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

NCT05306080 / RecruitingEarly Phase 1IIT

Pilot, Open-Label Study Evaluating the Safety and Feasibility of Using Rescue Therapies for CAR T Cell Related Cytokine Release Syndrome (CRS) and HLH-like Syndrome

This is a pilot, open-label study to assess the safety and feasibility of using investigational drug(s) as rescue therapies for CAR T cell related CRS and HLH-like syndrome (CRHLS).

Start Date17 Apr 2022

Sponsor / Collaborator

University of Pennsylvania

100 Clinical Results associated with Eicosapentaenoic acid

100 Translational Medicine associated with Eicosapentaenoic acid

100 Patents (Medical) associated with Eicosapentaenoic acid

13,062

Literatures (Medical) associated with Eicosapentaenoic acid

01 May 2024·Food chemistry

The same species, different nutrients: Lipidomics analysis of muscle in mud crabs (Scylla paramamosain) fed with lard oil and fish oil

Article

Author: Wang, Ziyi ; Zhang, Ziping ; Tang, Mengyao ; Ye, Zihao ; Zhang, Yi ; Xu, Yifang ; Liu, Jinjin ; Huang, Weiqing ; Wang, Xuexi ; Cui, Shihui

Aiming to assess the effects of lard oil (LO) and fish oil (FO) on the nutritional value of mud crabs (Scylla paramamosain), non-targeted lipidomics analysis was performed on the muscle of crabs after eight weeks of feeding trail. Compared to FO, dietary LO reduced the content of phosphatidylethanolamine (PE) and phosphatidylserine (PS) with 18:0 bound at sn-1/3 site, the content of ether phospholipids containing 20:5n-3 (EPA) and 22:6n-3 (DHA) combined at sn-2 site, and increased the content of ether PE containing 18:0 and 18:1n-9. Furthermore, the deposition of 16:0, 16:1n-7, 18:2n-6, 18:3n-3, 20:4n-6, EPA and DHA at each site of PE, PS, phosphatidylcholine and/or triacylglycerols were reduced by dietary LO, while the DHA content at the sn-2 position of PE was increased. In conclusion, the nutritional value of mud crabs was reduced by dietary LO with the manifestation of variation in FA composition and positional distribution on phospholipids.

01 Apr 2024·Prostaglandins & other lipid mediators

Untargeted and temporal analysis of retinal lipidome in bacterial endophthalmitis

Review

Author: Kumar, Ashok ; Singh, Sukhvinder ; Ahmad, Zeeshan ; Sharma, Ashok ; Giri, Shailendra ; Lee, Tae Jin ; Lydic, Todd A

Bacterial endophthalmitis is a blinding infectious disease typically acquired during ocular surgery. We previously reported significant alterations in retinal metabolism during Staphylococcus (S) aureus endophthalmitis. However, the changes in retinal lipid composition during endophthalmitis are unknown. Here, using a mouse model of S. aureus endophthalmitis and an untargeted lipidomic approach, we comprehensively analyzed temporal alterations in total lipids and oxylipin in retina. Our data showed a time-dependent increase in the levels of lipid classes, sphingolipids, glycerolipids, sterols, and non-esterified fatty acids, whereas levels of phospholipids decreased. Among lipid subclasses, phosphatidylcholine decreased over time. The oxylipin analysis revealed increased prostaglandin-E2, hydroxyeicosatetraenoic acids, docosahexaenoic acid, eicosapentaenoic acid, and α-linolenic acid. In-vitro studies using mouse bone marrow-derived macrophages showed increased lipid droplets and lipid-peroxide formation in response to S. aureus infection. Collectively, these findings suggest that S. aureus-infection alters the retinal lipid profile, which may contribute to the pathogenesis of bacterial endophthalmitis.

