Amarin Corporation plc (NASDAQ:AMRN) today announced the first European launch of VAZKEPA (icosapent ethyl) in Germany. VAZKEPA received marketing authorization from the European Commission in March 2021 and the Medicines and Healthcare Products Regulatory Agency (MHRA) in Great Britain in April 2021. VAZKEPA is indicated as a treatment to reduce the risk of cardiovascular events in statin-treated adult patients at high cardiovascular risk who have elevated triglycerides (≥ 150 mg/dL [≥ 1.7 mmol/L]) and either established cardiovascular disease or diabetes and at least one additional cardiovascular risk factor.1

The European launch of VAZKEPA, beginning in Germany, is supported by more than a decade of evidence-based cardiovascular clinical outcomes research including the landmark REDUCE-IT® study, a groundbreaking study2 which established that VASCEPA®/VAZKEPA lowers the risk of a life-threatening heart attack or stroke by 25% when added to a statin in the targeted population. Importantly, VASCEPA/VAZKEPA has been included in the treatment guidelines for cardiovascular disease (CVD) prevention by the European Society of Cardiology, the European Association of Preventive Cardiology and the European Atherosclerosis Society, in addition to 17 other medical guidelines around the world.

The launch of VAZKEPA in Germany featured a scientific conference in Berlin titled, “New therapeutic strategies for residual CV risk management,” which highlighted the scientific underpinnings and clinical benefits of VASCEPA/VAZKEPA in reducing cardiovascular risk. The symposium was led by eleven internationally renowned cardiovascular specialists, was attended by more than 200 healthcare professionals from Germany and was live streamed to many more physicians across the continent. The event has been archived and is available to thousands of physicians across Europe.

Amarin’s president and chief executive officer, Karim Mikhail, stated, “The German launch is a historic moment for Amarin, as it is the first European country where VAZKEPA’s proven cardioprotective benefits are available to healthcare providers and patients. This is particularly important as CVD is the number one cause of death in Europe.” Mr. Mikhail added, “Our European launch marks a key milestone in our corporate growth strategy to bring the cardiovascular risk reduction benefits of VASCEPA/VAZKEPA to at-risk patients around the world. As Germany is the fourth largest global economy and there are more than 300,000 deaths due to CVD in Germany every year3, it represents both a significant market need and opportunity.”

Laurent Abuaf, recently appointed as senior vice president and president of Europe, further noted, “Throughout last year Amarin made great progress building the commercial infrastructure in Europe and has recruited and trained a talented team of nearly 200 professionals to execute VAZKEPA’s launch. We are especially pleased with our successful German launch event and look forward to executing our plans to launch VAZKEPA across multiple European countries before the end of 2022.” Mr. Abuaf continued, “Cardiovascular disease (CVD) is one of Europe’s biggest health crises, costing the European Union €210 billion a year,4 and resulting in 3.9 million deaths.5 Amarin has ambitious plans to tackle this growing healthcare burden by working in partnership with healthcare professionals across the continent to challenge the conventions surrounding CVD care.”

Amarin has already filed market access dossiers in five out of the ten planned “first wave” European country submissions. The dossiers were filed in Germany, the United Kingdom, France, Italy and Denmark and, over the next quarter, Amarin plans to submit the remaining five dossiers. The company is committed to bringing the benefits of VAZKEPA to as many patients in Europe as quickly as possible.

With its global headquarters in Ireland and a new commercial hub in Zug, Switzerland, Amarin has strong European roots and the infrastructure necessary to support the company’s plans to build a local commercial presence in all major European markets for a series of successful launches across the continent.

About AmarinAmarin 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 and Zug in Switzerland, as well as commercial partners and suppliers around the world. We are committed to advancing the scientific understanding of cardiovascular risk and its impact on society, in particular, the significant residual risk that exists beyond traditional therapies, such as statins for cholesterol management.

About Cardiovascular RiskCardiovascular disease is the number one cause of death in the world and one of Europe’s biggest health crises, costing the European Union €210 billion a year,6 and resulting in 3.9 million deaths.7 In the United States, cardiovascular disease results in 859,000 deaths per year.8 And the number of deaths in the United States attributed to cardiovascular disease continues to rise.

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%.9 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.10,11,12

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.13 The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.14 The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.15 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. Food and Drug Administration (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. In addition to the United States, VASCEPA is approved and sold in Canada, Lebanon 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.

Indications and Limitation of Use (in the United States)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 U.S. FDA-APPROVED VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.

FOR FURTHER INFORMATION ABOUT THE SUMMARY OF PRODUCT CHARACTERISTICS (SMPC) FOR VAZKEPA® IN EUROPE, PLEASE click here.

