AMRN Amarin Corporation plc

5.93
-0.07  -1%
Previous Close 6
Open 5.99
52 Week Low 3.36
52 Week High 9.25
Market Cap $2,334,258,319
Shares 393,635,467
Float 385,983,204
Enterprise Value $1,870,032,802
Volume 2,619,695
Av. Daily Volume 6,841,127
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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. Reimbursement dossiers for first 10 countries to be filed in coming months

    150 people hired and on-track to be deployed by mid-Q2 2021 supplemented by digital outreach and medical education programs with initial top priority on Germany

    VAZKEPA commercial launch in Germany planned for Q3 2021

    DUBLIN, Ireland and BRIDGEWATER, N.J., April 06, 2021 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today provided updates regarding its plans for the commercial launch of VAZKEPA (icosapent ethyl) in Europe following the March 30, 2021 announcement of receipt of market authorization from the European Commission (EC). VAZKEPA is the first EC-approved product to be marketed and sold for cardiovascular risk reduction in high-risk, statin-treated…

    Reimbursement dossiers for first 10 countries to be filed in coming months

    150 people hired and on-track to be deployed by mid-Q2 2021 supplemented by digital outreach and medical education programs with initial top priority on Germany

    VAZKEPA commercial launch in Germany planned for Q3 2021

    DUBLIN, Ireland and BRIDGEWATER, N.J., April 06, 2021 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today provided updates regarding its plans for the commercial launch of VAZKEPA (icosapent ethyl) in Europe following the March 30, 2021 announcement of receipt of market authorization from the European Commission (EC). VAZKEPA is the first EC-approved product to be marketed and sold for cardiovascular risk reduction in high-risk, statin-treated adult patients who have elevated triglycerides (≥150 mg/dL) and other risk characteristics as studied in REDUCE-IT®.

    Following this approval, Amarin commenced training sales representatives in Germany to advance pre-launch disease and brand awareness initiatives in preparation for the planned commercial launch of VAZKEPA in Germany before the end of Q3 2021. The company expects to have approximately 150 sales representatives deployed for pre-launch product and disease state awareness programs by mid-Q2 2021.

    "We have hired talented and experienced pharmaceutical sales and marketing professionals for our European commercial team and are activating steps to increase product and market need awareness, while advancing our market access negotiations," said Karim Mikhail, senior vice president, commercial head Europe of Amarin. "We are taking a thoughtful and proactive approach to leveraging the vast global experience of our team, while incorporating the learnings from other product launches made during the COVID-19 era. We are highly motivated to effectively launch VAZKEPA in Europe as it offers an exciting opportunity to help patients at risk of cardiovascular events. VAZKEPA is a safe and effective new product that benefits from more than a decade of worldwide clinical development and testing that support its use to significantly reduce cardiovascular events."

    Use of icosapent ethyl is now recommended by 15 medical societies for cardiovascular risk reduction reflecting that the data supporting the effectiveness of VAZKEPA is robust, the medical need is high and key opinion leaders in these medical societies agree this important new drug should be used to improve patient care. As VAZKEPA was just recently authorized in Europe as a new drug (new active substance), and there is no other product approved in Europe for VAZKEPA's indication, current awareness of VAZKEPA in Europe among healthcare professionals at-large is relatively low.

    Amarin believes that increasing awareness of VAZKEPA in Germany and illuminating the patient population that can benefit from this new drug are important to VAZKEPA's early launch success. Prior to VAZKEPA's recent approval, as is typical for any new drug, branded market education regarding VAZKEPA was prohibited in Europe. Consequently, immediately following VAZKEPA's approval in the European Union the company has initiated its educational and promotional plans to underscore the significant residual cardiovascular risk for the patient population indicated for VAZKEPA and to introduce to healthcare professionals the value VAZKEPA has demonstrated in lowering such risk.

    Starting in the second quarter 2021, outreach by Amarin's field force in Germany will be supplemented by various forms of market education, including digital outreach and omnichannel engagement for key stakeholders. Amarin's planned educational initiatives are intended to increase awareness among cardiologists, diabetologists, and general practitioners. In addition, based on the differentiated safety and efficacy profile of this unique drug for its approved label and the growing global data in support of its pharmacoeconomic benefits, our planned educational efforts will also be aimed at regional payers.

