Amarin Announces CEO Succession Plan
John Thero to Retire as President and CEO on August 1, 2021 Board Appoints Karim Mikhail, Current SVP and Head of Commercial for Europe, as Successor DUBLIN, Ireland and BRIDGEWATER, N.J., April 12, 2021 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN) as we speak introduced that John F. Thero, 60, has knowledgeable the board of administrators of his plan to retire as president and chief government officer, efficient August 1, 2021. He may even step down from the board at the moment. The board has appointed Karim Mikhail, 50, Amarin’s senior vp and head of economic for Europe, to succeed Mr. Thero as the firm’s subsequent president and chief government officer. Mr. Mikhail will be a part of the board upon his efficient date. Mr. Thero will proceed to supply his steering and experience to the firm in an advisory capability by way of the finish of 2021. Mr. Mikhail joined Amarin in 2020 from THEODON, a worldwide business technique consultancy he based in 2018. Prior to this, Mr. Mikhail spent greater than 20 years at Merck, the place from 2014 to 2018 he served as world business chief for Merck’s $Four billion lipid franchise, overseeing P&L and main the worldwide launch of ezetimibe with the IMPROVE-IT examine indication. In this function, he was accountable for reversing the enterprise’ decline in the U.S. market and globally, accelerating income by an extra $380 million by way of the launch of ATOZET and driving EBITDA progress by way of worldwide growth. Prior to that, Mr. Mikhail led the profitable business launch of dozens of merchandise, together with ezetimibe and numerous molecules in diabetes, hypertension, immunology, and oncology, and served as Merck’s chief advertising officer for Europe, Middle East and Africa and chief working officer for rising markets. At Amarin, Mr. Mikhail has been accountable for making ready commercialization of the firm’s lead product in Europe, for which regulatory approval was acquired on March 30, 2021. Dr. Lars Ekman, Chairman of Amarin’s Board of Directors, commented, “After 12 years at Amarin, and the final seven as CEO, John has determined now could be the proper time to announce his retirement. We owe monumental gratitude to John as underneath his management roles, with the assist of the complete Amarin group, the firm has accomplished a number of profitable medical trials, launched its lead product VASCEPA® (icosapent ethyl) in the United States, and has initiated its worldwide growth plans, together with commercialization in Europe following the latest advertising authorization of VAZKEPA from the European Commission. John and the complete board have taken a considerate strategy to succession planning designed to make sure that Amarin is greatest positioned to each proceed its progress in the United States and speed up its progress trajectory globally. The board has been more and more impressed with Karim’s strategic and operational capabilities, and his clear ardour for VASCEPA and imaginative and prescient for persevering with Amarin’s progress worldwide make him the clear option to succeed John. We sit up for an thrilling new chapter for the extremely succesful Amarin group underneath Karim’s management.” “While saying my retirement is a bittersweet second for me, I’ve each confidence in Amarin and its excellent staff who’re devoted to the sufferers and shareholders we serve,” mentioned Mr. Thero. “2021 is a pivotal 12 months for Amarin as we proceed to develop markets for our necessary drug, VASCEPA. As the first-and-only drug authorized by every of the U.S. FDA, European Commission, and Health Canada for remedy of the studied high-risk sufferers with persistent cardiovascular danger after statin remedy, we’re happy with our function in ushering in a brand new period in cardiovascular care. With our distinctive therapeutic resolution and deep bench of inside expertise, I imagine that now is a perfect time to transition management to Karim as we work to appreciate Amarin’s full potential. Since Karim joined Amarin final 12 months, he has confirmed himself to be a useful member of the management group and a real companion to me as we put together for the commercialization of VAZKEPA in Europe. I’m excited to proceed working carefully with him and the board to facilitate a profitable transition over the coming months.” Mr. Mikhail said, “I joined Amarin final 12 months as a result of I used to be impressed by the firm’s entrepreneurial spirit in addressing such a big unmet medical want and the potential to set a brand new customary of cardiovascular care. I’m honored to tackle this new function. We have an unparalleled product with excellent proof, optimistic