AMRN Amarin Corporation plc

6.92
-0.11  -2%
Previous Close 7.03
Open 6.99
52 Week Low 3.95
52 Week High 26.12
Market Cap $2,668,322,998
Shares 385,595,809
Float 381,858,258
Enterprise Value $2,236,712,537
Volume 4,010,942
Av. Daily Volume 8,121,806
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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. DUBLIN, Ireland and BRIDGEWATER, N.J., June 16, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) announced today a settlement agreement with Apotex Inc. (Apotex) that resolves patent litigation that would have resulted from the previously disclosed abbreviated new drug application (ANDA) filed by Apotex with U.S. Food and Drug Administration (FDA) and amended in May 2020 seeking approval of a generic form of VASCEPA® (icosapent ethyl) capsules based on the MARINE study.

    As previously disclosed, Amarin is currently appealing to the U.S. Court of Appeals for the Federal Circuit a March 2020, patent invalidity ruling of the U.S. District Court for the District of Nevada in favor of generic companies, Hikma Pharmaceuticals USA…

    DUBLIN, Ireland and BRIDGEWATER, N.J., June 16, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) announced today a settlement agreement with Apotex Inc. (Apotex) that resolves patent litigation that would have resulted from the previously disclosed abbreviated new drug application (ANDA) filed by Apotex with U.S. Food and Drug Administration (FDA) and amended in May 2020 seeking approval of a generic form of VASCEPA® (icosapent ethyl) capsules based on the MARINE study.

    As previously disclosed, Amarin is currently appealing to the U.S. Court of Appeals for the Federal Circuit a March 2020, patent invalidity ruling of the U.S. District Court for the District of Nevada in favor of generic companies, Hikma Pharmaceuticals USA Inc. and Dr. Reddy's Laboratories, Inc. Because Apotex is not a party to that litigation, it is not directly subject to related rulings. As such, patent litigation against Apotex would need to be pursued separately.

    As part of the settlement agreement, Apotex may not sell a generic version of VASCEPA in the United States until August 9, 2029 (the same such date provided for under the 2018 settlement agreement with Teva Pharmaceuticals USA, Inc. (Teva)) or earlier under certain customary circumstances.  As currently relevant, such circumstances include if Amarin is not successful in its pending appeal of the March 2020 Nevada district court decision after issuance of the Federal Circuit mandate following any Federal Circuit rehearing or en banc review. The agreement also substantially resolves future litigation with Apotex that could have ensued related to the December 2019 cardiovascular risk reduction indication of VASCEPA based on the REDUCE-IT® study. Other terms of the agreement are confidential. The agreement is subject to review by applicable federal authorities.

    "This settlement involves no financial payment from Amarin to Apotex and allows Amarin to avoid incremental litigation expense and distraction associated with Apotex's participation in patent litigation related to the MARINE and REDUCE-IT indications," said John F. Thero, president and chief executive officer of Amarin.

    For a generic product to be launched in the United States the generic company's ANDA must be approved by the FDA.  In this settlement, consistent with terms of Amarin's 2018 settlement agreement with Teva, Amarin does not commit to supplying Apotex with icosapent ethyl at any time.  Outside of the United States, Amarin holds various patents and regulatory exclusivity rights to icosapent ethyl which are not part of this settlement and not part of any current litigation.  

    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. Amarin, together with its commercial partners in select geographies, is pursuing additional regulatory approvals for VASCEPA in China, the European Union and the Middle East. For more information about Amarin, visit 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 and is covered by most major medical insurance plans. The new, cardiovascular risk indication for VASCEPA was approved by the FDA in December 2019 based on the results of the landmark REDUCE-IT® trial.