    As is typical of drug launches in Europe, following approval and prior to launch, market access (reimbursement) needs to be secured on a country-by-country basis and product awareness of VAZKEPA needs to increase in each country1. In seeking market access, the company expects to file dossiers in ten (10) European countries in the coming months, including the largest countries of Europe. Each of these dossiers have already undergone months of preparation and include the data demonstrating the uniqueness of VAZKEPA from a scientific perspective, various country-specific demographic data sets to define the eligible patient population based on the label, and finally proposed pricing. Amarin is seeking pricing that it believes is well justified based on the demonstrated effectiveness of VAZKEPA and the high cost to society of heart attacks, strokes and other cardiovascular events that VAZKEPA can help avoid while also reducing pain and suffering for at-risk patients and their families. After the first wave of 10 country submissions in Europe, Amarin intends to pursue a second wave of European reimbursement dossiers in its efforts to bring VAZKEPA to all patients who can benefit from it.

    Amarin anticipates direct access to healthcare professionals and at-risk patients will remain constrained while COVID-19 persists. Learning from the experience of other drugs launched during the COVID-19 pandemic, part of the planned multi-faceted educational programs in Europe will include increased awareness of the unique effects of VAZKEPA. For example, key elements of the planned education initiatives are expected to focus on increasing the scientific awareness of the importance of measuring and using triglyceride (TG) levels as an identifier of cardiovascular risk, noting that VAZKEPA's cardiovascular risk reduction effects extend beyond TG lowering and are believed to be multifactorial, including anti-inflammatory and antiplatelet effects. While many people are speculating that the impact of COVID-19 will gradually abate around the planned commercial launch of VAZKEPA in Germany in Q3 2021, digital outreach, and other forms of educating healthcare professionals will be emphasized to support the work of the sales professionals being deployed. In order to advance pre-launch market awareness of VAZKEPA, to allow time for the impact of COVID-19 to recede and to avoid the challenges of launching prior to the summer holiday period when access to healthcare professionals can be more difficult, it is likely that the launch in Germany will be the latter half of Q3. Launch timing will be further refined after feedback is received from the company's early branded awareness and education initiatives.

    Amarin is giving initial priority to launching VAZKEPA in Germany while making plans for commercialization in countries throughout Europe. Staffing in other European countries, and launch timing in these other countries, will depend on progress in gaining market access on a country-by-country basis.

    Previously Amarin had provided guidance that its European staffing at the end of 2021 would be approximately 200 people. Based on the company's current plans and expectations, Amarin now expects to grow its staffing in Europe to approximately 300 people by the end of 2021, with further increases planned as market access is expanded in various countries. This increase in expected staffing reflects the breadth of the EC-approved label for VAZKEPA, positive initial feedback Amarin is receiving from European scientific leaders, and optimism that the impact of COVID-19 will recede during the second half of 2021.

    About Amarin

    Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. From our scientific research foundation to our focus on clinical trials, and now our commercial expansion, we are evolving and growing rapidly. Amarin has offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, and Zug in Switzerland as well as commercial partners and suppliers around the world. We are committed to rethinking cardiovascular risk through the advancement of scientific understanding of the impact on society of significant residual risk that exists beyond traditional therapies, such as statins for cholesterol management.

    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.2 The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.3 The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.4 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 U.S. Food and Drug Administration (FDA) comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was launched in the United States in January 2020 as the first and only drug approved by the U.S. FDA for treatment of the studied high-risk patients with persistent cardiovascular risk after statin therapy. VASCEPA was initially launched in the United States in 2013 based on the drug's initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed over ten million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, VASCEPA is approved and sold in Canada, Lebanon and the United Arab Emirates. In Europe, marketing authorization was granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA.

    Indications and Limitation of Use (in the United States)

    VASCEPA is indicated:

    • As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and
      • established cardiovascular disease or
      • diabetes mellitus and two or more additional risk factors for cardiovascular disease.
    • As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.

    The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.

    Important Safety Information

    • VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components.
    • VASCEPA was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter.
    • It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if any reactions occur.
    • VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel or warfarin.
    • Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).
    • Common adverse reactions in the hypertriglyceridemia trials (incidence >1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%).
    • Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
    • Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding.

    Key clinical effects of VASCEPA on major adverse cardiovascular events are included in the Clinical Studies section of the prescribing information for VASCEPA as set forth below:

    Effect of VASCEPA on Time to First Occurrence of Cardiovascular Events in Patients with

    Elevated Triglyceride levels and Other Risk Factors for Cardiovascular Disease in REDUCE-IT

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

    Forward-Looking Statements

    This press release contains forward-looking statements, including statements about the timing of promotional and educational initiatives, the timing of market access initiatives and the potential of VAZKEPA (known as VASCEPA in the United States) to favorably affect cardiovascular risk in appropriate patients, to make a difference in the lives of the many millions of patients throughout Europe who are at risk of a cardiovascular event, with respect to Amarin being well-positioned for a successful European launch and related to the potential for extended patent protection. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties that may individually or together impact the matters herein and cause actual results, events and performance to differ materially from such forward-looking statements. Among the factors that could cause actual results to differ materially from those described or projected herein include the following: events that could impact future regulatory assessment by the European Commission, such as delays due to COVID-19 restrictions, later arising data, regulatory reviews and pricing assessments, and the successful implementation of commercialization plans or other information, events that could interfere with the grant or issuance of a patent, continued validity or enforceability of a patent; uncertainties associated with litigation generally and patent litigation specifically; Amarin's ability generally to maintain adequate patent protection and successfully enforce patent claims against third parties; and uncertainties associated generally with research and development and regulatory submissions, reviews, action dates and approvals. 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.