01 Apr 2024·Redox biology

Identification of novel F2-isoprostane metabolites by specific UDP-glucuronosyltransferases

Article

Author: Yang, Gong ; Thomas, Sarah ; Sanchez, Stephanie C ; Durand, Thierry ; Amin, Warda ; Nogueira, Marina S ; Milne, Ginger L ; Oger, Camille ; Murff, Harvey J ; Gao, Benlian ; Galano, Jean-Marie

UDP-glucuronosyltransferases (UGTs) catalyze the conjugation of glucuronic acid with endogenous and exogenous lipophilic small molecules to facilitate their inactivation and excretion from the body. This represents approximately 35 % of all phase II metabolic transformations. Fatty acids and their oxidized eicosanoid derivatives can be metabolized by UGTs. F₂-isoprostanes (F₂-IsoPs) are eicosanoids formed from the free radical oxidation of arachidonic acid. These molecules are potent vasoconstrictors and are widely used as biomarkers of endogenous oxidative damage. An increasing body of evidence demonstrates the efficacy of measuring the β-oxidation metabolites of F₂-IsoPs rather than the unmetabolized F₂-IsoPs to quantify oxidative damage in certain settings. Yet, the metabolism of F₂-IsoPs is incompletely understood. This study sought to identify and characterize novel phase II metabolites of 15-F_2t-IsoP and 5-epi-5-F_2t-IsoP, two abundantly produced F₂-IsoPs, in human liver microsomes (HLM). Utilizing liquid chromatography-mass spectrometry, we demonstrated that glucuronide conjugates are the major metabolites of these F₂-IsoPs in HLM. Further, we showed that these molecules are metabolized by specific UGT isoforms. 15-F_2t-IsoP is metabolized by UGT1A3, 1A9, and 2B7, while 5-epi-5-F_2t-IsoP is metabolized by UGT1A7, 1A9, and 2B7. We identified, for the first time, the formation of intact glucuronide F₂-IsoPs in human urine and showed that F₂-IsoP glucuronidation is reduced in people supplemented with eicosapentaenoic and docosahexaenoic acids for 12 weeks. These studies demonstrate that endogenous F₂-IsoP levels can be modified by factors other than redox mechanisms.

News (Medical) associated with Eicosapentaenoic acid

08 Apr 2024

·www.globenewswire.com

Amarin Highlights Key Data Providing Mechanistic Insights into Eicosapentaenoic Acid (EPA) at ACC.24