    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 related to Amarin's patents and interpretation of related settlement agreements and litigation. 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 herein include the following: events that could interfere with the continued validity or enforceability of a patent; and Amarin's ability generally to maintain adequate patent protection and successfully enforce patent claims against third parties and the company's understanding of current settlement and litigation positions and potential outcomes. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including its most recent Quarterly Report on Form 10-Q.  Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Amarin undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

    Availability of Other Information About 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 and Media Inquiries:

    Elisabeth Schwartz

    Investor Relations

    Amarin Corporation plc

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

    (investor inquiries)

    (media inquiries)

    Lee M. Stern

    Solebury Trout

    In U.S.: +1 (646) 378-2992

    Primary Logo

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  2. Primary composite first and total major adverse cardiovascular event (MACE) reductions of 23% each shown with VASCEPA in prespecified tertiary and post hoc exploratory analyses of the subgroup of people with diabetes

    Key secondary composite first and total MACE reductions of 30% and 29%, respectively, shown with VASCEPA in prespecified tertiary and post hoc exploratory subgroup analyses

    Reductions also observed in post hoc exploratory analyses of other composite endpoints, in people with diabetes, and in people with established cardiovascular disease with or without diabetes at baseline

    DUBLIN, Ireland and BRIDGEWATER, N.J., June 15, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that data from the REDUCE-IT®…

    Primary composite first and total major adverse cardiovascular event (MACE) reductions of 23% each shown with VASCEPA in prespecified tertiary and post hoc exploratory analyses of the subgroup of people with diabetes

    Key secondary composite first and total MACE reductions of 30% and 29%, respectively, shown with VASCEPA in prespecified tertiary and post hoc exploratory subgroup analyses

    Reductions also observed in post hoc exploratory analyses of other composite endpoints, in people with diabetes, and in people with established cardiovascular disease with or without diabetes at baseline

    DUBLIN, Ireland and BRIDGEWATER, N.J., June 15, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that data from the REDUCE-IT® study presented during the 80th Scientific Sessions of the American Diabetes Association by Deepak L. Bhatt, M.D., M.P.H., Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, showed that administration of 4 g/day of VASCEPA® (icosapent ethyl) resulted in significant 23% reductions in both first and total primary composite major adverse cardiovascular events (5-point MACE) in people with diabetes. Reductions of 30% and 29% were observed in both first and total hard (3-point) MACE, the key secondary composite endpoint, respectively. The late-breaking presentation, titled "Substantial Cardiovascular Benefit from Icosapent Ethyl in Patients with Diabetes: REDUCE-IT DIABETES" was heard on June 13, 2020 at 10:00 am CST. 

    The leading cause of morbidity and mortality in type 2 diabetes mellitus continues to be cardiovascular disease, especially in those patients who already have established atherosclerotic cardiovascular disease (ASCVD).1  Above normal blood levels of triglycerides (TG) are common in patients with diabetes,2,3 and have been associated with increased ASCVD (30% and 23% higher risk for non-fatal myocardial infarction (MI) and stroke, respectively) in this patient population, despite statin therapy.4

    Many of the world's leading diabetes and cardiovascular disease professional societies, including the American Diabetes Association (ADA) and the American Heart Association (AHA), are working to educate patients and clinicians on the urgent need to identify and manage risk with appropriate therapies. The AHA Scientific Statement on Clinical Management of Stable Coronary Artery Disease in Patients with Type 2 Diabetes Mellitus, published in April of this year, states that "icosapent ethyl is the first non–LDL (low-density lipoprotein)-focused lipid therapy to demonstrate cardiovascular benefit and should be considered first-line therapy for patients with T2DM (type 2 diabetes mellitus) and CAD (coronary artery disease) whose triglycerides remain elevated (>135 mg/dL) despite maximally tolerated statin and lifestyle changes."1  

    "People with diabetes are at markedly increased risk of cardiovascular disease, and that intersection has become a target for research and a focus for clinical care," commented Dr. Deepak L. Bhatt, M.D., M.P.H., Executive Director of Interventional Cardiovascular Programs at Brigham and Women's Hospital Heart & Vascular Center and Professor of Medicine at Harvard Medical School, and senior author of the REDUCE-IT DIABETES analyses. "In these analyses, we see the substantial impact that icosapent ethyl could have on reducing cardiovascular risks and complications from diabetes." 

    The prespecified tertiary and post hoc exploratory analyses from the REDUCE-IT study showed that, for the primary composite endpoint of 5-point MACE, time to first event was significantly reduced with VASCEPA versus placebo by 23% (p<0.0001) and total (first and subsequent) events were also reduced by 23% (p=0.0003) in the subgroup of people with diabetes. For the key secondary composite endpoint of 3-point MACE, time to first event was reduced by 30% (p<0.0001) and total events were reduced by 29% (p<0.0001) in the subgroup of people with diabetes. Observed reductions in MACE were supported by further post hoc exploratory analyses of the data across cardiovascular risk category and diabetes status at baseline.

