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Yes, Springer is a major publisher in all areas of science and engineering
https://group.springernature.com/gp/group/about-us/health-business
https://www.springermedizin.de/hypercholesterinaemie/praevention-und-rehabilitation-in-der-kardiologie/triglyzeridsenker-schuetzt-nicht-nur-hochrisikopatienten/27045912
Icosapent Ethyl for cardiovascular risk reduction (apparently featuring recent ACC24 data) published in yesterday’s news section of German SpringerMedizin.de - My expertise
Better informed doctors make better decisions.
The bundled expertise from all specialties supports you in keeping an eye on medical progress and being able to offer the best possible treatment.
https://www.springermedizin.de/
https://www.statnews.com/2024/04/29/alex-denner-bioverative-settlement/
Activist investor Alex Denner, Bioverativ shareholder reach tentative settlement in insider trading case
Regarding reported expiration of former CEO Karim Mikhail’s exercisable options on May 1:
Found this Feb. 29 21 page court decision in Mikhail vs Amarin denying defendants motion to dismiss and allowing limited discovery. Interesting references to altar ego and veil piercing arguments regarding establishing jurisdiction, & relationships between NJ based Amarin Inc vs Amarin plc vs Amarin Switzerland.
As KM’s employment contract had terms regarding accelerated vesting of options under change of control as he is claiming led to his termination, I assume his expiring options might still be in play until lawsuit is settled. Perhaps not something to get too excited about on May 1.
https://law.justia.com/cases/federal/district-courts/new-jersey/njdce/3:2023cv01856/510557/33/
https://cases.justia.com/federal/district-courts/new-jersey/njdce/3:2023cv01856/510557/33/0.pdf?ts=1709398751
dogn
Effects of icosapent ethyl according to baseline residual risk in patients with atherosclerotic cardiovascular disease: results from REDUCE-IT
Pascal M Burger, MD, Deepak L Bhatt, MD, MPH, MBA, Jannick A N Dorresteijn, MD, PhD, Stefan Koudstaal, MD, PhD, Arend Mosterd, MD, PhD, Fabrice M A C Martens, MD, PhD, P Gabriel Steg, MD, Frank L J Visseren, MD, PhD for the REDUCE-IT Investigators
European Heart Journal - Cardiovascular Pharmacotherapy, pvae030, https://doi.org/10.1093/ehjcvp/pvae030
Published: 27 April 2024
https://academic.oup.com/ehjcvp/advance-article/doi/10.1093/ehjcvp/pvae030/7659360
Lp(a) Linked to Higher ASCVD Risks in Diverse Patient Groups
Investigators and others think it might be time for everybody in the US to have their Lp(a) screened at least once in a lifetime.
https://www.tctmd.com/news/lpa-linked-higher-ascvd-risks-diverse-patient-groups
High on Lipoprotein-
https://www.jacc.org/jacc-edge/current
Review | Open Access | 7 Apr 2024
Lipid-lowering therapies in patients undergoing percutaneous coronary intervention
https://www.oaepublish.com/articles/2574-1209.2023.136
“Furthermore, icosapent ethyl, a purified derivative of eicosapentaenoic acid, targets hypertriglyceridemia and has shown cardiovascular benefits compared to placebo. In this article, we delve into the mechanisms of blood lipids and molecular targets in connection with CAD undergoing PCI. We also explore the current landscape of available LLT options, guidelines in practice, and the subtleties of therapy.”
Activist Investor Conference Coverage Team April 9, 2024 Show Notes:
Why should investors pay attention to activism in healthcare? In this episode, Adam Torres and Patrice Bonfiglio, President at Sarissa Capital Management LP, explore the current state of activism in healthcare.
