Amarin Corporation plc (NASDAQ:AMRN), announced today an expansion
of the scope of its VASCEPA® (icosapent ethyl) cardiovascular (CV)
risk reduction patent infringement lawsuit against Hikma
Pharmaceuticals PLC to include a health care insurance provider in
the United States, Health Net, LLC. The lawsuit was filed in the
United States District Court in Delaware. A copy of the amended
complaint is available through the FAQ section of the Amarin
investor relations website.
Multiple healthcare insurance providers and
managed care enterprises have respected Amarin’s patent rights. As
detailed in the complaint, Health Net is not among them. Through
insurance coverage and economic incentives Amarin alleges that
Health Net has actively induced pharmacies to dispense, and
patients to use, Hikma generic icosapent ethyl capsules in
infringement of U.S. Patent Nos. 9,700,537 (Composition for
preventing the occurrence of cardiovascular event in multiple risk
patient), 8,642,077 (Stable pharmaceutical composition and methods
of using same), and 10,568,861 (Methods of reducing the risk of a
cardiovascular event in a subject at risk for cardiovascular
disease).
Amarin alleges that Health Net, like Hikma,
understands that the vast majority of VASCEPA prescriptions are for
use in CV risk reduction, that Hikma does not have an FDA approved
indication for that use and that inducement for such use would
infringe the subject patents. The Hikma generic icosapent ethyl
product has the benefit of court judgments but only with respect to
patents related to an indication currently representing no more
than 7% of VASCEPA prescriptions in the United States: for use as
an adjunct to diet to lower triglyceride levels in adult patients
with severely high (≥500 mg/dL) triglyceride levels. In November
2020, Hikma began to market and sell its generic version of
VASCEPA, but in limited supply due to significant and continuing
supply constraints.
In the complaint, Amarin is seeking remedies
including a permanent injunction against the unlawful inducement by
Hikma and Health Net of infringing uses of the Hikma generic
product, i.e., uses to reduce CV risk as detailed in the patents,
and monetary damages in an amount sufficient to compensate Amarin
for such infringement.
Amarin is continually considering its legal
options against parties similarly situated to Health Net and Hikma
and acting in concert with either by making or selling any drug
product or component thereof covered by the subject patents, or
inducing others to do the same.
“The patents at issue in this litigation reflect
inventions heralded by the medical community as among the most
significant advances in preventative cardiovascular care since
statin therapy,” stated John Thero, president and chief executive
officer of Amarin. “As a pioneering pharmaceutical company with
over a decade of effort invested to bring these inventions to
patients, Amarin plans to pursue this litigation vigorously.
Proceeds from Amarin’s sale of VASCEPA are critical to help
continue funding the education of patients, caregivers, and health
care providers about the landmark REDUCE-IT® cardiovascular
outcomes trial of VASCEPA and the associated cardiovascular risk
reduction indication that FDA approved a little over one year
ago.”
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. VASCEPA is
not yet approved and available in any other countries. Amarin, on
its own or together with its commercial partners in select
geographies, is pursuing additional regulatory approvals for
VASCEPA in China, Europe and the Middle East. For more information
about Amarin, visit www.amarincorp.com.
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.1 The primary results of REDUCE-IT were published in The
New England Journal of Medicine in November 2018.2 The total events
results of REDUCE-IT were published in the Journal of the American
College of Cardiology in March 2019.3 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. 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.
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 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 (%) |
IncidenceRate (per
100patientyears) |
N = 4090n (%) |
IncidenceRate (per
100patientyears) |
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 about the subject patent litigation, Amarin’s plan to
pursue the litigation vigorously and the validity or enforceability
of the subject patents. These forward-looking statements are not
promises or guarantees and involve substantial risks and
uncertainties that may individually or mutually impact the matters
herein, and cause actual results, events and performance to differ
materially from such forward looking statements. Among the factors
that could cause actual results to differ materially from those
described or projected herein include the following: events that
could interfere with the continued validity or enforceability of a
patent; uncertainties associated with litigation generally and
patent litigation specifically; Amarin's ability generally to
maintain adequate patent protection and successfully enforce patent
claims against third parties; commercializing Vascepa without
violating the intellectual property rights of others; and
uncertainties associated generally with research and development
and regulatory submissions, action dates and approvals. 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
InformationInvestor Inquiries:Investor RelationsAmarin
Corporation plcIn U.S.: +1 (908) 719-1315
IR@amarincorp.com (investor inquiries)
Solebury Troutamarinir@troutgroup.com
Media Inquiries:Alina
KolomeyerCommunicationsAmarin Corporation plcIn U.S.: +1 (908)
892-2028 PR@amarincorp.com (media inquiries)
______________________________1 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;40:138-148.2 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;380:11-22.3 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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