    "The REDUCE-IT DIABETES subgroup analyses further our understanding of the potential for VASCEPA to benefit people with diabetes," said Steven Ketchum, Ph.D., senior vice president and president, research & development and chief scientific officer, Amarin. "The data in our analyses shows consistent outcomes across the at-risk population and supports that VASCEPA can help reduce the already significant burden of cardiovascular disease in people with diabetes."  

    These REDUCE-IT analyses suggest benefits with VASCEPA that are incremental to those of statin and other therapies with known cardiovascular benefit, including anti-diabetic medications that were well-utilized across people with diabetes, approximately half of whom were taking two or more anti-diabetic therapies.

    REDUCE-IT was not specifically powered to examine patient subgroups, therefore p-values presented for these diabetes analyses are nominal and exploratory with no adjustment for multiple comparisons. In addition, while the cardiovascular risk categories of established cardiovascular disease or diabetes plus additional risks were stratification factors, the presence or absence of diabetes in patients with established cardiovascular disease was not. These REDUCE-IT DIABETES results include both prespecified tertiary and post hoc exploratory analyses. Nonetheless, results from these time to first and total events analyses consistently suggest benefit across the various endpoints and recurrent event statistical models. Together, the REDUCE-IT DIABETES first and total events results support the robustness and consistency of the clinical benefit of VASCEPA therapy beyond current standards of medical management in reducing cardiovascular events in patients with diabetes.

    Slides from the presentation will be made available on www.acc.org.   

    Financial Disclosure

    Funding from Amarin was provided to Brigham and Women's Hospital for Dr. Deepak L. Bhatt's work as the REDUCE-IT study chair and global principal investigator.

    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. Amarin, together with its commercial partners in select geographies, is pursuing additional regulatory approvals for VASCEPA in China, the European Union 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.5 In aggregate, this is 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%.6 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.7,8,9

    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.10 The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.11 The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.12 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:

    Elisabeth Schwartz

    Investor Relations

    Amarin Corporation plc

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

    (investor inquiries)

    Lee M. Stern

    Solebury Trout

    In U.S.: +1 (646) 378-2992

    Media Inquiries:

    Alina Kolomeyer

    Communications

    Amarin Corporation plc

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

    (media inquiries)



    ___________________________________

    1 Arnold SV, Bhatt DL, Barsness GW, et al. Clinical Management of Stable Coronary Artery Disease in Patients With Type 2 Diabetes Mellitus: A Scientific Statement From the American Heart Association. Circulation. 2020;141(19):e779‐e806. doi:10.1161/CIR.0000000000000766

    2 Fan W, Philip S, Granowitz C, Toth PP, Wong ND. Residual Hypertriglyceridemia and Estimated Atherosclerotic Cardiovascular Disease Risk by Statin Use in U.S. Adults With Diabetes: National Health and Nutrition Examination Survey 2007-2014. Diabetes Care. 2019;42(12):2307‐2314.

    3 Rana JS, Liu JY, Moffet HH, et al. Metabolic dyslipidemia and risk of coronary heart disease in 28,318 adults with diabetes mellitus and low-density lipoprotein cholesterol <100 mg/dl. Am J Cardiol. 2015;116:1700-1704.

    4 Nichols GA, Philip S, Reynolds K, Granowitz CB, Fazio S. Increased residual cardiovascular risk in patients with diabetes and high versus normal triglycerides despite statin-controlled LDL cholesterol. Diabetes Obes Metab. 2019;21(2):366‐371.

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

    6 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.

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

    8 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.

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

    10 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.

    11 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.

    12 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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  3. DUBLIN, Ireland and BRIDGEWATER, N.J., June 01, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), today announced that it intends to increase the level and breadth of its promotion and education initiatives regarding VASCEPA® (icosapent ethyl).  As early signs emerge of patients returning to physicians' offices, Amarin plans to emphasize its key marketing messages including positioning VASCEPA as the only FDA-approved drug for lowering the persistent cardiovascular risk beyond statin therapy for millions of high-risk patients. 

