Amarin Corporation plc (NASDAQ:AMRN) today announces that the UK’s
National Institute for Health and Care Excellence (NICE) is
recommending icosapent ethyl (marketed under the brand name
VAZKEPA®) for reimbursement and use across the National Health
Service (NHS) in England and Wales to reduce the risk of
cardiovascular (CV) events in adult statin-treated patients at high
cardiovascular risk who have elevated triglycerides (≥150 mg/dL [≥
1.7 mmol/L]), LDL-C levels >1.04 mmol/L (and ≤ 2.60 mmol/L) and
established cardiovascular disease (eCVD), at a price of £144.21
per 120 soft capsules (i.e. 30-day supply; equivalent of
approximately 170 EUR or 181 USD*).1,2
“We are extremely pleased with today’s positive
recommendation by NICE,” said Karim Mikhail, president and chief
executive officer. “This is another important step forward in
successfully executing our European growth strategy, and
considering that the UK has historically served as a reference
market with regard to Health Technology Assessments, it is a major
step toward unlocking the company’s multi-billion-dollar revenue
opportunity outside of the U.S.**”
Cardiovascular disease ranks as one of the UK’s
leading causes of death3. More than six million people live with
cardiovascular disease in England, costing the NHS around £7.4
billion each year3,4. VAZKEPA represents an important scientific
innovation for reducing cardiovascular risk in eligible patients
across England and Wales, supported by the clinical data from the
landmark REDUCE-IT® cardiovascular outcome study5.
The Final Appraisal Document (FAD) is part of
NICE’s Health Technology Appraisal (HTA) process aimed at making
recommendations on both the clinical and cost effectiveness of
medicines and treatments in England to help ensure that the NHS
uses its resources fairly and cost-effectively. Today’s FAD
represents the NICE appraisal committee’s draft final guidance
related to the use of icosapent ethyl within the NHS in England.
NICE’s final guidance is expected to be published on the 13th of
July 2022, after which all local NHS formularies are expected to
make the product available within 3 months. Based on a
collaboration with the Welsh Government and the All Wales Medicines
Strategy Group (AWMSG), the final NICE guidances will also apply to
Wales and be implemented across the NHS in Wales.
“This positive recommendation is the outcome of many months of
constructive scientific discussions with multiple stakeholders and
a detailed systematic review of clinical and economic evidence,”
commented Laurent Abuaf, senior vice president and president Amarin
Europe. “Following Sweden, this is now the second Health Technology
Assessment in Europe that recognizes the potential value of VAZKEPA
for strengthening cardiovascular care in England and Wales,
following a very rigorous clinical and economic evaluation process.
We look forward to working with all relevant stakeholders in the
NHS to offer this important new treatment option to eligible
cardiovascular patients across these countries in the UK.”
In parallel, Amarin continues to progress well with its
reimbursement discussions in the other European markets and remains
on track to receive pricing decisions in up to eight countries with
plans to launch VAZKEPA in up to six European countries this
year.
*Based on exchange rate of EUR and USD as of the date of this
release.** U.S. Dollar
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,
Zug in Switzerland, and other countries in Europe 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 VASCEPA®/VAZKEPA® (icosapent ethyl)
Capsules
VASCEPA capsules are the first prescription
treatment approved by the U.S. Food and Drug Administration (FDA)
comprised solely of the active ingredient, icosapent ethyl, 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 18 million times. VASCEPA is
covered by most major medical insurance plans. In addition to the
United States, icosapent ethyl is approved and sold in Canada,
Lebanon, Germany 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. In April 2021 marketing authorization for VAZKEPA
(icosapent ethyl) was granted in Great Britain. The Great Britain
Marketing Authorization for VAZKEPA applies to England, Scotland
and Wales.
United Kingdom Indication &
Important Safety Information
VAZKEPA® (Icosapent Ethyl) 998 mg soft capsulesThis medicine is
subject to additional monitoring. This will allow quick
identification of new safety information. You can help by reporting
any side effects.
Prescribers should refer to the Summary of Product
Characteristics (SmPC) before prescribing.
Indication: Vazkepa is indicated to reduce the risk of
cardiovascular events in adult statin-treated patients at high
cardiovascular risk with elevated triglycerides (≥150 mg/dL;≥ 1.7
mmol/L) and either: established cardiovascular disease, or diabetes
and at least one other cardiovascular risk factor.
Dosage: Adults: two 998 mg capsules twice daily. Oral
administration, taken with or following a meal. Swallow capsules
whole. Do not break, crush, dissolve, or chew. Elderly (≥ 65
years): No dose adjustment necessary based on age. Renal
impairment: No dose reduction is recommended. Hepatic impairment:
No dose reduction is recommended.
Contraindications: Hypersensitivity to the active substance,
soya, peanut or to any of the excipients.
Special warnings and precautions: Allergies to fish/shellfish:
Vazkepa is obtained from fish oil. It is not known whether patients
with allergies to fish and/or shellfish are at increased risk of an
allergic reaction to Vazkepa. Vazkepa should be used with caution
in patients with known hypersensitivity to fish and/or shellfish.
