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Impact of GSK-Teva case on Amarin-Hikma
From “Inducement in a Pharmaceutical, Post-Launch Non-Hatch-Waxman World: Evaluating the Effect of a Skinny Label, Implications of GSK v. Teva”
https://www.marburylaw.com/inducement-in-a-pharmaceutical-post-launch-non-hatch-waxman-world-evaluating-the-effect-of-a-skinny-label-implications-of-gsk-v-teva/
Link leads to https://www.straffordpub.com/products/inducement-in-a-pharmaceutical-post-launch-non-hatch-waxman-world-2023-07-06
Recording available for fee
Slides available under Course Materials, with slides 63-75 specifically addressing ongoing (via appeal) Amarin-Hikma infringement suit (US District Court of Delaware) .
-dogn
This CLE course will guide patent counsel on the Federal Circuit's recent GSK v. Teva decision, and any other relevant post-launch non-Hatch Waxman pharmaceutical litigation. The panel will also discuss strategies and tactics regarding claim language and label language, as well as types of evidence to adduce to prove inducement of infringement.
Description
On May 15, 2023, the U.S. Supreme Court denied certiorari in Teva Pharms. USA Inc. v. GlaxoSmithKline L.L.C., which brought attention to alleged skinny labels for generics. The Federal Circuit had twice reinstated the jury verdict of induced infringement in a drug patent case that was post-launch and non-Hatch Waxman [GlaxoSmithKline L.L.C. v. Teva Pharms. USA Inc. (Fed. Cir. Oct. 2, 2020)]. The appeals court found to be substantial evidence of inducement Teva's press releases and promotional materials affirmatively, inter alia, promoting its carvedilol tablet as the AB generic equivalent of Coreg®.
The decisions provide guidance regarding what is a skinny label and other evidence such as press releases, promotional materials, and drug classification, such as AB rating, in a post-launch, non-Hatch Waxman pharmaceutical litigation, most notably that the carveout is not a guarantee of avoiding induced infringement under circumstances where the generic label is not truly a skinny label. The Federal Circuit majority agreed with GSK that "precedent makes clear that when the provider of an identical product knows of and markets the same product for intended direct infringing activity, the criteria of induced infringement are met."
Listen as our authoritative panel of patent attorneys examines the recent decision in Teva v. GSK and GSK v. Teva decision and any other relevant, post-launch, non-Hatch Waxman pharmaceutical litigations, and the implications for post-launch, non-Hatch Waxman induced infringement cases. The panel will also discuss strategies and tactics regarding claim language and label language, as well as types of evidence to adduce to prove inducement of infringement.
[see straffordpub link for outline]
The panel will review these and other noteworthy issues:
What impact will GSK v. Teva and other recent decisions have on proving induced infringement?
What impact will recent decisions have on claim and label drafting?
What strategic considerations should patent owners keep in mind when labeling FDA-approved drugs?
Panel Faculty:
Mark J. Feldstein, Ph.D., Partner
Kyu Yun Kim, Associate
Finnegan Henderson Farabow Garrett & Dunner
Thomas L. Irving, Partner
Michelle E. O'Brien, Partner
The Marbury Law Group
Another “It’s the EPA, stupid” arrow in the quiver for battle against EPA deniers
Lipid Structure Influences the Digestion and Oxidation Behavior of Docosahexaenoic and Eicosapentaenoic Acids in the Simulated Digestion System
Gabriele Beltrame, Eija Ahonen, Annelie Damerau, Haraldur G. Gudmundsson, Gudmundur G. Haraldsson, and Kaisa M. Linderborg
J. Agric. Food Chem. 2023
Published by American Chemical Society
Publication Date:June 20, 2023
https://doi.org/10.1021/acs.jafc.3c02207
From abstract:
Ethyl esters were mainly unaffected. EPA was expectedly less susceptible to oxidation prior to and during the digestion process, particularly in sn-2. These results are relevant for the production of tailored omega-3 structures to be used as supplements or ingredients.
In general, EPA was more resistant to oxidation and less resistant to digestion compared to DHA.
