Epidemiological studies suggest that consumption of omega-3 polyunsaturated fatty acids (n-3 PUFAs) derived from fish oil, mainly consisting of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), is associated with lower cardiovascular risk. However, interventional clinical trials aimed at reducing cardiovascular incidents by n-3 PUFAs supplementations have yielded inconsistent results. An intriguing fact is that only the outcome trials using EPA, but not those testing EPA/DHA mixed regimens, showed beneficial results. This discrepancy begs the question of whether EPA and DHA have differential effects and whether DHA blunts the cardiovascular benefits of EPA. However, no head-to-head clinical trial comparison of the biological effects of EPA and DHA in the hyperlipidemia patients has been reported. Hence, a well-designed, controlled, proof-of-concept clinical study testing EPA versus DHA in a relevant population is urgently required. In this study, the human subjects with atherogenic dyslipidemia will be randomized to dietary supplementation with four grams of either EPA or DHA n-3 PUFAs for eight weeks. At baseline and after the supplementation, various markers of thrombogenesis will be assessed, including biomarkers of the clotting cascade, thromboelastography, urinary thromboxane metabolites, whole blood aggregation, platelet aggregation, and flow cytometry analysis of platelets and platelet-leukocyte aggregates will also be performed.

Start Date01 Aug 2024

Sponsor / Collaborator

The Miriam Hospital

[+1]

CTRI/2023/01/049031 / CompletedPhase 1

A Single Dose, Double-Blind, Two-Period, Two Sequence, Crossover Comparative Pharmacokinetic Study of DRL_DA, and EU approved Reference Medicinal Product (Aranesp®), Administered by the Intravenous Route to Male Healthy Volunteers

Start Date15 Feb 2023

Sponsor / Collaborator

Dr. Reddy's Laboratories Ltd.

IRCT20170608034390N9 / SuspendedPhase 3IIT

Evaluation of the efficacy of eicosapentaenoic acid in patients with chronic migraine headache; a randomized controlled trial

Start Date22 Jun 2022

Sponsor / Collaborator

Shahid Beheshti University of Medical Sciences

100 Clinical Results associated with Eicosapentaenoic acid

100 Translational Medicine associated with Eicosapentaenoic acid

100 Patents (Medical) associated with Eicosapentaenoic acid

13,506

Literatures (Medical) associated with Eicosapentaenoic acid

01 Feb 2025·Food Chemistry

The pasture system improves natural antioxidants and functional lipids while reducing lipid peroxidation in Ctenopharyngodon idella (grass carp) burgers during storage

Article

Author: Montenegro Gallazzi, L.F. ; Rizzo, S A ; Rizzo, S.A. ; Descalzo, A.M. ; Pérez, C.D. ; Rossetti, L. ; Pérez, C D ; Cunzolo, S. ; Descalzo, A M ; Cunzolo, S ; Rossetti, L ; Montenegro Gallazzi, L F

C. idella burgers made from a pasture-based system provide a natural method for producing high-quality fish products, resulting in meat enriched with polyunsaturated fatty acids, particularly EPA and DHA, as well as fat-soluble vitamins and antioxidants. In this study, C. idella meat burgers were made from two types of diets: pasture-based (PS) and grain-based (GS). A total of 36 burgers were stored in plastic trays (three burgers per tray; 12 trays per group), in a refrigeration chamber at 4 °C ± 0.1 °C for 120 h to conduct a shelf-life experiment comparing the meats. Initial fatty acid profile and nutritional composition were determined at 0 h. Additionally, fat-soluble vitamins, antioxidants, TBA, and FRAP were measured at 0, 24, 48, 72, 96, and 120 h. PS burgers exhibited higher concentrations of n-3 LC-PUFAs, vitamins, antioxidants, except for gamma-tocopherol, and FRAP than GS burgers (P < 0.05), while GS burgers had higher TBA and γ-tocopherol (P < 0.05). Both burgers experienced vitamin reduction during storage, with PS burgers maintaining higher concentrations. Vitamin decline correlated with increased oxidation (TBA) in both burger types. These results suggest that pasture-fed burgers have longer shelf life than GS burgers due to reduced oxidation and enhanced stability of bioactive compounds.

01 Jan 2025·Brain, Behavior, and Immunity

Chemogenetic targeting TRPV1 in obesity-induced depression: Unveiling therapeutic potential of eicosapentaenoic acid and acupuncture

Article

Author: Zailani, Halliru ; Liu, Wen-Chun ; Cheng, Szu-Wei ; Hung, Mien-Chie ; Wu, Suet-Kei ; Lin, Yi-Wen ; Su, Kuan-Pin

The comorbidity of obesity and depression has major public health impacts, highlighting the need to understand their shared mechanisms. This study explored the connection between obesity and depression through the transient receptor potential V1 (TRPV1) signaling pathway, using obese/depressed murine models and clinical data. Mice fed a high-fat diet showed altered TRPV1 pathway expression in brain regions of the mice: downregulated in the medial prefrontal cortex (mPFC) and hippocampus, and upregulated in the hypothalamus and amygdala, influencing depression-like behaviors and inflammation. Treatments like eicosapentaenoic acid (EPA) and acupoint catgut embedding (ACE) reversed these effects, similar to observations in Trpv1^-/- mice. Furthermore, chemogenetic activation in the ventral mPFC also alleviated depression via TRPV1. In our clinical validation, single nucleotide polymorphisms (SNPs) in TRPV1-related genes (PIK3C2A and PRKCA) were linked to interferon-induced depression. These findings underscore the potential of targeting TRPV1 as a therapeutic approach for obesity-related depression.