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 beliefs about the world-wide market potential for VASCEPA/VAZKEPA; expectations regarding financial metrics and performance such as prescription growth, revenue growth, operating expenses, inventory purchases, and managed care coverage for VASCEPA/VAZKEPA, including the impact of the COVID-19 pandemic, the disappointing outcome of patent litigation and the launch of generic competition on these metrics; beliefs that Amarin is well positioned to deliver on its goals to grow VASCEPA in the U.S. and beyond; beliefs about patient needs for VASCEPA/VAZKEPA; effects of the COVID-19 pandemic on Amarin's operations and on the healthcare industry more broadly, which effects continue to be fluid; beliefs that Amarin's strategy for reducing the effects of cardiovascular disease is sound and that Amarin is efficiently reaching physicians, payors, pharmacists and patients; plans for Amarin's go-to-market model; the timing and outcome of regulatory reviews, recommendations and approvals and related reimbursement decisions and commercial launches in Europe, the China region and elsewhere; plans for Amarin's expected launch of VASCEPA/VAZKEPA directly in major markets in Europe, directly and indirectly; beliefs about the cardioprotective and other benefits of VASCEPA/VAZKEPA; beliefs about the strength of data in market access dossiers and other reports; expectations for the timing, effectiveness and outcome of promotional activities, including patient-oriented campaigns, conference and posted presentations and education of healthcare professionals; commercial and international expansion, prescription growth and revenue growth and future revenue levels, including the contributions of sales representatives and the new leadership team; beliefs that Amarin's current resources are sufficient to fund projected operations; ongoing patent litigation efforts; and the impact of the COVID-19 pandemic on all of the forgoing. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Amarin's ability to effectively commercialize VASCEPA/VAZKEPA and maintain or grow market share will depend in part on Amarin’s ability to continue to effectively finance its business, VASCEPA/VAZKEPA approval in geographies outside the U.S., efforts of third parties, Amarin’s ability to create and increase market demand for VASCEPA/VAZKEPA through education, marketing and sales activities, to achieve broad market acceptance of VASCEPA/VAZKEPA, to receive adequate levels of reimbursement from third-party payers, to develop and maintain a consistent source of commercial supply at a competitive price, to comply with legal and regulatory requirements in connection with the sale and promotion of VASCEPA/VAZKEPA and to secure, maintain and defend its patent protection for VASCEPA/VAZKEPA. Among the factors that could cause actual results to differ materially from those described or projected herein include the following: the possibility that VASCEPA/VAZKEPA may not receive regulatory approval in the China region or other geographies on the expected timelines or at all, the risk that additional generic versions of VASCEPA/VAZKEPA will enter the market and that generic versions of VASCEPA/VAZKEPA will achieve greater market share and more commercial supply than anticipated, particularly in light of the recent and disappointing outcome of Amarin's litigation against two generic drug companies and subsequent requests for appeal; the risk that the scope and duration of the COVID-19 pandemic will continue to impact access to and sales of VASCEPA/VAZKEPA; the risk that Amarin has overestimated the market potential for VASCEPA/VAZKEPA in the U.S., Europe and other geographies; risks associated with Amarin's expanded enterprise; uncertainties associated generally with research and development, clinical trials and related regulatory approvals; the risk that sales may not meet expectations and related cost may increase beyond expectations; the risk that patents may be determined to not be infringed or not be valid in patent litigation and applications may not result in issued patents sufficient to protect the VASCEPA/VAZKEPA franchise. 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 quarterly report on Form 10-Q for the quarter ended June 30, 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 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) 719-1315IR@amarincorp.com (investor inquiries)Solebury Troutamarinir@troutgroup.com

Media Inquiries:CommunicationsAmarin Corporation plcIn U.S.: +1 (908) 892-2028PR@amarincorp.com (media inquiries)

AMARIN, REDUCE-IT, VASCEPA and VAZKEPA are trademarks of Amarin Pharmaceuticals Ireland Limited. VAZKEPA is a registered trademark in Europe and other countries and regions and is pending registration in the United States.

1 Summary of Product Characteristics Vazkepa – April 2021 https://ec.europa.eu/health/documents/community-register/2021/20210326150935/anx_150935_en.pdf. Accessed August 20212 REDUCE-IT® study N Engl J Med. 2019;380(1):11-22.3 Destatis: Federal Statistical Office: Causes of death - the number of deaths fell by 1.6% in 2019. (last accessed on January 6, 2021)4 European Society of Cardiology. ESC Cardiovascular Realities 2020. https://www.flipsnack.com/Escardio/esc-cardiovascular-realities-2020/full-view.html. Accessed August 20215 European Heart Network. European Cardiovascular Disease Statistics 2017. https://ehnheart.org/cvd-statistics/cvd-statistics-2017.html. Accessed August 20216 European Society of Cardiology. ESC Cardiovascular Realities 2020. https://www.flipsnack.com/Escardio/esc-cardiovascular-realities-2020/full-view.html. Accessed August 20217 European Heart Network. European Cardiovascular Disease Statistics 2017. https://ehnheart.org/cvd-statistics/cvd-statistics-2017.html. Accessed August 20218 American Heart Association. Heart Disease and Stroke Statistics—2020 Update: A Report From the American Heart Association. Circulation. 2020;141:e139-e596.9 Ganda OP, Bhatt DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia therapy in hypertriglyceridemia management. J Am Coll Cardiol. 2018;72(3):330-343.10 Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.11 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):e008740.12 Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease - New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563.13 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;40:138-148.14 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;380:11-22.15 Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT investigators. Effects of Icosapent Ethyl on Total Ischemic Events: From REDUCE-IT. J Am Coll Cardiol. 2019;73:2791-2802.

 

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