AMRN Amarin Corporation plc

4.21
+0.17  (+4%)
Previous Close 4.04
Open 3.98
52 Week Low 3.36
52 Week High 26.12
Market Cap $1,636,314,934
Shares 388,673,381
Float 384,891,656
Enterprise Value $1,043,345,524
Volume 9,190,795
Av. Daily Volume 9,413,099
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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., Sept. 09, 2020 (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 2020 Cantor Virtual Global Healthcare Conference on Wednesday, September 16, 2020 from 11:20 - 11:50 a.m. Eastern Time.

    A live audio webcast of the presentation will be available at: http://investor.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…

    DUBLIN, Ireland and BRIDGEWATER, N.J., Sept. 09, 2020 (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 2020 Cantor Virtual Global Healthcare Conference on Wednesday, September 16, 2020 from 11:20 - 11:50 a.m. Eastern Time.

    A live audio webcast of the presentation will be available at: http://investor.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 (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)

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  2. DUBLIN, Ireland and BRIDGEWATER, N.J., Sept. 03, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today provided an update following the decision by the U.S. Court of Appeals for the Federal Circuit in the company's ongoing patent litigation. The Court upheld the March ruling by the U.S. District Court for the District of Nevada in favor of two generic companies in connection with their abbreviated new drug applications, or ANDAs, related to Amarin's VASCEPA® (icosapent ethyl) capsule franchise. Amarin is currently reviewing its legal options and within 30 days expects to file a petition for an en banc review of the current panel decision by the full panel of 12 active judges at the U.S. Court of Appeals for the Federal Circuit…

    DUBLIN, Ireland and BRIDGEWATER, N.J., Sept. 03, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today provided an update following the decision by the U.S. Court of Appeals for the Federal Circuit in the company's ongoing patent litigation. The Court upheld the March ruling by the U.S. District Court for the District of Nevada in favor of two generic companies in connection with their abbreviated new drug applications, or ANDAs, related to Amarin's VASCEPA® (icosapent ethyl) capsule franchise. Amarin is currently reviewing its legal options and within 30 days expects to file a petition for an en banc review of the current panel decision by the full panel of 12 active judges at the U.S. Court of Appeals for the Federal Circuit.  

    "We are extremely disappointed with today's ruling and plan to vigorously pursue available remedies," said John Thero, president and chief executive officer, Amarin. "Importantly, we and our partners are continuing to pursue additional regulatory approvals for VASCEPA in China, Europe and the additional countries in the Middle East, and remain confident in the global market potential of VASCEPA. We are particularly excited about the anticipated commercialization opportunities for VASCEPA in Europe as we prepare for expected approval and launch in early 2021. At the same time, we will continue to meet the strong demand for VASCEPA here in the United States through our proven manufacturing capabilities."

    Amarin anticipates that generics companies, when they launch in the United States, are likely to have limited supply capacity for VASCEPA. Based on this assumption and given the need for greater awareness of VASCEPA by healthcare professionals and at-risk patients, Amarin intends to continue current promotion levels of VASCEPA in the United States. After assessing the scope, timing and pricing of potential generic competition, Amarin will decide whether to further expand, contract or maintain such levels of VASCEPA promotion.

    Geographies outside the United States in which VASCEPA is sold and under regulatory review are not subject to this litigation and judgment. No generic litigation is pending outside the United States. VASCEPA remains available by prescription in Canada, Lebanon and the United Arab Emirates. In Canada, VASCEPA has the benefit of eight years of data protection afforded through Health Canada (until the end of 2027), in addition to separate patent protection related to the REDUCE-IT® study of VASCEPA, which was not at issue in the subject U.S. litigation, with expiration dates that could extend into 2039. Amarin, on its own and together with its commercial partners in select geographies, is pursuing additional regulatory approvals for VASCEPA in Europe, China and other countries in the Middle East. Ten years of market protection is anticipated due to regulatory exclusivity in the European Union subject to pending VASCEPA approval, in addition to pending patent protection related to the REDUCE-IT study of VASCEPA that could extend into 2039.