Data Further Advance Understanding of VASCEPA®/VAZKEPA® Potential Mechanism of ActionDUBLIN, Ireland and BRIDGEWATER, N.J., April 08, 2024 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today highlighted three data presentations at ACC.24 showcasing the mechanistic activity of Eicosapentaenoic acid (EPA), including the potential effects of EPA on endothelial cell dysfunction and on oxidation of samples enriched with Lp(a). ”The data presented at ACC.24 provide new evidence surrounding the mechanism of action for VASCEPA/VAZKEPA, including the effect of the compound in combination with high-intensity statin on endothelial cell function during inflammation and the compound’s effect on Lp(a) levels,” said R. Preston Mason, Ph.D., Brigham and Women’s Hospital. “These learnings further advance understanding of how EPA and VASCEPA/VAZKEPA work to reduce cardiovascular events in at-risk patients.” The studies and their key findings are outlined below: Eicosapentaenoic acid (EPA) and a High Intensity Statin Enhanced Expression of Proteins for Detoxification of Reactive Oxygen Species during Angiotensin II Challenge in Endothelial Cells This analysis measured the separate and combined effects of EPA and rosuvastatin on expression of proteins involved in detoxification in vascular endothelial cells under inflammatory conditions with angiotensin II (Ang II). The combination of EPA and rosuvastatin favorably modulated the expression of proteins related to oxidative stress and detoxification under disease-like conditions. These findings indicate that the net benefits of a high intensity statin and EPA, compared to statin alone, on expression of detoxification proteins during inflammation may contribute to reduced atherothrombotic risk in outcome trials. Eicosapentaenoic Acid (EPA) and Rosuvastatin Modulate Expression of Endothelial Proteins that Regulate Function and Platelet Activity during Angiotensin II Stimulation In this analysis, investigators compared the separate and combined effects of EPA and rosuvastatin on expression of proteins that regulate platelet signaling and nitric oxide (NO) levels in human umbilical vein endothelial cells (HUVECs) subjected to angiotensin II (Ang II) stimulus. The combination of EPA and rosuvastatin favorably modulated proteins involved in platelet degranulation and NO bioavailability in HUVECs under inflammatory conditions to a greater extent than their separate treatments. The beneficial effects of a high intensity statin and EPA on endothelial dysfunction may contribute to reduced atherothrombotic risk in outcome trials. Eicosapentaenoic Acid (EPA) Inhibits Lipoprotein(a) [Lp(a)] Oxidation due to Scavenging Mechanisms In Vitro Elevated Lp(a) levels are an independent and causal risk factor for cardiovascular (CV) disease with limited treatments available. Oxidized Lp(a) stimulates foam cell formation, endothelial dysfunction, and inflammation. In this analysis, investigators tested EPA effects on oxidation of samples enriched with Lp(a) compared to the fully saturated eicosaenoic acid (EA; 20:0) and Trolox, a water-soluble analog of Vitamin E. Investigators found that EPA inhibited oxidation of Lp(a) enriched plasma in a time-dependent fashion consistent with a free radical scavenging mechanism. The potent antioxidant actions of EPA may contribute to reduced CV events in REDUCE-IT, including among those subjects with elevated Lp(a). 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 The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.2 The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.3 These and other publications can be found in the R&D section on the company’s website at www.amarincorp.com.  About Cardiovascular Risk Cardiovascular disease is the number one cause of death in the world. In the United States alone, cardiovascular disease results in 859,000 deaths per year.4 And the number of deaths in the United States attributed to cardiovascular disease continues to rise. In addition, in the United States there are 605,000 new and 200,000 recurrent heart attacks per year (approximately 1 every 40 seconds). Stroke rates are 795,000 per year (approximately 1 every 40 seconds), accounting for 1 of every 19 U.S. deaths. In aggregate, in the United States alone, there are more than 2.4 million major adverse cardiovascular events per year from cardiovascular disease or, on average, 1 every 13 seconds. Controlling bad cholesterol, also known as LDL-C, is one way to reduce a patient’s risk for cardiovascular events, such as heart attack, stroke or death. However, even with the achievement of target LDL-C levels, millions of patients still have significant and persistent risk of cardiovascular events, especially those patients with elevated triglycerides. Statin therapy has been shown to control LDL-C, thereby reducing the risk of cardiovascular events by 25-35%.5 Significant cardiovascular risk remains after statin therapy. People with elevated triglycerides have 35% more cardiovascular events compared to people with normal (in range) triglycerides taking statins.6,7,8 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 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 twenty 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, 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. In April 2021 marketing authorization for VAZKEPA (icosapent ethyl) was granted in Great Britain (applying to England, Scotland and Wales). VAZKEPA (icosapent ethyl) is currently approved and sold in Europe in Sweden, Denmark, Finland, Austria, the UK, Spain and the Netherlands.   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 click here.   Globally, prescribing information varies; refer to the individual country product label for complete information.   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 Amarin communicates with its investors and the public using the company website (www.amarincorp.com) and the investor relations website (amarincorp.com/investor-relations), including but not limited to investor presentations and FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933. Amarin Contact Information Investor & Media Inquiries: Mark Marmur Amarin Corporation plc PR@amarincorp.com Investor.relations@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;380:11-223 Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Effects of Icosapent Ethyl on Total Ischemic Events: From REDUCE-IT. J Am Coll Cardiol. 2019;73:2791-2802.4 American Heart Association. Heart Disease and Stroke Statistics—2020 Update: A Report From the American Heart Association. Circulation. 2020;141:e139-e596.5 Ganda OP, Bhatt DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia therapy in hypertriglyceridemia management. J Am Coll Cardiol. 2018;72(3):330-343.6 Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.7 Toth PP, Granowitz C, Hull M, et al. High triglycerides are associated with increased cardiovascular events, medical costs, and resource use: A real-world administrative claims analysis of statin-treated patients with high residual cardiovascular risk. J Am Heart Assoc. 2018;7(15):e008740.8 Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease - New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563

Drug ApprovalClinical ResultAHA

25 Mar 2024

·www.globenewswire.com

Research Evaluating Benefits of VASCEPA®/VAZKEPA® (icosapent ethyl) to be Presented at the American College of Cardiology’s (ACC) Annual Scientific Session & Expo