    Availability of Other Information About Amarin

    Investors and others should note that Amarin communicates with its investors and the public using the company website (www.amarincorp.com), the investor relations website (investor.amarincorp.com), including but not limited to investor presentations and investor FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media, and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin's investor relations website and may include social media channels. The contents of Amarin's website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

    Amarin Contact Information

    Investor Inquiries:

    Investor Relations

    Amarin Corporation plc

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

    (investor inquiries)

    Solebury Trout

    Media Inquiries:

    Communications

    Amarin Corporation plc

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

    (media inquiries)

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

    ________________________

    1 For more information see the FAQ titled, What are Amarin's plans and timing for VAZKEPA initial commercial launch in Europe?, in the investor relations section of the Amarin corporate website at https://investor.amarincorp.com/.

    2 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.

    3 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.

    4 Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Reduction in first and total ischemic events with icosapent ethyl across baseline triglyceride tertiles. J Am Coll Cardiol. 2019;74:1159-1161.



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  2. Marks first and only EC-approved treatment to reduce cardiovascular risk in high-risk, statin-treated adult patients who have elevated triglycerides (≥150 mg/dL) and other risk characteristics as studied in REDUCE-IT® 1, 2

    DUBLIN, Ireland and BRIDGEWATER, N.J., March 30, 2021 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that following a review and approval recommendation by the European Medicines Agency (EMA), the European Commission (EC) has approved the marketing authorization application for VAZKEPA (icosapent ethyl) to reduce the risk of cardiovascular events in high-risk, statin-treated adult patients who have elevated triglycerides (≥150 mg/dL) and either established cardiovascular disease or diabetes and…

    Marks first and only EC-approved treatment to reduce cardiovascular risk in high-risk, statin-treated adult patients who have elevated triglycerides (≥150 mg/dL) and other risk characteristics as studied in REDUCE-IT® 1, 2

    DUBLIN, Ireland and BRIDGEWATER, N.J., March 30, 2021 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that following a review and approval recommendation by the European Medicines Agency (EMA), the European Commission (EC) has approved the marketing authorization application for VAZKEPA (icosapent ethyl) to reduce the risk of cardiovascular events in high-risk, statin-treated adult patients who have elevated triglycerides (≥150 mg/dL) and either established cardiovascular disease or diabetes and at least one additional cardiovascular risk factor.

    Amarin's icosapent ethyl was approved for cardiovascular risk reduction by the U.S. Food and Drug Administration (FDA) in December 2019 and is marketed in the U.S. under the brand name, VASCEPA®.

    "The approval of VAZKEPA marks a significant milestone for high-risk cardiovascular patients in Europe as it offers the first and only EC-approved therapy to reduce cardiovascular risk in high-risk statin-treated patients who have elevated triglycerides," said Steven Ketchum, senior vice president, president of R&D and chief scientific officer of Amarin. "We look forward to launching VAZKEPA in Europe as it is an exciting opportunity for Amarin to make a difference in the lives of the many millions of patients throughout Europe who are at risk of a cardiovascular event."

    The EC approval for VAZKEPA is based on over a decade of development and testing of icosapent ethyl, including efficacy and safety data from the REDUCE-IT® cardiovascular outcomes study.2 REDUCE-IT evaluated more than 8,000 high risk patients who despite having their cholesterol levels well controlled by statin therapy remained at significant risk of heart attack, stroke, or other major adverse cardiovascular events (MACE), including death. As published, patients in the REDUCE-IT study had a median follow-up period of nearly five years. Results from this study, in which all patients remained treated with statins (and with other contemporary therapies) and where half the patients received icosapent ethyl and the other half received placebo, demonstrated a 25% relative risk reduction (p<0.001) in the first occurrence of MACE in the intent-to-treat patient population with use of icosapent ethyl (4 grams daily) compared with placebo.

    "We are especially pleased to receive the EC's approval of VAZKEPA to reduce cardiovascular risk as cardiovascular disease remains the number one cause of death in the European Union and its economic burden exceeds €210 billion per year3," stated John F. Thero, president and chief executive officer. "We believe we are well positioned for a successful launch based on the high rate of cardiovascular events in Europe, the lack of an approved therapy for the indication VAZKEPA is positioned to address, and because of the demonstrated efficacy and safety profile of this unique drug."

