AMRN Amarin Corporation plc

6.07
-0.06  -1%
Previous Close 6.13
Open 6.18
52 Week Low 3.36
52 Week High 21.82
Market Cap $2,360,194,476
Shares 388,829,403
Float 384,691,069
Enterprise Value $1,822,488,476
Volume 4,826,634
Av. Daily Volume 7,979,901
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Drug Pipeline

Drug Stage Notes
Vascepa
High Triglycerides With Mixed Dyslipidemia
Approved
Approved
FDA Approval announced December 13, 2019.

Latest News

  1. Unaudited 2020 Total Net Revenue Estimated to Be Approximately $610 Million, an Increase of Approximately 42% Compared with 2019

    Completion of European Regulatory Review and Submission of China Regulatory Application for VASCEPA® (icosapent ethyl) Expected in Late January or February 2021

    DUBLIN, Ireland and BRIDGEWATER, N.J., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today provided a business update, including preliminary unaudited full-year 2020 revenue results. Amarin plans to discuss these results and expectations with investors in connection with the 39th Annual J.P. Morgan Healthcare Conference at which Amarin is scheduled to present on Tuesday, January 12, 2020, at 2:00 pm Eastern time.

    Preliminary

    Unaudited 2020 Total Net Revenue Estimated to Be Approximately $610 Million, an Increase of Approximately 42% Compared with 2019

    Completion of European Regulatory Review and Submission of China Regulatory Application for VASCEPA® (icosapent ethyl) Expected in Late January or February 2021

    DUBLIN, Ireland and BRIDGEWATER, N.J., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today provided a business update, including preliminary unaudited full-year 2020 revenue results. Amarin plans to discuss these results and expectations with investors in connection with the 39th Annual J.P. Morgan Healthcare Conference at which Amarin is scheduled to present on Tuesday, January 12, 2020, at 2:00 pm Eastern time.

    Preliminary (unaudited) 2020 Financial Results

    Record Revenue Levels: Full-year 2020 total net revenue, subject to audit, are expected to be approximately $610 million. Despite the impact of COVID-19, this estimated 2020 net revenue expectation represents an increase of approximately 42% compared with full-year 2019 results. This growth was primarily driven by increased prescription levels of VASCEPA® in the United States.

    Liquid Assets: Amarin ended 2020 with more than $550 million in cash and investments, approximately $150 million in net accounts receivable and approximately $180 million in inventory.

    No Debt: At year-end 2020, Amarin had no debt, having fully repaid its prior royalty-like debt instrument in the fourth quarter of 2020, which from 2013 through most of 2020 required approximately 10% of net revenue to be paid against this prior obligation.

    Management Commentary

    "Amarin has the people, product and resources to expand globally starting with anticipated 2021 VASCEPA regulatory approval and commercial launch in Europe. Our expected growth in Europe and elsewhere overseas will build on our growth and experience in the United States," commented John F. Thero, president and chief executive officer. "We intend to build on our strong scientific foundation and medical experience. As patients begin to return for medical care beyond the COVID-19 era, we aim to ensure that VASCEPA is increasingly prescribed to help at-risk patients. While 2020 was a challenging year, I am thankful to our employees for the progress they made in countless areas. Their hard work and passion provide a strong foundation from which we will further launch VASCEPA to reduce persistent cardiovascular risk in appropriate patients, or P-CVR, in the United States, Europe and around the world."

    Highlights from 2020 and Outlook

    U.S. Commercial

    Amarin achieved a number of important commercial milestones in 2020, despite the challenges Amarin faced with COVID-19 and the November launch of generic icosapent ethyl in the United States.

    U.S. commercial highlights from 2020 include:

    • Record levels of VASCEPA revenues, prescriptions, prescribers and patients
    • Faster prescription growth for VASCEPA as compared to most other cardiovascular drugs that reported positive outcomes studies in recent years, despite VASCEPA having a lower level of promotional spend than many such drugs

      • VASCEPA growth in 2020 due to COVID-19 was slower than initially expected but compares well with the growth in 2020 of peer drugs
    • The P-CVR indication has quickly garnered the largest part of the market as approximately 93% of VASCEPA prescriptions based on the most recent data reported to us by IQVIA were for patients with triglyceride (TG) levels below 500 mg/dL
    • Further expanded managed care coverage for VASCEPA during 2020 with additional improvements agreed for 2021

      • Such increases are consistent with third-party analysis, which found VASCEPA to be cost effective, and with medical guidelines or recommendations from six leading U.S. medical societies
    • Doubled size of sales force (training for this expanded group was completed in March 2020 just before Amarin's customer-facing team was temporarily prohibited from conducting in-person meetings due to COVID-19)
    • Adapted to COVID-19 protocols with various tele-sales, tele-marketing and virtual education initiatives as well as training representatives to safely interact with healthcare professionals where possible

    U.S. commercial outlook includes:

    • Confidence that millions of at-risk patients remain untreated for P-CVR and could benefit from VASCEPA
    • Recognition that many at-risk patients ceased doctor visits for ordinary care in 2020 but are likely to return to their doctors for needed care as COVID-19 risk recedes

      • According to IQVIA, patient visits to medical offices for non-emergency medical care were down approximately 70% in April 2020 during the height of COVID-19, with visits steadily increasing thereafter. In December 2020, as a result of a spike in COVID-19 cases, patient visits have decreased approximately 50% compared to pre-COVID levels
    • Following a resurgence of COVID-19 in recent months, Amarin intends to reduce spending levels for certain forms of promotion (e.g., television advertisements) in early 2021

      • U.S. promotional spending likely to be variable with adjustments upward or downward in response to the changing impact from COVID-19 and generic competition
    • As COVID-19 vaccine progress is made, along with other mitigating approaches, Amarin plans to increasingly resume its promotion of VASCEPA for P-CVR while continuing to adapt to market changes

      • Generic competition launched in November 2020 only for the original indication (TG >500 mg/dL) and is expected to continue to face supply limits, despite stockpiles of generic product likely created prior to launch

      • Variability is expected as patients, pharmacies and payers adjust to the availability, pricing and label of this generic competition

      • Due to the uncertainties regarding COVID-19 and potential generic supply, Amarin will continue to withhold 2021 revenue guidance for VASCEPA in the U.S. until there is greater clarity on the impact of these issues
    • Amarin intends to continue to manage its U.S. commercial operations to expand patient care and enhance profits from U.S. operations

    Europe

    Europe highlights from 2020 include:

    • Reached Day 180 of the European Medicines Agency, or EMA, centralized regulatory review of VASCEPA assuring that the United Kingdom is grandfathered into a facilitated review process despite its withdrawal from the European Union
    • An expanded recommendation was issued by the European Society of Cardiology regarding use of icosapent ethyl (U.S. brand name VASCEPA)
    • Increased the size of the Amarin team in Europe to approximately 50 experienced professionals to support pre-approval and pre-launch preparations for VASCEPA in select countries
    • Commenced interactions with authorities in select countries regarding VASCEPA market access assuming approval, noting that more formal proceedings cannot progress until after the product is approved and the label is established
    • Made major advances in expanding company-wide systems to support expected commercial launch of VASCEPA in Europe in 2021

    Europe outlook includes:

    • Millions of at-risk patients could benefit from VASCEPA in Europe

      • There are more patients on statins in Europe in aggregate compared to the U.S. and the rate of death from cardiovascular disease is higher
    • Regulatory approval expected in early 2021