01 Jan 2025·Food Chemistry

Enrichment of EPA and DHA in glycerides by selective enzymatic ethanolysis

Article

Author: Fu, Yijie ; Wang, Xiaosan ; Li, Zongrun ; Bao, Weijia ; Tang, Xiao ; Yu, Junwen ; Wang, Xiaowen

It has been reported that eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in glycerides have various biological functions. This study presents an effective method for enriching glycerides rich in EPA and DHA through lipase-catalyzed alcoholysis. The results showed that Eversa® Transform 2.0 had the strongest discrimination against DHA and EPA in alcoholysis, which was verified by molecular docking. Additionally, selectivity of the lipase and ratio of DHA and EPA in glyceride products were significantly affected by alcohol type. Under the optimal conditions, the contents of EPA and DHA in glycerides after ethanolysis reached 12.91 % and 55.40 %, respectively, with a DHA yield of 79.22 %. In this study, an interesting finding was that Eversa® Transform 2.0 could effectively differentiate EPA and DHA during alcoholysis to allow us to prepare DHA-enriched glycerides and EPA-enriched ethyl esters after removing saturated and monounsaturated ethyl esters.

News (Medical) associated with Eicosapentaenoic acid

30 Oct 2024

·www.globenewswire.com

Amarin Reports Third Quarter 2024 Financial Results and Provides Business Update

-- Strong Cash Position of $306 Million; 9th Consecutive Quarter of Positive or Neutral Cash Balance ---- Total Net Revenue of $42 Million Represents Continued Source of Cash from the U.S., RoW Partnerships and Early Phases of European Launches ---- Positive European Momentum Continues with Progress from Pricing & Reimbursement Efforts and Incremental Revenue Growth Driven Primarily by Spain and the UK ---- Company to Host Virtual Analyst & Investor Day November 14 ---- Company Remains Committed to Maintaining Public Listing – DUBLIN and BRIDGEWATER, N.J., Oct. 30, 2024 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ: AMRN), today reported financial results for the third quarter ended September 30, 2024, and provided a business update. At Amarin, the company’s product -- VASCEPA®/VAZKEPA® (icosapent ethyl) -- has significant growth and value potential globally. This continues to be validated by progress around the world. During the quarter, VAZKEPA sales grew 19% sequentially in Europe, driven primarily by Spain and the UK. Notably, in Italy, the Company has taken additional steps with the Italian authorities and hopes to be in a position to share news soon. In the U.S., the Company has maintained +50% share of the IPE market through the third quarter. As a result, the U.S. business has continued to generate significant cash representing +$300M consistently over the last nine quarters, all in the face of ongoing generic competition. Additionally, the Company continues to assess the potential optimal timing for an authorized generic launch. Commenting on the Company and its third quarter results, Aaron Berg, Amarin’s President and CEO stated, “While we and our global partners continue to execute on our multipronged global strategy focused on getting VASCEPA/VAZKEPA into the hands of as many patients as possible, the senior leadership team and I, as well as the Board of Directors, remain committed to evaluating all opportunities to maximize the value and impact of this highly impactful product. To that end, we look forward to highlighting the global opportunity for VASCEPA/VAZKEPA and to hear directly from both prescribers and select partners from around the world on the impact of VASCEPA/VAZKEPA during our upcoming virtual Analyst and Investor Day on November 14.” Continuing, Berg said, “We remain fully committed to our public listing – it is very important for us as well as our shareholders. In addition to continuing to drive the business, there are a number of paths available to us to resolve the issue.” Third Quarter Operational Highlights Amarin continued to advance pricing and reimbursement efforts across additional European and Rest of World (RoW) markets, including: In Italy, realized further progress with the pricing and reimbursement authorities, and the Company hopes to be able to share further updates soon.In Portugal, secured national reimbursement for VAZKEPA.In Australia, in collaboration with our partner CSL Seqirus, secured national reimbursement for VAZKEPA in Australia, where CSL is now launching the product. Investigators presented new subgroup data from the landmark REDUCE-IT® cardiovascular outcomes trial with VASCEPA/VAZKEPA, as well as abstracts showcasing the mechanistic activity of eicosapentaenoic acid (EPA) at the European Society of Cardiology (ESC) Congress.Investigators presented new research on the clinical impact of VASCEPA/VAZKEPA in patients with diabetes and high cardiovascular risk and the anti-Lp(a) oxidation mechanistic effects of eicosapentaenoic acid (EPA) at the 60th Annual European Association for the Study of Diabetes (EASD) Meeting. Financial Update Financial Highlights ($ in millions)Three months ended September 30, 