    While VASCEPA has been developed and clinically tested for over a decade, it was less than six months ago (December 2019) that the FDA approved VASCEPA for its unique cardiovascular risk reduction indication…

    DUBLIN, Ireland and BRIDGEWATER, N.J., June 01, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), today announced that it intends to increase the level and breadth of its promotion and education initiatives regarding VASCEPA® (icosapent ethyl).  As early signs emerge of patients returning to physicians' offices, Amarin plans to emphasize its key marketing messages including positioning VASCEPA as the only FDA-approved drug for lowering the persistent cardiovascular risk beyond statin therapy for millions of high-risk patients. 

    While VASCEPA has been developed and clinically tested for over a decade, it was less than six months ago (December 2019) that the FDA approved VASCEPA for its unique cardiovascular risk reduction indication. Most healthcare professionals and at-risk patients are unaware that VASCEPA is the first and only drug with this important new indication. For this reason, and the emerging return of patients, Amarin believes the opportunity exists for increasing awareness of VASCEPA and its potential to provide an important healthcare solution to reduce cardiovascular risk in high-risk patients.  

    In the United States alone, someone suffers a heart attack, stroke, or other major adverse event from cardiovascular disease on average every 13 seconds. Cardiovascular disease impacts adults of all ages and is the number one cause of death in the United States. Urgent attention and a proven treatment, such as VASCEPA, is needed for the vast and growing need to reduce the risk of major adverse cardiovascular events in high-risk cardiovascular patients.

    Amarin's president and chief executive officer, John Thero, commented, "Particularly in these difficult times, Amarin believes that patients would benefit from receiving preventative healthcare solutions with demonstrated outcomes-based results. VASCEPA is one of those solutions. It is proven to reduce risk, it has been found to be affordable and cost-effective and it is covered by most insurance policies. However, while millions of people are included within the new VASCEPA indication, most are unaware of VASCEPA." He added, "As American society begins to open up again, Amarin currently plans to restore approximately $80 million in educational and promotional spending in 2020 to increase awareness of VASCEPA as an important new treatment recently approved to lower the risk of heart attacks, strokes, and other major adverse cardiovascular events in high risk patients beyond standard of care statin therapy."

    Planned promotion and educational efforts include the sponsorship of continuing medical education, social media-based communications, and advertisements on television and other forms of media. Amarin also plans increased sponsorship of investigator-initiated research, such as the recently announced clinical investigation of VASCEPA in the treatment of COVID-19. These initiatives should become increasingly visible in July 2020 and beyond. At the start of 2020, Amarin had intended to commence such expanded promotion in mid-2020 but cancelled such plans following the onset of COVID-19 and the prospects for a potential launch of generic versions of VASCEPA. Amarin's current plans restore most of that intended promotion.

    In addition, as the United States reopens from the COVID-19 epidemic, Amarin intends to resume field-based face-to-face interactions with healthcare providers by its sales force, commencing on a pilot scale basis before the end of June 2020, based on current expectations. Assuming that these interactions prove to be helpful and other parts of the country reopen, the company plans to expand such interactions on a phased basis across select geographies. Prescription growth on a year-over-year basis in Q2'20 has, as expected due to COVID-19, been considerably slower than in Q1'20. However, Amarin believes that there are early signs that patient care for chronic conditions, such as treating the risks of cardiovascular disease, is increasing with more patients returning to their healthcare providers for routine medical visits.

    Amarin plans to adjust its level of promotion and educational activities upward or downward based on various factors, including whether any generic company takes the risk of launching a generic version of VASCEPA during the patent litigation appeal process and the amount of any product launched. Amarin does not believe generic companies have made the investment of resources, know-how and time to develop sufficient quantities of quality supply to meet current and growing demand. Accordingly, Amarin believes that if any generic determines to launch its product after an FDA approval that any such launch would be limited in scope.  

    If Amarin wins on its patent litigation appeal the benefits of Amarin's planned increased promotion and education efforts should accrue to both improved patient care and to increased sales of VASCEPA by Amarin. If Amarin loses on the patent litigation appeal, increased VASCEPA usage as a result of increased promotion and education efforts should still benefit patient care. The larger market would potentially be split among branded VASCEPA, a potential authorized generic version of VASCEPA, if then launched by Amarin (which Amarin could launch rapidly if warranted), and generic versions of VASCEPA from third-parties. As noted, Amarin believes any launch of generic versions of VASCEPA by such third parties would be subject to supply limitations. Amarin reiterated that it believes that it has strong arguments in its patent litigation appeal but that it cannot predict the outcome.  