Diabetic benefit: EPA found to reduce cardiovascular risk in patients – meta analysis
https://www.nutraingredients-asia.com/Article/2023/06/13/epa-in-omega-3-fatty-acids-found-to-reduce-cardiovascular-risk-in-diabetic-patients
EPA and Mixed Omega-3 Fatty Acids: Impact on Dyslipidemia and Cardiovascular Events in Patients with Diabetes
https://link.springer.com/chapter/10.1007/978-3-031-26681-2_25
Chapter
First Online: 17 June 2023
Part of the Contemporary Diabetes book series (CDI)
Abstract
Diabetes is a global issue, affecting 537 million people worldwide and projected to reach 783 million by 2045. Patients with type 2 diabetes mellitus have up to a threefold increased risk for atherosclerotic cardiovascular disease (ASCVD). While statins help reduce this risk, residual risk persists. Elevated triglyceride levels contribute to residual CV risk and have been shown to be an independent risk factor for ASCVD. Prescription omega-3 fatty acids (OM3FAs) are approved to reduce elevated triglyceride levels, and in 2019, the highly purified eicosapentaenoic acid agent, icosapent ethyl, became the only OM3FA approved to reduce the risk of CV events in patients with established ASCVD or those with diabetes and at least two other risk factors. This chapter provides insight on the impact of OM3FAs on lipid levels, proposed mechanisms of action conferring cardioprotective effects, results of key clinical trials, and current guidelines for use of OM3FAs in patients with diabetes.
Chinese VHTG study results
Published: 10 June 2023
Icosapent ethyl therapy for very high triglyceride levels: a 12-week, multi-center, placebo-controlled, randomized, double-blinded, phase III clinical trial in China
Zhen Wang, Xin Zhang, …Junbo Ge
Lipids in Health and Disease volume 22, Article number: 71 (2023)
https://doi.org/10.1186/s12944-023-01838-8
Conclusions
IPE at 4 g/day dramatically lowered other atherogenic lipids without a noticeable increase in LDL-C, thereby decreasing TG levels in an exceptionally high-TG Chinese population.
The authors believe that the REDUCE-IT study's findings might be used to further support the therapeutic benefits of cardiovascular risk reduction in Chinese patients
New IAS guidelines include Icosapent Ethyl
Watts, G.F., Gidding, S.S., Hegele, R.A. et al. International Atherosclerosis Society guidance for implementing best practice in the care of familial hypercholesterolaemia. Nat Rev Cardiol (2023).
Accepted 12 May 2023, Published 15 June 2023
DOI https://doi.org/10.1038/s41569-023-00892-0
See within Treatment section:
In patients with FH and established clinical ASCVD, the use of aspirin, colchicine and eicosapentaenoic acid should be implemented according to evidence-based guidelines for secondary prevention of ASCVD172,173,174,175,176,177,178.
172. Bhatt, D. L. et al. Cardiovascular risk reduction with icosapent ethyl for hypertriglyceridemia. N. Engl. J. Med. 380, 11–22 (2019).
173. Orringer, C. E., Jacobson, T. A. & Maki, K. C. National Lipid Association Scientific Statement on the use of icosapent ethyl in statin-treated patients with elevated triglycerides and high or very-high ASCVD risk. J. Clin. Lipidol. 13, 860–872 (2019).
174. Budoff, M. J. et al. Effect of icosapent ethyl on progression of coronary atherosclerosis in patients with elevated triglycerides on statin therapy: final results of the EVAPORATE trial. Eur. Heart J. 41, 3925–3932 (2020).
175. Skulas-Ray, A. C. et al. Omega-3 fatty acids for the management of hypertriglyceridemia: a science advisory from the American Heart Association. Circulation 140, e673–e691 (2019).
176. Visseren, F. L. et al. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice: Developed by the Task Force for cardiovascular disease prevention in clinical practice with representatives of the European Society of Cardiology and 12 medical societies With the special contribution of the European Association of Preventive Cardiology (EAPC). Eur. Heart J. 42, 3227–3337 (2021).
Jefferies Healthcare Conference (June 7-9, 2023; New York, New York)
Date/Time: June 7, 2023, 8:00 a.m. ET
Webcast: https://wsw.com/webcast/jeff281/amrn/1850420
I used email after finding the web contact form broken/glitchy (they said they’re letting their web developer know):
investor.relations@amarincorp.com
Swiss pharma giant Novartis expects China to be its second biggest market by 2024
"Currently, China is one of our most strategic markets globally. It ranks third within our global revenue. Last year, we were among the fastest-growing companies in China. We had a 19 percent growth which was really very strong," he added.