2024Three months ended September 30, 2023% ChangeTotal Net Revenue$42.3$66.1-36%Operating Expenses1$41.4$50.5-18%Cash$305.7$320.7-5% 1 – Excludes restructuring expense of $0.7 million in the 3 months ended September 30, 2023 Total net revenue for the three months ended September 30, 2024 was $42.3 million, compared to $66.1 million in the corresponding period of 2023, a decrease of 36%. Net product revenue for the three months ended September 30, 2024 was $41.9 million, compared to $64.9 million in the corresponding period of 2023, a decrease of 36%. This decrease was driven primarily by an impact in net selling price due to US generic competition as well as a decrease in volume primarily related to CVS moving from an exclusive account to no longer covering VASCEPA. U.S. net product revenue was $30.6 million for the three months ended September 30, 2024 compared to $62.4 million in the corresponding period of 2023. For the three months ended September 30, 2024, European net product revenue was $4.3 million and Rest of World (RoW) net product revenue was $6.9 million, compared to $0.8 million and $1.8 million, respectively in the corresponding period in 2023. Cost of goods sold for the three months ended September 30, 2024 was $26.0 million, compared to $36.2 million in the corresponding period of 2023. Overall gross margin on net product revenue for the three months ended September 30, 2024 and 2023 was 38% and 44%, respectively. Excluding the inventory restructuring charge in Q3 2023 gross margin was 64%. Selling, general and administrative expenses for the three months ended September 30, 2024 was $36.9 million, compared to $45.5 million in the corresponding period of 2023. This decrease was primarily due to cost optimization efforts across the business. Research and development expenses for the three months ended September 30, 2024 were $4.5 million, compared to $5.1 million in the corresponding period of 2023. Under U.S. GAAP, the Company reported net loss of $25.1 million for the three months ended September 30, 2024, or basic and diluted loss per share of $0.06. This net loss includes $4.7 million in non-cash stock-based compensation. For the three months ended September 30, 2023, the Company reported net loss of $19.3 million, or basic and diluted loss per share of $0.05. This net loss included $4.6 million in non-cash stock-based compensation expense. Excluding non-cash stock-based compensation expense and restructuring expense, non-GAAP adjusted net loss was $20.4 million for the three months ended September 30, 2024 or non-GAAP adjusted basic and diluted loss per share of $0.05, compared with non-GAAP adjusted net loss of $1.3 million for the three months ended September 30, 2023 or non-GAAP adjusted basic and diluted loss per share of $0.00. As of September 30, 2024, the Company reported aggregate cash and investments of $305.7 million, which includes receipt of the $15 million EDDING CVRR milestone payment in the quarter, compared to aggregate cash and investment of $306.7 million as of June 30, 2024. 2024 Financial Outlook The Company is committed to executing against the significant opportunity in Europe. The Company is focused on maintaining market share in the U.S. and maximizing cash generation from the attractive and growing Rest of World (RoW) income stream. The Company continues to make progress on reducing operating expenses and managing its cash position, including $10 million of operating expense savings in the third quarter of 2024 compared to the third quarter of 2023. The Company reaffirms its belief that current cash and investments and other assets are adequate to support continuing operations for the foreseeable future. Virtual Analyst & Investor Day 2024 – November 14 Amarin will host a virtual analyst and investor day on Thursday, November 14, 2024, from 8:00 AM EST to 10:00 AM EST. The event will be hosted by members of the Amarin senior management team and will focus on updating the investment community on the current state of the VASCEPA/VAZKEPA franchise, with particular attention given to discussions on the dynamics of key geographies that represent the future value of the franchise, including Europe. In addition, a dedicated question and answer session will be held during which the Amarin senior management team will entertain questions submitted in advance to investor.relations@amarincorp.com. As a virtual event, the program will be webcast and archived for future reference and will be open to all participants; participation will require a simple registration step before joining, which will be available through the Company website prior to this event. Throughout the event, there will be no live interaction with audience participants. Q3 2024 Earnings Conference Call and Webcast Information Amarin will host a conference call on October 30, 2024, at 5:00 p.m. ET to discuss this information. The conference call can be accessed on the investor relations section of the company's website at www.amarincorp.com, or via telephone by dialing 888-506-0062 within the United States, 