      • CHMP opinion expected in late January or February 2021

      • EMA approval decision expected within 67 days of CHMP decision
    • Market access negotiations anticipated on a country-by-country basis promptly after approval

      • Seeking net pricing that equals or exceeds U.S. net pricing with focus on P-CVR indication based on outcomes data in Europe, whereas pricing in the U.S was based on original TG lowering indication
    • Launch timing by country dependent on market access (i.e., insurance coverage)

      • At a minimum, launch expected in Germany in 2021 after initial product awareness campaign

      • Launch in Germany and other countries is anticipated to give priority to specialists (e.g., cardiologists) and to also include substantial digital educational and promotional initiatives

      • Target of approximately 200 employees (or contractors) in the European commercial team by end of 2021

    Rest of World

    Rest of world, or ROW, highlights from 2020 include:

    • China positive clinical study results reported
    • Canada commercial launch of VASCEPA initiated (just prior to slowdown from COVID-19)
    • Canada reimbursement levels for VASCEPA established within six months of product regulatory approval to facilitate treating patients with established cardiovascular disease

    ROW outlook includes:

    • Large at-risk patient opportunities

      • In China 290 million people are reported to have cardiovascular disease, a number which has been increasing rapidly in recent years, including approximately 52 million reported to have high TG levels, a substantial portion of whom might be able to benefit from VASCEPA
    • Plans to submit application for regulatory approval through Amarin's commercial partner in the People's Republic of China
    • Anticipate inclusion of VASCEPA in the treatment guidelines in Chinese medical societies
    • Pursue opportunities for VASCEPA in untapped countries after approval and market access in Europe is secured, with such approval and market access expected to enhance ROW positioning

    R&D and Medical Advancement

    R&D and medical advancement highlights from 2020 include:

    • EVAPORATE exploratory study results, as previously reported, reported 17% reduction in plaque volume in patients with coronary atherosclerosis treated with VASCEPA
    • Numerous other studies presented in support of the potential unique mechanism of action of VASCEPA

      • In aggregate, Amarin supported over 40 scientific publications and presentations in 2020
    • CardioLink-19 exploratory study results, as previously reported, evaluated a higher initial dose of VASCEPA and suggested VASCEPA could potentially have utility as a therapeutic option for mitigating COVID-19 effects in an out-patient setting

      • This pilot study was rapidly commenced and completed with results that exceeded expectations

      • Additional COVID-19 investigational studies of VASCEPA were also commenced in 2020
    • Witnessed an increase to twelve (12) the number of medical societies globally that now include icosapent ethyl in their guidelines or have otherwise recommended its use

    R&D and medical outlook includes:

    • Supporting approval of VASCEPA in Europe and regulatory review processes initiated by Amarin's commercial partner in the People's Republic of China
    • Supporting cost-effectiveness studies and market access for VASCEPA wherever it is approved
    • Support completion of COVID-19 investigational studies and, based on the results, decide on appropriate next steps
    • Continue to study and differentiate the unique clinical and biological effects of VASCEPA
    • In concert with Amarin's business development and other efforts, prioritize and execute on potential opportunities to expand indications for VASCEPA or develop new products

    Financial Resources

    Amarin reiterates that it believes its current cash resources are adequate to support the European launch and its planned operations and priorities in the United States and globally. Such guidance included anticipated resources likely needed to further expand its VASCEPA supply capacity in anticipation of launches of VASCEPA in Europe, China and other countries as well as the opportunity to continue to grow prescription levels in the United States after COVID-19 recedes, continuing the launch of VASCEPA for P-CVR as commenced in 2020.

    Currently, Amarin anticipates 2021 operating expenses of approximately $550 million to $600 million which represents an increase of approximately 10% to 20%, compared with 2020 levels. Included in these anticipated expenses are increased costs associated with Amarin's commercial launch preparations and initial launch in Europe as well as continued U.S. promotional activities, including increased face to face interactions between Amarin's sales professionals and health care providers and direct-to-consumer advertising in the U.S. after the impact of COVID-19 becomes less pronounced and at-risk patients begin returning to their doctors for non-urgent medical care. With continued investment in consumer and in-person marketing, Amarin expects VASCEPA revenue growth in the U.S. As described above, these spending levels may vary from quarter to quarter. Further these operating expense levels assume substantial societal recovery in 2021 from COVID-19 and the continued limited availability of supply to the generic companies. Amarin will re-evaluate its planned spend in 2021 if any of these assumptions change.

    More Information to Follow

    Amarin expects to provide further details regarding its 2020 results and perspective regarding its future outlook in the company's annual report on Form 10-K.

    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 Cardiovascular Risk

    Cardiovascular disease is an enormous and growing public burden globally. In the United States alone there are 605,000 new and 200,000 recurrent heart attacks per year (approximately 1 every 40 seconds), in the United States. Stroke rates are 795,000 per year (approximately 1 every 40 seconds), accounting for 1 of every 19 U.S. deaths. Cardiovascular disease results in 859,000 deaths per year in the United States.1 In aggregate, there are more than 2.4 million major adverse cardiovascular events per year from cardiovascular disease or, on average, one every 13 seconds in the United States alone.

    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%.2 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.3,4,5

    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.6 The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.7 The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.8 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) 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. VASCEPA 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 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.

    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

     VASCEPAPlaceboVASCEPA

    vs Placebo
    N = 4089

    n (%)
    Incidence Rate

    (per 100 patient years)
    N = 4090

    n (%)
    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)
    4.3901

    (22.0)
    5.70.75

    (0.68, 0.83)
    Key secondary composite endpoint
    Cardiovascular death, myocardial infarction, stroke (3-point MACE)459

    (11.2)
    2.7606

    (14.8)
    3.70.74

    (0.65, 0.83)
    Other secondary endpoints
    Fatal or non-fatal myocardial infarction250

    (6.1)
    1.5355

    (8.7)
    2.10.69

    (0.58, 0.81)
    Emergent or urgent coronary revascularization216

    (5.3)
    1.3321

    (7.8)
    1.90.65

    (0.55, 0.78)
    Cardiovascular death [1]174

    (4.3)
    1.0213

    (5.2)
    1.20.80

    (0.66, 0.98)
    Hospitalization for unstable angina [2]108

    (2.6)
    0.6157

    (3.8)
    0.90.68

    (0.53, 0.87)
    Fatal or non-fatal stroke98

    (2.4)
    0.6134

    (3.3)
    0.80.72

    (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 regarding revenue and prescription growth, the impacts of COVID-19, including its future trajectory and effects on non-urgent medical care, the impacts of generic competition, including expected levels of generic supply, changes to U.S. commercial operations, including to spending and promotional levels, plans for commercial and international expansion, including the timing and outcome of regulatory approvals, market access negotiations and commercial launch, R&D and medical outlook, including the timing and results of future studies, market access efforts and indication expansion opportunities, the adequacy of its current cash resources and its 2021 operating expenses. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. 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 broad 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, to comply with legal and regulatory requirements in connection with the sale and promotion of VASCEPA and to secure and maintain patent protection for VASCEPA. Among the factors that could cause actual results to differ materially from those described or projected herein include the following: uncertainties associated with the COVID-19 pandemic and generic competition; factors outside of our control may prevent VASCEPA from achieving market acceptance and commercial success; the commercial value of VASCEPA outside the United States may be smaller than we anticipate; uncertainties associated generally with research and development, clinical trials and related regulatory approvals; and 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 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. 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 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 Inquiries:

    Investor Relations

    Amarin Corporation plc

    In U.S.: +1 (908) 719-1315

    (investor inquiries)

    Solebury Trout

    Media Inquiries:

    Communications

    Amarin Corporation plc

    In U.S.: +1 (908) 892-2028

    (media inquiries)

    ________________________________
    1 American Heart Association. Heart Disease and Stroke Statistics—2020 Update: A Report From the American Heart Association. Circulation. 2020;141:e139–e596.
    2 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.
    3 Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.
    4 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.
    5 Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease - New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563.
    6 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.
    7 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.
    8 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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  2. DUBLIN, Ireland and BRIDGEWATER, N.J., Jan. 04, 2021 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) announced today that John F. Thero, Amarin's president and chief executive officer, is scheduled to present at the 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12, 2021 from 2:00 - 2:40 p.m. Eastern Time.