With more than 36 years of history in China, Novartis has primarily focused on providing innovative medicines to the Chinese market, Brindle said.
https://english.news.cn/20220813/a3617b8ec4aa4ca6b4bc6d75e8efaa15/c.html
Mentions Novartis China (From April 2021)
Last year, Novartis China sales grew 16 percent to US$2.6 billion, compared with a global increase of 3 percent. The company said it plans to double its China business, with 50 new drug applications by 2024.
Novartis China (From April 2021)
Last year, Novartis China sales grew 16 percent to US$2.6 billion, compared with a global increase of 3 percent. The company said it plans to double its China business, with 50 new drug applications by 2024.
Another EPA & air pollution study… highly relevant for Vascepa uptake in China
Sherratt SCR, Libby P, Dawoud H, Bhatt DL, Malinski T, Mason RP. Eicosapentaenoic acid (EPA) reduces pulmonary endothelial dysfunction and inflammation due to changes in protein expression during exposure to particulate matter air pollution. Biomed Pharmacother. 2023 Jun;162:114629. doi: 10.1016/j.biopha.2023.114629. Epub 2023 Apr 5. PMID: 37027984.
https://pubmed.ncbi.nlm.nih.gov/37027984/
Conclusion: These cellular changes may contribute to anti-inflammatory, cytoprotective and lipid changes associated with EPA treatment during air pollution exposure.
Eicosapentaenoic acid (EPA) treatment increased the ratio to arachidonic (EPA/AA) and reduced adhesion molecule expression in vascular endothelium during inflammation
S C R Sherratt, P Libby, D L Bhatt, P Mason
European Journal of Preventive Cardiology, Volume 30, Issue Supplement_1, June 2023, zwad125.177
https://doi.org/10.1093/eurjpc/zwad125.177
Published: 24 May 2023
Results
EPA treatment increased the EPA/AA ratio by >20-fold compared to IL-6 treatment alone (1.55 ± 0.11 vs. 0.07 ± 0.003, p<0.001). The increased EPA/AA ratio correlated with EPA and docosapentaenoic acid (DPA) levels in lysates, which increased by 19-fold (26.71 ± 1.28 vs. 1.28 ± 0.05 mg/g protein, p<0.001) and 4-fold (29.42 ± 1.91 vs. 6.17 ± 0.36 mg/g protein, p<0.001), respectively, compared to IL-6. While IL-6 treatment increased sICAM-1 release (83%, p<0.001), subsequent treatment with EPA reduced sICAM-1 release by 39% (p<0.001).
Conclusion
In human ECs, EPA increased the EPA/AA ratio along with other n3-FAs under conditions of inflammation. Changes in the EPA/AA ratio correlated with reductions in sICAM-1 release with IL-6 exposure. As on-treatment EPA levels predict reduced CV risk, these direct vascular benefits of EPA may contribute to reduced CV risk observed in outcome trials.
Sleven, IR confirms job postings aren’t real:
Thank you for sending. It is inaccurate and we will work to fix this.
-----Original Message-----
From: investor.relations@amarincorp.com <investor.relations@amarincorp.com>
Sent: Thursday, June 1, 2023 10:25 AM
Are the 47 job postings at … legitimate or possibly falsified? Please see my post at … I also reported to PharmVille that these look suspicious and suggest they contact you to verify.
Sleven, so I did just send a note to IR to inquire if the job postings are legitimate and submitted a comment to PharmVille suggesting they should be verified. Will let you know if I hear anything.
dogn
Sleven, I don't think these job posts are authentic.
If you go to the Pharmville link you can click on the job titles to open up a description, e.g. see https://www.pharmaceuticaljobboard.com/job/337766/sales-professional/
Putting the text in Google Search led me to identical text from 2021 job postings:
e.g. https://lensa.com/sales-professional-baltimore-md-jobs/baltimore/jd/8bee2a1941b0e877baae4e06ea38afb7 which states "This job was posted on Mon Jul 26 2021 and expired on Thu Jul 29 2021."
Searching for Amarin jobs at Lensa today also seemed to produce no results.