973-528-0011 from outside the United States, and referencing conference ID 732244. A replay of the call will be made available for a period of two weeks following the conference call. To listen to a replay of the call, dial 877-481-4010 from within the United States and 919-882-2331 from outside of the United States, and reference conference ID 51361. A replay of the call will also be available through the company's website shortly after the call. About AmarinAmarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. We are committed to increasing the scientific understanding of the cardiovascular risk that persists beyond traditional therapies and advancing the treatment of that risk for patients worldwide. Amarin has offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, Zug in Switzerland, and other countries in Europe as well as commercial partners and suppliers around the world. About VASCEPA®/VAZKEPA® (icosapent ethyl) Capsules VASCEPA (icosapent ethyl) capsules are the first 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 drug approved by the U.S. FDA for the treatment of high-risk patients with persistent cardiovascular risk despite being on 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 more than twenty-five million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, VASCEPA is approved and sold in Canada, China, Australia, Lebanon, the United Arab Emirates, Kuwait, Saudi Arabia, Qatar and Bahrain. In Europe, in March 2021 marketing authorization was granted via a centralized procedure for 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. VAZKEPA (icosapent ethyl) is currently sold in Europe in Sweden, Finland, Austria, the UK (including England, Wales & Scotland and Northern Ireland), Spain, Portugal, Greece and the Netherlands. In April 2021 marketing authorization for VAZKEPA (icosapent ethyl) was granted in Great Britain (applying to England, Scotland, Wales and Northern Ireland). United States Indications and Limitation of Use VASCEPA is indicated: As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease. As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. Important Safety Information VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components. VASCEPA was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter. It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if any reactions occur. VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel or warfarin. Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%). Common adverse reactions in the hypertriglyceridemia trials (incidence >1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%). Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088. Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding. FULL U.S. FDA-APPROVED VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM. Europe For further information about the Summary of Product Characteristics (SmPC) for VAZKEPA® in Europe, please visit: https://www.medicines.org.uk/emc/product/12964/smpc. Globally, prescribing information varies; refer to the individual country product label for complete information. Use of Non-GAAP Adjusted Financial Information Included in this press release are non-GAAP adjusted financial information as defined by U.S. Securities and Exchange Commission Regulation G. The GAAP financial measure most directly comparable to each non-GAAP adjusted financial measure used or discussed, and a reconciliation of the differences between each non-GAAP adjusted financial measure and the comparable GAAP financial measure, is included in this press release after the condensed consolidated financial statements. Non-GAAP adjusted net (loss) income was derived by taking GAAP net loss and adjusting it for non-cash stock-based compensation expense, restructuring expense and other one-time expenses. Management uses these non-GAAP adjusted financial measures for internal reporting and forecasting purposes, when publicly providing its business outlook, to evaluate the company’s performance and to evaluate and compensate the company’s executives. The company has provided these non-GAAP financial measures in addition to GAAP financial results because it believes that these non-GAAP adjusted financial measures provide investors with a better understanding of the company’s historical results from its core business operations. While management believes that these non-GAAP adjusted financial measures provide useful supplemental information to investors regarding the underlying performance of the company’s business operations, investors are reminded to consider these non-GAAP measures in addition to, and not as a substitute for, financial performance measures prepared in accordance with GAAP. Non-GAAP measures have limitations in that they do not reflect all of the amounts associated with the company’s results of operations as determined in accordance with GAAP. In addition, it should be noted that these non-GAAP financial measures may be different from non-GAAP measures used by other companies, and management may utilize other measures to illustrate performance in the future. Forward-Looking StatementsThis press release contains forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including beliefs about Amarin’s key achievements in 2023 and the potential impact and outlook for achievements in 2024 and beyond; Amarin’s 2024 financial outlook and cash position; Amarin’s overall efforts to expand access and reimbursement to VAZKEPA across global markets; and the overall potential and future success of VASCEPA/VAZKEPA and Amarin generally. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. 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 Amarin’s quarterly report on Form 10-Q for the period ending September 30, 2024 and annual report on Form 10-K for the full year ended 2023. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. Amarin undertakes no obligation to update or revise the information contained in its forward-looking statements, 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 AmarinInvestors and others should note that Amarin communicates with its investors and the public using the company website (www.amarincorp.com), the investor relations website (www.amarincorp.com/investor-relations), including but not limited to investor presentations and investor FAQs, U.S. 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 InformationInvestor & Media Inquiries: Mark Marmur Amarin Corporation plc PR@amarincorp.com -Tables to Follow- CONSOLIDATED BALANCE SHEET DATA (U.S. GAAP) Unaudited September 30, 2024 December 31, 2023 (in thousands) ASSETS Current Assets: Cash and cash equivalents $156,944 $199,252 Restricted cash 526 525 Short-term investments 148,788 121,407 Accounts receivable, net 112,642 133,563 Inventory 224,000 258,616 Prepaid and other current assets 7,316 11,618 Total current assets 650,216 724,981 Property, plant and equipment, net 24 114 Long-term inventory 74,023 77,615 Operating lease right-of-use asset 7,984 8,310 Other long-term assets 1,250 1,360 Intangible asset, net 17,118 19,304 TOTAL ASSETS $750,615 $831,684 LIABILITIES AND STOCKHOLDERS’ EQUITY Current Liabilities: Accounts payable $40,507 $52,762 Accrued expenses and other current liabilities 161,047 204,174 Current deferred revenue — 2,341 Total current liabilities 201,554 259,277 Long-Term Liabilities: Long-term deferred revenue — 2,509 Long-term operating lease liability 8,215 8,737 Other long-term liabilities 9,471 9,064 Total liabilities 219,240 279,587 Stockholders’ Equity: Common stock 305,202 302,756 Additional paid-in capital 1,911,445 1,899,456 Treasury stock (65,344) (63,752) Accumulated deficit (1,619,928) (1,586,363) Total stockholders’ equity 531,375 552,097 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $750,615 $831,684 CONSOLIDATED STATEMENTS OF OPERATIONS DATA (U.S. GAAP) Unaudited Three months ended September 30, Nine months ended September 30, (in thousands, except per share amounts) (in thousands, except per share amounts) 2024 2023 2024 2023 Product revenue, net$41,852 $64,903 $144,522 $214,744 Licensing and royalty revenue 446 1,153 21,786 17,454 Total revenue, net 42,298 66,056 166,308 232,198 Less: Cost of goods sold 26,022 23,560 75,359 72,553 Less: Cost of goods sold - restructuring inventory — 12,674 — 39,228 Gross margin 16,276 29,822 90,949 120,417 Operating expenses: Selling, general and administrative (1) 36,904 45,457 115,340 155,997 Research and development (1) 4,540 5,105 14,884 16,428 Restructuring — 711 — 10,743 Total operating expenses 41,444 51,273 130,224 183,168 Operating loss (25,168) (21,451) (39,275) (62,751) Interest income, net 3,374 3,216 10,028 8,438 Other income (expense), net 265 (575) 1,954 3,092 Loss from operations before taxes (21,529) (18,810) (27,293) (51,221) Provision for income taxes (3,605) (501) (6,272) (2,110) Net loss$(25,134) $(19,311) $(33,565) $(53,331) Loss per share: Basic$(0.06) $(0.05) $(0.08) $(0.13) Diluted$(0.06) $(0.05) $(0.08) $(0.13) Weighted average shares: Basic 411,150 408,417 410,786 407,489 Diluted 411,150 408,417 410,786 407,489 (1) - Excluding non-cash stock-based compensation, selling, general and administrative expenses were $33,075 and $41,807 for the three months ended September 30, 2024 and 2023, respectively, and research and development expenses were $3,671 and $4,113, respectively, for the same periods. RECONCILIATION OF NON-GAAP NET INCOME (LOSS) Unaudited Three months ended September 30, Nine months ended September 30, (in thousands, except per share amounts) (in thousands, except per share amounts) 2024 2023 2024 2023 Net loss for EPS1 - GAAP (25,134) (19,311) (33,565) (53,331) Stock-based compensation expense 4,698 4,643 14,303 12,034 Restructuring inventory — 12,674 — 39,228 Restructuring expense — 711 — 10,743 Advisor fees — — — 6,270 Net (loss) income for EPS1 - non-GAAP $(20,436) $(1,283) $(19,262) $14,944 1basic and diluted (Loss) earnings per share: Basic - non-GAAP $(0.05) $(0.00) $(0.05) $0.04 Diluted - non-GAAP $(0.05) $(0.00) $(0.05) $0.04 Weighted average shares: Basic 411,150 408,417 410,786 407,489 Diluted 411,150 408,417 410,786 417,117