    A live audio webcast of the presentation will be available at: http://www.amarincorp.com and will be accessible at the same link for 30 days.

    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…

    DUBLIN, Ireland and BRIDGEWATER, N.J., Jan. 04, 2021 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) announced today that John F. Thero, Amarin's president and chief executive officer, is scheduled to present at the 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12, 2021 from 2:00 - 2:40 p.m. Eastern Time.

    A live audio webcast of the presentation will be available at: http://www.amarincorp.com and will be accessible at the same link for 30 days.

    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.

    Availability of Other Information About Amarin

    Investors and others should note that Amarin communicates with its investors and the public using the company website (http://www.amarincorp.com/), the investor relations website (http://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 Inquiries:

    Investor Relations

    Amarin Corporation plc

    In U.S.: +1 (908) 719-1315

    (investor inquiries)

    Solebury Trout

    Media Inquiries:

    Communications

    Amarin Corporation plc

    In U.S.: +1 (908) 892-2028

    (media inquiries)



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  3. REDUCE-IT® EPA Encore Presentation reinforces Eicosapentaenoic Acid (EPA) levels from VASCEPA® (icosapent ethyl) strongly correlated to cardiovascular outcomes, more so than other biomarkers

    VASCEPA COVID-19 CardioLink-9 Randomized Trial suggests improvement in outpatient-reported COVID-19 symptoms while achieving its primary endpoint by demonstrating a 25% reduction in high-sensitivity C-reactive protein (hsCRP) with encouraging short-term safety and tolerability data using VASCEPA loading dose

    Amarin to Webcast Discussion of Presented Data Today, Monday, December 14, 2020 at 8:00 a.m., Eastern Standard Time

    DUBLIN, Ireland and BRIDGEWATER, N.J., Dec. 14, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced the…

    REDUCE-IT® EPA Encore Presentation reinforces Eicosapentaenoic Acid (EPA) levels from VASCEPA® (icosapent ethyl) strongly correlated to cardiovascular outcomes, more so than other biomarkers

    VASCEPA COVID-19 CardioLink-9 Randomized Trial suggests improvement in outpatient-reported COVID-19 symptoms while achieving its primary endpoint by demonstrating a 25% reduction in high-sensitivity C-reactive protein (hsCRP) with encouraging short-term safety and tolerability data using VASCEPA loading dose

    Amarin to Webcast Discussion of Presented Data Today, Monday, December 14, 2020 at 8:00 a.m., Eastern Standard Time

    DUBLIN, Ireland and BRIDGEWATER, N.J., Dec. 14, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced the presentation of important VASCEPA® (icosapent ethyl)-related scientific findings during the National Lipid Association (NLA) Scientific Sessions 2020, held virtually from December 10 – 12, 2020, from a variety of academic collaborators and based on research or analyses supported by Amarin.

    "We are privileged to have supported several important presentations at NLA Scientific Sessions 2020, including two Late Breakers," said Steven Ketchum, Ph.D., senior vice president and president, research & development, and chief scientific officer, Amarin. "We continue to forge ahead with scientifically-driven evidence of the uniqueness of VASCEPA in cardiovascular risk reduction while providing support to investigators exploring other ways in which VASCEPA can potentially improve public health while potentially lowering the cost of patient care."

    These presentations were on the following topics:

    1.   Late Breakers

    • "EPA Levels and Cardiovascular Outcomes in the Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial" – presented on behalf of all authors by Michael Miller, M.D., University of Maryland Medical System, Baltimore, MD

    Highlights: Following administration of VASCEPA, a pure, stable, unique prescription eicosapentaenoic acid (EPA)-based therapy at 4 g/day in the successful REDUCE-IT cardiovascular outcomes study, analysis shows that median serum EPA levels increased in year 1 to well over 100 ug/mL (144 μg/mL; p=1x10-30) and increased approximately 400% across the study from baseline (26.1 μg/mL) versus placebo. Docosahexaenoic acid (DHA) levels were measured and showed a decrease of 2.9% (p=0.002).

    On-treatment EPA levels in the VASCEPA group were found in these analyses to be associated strongly with reduced cardiovascular events, including benefits observed in the primary (5-point MACE, consisting of cardiovascular death, myocardial infarction, stroke, revascularization, and hospitalization for unstable angina) and key secondary (3-point MACE, consisting of cardiovascular death, myocardial infarction, and stroke) endpoints.

    "These analyses suggest that achieved EPA levels with 4 g/day of icosapent ethyl is a marker for the majority of the relative risk reduction observed in REDUCE-IT," said Michael Miller M.D., University of Maryland Medical System, Baltimore, MD. "The EPA levels achieved in REDUCE-IT were well above levels that can be achieved with diet or with dietary supplements and the clinical results have not been demonstrated by any other agent, reflecting the uniqueness of this FDA-approved prescription therapy."

    • "First Human Trial of a Loading Dose of Icosapent Ethyl in Patients with COVID-19: Primary Results of the VASCEPA COVID-19 CardioLink-9 Randomized Trial" – presented on behalf of all authors by Deepak L. Bhatt, M.D., M.P.H., Brigham and Women's Hospital, Harvard Medical School, Boston, MA (as described in a separate press release dated December 12, 2020 and related FAQ on Amarin's website)

    Highlights: The VASCEPA COVID-19 CardioLink-9 Trial was a randomized, open-label trial enrolling 100 SARS-CoV-2 positive and symptomatic outpatients displaying at least one of the following: fever, cough, sore throat, shortness of breath, myalgia. Patients in the VASCEPA arm received a loading dose of 8 g/day for 3 days followed by 4 g/day for 11 days on top of usual care. Patients randomized to the non-active arm received usual care. Baseline characteristics were comparable between groups.

    The primary biomarker endpoint of the study was within-group changes in high-sensitivity C-reactive protein (hsCRP), a measure of inflammation. Within-group changes in D-dimer were also examined. VASCEPA administration resulted in a 25% reduction in hsCRP (p=0.011) as well as a reduction in D-dimer (p=0.048).

    In addition to these biomarker changes, assessment was made of COVID-19 symptom changes from baseline to 14 days in the influenza patient-reported outcome (FLU-PRO) score, a validated patient-reported outcome measure designed to evaluate the presence, severity and duration of flu symptoms in clinical trials. VASCEPA administration resulted in a significant 52% reduction of the total FLU-PRO prevalence score as compared to a 24% reduction in the usual care group (p=0.003 between groups), with reductions across individual score domains, including a significantly larger reduction compared to usual care in the body/systemic domain (54% vs. 26%; p=0.003). Significant reductions in the FLU-PRO symptom score compared to usual care were also observed in the total symptom score (p=0.003), as well as in the body/systemic (p=0.0007) and chest/respiratory (p=0.01) domains.

