Amarin Receives Positive Recommendation from United & More News Here

UK’s NICE issued its draft Final Appraisal Document (FAD) recommending using VAZKEPA^® (icosapent ethyl) in England and Wales to scale back the danger of cardiovascular (CV) occasions in grownup statin-treated sufferers at excessive CV threat who’ve elevated triglycerides (≥150 mg/dL [≥ 1.7 mmol/L]) and established heart problems (eCVD) ^1,2

Positive reimbursement advice follows the current nationwide reimbursement for VAZKEPA in Sweden and marks one other main milestone within the firm’s European development technique

DUBLIN, Ireland and BRIDGEWATER, N.J., June 10, 2022 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN) right now broadcasts that the UK’s National Institute for Health and Care Excellence (NICE) is recommending icosapent ethyl (marketed below the model identify VAZKEPA^®) for reimbursement and use throughout the National Health Service (NHS) in England and Wales to scale back the danger of cardiovascular (CV) occasions in grownup statin-treated sufferers at excessive cardiovascular threat who’ve elevated triglycerides (≥150 mg/dL [≥ 1.7 mmol/L]), LDL-C ranges >1.04 mmol/L (and ≤ 2.60 mmol/L) and established heart problems (eCVD), at a value of £144.21 per 120 comfortable capsules (i.e. 30-day provide; equal of roughly 170 EUR or 181 USD*).^1,2

“We are extremely pleased with today’s positive recommendation by NICE,” mentioned Karim Mikhail, president and chief government 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 illness ranks as one of many UK’s main causes of demise³. More than six million folks stay with heart problems in England, costing the NHS round £7.4 billion annually^3,4. VAZKEPA represents an necessary scientific innovation for decreasing cardiovascular threat in eligible sufferers throughout England and Wales, supported by the scientific information from the landmark REDUCE-IT^® cardiovascular final result examine⁵.

The Final Appraisal Document (FAD) is a part of NICE’s Health Technology Appraisal (HTA) course of geared toward making suggestions on each the scientific and price effectiveness of medicines and coverings in England to assist be certain that the NHS makes use of its assets pretty and cost-effectively. Today’s FAD represents the NICE appraisal committee’s draft last steering associated to using icosapent ethyl throughout the NHS in England. NICE’s last steering is predicted to be revealed on the 13^th of July 2022, after which all native NHS formularies are anticipated to make the product out there inside 3 months. Based on a collaboration with the Welsh Government and the All Wales Medicines Strategy Group (AWMSG), the ultimate NICE guidances can even apply to Wales and be carried out throughout 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 chairman 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 effectively with its reimbursement discussions within the different European markets and stays on monitor to obtain pricing selections in as much as eight nations with plans to launch VAZKEPA in as much as six European nations this 12 months.

*Based on alternate price of EUR and USD as of the date of this launch.
** U.S. Dollar

About Amarin^®
Amarin is an modern pharmaceutical firm main a brand new paradigm in heart problems administration. From our scientific analysis basis to our concentrate on scientific trials, and now our industrial growth, we’re evolving and rising quickly. Amarin has places of work in Bridgewater, New Jersey within the United States, Dublin in Ireland, Zug in Switzerland, and different nations in Europe in addition to industrial companions and suppliers all over the world. We are dedicated to rethinking cardiovascular threat by way of the development of scientific understanding of the impression on society of serious residual threat that exists past conventional therapies, resembling statins for ldl cholesterol administration.

About VASCEPA^®/VAZKEPA^® (icosapent ethyl) Capsules

VASCEPA capsules are the primary prescription therapy accredited by the U.S. Food and Drug Administration (FDA) comprised solely of the lively ingredient, icosapent ethyl, a singular type of eicosapentaenoic acid. VASCEPA was launched within the United States in January 2020 as the primary and solely drug accredited by the U.S. FDA for therapy of the studied high-risk sufferers with persistent cardiovascular threat after statin remedy. VASCEPA was initially launched within the United States in 2013 primarily based on the drug’s preliminary FDA accredited indication to be used as an adjunct remedy to food plan to scale back triglyceride ranges in grownup sufferers with extreme (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed over 18 million occasions. VASCEPA is roofed by most main medical insurance policy. In addition to the United States, icosapent ethyl is accredited and bought in Canada, Lebanon, Germany and the United Arab Emirates. In Europe, in March 2021 advertising and marketing authorization was granted to icosapent ethyl within the European Union for the discount of threat of cardiovascular occasions in sufferers at excessive cardiovascular threat, below the model identify VAZKEPA. In April 2021 advertising and 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 comfortable capsules
This medication is topic to further monitoring. This will permit fast identification of latest security data. You will help by reporting any unwanted side effects.