Drug ApprovalFinancial Statement

26 Aug 2024

·www.fiercehealthcare.com

Tackling the Prior Authorization Problem with Innovative Technologies

None By: Christie Callahan, Chief Operating Officer, Arrive Health Prior authorization (PA) is a balancing act designed to manage utilization on the one hand and ensure that patients receive necessary, cost-effective treatments on the other. In today’s health care landscape, though, many providers view the traditional PA process as a necessary hurdle that often causes unnecessary care disruptions. PAs take physicians and their staff ~12 hours each week to complete, creating significant administrative burden. Moreover, according to a recent survey, 87% of physicians report that PAs led to higher utilization of health care resources and 24% say that PA has led to a serious adverse event for a patient in their care.[1]The integration of real-time prescription benefit (RTPB) tools with electronic prior authorization (ePA) systems presents a transformative opportunity, enabling providers and payers to fulfill the intended purpose of PA—managing medication use and costs without sacrificing optimized patient care. Role of Prior Authorization in Health careThe intent behind PA is to avoid unnecessary treatments, manage health care expenditures, and provide the most effective care based on scientific evidence and clinical guidelines. However, the traditional PA process is hampered by drawbacks, including the time and resources needed to complete paperwork and the high probability of treatment abandonment post-denial. On average, physicians complete 43 PAs per week and 27% report their PAs are often or always denied.1 Integrating RTPB and ePARTPB tools provide patient-specific prescription benefit information at the point of prescribing, offering instant visibility into drug coverage, utilization management scenarios, and out-of-pocket costs. This allows providers and patients to make informed decisions and expands the range of treatment options by offering covered or unrestricted formulary alternatives.When the PA process is technology enabled through ePA systems, providers submit electronic requests regarding PA requirements electronically and receive timely payer responses. This real-time process reduces unnecessary paperwork, phone calls, and faxes, thereby expediting approvals and minimizing treatment delays.When you combine RTPB and ePA, a new paradigm is possible. Providers no longer wait for a denied claim at the pharmacy to start a PA. Patients no longer wait days for PA resolution. Instead, RTPB allows the best medication choice at prescribing, immediately initiates an ePA when PA is required, and a PA decision is received in hours. All allowing the patient to pick up their medication on the same day. Realizing the Intent of Prior Authorization Through IntegrationThe integration of RTPB and ePA enables both providers and payers to fulfill the core objectives of prior authorization. Both actions occur seamlessly within electronic health record (EHR) systems, streamlining the workflow and reducing administrative burden.Formulary adherence and cost controlProviders view formulary alternatives and their associated costs, encouraging the selection of cost-effective therapies based on each patient’s unique insurance coverage. Timely access to careProviders make informed decisions in real time, reducing the likelihood of prescribing medications that require PA or will face PA denial, and when a PA is required, it is automatically started. Greater transparency, choice, and affordabilityPatients fully understand their treatment options at the point of care, avoiding surprises and delays at the pharmacy, and are informed throughout their treatment journey.By automating the PA process and spotlighting expanded access opportunities, RTPB and ePA integration frees up provider resources to focus on patient care, minimizes the administrative workload for payers, and accelerates patient access to medication. Optimizing for Replicable OutcomesBoth RTPB and ePA are tools that have been leveraged by providers and their staff for years. While driving initial efficiency gains, the full promise of these tools has not been fulfilled. PA is still highlighted as the #1 barrier to medication adherence with 88% of physicians noting that PA interferes with continuity of patient care. 1 In addition, a significant majority of physicians report that the number of PAs required for prescription medications (83%) and medical services (82%) has increased over the last 5 years.1Out-of-the box solutions are not enough. RTPB and ePA should not be used independently but should be paired together to ensure the best results. New technologies, like large language models, must also be applied to share information differently. These technological advances are not just possibilities but are a reality that offer unmatched benefits as compared to the current state.Enhancing prescribing accuracy and efficiencyConferring providers with access to real-time benefit information and PA criteria empowers providers to make evidence-based treatment decisions that are more likely to be approved by payers, reducing the incidence of denials and appeals. Decreasing the number of denials and appealsThe integration of RTPB and ePA puts clear, real-time guidance on coverage requirements at the fingertips of physicians, clarifying the PA process and preventing PA requests that do not meet coverage criteria. Supporting shared clinical decision-makingAccess at prescribing facilitates provider-patient communication, enabling shared decision-making that considers each patient's unique treatment preferences and financial realities. This collaboration strengthens the provider-patient relationship and encourages patients to be their own advocates, leading to greater satisfaction and reducing the likelihood of non-adherence. Key TakeawaysThe future of health care lies in widespread utilization of fit-for-purpose technologies that enhance the interactions among providers, payers, and patients. The right integration of RTPB tools and ePA systems can represent a leap forward in the efficiency and effectiveness of the PA process, providing a strong incentive to allow providers to operate at the top of their license. The coupling of these technologies helps realize the true intent of PA—ensuring that patients receive appropriate, cost-effective care without unnecessary delays. Ultimately, increased transparency can optimize prescribing behavior, leading to better outcomes for patients and more value-driven investment of health care resources.[1] American Medical Association. 2023 AMA prior authorization physician survey. Available at https://www.ama-assn.org/system/files/prior-authorization-survey.pdf.About Arrive HealthArrive Health works to make care decisions better for patients and providers, improving affordability, access, and outcomes — all while reducing administrative burden. Our unmatched network of PBMs, health plans, health systems, providers and other healthcare innovators sets us apart. Visit our website to learn more about the Arrive Health solutions and the power of joining our network.