    "Importantly, this EC approval provides ten years of market protection for VAZKEPA in the European Union. In addition, we have pending patent applications related to the REDUCE-IT study, which have the potential to extend exclusivity in Europe into 2039," added Mr. Thero.

    In anticipation of the commercial availability of VAZKEPA in Europe, the European Society of Cardiology and European Atherosclerosis Society updated its 2019 Dyslipidemia Management Guidelines to recommend the use of icosapent ethyl in high-risk, statin-treated patients.4 Globally, there are 15 medical societies that recommend the use of icosapent ethyl in appropriate patients, emphasizing that the positive clinical results of the REDUCE-IT cardiovascular outcomes study should not be generalized to any product other than icosapent ethyl, and noting that the clinical results are unique to VASCEPA/VAZKEPA.

    Information regarding Amarin's plans for commercialization and securing market access in Europe can be found in the FAQ section under investor relations at www.amarincorp.com.

    About Amarin

    Amarin is a rapidly growing, innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. From our scientific research foundation to our focus on clinical trials, and now our commercial expansion, we are evolving and growing. In 2009, Amarin had fewer than twenty employees. Today, with offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, and Zug in Switzerland, Amarin has approximately 1,000 employees and commercial partners and suppliers around the world. We are committed to rethinking cardiovascular risk through the advancement of scientific understanding of the impact on society of significant residual risk that exists beyond traditional therapies, such as statins for cholesterol management.

    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.5 The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.2 The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.6 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 U.S. Food and Drug Administration (FDA) comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was launched in the United States in January 2020 as the first and only drug approved by the U.S. FDA for treatment of the studied high-risk patients with persistent cardiovascular risk after statin therapy. VASCEPA was initially launched in the United States in 2013 based on the drug's initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed over ten million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, VASCEPA is approved and sold in Canada, Lebanon and the United Arab Emirates. In Europe, marketing authorization was granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA.

    Indications and Limitation of Use (in the United States)

    VASCEPA is indicated:

    • As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and
      • established cardiovascular disease or
      • diabetes mellitus and two or more additional risk factors for cardiovascular disease.
    • As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.

    The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.

    Important Safety Information

    • VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components.
    • VASCEPA was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter.
    • It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if any reactions occur.
    • VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel or warfarin.
    • Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).
    • Common adverse reactions in the hypertriglyceridemia trials (incidence >1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%).
    • Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
    • Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding.

    Key clinical effects of VASCEPA on major adverse cardiovascular events are included in the Clinical Studies section of the prescribing information for VASCEPA as set forth below:

    Effect of VASCEPA on Time to First Occurrence of Cardiovascular Events in Patients with

    Elevated Triglyceride levels and Other Risk Factors for Cardiovascular Disease in REDUCE-IT

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

    Forward-Looking Statements

    This press release contains forward-looking statements, including statements about the potential of VAZKEPA (known as VASCEPA in the United States) to favorably affect cardiovascular risk in appropriate patients, to make a difference in the lives of the many millions of patients throughout Europe who are at risk of a cardiovascular event, with respect to Amarin being well-positioned for a successful European launch and related to the potential for extended patent protection. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties that may individually or together impact the matters herein and cause actual results, events and performance to differ materially from such forward-looking statements. Among the factors that could cause actual results to differ materially from those described or projected herein include the following: events that could impact future regulatory assessment by the European Commission, such as delays due to COVID-19 restrictions, later arising data, regulatory reviews and pricing assessments, and the successful implementation of commercialization plans or other information, events that could interfere with the grant or issuance of a patent, continued validity or enforceability of a patent; uncertainties associated with litigation generally and patent litigation specifically; Amarin's ability generally to maintain adequate patent protection and successfully enforce patent claims against third parties; and uncertainties associated generally with research and development and regulatory submissions, reviews, action dates and approvals. 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.

    Availability of Other Information About Amarin

    Investors and others should note that Amarin communicates with its investors and the public using the company website (www.amarincorp.com), the investor relations website (investor.amarincorp.com), including but not limited to investor presentations and investor FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media, and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin's investor relations website and may include social media channels. The contents of Amarin's website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

    Amarin Contact Information

    Investor Inquiries:

    Investor Relations

    Amarin Corporation plc

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

    (investor inquiries)

    Solebury Trout

    Media Inquiries:

    Communications

    Amarin Corporation plc

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

    (media inquiries)

    ____________________________

    1 Union Register of medicinal products - Public health - European Commission. https://ec.europa.eu/health/documents/community-register/html/h1524.htm. Accessed March 30, 2021.