Prescribers ought to check with the Summary of Product Characteristics (SmPC) earlier than prescribing.

Indication: Vazkepa is indicated to scale back the danger of cardiovascular occasions in grownup statin-treated sufferers at excessive cardiovascular threat with elevated triglycerides (≥150 mg/dL;≥ 1.7 mmol/L) and both: established heart problems, or diabetes and at the very least one different cardiovascular threat issue.

Dosage: Adults: two 998 mg capsules twice every day. Oral administration, taken with or following a meal. Swallow capsules entire. Do not break, crush, dissolve, or chew. Elderly (≥ 65 years): No dose adjustment mandatory primarily based on age. Renal impairment: No dose discount is advisable. Hepatic impairment: No dose discount is advisable.

Contraindications: Hypersensitivity to the lively substance, soya, peanut or to any of the excipients.

Special warnings and precautions: Allergies to fish/shellfish: Vazkepa is obtained from fish oil. It just isn’t identified whether or not sufferers with allergy symptoms to fish and/or shellfish are at elevated threat of an allergic response to Vazkepa. Vazkepa needs to be used with warning in sufferers with identified hypersensitivity to fish and/or shellfish. Hepatic impairment: In sufferers with hepatic impairment, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) concentrations needs to be monitored as clinically indicated earlier than the beginning of therapy and at acceptable intervals throughout therapy. Atrial fibrillation or flutter: Vazkepa was related to an elevated threat of atrial fibrillation or flutter requiring hospitalisation in a double-blind placebo-controlled trial. The incidence of atrial fibrillation was larger in sufferers with a earlier historical past of atrial fibrillation or flutter. Patients, notably these with a related medical historical past, needs to be monitored for scientific proof of atrial fibrillation or atrial flutter. Electrocardiographic analysis needs to be carried out when clinically indicated. Bleeding: Treatment with Vazkepa has been related to an elevated incidence of bleeding. Patients taking Vazkepa together with antithrombotic brokers, i.e., antiplatelet brokers, together with acetylsalicylic acid, and/or anticoagulants, could also be at elevated threat of bleeding and needs to be monitored periodically.

Interactions: Vazkepa was studied with the next medicinal merchandise that are typical substrates of cytochrome P450 enzymes: omeprazole, rosiglitazone, warfarin and atorvastatin. No interactions have been noticed.

Pregnancy / lactation: Limited human information on use throughout being pregnant can be found. Use of Vazkepa throughout being pregnant needs to be averted until the advantage of use outweighs the potential threat to the foetus. It just isn’t identified whether or not Vazkepa is excreted in human milk. A threat to the suckling little one can’t be excluded. A choice have to be made whether or not to discontinue breast-feeding or to discontinue/abstain from Vazkepa remedy contemplating the advantage of breast-feeding for the kid and the advantage of remedy for the girl.

Side results: Refer to SmPC for full listing of undesirable results. Very widespread (≥1/10): bleeding; Common (≥1/100 to <1/10): gout, atrial fibrillation or flutter, constipation, eructation, rash, musculoskeletal ache, peripheral oedema; Uncommon (≥1/1000 to <1/100): hypersensitivity, dysgeusia. Not Known: pharyngeal swelling.

Legal Category: Prescription solely medication (POM).

Pack portions: Vazkepa is on the market in HDPE bottles containing 120 comfortable 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 final revision: April 2022

Adverse occasions needs to be reported. Reporting varieties and knowledge will be discovered at https://yellowcard.mhra.gov.uk/
Adverse occasions must also be reported to Amarin Pharmaceuticals Ireland Limited:
Tel: 0800 0478 673 or e-mail: [email protected]

Europe

For additional details about the Summary of Product Characteristics (SmPC) for VAZKEPA^® in Europe, please click on right here.

Globally, prescribing data varies; check with the person nation product label for full data.

United States
Indications and Limitation of Use

VASCEPA is indicated:

• As an adjunct to maximally tolerated statin remedy to scale back the danger of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in grownup sufferers with elevated triglyceride (TG) ranges (≥ 150 mg/dL) and
  • established heart problems or
  • diabetes mellitus and two or extra further threat components for heart problems.
• As an adjunct to food plan to scale back TG ranges in grownup sufferers with extreme (≥ 500 mg/dL) hypertriglyceridemia.

The impact of VASCEPA on the danger for pancreatitis in sufferers with extreme hypertriglyceridemia has not been decided.