-- Subgroup Analyses from REDUCE-IT® and Mechanistic Data on Icosapent Ethyl(IPE)/Eicosapentaenoic Acid (EPA) Featured at the Meeting -- DUBLIN, Ireland and BRIDGEWATER, N.J., March 25, 2024 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that additional patient subgroup analyses from the landmark REDUCE-IT outcomes trial and mechanistic data on icosapent ethyl (IPE)/eicosapentaenoic acid (EPA) will be presented at the American College of Cardiology’s Annual Scientific Session & Expo, April 6 – 8, 2024 in Atlanta, GA. "The data being featured at ACC.24 continues to support and explain the clinical utility and value of VASCEPA®/VAZKEPA® (icosapent ethyl), not only in the overall REDUCE IT patient population, but in the different sub-populations analyzed so far,” said Nabil Abadir, MB. CH.B., SVP, Chief Medical Officer, and Head of Global Medical Affairs at Amarin "The data highlight VASCEPA/VAZKEPA’s effect on reducing MACE in patients with different baseline levels of Lipoprotein(a) [Lp(a)] including among those with clinically relevant Lp(a) elevation as well as among patients with high and low LDL-C baseline levels. These data demonstrate the molecule’s impact in reducing patients’ residual cardiovascular event risk across these patient sub-groups regardless of their baseline Lp(a) or LDL-C levels. Additionally, the meeting provides an opportunity to highlight further evidence regarding the potential mechanistic activity of EPA in reducing cardiovascular events in at-risk patients." “This latest research reaffirms Amarin's commitment to advancing cardiovascular care and should help further advance the medical community’s understanding of the role, the value and the potential mechanism of action of VASCEPA/VAZKEPA to reduce cardiovascular events in at-risk patients globally,” concluded Abadir. Featured Amarin-supported abstracts to be presented by international academic collaborators at ACC Scientific Sessions 2024 include: Moderated Poster Presentations Icosapent Ethyl Reduces MACE in Patients with Elevated Triglycerides and High or Low Lipoprotein(a) Concentrations: A REDUCE-IT SubanalysisMichael Szarek, Deepak L. Bhatt, Elliot A. Brinton, Michael Miller, et al.–Available April 6th, 3:30-3:40 PM-Moderated Poster Theater 06 Efficacy of Icosapent Ethyl for Reducing Cardiovascular Outcomes by Baseline Low Density Lipoprotein Cholesterol LevelRahul Aggarwal, Deepak L. Bhatt, Philippe Gabriel Steg, Michael Miller, et al.-Available Apil 6th, 12:15-12:25 PM-Moderated Poster Theater 08 Eicosapentaenoic Acid (EPA) Inhibits Lipoprotein(a) [Lp(a)] Oxidation due to Scavenging Mechanisms in VitroSamuel C.R. Sherratt, Peter Libby, Deepak L. Bhatt, R. Preston Mason, et al.-Available April 7th, 9:30-9:40 AM-Moderated Poster Theater 06 Poster Presentations Eicosapentaenoic Acid (EPA) and a High Intensity Statin Enhanced Expression of Proteins for Detoxification of Reactive Oxygen Species During Angiotensin II Challenge in Endothelial CellsSamuel C.R. Sherratt, Peter Libby, Deepak L. Bhatt, R. Preston Mason, et al.-Available April 7th, 1:15-2:00 PM-Hall B4-5 Eicosapentaenoic Acid and Rosuvastatin Modulate Expression of Endothelial Proteins that Regulate Function and Platelet Activity During Angiotensin II StimulationSamuel C.R. Sherratt, Peter Libby, Deepak L. Bhatt, R. Preston Mason, et al.-Available April 7th, 1:15-2:00 PM-Hall B4-5 Effects of Icosapent Ethyl on Vascular Regenerative Cells in Individuals with Elevated Triglycerides: Insights From the IPE-Prevention Cardiolink-14 TrialEhab Bakbak, Aishwarya Krishnaraj, Deepak L. Bhatt, Brady Park, et al.–Available April 8th, 12:45-1:30 PM- Hall B4-5 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 Cardiovascular RiskCardiovascular disease is the number one cause of death in the world. In the United States alone, cardiovascular disease results in 859,000 deaths per year.1 And the number of deaths in the United States attributed to cardiovascular disease continues to rise. In addition, in the United States there are 605,000 new and 200,000 recurrent heart attacks per year (approximately 1 every 40 seconds). Stroke rates are 795,000 per year (approximately 1 every 40 seconds), accounting for 1 of every 19 U.S. deaths. In aggregate, in the United States alone, there are more than 2.4 million major adverse cardiovascular events per year from cardiovascular disease or, on average, 1 every 13 seconds. Controlling bad cholesterol, also known as LDL-C, is one way to reduce a patient’s risk for cardiovascular events, such as heart attack, stroke or death. However, even with the achievement of target LDL-C levels, millions of patients still have significant and persistent risk of cardiovascular events, especially those patients with elevated triglycerides. Statin therapy has been shown to control LDL-C, thereby reducing the risk of cardiovascular events by 25-35%.2 Significant cardiovascular risk remains after statin therapy. People with elevated triglycerides have 35% more cardiovascular events compared to people with normal (in range) triglycerides taking statins.3,4 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 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 twenty 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, 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. In April 2021 marketing authorization for VAZKEPA (icosapent ethyl) was granted in Great Britain (applying to England, Scotland and Wales). VAZKEPA (icosapent ethyl) is currently approved and sold in Europe in Sweden, Denmark, Finland, Austria, the UK, Spain and the Netherlands.  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 click here. Globally, prescribing information varies; refer to the individual country product label for complete information.  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 Amarin communicates with its investors and the public using the company website (www.amarincorp.com) and the investor relations website (investor.amarincorp.com), including but not limited to investor presentations and FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933. Amarin Contact Information Investor & Media Inquiries:Mark MarmurAmarin Corporation plcPR@amarincorp.comInvestor.relations@amarincorp.com 1 American Heart Association. Heart Disease and Stroke Statistics—2020 Update: A Report From the American Heart Association. Circulation. 2020;141:e139-e596.2 Ganda OP, Bhatt DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia therapy in hypertriglyceridemia management. J Am Coll Cardiol. 2018;72(3):330-343.3 Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.4 Toth PP, Granowitz C, Hull M, et al. High triglycerides are associated with increased cardiovascular events, medical costs, and resource use: A real-world administrative claims analysis of statin-treated patients with high residual cardiovascular risk. J Am Heart Assoc. 2018;7(15):e008740.