    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.

    3 ESC Cardiovascular Realities 2020 by... - Flipsnack. https://www.flipsnack.com/Escardio/esc-cardiovascular-realities-2020/full-view.html. Accessed March 30, 2021. 

    4 Mach F, Baigent C, Catapano AL, et al. 2019 ESC/EAS guidelines for the management of dyslipidaemias: Lipid modification to reduce cardiovascular risk. Atherosclerosis. 2019;290:140-205. doi:10.1016/j.atherosclerosis.2019.08.014 

    5 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.

    6 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.

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



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  3. Recent recommendations or guidances, from Canada and Egypt, expand the global recognition of this important therapy and its demonstrated favorable outcomes study results

    DUBLIN, Ireland and BRIDGEWATER, N.J., March 29, 2021 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that the Canadian Cardiovascular Society (CCS) and the Egyptian Heart Journal (EHJ) (the official journal of the Egyptian Cardiovascular Society) have included icosapent ethyl in the 2021 Canadian Cardiovascular Society Guidelines1 and in the Egyptian Heart Journal's Practical Guidance in Lipid Management2 respectively, for the reduction of cardiovascular risk. These recommendations increase to 15 the number of global organizations or medical societies…

    Recent recommendations or guidances, from Canada and Egypt, expand the global recognition of this important therapy and its demonstrated favorable outcomes study results

    DUBLIN, Ireland and BRIDGEWATER, N.J., March 29, 2021 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that the Canadian Cardiovascular Society (CCS) and the Egyptian Heart Journal (EHJ) (the official journal of the Egyptian Cardiovascular Society) have included icosapent ethyl in the 2021 Canadian Cardiovascular Society Guidelines1 and in the Egyptian Heart Journal's Practical Guidance in Lipid Management2 respectively, for the reduction of cardiovascular risk. These recommendations increase to 15 the number of global organizations or medical societies that recommend icosapent ethyl for cardiovascular risk reduction following its previously reported favorable outcomes study results. These independent recommendations support the company's view that this important drug, marketed in the United States as VASCEPA®, is rapidly becoming a new standard of care for the treatment of appropriate high-risk patients.

    The CCS guideline recommends, "the use of icosapent ethyl to lower the risk of CV events in patients with atherosclerotic cardiovascular disease (ASCVD), or with diabetes and ≥1 CVD risk factors, who have an elevated fasting triglyceride level of 1.5-5.6 mmol/L despite treatment with maximally tolerated statin therapy". Further, CCS guideline authors, "do not recommend the use of over-the-counter omega-3 polyunsaturated fatty acids supplements (marketed as natural health products in Canada) to reduce CVD risk".1 The reference to over-the-counter is understood in other parts of the world to refer to dietary supplements.

    The Egyptian Heart Journal practical guidance in lipid management lists icosapent ethyl as a consideration in patients with high triglyceride (HTG) levels (above 200 mg/dL). The recommendation excludes secondary causes of HTG [TG levels > 200 mg/dL] as part of patient management and advises to treat them separately. Patients with HTG and at high risk must receive a statin as a first-line treatment to reduce cardiovascular disease (CVD) risk. In high-risk (or above) patients with TG levels between 135 and 499 mg/dL despite statin treatment, n-3 PUFAs (icosapent ethyl 2 × 2g/day) should be considered in combination with a statin.2

    "Inclusion in these new guidelines underscores the growing global acceptance of the clinical benefits of pure icosapent ethyl in reducing cardiovascular risk as supported by the landmark REDUCE-IT® study of VASCEPA and further validates the independent support of this unique agent by the scientific community," stated Craig B. Granowitz, M.D., Ph.D., senior vice president and chief medical officer of Amarin. "With these new recommendations, icosapent ethyl is now included in the treatment guidelines or otherwise recommended for use by 15 medical associations internationally, further validating icosapent ethyl as an important treatment option beyond cholesterol management for millions of patients worldwide at risk for a cardiovascular event."

    The recommendation from the CCS was classified as ‘Strong Recommendation; High-Quality Evidence' and supported by the results of the REDUCE-IT cardiovascular outcomes study. The results of REDUCE-IT cannot be extrapolated to other non-prescription omega-3 fatty acids.

    The CCS and the EHJ do not provide endorsements of any brand name commercial product. Accordingly, the CCS "2021 Canadian Cardiovascular Society Guidelines for the Management of Dyslipidemia for the Prevention of Cardiovascular Disease in the Adult" and the EHJ "Egyptian Practical Guidance in Lipid Management" reference icosapent ethyl. The guidelines do not reference VASCEPA, the brand name of icosapent ethyl in the United States, and such guidelines should not be construed as an endorsement or approval of VASCEPA by the CCS or EHJ.