Important Safety Information

• VASCEPA is contraindicated in sufferers with identified hypersensitivity (e.g., anaphylactic response) to VASCEPA or any of its parts.
• VASCEPA was related to an elevated threat (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was larger in sufferers with a earlier historical past of atrial fibrillation or atrial flutter.
• It just isn’t identified whether or not sufferers with allergy symptoms to fish and/or shellfish are at an elevated threat of an allergic response to VASCEPA. Patients with such allergy symptoms ought to discontinue VASCEPA if any reactions happen.
• VASCEPA was related to an elevated threat (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was larger in sufferers receiving concomitant antithrombotic medicines, resembling aspirin, clopidogrel or warfarin.
• Common hostile reactions within the cardiovascular outcomes trial (incidence ≥3% and ≥1% extra frequent than placebo): musculoskeletal ache (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).
• Common hostile reactions within the hypertriglyceridemia trials (incidence >1% extra frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal ache (1% vs 0.3%).
• Adverse occasions could also 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 brokers needs to be monitored for bleeding.

FULL U.S. FDA- APPROVED VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM

Forward-Looking Statements
This press launch incorporates forward-looking statements that are made pursuant to the protected harbor provisions of the Private Securities Litigation Reform Act of 1995, together with, however not restricted to, beliefs in regards to the market potential for VAZKEPA; expectations concerning efficiency resembling prescription development and market entry for VAZKEPA; plans for Amarin’s go-to-market mannequin within the UK; the timing and final result of associated reimbursement selections and industrial launches within the UK and elsewhere; and expectations for the timing, effectiveness and final result of promotional actions. These forward-looking statements aren’t guarantees or ensures and contain substantial dangers and uncertainties, together with, with respect to the UK, Amarin’s capability to successfully commercialize VAZKEPA and preserve or develop market share will rely partly on Amarin’s capability to proceed to successfully finance its enterprise; Amarin’s capability to create and enhance market demand and obtain broad market acceptance for VAZKEPA; to develop and preserve a constant supply of business provide at a aggressive value; and to adjust to authorized and regulatory necessities in reference to the sale and promotion of VAZKEPA. Among the components that might trigger precise outcomes to vary materially from these described or projected embody the next: the danger that Amarin has overestimated the market potential for VAZKEPA; dangers related to Amarin’s expanded enterprise; uncertainties related usually with analysis and growth, scientific trials and associated regulatory approvals; and the danger that gross sales could not meet expectations and associated prices could enhance past expectations. An additional listing and outline of those dangers, uncertainties and different dangers related to an funding in Amarin will be present in Amarin’s filings with the U.S. Securities and Exchange Commission, together with Amarin’s annual report on Form 10-Okay for the 12 months ended December 31, 2021, filed on or in regards to the date hereof. Existing and potential buyers are cautioned to not place undue reliance on these forward-looking statements, which converse solely as of the date they’re made. Amarin undertakes no obligation to replace or revise the data contained in its forward-looking statements, whether or not because of new data, future occasions or circumstances or in any other case. Amarin’s forward-looking statements don’t replicate the potential impression of serious transactions the corporate could enter into, resembling mergers, acquisitions, inclinations, joint ventures or any materials agreements that Amarin could enter into, amend or terminate.

Availability of Other Information About Amarin
Investors and others ought to word that Amarin communicates with its buyers and the general public utilizing the corporate web site (www.amarincorp.com), the investor relations web site (investor.amarincorp.com), together with however not restricted to investor displays, Securities and Exchange Commission filings, press releases, public convention calls and webcasts. The data that Amarin posts on these channels and web sites may very well be deemed to be materials data. As a consequence, Amarin encourages buyers, the media, and others keen on Amarin to overview the data that’s posted on these channels, together with the investor relations web site, frequently. This listing of channels could also be up to date from time to time on Amarin’s investor relations web site and will embody social media channels. The contents of Amarin’s web site or these channels, or some other web site that could be accessed from its web site or these channels, shall not be deemed integrated by reference in any submitting below the Securities Act of 1933.

Amarin Contact Information

Media Inquiries:

Mark Marmur
Communications Amarin Corporation plc
[email protected]

Investor Inquiries:
Lisa DeFrancesco
Investor Relations Amarin Corporation plc
[email protected]

¹ National Institute for Health and Care Excellence. Final Draft Guidance: Icosapent ethyl with statin remedy for decreasing the danger of cardiovascular occasions in folks 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 issues: stopping heart problems. 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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