Drug ApprovalAHA

04 Jan 2024

·www.biospace.com

Amneal Launched Record Number of 39 New Retail and Injectable Products in 2023, Including 13 in Q4 2023

More new product innovations in 2023, as compared to 26 in 2022 13 new products launched in the fourth quarter of 2023 BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal”) today announces that it has launched 39 new retail and injectable medicines in 2023, as compared to 26 new launches in 2022. In the fourth quarter of 2023, Amneal launched 13 new products, including 5 injectables. New injectable products added include potassium phosphate vials, tranexamic acid and esmolol intravenous bags. These launches provide a strong foundation for higher injectable revenues going forward. In addition, Amneal launched several key new retail products in the fourth quarter, including spironolactone suspension with 180-day exclusivity, valsartan and hydrochlorothiazide tablets, and icosapent capsules. “We are pleased to have brought an impressive number of new products to market in 2023,” said Dr. Srinivas Kone, Senior Vice President, Generics R&D. “Our R&D portfolio prioritizes complex and high-value products that provide better access to affordable medicines for providers and patients.” About Amneal Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a fully integrated global pharmaceuticals company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 270 pharmaceutical products, primarily within the United States. In its Generics segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit . Cautionary Statement on Forward-Looking Statements Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations, including international expansion; expected or estimated operating results and financial performance; the Company’s growth prospects and opportunities as well as its strategy for growth; product development and launches; the successful commercialization and market acceptance of new products, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events, including with respect to future market conditions, company performance and financial results, operational investments, business prospects, new strategies and growth initiatives, the competitive environment, and other events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Company. Such risks and uncertainties include, but are not limited to: our ability to successfully develop, license, acquire and commercialize new products on a timely basis; the competition we face in the pharmaceutical industry from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our ability to obtain exclusive marketing rights for our products; our ability to manage our growth through acquisitions and otherwise; our revenues are derived from the sales of a limited number of products, a substantial portion of which are through a limited number of customers; the continuing trend of consolidation of certain customer groups; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods; our ability to complete the proposed holding company reorganization on the anticipated timeline or at all and to realize the expected benefits of such reorganization; our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness; our ability to secure satisfactory terms when negotiating a refinancing or other new indebtedness; our dependence on third-party agreements for a portion of our product offerings; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; risks related to federal regulation of arrangements between manufacturers of branded and generic products; our reliance on certain licenses to proprietary technologies from time to time; the significant amount of resources we expend on research and development; the risk of product liability and other claims against us by consumers and other third parties; risks related to changes in the regulatory environment, including U.S. federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to Food and Drug Administration product approval requirements; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; our potential expansion into additional international markets subjecting us to increased regulatory, economic, social and political uncertainties, including recent events affecting the financial services industry; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; the impact of global economic, political or other catastrophic events; our ability to attract, hire and retain highly skilled personnel; our obligations under a tax receivable agreement may be significant; and the high concentration of ownership of our Class A Common Stock and the fact that we are controlled by the Amneal Group. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof. View source version on businesswire.com: Contacts Investors: Anthony DiMeo Head of Investor Relations anthony.dimeo@amneal.com Source: Amneal Pharmaceuticals, Inc. View this news release online at:

100 Deals associated with Eicosapentaenoic acid

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KEGG	Wiki	ATC	Drug Bank
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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Severe Acute Respiratory Syndrome	Phase 3	ES	S.L.A. Pharma AG	08 Jan 2021
Severe Acute Respiratory Syndrome	Phase 3	GB	S.L.A. Pharma AG	08 Jan 2021
COVID-19	Phase 3	-	S.L.A. Pharma AG	09 Nov 2020
Colorectal Cancer	Phase 3	CN	Sun Yat-Sen University	01 Dec 2009
Stomach Cancer	Phase 3	CN	Sun Yat-Sen University	01 Dec 2009
Adenomatous Polyposis Coli	Phase 3	GB	S.L.A. Pharma AG	01 Nov 2006
Adenomatous Polyps	Phase 3	IT	S.L.A. Pharma AG	01 Oct 2006
Colonic Polyps	Phase 3	IT	S.L.A. Pharma AG	01 Oct 2006
Colonic Polyps	Phase 3	GB	S.L.A. Pharma AG	01 Oct 2006
lipoprotein Disorder	Phase 2	US	National Heart, Lung & Blood Institute	30 Oct 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03954704 (CTgov)	Phase 1	Advanced Malignant Solid Neoplasm	22	GS-1423 (Phase 1a (Part A) Cohort 1: GS-1423 0.3 mg/kg)	noypimulsw(vrumphqzpe) = tffwpddity xhfsfwwgya (zgycrbmost, ifpsbvggmd - hlexoyxijf) View more	-	21 Nov 2023
				GS-1423 (Phase 1a (Part A) Cohort 2: GS-1423 1 mg/kg)	noypimulsw(vrumphqzpe) = vdtvermjza xhfsfwwgya (zgycrbmost, yzitxrmogt - poyzonblez) View more
NCT01351805 (CTgov)	Not Applicable	Patellofemoral Pain Syndrome \| Osteoarthritis \| Inflammation ... View more	25,871	Vitamin D3 (Active Vitamin D)	fwcszqspnr(urvshbetyu) = bsujrsdwnf utbqiiihds (dboxltqicq, zichulhfer - ifsgqukfzp) View more	-	08 Jan 2021
				Vitamin D (Placebo Vitamin D)	fwcszqspnr(urvshbetyu) = skjooopcis utbqiiihds (dboxltqicq, dvxfeimqxg - fpidrtdawv) View more
EASL2020	Not Applicable	Ascites	35	Automated low flow ascites (ALFA) pump	nyenstfgwq(abcizqobsf) = fgzflwqqyd bgcxvdvdfs (brtmenoqlr ) View more	-	27 Aug 2020
NCT02553915 (CTgov)	Phase 2/3	Depressive Disorder, Major \| Inflammation \| Overweight	61	Placebo (Placebo)	lodyirupmx(nyeirnlpqo) = wdhfcwnwue ccdijgeffj (ykisbqranu, dhgyrgzdet - rcegaansqc) View more	-	18 Nov 2019
				Placebo+EPA 1 g/day (EPA 1 g/Day)	lodyirupmx(nyeirnlpqo) = idgdcjebcg ccdijgeffj (ykisbqranu, chkmwnvewl - xlcljvqugc) View more