    About Amarin

    Amarin Corporation 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, on its own or together with its commercial partners in select geographies, is pursuing additional regulatory reviews for VASCEPA in China, Europe and other parts of 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, 1 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 expectations regarding potential plans for further appeal, the degree to which we would continue promotional activities for VASCEPA in the United States, plans to seek to regulatory approvals and seek and maintain exclusivity for VASCEPA in various jurisdictions and the expected expiration dates of patent applications and issued patents to correspond with associated exclusivity protection. There can be no guarantee we would be successful in any of such efforts. 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 the commercial success of pharmaceutical products such as VASCEPA; the risk of loss in the planned appeal; that patent applications may not result in issued patents, and that issued patents may not prevent competitors from competing with VASCEPA; the risk that new competitors may further challenge the exclusivity afforded by the same patents at issue in this litigation through a new litigation or otherwise seek to gain marketing approval for generic versions of VASCEPA or branded competitive products based on new clinical studies; and the risk that trade secrets may not be maintained and that other circumstances that create barriers to competition with VASCEPA may not last. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. In addition, 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 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, and to comply with legal and regulatory requirements in connection with the sale and promotion of VASCEPA. 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 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   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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  3. VASCEPA is the first and only agent studied on top of statin therapy reported to exhibit coronary plaque regression in hypertriglyceridemic patients

    VASCEPA in REDUCE-IT® cardiovascular outcomes study achieved statistical significance for primary and secondary endpoints at predefined blinded first and second interim analyses that persisted at final analyses

    VASCEPA demonstrated significantly greater benefits in total (first and subsequent) cardiovascular events vs. placebo across studied baseline statin types and prespecified baseline levels of triglycerides, LDL-C, and hsCRP and in patients with or without low HDL-C and elevated triglycerides at baseline

    DUBLIN, Ireland and BRIDGEWATER, N.J., Sept. 01, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation…

    VASCEPA is the first and only agent studied on top of statin therapy reported to exhibit coronary plaque regression in hypertriglyceridemic patients

    VASCEPA in REDUCE-IT® cardiovascular outcomes study achieved statistical significance for primary and secondary endpoints at predefined blinded first and second interim analyses that persisted at final analyses

    VASCEPA demonstrated significantly greater benefits in total (first and subsequent) cardiovascular events vs. placebo across studied baseline statin types and prespecified baseline levels of triglycerides, LDL-C, and hsCRP and in patients with or without low HDL-C and elevated triglycerides at baseline

    DUBLIN, Ireland and BRIDGEWATER, N.J., Sept. 01, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) supported new data, presented at ESC Congress 2020, the annual meeting of the European Society of Cardiology (ESC), held from August 29 - September 1, 2020, adding to the growing body of knowledge on VASCEPA® (icosapent ethyl) in patients at risk for major adverse cardiovascular events.

    "Cardiovascular disease continues to impact and challenge us all," said Craig Granowitz, M.D., Ph.D., Amarin's senior vice president and chief medical officer. "We see the detrimental effects it has on patients and those who care for them, as well as healthcare systems around the world. Data presented at ESC Congress 2020 provides additional support for potential ways in which VASCEPA can help to alleviate the burden of the worldwide public health crisis that is cardiovascular disease."

    Key data presented at ESC Congress 2020

    "Effect of Icosapent Ethyl on Progression of Coronary Atherosclerosis in Patients with Elevated Triglycerides on Statin Therapy: Final results of the EVAPORATE Study" – presented on behalf of all authors by Matthew Budoff, M.D., The Lundquist Institute

    Highlights: VASCEPA demonstrated significant, 17% regression of low attenuation plaque (LAP) volume on multidetector computed tomography (MDCT) compared with placebo over 18 months.

    A total of 80 patients were enrolled in the randomized, double-blind, placebo-controlled EVAPORATE trial. Patients had to have coronary atherosclerosis as documented by MDCT (1 or more angiographic stenoses with ≥20% narrowing), be on statin therapy, and have persistently elevated triglyceride (TG) levels (mean TG at baseline was 259.1 mg/dL [+/- 78.1]). Patients underwent an interim scan at 9 months and a final scan at 18 months. The prespecified primary endpoint was a comparison of change in LAP volume at 18 months between icosapent ethyl and placebo.

    Final results showed a significant reduction in the primary endpoint; icosapent ethyl reduced LAP plaque volume by 17% from baseline to the 18-month scan, whereas there was a progression of LAP plaque volume in the placebo group. There were significant differences between icosapent ethyl and placebo at study end for secondary endpoints of other types of plaque volume changes, including and sequentially total, total non-calcified, fibrofatty, and fibrous plaque volumes. All of these forms of coronary plaque regressed in the icosapent ethyl group and progressed in the placebo group, (p<0.01 for all). The only secondary endpoint which did not achieve a significant difference between groups in multivariable modeling was dense calcium (p=0.053). VASCEPA is the first and only agent studied on top of statin therapy reported to exhibit coronary plaque regression in hypertriglyceridemic patients.