About Sarissa Capital Management LP
Sarissa Capital Management was founded by Alex Denner, Ph.D., in 2013 to capitalize on compelling opportunities for constructive shareholder activism within the healthcare sector. Sarissa’s team of subject matter experts and philosophy of thoughtful engagement aims to create positive outcomes for investors, shareholders and patients by taking an owner-oriented approach to their investments. Sarissa seeks to optimize healthcare companies so they can efficiently provide important medicines to society and increase the impact of medical innovation, while also generating value to shareholders.
https://missionmatters.com/current-state-of-activism-in-healthcare/
There’s mention of Amarin, proxy fight, global expansion, patent extension, etc
Correction to: Cost-Effectiveness of Icosapent Ethyl in REDUCE-IT USA: Results From Patients Randomized in the United States
Originally published 2 Apr 2024
https://doi.org/10.1161/JAHA.123.027774
Journal of the American Heart Association. 2024;0:e9534
Because the added cost of icosapent ethyl was overestimated, there were errors in the cost difference between icosapent ethyl and standard care.
The last sentence of the Abstract, which read “At a medication cost of $11.48 per day, the cost per quality-adjusted life-year gained was $36 208 in trial and $9582 over the lifetime” has been corrected to read “At a medication cost of $11.48 per day, the cost per quality-adjusted life-year gained was $36 208 in trial and $4135 over the lifetime.”
…
In the first paragraph of the Discussion section, the incremental cost-effectiveness ratio was described as follows: “At $11.48 per day, the ICER was $9582. At a threshold of <$50 000 per QALY gained, IPE was cost-effective in 99.7% of simulations using net cost and 91.3% WAC costs.” This was corrected to read “At $11.48 per day, the ICER was $4135. At a threshold of <$50 000 per QALY gained, IPE was cost-effective in 99.7% of simulations using net cost and 93.1% WAC costs.”
The authors regret the errors.
Here’s that link:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174171442
“Scientists hypothesize that GLP-1 drugs may help with Parkinson’s by reducing inflammation and protecting neurons from dying, which — if proven out — would be a critical new way of treating the disease.”
Thanks for pointing to this, North.
dogn
Sleven,
Optimistic over recent appeal status & EU patent extension. Keep up with the board most days and grateful always for your thoughtful & informative posts. Continue to reduce losses, basis and risk, anticipating brighter days ahead for this drug.
Best,
dogn
lol
I give up fighting iHub duplicates
Practice Update STORY OF THE WEEK
Published in Cardiology
Journal Scan / Research · April 03, 2024
Lp(a) Blood Levels and Cardiovascular Risk Reduction With Icosapent Ethyl
Journal of the American College of Cardiology
TAKE-HOME MESSAGE
This post hoc analysis of a large, randomized, placebo-controlled trial (REDUCE-IT) evaluated the use of icosapent ethyl (IPE; an active form of omega-3 and the generic form of Vascepa) in reducing the risk of major adverse cardiovascular events (MACE) across a range of lipoprotein(a) (Lp[a]) levels. The authors found that IPE therapy reduced the risk of MACE in all patients, including those with clinically relevant elevated Lp(a) levels.
Lp(a) is a common genetic variant of lipoprotein that elevates MACE risk despite statin therapy and LDL-C control. This study suggests a role for IPE therapy in lowering the risk of MACE in this population, who otherwise has limited treatment options.
– Timothy Overton, MD, MPH
https://www.practiceupdate.com/content/lpa-blood-levels-and-cardiovascular-risk-reduction-with-icosapent-ethyl/164034
Medscape Medical News > Conference News > ACC 2024
Lp(a) Tied to Higher CVD Events; Risk Reduction With IPE
Pauline Anderson
April 04, 2024
https://www.medscape.com/viewarticle/lp-tied-higher-cvd-events-risk-reduction-ipe-2024a10006d8
New from Saudi Arabia authors
Taher Z A, Taher A A, Radi S (March 16, 2024) An Update on Dyslipidemia Management and Medications: A Review. Cureus 16(3): e56255. doi:10.7759/cureus.56255
https://www.cureus.com/articles/225432-an-update-on-dyslipidemia-management-and-medications-a-review
https://assets.cureus.com/uploads/review_article/pdf/225432/20240316-1782-zyexoy.pdf
Omega-3 Fatty Acids (FAs)
“Similar to fibrates, omega-3 FAs primarily impact triglycerides, reducing levels by 25%-30%. They are approved by the American Heart Association for use in hypertriglyceridemia. However, certain forms of omega-3 FAs may increase LDL-C levels. Despite extensive clinical trials, Omega-3 FAs have failed to demonstrate a mortality benefit in cardiovascular patients. Trials like ASCEND and STRENGTH, involving large sample sizes, did not show cardiovascular benefits [23,24]. The STRENGTH trial was terminated early due to the absence of cardiovascular benefits and common gastrointestinal side effects in the active treatment group. Unfortunately, the exact mechanism of action for Omega-3 FAs in triglyceride reduction is not well understood [25].
