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VASCEPA becomes the aboriginal and alone FDA-approved medication for abbreviation cardiovascular accident aloft cholesterol blurred assay in high-risk patients accustomed for treatment

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DUBLIN, Ireland and BRIDGEWATER, N.J., Dec. 13, 2019 (GLOBE NEWSWIRE) — Amarin Corporation plc (AMRN) today appear that the U.S. Food and Biologic Administration (FDA) has accustomed a new adumbration and characterization amplification for VASCEPA® (icosapent ethyl) capsules. Afterwards added than a decade of development and testing, VASCEPA is now the aboriginal and alone biologic accustomed by the FDA “as an accessory to maximally acceptable statin assay to abate the accident of myocardial infarction, stroke, coronary revascularization, and ambiguous angina astute assay in developed patients with animated triglyceride (TG) levels (≥150 mg/dL) and accustomed cardiovascular ache or diabetes mellitus and two or added added accident factors for cardiovascular disease.” It is estimated that millions of high-risk patients in the United States could account from this one-of-a-kind decree therapy.1

“We at Amarin are aflame and able to now accept the befalling to acquaint VASCEPA as a new FDA-approved assay advantage to abate the assiduous cardiovascular accident that abounding patients face admitting use of statins with added abreast standard-of-care therapies,” said John F. Thero, admiral and arch authoritative administrator of Amarin. “We aim to advice millions of high-risk patients, including statin-treated patients and statin-intolerant patients. For the aboriginal time, physicians, patients and payers accept an FDA-approved assay advantage aloft cholesterol blurred that has been accustomed to decidedly abate aloft adverse cardiovascular contest aback acclimated on top of a statin. We attending advanced to allowance brainwash physicians and patients on the amount of VASCEPA. The broadcast adumbration and accompanying analytic abstraction labeling is broadly worded, advisory on the abounding furnishings of VASCEPA and will empower physicians with analytical advice to advice them administer their analytic acumen in acclamation cardiovascular ache accident for patients in need.”

Amarin reaffirmed its ambition to promptly barrage VASCEPA in the United States for this important new bactericide affliction indication. As ahead disclosed, Amarin angled the admeasurement of its sales force abreast the alpha of 2019 and is on clue to bifold the admeasurement of its sales force afresh to a absolute of 800 sales assembly abreast the alpha of 2020.

“The FDA approval of icosapent ethyl as an accession to statin assay to abate the accident of cardiovascular contest is a aloft anniversary in cardiovascular prevention,” said Deepak L. Bhatt, M.D., M.P.H., authoritative administrator of Interventional Cardiovascular Programs at Brigham and Women’s Hospital, assistant of anesthetic at Harvard Medical School, and beforehand investigator of the REDUCE-IT abstraction which served as the base for the added New Biologic Application to the FDA for VASCEPA. “Nothing this cogent has happened in the apple of cardiovascular blockage aback the accession of statins about three decades ago. Abounding patients angle to account from this celebrated beforehand in care.”

In the all-around REDUCE-IT®cardiovascular outcomes study, about 28 percent of patients in the ascendancy arm advised with statins and added abreast assay but not advised with VASCEPA accomplished a aloft adverse cardiovascular accident (MACE), authentic as the aboriginal accident of either myocardial infarction (heart attack), stroke, coronary revascularization, ambiguous angina astute assay or cardiovascular death.2 As apparent by this MACE occurrence, there is a accumulation of patients who, admitting authoritative their cholesterol on statin therapy, abide to accept a aerial charge for added bactericide cardiovascular care. For those developed patients in this accumulation who accept animated triglycerides (TG) ≥150 mg/dL and accustomed cardiovascular ache or diabetes and two or added added accident factors for cardiovascular disease, VASCEPA is the aboriginal biologic accustomed to advice abate this assiduous cardiovascular risk. In a appear basic assay of the REDUCE-IT study, analytical absolute (first and subsequent) cardiovascular contest over a aeon of about bristles years, patients demography VASCEPA on boilerplate accomplished one beneath MACE per six patients studied, apery a 30 percent accident abridgement in absolute MACE compared to placebo.3   

The all-embracing ante of adverse contest and austere adverse contest in the 5-year REDUCE-IT abstraction were agnate amid VASCEPA-treated patients and placebo-treated patients. As reflected in VASCEPA’s broadcast characterization and declared below, VASCEPA has been associated with added risks of bleeding and atrial fibrillation/flutter, the closing actuality added accustomed in patients with a antecedent history of atrial fibrillation or flutter. It is recommended that patients demography VASCEPA and accessory anticoagulants and/or anti-platelet agents for bleeding be monitored. Additionally acclaimed in the REDUCE-IT abstraction is that patients for whom bleeding and/or atrial fibrillation/flutter were appear appeared to access a agnate abridgement in MACE as patients not advertisement such adverse events. Such allegation are constant with appear after-effects of the study, which acclaimed that the added ante of such adverse contest were low, conspicuously lower than the abridgement in MACE.3  