    The presentation is available here and has been published in European Heart Journal.

    "REDUCE-IT: Accumulation of Data Across Prespecified Interim Analyses to Final Results" – presented on behalf of all authors by Brian Olshansky, M.D., University of Iowa

    Highlights: The presentation at ESC Congress 2020 was the first presentation of results from the pre-specified interim analyses for the landmark REDUCE-IT® cardiovascular outcomes study. An independent, unblinded DMC (Data and Safety Monitoring Committee) performed interim analyses of data during the REDUCE-IT cardiovascular outcomes study at approximately 60% and 80% (2.9 and 3.7 years of median primary endpoint follow-up, respectively), with a final analysis at 4.9 years median follow-up. Primary and key secondary endpoints were the reduction in the first occurrence of composite of 5-point (cardiovascular death, myocardial infarction [MI], stroke, coronary revascularization or unstable angina) and 3-point (cardiovascular death, MI, stroke) major adverse cardiovascular events (MACE).

    Highly statistically significant outcomes were achieved for both primary and key secondary composite endpoints at the first interim, persisted at the second interim, and fully evolved at the final analysis. Consistent, statistically significant outcome measures demonstrating the robust and early benefit of icosapent ethyl were evident for the primary composite endpoint starting at 21 months, and for the key secondary composite endpoint at 25 months. Allowing the REDUCE-IT dataset to mature fully provided physicians and patients with robust, consistent, and reliable efficacy and safety data upon which to base clinical decisions for icosapent ethyl in cardiovascular risk reduction.

    "REDUCE-IT: Total Ischemic Events Reduced Across the Full Range of Baseline LDL-Cholesterol and Other Key Subgroups" – presented on behalf of all authors by Deepak L. Bhatt, M.D., M.P.H., Brigham and Women's Hospital

    Highlights: VASCEPA administered at 4 g/day in the REDUCE-IT cardiovascular outcomes study, as previously reported, significantly reduced total ischemic events in statin-treated patients with elevated triglycerides and other cardiovascular risk factors despite well-controlled LDL-C (<100 mg/dL). Presented at ESC Congress 2020 was that, similar to the results of analyses of first occurrences of MACE, reductions in total (first and subsequent) occurrences of MACE were observed across a variety of predefined subgroups, including baseline levels of triglycerides and LDL-C, with substantial reductions across already low LDL-C tertiles in both primary (5-point MACE) and key secondary (3-point MACE) endpoints, as well as in the subgroups with or without elevated hsCRP or low HDL and elevated triglycerides at baseline.

    "Are the Results of Clinical Trials Relevant in The Real World? The Applicability of REDUCE-IT to the FAST-MI Registry." – presented on behalf of all authors by Jean Ferrières, M.D., M.Sc., FESC, Toulouse Rangueil University Hospital

    Highlights: In order to evaluate the applicability of results of the REDUCE-IT cardiovascular outcomes study in a French population, the inclusion and exclusion criteria of this landmark study were applied to French patients who were admitted to coronary or intensive care units within 48 hours of symptom onset during a 1-month period (Registry on Acute ST-elevation and non-ST-elevation Myocardial Infarction (FAST-MI), 2010 and 2015). The results support that, even in this limited registry of patients, many French patients would qualify for the inclusion criteria of REDUCE-IT in which patients treated with VASCEPA experienced significant reductions in major adverse cardiovascular events.