“It's intriguing that despite the association between hypertriglyceridemia and increased ASCVD events, omega-3 FAs and other triglyceride-lowering agents like fenofibrate have not demonstrated a decrease in ASCVD morbidity or mortality. As a result, their approval is limited to cases of severe hypertriglyceridemia (>500-1000) to prevent pancreatitis.
“The controversy surrounding this may be attributed to the possibility that omega-3 FAs were used in less effective doses or the use of different forms, such as eicosapentaenoic acid (EPA) and/or docosahexaenoic acid. This highlights the importance of understanding the nuances in dosages and specific formulations when studying the effectiveness of these agents in preventing cardiovascular events [26].
“The REDUCE-IT trial focused on studying icosapent ethyl, a form of omega-3 FA, administered at a dosage of 2 g twice daily with meals. This trial spanned five years and included nearly 5000 participants. The findings revealed that individuals in the active treatment group were 25% less likely than the comparison group to develop unstable angina, undergo coronary revascularization, experience non-fatal myocardial infarction, and suffer a stroke [27).
Following the positive outcomes from the REDUCE-IT trial, the FDA granted approval to EPA in December 2019 for use in patients with triglyceride levels >150 mg/dL, established cardiovascular disease or diabetes, and two or more additional risk factors for cardiovascular disease. This underscores the potential of specific formulations and dosages of omega-3 FAs in reducing cardiovascular events in high-risk individuals [28].”
dogn
Change in Cardiology 4,0
11 - 12 - 13 April 2024
Lingotto Congress Center - Turin, Italy
https://www.changeincardiology.it/
5.1 training credits
From https://www.changeincardiology.it/wp-content/uploads/2023/12/V3-PROGRAMMA-PRELIMINARE.pdf
Thursday April 11 session “Lipid-lowering agents and antithrombotic therapy in the acute stage,” final talk before discussion “How to deal with residual risk beyond LDL: the role of icosapent ethyl”
Change in Cardiology 4,0
11 - 12 - 13 April 2024
Lingotto Congress Center - Turin, Italy
5.1 training credits
https://www.changeincardiology.it/wp-content/uploads/2023/12/V3-PROGRAMMA-PRELIMINARE.pdf
Thursday April 11 session “Lipid-lowering agents and antithrombotic therapy in the acute stage,” final talk before discussion “How to deal with residual risk beyond LDL: the role of icosapent ethyl”
From JP Morgan transcript at https://seekingalpha.com/article/4662245-amarin-corporation-plc-amrn-42nd-annual-jpmorgan-healthcare-conference-transcript
“Lastly, we are very encouraged by our rest of world progress, particularly China, where we've launched the very high triglyceride indication and we have had -- the China FDA accepted our filing for cardiovascular risk reduction.”
I understood this to mean the filing was received, perhaps met compliance checks: “we got your filing”… and not yet evaluated let alone approved.
Later Holt said:
“When we think about rest of world, there are millions of patients that we have the opportunity to access with our important partners globally. As one example, in China, we have just now launched the very high triglyceride indication in China and we have had the, as I mentioned, the larger cardiovascular risk reduction indication accepted by the China FDA with a clinical trial waiver, which is a very important milestone for the business via our partners, Eddingpharm.”
I don’t think he was choosing words carefully to mislead but unfortunate if read as stated that the “CRR indication” was accepted as it’s clearly just the filing from everything else that has been publicly disclosed. I would like to hear more about the details/meaning & confirmation of “clinical trial waiver”... how is it waived before filing is processed and approved? I know very little about the Chinese drug approval process.