    Amarin acknowledges the rigor with which these documents are developed and approved by the CCS and the EHJ, which are comprised of leading medical professionals in Canada and Egypt who specialize in the care of patients with CVD.

    The complete "2021 Canadian Cardiovascular Society Guidelines for the Management of Dyslipidemia for the Prevention of Cardiovascular Disease in the Adult" addressing Primary and Secondary Prevention of Cardiovascular Diseases with icosapent ethyl published in the Canadian Journal of Cardiology can be accessed online here. The "Egyptian Practical Guidance in Lipid Management" as published in The Egyptian Heart Journal can be accessed online here.

    Information on other medical societies that include icosapent ethyl in their guidelines can be accessed here.

    About Amarin

    Amarin is a rapidly growing, innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. From our scientific research foundation to our focus on clinical trials, and now our commercial expansion, we are evolving and growing. In 2009, Amarin had fewer than twenty employees. Today, with offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, and Zug in Switzerland, Amarin has approximately 1,000 employees and commercial partners and suppliers around the world. We are committed to rethinking cardiovascular risk through the advancement of scientific understanding of the impact on society of significant residual risk that exists beyond traditional therapies, such as statins for cholesterol management.

    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.3 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%.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.5,6,7

    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.8 The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.9 The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.10 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 U.S. FDA comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was launched in the United States in January 2020 as the first and only drug approved by the U.S. FDA for treatment of the studied high-risk patients with persistent cardiovascular risk after statin therapy. VASCEPA was initially launched in the United States in 2013 based on the drug's initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed over ten million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, VASCEPA is approved and sold in Canada, Lebanon and the United Arab Emirates. In Europe, approval is anticipated in April 2021 following the January 28, 2021 favorable opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending that marketing authorisation be granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA.

    Indications and Limitation of Use (in the United States)

    VASCEPA is indicated:

    • As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and
      • established cardiovascular disease or
      • diabetes mellitus and two or more additional risk factors for cardiovascular disease.
    • As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.

    The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.

    Important Safety Information

    • VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components.
    • VASCEPA was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter.
    • It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if any reactions occur.
    • VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel or warfarin.
    • Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).
    • Common adverse reactions in the hypertriglyceridemia trials (incidence >1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%).
    • Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
    • Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding.

    Key clinical effects of VASCEPA on major adverse cardiovascular events are included in the Clinical Studies section of the prescribing information for VASCEPA as set forth below:

    Effect of VASCEPA on Time to First Occurrence of Cardiovascular Events in Patients with

    Elevated Triglyceride levels and Other Risk Factors for Cardiovascular Disease in REDUCE-IT

     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 U.S. FDA-APPROVED 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 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 Inquiries:

    Investor Relations

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

    Amarin Corporation plc

    (investor inquiries)

    Solebury Trout

    Media Inquiries:

    Alina Kolomeyer

    Communications

    Amarin Corporation plc

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

    (media inquiries)

    1Pearson GJ, et al. 2021 Canadian Cardiovascular Society Guidelines for the Management of Dyslipidemia for the

    Prevention of Cardiovascular Disease in the Adult. Can J Cardiol. 2021, Article in Press. DOI: https://doi.org/10.1016/j.cjca.2021.03.016 Epub 2021 March 26.
    2Taha HSED, et al. Egyptian practical guidance in lipid management 2020. Egypt Heart J. 2021;73(1):17. doi: 10.1186/s43044-021-00140-1.
    3American Heart Association. Heart Disease and Stroke Statistics—2020 Update: A Report From the American Heart     Association. Circulation. 2020;141:e139–e596.
    4Ganda 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.
    5Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.
    6Toth 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.
    7Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease - New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563.
    8Bhatt 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.
    9Bhatt 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.
    10Bhatt 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.

     

     

     

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



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    • CCS dyslipidemia management guidelines published in the Canadian Journal of Cardiology (CJC) on March 26, 2021
    • Strong recommendation for the use of icosapent ethyl for Primary Prevention (diabetes and ≥1 cardiovascular disease (CVD) risk factors) and Secondary Prevention (atherosclerotic cardiovascular disease (ASCVD))
    • Guidelines do not recommend the use of over-the-counter omega-3 polyunsaturated fatty acids supplements to reduce CVD risk

    TORONTO, March 29, 2021 /CNW/ - HLS Therapeutics Inc. ("HLS" or the "Company") (TSX:HLS), a specialty pharmaceutical company focusing on central nervous system and cardiovascular markets, announces that the Canadian Cardiovascular Society ("CCS") has included icosapent ethyl (Vascepa) in its 2021 Canadian Cardiovascular…