efficacy and security profile, and great momentum with our near-term European launch plans and anticipated business approval in China close the finish of 2021. Amarin’s group is first fee and I’m excited to construct upon the robust business progress in the United States. I sit up for working with John, the board and the complete Amarin group as we seize the vital progress alternatives forward.” About Karim Mikhail Mr. Mikhail, 50, joined Amarin in July 2020, and presently serves as senior vp and head of economic for Europe the place he has duty for the firm’s commercialization of VAZKEPA in Europe. He was beforehand with Merck for 22 years, in seven completely different international locations, spanning three continents, the place he held positions of accelerating duty, together with as world business chief for Merck’s $Four billion lipid franchise and chief advertising officer for Europe, Middle East and Africa and chief working officer for rising markets. Mr. Mikhail led THEODON, a worldwide business technique consultancy he based in 2018. Mr. Mikhail is a pharmacist by coaching and holds a grasp’s diploma in biopharmaceutical advertising and administration from the graduate college of enterprise in Paris, École Supérieure de Commerce de Paris (ESCP). About Amarin Amarin is an revolutionary pharmaceutical firm main a brand new paradigm in heart problems administration. From our scientific analysis basis to our deal with medical trials, and now our business growth, we’re evolving and rising quickly. Amarin has workplaces in Bridgewater, New Jersey in the United States, Dublin in Ireland, and Zug in Switzerland in addition to business companions and suppliers round the world. We are dedicated to rethinking cardiovascular danger by way of the development of scientific understanding of the influence on society of great residual danger that exists past conventional therapies, reminiscent of statins for ldl cholesterol administration. About Cardiovascular RiskCardiovascular illness is the primary reason for demise in the world. In the United States alone, heart problems ends in 859,000 deaths per 12 months.1 And the variety of deaths in the United States attributed to heart problems continues to rise. In addition, in the United States there are 605,000 new and 200,000 recurrent coronary heart assaults per 12 months (roughly 1 each 40 seconds). Stroke charges are 795,000 per 12 months (roughly 1 each 40 seconds), accounting for 1 of each 19 U.S. deaths. In combination, in the United States alone, there are greater than 2.Four million main antagonistic cardiovascular occasions per 12 months from heart problems or, on common, 1 each 13 seconds. Controlling unhealthy ldl cholesterol, also referred to as LDL-C, is one strategy to cut back a affected person’s danger for cardiovascular occasions, reminiscent of coronary heart assault, stroke or demise. However, even with the achievement of goal LDL-C ranges, hundreds of thousands of sufferers nonetheless have vital and protracted danger of cardiovascular occasions, particularly these sufferers with elevated triglycerides. Statin remedy has been proven to manage LDL-C, thereby lowering the danger of cardiovascular occasions by 25-35%.2 Significant cardiovascular danger stays after statin remedy. People with elevated triglycerides have 35% extra cardiovascular occasions in comparison with individuals with regular (in vary) triglycerides taking statins.3,4,5 About REDUCE-IT®REDUCE-IT was a worldwide cardiovascular outcomes examine designed to judge the impact of VASCEPA in grownup sufferers with LDL-C managed to between 41-100 mg/dL (median baseline 75 mg/dL) by statin remedy and numerous cardiovascular danger components together with persistent elevated triglycerides between 135-499 mg/dL (median baseline 216 mg/dL) and both established heart problems (secondary prevention cohort) or diabetes mellitus and no less than one different cardiovascular danger issue (main prevention cohort). REDUCE-IT, carried out over seven years and accomplished in 2018, adopted 8,179 sufferers at over 400 medical websites in 11 international locations with the largest variety of websites situated inside the United States. REDUCE-IT was carried out based mostly on a particular protocol evaluation settlement with FDA. The design of the REDUCE-IT examine was printed in March 2017 in Clinical Cardiology.6 The main outcomes of REDUCE-IT had been printed in The New England Journal of Medicine in November 2018.7 The whole occasions outcomes of REDUCE-IT had been printed in the Journal of the American College of Cardiology in March 2019.8 These and different publications will be present in the R&D part on the firm’s web site at www.amarincorp.com. About