Here is the Eddingpharm press release:
NMPA Accepts Marketing Application for VASCEPA® (icosapent ethyl) Cardiovascular Risk Reduction (CVRR) Indication
https://www.eddingpharm.com/EN/newsDetail/1141
SHANGHAI, CHINA, November 14, 2023 - EDDING announced that the new indication marketing application for the innovative cardiovascular drug VASCEPA® (icosapent ethyl) has been officially accepted by the National Medical Products Administration (NMPA).This indication would allow for VASCEPA® to be used in combination with statins for adult patients with elevated and high triglycerides (TG)and established cardiovascular disease or diabetes mellitus with =2 other cardiovascular disease risk factors, combined with hypertriglyceridemia, to prevent and reduce the risk of cardiovascular events (including cardiovascular death, myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization).
“"We are very pleased that the application for the CVRR Indication of VASCEPA® was accepted by the NMPA”, said Jing Zhai, Vice President of Business Department, EDDING.”
“For the currently submitted indication, VASCEPA® can provide a new and strong evidence-based treatment option to reduce residual cardiovascular risk in statin treated patients with elevated and high TG levels in clinical practice. We will hope that in the future, VASCEPA® could help to reduce ASCVD risk and events in patients, contributing to the comprehensive management and prevention of cardiovascular diseases in China."
“On behalf of the Amarin we team, we congratulate our partners at EDDING for this critical step in their efforts to secure the CVRR indication for VASCEPA® as a potential expanded indication for patients in China," said Steven Ketchum, Ph.D., President, Research & Development and Chief Scientific Officer, Amarin.
dogn
New Research from China
ORIGINAL RESEARCH article
Front. Cardiovasc. Med., 14 March 2024
Sec. Cardiovascular Epidemiology and Prevention
Volume 11 - 2024 | https://doi.org/10.3389/fcvm.2024.1328087
Decreased circulating omega-3 fatty acids increase the risk of myocardial infarction: a two-sample Mendelian randomization study
Wei Wang1,2 Linfei Yang1,2 Jing Zhang1,2 Haiyun Xiang2,3*
1Department of Cardiology, The Second People’s Hospital of Hefei, Hefei, Anhui, China
2Department of Cardiology, Hefei Hospital Affiliated to Anhui Medical University, Hefei, Anhui, China
3Infant Care Services and Management, Institution of Culture Tourism and Education, Anhui Technical College of Industry and Economy, Hefei, Anhui, China
“In this research, we extracted the summary data from published large genetic studies to detect whether there was a causal relationship between omega-3 fatty acids and the risk for MI by TSMR analysis.”
“study theoretically proved the causal relationship between omega-3 fatty acids and myocardial infarction” in subjects of European ancestry
“Conclusion
This study highlights the potential value of omega-3 fatty acids in reducing the risk of myocardial infarction.”
relevant citations:
References
1. Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, et al. Cardiovascular risk reduction with icosapent ethyl for hypertriglyceridemia. N Engl J Med. (2019) 380(1):11–22. doi: 10.1056/NEJMoa181279230415628
42. Mason RP, Libby P, Bhatt DL. Emerging mechanisms of cardiovascular protection for the omega-3 fatty acid eicosapentaenoic acid. Arterioscler Thromb Vasc Biol. (2020) 40(5):1135–47. doi: 10.1161/ATVBAHA.119.31328632212849
dogn
Disease-Modifying Treatments and Their Future in Alzheimer’s Disease Management
Blake Smith • Raymond L. Ownby
Published: March 13, 2024
DOI: 10.7759/cureus.56105
https://www.cureus.com/articles/231134-disease-modifying-treatments-and-their-future-in-alzheimers-disease-management#!/
Comprehensive new review on AD treatments
Nice Fig 1 by authors on Amyloid plaque formation & subsequent inflammation through oxidative damage.
“Neuroinflammation is a key component in the pathology of AD.”