    Amarin is progressing its plans for international expansion. Those plans are not directly impacted by increased promotion in the United States but could benefit from the company's anticipated expanded educational initiatives.

    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. Amarin, together with its commercial partners in select geographies, is pursuing additional regulatory approvals for VASCEPA in China, the European Union 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.1 There are 605,000 new and 200,000 recurrent heart attacks per year (approximately 1 every 40 seconds)1, 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.1 Cardiovascular disease results in 859,000 deaths per year in the United States.1 In aggregate, this is 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% – but that still leaves a 65-75% risk remaining.2 People with elevated triglycerides have 35% more cardiovascular events compared to people with normal (in range) triglycerides taking statins.3,4,5

    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 and is covered by most major medical insurance plans. The new, cardiovascular risk indication for VASCEPA was approved by the FDA in December 2019 based on the results of the landmark REDUCE-IT® trial.

    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

      VASCEPA Placebo VASCEPA
    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)
    4.3 901

    (22.0)
    5.7 0.75

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

    (11.2)
    2.7 606

    (14.8)
    3.7 0.74

    (0.65, 0.83)
    Other secondary endpoints
    Fatal or non-fatal myocardial infarction 250

    (6.1)
    1.5 355

    (8.7)
    2.1 0.69

    (0.58, 0.81)
    Emergent or urgent coronary revascularization 216

    (5.3)
    1.3 321

    (7.8)
    1.9 0.65

    (0.55, 0.78)
    Cardiovascular death [1] 174

    (4.3)
    1.0 213

    (5.2)
    1.2 0.80

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

    (2.6)
    0.6 157

    (3.8)
    0.9 0.68

    (0.53, 0.87)
    Fatal or non-fatal stroke 98

    (2.4)
    0.6 134

    (3.3)
    0.8 0.72

    (0.55, 0.93)
    [1] Includes adjudicated cardiovascular deaths and deaths of undetermined causality.

    [2] Determined to be caused by myocardial ischemia by invasive/non-invasive testing and requiring emergent hospitalization.

    FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.

    Forward-Looking Statements

    This press release contains forward-looking statements, including statements regarding Amarin plans for increased promotion, educational and research activities in various forms, over specified periods of time and to various degrees, such efforts accruing to benefit Amarin under various scenarios, Amarin's belief in the strength of its arguments in connection with its patent litigation appeal, Amarin's expectations with respect to the potential timing and extent of launch of generic versions of VASCEPA and Amarin's beliefs related to access to supply capacity of icosapent ethyl by generic companies. 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 promotional, educational and research efforts, the launch of generic icosapent ethyl, the availability of supply of generic icosapent ethyl, the extent and impact of any such launch on Amarin's plans and assumptions, the extent of icosapent ethyl supply available to generic companies and risks associated with litigation. 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 and Media Inquiries:
    Elisabeth Schwartz
    Investor Relations
    Amarin Corporation plc
    In U.S.: +1 (908) 719-1315
    (investor inquiries)
    (media inquiries)

    Lee M. Stern
    Solebury Trout
    In U.S.: +1 (646) 378-2992

    References

    ____________

    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.

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  4. TORONTO, May 21, 2020 /CNW/ - HLS Therapeutics Inc. ("HLS" or the "Company") (TSX:HLS), a specialty pharmaceutical company focusing on central nervous system and cardiovascular markets, announces that in collaboration with Amarin Corporation (NASDAQ:AMRN) it is supporting a trial to investigate the effects of Vascepa® (icosapent ethyl, or "IPE") on inflammatory biomarkers in individuals with COVID-19. The trial sponsored by the Canadian Medical and Surgical Knowledge Translation Research Group, is being led by Dr. Subodh Verma MD, PhD, FRCSC, FAHA, a cardiac surgeon‐scientist at St Michael's Hospital in Toronto,  Professor at the University of Toronto and Canada Research Chair in Cardiovascular Surgery, and Dr. Deepak L. Bhatt MD MPH, Executive…