    Limitations of this study include the modest sample size, the unblinded nature of this randomized trial, and that the trial was not powered for clinical events. These results have not yet been published or reviewed by regulatory authorities. Additional study is needed.

    This randomized trial represents the first human experience with an 8 g/day loading dose of icosapent ethyl and has suggested short-term safety and tolerability in a modest sample size. Regarding COVID-19, this study provides the first evidence of potential early anti-inflammatory effect of icosapent ethyl in symptomatic, COVID-19 positive outpatients.

    Amarin added that the VASCEPA COVID-19 CardioLink-9 trial is the first in a series of ongoing investigator-sponsored studies into the potential role of VASCEPA therapy in COVID-19 settings. Other ongoing trials include PREPARE-IT: Prevention of COVID19 With EPA in Healthcare Providers at Risk - Intervention Trial sponsored by Estudios Clínicos Latino América, and A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults (MITIGATE) sponsored by Kaiser Permanente.

    "This randomized trial represents the first human experience with a loading dose of icosapent ethyl and has demonstrated short-term safety and tolerability in a modest sample size," commented Deepak L. Bhatt, M.D., M.P.H., Executive Director of Interventional Cardiovascular Programs at Brigham and Women's Hospital and Professor of Medicine at Harvard Medical School, principal investigator of VASCEPA COVID-19 CardioLink-9 and REDUCE-IT. "Regarding COVID-19, this study provides the first evidence of an early anti-inflammatory effect of icosapent ethyl in symptomatic, COVID-19 positive outpatients. The large and significant improvement in patient-reported symptoms may provide a safe, well-tolerated, and relatively inexpensive option to impact upon COVID-19-related morbidity, though these results should be confirmed in a bigger trial."

    Amarin thanks the patients, investigators, support staff, and all others involved in the VASCEPA COVID-19 CardioLink-9 study.

    2.   Other Amarin-supported REDUCE-IT abstracts presented include:

    • "REDUCE-IT USA: Results from the 3146 Patients Randomized in the United States" – presented on behalf of all authors by Michael Miller, M.D., University of Maryland Medical System, Baltimore, MD

    Highlights: In the REDUCE-IT USA subgroup, 3,146 patients (38.5% of the full trial cohort) were randomized and followed for a median of 4.9 years. This prespecified REDUCE-IT subgroup analysis showed robust risk reductions in the USA patients treated with icosapent ethyl 4 g/day versus placebo across all prespecified composite and individual primary and secondary endpoints, including 31% relative risk reduction and 6.5% absolute risk reduction in first occurrence of 5-point major adverse cardiovascular events (MACE), corresponding to a number needed to treat of 15 (NNT=15), and a significant 30% relative and 2.6% absolute risk reduction (NNT=38) in all-cause mortality in the USA subgroup. Safety and tolerability findings in the USA subgroup were consistent with the full study cohort.

    Additional prespecified cardiovascular endpoints in which the REDUCE-IT USA subgroup showed significant relative risk reduction included myocardial infarction, cardiovascular death, and stroke, similar to the full cohort in the overall REDUCE-IT global results. These results were incremental to the cardiovascular risk reduction achieved by conventional therapy administered to the high-risk patients studied, including incremental to statin therapy.

    3.   Other Amarin-supported abstracts providing mechanism of action insights include:

    • "Eicosapentaenoic Acid Maintains Normal Membrane Cholesterol Distribution under Hyperglycemic Conditions unlike a Mixed Omega-3 Fatty Acid Supplement" – presented on behalf of all authors by R. Preston Mason, Ph.D., Brigham and Women's Hospital, Harvard Medical School, Boston, MA, Elucida Research LLC, Beverly, MA

    Highlights: This study compared the effects of EPA and mixed omega-3 fatty acid (O3FA) supplement on membrane structure and cholesterol crystalline domain formation under conditions of hyperglycemia and oxidative stress. Membranes containing either EPA or the mixed O3FA supplement had a structure characterized by normal cholesterol distribution prior to oxidation. EPA preserved normal membrane structure and cholesterol distribution while reducing lipid oxidation under conditions of hyperglycemia in a manner that was not reproduced with a DHA-containing mixed O3FA supplement. These data indicate a unique hydrocarbon chain length and number of unsaturated fatty acids for EPA that preserves membrane structure and cholesterol distribution under conditions of hyperglycemia and oxidative stress.

    • "Eicosapentaenoic Acid Improves Endothelial Nitric Oxide Bioavailability and Changes Fatty Acid Content in a Manner Distinct from Docosahexaenoic Acid" – presented on behalf of all authors by R. Preston Mason, Ph.D., Brigham and Women's Hospital, Harvard Medical School, Boston, MA, Elucida Research LLC, Beverly, MA

    Highlights: This study compared the treatment effects of EPA, DHA and the omega-6 fatty acid arachidonic acid (AA) on endothelial cell (EC) functions and fatty acid composition. ECs treated with EPA, but not DHA or AA, had significantly greater nitric oxide/peroxynitrite (NO/ONOO−) release ratio at all time points with an average increase of 37%, and only EPA treatment also increased NO levels at all time points compared with vehicle. These findings support a preferential benefit of EPA on an index of EC function that correlates with its rapid metabolism without increases in AA levels. While DHA and AA levels increased with treatment, there was no correlation of either with improved EC function.

    • "Eicosapentaenoic acid Reduces Expression of Pulmonary Endothelial Angiotensin Converting Enzyme (ACE) Linked to Inflammation" – presented on behalf of all authors by R. Preston Mason, Ph.D., Brigham and Women's Hospital, Harvard Medical School, Boston, MA, Elucida Research LLC, Beverly, MA

    Highlights: This study tested the effects of EPA on protein expression in human pulmonary endothelial cells (ECs) under conditions of inflammation using the cytokine interleukin-6 (IL-6). Human lung microvascular ECs pretreated with EPA and then challenged with IL-6 showed down-regulation of >60 proteins compared with untreated controls. Among the proteins significantly down-regulated by EPA was angiotensin-converting enzyme (ACE) by 3-fold (p<0.05) compared with IL-6 treated cells. The reduction in ACE expression with EPA correlated with reduced expression of other inflammatory proteins, including ICAM-1 (p<0.05). Gene set enrichment analysis also revealed changes in several pathways related to transcription regulation with EPA treatment.

    • "Eicosapentaenoic Acid Reverses Endothelial Dysfunction following Exposure to the Cytokine IL-6 in Contrast to Docosahexaenoic and Arachidonic Acids" – presented on behalf of all authors by R. Preston Mason, Ph.D., Brigham and Women's Hospital, Harvard Medical School, Boston, MA, Elucida Research LLC, Beverly, MA

    Highlights: This study compared the treatment effects of EPA, DHA and AA on endothelial cell function under conditions of inflammation using the cytokine IL-6. EPA preserved nitric oxide bioavailability under conditions of inflammation caused by IL-6 exposure, unlike DHA or AA.

    • "Variability in Content of Omega-3 Fatty Acids and other Fatty Acids in Multiple Lots of a Widely Used Fish Oil Dietary Supplement" – presented on behalf of all authors by R. Preston Mason, Ph.D., Brigham and Women's Hospital, Harvard Medical School, Boston, MA, Elucida Research LLC, Beverly, MA

    Highlights: This study measured the fatty acid (FA) content of a leading (by sales) fish oil dietary supplement (FODS) in multiple lots, including the O3FAs EPA and DHA. Multiple lots of the leading FODS examined had substantially less than the advertised amount of O3FA. The FODS also had high levels of saturated FAs and other non-O3FAs that exceeded the total amounts of O3FAs. The levels of EPA and DHA varied markedly from lot to lot in the FODS. These data indicate that the FODS tested is not an appropriate substitute for prescription EPA for CV patients.