AHA

22 Aug 2024

·www.globenewswire.com

Latest Research Highlighting VASCEPA®/VAZKEPA® (icosapent ethyl) REDUCE-IT® Subgroup Data and New Mechanistic Insights into Eicosapentaenoic Acid (EPA) to be Presented at European Society of Cardiology (ESC) Congress

DUBLIN, Ireland and BRIDGEWATER, N.J., Aug. 22, 2024 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced new supported and/or funded subgroup data from the landmark REDUCE-IT® cardiovascular outcomes trial with VASCEPA®/VAZKEPA® (icosapent ethyl), as well as abstracts showcasing the mechanistic activity of eicosapentaenoic acid (EPA) that will be presented at the European Society of Cardiology (ESC) Congress in London, United Kingdom, August 30 – September 2, 2024. The accepted abstracts include a REDUCE-IT subgroup analysis to assess if baseline small dense low density lipoprotein cholesterol (sdLDL-C) modifies the effect of icosapent ethyl (IPE) on cardiovascular events. A second abstract examines the association of triglycerides with cardiovascular events in patients with initial or recurrent acute coronary syndrome (ACS). A third abstract estimates the number of ACS patients eligible for IPE in Spanish hospitals, and finally, a fourth abstract measures the effects of EPA on oxidation of Lp(a) under experimental conditions of high glucose. These data will be presented by a variety of international academic collaborators based on research or analyses supported by Amarin. Featured Amarin-supported abstracts to be presented at ESC Congress 2024 include: Oral Presentation Icosapent Ethyl by Baseline Small Dense Low-Density Lipoprotein Cholesterol: An Analysis of REDUCE-ITRahul Aggarwal, MD, Deepak L. Bhatt, MD, MPH, P. Gabriel Steg, MD, Michael Miller, MD et al. Session Date & Time: August 30th from 13:45 to 15:00Location: Warsaw (Room) Moderated Poster Presentations Effect Of Triglycerides on Cardiovascular Risk in Patients with A First Vs. Recurrent Acute Coronary Syndrome Alberto Cordero, Rosa Fernandez Olmo, Leticia A. Fernández-Friera, Sergio Manzano, et al. Session Date & Time: September 2nd from 12:00 to 12:50Location: Station 4 Estimate And Prognosis of Patients Who Are Candidates for Treatment with Eicosapentaenoic Acid After an Acute Coronary Syndrome Alberto Cordero, Rosa Fernandez Olmo, Leticia A. Fernández-Friera, Sergio Manzano, et al. Session Date & Time: September 2nd from 12:00 to 12:50Location: Station 4 High Glucose Enhanced Lipoprotein(a) [Lp(a)] Oxidation in a Manner Inhibited by Eicosapentaenoic Acid (EPA) In VitroSamuel C.R. Sherratt, PhD, Peter Libby, MD, Richard L. Dunbar, MD, Deepak L Bhatt, MD, MPH, R. Preston Mason, PhD Session Date & Time: September 2nd from 15:00 to 15:50Location: Station 9 “At Amarin, we are committed to continuing to invest in research that helps clinicians further reduce additional residual cardiovascular risk for their patients beyond the management of LDL-C and other lipids and understand the added value of VASCEPA/VAZKEPA in reducing this residual cardiovascular risk for patients; we are also focused on and supporting research activities to understand the mechanism of action for IPE/EPA in this process,” said Nabil Abadir, MB. CH.B., SVP, Chief Medical Officer and Head of Global Medical Affairs, Amarin. “These data at ESC help to achieve that, as well as enhance clinical understanding around the prevalence of residual cardiovascular risk associated with elevated triglyceride levels and around the mechanism of action of IPE/EPA, as well as providing additional validation of the clinical utility and value of VASCEPA/VAZKEPA for patients most at-risk of a cardiovascular event.”About Amarin Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. We are committed to increasing the scientific understanding of the cardiovascular risk that persists beyond traditional therapies and advancing the treatment of that risk for patients worldwide. Amarin has offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, Zug in Switzerland, and other countries in Europe as well as commercial partners and suppliers around the world.   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.[1] [2] These and other publications can be found in the Science section on the company’s website at www.amarincorp.com. About VASCEPA® (icosapent ethyl) CapsulesVASCEPA (icosapent ethyl) capsules are the first 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 drug approved by the U.S. FDA for treatment of the studied high-risk patients with persistent cardiovascular risk despite being on 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 more than 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, Germany, Lebanon and the United Arab Emirates. In Europe, in March 2021 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 ordiabetes 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. 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 which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including beliefs about the potential for VASCEPA (marketed as VAZKEPA in Europe); beliefs about icosapent ethyl (IPE)’s role concerning appropriate patients suffering from cardiovascular disease (CVD) and potential population health impact, as well as general beliefs about the safety and effectiveness of VASCEPA. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. 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 Amarin’s annual report on Form 10-K for the full year ended 2023. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. Amarin undertakes no obligation to update or revise the information contained in its forward-looking statements, 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 AmarinInvestors and others should note that Amarin communicates with its investors and the public using the company website (www.amarincorp.com) and the investor relations website (www.amarincorp.com/investor-relations), including but not limited to investor presentations, 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 & Media Inquiries:Mark MarmurAmarin Corporation plcPR@amarincorp.com ________________________ 1 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. 2 Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019;380:11-22.

