Amarin Corporation plc (NASDAQ:AMRN) today provided an update
following the decision by the U.S. Court of Appeals for the Federal
Circuit in the company’s ongoing patent litigation. The Court
upheld the March ruling by the U.S. District Court for the District
of Nevada in favor of two generic companies in connection with
their abbreviated new drug applications, or ANDAs, related to
Amarin’s VASCEPA® (icosapent ethyl) capsule franchise. Amarin is
currently reviewing its legal options and within 30 days expects to
file a petition for an en banc review of the current panel decision
by the full panel of 12 active judges at the U.S. Court of Appeals
for the Federal Circuit.
“We are extremely disappointed with today’s
ruling and plan to vigorously pursue available remedies,” said John
Thero, president and chief executive officer, Amarin. “Importantly,
we and our partners are continuing to pursue additional regulatory
approvals for VASCEPA in China, Europe and the additional countries
in the Middle East, and remain confident in the global market
potential of VASCEPA. We are particularly excited about the
anticipated commercialization opportunities for VASCEPA in Europe
as we prepare for expected approval and launch in early 2021. At
the same time, we will continue to meet the strong demand for
VASCEPA here in the United States through our proven manufacturing
capabilities.”
Amarin anticipates that generics companies, when
they launch in the United States, are likely to have limited supply
capacity for VASCEPA. Based on this assumption and given the need
for greater awareness of VASCEPA by healthcare professionals and
at-risk patients, Amarin intends to continue current promotion
levels of VASCEPA in the United States. After assessing the scope,
timing and pricing of potential generic competition, Amarin will
decide whether to further expand, contract or maintain such levels
of VASCEPA promotion.
Geographies outside the United States in which
VASCEPA is sold and under regulatory review are not subject to this
litigation and judgment. No generic litigation is pending outside
the United States. VASCEPA remains available by prescription in
Canada, Lebanon and the United Arab Emirates. In Canada, VASCEPA
has the benefit of eight years of data protection afforded through
Health Canada (until the end of 2027), in addition to separate
patent protection related to the REDUCE-IT® study of VASCEPA, which
was not at issue in the subject U.S. litigation, with expiration
dates that could extend into 2039. Amarin, on its own and together
with its commercial partners in select geographies, is pursuing
additional regulatory approvals for VASCEPA in Europe, China and
other countries in the Middle East. Ten years of market protection
is anticipated due to regulatory exclusivity in the European Union
subject to pending VASCEPA approval, in addition to pending patent
protection related to the REDUCE-IT study of VASCEPA that could
extend into 2039.
About Amarin
Amarin Corporation 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, on its own or
together with its commercial partners in select geographies, is
pursuing additional regulatory reviews for VASCEPA in China, Europe
and other parts of the Middle East.
For more information about Amarin, visit
www.amarincorp.com.
About Cardiovascular RiskThe
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.1 In aggregate, there are 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%.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 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. VASCEPA is
covered by most major medical insurance plans. The new,
cardiovascular risk indication for VASCEPA was approved by the FDA
in December 2019.
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 = 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 VASCEPA
PRESCRIBING INFORMATION CAN BE FOUND
AT WWW.VASCEPA.COM.
Forward-Looking Statements This
press release contains forward-looking statements, including
expectations regarding potential plans for further appeal, the
degree to which we would continue promotional activities for
VASCEPA in the United States, plans to seek to regulatory approvals
and seek and maintain exclusivity for VASCEPA in various
jurisdictions and the expected expiration dates of patent
applications and issued patents to correspond with associated
exclusivity protection. There can be no guarantee we would be
successful in any of such efforts. 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 the
commercial success of pharmaceutical products such as VASCEPA; the
risk of loss in the planned appeal; that patent applications may
not result in issued patents, and that issued patents may not
prevent competitors from competing with VASCEPA; the risk that new
competitors may further challenge the exclusivity afforded by the
same patents at issue in this litigation through a new litigation
or otherwise seek to gain marketing approval for generic versions
of VASCEPA or branded competitive products based on new clinical
studies; and the risk that trade secrets may not be maintained and
that other circumstances that create barriers to competition with
VASCEPA may not last. These forward-looking statements are not
promises or guarantees and involve substantial risks and
uncertainties. In addition, 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 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, and to comply
with legal and regulatory requirements in connection with the sale
and promotion of VASCEPA. 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.
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 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)
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.
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., on behalf of the
REDUCE-IT Investigators. Cardiovascular Risk Reduction with
Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med.
2019;380:11-22.
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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