    • "Icosapent Ethyl Mitigates Dyslipidemia by Both Hastening LDL Clearance and Slowing Triglyceride-Rich Lipoprotein Production" – presented on behalf of all authors by Richard Dunbar, M.D., formerly of the Perelman School of Medicine, University of Pennsylvania, and currently senior director, clinical development, Amarin.

    Highlights: This Vascepa to Accelerate Lipoprotein Uptake and Elimination (VALUE) Study was a randomized parallel-arm clinical mechanistic study of icosapent ethyl effects on lipoprotein kinetics in statin-treated patients with residual hypertriglyceridemia. Patients were randomized to icosapent ethyl 4 g/d plus statin (n=12) or statin alone (n=8) for > 14 weeks. The results suggest that icosapent ethyl 4 g/day suppresses atherogenic lipoproteins at both ends of the non-high-density lipoprotein (apolipoprotein B) density spectrum, by limiting triglyceride-rich lipoprotein production and hastening cholesterol-rich low-density lipoprotein uptake and elimination.

    • "Comparing Eicosapentaenoic Acid Between Plasma and Serum from a Randomized-Controlled Clinical Trial" – presented on behalf of all authors by Richard Dunbar, M.D., formerly of the Perelman School of Medicine, University of Pennsylvania, and currently senior director, clinical development, Amarin.

    Highlights: This analysis used blood samples collected from the VALUE study described above to assess the relationship between plasma and serum EPA levels in matching samples collected from individual patients. This study found that EPA levels in plasma and serum were strongly related and this relationship was not affected by demographics, fasting versus fed state, or treatment arm. Serum EPA levels were roughly comparable to plasma EPA, with discrepancies being modest and resembling the gap between plasma versus serum electrolytes or glucose. Therefore, for non-quantitative uses, plasma and serum EPA could be treated as nearly equivalent. For quantitative analyses, plasma levels were slightly higher than serum levels and the derived regression models could be used to convert one to the other.  

    All analyses highlighted above were funded by Amarin. The VASCEPA COVID-19 CardioLink-9 study was also funded by HLS Therapeutics, Inc.

    Additional information on NLA Scientific Sessions 2020 can be found here.

    Audio Webcast Information

    Amarin will host an audio webcast today, Monday, December 14, 2020, at 8:00 a.m. EST to further discuss these and other VASCEPA-related findings presented during the NLA Scientific Sessions 2020, with replay available for a period of 14 days. The discussion will include various clinicians and scientists and will be moderated by Amarin's chief medical officer, Craig Granowitz, M.D., Ph.D. To listen please register here, listen live on the investor relations section of the company's website at www.amarincorp.com, or via telephone by dialing 877-407-8033 within the United States, 201-689-8033 from outside the United States. Any opinions or views expressed by the clinicians and scientists on the audio webcast are theirs alone. They have neither been scripted nor previewed by Amarin. While Amarin respects the scientific opinions of these clinicians and scientists, Amarin takes no responsibility for those opinions. Rather, this audio webcast is intended to provide summaries of recently presented scientific data for consideration by Amarin's investors.

    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 COVID-19

    Current understanding of the biology of COVID-19 is that patients that have or are at high risk for developing atherosclerotic cardiovascular disease (ASCVD) are at higher risk of death and severe effects from infection, and that the morbidity and mortality associated with COVID-19 are due both to the direct toxicity of the virus as well as the body's robust inflammatory response leading to ‘cytokine storm'.1,2,3,4

    Scientific Rationale for Study of VASCEPA in COVID-19 Patients

    Based on data related to the mechanism of action and effects of VASCEPA, it is hypothesized that VASCEPA may play a potential beneficial role in preventing SARS-CoV-2 infection and to potentially reduce clinical severity in patients infected by the virus.4,5,6

    The clinical effects of VASCEPA are multi-factorial. Multiple mechanisms of action associated with VASCEPA based on clinical and mechanistic studies support the rationale to test its effects in patients with or at risk for COVID-19 disease. Some of these postulated mechanisms include the following:

    • Potential antiviral/antimicrobial effects7,8
    • Fibrosis and cardiac damage mitigation in animal models9,10
    • Anti-inflammatory effects (acute) in pulmonary/lung tissue11,12

    Ongoing preclinical and clinical research may provide further insights into the scientific and clinical understanding of these hypothetical effects of VASCEPA in COVID-19 disease mitigation. Whereas vaccines are intended to help eradicate the virus from proliferating, other therapeutics under development and clinical testing such as antibodies or other medicines may play roles in the treatment of patients in various settings across the infection and recovery continuum.

    For more information on studies of VASCEPA in COVID-19 patients, see the frequently asked question entry on Amarin's corporate website, here.  

    About Cardiovascular Risk

    The number of deaths in the United States attributed to cardiovascular disease continues to rise. There are 605,000 new and 200,000 recurrent heart attacks per year (approximately 1 every 40 seconds), in the United States. Stroke rates are 795,000 per year (approximately 1 every 40 seconds), accounting for 1 of every 19 U.S. deaths. Cardiovascular disease results in 859,000 deaths per year in the United States.13 In aggregate, there are more than 2.4 million major adverse cardiovascular events per year from cardiovascular disease or, on average, one every 13 seconds in the United States alone.

    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%.14 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.15,16,17

    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.18 The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.19 The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.20 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) 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. VASCEPA 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 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.

    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

     VASCEPAPlaceboVASCEPA

    vs Placebo
    N = 4089

    n (%)
    Incidence Rate

    (per 100 patient years)
    N = 4090

    n (%)
    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)
    4.3901

    (22.0)
    5.70.75

    (0.68, 0.83)
    Key secondary composite endpoint
    Cardiovascular death, myocardial infarction, stroke (3-point MACE)459

    (11.2)
    2.7606

    (14.8)
    3.70.74

    (0.65, 0.83)
    Other secondary endpoints
    Fatal or non-fatal myocardial infarction250

    (6.1)
    1.5355

    (8.7)
    2.10.69

    (0.58, 0.81)
    Emergent or urgent coronary revascularization216

    (5.3)
    1.3321

    (7.8)
    1.90.65

    (0.55, 0.78)
    Cardiovascular death [1]174

    (4.3)
    1.0213

    (5.2)
    1.20.80

    (0.66, 0.98)
    Hospitalization for unstable angina [2]108

    (2.6)
    0.6157

    (3.8)
    0.90.68

    (0.53, 0.87)
    Fatal or non-fatal stroke98

    (2.4)
    0.6134

    (3.3)
    0.80.72

    (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 regarding the potential impact of VASCEPA in various clinical uses. 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 research and development and clinical trials such as further clinical evaluations failing to confirm earlier findings. 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. 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 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 Inquiries:

    Investor Relations

    Amarin Corporation plc

    In U.S.: +1 (908) 719-1315

    (investor inquiries)

    Solebury Trout

    Media Inquiries:

    Alina Kolomeyer

    Communications

    Amarin Corporation plc

    In U.S.: +1 (908) 892-2028

    (media inquiries)

    1 Cummings MJ, Baldwin MR, Abrams D, et al. Epidemiology, clinical course, and outcomes of critically ill adults with COVID- 19 in New York City: a prospective cohort study. Lancet. 2020; (published online May 19.) https://doi.org/10.1016/S0140-6736(20)31189-2.