Drug ApprovalClinical ResultAHA

100 Deals associated with Eicosapentaenoic acid

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KEGG	Wiki	ATC	Drug Bank
-	Eicosapentaenoic acid	-	DB00159

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 3	-	1 A Pharma GmbH	-
Adenomatous Polyps	Phase 2	GB	S.L.A. Pharma AG	01 Oct 2006
Adenomatous Polyps	Phase 2	IT	S.L.A. Pharma AG	01 Oct 2006
Colonic Polyps	Phase 2	IT	S.L.A. Pharma AG	01 Oct 2006
Colonic Polyps	Phase 2	GB	S.L.A. Pharma AG	01 Oct 2006

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESC2024	Not Applicable	Cardiovascular Diseases	-	Eicosapentaenoic acid (EPA)	(guzfihahdm) = nfyaivqbjh vbseooogpj (rsmfazktac, 0.95 - 0.98)	-	02 Sep 2024
				Docosahexaenoic acid (DHA)	(guzfihahdm) = paznfkjdlh vbseooogpj (rsmfazktac, 0.86 - 0.89)
ESC2024	Not Applicable	-	-	eicosapentaenoic acid (EPA) (Lp(a)-enriched plasma)	rbxciqnthp(qrvqdkxqfp) = sabmvhhhss qyxzhszyww (utvuzdiupn )	-	02 Sep 2024
				eicosapentaenoic acid (EPA) (Non-modified LDL)	rbxciqnthp(qrvqdkxqfp) = aylbizfvcp qyxzhszyww (utvuzdiupn )
EASL2020	Not Applicable	Ascites	35	Automated low flow ascites (ALFA) pump	ktfdndteyo(mlendcqeam) = opvhhxyvxl wmvwagbcvi (ddzrcnbytt ) View more	-	27 Aug 2020
NCT02553915 (CTgov)	Phase 2/3	Depressive Disorder, Major \| Inflammation \| Overweight	61	Placebo (Placebo)	ibovugbphe(xtvoerwzqu) = butibkwcry ymukcnlzmw (qxagchsnqy, rjeiludbmd - sbvgfqiqua) View more	-	18 Nov 2019
				Placebo+EPA 1 g/day (EPA 1 g/Day)	ibovugbphe(xtvoerwzqu) = mzbuyqfzel ymukcnlzmw (qxagchsnqy, wyherymzwo - kobbnlapby) View more
UEGW2018	Not Applicable	Adenoma	-	99%EPA-FFA 2g	tpdzkgjnah(buswlsfflv) = EPA and aspirin treatment were well tolerated with an excess of mild-moderate GI adverse events (AEs), prominent in the EPA alone arm ngebadntff (vdultugudm ) View more	-	01 Oct 2018
				90%EPA-TG 2780mg
NCT02057406 (OCEAN, CTgov)	Phase 3	Depressive Disorder \| Heart Failure	108	2:1 EPA/DHA (2:1 EPA/DHA)	mkidtvvzdh(tuikemihca) = ldhtptldzq qoxnseuwdp (aladykixqp, yxmzuqtcok - uuqzparnzy) View more	-	12 Jun 2017
				High EPA (High EPA)	mkidtvvzdh(tuikemihca) = mjzpsaqltj qoxnseuwdp (aladykixqp, kulqkgraxg - gthjkfefyu) View more
NCT00711971 (CTgov)	Phase 2/3	Depressive Disorder	126	EPA-rich fish oil supplement (EPA-rich Fish Oil Supplement)	bvgcvcyqrs(qcxhthajav) = alyevgbdau gcmvuvcork (nauwriomov, qnzttelmqe - pmesxizmfo) View more	-	28 Apr 2017
				DHA-rich fish oil supplement (DHA-rich Fish Oil Supplement)	bvgcvcyqrs(qcxhthajav) = rspqfjdbwe gcmvuvcork (nauwriomov, hykutitcsy - kqwrjxqkir) View more
JPRN-UMIN000006380 (ASCO_GI2016)	Phase 3	Stomach Cancer	127	enteral EPA-enriched immunonutrition (Standard diet)	fjjbvxiuwt(zogamveqpj) = ofrsurisff hsuuaqwakg (qipqzmvegz )	-	01 Feb 2016
				Standard diet with oral supplementation of ProSure including 600 kcal with 2.2 g EPA	fjjbvxiuwt(zogamveqpj) = yzkndwzqdw hsuuaqwakg (qipqzmvegz )
SP644 (ERA2015)	Not Applicable	serum 1,25D levels \| 25-hydroxyvitaminD (25D)	222	calcitriol	(tigspynbex): HR = 0.55, P-Value = 0.03	Negative	21 May 2015
				calcitriol
Pubmed \| Prostaglandins Leukot Essent Fatty Acids	Not Applicable	Hypertriglyceridemia	93	DHA-O (microalgal oil)	iospbwpwdy(xkllhxccei) = myoebowwir mqjbolqoip (krahmejezl )	-	01 Oct 2014
				microalgal DHA- and EPA-containing oil (Fish oil (FO))	iospbwpwdy(xkllhxccei) = vjipiwlgal mqjbolqoip (krahmejezl )

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