    "REDUCE-IT: Outcomes by Baseline Statin Type" – presented on behalf of all authors by Deepak L. Bhatt, M.D., M.P.H., Brigham and Women's Hospital

    Highlights: The objectives of this analysis were to explore the impact of baseline and concomitant statin type on atherosclerotic cardiovascular disease (ASCVD) outcomes and on LDL-C and ApoB levels in the results of the REDUCE-IT cardiovascular outcomes study. The exploratory analysis examined the primary and key secondary endpoints of REDUCE-IT by individual statin type: atorvastatin, simvastatin, rosuvastatin, pravastatin, lovastatin, fluvastatin, or pitavastatin; and by statin category: lipophilic (i.e., hydrophobic: atorvastatin, simvastatin) vs. lipophobic (i.e., hydrophilic: rosuvastatin, pravastatin). Icosapent ethyl demonstrated similar benefits vs. placebo across all individual baseline statin types and both lipophilic and lipophobic statin categories. Individual baseline statin type and lipophilic/lipophobic category had no meaningful impact on the modest median LDL-C changes from baseline to 1 year and ApoB changes from baseline to 2 years observed with VASCEPA vs. placebo. Primary and key secondary composite endpoint outcomes and changes in LDL-C and ApoB by concomitant statin use yielded similar results. These data provide clinicians with additional insight regarding concomitant statin therapy considerations when prescribing icosapent ethyl and suggest there are important mechanisms of action for the substantial ASCVD risk reduction observed with VASCEPA that are distinct from the LDL-C receptor pathway.

    All analyses highlighted above were funded by Amarin.

    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 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   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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    • Primary endpoint of slowed coronary plaque progression reported to have been met with VASCEPA
    • Significant coronary plaque regression of low attenuation plaque (LAP) reported with VASCEPA provides further insight to potential mechanisms of action
    • VASCEPA is the first and only agent studied on top of statins reported to exhibit coronary plaque regression in hypertriglyceridemic patients

    TORONTO, Aug. 31, 2020 /CNW/ - HLS Therapeutics Inc. ("HLS" or the "Company") (TSX:HLS), a specialty pharmaceutical company focusing on central nervous system and cardiovascular markets, announced today that the trial results from Effect of Icosapent Ethyl on Progression of Coronary Atherosclerosis in Patients with Elevated Triglycerides on Statin Therapy: Final

    • Primary endpoint of slowed coronary plaque progression reported to have been met with VASCEPA
    • Significant coronary plaque regression of low attenuation plaque (LAP) reported with VASCEPA provides further insight to potential mechanisms of action
    • VASCEPA is the first and only agent studied on top of statins reported to exhibit coronary plaque regression in hypertriglyceridemic patients

    TORONTO, Aug. 31, 2020 /CNW/ - HLS Therapeutics Inc. ("HLS" or the "Company") (TSX:HLS), a specialty pharmaceutical company focusing on central nervous system and cardiovascular markets, announced today that the trial results from Effect of Icosapent Ethyl on Progression of Coronary Atherosclerosis in Patients with Elevated Triglycerides on Statin Therapy: Final results of the EVAPORATE Trial were presented at ESC Congress 2020, the annual meeting of the European Society of Cardiology, on August 29, 2020, by Matthew Budoff, M.D., Director of Cardiovascular CT at The Lundquist Institute and Professor of Medicine at the David Geffen School of Medicine at UCLA, the study sponsor. VASCEPA® (icosapent ethyl) demonstrated significant, 17% regression of low attenuation plaque (LAP) volume on multidetector computed tomography (MDCT) compared with placebo over 18 months. As referenced below, these final results can be found in the concurrent publication in European Heart Journal.

    "EVAPORATE provides important mechanistic data on coronary plaque characteristics that are potentially relevant to the overall REDUCE-IT® results and clinical use of icosapent ethyl," commented Matthew Budoff, M.D., Director of Cardiovascular CT at The Lundquist Institute and Professor of Medicine at the David Geffen School of Medicine at UCLA. "The REDUCE-IT REVASC analysis presented at American Society of Preventive Cardiology last month reported an early coronary revascularization benefit signal with sustained statistical significance attained by 11 months. EVAPORATE is the first demonstration of imaging results with icosapent ethyl using MDCT. The coronary plaque reduction shown in EVAPORATE is consistent with the benefits of icosapent ethyl in cardiovascular event outcomes shown in REDUCE-IT, a separate study."

    A total of 80 patients were enrolled in the randomized, double-blind, placebo-controlled EVAPORATE trial. Patients had to have coronary atherosclerosis as documented by MDCT (1 or more angiographic stenoses with ≥20% narrowing), be on statin therapy, and have persistently elevated triglyceride (TG) levels (mean TG at baseline was 259.1 mg/dL [+/- 78.1] , (2.93 mmol/L [+/-0.88]). Patients underwent an interim scan at 9 months and a final scan at 18 months. The prespecified primary endpoint was a comparison of change in LAP volume at 18 months between icosapent ethyl and placebo. EVAPORATE was not powered for long-term outcomes.