Recurrent accident analyses were conducted of the absolute primary endpoint contest and absolute key accessory endpoints in REDUCE-IT application a alternation of statistical models and appear in the Journal of the American College of Cardiology. These analyses are not in FDA labeling, were tertiary or basic endpoints; best of the models acclimated were prespecified and one was column hoc. Anniversary alternate accident statistical archetypal has inherent strengths and weaknesses, with no distinct archetypal advised absolute or outperforming the added models, and this is an evolving acreage of science. Nonetheless, after-effects from these analyses are constant aloft the assorted models; they additionally are constant with the aboriginal primary and accessory endpoint results. Together, the REDUCE-IT alternate accident analyses and the aboriginal primary and key accessory endpoint analyses abutment the robustness of the analytic account of VASCEPA assay in abbreviation cardiovascular risk.

Need Is Astute for a Cost-Effective, Preventative-Care Assay Like VASCEPADespite accepted assay options, in the United States, there is one achievement and one affection advance anniversary occurring on boilerplate every 40 seconds, and one cardiovascular afterlife occurring on boilerplate every 38 seconds, or, in accumulated one such cardiovascular accident every 14 seconds.4,5 Cardiovascular ache costs in the United States are in balance of $500 billion anniversary year, authoritative it the nation’s best big-ticket disease.6 The cardinal of cardiovascular deaths is additionally increasing, confined as the No. 1 account of afterlife for men and women in the United States.7 These facts point to an astute charge for added accession in the cardiovascular ache ameliorative area.

Since statin assay was alien about three decades ago, healthcare professionals accept accustomed able bactericide affliction assay options to abate assiduous cardiovascular accident aloft administration of cholesterol. Abounding abeyant solutions bootless to appearance favorable furnishings in cardiovascular outcomes studies. The development of VASCEPA included learnings from these failures and now VASCEPA is the aboriginal and alone biologic to accomplish in abbreviation that accident in the accommodating accumulation included in the new VASCEPA label.    

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Recently, a bloom economics abstraction conducted by an able accumulation presented at the American Affection Association 2019 Accurate Sessions showed that use of VASCEPA offers abeyant amount accumulation for the all-embracing healthcare arrangement (i.e., the amount of VASCEPA is account by amount accumulation from abbreviation the accident of high-cost aloft adverse cardiovascular events).7 This attenuate award follows abstracts from a abstracted absolute biologic appraisement babysitter accumulation that begin VASCEPA amount able for cardiovascular accident reduction, a aftereffect hardly accomplished in this organization’s analyses.8 

Based on the aberrant after-effects of the REDUCE-IT outcomes study, assorted able societies accept adapted guidelines or issued advisories to absorb icosapent ethyl, including the American Diabetes Association,9 the European Society of Cardiology, The European Atherosclerosis Association,10 and the National Lipid Association.11

Today’s appear new adumbration for VASCEPA is incremental to its adumbration for which it was initially FDA approved, as an accessory to diet to abate triglyceride levels in developed patients with astringent (≥500 mg/dL) hypertriglyceridemia. The aftereffect of VASCEPA on the accident for pancreatitis in patients with astringent hypertriglyceridemia has not been determined.

“In accomplishing this broadcast indication, Amarin appreciates the FDA’s advice in the architecture and conduct of assorted analytic trials of VASCEPA aloft the accomplished decade and for its activity in reviewing the after-effects of these studies,” said Steven Ketchum, Ph.D., arch carnality admiral and president, analysis & development and arch accurate officer, Amarin. “Moreover, Amarin is beholden to the bags of patients and analytic sites who alternate in the all-encompassing abstraction of VASCEPA, which exceeded 37,000 patient-years of abstraction in the analytic development program. Amarin additionally acknowledgment its committed advisers and admiral who overcame abounding challenges to accomplish this important life-saving accomplishment.”

Revenue Advice Adapted for 2019 and Provided for 2020 Amarin aftermost adapted its acquirement advice for 2019 in its columnist absolution anachronous July 2, 2019.  Amarin now makes the afterward amend to that advice and issues its aboriginal advice for 2020:

With account to the year catastrophe December 31, 2019, while the year is not yet complete, Amarin increases its advice for absolute net acquirement to a ambit of $410 to $425 million. Prior advice for this aeon accustomed in July 2019 was absolute net acquirement in a ambit of $380 to $420 million. The mean of this new full-year 2019 guidance, $417.5 million, would represent an access of about 82% over abounding year 2018 results.