Found identical job description text at this "ChatGPT for Job Seekers" site:
https://tarta.ai/j/THy7e4MBf__BEUSnh2JT0922-sales-professional-portland-sw-or-in-portland-oregon-at-amarin-corporation
which says posting was April 27, 2021.
Search also led to an old job posting with identical text in Charlotte, NC on Linked in: https://www.linkedin.com/jobs/view/136957105/
This post is undated but has text "No longer accepting applications"
It appears that ANYONE can register and post jobs on PharmVille (though I didn't try to register): https://www.pharmaceuticaljobboard.com/registration/?user_group_id=Employer
leading me to believe these may be forged, perhaps by someone trying to pump the stock?
Note the PharmVille "terms & conditions" at https://www.pharmaceuticaljobboard.com/terms-of-use/ contains the text (emphasis mine):
User Information
PharmVille does not hold responsibility for any untruthful and/or inaccurate information included in job posts and profiles.
PharmVille reserves the right to edit or delete any information submitted by the user to the website.
Thanks, I missed that... had just searched doc for "BRAVE".... but now see they mention under "Research underway": "brain amyloid and vascular effects [of eicosapentaenoic acid] in Alzheimer's disease."
NS, may be dated source of job info?
These direct sources from Amarin show only 2-7 job openings, all in Europe:
2: https://www.linkedin.com/jobs/amarin-corporation-jobs-worldwide/?currentJobId=3618571032
7: https://amarincorp.com/our-commitment/open-positions
7: https://www.linkedin.com/company/amarin-corporation/jobs/
A Cognitive Vitality Report on EPA written by neuroscientists at the Alzheimer’s Drug
Discovery Foundation
https://www.alzdiscovery.org/uploads/cognitive_vitality_media/EPA-prescription-Cognitive-Vitality-For-Researchers.pdf
From 2018, but I had not seen this before. Does not mention BRAVE study.
Neuroprotective Benefit: Not likely beneficial unless you have low levels of EPA or high triglycerides.
Types of evidence:
• 6 epidemiology studies for risk of dementia, cognitive decline, or brain imaging
• 1 meta-analysis for levels in dementia patients
• 1 pilot open-label study in dementia patients
• 1 preclinical study in PBMCs from Alzheimer’s patients
UK NHS Updated lipid pathway
The lipid management pathway for secondary prevention of cardiovascular disease has been updated. Changes include:
A statement has been added to ensure statin intolerance pathway has a clear emphasis
Further highlighting of the position of icosapent ethyl (Vaskepa®)
Inclisiran option for prescribing has been made clearer
The updated pathway is available on the clinical guidance and pathways page, along with links to other lipid management resources.
https://gmmmg.nhs.uk/updated-lipid-pathway/
[Guidelines have Feb 2023 issue date but this page shows update per google search posted 4 days ago]
The benefits of icosapent ethyl in addressing residual risk: What is the evidence?
10' EDUCATION - MAY 26, 2023 - LALE TOKGÖZOGLU, MD - ANKARA, TURKEY
https://pace-cme.org/2023/05/26/the-benefits-of-icosapent-ethyl-in-addressing-residual-risk-what-is-the-evidence/
Potential mechanisms of benefit with EPA 0:18
Findings of studies with EPA 2:17
Findings of studies with a mixture of EPA and DHA 5:00
Differences in studies with omega-3 fatty acids 5:47
Additional studies with EPA 7:55
Conclusive remarks 8:56
Educational information
This lecture by Lale Tokgözoglu was part of the EBAC-accredited symposium " New paradigms in the prevention of ASCVD: The role of EPA and triglycerides" held during ESC Preventive Cardiology in Malaga, Spain.
Faculty
Prof. Lale Tokgözoglu, MD, is Professor of Cardiology at Hacettepe University, Ankara, Turkey.
Disclosures
This recording was independently developed under auspices of PACE-cme. The views expressed in this recording are those of the individual presenter and do not necessarily reflect the views of PACE-cme.
Funding
Funding for this educational program was provided by an unrestricted educational grant received from Amarin.