Hepatic impairment: In patients with hepatic impairment, alanine
aminotransferase (ALT) and aspartate aminotransferase (AST)
concentrations should be monitored as clinically indicated before
the start of treatment and at appropriate intervals during
treatment. Atrial fibrillation or flutter: Vazkepa was associated
with an increased risk of atrial fibrillation or flutter requiring
hospitalisation in a double-blind placebo-controlled trial. The
incidence of atrial fibrillation was greater in patients with a
previous history of atrial fibrillation or flutter. Patients,
particularly those with a relevant medical history, should be
monitored for clinical evidence of atrial fibrillation or atrial
flutter. Electrocardiographic evaluation should be performed when
clinically indicated. Bleeding: Treatment with Vazkepa has been
associated with an increased incidence of bleeding. Patients taking
Vazkepa in combination with antithrombotic agents, i.e.,
antiplatelet agents, including acetylsalicylic acid, and/or
anticoagulants, may be at increased risk of bleeding and should be
monitored periodically.
Interactions: Vazkepa was studied with the following medicinal
products which are typical substrates of cytochrome P450 enzymes:
omeprazole, rosiglitazone, warfarin and atorvastatin. No
interactions were observed.
Pregnancy / lactation: Limited human data on use during
pregnancy are available. Use of Vazkepa during pregnancy should be
avoided unless the benefit of use outweighs the potential risk to
the foetus. It is not known whether Vazkepa is excreted in human
milk. A risk to the suckling child cannot be excluded. A decision
must be made whether to discontinue breast-feeding or to
discontinue/abstain from Vazkepa therapy considering the benefit of
breast-feeding for the child and the benefit of therapy for the
woman.
Side effects: Refer to SmPC for full list of undesirable
effects. Very common (≥1/10): bleeding; Common (≥1/100 to
<1/10): gout, atrial fibrillation or flutter, constipation,
eructation, rash, musculoskeletal pain, peripheral oedema; Uncommon
(≥1/1000 to <1/100): hypersensitivity, dysgeusia. Not Known:
pharyngeal swelling.
Legal Category: Prescription only medicine (POM).
Pack quantities: Vazkepa is available in HDPE bottles containing
120 soft capsules.
Marketing Authorisation Holder: Amarin Pharmaceuticals Ireland
Limited, 88 Harcourt Street, Dublin 2, D02DK18 Ireland
Marketing Authorisation Numbers: Great Britain: PLGB 51241/0002
Northern Ireland: EU/1/20/1524/001
Date of last revision: April 2022
Adverse events should be reported. Reporting
forms and information can be found at
https://yellowcard.mhra.gov.uk/Adverse events
should also be reported to Amarin Pharmaceuticals Ireland Limited:
Tel: 0800 0478 673 or e-mail:
AmarinConnect@amarincorp.eu
Europe
For further information about the Summary of Product
Characteristics (SmPC) for VAZKEPA® in Europe, please click
here.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
United StatesIndications 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.
FULL U.S. FDA- APPROVED VASCEPA
PRESCRIBING INFORMATION CAN BE FOUND
AT WWW.VASCEPA.COM
Forward-Looking StatementsThis
press release contains forward-looking statements which are made
pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995, including, but not limited to,
beliefs about the market potential for VAZKEPA; expectations
regarding performance such as prescription growth and market access
for VAZKEPA; plans for Amarin’s go-to-market model in the UK; the
timing and outcome of related reimbursement decisions and
commercial launches in the UK and elsewhere; and expectations for
the timing, effectiveness and outcome of promotional activities.
These forward-looking statements are not promises or guarantees and
involve substantial risks and uncertainties, including, with
respect to the UK, Amarin’s ability to effectively commercialize
VAZKEPA and maintain or grow market share will depend in part on
Amarin’s ability to continue to effectively finance its business;
Amarin’s ability to create and increase market demand and achieve
broad market acceptance for VAZKEPA; 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 VAZKEPA. Among the factors that could
cause actual results to differ materially from those described or
projected include the following: the risk that Amarin has
overestimated the market potential for VAZKEPA; risks associated
with Amarin's expanded enterprise; uncertainties associated
generally with research and development, clinical trials and
related regulatory approvals; and the risk that sales may not meet
expectations and related costs may increase beyond expectations. 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 Amarin’s annual report on Form 10-K for the year ended
December 31, 2021, filed on or about the date hereof. 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
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, 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
Media Inquiries:
Mark MarmurCommunications Amarin Corporation plc
PR@amarincorp.com
Investor Inquiries:Lisa DeFrancescoInvestor
Relations Amarin Corporation
plcinvestor.relations@amarincorp.com
1 National Institute for Health and Care Excellence. Final Draft
Guidance: Icosapent ethyl with statin therapy for reducing the risk
of cardiovascular events in people with raised triglycerides
[ID3831]. NICE; 2022. Available from:
https://www.nice.org.uk/guidance/gid-ta10736/documents/final-appraisal-determination-document.
Accessed June 2022.
2 VAZKEPA (icosapent ethyl) Summary of Product Characteristics
(April 2022)
https://www.medicines.org.uk/emc/product/12964/smpc#gref. Accessed
May 2022.3 British Heart Foundation. UK Factsheet January 2022.
https://www.bhf.org.uk/-/media/files/research/heart-statistics/bhf-cvd-statistics---uk-factsheet.pdf.
Accessed May 2022.4 Public Health England. Health matters:
preventing cardiovascular disease.
https://www.gov.uk/government/publications/health-matters-preventing-cardiovascular-disease/health-matters-preventing-cardiovascular-disease.
Accessed May 2022.5 Bhatt DL, Steg PG, Miller M, et al.
Cardiovascular Risk Reduction with Icosapent Ethyl for
Hypertriglyceridemia. N Engl J Med. 2019;380(1):11-22.
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