    TORONTO, May 21, 2020 /CNW/ - HLS Therapeutics Inc. ("HLS" or the "Company") (TSX:HLS), a specialty pharmaceutical company focusing on central nervous system and cardiovascular markets, announces that in collaboration with Amarin Corporation (NASDAQ:AMRN) it is supporting a trial to investigate the effects of Vascepa® (icosapent ethyl, or "IPE") on inflammatory biomarkers in individuals with COVID-19. The trial sponsored by the Canadian Medical and Surgical Knowledge Translation Research Group, is being led by Dr. Subodh Verma MD, PhD, FRCSC, FAHA, a cardiac surgeon‐scientist at St Michael's Hospital in Toronto,  Professor at the University of Toronto and Canada Research Chair in Cardiovascular Surgery, and Dr. Deepak L. Bhatt MD MPH, Executive Director of Interventional Cardiovascular Programs at Brigham and Women's Hospital and Professor, Harvard Medical School. 

    The trial design is based on the scientific hypothesis that IPE may possess anti-inflammatory, anti-thrombotic, and potentially anti-viral properties (1, 2, 3, 4, 5, 6, 7) which could be beneficial to patients suffering from COVID-19. The goal of the trial is to document the short-term effect of IPE versus usual care on inflammatory biomarkers, such as C-reactive protein, in adults with documented COVID-19.

    The trial is a 14-day long prospective, multi-site, two-armed, randomized, open-label study that will enroll approximately 100 individuals with COVID-19 who have undergone testing in Canada. Participants will be randomized (1:1) to receive either IPE (a loading dose of 4 g BID for 3 days, then 2 g BID for the subsequent 11 days) or usual care. Blood samples will be collected to determine if IPE use lowers circulating proinflammatory biomarkers. The trial is expected to commence in May 2020.

    "The COVID-19 pandemic has created a great sense of urgency to identify novel treatment options for those afflicted with the virus," said Dr. Subodh Verma. "IPE, or Vascepa, is known to exert endothelial protective and anti-inflammatory effects, and in a large trial of patients with cardiovascular disease or diabetes has been shown to reduce cardiovascular death. There are emerging data that COVID-19 leads to increased inflammation and widespread endothelial injury and hence it is reasonable to test the hypothesis that IPE can reduce markers of inflammation in this disease."

    "We are pleased to support a study that could bring relief to those suffering from COVID-19 and to help those in the healthcare community seeking treatment options to the virus," said Greg Gubitz, CEO of HLS. "In the current situation, it will be necessary to gather data from many such trials in order to understand what those best treatment options are for patients."

    ABOUT VASCEPA (ICOSAPENT ETHYL) CAPSULES
    Vascepa is approved for use in Canada to reduce the risk of cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization or hospitalization for unstable angina) in statin-treated patients with elevated triglycerides, who are at high risk of cardiovascular events due to established cardiovascular disease, or diabetes, and at least one other cardiovascular risk factor, and has not been demonstrated to be safe or effective for use in the treatment of those with COVID-19.

    Vascepa was added to Health Canada's Register of Innovative Drugs and benefits from data protection for a term of eight years, as well as being the subject of multiple issued and pending patents based on its unique clinical profile. HLS in-licensed the exclusive rights to Vascepa for the Canadian market from Amarin Corporation (NASDAQ:AMRN).

    ABOUT HLS THERAPEUTICS INC.
    Formed in 2015, HLS is a specialty pharmaceutical company focused on the acquisition and commercialization of late stage development, commercial stage promoted and established branded pharmaceutical products in the North American markets. HLS's focus is on products targeting the central nervous system and cardiovascular therapeutic areas. HLS's management team is composed of seasoned pharmaceutical executives with a strong track record of success in these therapeutic areas and at managing products in each of these lifecycle stages. For more information visit: www.hlstherapeutics.com

    REFERENCES

    1. Das UN. Can Bioactive Lipids Inactivate Coronavirus (COVID-19)? [published online ahead of print, 2020 Mar 27]. Arch Med Res. 2020;S0188-4409(20)30292-7. doi:10.1016/j.arcmed.2020.03.004
    2. Bhatt DL, Steg PG, Miller M, et al. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019;380(1):11‐22. doi:10.1056/NEJMoa1812792
    3. Morita M, Kuba K, Ichikawa A, et al. The lipid mediator protectin D1 inhibits influenza virus replication and improves severe influenza. Cell. 2013;153(1):112‐125. doi:10.1016/j.cell.2013.02.027
    4. 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. doi:10.1194/jlr.M062034
    5. 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. doi:10.1002/osp4.50
    6. 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 Nutr. 2009;28(1):71‐77. doi:10.1016/j.clnu.2008.10.012
    7. 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. doi:10.1073/pnas.1206641109

