Amarin Corporation plc (NASDAQ:AMRN) today commented on the United
States District Court for the District of Nevada’s ruling in favor
of the generic companies in the company’s patent litigation against
two filers of abbreviated new drug applications, or ANDAs, for
Amarin’s VASCEPA® (icosapent ethyl) capsule franchise. Based on
Amarin’s review of U.S. Food and Drug Administration’s (FDA’s)
website, an ANDA for VASCEPA has not been approved, which would be
required for launch of a generic product in the United States. The
company thus does not believe there is an impending generic launch
by the litigants that would compete with VASCEPA at this time.
“Amarin strongly disagrees with the ruling and
will vigorously pursue all available remedies, including an appeal
of the Court’s decision and a preliminary injunction pending appeal
to, if an ANDA is approved by FDA, prevent launch of generic
versions of VASCEPA in the United States,” said John F. Thero,
president and chief executive officer of Amarin. “At Amarin, we
have a strong balance sheet with capacity and flexibility, and we
plan to fight to protect our VASCEPA franchise for the benefit of
our patients, physicians, the broader healthcare community and our
investors. We believe we are favorably situated to obtain an
injunction against generic launch pending appeal, subject to our
posting a bond to secure generics’ lost profits in the event that
generics prevail on appeal. As we work to take all legal actions
necessary to defend and protect our intellectual property, we will
continue to press forward with our educational and promotional
efforts for VASCEPA in treating indicated patients at high risk of
cardiovascular events, such as heart attack and stroke. After we
determine the outcome of our effort to prevent a generic launch (if
an ANDA approval is obtained), we expect to provide an update on
how we would adjust certain promotional activities for VASCEPA in
the United States.”
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 with expiration dates that could extend into
2039. Amarin, together with its commercial partners in select
geographies, is pursuing additional regulatory approvals for
VASCEPA in the European Union, China and the Middle East. Ten to
eleven years of market protection is anticipated due to regulatory
exclusivity in the European Union subject to pending VASCEPA
approval expected later this year, in addition to pending patent
protection that could extend into 2033.
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
Disease
Cardiovascular disease is an enormous and
growing medical issue worldwide.1,2 In the United States
alone, a heart attack, stroke, death or other major cardiovascular
event is experienced every 14 seconds.3
Controlling bad cholesterol, also known as
LDL-C, is one way to reduce a patient’s risk of experiencing a
cardiovascular event. However, even with the achievement of target
LDL-C levels, millions of patients still have significant and
persistent cardiovascular risk, especially those patients with high
triglycerides. Statin therapy has been shown to control LDL-C,
thereby reducing the risk of cardiovascular events by 25-35% – but
that still leaves 65-75% of risk remaining.4 People with high
triglycerides have 35% more cardiovascular events compared to
people with normal (in range) triglycerides taking
statins.5,6,7
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.
Indications and Limitation of UseVASCEPA 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 for bleeding
should be monitored.
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 plans for appeal, to
obtain an injunction against generic launch pending appeal, subject
to our posting a bond to secure generics’ lost profits in the event
that generics prevail on appeal, to update on the degree to which
we would scale back certain promotional activities for VASCEPA in
the United States, to otherwise seek to maintain exclusivity for
VASCEPA in the United States and elsewhere based on, as applicable,
litigation, regulatory exclusivity and issued and allowed patents
and the expected expiration dates of those patent applications and
issued patents to correspond with associated exclusivity protection
and plans to continue commercialization efforts in the United
States. 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 of the Court’s judgment and in seeking preliminary
injunction; 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 annual report on Form 10-K. 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
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 – 2019 Update: A Report from the American Heart
Association. Published January 31, 2019.2 American Heart
Association / American Stroke Association. 2017. Cardiovascular
disease: A costly burden for America projections through 2035.3
American Heart Association: Heart Disease and Stroke Statistics --
2019 At-a-Glance.4 Ganda OP, Bhatt DL, Mason RP, et al. Unmet need
for adjunctive dyslipidemia therapy in hypertriglyceridemia
management. J Am Coll Cardiol. 2018;72(3):330-343.5 Budoff M.
Triglycerides and triglyceride-rich lipoproteins in the causal
pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.6
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):e008740.7 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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