VASCEPA® (icosapent ethyl) CapsulesVASCEPA (icosapent ethyl) capsules are the first-and-only prescription remedy authorized by the U.S. Food and Drug Administration (FDA) comprised solely of the lively ingredient, icosapent ethyl (IPE), a singular type of eicosapentaenoic acid. VASCEPA was launched in the United States in January 2020 as the first and solely drug authorized by the U.S. FDA for remedy of the studied high-risk sufferers with persistent cardiovascular danger after statin remedy. VASCEPA was initially launched in the United States in 2013 based mostly on the drug’s preliminary FDA authorized indication to be used as an adjunct remedy to weight loss program to scale back triglyceride ranges in grownup sufferers with extreme (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed over ten million instances. VASCEPA is roofed by most main medical insurance policy. In addition to the United States, VASCEPA is authorized and bought in Canada, Lebanon and the United Arab Emirates. In Europe, in March 2021 advertising authorization was granted to icosapent ethyl in the European Union for the discount of danger of cardiovascular occasions in sufferers at excessive cardiovascular danger, underneath the model identify VAZKEPA. Indications and Limitation of Use (in the United States)VASCEPA is indicated: As an adjunct to maximally tolerated statin remedy to scale back the danger of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in grownup sufferers with elevated triglyceride (TG) ranges (≥ 150 mg/dL) and established heart problems ordiabetes mellitus and two or extra extra danger components for heart problems. As an adjunct to weight loss program to scale back TG ranges in grownup sufferers with extreme (≥ 500 mg/dL) hypertriglyceridemia. The impact of VASCEPA on the danger for pancreatitis in sufferers with extreme hypertriglyceridemia has not been decided. Important Safety Information VASCEPA is contraindicated in sufferers with recognized hypersensitivity (e.g., anaphylactic response) to VASCEPA or any of its elements.VASCEPA was related with an elevated danger (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was higher in sufferers with a earlier historical past of atrial fibrillation or atrial flutter.It isn’t recognized whether or not sufferers with allergic reactions to fish and/or shellfish are at an elevated danger of an allergic response to VASCEPA. Patients with such allergic reactions ought to discontinue VASCEPA if any reactions happen.VASCEPA was related with an elevated danger (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was higher in sufferers receiving concomitant antithrombotic medicines, reminiscent of aspirin, clopidogrel or warfarin.Common antagonistic reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% extra frequent than placebo): musculoskeletal ache (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).Common antagonistic reactions in the hypertriglyceridemia trials (incidence >1% extra frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal ache (1% vs 0.3%).Adverse occasions could also 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 brokers must be monitored for bleeding. Key medical results of VASCEPA on main antagonistic cardiovascular occasions are included in the Clinical Studies part of the prescribing data for VASCEPA as set forth beneath: Effect of VASCEPA on Time to First Occurrence of Cardiovascular Events in Patients with Elevated Triglyceride ranges and Other Risk Factors for Cardiovascular Disease in REDUCE-IT VASCEPAPlaceboVASCEPA vs PlaceboN = 4089n (%)Incidence Rate (per 100 affected person years)N = 4090n (%)Incidence Rate (per 100 affected person years)Hazard Ratio (95% CI)Primary composite endpointCardiovascular demise, 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 endpointCardiovascular demise, myocardial infarction, stroke (3-point MACE)459(11.2)2.7606(14.8)3.70.74(0.65, 0.83)Other secondary endpointsFatal or non-fatal myocardial infarction250(6.1)1.5355(8.7)2.10.69(0.58, 0.81)Emergent or pressing coronary revascularization216(5.3)1.3321(7.8)1.90.65(0.55, 0.78)Cardiovascular demise 174(4.3)1.0213(5.2)1.20.80(0.66, 0.98)Hospitalization for unstable angina 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) Includes adjudicated cardiovascular deaths and deaths of undetermined causality. Determined to be attributable to 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 StatementsThis press launch incorporates forward-looking statements, together with statements about expectations for continued firm progress in the United States and accelerated progress trajectory globally, anticipated regulatory approvals and – timing and a clean administration