    FORWARD LOOKING INFORMATION
    This release includes forward-looking statements regarding HLS and its business. Such statements are based on the current expectations and views of future events of HLS's management. In some cases the forward-looking statements can be identified by words or phrases such as "may", "will", "expect", "plan", "anticipate", "intend", "potential", "estimate", "believe" or the negative of these terms, or other similar expressions intended to identify forward-looking statements, including, among others, statements with respect to HLS's pursuit of additional product and pipeline opportunities in certain therapeutic markets, statements regarding growth opportunities and expectations regarding financial performance. The forward-looking events and circumstances discussed in this release may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting HLS, including risks relating to the specialty pharmaceutical industry, risks related to the regulatory approval process, economic factors and many other factors beyond the control of HLS. Forward-looking statements and information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause HLS's actual results, performance or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statement or information. Accordingly, readers should not place undue reliance on any forward-looking statements or information. A discussion of the material risks and assumptions associated with this release can be found in the Company's Annual Information Form dated March 18, 2020, which has been filed on SEDAR and can be accessed at www.sedar.com. Accordingly, readers should not place undue reliance on any forward-looking statements or information. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and HLS undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.

    SOURCE HLS Therapeutics Inc.

    Cision View original content: http://www.newswire.ca/en/releases/archive/May2020/21/c2616.html

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  5. DUBLIN, Ireland and BRIDGEWATER, N.J., May 21, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), today announced support for a clinical trial to investigate the effects of icosapent ethyl (IPE) (VASCEPA®) on inflammatory biomarkers and other patient outcomes in individuals with COVID-19. The trial is sponsored by the Canadian Medical and Surgical Knowledge Translation Research Group and is being led by Dr. Subodh Verma MD, FRCSC, FAHA, PhD, cardiac surgeon‐scientist at St. Michael's Hospital in Toronto, and professor at the University of Toronto, and Dr. Deepak L. Bhatt MD, MPH, Executive Director of Interventional Cardiovascular Programs at Brigham and Women's Hospital and Professor, Harvard Medical School. The trial primary…

    DUBLIN, Ireland and BRIDGEWATER, N.J., May 21, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), today announced support for a clinical trial to investigate the effects of icosapent ethyl (IPE) (VASCEPA®) on inflammatory biomarkers and other patient outcomes in individuals with COVID-19. The trial is sponsored by the Canadian Medical and Surgical Knowledge Translation Research Group and is being led by Dr. Subodh Verma MD, FRCSC, FAHA, PhD, cardiac surgeon‐scientist at St. Michael's Hospital in Toronto, and professor at the University of Toronto, and Dr. Deepak L. Bhatt MD, MPH, Executive Director of Interventional Cardiovascular Programs at Brigham and Women's Hospital and Professor, Harvard Medical School. The trial primary endpoint is the effect of VASCEPA versus usual care on high-sensitivity C-reactive protein levels from baseline to 14 days in adults with a COVID-19-positive diagnosis. The clinical study design also includes other endpoints that assess rates and severity of COVID-19 infection in this high-risk group.

    Based on our current understanding of the biological effects of a COVID-19 infection, including that patients at high risk of cardiovascular disease are at higher risk of mortality and severe effects from a COVID-19 infection, and based on data related to the mechanism of action and effects of VASCEPA in lowering cardiovascular risk in certain high-risk patients, it is believed that VASCEPA could play a beneficial clinical role in helping patients infected by the virus.

