Amarin Corporation plc (NASDAQ:AMRN), today announced that it
intends to increase the level and breadth of its promotion and
education initiatives regarding VASCEPA® (icosapent ethyl).
As early signs emerge of patients returning to physicians’ offices,
Amarin plans to emphasize its key marketing messages including
positioning VASCEPA as the only FDA-approved drug for lowering the
persistent cardiovascular risk beyond statin therapy for millions
of high-risk patients.
While VASCEPA has been developed and clinically
tested for over a decade, it was less than six months ago (December
2019) that the FDA approved VASCEPA for its unique cardiovascular
risk reduction indication. Most healthcare professionals and
at-risk patients are unaware that VASCEPA is the first and only
drug with this important new indication. For this reason, and the
emerging return of patients, Amarin believes the opportunity exists
for increasing awareness of VASCEPA and its potential to provide an
important healthcare solution to reduce cardiovascular risk in
high-risk patients.
In the United States alone, someone suffers a
heart attack, stroke, or other major adverse event from
cardiovascular disease on average every 13 seconds. Cardiovascular
disease impacts adults of all ages and is the number one cause of
death in the United States. Urgent attention and a proven
treatment, such as VASCEPA, is needed for the vast and growing need
to reduce the risk of major adverse cardiovascular events in
high-risk cardiovascular patients.
Amarin’s president and chief executive officer,
John Thero, commented, “Particularly in these difficult times,
Amarin believes that patients would benefit from receiving
preventative healthcare solutions with demonstrated outcomes-based
results. VASCEPA is one of those solutions. It is proven to reduce
risk, it has been found to be affordable and cost-effective and it
is covered by most insurance policies. However, while millions of
people are included within the new VASCEPA indication, most are
unaware of VASCEPA.” He added, “As American society begins to open
up again, Amarin currently plans to restore approximately $80
million in educational and promotional spending in 2020 to increase
awareness of VASCEPA as an important new treatment recently
approved to lower the risk of heart attacks, strokes, and other
major adverse cardiovascular events in high risk patients beyond
standard of care statin therapy.”
Planned promotion and educational efforts
include the sponsorship of continuing medical education, social
media-based communications, and advertisements on television and
other forms of media. Amarin also plans increased sponsorship of
investigator-initiated research, such as the recently announced
clinical investigation of VASCEPA in the treatment of COVID-19.
These initiatives should become increasingly visible in July 2020
and beyond. At the start of 2020, Amarin had intended to commence
such expanded promotion in mid-2020 but cancelled such plans
following the onset of COVID-19 and the prospects for a potential
launch of generic versions of VASCEPA. Amarin’s current plans
restore most of that intended promotion.
In addition, as the United States reopens from
the COVID-19 epidemic, Amarin intends to resume field-based
face-to-face interactions with healthcare providers by its sales
force, commencing on a pilot scale basis before the end of June
2020, based on current expectations. Assuming that these
interactions prove to be helpful and other parts of the country
reopen, the company plans to expand such interactions on a phased
basis across select geographies. Prescription growth on a
year-over-year basis in Q2’20 has, as expected due to COVID-19,
been considerably slower than in Q1’20. However, Amarin believes
that there are early signs that patient care for chronic
conditions, such as treating the risks of cardiovascular disease,
is increasing with more patients returning to their healthcare
providers for routine medical visits.
Amarin plans to adjust its level of promotion
and educational activities upward or downward based on various
factors, including whether any generic company takes the risk of
launching a generic version of VASCEPA during the patent litigation
appeal process and the amount of any product launched. Amarin does
not believe generic companies have made the investment of
resources, know-how and time to develop sufficient quantities of
quality supply to meet current and growing demand. Accordingly,
Amarin believes that if any generic determines to launch its
product after an FDA approval that any such launch would be limited
in scope.
If Amarin wins on its patent litigation appeal
the benefits of Amarin’s planned increased promotion and education
efforts should accrue to both improved patient care and to
increased sales of VASCEPA by Amarin. If Amarin loses on the patent
litigation appeal, increased VASCEPA usage as a result of increased
promotion and education efforts should still benefit patient care.
The larger market would potentially be split among branded VASCEPA,
a potential authorized generic version of VASCEPA, if then launched
by Amarin (which Amarin could launch rapidly if warranted), and
generic versions of VASCEPA from third-parties. As noted, Amarin
believes any launch of generic versions of VASCEPA by such third
parties would be subject to supply limitations. Amarin reiterated
that it believes that it has strong arguments in its patent
litigation appeal but that it cannot predict the outcome.
Amarin is progressing its plans for
international expansion. Those plans are not directly impacted by
increased promotion in the United States but could benefit from the
company’s anticipated expanded educational initiatives.
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, the European Union 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.1 There are
605,000 new and 200,000 recurrent heart attacks per year
(approximately 1 every 40 seconds)1, 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.1 Cardiovascular disease
results in 859,000 deaths per year in the United States.1 In
aggregate, this is more than 2.4 million major adverse
cardiovascular events per year from cardiovascular disease or, on
average, one 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% – but that still leaves a 65-75%
risk remaining.2 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 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 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 eight million times and is covered by most major medical
insurance plans. The new, cardiovascular risk indication for
VASCEPA was approved by the FDA in December 2019 based on the
results of the landmark REDUCE-IT® trial.
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 statements regarding Amarin plans for
increased promotion, educational and research activities in various
forms, over specified periods of time and to various degrees, such
efforts accruing to benefit Amarin under various scenarios,
Amarin’s belief in the strength of its arguments in connection with
its patent litigation appeal, Amarin’s expectations with respect to
the potential timing and extent of launch of generic versions of
VASCEPA and Amarin’s beliefs related to access to supply capacity
of icosapent ethyl by generic companies. 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 promotional, educational and research efforts, the launch of
generic icosapent ethyl, the availability of supply of generic
icosapent ethyl, the extent and impact of any such launch on
Amarin’s plans and assumptions, the extent of icosapent ethyl
supply available to generic companies and risks associated with
litigation. 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 and Media Inquiries:Elisabeth
SchwartzInvestor RelationsAmarin Corporation plcIn U.S.: +1 (908)
719-1315investor.relations@amarincorp.com (investor
inquiries)PR@amarincorp.com (media inquiries)
Lee M. SternSolebury TroutIn U.S.: +1 (646)
378-2992lstern@soleburytrout.com
References
____________
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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