[Click on slides to view w/o need to log in]
Pharmacotherapeutics for dyslipidemia management
El Hussein, Mohamed Toufic PhD, RN, NP; Sharma, Aditi RN; Parmar, Komal RN; Shelat, Krupa RN
The Nurse Practitioner 48(6):p 36-47, June 2023. | DOI:10.1097/01.NPR.0000000000000059
Effective management of dyslipidemia is of paramount importance to prevent cardiovascular (CV) complications. Using current clinical practice guidelines is recommended to correct lipid levels and prevent further pathologic processes. This article presents an overview of treatment options for patients with dyslipidemia and CV disease, with a special focus on the following drug classes: HMG-CoA reductase inhibitors (also called statins), cholesterol absorption inhibitors (ezetimibe), bile acid sequestrants, fibrates, icosapent ethyl, and PCSK9 inhibitors.
New Drugs for Cardiovascular Disease
https://vial.com/blog/articles/beating-the-odds-the-development-of-new-drugs-for-cardiovascular-disease/
The identification of new cardiovascular drug targets has led to advancements in drug development over recent years. These emerging medications have transformed the landscape of cardiovascular treatments by addressing unmet medical needs or supporting existing therapies. Below we list a few of the advancement of new drugs for cardiovascular disease.
1. Inclisiran
The U.K. National Health Service and the National Institute for Health and Care Excellence (NICE) collaborated in 2020 with pharmaceutical company Novartis to test the drug inclisiran, as a treatment to lower cholesterol. Early results from previous trials suggested that out of 300,000 patients taking inclisiran annually, the treatment could prevent 55,000 heart attacks and strokes.
The U.S. FDA approved inclisiran (Leqvio) in 2021.
Inclisiran is a bi-annual injection that lowers low-density lipoprotein cholesterol (LDL or “bad cholesterol”) with 2 doses a year. It improves the liver’s natural ability to mitigate the production of a protein that maintains high levels of circulating cholesterol. It is intended for use alongside proper diet and maximally tolerated statin therapy.
2. Icosapent ethyl
In 2021, the E.U. approved the use of icosapent ethyl (Vazkepa) as a medication to reduce the risk of cardiovascular events such as heart attacks and strokes. It is intended as a tandem treatment to statin medicine for adults with high levels of triglycerides in their blood.
Icosapent ethyl can be taken by patients who either have a cardiovascular disease or have other comorbidities that increase the risk of a cardiovascular event.
Vazkepa is prescribed as a capsule with 998mg of icosapent ethyl, taken twice daily with or after meals. The active compound has an anti-inflammatory effect, reduces harmful triglyceride-rich proteins, and incites a protective antioxidant effect.
3. Mavacamten
In late 2020, Bristol-Myers Squibb acquired the heart drug company MyoKardia, which specializes in small molecule therapies for patients with genetic heart disease. MyoKardia focuses on diseases such as hypertrophic cardiomyopathy (thickening of heart walls) and dilated cardiomyopathy (weakening of heart walls).
MyoKardia’s biggest asset is the compound mavacamten, a “potentially revolutionary” medicine for treating obstructive hypertrophic cardiomyopathy (HCM). This chronic heart disease has a high morbidity rate and is most prevalent in people aged 40–50 years old.
The drug company uses its proprietary drug discovery platform to combine cardiovascular genomics and heart muscle biology to target heart conditions at the genetic level.
In 2022, Bristol-Myers Squibb announced that the U.S. FDA had approved mavacamten (Camzyos) for treatment.
The Emerging Role of Icosapent Ethyl in Patients with Cardiovascular Disease: Mechanistic Insights and Future Applications
https://www.mdpi.com/2077-0383/12/11/3758
In conclusion, recent clinical and imaging studies have demonstrated the protective effects of highly purified omega-3 fatty acids in reducing residual cardiovascular risk in statin-treated patients. The inconsistency in some clinical outcome data is likely related to the type of experimented omega-3 PUFA and the targeted cohort. The disconnection between cardiovascular risk reduction with omega-3 PUFAs and triglyceride levels would urge better identification of patients who are likely to benefit from this emerging treatment.
This research received no external funding.