    The final results showed a significant reduction in the primary endpoint; icosapent ethyl reduced LAP plaque volume by 17% from baseline to the 18-month scan, whereas there was a progression of LAP plaque volume in the placebo group. There were significant differences between icosapent ethyl and placebo at study end for secondary endpoints of other types of plaque volume changes, including sequentially total, total non-calcified, fibrofatty, and fibrous plaque volumes. All regressed in the icosapent ethyl group and progressed in the placebo group, (p<0.01 for all). The only secondary endpoint which did not achieve a significant difference between groups in multivariable modeling was dense calcium (p=0.053).

    "Coronary plaque regression is an important finding with VASCEPA and may explain, in part, the substantial cardiovascular benefit seen in REDUCE-IT," said Dr Jason Gross, HLS Vice President of Scientific Affairs. "The EVAPORATE study results potentially shed further light on how VASCEPA works to lower residual cardiovascular risk."

    The mineral oil placebo, used for consistency with REDUCE-IT, was also analyzed against plaque changes from baseline in another placebo in a separate study. Rates of plaque changes in patients randomized to mineral oil (the placebo cohort) in the EVAPORATE study were compared with rates of plaque changes in the placebo arm of a second study that used a cellulose-based placebo. There was no difference in plaque progression between mineral oil and cellulose based placebos.1

    Limitations of this single study include a small sample size. More study is needed to demonstrate the effects of VASCEPA on coronary plaque to determine the relationship of such effects, if any, on cardiovascular risk reduction.

    The publication can be accessed via the following hyperlink to European Heart Journal.

    Financial Disclosure

    Funding from Amarin Corporation was provided to the sponsor of the EVAPORATE study, The Lundquist Institute, for Dr. Matthew Budoff's work on the study.

    ABOUT CARDIOVASCULAR DISEASE

    Worldwide, cardiovascular disease (CVD) remains the #1 cause of mortality of men and women.

    Multiple primary and secondary prevention trials have shown a significant reduction of 25% to 35% in the risk of cardiovascular events with statin therapy, leaving significant persistent residual risk despite the achievement of target LDL-C levels.2

    Beyond the cardiovascular risk associated with LDL-C, genetic, epidemiologic, clinical and real-world data suggest that patients with elevated triglycerides (TG) (fats in the blood), and TG-rich lipoproteins, are at increased risk for cardiovascular disease.3, 4, 5, 6

    ABOUT VASCEPA (ICOSAPENT ETHYL) CAPSULES

    VASCEPA (icosapent ethyl) capsules are the first-and-only prescription treatment comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. Vascepa was approved by Health Canada, 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. Lakshmanan S, Shekar C, Kinninger A, et al. Comparison of mineral oil and non-mineral oil placebo on coronary plaque progression by coronary computed tomography angiography. Cardiovasc Res. 2020;116(3):479-482.
    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. Nordestgaard BG, Varbo A. Triglycerides and cardiovascular disease. Lancet. 2014;384:626–635.

    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 and Management's Discussion and Analysis dated August 5, 2020, both of which have 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/August2020/31/c5157.html

    View Full Article Hide Full Article
  4. Primary endpoint of slowed coronary plaque progression reported to have been met with VASCEPA

    Significant coronary plaque regression of low attenuation plaque (LAP) reported with VASCEPA provides further insight to potential mechanisms of action

    VASCEPA is the first and only agent studied on top of statins reported to exhibit coronary plaque regression in hypertriglyceridemic patients

    DUBLIN, Ireland and BRIDGEWATER, N.J., Aug. 29, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that the trial results from Effect of Icosapent Ethyl on Progression of Coronary Atherosclerosis in Patients with Elevated Triglycerides on Statin Therapy: Final results of the EVAPORATE Trial were presented at ESC Congress 2020, the…

    Primary endpoint of slowed coronary plaque progression reported to have been met with VASCEPA

    Significant coronary plaque regression of low attenuation plaque (LAP) reported with VASCEPA provides further insight to potential mechanisms of action

    VASCEPA is the first and only agent studied on top of statins reported to exhibit coronary plaque regression in hypertriglyceridemic patients