    • CCS dyslipidemia management guidelines published in the Canadian Journal of Cardiology (CJC) on March 26, 2021
    • Strong recommendation for the use of icosapent ethyl for Primary Prevention (diabetes and ≥1 cardiovascular disease (CVD) risk factors) and Secondary Prevention (atherosclerotic cardiovascular disease (ASCVD))
    • Guidelines do not recommend the use of over-the-counter omega-3 polyunsaturated fatty acids supplements to reduce CVD risk

    TORONTO, March 29, 2021 /CNW/ - HLS Therapeutics Inc. ("HLS" or the "Company") (TSX:HLS), a specialty pharmaceutical company focusing on central nervous system and cardiovascular markets, announces that the Canadian Cardiovascular Society ("CCS") has included icosapent ethyl (Vascepa) in its 2021 Canadian Cardiovascular Society Guidelines for the Management of Dyslipidemia for the Prevention of Cardiovascular Disease in the Adult, published in the Canadian Journal of Cardiology. The guideline authors recommend the use of icosapent ethyl to lower the risk of cardiovascular ("CV") events in patients with ASCVD, or with diabetes and ≥1 CVD risk factors, who have an elevated fasting triglyceride level between 1.5-5.6 mmol/L despite treatment with maximally tolerated statin therapy.  The Guidelines specifically do not recommend the use of over-the-counter omega-3 polyunsaturated fatty acids supplements (marketed as natural health products in Canada) and specified the lack of CV benefit of omega-3 fatty acids from dietary sources or other formulations/supplements.

    "By including Vascepa in the guidelines, the CCS is indicating its focus on improving patient care by reducing the risk of atherosclerotic cardiovascular disease," said Gilbert Godin, CEO of HLS. "To have this highly credible medical society recognize the benefit of Vascepa as a new treatment option for Canadians on statins with elevated triglycerides who are at risk of cardiovascular events such as Heart Attack, Stroke, Revascularization or Death is a tremendous development for those eligible patients."

    In Canada, up to two million people have triglycerides ≥ 1.5 mmol/L and established cardiovascular disease, or diabetes with risk factors despite statin treatment.1,2,3

    "These updated guidelines from the Canadian Cardiovascular Society reaffirm the importance of the REDUCE-IT trial findings to Canadian patients, not only in enhancing care, but also in broadening awareness of the need for an icosapent ethyl treatment among patients who may have their cholesterol controlled with a statin, but still face a residual risk of major cardiac events," said Dr Jean-Claude Tardif, Director of the Research Center at the Montreal Heart Institute and professor of medicine at University of Montreal. "Based on what we have learned on icosapent ethyl, I foresee the beginning of a change in clinical practice in how best to treat patients with multifactorial risks of cardiovascular events beyond cholesterol management."

    Added Mr. Godin: "With this new recommendation, Vascepa is now included in the treatment guidelines or otherwise recommended for use by 14 major medical associations internationally, solidifying its role as an important treatment option beyond cholesterol management for millions of patients worldwide at risk for a cardiovascular event."

    The icosapent ethyl recommendation was classified as 'Strong Recommendation; High-Quality Evidence' and supported by the results of the REDUCE-IT cardiovascular outcomes study. The Guidelines state: "As icosapent ethyl is a purified form of ethyl EPA, the results of REDUCE-IT cannot be extrapolated to other non-prescription omega-3 fatty acids, which typically contain a mixture of EPA and docosahexaenoic acid ("DHA")".

    The CCS does not provide endorsements or any form of certification for brand name commercial products. Accordingly, the inclusion of icosapent ethyl in the CCS Guidelines should not be understood as an endorsement by CCS of Vascepa.

    The complete 2021 Canadian Cardiovascular Society Guidelines for the Management of Dyslipidemia for the Prevention of Cardiovascular Disease in the Adult addressing Primary and Secondary Prevention of Cardiovascular Diseases with icosapent ethyl published in the Canadian Journal of Cardiology can be accessed online here https://www.onlinecjc.ca/article/S0828-282X(21)00165-3/fulltext (payment/subscription may be needed).