    2 Zhou F, Yu T, Du R, et al. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020;395(10229):1054-1062.

    3 Mehta P, McAuley DF, Brown M, et al. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020;395(10229):1033‐1034.

    4 Panigrahy D, Gilligan MM, Huang S, et al. Inflammation resolution: a dual-pronged approach to averting cytokine storms in COVID-19? Cancer Metastasis Rev. 2020;1‐4. doi:10.1007/s10555-020-09889-4.

    5 Morita M, Kuba K, Ichikawa A, et al. The lipid mediator protectin D1 inhibits influenza virus replication and improves severe influenza. Cell. 2013;153:112-25.

    6 Das UN. Can Bioactive Lipids Inactivate Coronavirus (COVID-19)? Arch Med Res. 2020;51(3):282‐286.

    7 Morita M, Kuba K, Ichikawa A, et al. The lipid mediator protectin D1 inhibits influenza virus replication and improves severe influenza. Cell. 2013;153:112-25.

    8 Desbois, A.P. (2013). Antimicrobial Properties of Eicosapentaenoic Acid (C20:5n −3). In Marine Microbiology, S.‐K. Kim (Ed.). doi:10.1002/9783527665259.ch20.

    9 Eclov JA, Qian Q, Redetzke R, et al. EPA, not DHA, prevents fibrosis in pressure overload-induced heart failure: potential role of free fatty acid receptor 4. J Lipid Res. 2015;56(12):2297‐2308.

    10 Ito S, Sano Y, Nagasawa K, et al. Highly purified eicosapentaenoic acid ameliorates cardiac injury and adipose tissue inflammation in a rat model of metabolic syndrome. Obes Sci Pract. 2016;2(3):318‐329.

    11 Mickleborough TD, Tecklenburg SL, Montgomery GS, Lindley MR. Eicosapentaenoic acid is more effective than docosahexaenoic acid in inhibiting proinflammatory mediator production and transcription from LPS-induced human asthmatic alveolar macrophage cells. Clin Nutrition. 2009;28:71-77.

    12 El Kebir D, Gjorstrup P, Filep JG. Resolvin E1 promotes phagocytosis-induced neutrophil apoptosis and accelerates resolution of pulmonary inflammation. Proc Natl Acad Sci U S A. 2012;109(37):14983‐14988.

    13 American Heart Association. Heart Disease and Stroke Statistics—2020 Update: A Report From the American Heart Association. Circulation. 2020;141:e139–e596.

    14 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.

    15 Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.

    16 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.

    17 Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease - New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563.

    18 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.

    19 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.

    20 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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  4. VASCEPA COVID-19 CardioLink-9 Randomized Trial suggests improvement in patient-reported COVID-19 symptoms while achieving its primary endpoint by demonstrating a 25% reduction in high-sensitivity C-reactive protein (hsCRP) with encouraging short-term safety and tolerability data using VASCEPA loading dose

    VASCEPA administration resulted in a significant 52% reduction of the total patient-reported symptom outcome prevalence score as compared to a 24% reduction in the usual care group

    Larger follow-on clinical studies have commenced of VASCEPA as a therapeutic option in COVID-19 settings, anticipated to be completed in 2021

    Amarin to Webcast Discussion of Presented Data on Monday, December 14, 2020 at 8:00 a.m., Eastern Standard

    VASCEPA COVID-19 CardioLink-9 Randomized Trial suggests improvement in patient-reported COVID-19 symptoms while achieving its primary endpoint by demonstrating a 25% reduction in high-sensitivity C-reactive protein (hsCRP) with encouraging short-term safety and tolerability data using VASCEPA loading dose

    VASCEPA administration resulted in a significant 52% reduction of the total patient-reported symptom outcome prevalence score as compared to a 24% reduction in the usual care group

    Larger follow-on clinical studies have commenced of VASCEPA as a therapeutic option in COVID-19 settings, anticipated to be completed in 2021

    Amarin to Webcast Discussion of Presented Data on Monday, December 14, 2020 at 8:00 a.m., Eastern Standard Time

    DUBLIN, Ireland and BRIDGEWATER, N.J., Dec. 12, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced the presentation of clinical results from the CardioLink-9 Trial, the first results of a study of VASCEPA® (icosapent ethyl) in COVID-19 infected outpatients. The presentation, "First Human Trial of a Loading Dose of Icosapent Ethyl in Patients with COVID-19: Primary Results of the VASCEPA COVID-19 CardioLink-9 Randomized Trial", was made virtually as a Late Breaker at the National Lipid Association (NLA) Scientific Sessions 2020, and was presented on behalf of all authors by Deepak L. Bhatt, M.D., M.P.H., Brigham and Women's Hospital, Harvard Medical School, Boston, MA.

    "In the current environment, most COVID-19 positive patients remain outside of the clinical setting, following the advice of their doctor to stay home and quarantine unless absolutely necessary to enter the hospital," commented Subodh Verma, M.D., Ph.D., FRCSC, Professor and Cardiac Surgeon at University of Toronto and co-principal investigator of COVID-19 CardioLink-9 and the encouraging results of this pilot study. "The large and significant improvement in patient-reported symptoms may provide a safe, well-tolerated, and relatively inexpensive option to impact upon COVID-19-related morbidity. The reduction in markers of inflammation with icosapent ethyl is also important given what we know about the pathobiology of COVID-19."

    The VASCEPA COVID-19 CardioLink-9 Trial was a randomized, open-label trial enrolling 100 SARS-CoV-2 positive and symptomatic outpatients displaying at least one of the following: fever, cough, sore throat, shortness of breath, myalgia. Patients in the VASCEPA arm received a loading dose of 8 g/day for 3 days followed by 4 g/day for 11 days on top of usual care. Patients randomized to the non-active arm received usual care. Baseline characteristics were comparable between groups.

    The primary biomarker endpoint of the study was within-group changes in high-sensitivity C-reactive protein (hsCRP), a measure of inflammation. Within-group changes in D-dimer were also examined. VASCEPA administration resulted in a 25% reduction in hsCRP (p=0.011) as well as a reduction in D-dimer (p=0.048).

    In addition to these biomarker changes, assessment was made of COVID-19 symptom changes from baseline to 14 days in the influenza patient-reported outcome (FLU-PRO) score, a validated patient-reported outcome measure designed to evaluate the presence, severity and duration of flu symptoms in clinical trials. VASCEPA administration resulted in a significant 52% reduction of the total FLU-PRO prevalence score as compared to a 24% reduction in the usual care group (p=0.003 between groups), with reductions across individual score domains, including a significantly larger reduction compared to usual care in the body/systemic domain (54% vs. 26%; p=0.003). Significant reductions in the FLU-PRO symptom score compared to usual care were also observed in the total symptom score (p=0.003), as well as in the body/systemic (p=0.0007) and chest/respiratory (p=0.01) domains.   

    VASCEPA CardioLink-9 Study is an investigator-initiated study supported by Amarin and by HLS Therapeutics, Inc. The principal investigators of the study were Subodh Verma, M.D., Ph.D., FRCSC, Professor and Cardiac Surgeon at University of Toronto and Deepak L. Bhatt, M.D., M.P.H., Executive Director of Interventional Cardiovascular Programs at Brigham and Women's Hospital and Professor of Medicine at Harvard Medical School.

    Limitations of this study include the modest sample size, the unblinded nature of this randomized trial, and that the trial was not powered for clinical events. These results have not yet been published or reviewed by regulatory authorities. Additional study is needed.