NCT02057406 (CTgov)	Phase 3	Depressive Disorder \| Heart Failure \| Depression	108	2:1 EPA/DHA (2:1 EPA/DHA)	dcyypzyheq(raecredxpw) = eczkpoqpsm edejubhbuh (yqlydrrhhy, azwupjfuas - mqkhuzumrk) View more	-	12 Jun 2017
				High EPA (High EPA)	dcyypzyheq(raecredxpw) = xweodnpxoh edejubhbuh (yqlydrrhhy, wfeetuwanq - qskfwrifua) View more
NCT00711971 (CTgov)	Phase 2/3	Depressive Disorder \| Depression	126	EPA-rich fish oil supplement (EPA-rich Fish Oil Supplement)	wlrfahvudg(eoeczzuwfm) = rmzzokpqqo ihzgwavwtr (kbjjgegzff, pzhxeamoqn - idaahkocyf) View more	-	28 Apr 2017
				DHA-rich fish oil supplement (DHA-rich Fish Oil Supplement)	wlrfahvudg(eoeczzuwfm) = xgrzyaxzpz ihzgwavwtr (kbjjgegzff, qeajmmjeob - xkswoiukhw) View more
NCT00167310 (CTgov)	Phase 2	Coronary Artery Disease \| Bipolar Disorder \| Schizoaffective disorder ... View more	57	Omega-3 Fatty Acid (Omega-3 Fatty Acid)	cmpbwrnrpl(vqbvvvxwis) = ejlkxibgrf lwmkjlamaa (ednwnmmxas, trrkdhijtb - ducfrqqvip) View more	-	10 Apr 2017
				Placebo+soy bean oil (Placebo)	cmpbwrnrpl(vqbvvvxwis) = rjtyxgtwfs lwmkjlamaa (ednwnmmxas, incrzowcuw - gnisfqgyvy) View more
JPRN-UMIN000006380 (ASCO_GI2016)	Phase 3	Stomach Cancer	127	enteral EPA-enriched immunonutrition (Standard diet)	rsntyiisgs(tjeqzvxftg) = libjiuuzbc ylikbbjion (ebyvmvdzqx )	-	01 Feb 2016
				Standard diet with oral supplementation of ProSure including 600 kcal with 2.2 g EPA	rsntyiisgs(tjeqzvxftg) = ghxchilohd ylikbbjion (ebyvmvdzqx )
EASD2014	Not Applicable	NAD(P)H oxidase subunits	-	EPA	vykqvmkzkr(umvbfohzyu) = sshhhnqntj lgdnirpfmf (qwutisofra ) View more	Positive	18 Sep 2014
				ω-3 fatty acids (50 µM EPA + 50 µM DHA)	vykqvmkzkr(umvbfohzyu) = ikdazteisn lgdnirpfmf (qwutisofra ) View more
NCT00510692 (CTgov)	Phase 2/3	Adenomatous Polyposis Coli	58	Biopsies taken (Placebo)	gqrrbshlft(ljuaizlqgq) = xqjhuxrcdu awrhfdygif (enmsluyoum, cizrkbplmm - jiaomkoitz) View more	-	22 Aug 2014
				Biopsies taken (2g/Day Eicosapentanoic Acid (EPA))	oldtgdmcqp(podtvgeciv) = atklvgvmws pnpnghcefc (tnkuvsiqyj, whtybpteon - xvapdckqhy) View more

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