Captain,
Please feel free to post on Twitter… I don’t follow my account there. Posted on ST
dogn
A Critical Review of Icosapent Ethyl in Cardiovascular Risk Reduction
https://pubmed.ncbi.nlm.nih.gov/37188993/
Conclusions
While the mechanism is not thoroughly understood, evidence shows that IPE is efficacious in reducing risk of CV events in those with elevated TG levels, and many global medical societies recognize IPE as an important therapy in CV prevention and treatment. IPE with its 99.99% pure composition of EPA, is the first fish oil or omega-3 ethyl ester to show these results. With each new analysis, new hypotheses are made as to the reasons for its efficacy. Major clinical studies are ongoing and will hopefully provide more insight and data to further support the possibility of IPE serving as an alternative option for patients who cannot tolerate statins or who require additional therapy for CV risk reduction or reduction of TG levels.
Happy Birthday, North.
dogn
Don’t know if that’s the same trial or not. Placebo composition and citation was quoted in my post “…non-mineral oil placebo group (per 100 mg: microcrystalline cellulose 89.83 mg, hydroxypropyl cellulose 10.07 mg, and caramel 0.10 mg) from the Garlic 5 study [Citation138].”
Kiwi, see "EPA’s pleiotropic mechanisms of action: a narrative review"
https://www.tandfonline.com/doi/full/10.1080/00325481.2021.1921491
"In light of the previous comments regarding mineral oil as a placebo, it was decided to compare the rates of progression of total plaque and total non-calcified plaque on coronary computed tomography angiography in the mineral oil placebo group from EVAPORATE with the non-mineral oil placebo group (per 100 mg: microcrystalline cellulose 89.83 mg, hydroxypropyl cellulose 10.07 mg, and caramel 0.10 mg) from the Garlic 5 study [Citation138]. This comparison found no significant differences in progression of log total plaque volume (ß: 0.03 ± 0.13; P = 0.84) or log total non-calcified plaque volume (ß: 0.01 ± 0.16; P = 0.94) between the mineral oil and non-mineral oil placebo groups. Conversely, the HEARTS trial, which investigated the effects of a mixed EPA plus DHA product on plaque, failed to show a significant difference in the change from baseline of non-calcified plaque, fibrous plaque, fatty plaque, calcified plaque, and total plaque when compared with placebo at 30 months [Citation139]."
And "The Evolving Role of Omega 3 Fatty Acids in Cardiovascular Disease: Is Icosapent Ethyl the Answer?"
https://www.touchcardio.com/atherosclerosis/journal-articles/the-evolving-role-of-omega-3-fatty-acids-in-cardiovascular-disease-is-icosapent-ethyl-the-answer/
"There has been some interest in the effect of different placebos used in the REDUCE-IT trial (mineral oil) versus the STRENGTH trial (corn oil) on the differential outcomes of the trials. Concerns have been raised regarding the validity of results in the REDUCE-IT trial, in part questioning the stipulated biological activity of the mineral oil placebo linked to observed changes in cardiac biomarkers in the placebo arm of the trial. In a post-hoc analysis comparing serial CCTA in the mineral oil placebo arm in EVAPORATE to a cellulose-based placebo cohort in the GARLIC5 study, no differences were observed in the rate of coronary plaque progression in the two groups.56,57 In addition, consistent and significant benefits of EPA on coronary atherosclerosis and CV outcomes have been demonstrated in Japanese populations in the open-label CHERRY and JELIS trials, where no placebo comparator groups were included.40,58
A detailed review of literature has shown that mineral-oil-related changes in TGL, low-density lipoprotein cholesterol and other biomarkers have been mostly inconsistent across studies, and are not clinically meaningful to explain the substantially positive results of REDUCE-IT.59 In a review of REDUCE-IT by the US Food and Drug Administration (FDA), they concluded that the magnitude of difference in outcomes between IPE and mineral oil groups could not be explained by the stipulated harmful effects of mineral oil placebo.60 Therefore, a summary of current evidence supports the validity of CV benefits with IPE in the REDUCE-IT and EVAPORATE trials, and attests to the results not being influenced by the small amount of mineral oil used in the placebo capsules."
Most likely EVAPORATE used mineral oil placebo for consistency with REDUCE-IT trial.
Deterioration in placebo arm assumed due to untreated plaque progression, placebo assumed to be inert
Authors of Evaporate previously "demonstrated that progression rates on mineral oil placebo is similar to non-mineral oil placebo cohort using same methodology, scanner and laboratory."