    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, please visit: www.hlstherapeutics.com

    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 17, 2021 and Management's Discussion and Analysis dated March 17, 2021, 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/March2021/29/c6600.html

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    • 28% and 32% significant reductions in first and total strokes, respectively, demonstrated with VASCEPA compared to placebo, as well as reductions in first and total ischemic strokes each by 36%, without increasing hemorrhagic stroke, in statin-treated patients with elevated cardiovascular risk
    • Consistent reductions in overall stroke and in ischemic stroke observed across multiple subgroups
    • Administration of pure icosapent ethyl, VASCEPA, represents a novel clinical approach to stroke reduction

    TORONTO, March 17, 2021 /CNW/ - HLS Therapeutics Inc. ("HLS" or the "Company") (TSX:HLS), a specialty pharmaceutical company focusing on central nervous system and cardiovascular markets, announces the presentation of REDUCE-IT® STROKE at the International…

    • 28% and 32% significant reductions in first and total strokes, respectively, demonstrated with VASCEPA compared to placebo, as well as reductions in first and total ischemic strokes each by 36%, without increasing hemorrhagic stroke, in statin-treated patients with elevated cardiovascular risk
    • Consistent reductions in overall stroke and in ischemic stroke observed across multiple subgroups
    • Administration of pure icosapent ethyl, VASCEPA, represents a novel clinical approach to stroke reduction

    TORONTO, March 17, 2021 /CNW/ - HLS Therapeutics Inc. ("HLS" or the "Company") (TSX:HLS), a specialty pharmaceutical company focusing on central nervous system and cardiovascular markets, announces the presentation of REDUCE-IT® STROKE at the International Stroke Conference 2021, being held virtually from March 17March 19, 2021, adding to the growing body of knowledge on the clinical impact of VASCEPA® (icosapent ethyl). These new analyses supported by Amarin Corporation plc ("Amarin") were presented on behalf of all authors by Deepak L. Bhatt, M.D., M.P.H., Brigham and Women's Hospital, Harvard Medical School, Boston, MA.

    "The REDUCE-IT STROKE analyses provide important data supporting a new approach to prevent strokes using icosapent ethyl in appropriate patients," commented Dr. Deepak L. Bhatt, M.D., M.P.H., Executive Director of Interventional Cardiovascular Programs at Brigham and Women's Hospital, Professor of Medicine at Harvard Medical School, and principal investigator of REDUCE-IT. "The findings of benefit in at-risk patients include significant reductions in overall strokes and in ischemic strokes. Importantly, with respect to safety, we did not observe any significant increase in hemorrhagic stroke. These results further strengthen the case for pure eicosapentaenoic acid (EPA) in the form of prescription icosapent ethyl as a key intervention beyond statins for stroke prevention in studied patients."

    The REDUCE-IT STROKE analyses examined stroke rates across the enrolled patient population (n=8179). Enrolled patients were required to be treated with statins and other conventional therapies, and all patients had either established cardiovascular disease or diabetes and had other cardiovascular risk factors such as elevated triglyceride levels. Event rates for time to first fatal or nonfatal stroke were 2.4% for VASCEPA vs. 3.3% for placebo for a relative risk reduction (RRR) of 28% (p=0.01). Ischemic stroke time to first event rates were 2.0% for VASCEPA vs. 3.0% for placebo for a RRR of 36% (p=0.002). Hemorrhagic stroke occurred at low rates with no significant difference for VASCEPA vs. placebo (0.3% vs 0.2%; p=0.55).

    Stroke is a major and often debilitating cardiovascular event significantly impacting not only patients and their loved ones, but also the healthcare system. Patients with elevated triglycerides despite statin therapy have increased risk for stroke-related events. An estimated 1.6 million Canadians have heart disease or are living with the effects of a stroke, according to the Public Health Agency of Canada. Among seniors, 14.8% of those ages 65 to 74 years report having heart disease, with the proportion climbing to 22.9% over age 75. In this same age group, 7.1% of Canadians report living with the effects of a stroke. There is also concern that cardiovascular disease could increase because of increased prevalence of obesity and diabetes, which are two of its risk factors1.

    "Strokes significantly impact the healthcare system, driving substantial immediate and long-term costs," said Jason Gross, VP Scientific Affairs, HLS. "The subgroup data presented at ISC 2021 provide new insight into the unique potential benefits of VASCEPA administration on alleviating the societal burden of strokes."

    The REDUCE-IT STROKE abstract received the prestigious Paul Dudley White International Scholar Award, recognizing the authors with the highest ranked abstract across the United States at the International Stroke Conference 2021. The esteemed Paul Dudley White Award is named in honor of one of Boston's most revered cardiologists, Dr. Paul Dudley White, who was a founding father of the American Heart Association and an early leader in preventive cardiology.

    REDUCE-IT was designed and powered for the primary composite endpoint, of which stroke was one of five prespecified components; it was not powered for subgroup analysis. Stroke was a prespecified secondary endpoint within the testing hierarchy; ischemic stroke was a prespecified tertiary endpoint; stroke subgroup analyses were post hoc.  No information was collected on stroke related disability, such as Rankin scores.

    Additional information on ISC 2021 can be found here.

    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, please visit: www.hlstherapeutics.com

    REFERENCES

    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 November 4, 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/March2021/17/c5157.html

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