    DUBLIN, Ireland and BRIDGEWATER, N.J., Aug. 29, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that the trial results from Effect of Icosapent Ethyl on Progression of Coronary Atherosclerosis in Patients with Elevated Triglycerides on Statin Therapy: Final results of the EVAPORATE Trial were presented at ESC Congress 2020, the annual meeting of the European Society of Cardiology, on August 29, 2020, 9:13 am CEST (Central European Summer Time) by Matthew Budoff, M.D., Director of Cardiovascular CT at The Lundquist Institute and Professor of Medicine at the David Geffen School of Medicine at UCLA, the study sponsor. VASCEPA® (icosapent ethyl) demonstrated significant, 17% regression of low attenuation plaque (LAP) volume on multidetector computed tomography (MDCT) compared with placebo over 18 months. As referenced below, these final results can be found in the concurrent publication in European Heart Journal.

    "EVAPORATE provides important mechanistic data on coronary plaque characteristics that are potentially relevant to the overall REDUCE-IT® results and clinical use of icosapent ethyl," commented Matthew Budoff, M.D., Director of Cardiovascular CT at The Lundquist Institute and Professor of Medicine at the David Geffen School of Medicine at UCLA. "The REDUCE-IT REVASC analysis presented at American Society for Preventive Cardiology last month reported an early coronary revascularization benefit signal with sustained statistical significance attained by 11 months. EVAPORATE is the first demonstration of imaging results with icosapent ethyl using MDCT. The coronary plaque reduction shown in EVAPORATE is consistent with the benefits of icosapent ethyl in cardiovascular event outcomes shown in REDUCE-IT, a separate study."

    A total of 80 patients were enrolled in the randomized, double-blind, placebo-controlled EVAPORATE trial. Patients had to have coronary atherosclerosis as documented by MDCT (1 or more angiographic stenoses with ≥20% narrowing), be on statin therapy, and have persistently elevated triglyceride (TG) levels (mean TG at baseline was 259.1 mg/dL [+/- 78.1]). Patients underwent an interim scan at 9 months and a final scan at 18 months. The prespecified primary endpoint was a comparison of change in LAP volume at 18 months between icosapent ethyl and placebo. EVAPORATE was not powered for long-term outcomes.

    The final results showed a significant reduction in the primary endpoint; icosapent ethyl reduced LAP plaque volume by 17% from baseline to the 18-month scan, whereas there was a progression of LAP plaque volume in the placebo group. There were significant differences between icosapent ethyl and placebo at study end for secondary endpoints of other types of plaque volume changes, including and sequentially total, total non-calcified, fibrofatty, and fibrous plaque volumes. All regressed in the icosapent ethyl group and progressed in the placebo group, (p<0.01 for all). The only secondary endpoint which did not achieve a significant difference between groups in multivariable modeling was dense calcium (p=0.053).  

    The mineral oil placebo, used for consistency with REDUCE-IT, was also analyzed against plaque changes from baseline in another placebo in a separate study. Rates of plaque changes in patients randomized to mineral oil (the placebo cohort) in the EVAPORATE study were compared with rates of plaque changes in the placebo arm of a second study that used a cellulose-based placebo. There was no difference in plaque progression between mineral oil and cellulose based placebos.1

    "Coronary plaque regression is an important finding with VASCEPA and may explain, in part, the substantial cardiovascular benefit seen in REDUCE-IT," said Craig Granowitz, M.D., Ph.D., Amarin's senior vice president and chief medical officer. "The EVAPORATE study results potentially shed further light on how VASCEPA works to lower residual cardiovascular risk."

    Limitations of this single study include a small sample size. More study is needed to demonstrate the effects of VASCEPA on coronary plaque to determine the relationship of such effects, if any, on cardiovascular risk reduction.

    The presentation will be available here with a concurrent publication in European Heart Journal.

    Financial Disclosure

    Funding from Amarin was provided to the sponsor of the EVAPORATE study, The Lundquist Institute, for Dr. Matthew Budoff's work on the study.

    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.2 In aggregate, there are more than 2.4 million major adverse cardiovascular events per year from cardiovascular disease or, on average, 1 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%.3 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.4,5,6

    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.7 The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.8 The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.9 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   Lakshmanan S, Shekar C, Kinninger A, et al. Comparison of mineral oil and non-mineral oil placebo on coronary plaque progression by coronary computed tomography angiography. Cardiovasc Res. 2020;116(3):479-482.

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

    3   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.

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

    5   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.

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

    7   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.

    8   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.

    9   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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