With account to 2020, Amarin projects that absolute net acquirement will be in a ambit of $650 to $700 million, mostly from sales of VASCEPA in the United States. Amarin is accouterment this projected acquirement advice for 2020 and has based its bump on a cardinal of factors, including, but not bound to, expectations on bazaar accepting of the anew broadcast characterization for VASCEPA and accepted affairs for broadcast promotion. VASCEPA revenues are advancing to abide to access in 2020, accompanied by anniversary industry variability, including alternating melancholia factors, decidedly in the aboriginal quarter. Accustomed that it takes time to brainwash providers and patients, Amarin expects a delayed appulse from planned promotional programs either because they are new, such as the appulse of new sales representatives, or, in the case of direct-to-consumer promotion, because abstracted authoritative approval is appropriate and not currently accepted until  mid-2020. In addition, while assorted studies accept assured that VASCEPA is amount effective, how managed affliction organizations will acknowledge to a cost-effective assay lacks able precedent.

Beyond 2020, Amarin believes that VASCEPA absolute net acquirement will abound to adeptness assorted billions of dollars. However, the history of added therapies for abiding altitude suggests that advance builds over assorted years. At this time, the aggregation is not accouterment advice apropos anniversary acquirement levels aloft 2020.

Conference Alarm and Webcast Information:Amarin will host a appointment alarm Monday, December 16, at 7:30 a.m. ET to altercate this information. The appointment alarm can be heard alive on the broker relations area of the company’s website at www.amarincorp.com, or via blast by dialing 877-407-8033 aural the United States, 201-689-8033 from alfresco the United States, or by application the alarm aback affection at https://bit.ly/35nxY8k. A epitomize of the alarm will be fabricated accessible for a aeon of two weeks afterward the appointment call. To apprehend a epitomize of the call, punch 877-481-4010, PIN: 56897. A epitomize of the alarm will additionally be accessible through the company’s website anon afterwards the call.

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About VASCEPA® (icosapent ethyl) CapsulesVASCEPA (icosapent ethyl) capsules are the first-and-only decree assay accustomed by the FDA comprised alone of the alive ingredient, icosapent ethyl (IPE), a different anatomy of eicosapentaenoic acid. VASCEPA was initially launched in the United States in 2013 based on the drug’s antecedent FDA accustomed adumbration for use as an accessory assay to diet to abate triglyceride levels in developed patients with astringent (≥500 mg/dL) hypertriglyceridemia. Aback launch, VASCEPA has been assigned over eight actor times and is covered by best aloft medical allowance plans. The new, cardiovascular accident adumbration for VASCEPA was accustomed by the FDA in December 2019.

Indications and Limitation of Use

VASCEPA is indicated:

The aftereffect of VASCEPA on the accident for pancreatitis in patients with astringent hypertriglyceridemia has not been determined.

Important Safety Information

Key analytic furnishings of VASCEPA on aloft adverse cardiovascular contest are included in the Analytic Studies area of the prescribing advice for VASCEPA, as set alternating below:

Effect of VASCEPA on Time to Aboriginal Accident of Cardiovascular Contest in Patients with Animated Triglyceride Levels and Added Accident Factors for Cardiovascular Ache in REDUCE-IT

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

About AmarinAmarin Corporation plc. is a rapidly growing, avant-garde biologic aggregation focused on developing and commercializing analysis to cost-effectively advance cardiovascular health. Amarin’s beforehand product, VASCEPA® (icosapent ethyl), is accessible by decree in the United States, Lebanon and the United Arab Emirates. Amarin, calm with its bartering ally in baddest geographies, is advancing added authoritative approvals for VASCEPA in Canada, China, the European Union and the Middle East. For added advice about Amarin, appointment www.amarincorp.com.