Text from conclusion slide at https://www.acc.org/education-and-meetings/image-and-slide-gallery/media-detail?id=bb727249a4bd45dcb9ed91b45bd5957c (non-mineral oil cohort GARLIC5 trial, compared to EVAPORATE in 3rd from last slide "Analysis of Covariance for Log_FU_Sum_TotPlaq_mm3"
(slides from Related Content section of https://www.acc.org/latest-in-cardiology/clinical-trials/2019/11/15/17/46/evaporate)
The EVAPORATE trial publication at https://academic.oup.com/eurheartj/article/41/40/3925/5898836 has been cited 233 times according to Google Scholar https://scholar.google.com/scholar?hl=en&as_sdt=0%2C15&q=EVAPORATE+budoff
Recent publications:
New IPE cost effectiveness study in Canadian population:
https://www.tandfonline.com/doi/full/10.2147/CEOR.S377935
“Based on the clinical trial evidence, we found that IPE could be a cost-effective strategy for treating these patients in Canada.”
New publication in European Heart Journal - Cardiovascular Imaging, “Benefit of icosapent ethyl on coronary physiology assessed by computed tomography angiography fractional flow reserve: EVAPORATE-FFRCT”:
https://academic.oup.com/ehjcimaging/advance-article/doi/10.1093/ehjci/jead063/7135508
“Conclusion: Icosapent ethyl demonstrated significant benefits in coronary physiology compared with placebo. This early and sustained improvement in FFRCT at 9- and 18-month follow-up provides mechanistic insight into the clinical benefit observed in the REDUCE-IT trial. Furthermore, this is the first assessment of FFRCT to determine drug effect.”
New publication "Clinical results and mechanism of action of icosapent ethyl" by
Claudio Borghi, Alessio Bragagni in European Heart Journal Supplements, Volume 25, Issue Supplement_B, April 2023, Pages B37–B40, https://doi.org/10.1093/eurheartjsupp/suad088
Published: 21 April 2023
“Surprisingly, these brilliant results seem to be, at least in part, not related to the reduction of triglyceride concentration. The purpose of this article is to examine the latest evidence regarding icosapent ethyl therapy, describing the results of the main clinical trials performed to date and formulating hypotheses on the potential mechanisms of action of this fascinating molecule.”
NS, Thanks.
dogn
I also do not understand the significance of Mochida being a plaintiff with Amarin in the infringement suit against Hikma & Healthnet, which I only noticed recently and have not seen any discussion of here. That suggests the partnership/alliance/license agreement between Amarin & Mochida is still in force, even though much is unclear, as you say.
https://casetext.com/case/amarin-pharma-v-hikma-pharmus
“ Civil Action No. 20-1630-RGA-JLH
01-04-2022
AMARIN PHARMA, INC., Amarin Pharmaceuticals Ireland Limited, Mochida Pharmaceutical Co., Ltd. Plaintiffs; v. HIKMA PHARMACEUTICALS USA INC., Hikma Pharmaceuticals PLC, and Health Net, LLC, Defendants.”
Amarin - Mochida collaboration:
June 12, 2018 PR: https://investor.amarincorp.com/news-releases/news-release-details/amarin-and-mochida-announce-collaboration-future-development-epa
2018: "In November 2017, Mochida entered an agreement with Meiji Seika Pharma Co., Ltd. to market in Thailand Epadel S, a high-purity ethyl icosapentate (EPA) product, which Mochida markets in Japan. In June 2018, Mochida also entered an agreement with Amarin Corporation Plc Group to develop and commercialize high-purity EPA products in the US and certain other countries under Mochida’s intellectual properties, including new EPA formulation."
https://www.mochida.co.jp/english/annual/docs/mochida_annual_review2018_full.pdf
2019: "Mochida also entered into an agreement with Amarin Corporation Plc in June 2018 for the development and commercialization of EPA-based drug products in the United States and certain other territories."
https://www.mochida.co.jp/english/annual/docs/mochida_annual_review2019_full.pdf
2020: "Mochida also entered into an agreement with Amarin Corporation Plc for the development and commercialization of high-purity EPA formulations in the United States and certain other territories by Amarin Corporation Plc."
https://www.mochida.co.jp/english/annual/docs/mochida_annual_review2020.pdf
2021 & 2022: no mention of Amarin in entire reports ??
https://www.mochida.co.jp/english/annual/docs/ir2021e.pdf
https://www.mochida.co.jp/english/annual/docs/ir2022e.pdf
Also, previously posted observation (https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169843958) that Mochida removed their 2018 press release (https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169630832) about the collaboration from their website https://www.mochida.co.jp/english/news/#anchor-2018
prior Sept. 7, 2022 post on Epadel EM launch: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169892084
prior post on collaboration agreement: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169848825
Denner, what happened here?