transition. These forward-looking statements are usually not guarantees or ensures and contain substantial dangers and uncertainties that will individually or collectively influence the issues herein and trigger precise outcomes, occasions and efficiency to vary materially from such ahead seeking statements. Among the components that would trigger precise outcomes to vary materially from these described or projected herein embrace the following: occasions that would influence future regulatory evaluation, reminiscent of delays on account of COVID-19 restrictions, later arising information, regulatory opinions and pricing assessments, and the profitable implementation of commercialization plans or different data, uncertainties related with litigation typically and patent litigation particularly; Amarin’s capacity typically to take care of sufficient patent safety and efficiently implement patent claims towards third events; and uncertainties related typically with analysis and improvement and regulatory submissions, opinions, motion dates and approvals. An extra record and outline of those dangers, uncertainties and different dangers related with an funding in Amarin will be present in Amarin’s filings with the U.S. Securities and Exchange Commission, together with its most up-to-date annual report on Form 10-K. Existing and potential traders are cautioned to not place undue reliance on these forward-looking statements, which converse solely as of the date hereof. Amarin undertakes no obligation to replace or revise the data contained on this press launch, whether or not because of new data, future occasions or circumstances or in any other case. Amarin’s forward-looking statements don’t replicate the potential influence of great transactions the firm could enter into, reminiscent of mergers, acquisitions, tendencies, joint ventures or any materials agreements that Amarin could enter into, amend or terminate. Availability of Other Information About AmarinInvestors and others ought to observe that Amarin communicates with its traders and the public utilizing the firm web site (www.amarincorp.com), the investor relations web site (investor.amarincorp.com), together with however not restricted to investor displays and investor FAQs, Securities and Exchange Commission filings, press releases, public convention calls and webcasts. The data that Amarin posts on these channels and web sites may very well be deemed to be materials data. As a outcome, Amarin encourages traders, the media, and others thinking about Amarin to assessment the data that’s posted on these channels, together with the investor relations web site, regularly. This record of channels could also be up to date now and again on Amarin’s investor relations web site and will embrace social media channels. The contents of Amarin’s web site or these channels, or every other web site that could be accessed from its web site or these channels, shall not be deemed included by reference in any submitting underneath the Securities Act of 1933. Amarin Contact InformationInvestor Inquiries:Investor RelationsAmarin Corporation plcIn U.S.: +1 (908) 719-1315 IR@amarincorp.com (investor inquiries) Solebury Troutamarinir@troutgroup.com Media Inquiries:CommunicationsAmarin Corporation plcIn U.S.: +1 (908) 892-2028 PR@amarincorp.com (media inquiries) AMARIN, REDUCE-IT, VASCEPA and VAZKEPA are emblems of Amarin Pharmaceuticals Ireland Limited. VAZKEPA is a registered trademark in Europe and different international locations and areas and is pending registration in the United States. 1 American Heart Association. Heart Disease and Stroke Statistics—2020 Update: A Report From the American HeartAssociation. Circulation. 2020;141:e139–e596. 2 Ganda OP, Bhatt DL, Mason RP, et al. Unmet want for adjunctive dyslipidemia remedy in hypertriglyceridemiamanagement. J Am Coll Cardiol. 2018;72(3):330-343.3 Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of heart problems. Am J Cardiol.2016;118:138-145.4 Toth PP, Granowitz C, Hull M, et al. High triglycerides are related with elevated cardiovascular occasions, medical prices,and useful resource use: An actual-world administrative claims evaluation of statin-treated sufferers with excessive residual cardiovascularrisk. J Am Heart Assoc. 2018;7(15):e008740.5 Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic heart problems – New insights fromepidemiology, 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. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019;380(1):11-22.8 Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Reduction in first and whole ischemic occasions with icosapent ethyl throughout baseline triglyceride tertiles. J Am Coll Cardiol. 2019;74:1159-1161.