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Forward-Looking StatementsThis columnist absolution contains advanced statements, including expectations apropos bartering amplification and the use of VASCEPA to potentially advice millions of patients, acquirement and decree growth, including adapted acquirement advice for 2019 and advice for 2020 and beyond; sales force amplification and business initiatives accepted in 2019 and beyond; managed affliction acceptance; the account and believability of REDUCE-IT after-effects and amount capability data. These advanced statements are not promises or guarantees and absorb abundant risks and uncertainties. In addition, Amarin’s adeptness to finer commercialize VASCEPA will depend in allotment on its adeptness to abide to finer accounts its business, efforts of third parties, its adeptness to accretion authoritative approvals, actualize bazaar appeal for VASCEPA through education, business and sales activities, to accomplish bazaar accepting of VASCEPA, to accept able levels of agreement from third-party payers, to advance and advance a constant antecedent of bartering accumulation at a aggressive price, to accede with acknowledged and authoritative requirements in affiliation with the auction and advance of VASCEPA and to advance apparent aegis for VASCEPA. Among the factors that could account absolute after-effects to alter materially from those declared or projected herein accommodate the following: uncertainties associated about with accepting of analytic balloon after-effects and accompanying authoritative approvals; the accident that sales may not accommodated expectations and accompanying amount may access aloft expectations; the accident that patents may not be upheld in apparent action and applications may not aftereffect in issued patents acceptable to assure the VASCEPA franchise. A added account and description of these risks, uncertainties and added risks associated with an advance in Amarin can be begin in Amarin’s filings with the U.S. Securities and Exchange Commission, including its best contempo anniversary abode on Anatomy 10-Q. Existing and -to-be investors are cautioned not to abode disproportionate assurance on these advanced statements, which allege alone as of the date hereof. Amarin undertakes no obligation to amend or alter the advice independent in this columnist release, whether as a aftereffect of new information, approaching contest or affairs or otherwise.

Availability of Added Advice About AmarinInvestors and others should agenda that Amarin communicates with its investors and the accessible application the aggregation website (www.amarincorp.com), the broker relations website (investor.amarincorp.com), including but not bound to broker presentations and broker FAQs, Securities and Exchange Commission filings, columnist releases, accessible appointment calls and webcasts. The advice that Amarin posts on these channels and websites could be accounted to be actual information. As a result, Amarin encourages investors, the media, and others absorbed in Amarin to analysis the advice that is acquaint on these channels, including the broker relations website, on a approved basis. This account of channels may be adapted from time to time on Amarin’s broker relations website and may accommodate amusing media channels. The capacity of Amarin’s website or these channels, or any added website that may be accessed from its website or these channels, shall not be accounted congenital by advertence in any filing beneath the Securities Act of 1933.

Amarin Acquaintance InformationInvestor Inquiries:Elisabeth SchwartzInvestor RelationsAmarin Corporation plcIn U.S.: 1 (908) 719-1315 [email protected]

Lee M. SternSolebury TroutIn U.S.: 1 (646) 378-2992 [email protected]

Media Inquiries:Gwen Fisher Corporate Communications Amarin Corporation plcIn U.S.: 1 (908) 325-0735 [email protected]

(Note for reporters: if you crave added assets to accompany your stories, including artefact photos or b-roll, amuse acquaintance Gwen Fisher at the aloft email address.)

References

1Fan W, Philip S, Toth PP, et al. Prevalence of United States adults with triglycerides ≥ 135 mg/dL: NHANES 2007–2014. Cardiol J. 2019;26(5). DOI: 10.5603/CJ.2019.0000.2Bhatt DL, Steg PG, Miller M, et al. Cardiovascular Accident Abridgement with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med 2019;380:11-22.3 Bhatt DL, Steg PG, Miller M, et al. Furnishings of Icosapent Ethyl on Absolute Ischemic Events: From REDUCE-IT. J Am Coll Cardiol 2019; 73:2791-2802.4American Affection Association: Affection Ache and Achievement Statistics — 2019 At-a-Glance.5American Affection Association. Affection Ache and Achievement Statistics – 2019 Update: A Abode from the American Affection Association. Appear January 31, 2019.6American Affection Association. 2017. Cardiovascular disease: A cher accountability for America projections through 2035.7Cost-Effectiveness of Icosapent Ethyl in REDUCE-IT. https://www.abstractsonline.com/pp8/#!/7891/presentation/35097.8https://icer-review.org/wp-content/uploads/2019/02/ICER_CVD_Final_Evidence_Report_10.17.19.pdf.9American Diabetes Association. [web annotation]. Diabetes Affliction 2019;42(Suppl.1):S103–S123.10Mach F, Baigent C, Catapano AL, et al. 2019 ESC/EAS Guidelines for the administration of dyslipidaemias: lipid modification to abate cardiovascular risk. Eur Affection J. 2019; ehz455. doi: 10.1093/eurheartj/ehz455.11 Orringer CE, Jacobson TA, Maki KC. National Lipid Association accurate account on the use of icosapent ethyl in statin-treated patients with animated triglycerides and high- or very-high ASCVD risk. J Clin Lipidol. 2019. doi: 10.1016/j.jacl.2019.10.014.

 

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