Epadel EM - From Mochida annual report
Epadel, launched in 1990, was the world’s first preparation of high purity eicosapentaenoic acid (EPA). EPA is one of the fatty acids found in fish such as sardines. Furthermore, we improved the formulation of this product aiming at maximizing intestinal absorption and launched Epadel EM in 2022.
“Looking at our development pipelines, we obtained manufacturing and marketing approval for Epadel EM (development code: MND-2119), for the treatment of hyperlipidemia.”
2022 Epadel EM
(a self-emulsifying formulation of highly purified EPA)
“We are also leveraging our alliances to globally expand our EPA drug with high purity in China, Thailand, Vietnam and the United States. In Thailand, the subsidiary of Meiji Seika Pharma Co., Ltd. obtained approval to import and market our EPA drug for the treatment of hypertriglyceridemia in October 2020 and commenced sales in April 2021. In Vietnam, an alliance partner of Meiji Seika Pharma is in the process of applying for approval to import and market our EPA drug.”
p. 13: In addition, we will strive to leverage our experience as a leading manufacturer of highly purified EPA drug in marketing activities for Epadel EM, a self-emulsifying
formulation of highly purified EPA launched in September 2022.
“Cardiovascular medicine
Urece®, a selective urate reabsorption inhibitor (SURI) released in 2020, is a therapeutic agent for gout and hyperuricemia. …
We are also making our presence felt in the cardiovascular field as a leading manufacturer of highly purified EPA drugs. In addition to Epadel, a high-purity EPA drug, which, through various mechanisms, slows atherosclerotic plaque progression, we launched Epadel EM, a new self-emulsifying formulation of Epadel, in September 2022. Epadel EM is a new formulation of Epadel for the treatment of hyperlipidemia. It uses self-emulsifying formulation technology in order to improve gastrointestinal absorption. As the world’s first high-purity EPA drug that can be given in a single daily dose, we expect Epadel EM to be able to help improve the QOL of patients.
With these high-purity EPA drugs and other products such as Atelec®, a calcium channel blocker with a long-acting hypotensive effect, and Treprost®, a therapeutic product for pulmonary arterial hypertension, we are taking on the cardiovascular field.
From https://www.mochida.co.jp/english/annual/docs/ir2022e_p.pdf
Why no mention of licenses or alliance with Amarin?
When Vascepa EM?
Icosapent ethyl and plaque regression: insights from the EVAPORATE-FFRCT study
Sykes, R. and McFarlane, R. (2023)
European Heart Journal: Cardiovascular Imaging, (Accepted for Publication)
Just Acceptance notice-Posted in past day- Not yet available
https://eprints.gla.ac.uk/296488/
My guess is some patients find swallowing the smaller 0.5g capsule to be easier, but I do wonder if there’s a strategic tactic for skirting patent infringement etc. , eg I think teva introduced only the 0.5g capsule (iirc)
Feb. 2023 Arnold & Palmer report "SIGNIFICANT 2022 DECISIONS AFFECTING PRIVATE COMPANY M&A"
includes 5+ pages on Goldstein v. Denner, C.A. No. 2020-1061-JTL, 2022 WL
1671006 (Del. Ch. May 26, 2022)
https://www.mondaq.com/pdf/1286004.pdf
Clear summary of case.
Includes in Takeaways an interesting footnote: 43 Sarissa is not a dedicated activist fund, but often acts more like a sophisticated life sciences private equity fund. Mr. Denner did not seem to have joined the Company’s board in an activist capacity.
IMO, this case (1) keeps Sarissa from buying more shares (which some posters harp about) and (2) may lead AD to prefer to not be on the board and (3) will help ensure every step towards the future Amarin sale is taken with extra care and caution.
dogs
Great comparison plot, Captain. Thanks
dogn