its new
Go-to-Market strategy to accelerate growth of VASCEPA® (icosapent
ethyl) in the United States, which focuses on expanding healthcare
professional engagement through a new omnichannel platform,
enhancing managed care access and optimizing VASCEPA prescriptions
for cardiovascular (CV) risk reduction.
“Amarin is embarking on a transformation to a
new, integrated Go-to-Market approach in the U.S., furthering our
mission of helping millions of untreated, at-risk patients gain
access to VASCEPA,” said Karim Mikhail, Amarin’s president and
chief executive officer. “We are seeing a dramatic shift in how
physicians prefer to engage and are applying key learnings from our
European launch initiatives as we work to maximize our impact with
both healthcare professionals and patients. We continue to believe
that there is enormous opportunity for VASCEPA/VAZKEPA in the U.S.
and throughout the rest of the world. With this new strategy, we
are confident in our ability to drive U.S. growth and realize the
full potential of our first-of-its kind product as we continue to
execute our global strategic plan to create value for all
shareholders.”
Aaron Berg, Amarin’s executive vice president
and president, U.S., added, “Our new Go-to-Market strategy is a
more dynamic, nimble and efficient approach to educating healthcare
professionals and patients about our product to reduce
cardiovascular risk. We believe this strategy will allow Amarin to
accelerate VASCEPA prescription growth and drive an increasingly
profitable U.S. franchise.”
Key Strategic Priorities
- Expanding Healthcare
Provider Engagement: Amarin’s omnichannel approach will
enhance the Company’s reach to healthcare professionals, targeting
a far greater number of the almost 700,000 statin prescribers
through high frequency, tailored and impactful messaging regarding
the significant benefits of VASCEPA for CV risk
reduction.Consistent with this model, Amarin will optimize its U.S.
field force and focus on the most productive territories. This will
result in a reduction of Amarin’s U.S. field force to approximately
300 sales representatives who will remain a critical part of the
Company’s commercial strategy going forward. Amarin will reinvest
the realized net savings towards its expanded educational and
promotional efforts.
- Enhancing Managed Care
Access: Amarin will continue working with payers to
enhance its strong managed care position and further remove
barriers to VASCEPA prescriptions to ensure that patients in need
of CV risk reduction receive proper therapy. Importantly, several
large Commercial and Medicare Part D payers currently cover VASCEPA
as the exclusive icosapent ethyl (IPE) product due to its
cost-effectiveness.
- Optimizing VASCEPA
Prescriptions for CV Risk Reduction: Today, branded
VASCEPA remains the only available U.S. Food and Drug
Administration (FDA) approved IPE medication for CV risk reduction.
To prevent improper generic substitution for this indication,
Amarin is continuing to aggressively educate critical stakeholders
in the prescribing continuum to ensure proper fulfillment at each
step. Additionally, Amarin is evaluating various innovative
solutions designed to better manage IPE prescriptions for CV risk
reduction.
Mr. Berg concluded, “Our people have always been
and remain the foundation of our business. Decisions that impact
people are never easy, and we are making every effort to support
those employees who are affected by our field force
optimization.”
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 Risk
Cardiovascular 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 VASCEPA® (icosapent ethyl)
Capsules
VASCEPA (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.
FULL U.S. FDA-APPROVED
VASCEPA PRESCRIBING
INFORMATION CAN BE FOUND
AT WWW.VASCEPA.COM.
Forward-Looking Statements
This press release contains forward-looking
statements which are made pursuant to the safe harbor provisions of
the Private Securities Litigation Reform Act of 1995 and other
securities laws. Any statements contained herein which do not
describe historical facts, including, among others, statements
regarding beliefs about Amarin’s go-to-market strategy and its
ability to accelerate growth of VASCEPA in the United States,
including through enhanced managed care access, prescription
optimization and capitalizing on existing revenue growth
opportunities; beliefs about physician engagement; expectations
regarding Amarin’s ability to drive U.S. growth, create shareholder
value and drive an increasingly profitable franchise; plans
regarding Amarin’s key strategic priorities, including to expand
healthcare provider engagement, enhance managed care access and
optimize prescriptions for cardiovascular risk reduction; plans to
reduce the Amarin field force and support impacted employees;
beliefs that there will be enormous worldwide opportunity for
VASCEPA and expectations regarding the full potential of VASCEPA as
a first-of-its kind product. These forward-looking statements
are not promises or guarantees and involve substantial risks and
uncertainties, which could cause actual results to differ
materially from those described or projected herein, including
(among others): Amarin may be unsuccessful in implementing its
go-to-market strategy or, even if successful, may not achieve the
expected results of such efforts; the risk that Amarin has
overestimated the market potential for VASCEPA in the United
States, Europe and other geographies; the possibility that VASCEPA
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 will enter the market and
that generic versions of VASCEPA 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;
risks associated with Amarin’s evolving 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
franchise. Further, Amarin’s ability to effectively
commercialize VASCEPA and maintain or grow market share will depend
in part on Amarin’s ability to continue to effectively finance its
business, VASCEPA approval in geographies outside the U.S., efforts
of third parties, Amarin’s ability to create and increase market
demand for VASCEPA through education, marketing and sales
activities, to achieve broad market acceptance of VASCEPA, 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
and to secure, maintain and defend its patent protection for
VASCEPA. A list of additional risks and uncertainties, and
further description of the foregoing risks and uncertainties,
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 and subsequent filings with the Commission. 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
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 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)________________________________________
1 American Heart Association. Heart Disease and Stroke
Statistics—2020 Update: A Report From the American Heart
Association. Circulation. 2020;141:e139-e596.2 Ganda OP, Bhatt DL,
Mason RP, et al. Unmet need for adjunctive dyslipidemia therapy in
hypertriglyceridemia management. J Am Coll Cardiol.
2018;72(3):330-343.3 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 cardiovascular risk. J Am Heart Assoc.
2018;7(15):e008740.5 Nordestgaard BG. Triglyceride-rich
lipoproteins and atherosclerotic cardiovascular disease - New
insights from epidemiology, genetics, and biology. Circ Res.
2016;118:547-563.
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