    This randomized trial represents the first human experience with an 8 g/day loading dose of icosapent ethyl and has suggested short-term safety and tolerability in a modest sample size. Regarding COVID-19, this study provides the first evidence of potential early anti-inflammatory effect of icosapent ethyl in symptomatic, COVID-19 positive outpatients.

    Amarin added that the VASCEPA COVID-19 CardioLink-9 trial is the first in a series of ongoing investigator-sponsored studies into the potential role of VASCEPA therapy in COVID-19 settings. Other ongoing trials include PREPARE-IT: Prevention of COVID19 With EPA in Healthcare Providers at Risk - Intervention Trial sponsored by Estudios Clínicos Latino América, and A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults (MITIGATE) sponsored by Kaiser Permanente.

    This presentation of CardioLink-9 study results was one of multiple data presentations at the NLA Scientific Sessions supported by Amarin. Additional information on NLA Scientific Sessions 2020 can be found here.

    Audio Webcast Information

    Amarin will host an audio webcast on Monday, December 14, 2020, at 8:00 a.m. EST to further discuss these and other VASCEPA-related findings presented during the NLA Scientific Sessions 2020. The discussion will include various clinicians and scientists and will be moderated by Amarin's chief medical officer, Craig Granowitz, M.D., Ph.D. To listen please register here, listen live on the investor relations section of the company's website at www.amarincorp.com, or via telephone by dialing 877-407-8033 within the United States, 201-689-8033 from outside the United States. Any opinions or views expressed by the clinicians and scientists on the audio webcast are theirs alone. They have neither been scripted nor previewed by Amarin. While Amarin respects the scientific opinions of these clinicians and scientists, Amarin takes no responsibility for those opinions. Rather, this audio webcast is intended to provide summaries of recently presented scientific data for consideration by Amarin's investors.

    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 COVID-19

    Current understanding of the biology of COVID-19 is that patients that have or are at high risk for developing atherosclerotic cardiovascular disease (ASCVD) are at higher risk of death and severe effects from infection, and that the morbidity and mortality associated with COVID-19 are due both to the direct toxicity of the virus as well as the body's robust inflammatory response leading to ‘cytokine storm'.1,2,3,4

    Scientific Rationale for Study of VASCEPA in COVID-19 Patients

    Based on data related to the mechanism of action and effects of VASCEPA, it is hypothesized that VASCEPA may play a potential beneficial role in preventing SARS-CoV-2 infection and to potentially reduce clinical severity in patients infected by the virus.4,5,6

    The clinical effects of VASCEPA are multi-factorial. Multiple mechanisms of action associated with VASCEPA based on clinical and mechanistic studies support the rationale to test its effects in patients with or at risk for COVID-19 disease. Some of these postulated mechanisms include the following:

    • Potential antiviral/antimicrobial effects7,8
    • Fibrosis and cardiac damage mitigation in animal models9,10
    • Anti-inflammatory effects (acute) in pulmonary/lung tissue11,12

    Ongoing preclinical and clinical research may provide further insights into the scientific and clinical understanding of these hypothetical effects of VASCEPA in COVID-19 disease mitigation. Whereas vaccines are intended to help eradicate the virus from proliferating, other therapeutics under development and clinical testing such as antibodies or other medicines may play roles in the treatment of patients in various settings across the infection and recovery continuum.

    For more information on studies of VASCEPA in COVID-19 patients, see the frequently asked question entry on Amarin's corporate website, here.  

    About Cardiovascular Risk

    The number of deaths in the United States attributed to cardiovascular disease continues to rise. There are 605,000 new and 200,000 recurrent heart attacks per year (approximately 1 every 40 seconds), in the United States. Stroke rates are 795,000 per year (approximately 1 every 40 seconds), accounting for 1 of every 19 U.S. deaths. Cardiovascular disease results in 859,000 deaths per year in the United States.13 In aggregate, there are more than 2.4 million major adverse cardiovascular events per year from cardiovascular disease or, on average, one every 13 seconds in the United States alone.

    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%.14 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.15,16,17

    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.18 The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.19 The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.20 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) 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. VASCEPA 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 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.

    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

     VASCEPAPlaceboVASCEPA

    vs Placebo
    N = 4089

    n (%)
    Incidence

    Rate


    (per 100

    patient

    years)
    N = 4090

    n (%)
    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)
    4.3901

    (22.0)
    5.70.75

    (0.68, 0.83)
    Key secondary composite endpoint
    Cardiovascular death, myocardial infarction, stroke (3-point MACE)459

    (11.2)
    2.7606

    (14.8)
    3.70.74

    (0.65, 0.83)
    Other secondary endpoints
    Fatal or non-fatal myocardial infarction250

    (6.1)
    1.5355

    (8.7)
    2.10.69

    (0.58, 0.81)
    Emergent or urgent coronary revascularization216

    (5.3)
    1.3321

    (7.8)
    1.90.65

    (0.55, 0.78)
    Cardiovascular death [1]174

    (4.3)
    1.0213

    (5.2)
    1.20.80

    (0.66, 0.98)
    Hospitalization for unstable angina [2]108

    (2.6)
    0.6157

    (3.8)
    0.90.68

    (0.53, 0.87)
    Fatal or non-fatal stroke98

    (2.4)
    0.6134

    (3.3)
    0.80.72

    (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 regarding the potential impact of VASCEPA in various clinical uses. 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 research and development and clinical trials such as further clinical evaluations failing to confirm earlier findings. 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. 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 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 Inquiries:

    Investor Relations

    Amarin Corporation plc

    In U.S.: +1 (908) 719-1315

    (investor inquiries)

    Solebury Trout

    Media Inquiries:

    Alina Kolomeyer

    Communications

    Amarin Corporation plc

    In U.S.: +1 (908) 892-2028

    (media inquiries)


    1 Cummings MJ, Baldwin MR, Abrams D, et al. Epidemiology, clinical course, and outcomes of critically ill adults with COVID-19 in New York City: a prospective cohort study. Lancet. 2020; (published online May 19.) https://doi.org/10.1016/S0140-6736(20)31189-2

    2 Zhou F, Yu T, Du R, et al. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020;395(10229):1054-1062.

    3 Mehta P, McAuley DF, Brown M, et al. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020;395(10229):1033‐1034.

    4 Panigrahy D, Gilligan MM, Huang S, et al. Inflammation resolution: a dual-pronged approach to averting cytokine storms in COVID-19? Cancer Metastasis Rev. 2020;1‐4. doi:10.1007/s10555-020-09889-4.

    5 Morita M, Kuba K, Ichikawa A, et al. The lipid mediator protectin D1 inhibits influenza virus replication and improves severe influenza. Cell. 2013;153:112-25.

    6 Das UN. Can Bioactive Lipids Inactivate Coronavirus (COVID-19)? Arch Med Res. 2020;51(3):282‐286.

    7 Morita M, Kuba K, Ichikawa A, et al. The lipid mediator protectin D1 inhibits influenza virus replication and improves severe influenza. Cell. 2013;153:112-25.

    8 Desbois, A.P. (2013). Antimicrobial Properties of Eicosapentaenoic Acid (C20:5n −3). In Marine Microbiology, S.‐K. Kim (Ed.). doi:10.1002/9783527665259.ch20.

    9 Eclov JA, Qian Q, Redetzke R, et al. EPA, not DHA, prevents fibrosis in pressure overload-induced heart failure: potential role of free fatty acid receptor 4. J Lipid Res. 2015;56(12):2297‐2308.