    The clinical effects of VASCEPA are multi-factorial. Multiple mechanisms of action associated with VASCEPA from clinical and mechanistic studies support the rationale to study its effects in patients with the COVID-19 infection. Additional postulated mechanisms that might play a role in the use of VASCEPA in the patients infected with COVID-19 include the following:

      Potential antiviral/antimicrobial effects1
      Fibrosis and cardiac damage mitigation in animal models2,3
      Anti-inflammatory effects (acute) in pulmonary/lung tissue4,5

    "We believe that this pilot study may provide important information on whether, how, and if icosapent ethyl has biological activity that could have beneficial effects in mitigating severity in COVID-19 infection. If a positive signal is achieved in this study, larger, more definitive studies could then be considered," stated Dr. Bhatt. "This pilot will also provide further insight into the effects of icosapent ethyl on various biomarkers, as well as valuable information about higher loading doses of this drug."

    For more information about Amarin's COVID-19 research, please visit the COVID-19 Related Materials section on Amarin's publications page at https://investor.amarincorp.com/publications.

    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. Amarin, together with its commercial partners in select geographies, is pursuing additional regulatory approvals for VASCEPA in China, the European Union 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.6,7 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 similar, accounting for 1 of every 19 U.S. deaths (approximately 1 every 40 seconds).8

    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% – but that still leaves a 65-75% risk remaining.9 People with elevated triglycerides have 35% more cardiovascular events compared to people with normal (in range) triglycerides taking statins.10,11,12

    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 and is covered by most major medical insurance plans. The new, cardiovascular risk indication for VASCEPA was approved by the FDA in December 2019 based on the results of the landmark REDUCE-IT trial.

    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

      VASCEPA Placebo VASCEPA
    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)
    4.3 901

    (22.0)
    5.7 0.75

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

    (11.2)
    2.7 606

    (14.8)
    3.7 0.74

    (0.65, 0.83)
    Other secondary endpoints
    Fatal or non-fatal myocardial infarction 250

    (6.1)
    1.5 355

    (8.7)
    2.1 0.69

    (0.58, 0.81)
    Emergent or urgent coronary revascularization 216

    (5.3)
    1.3 321

    (7.8)
    1.9 0.65

    (0.55, 0.78)
    Cardiovascular death [1] 174

    (4.3)
    1.0 213

    (5.2)
    1.2 0.80

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

    (2.6)
    0.6 157

    (3.8)
    0.9 0.68

    (0.53, 0.87)
    Fatal or non-fatal stroke 98

    (2.4)
    0.6 134

    (3.3)
    0.8 0.72

    (0.55, 0.93)
    [1] Includes adjudicated cardiovascular deaths and deaths of undetermined causality.

    [2] Determined to be caused by myocardial ischemia by invasive/non-invasive testing and requiring emergent hospitalization.

    FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.

    Forward-Looking Statements

    This press release contains forward-looking statements, including statements regarding the potential for benefit from the study of VASCEPA in the treatment of patients with COVID-19. 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. 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 Annual Report on Form 10-K. 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 and Media Inquiries:
    Elisabeth Schwartz
    Investor Relations
    Amarin Corporation plc
    In U.S.: +1 (908) 719-1315
    (investor inquiries)
    (media inquiries)

    Lee M. Stern
    Solebury Trout
    In U.S.: +1 (646) 378-2992

    References

    ________________________________
    1 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.
    2 Eclov_EPA not DHA prevents fibrosis in pressure overload induced HF_J Lipid Res 2015
    3 Ito_EPA reduces cardiac fibrosis and diast dysfunc in rat model of MetS_Obes Sci Pract 2016
    4 Mickleborough_EPA more effective than DHA on inflammation in human asthma alveolar macrophage cells_Clin Nutr 2009
    5 Kebir_resolvin E1 and pulm inflamm_PNAS 2012
    6 American Heart Association. Heart Disease and Stroke Statistics – 2019 Update: A Report from the American Heart Association. Published January 31, 2019.
    7 American Heart Association / American Stroke Association. 2017. Cardiovascular disease: A costly burden for America projections through 2035.
    8 American Heart Association: Heart Disease and Stroke Statistics -- 2019 At-a-Glance.
    9 Ganda OP, Bhatt DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia therapy in hypertriglyceridemia management. J Am Coll Cardiol. 2018;72(3):330-343.
    10 Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.
    11 Toth PP, Granowitz C, Hull M, et al. High triglycerides are associated with increased cardiovascular events, medical costs, and resource use: A real-world administrative claims analysis of statin-treated patients with high residual cardiovascular risk. J Am Heart Assoc. 2018;7(15):e008740.
    12 Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease - New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563.

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