    10 Ito S, Sano Y, Nagasawa K, et al. Highly purified eicosapentaenoic acid ameliorates cardiac injury and adipose tissue inflammation in a rat model of metabolic syndrome. Obes Sci Pract. 2016;2(3):318‐329.

    11 Mickleborough TD, Tecklenburg SL, Montgomery GS, Lindley MR. Eicosapentaenoic acid is more effective than docosahexaenoic acid in inhibiting proinflammatory mediator production and transcription from LPS-induced human asthmatic alveolar macrophage cells. Clin Nutrition. 2009;28:71-77.

    12 El Kebir D, Gjorstrup P, Filep JG. Resolvin E1 promotes phagocytosis-induced neutrophil apoptosis and accelerates resolution of pulmonary inflammation. Proc Natl Acad Sci U S A. 2012;109(37):14983‐14988.

    13 American Heart Association. Heart Disease and Stroke Statistics—2020 Update: A Report From the American Heart Association. Circulation. 2020;141:e139–e596.

    14 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.

    15 Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.

    16 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.

    17 Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease - New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563.

    18 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.

    19 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.

    20 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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  5. DUBLIN, Ireland and BRIDGEWATER, N.J., Dec. 07, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that scientific findings that add to the growing body of knowledge on VASCEPA® (icosapent ethyl) will be presented during the National Lipid Association (NLA) Scientific Sessions 2020, being held virtually from December 10 – 12, 2020. These findings will be featured in two Late Breaker and six e-Poster presentations from a variety of academic collaborators based on research or analyses supported by Amarin.

    "We are pleased to support several Late Breaker and numerous e-Poster presentations at the upcoming NLA Scientific Sessions 2020," said Steven Ketchum, Ph.D., senior vice president and president, research & development…

    DUBLIN, Ireland and BRIDGEWATER, N.J., Dec. 07, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that scientific findings that add to the growing body of knowledge on VASCEPA® (icosapent ethyl) will be presented during the National Lipid Association (NLA) Scientific Sessions 2020, being held virtually from December 10 – 12, 2020. These findings will be featured in two Late Breaker and six e-Poster presentations from a variety of academic collaborators based on research or analyses supported by Amarin.

    "We are pleased to support several Late Breaker and numerous e-Poster presentations at the upcoming NLA Scientific Sessions 2020," said Steven Ketchum, Ph.D., senior vice president and president, research & development and chief scientific officer, Amarin. "We continue to showcase data from our REDUCE-IT® study demonstrating the unique and proven efficacy of VASCEPA in cardiovascular risk reduction while providing support to investigators to explore other ways in which VASCEPA can potentially impact public health."

    Amarin added that the Late Breaker presentation of the VASCEPA COVID-19 CardioLink-9 Randomized Trial is of primary results from a trial supported by Amarin and HLS Therapeutics, Inc. that was conducted by independent investigators.

    Featured Amarin-supported Late Breakers to be presented:

    • "EPA Levels and Cardiovascular Outcomes in the Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial" – presented on behalf of all authors by Michael Miller, M.D., University of Maryland Medical System, Baltimore, MD – December 12, 4:30-5:15 pm CST



    • "First Human Trial of a Loading Dose of Icosapent Ethyl in Patients with COVID-19: Primary Results of the VASCEPA COVID-19 CardioLink-9 Randomized Trial" – presented on behalf of all authors by Deepak L. Bhatt, M.D., M.P.H., Brigham and Women's Hospital, Harvard Medical School, Boston, MA – December 12, 4:30-5:15 pm CST

    Other Amarin-supported REDUCE-IT abstracts to be presented include:

    • "REDUCE-IT USA: Results from the 3146 Patients Randomized in the United States" – presented on behalf of all authors by Michael Miller, M.D., University of Maryland Medical System, Baltimore, MD

    Other Amarin-supported abstracts providing mechanism of action insights include*:

    • "Eicosapentaenoic Acid Maintains Normal Membrane Cholesterol Distribution under Hyperglycemic Conditions unlike a Mixed Omega-3 Fatty Acid Supplement"



    • "Variability in Content of Omega-3 Fatty Acids and other Fatty Acids in Multiple Lots of a Widely Used Fish Oil Dietary Supplement"



    • "Eicosapentaenoic Acid Improves Endothelial Nitric Oxide Bioavailability and Changes Fatty Acid Content in a Manner Distinct from Docosahexaenoic Acid"



    • "Eicosapentaenoic Acid Reduces Expression of Pulmonary Endothelial Angiotensin Converting Enzyme (ACE) Linked to Inflammation"



    • "Eicosapentaenoic Acid Reverses Endothelial Dysfunction following Exposure to the Cytokine IL-6 in Contrast to Docosahexaenoic and Arachidonic Acids" 



      *Presented on behalf of all authors by R. Preston Mason, Ph.D., Brigham and Women's Hospital, Harvard Medical School, Boston, MA, Elucida Research LLC, Beverly, MA

    Additional information on NLA Scientific Sessions 2020 can be found here.

    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 Cardiovascular Risk

    The number of deaths in the United States attributed to cardiovascular disease continues to rise. There are 605,000 new and 200,000 recurrent heart attacks per year (approximately 1 every 40 seconds), in the United States. Stroke rates are 795,000 per year (approximately 1 every 40 seconds), accounting for 1 of every 19 U.S. deaths. Cardiovascular disease results in 859,000 deaths per year in the United States.1 In aggregate, there are more than 2.4 million major adverse cardiovascular events per year from cardiovascular disease or, on average, one every 13 seconds in the United States alone.

    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%.2 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.3,4,5

    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.6 The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.7 The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.8 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) 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. VASCEPA 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 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.

    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

     VASCEPAPlaceboVASCEPA 

    vs Placebo
    N = 4089

    n (%)
    Incidence

    Rate


    (per 100 patient

    years)
    N =4090

    n (%)
    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)
    4.3901

    (22.0)
    5.70.75

    (0.68, 0.83)
    Key secondary composite endpoint
    Cardiovascular death, myocardial

    infarction, stroke (3-point MACE)
    459

    (11.2)
    2.7606

    (14.8)
    3.70.74

    (0.65, 0.83)
    Other secondary endpoints
    Fatal or non-fatal myocardial

    infarction
    250

    (6.1)
    1.5355

    (8.7)
    2.10.69

    (0.58, 0.81)
    Emergent or urgent coronary

    revascularization
    216

    (5.3)
    1.3321

    (7.8)
    1.90.65

    (0.55, 0.78)
    Cardiovascular death [1]174

    (4.3)
    1.0213

    (5.2)
    1.20.80

    (0.66, 0.98)
    Hospitalization for unstable angina [2]108

    (2.6)
    0.6157

    (3.8)
    0.90.68

    (0.53, 0.87)
    Fatal or non-fatal stroke98

    (2.4)
    0.6134

    (3.3)
    0.80.72

    (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 regarding the potential impact of VASCEPA in various clinical uses. 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 research and development and clinical trials such as further clinical evaluations failing to confirm earlier findings. 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. 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 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 Inquiries:

    Investor Relations

    Amarin Corporation plc

    In U.S.: +1 (908) 719-1315

    (investor inquiries)

    Solebury Trout

    Media Inquiries:

    Alina Kolomeyer

    Communications

    Amarin Corporation plc

    In U.S.: +1 (908) 892-2028

    .com (media inquiries)

    1 American Heart Association. Heart Disease and Stroke Statistics—2020 Update: A Report From the American Heart Association. Circulation. 2020;141:e139–e596.

    2 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.

    3 Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.

    4 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.

    5 Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease - New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563.

    6 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.

    7 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.

    8 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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