“One hundred and eighty-seven unique treatment agents for AD are undergoing trials as of January 1, 2023 [7]. Disease modification was by far the most common classification of drug agents undergoing testing in these trials as 79% of the agents targeted disease modification [7]. Disease-modifying treatment (DMT) is a label given to therapeutic agents whose purpose is to change the biology or slow the progression of AD [7]. It is reassuring that the major area of focus for drug development regarding novel treatments for AD is DMTs, as aducanumab and lecanemab are the only DMTs readily available today. This narrative review aims to investigate DMTs that have recently received U.S. Food and Drug Administration (FDA) approval in addition to DMTs in phase three of development that have the potential for approval in the near future. Figure 3 and Table 1 illustrate the diversity in therapeutic target areas of these novel DMTs.“
Icosapent Ethyl among 3 DMTs targeting oxidative stress.
Oxidative Stress
Amyloid-ß plaques cause oxidative stress to nearby lipid-containing cell membranes, leading to inflammation [21]. A class of DMTs in phase 3 of trials focuses on reducing this oxidative stress. Hydralazine hydrochloride is one of these. Hydralazine hydrochloride is able to reduce lipid oxidative damage through its hydrazide functional group and possesses antioxidant properties [21]. Hydralazine hydrochloride can prevent some of this oxidative stress by scavenging and removing the harmful products of lipid oxygenation. Hydralazine hydrochloride prevents lipid modifications of amyloid-ß plaques like many hydrazides but is unique from other hydrazides in that it was shown to reduce amyloid-ß misfolding [21]. Although hydralazine was capable of reducing amyloid-ß misfolding, it was unable to reduce the aggregation of these misfolded proteins into their pathological plaques [21]. Another potential focus area for targeting oxidative stress in AD is through omega-3 fatty acids, or the purified form of one of these fatty acids, icosapent ethyl. Icosapent ethyl is a purified form of eicosapentaenoic acid and was previously confirmed to be cardioprotective [7]. The rationale for icosapent ethyl being a possible treatment option for AD is that eicosapentaenoic acid is capable of improving arterial and cerebrospinal blood flow [22]. An increase in cerebrospinal blood flow can improve the physiological functioning of the brain with various processes [22]. Icosapent ethyl and its effect on cerebrospinal blood flow may attenuate some of AD’s neurotoxic effects by improving the brain’s function in removing waste and toxins from the central nervous system (CNS).”
Waiting for BRAVE results.
dogn
A Practical Approach to the Management of Residual Cardiovascular Risk: United Arab Emirates Expert Consensus Panel on the Evidence for Icosapent Ethyl and Omega-3 Fatty Acids
Review Article
Open access
Published: 16 February 2024
https://link.springer.com/article/10.1007/s10557-023-07519-z
Abstract
Purpose
Patients with hyperlipidemia treated with statins remain at a residual cardiovascular (CV) risk. Omega-3 polyunsaturated fatty acids hold the potential to mitigate the residual CV risk in statin-treated patients, with persistently elevated triglyceride (TG) levels.
Method
We reviewed the current evidence on the use of icosapent ethyl (IPE), an omega-3 fatty acid yielding a pure form of eicosapentaenoic acid.
Results
REDUCE-IT reported a significant 25% reduction in CV events, including the need for coronary revascularization, the risk of fatal/nonfatal myocardial infarction, stroke, hospitalization for unstable angina, and CV death in patients on IPE, unseen with other omega-3 fatty acids treatments. IPE was effective in all patients regardless of baseline CV risk enhancers (TG levels, type-2 diabetes status, weight status, prior revascularization, or renal function). Adverse events (atrial fibrillation/flutter) related to IPE have occurred mostly in patients with prior atrial fibrillation. Yet, the net clinical benefit largely exceeded potential risks. The combination with other omega-3 polyunsaturated fatty acids, in particular DHA, eliminated the effect of EPA alone, as reported in the STRENGTH and OMEMI trials. Adding IPE to statin treatment seems to be cost-effective, especially in the context of secondary prevention of CVD, decreasing CV event frequency and subsequently the use of healthcare resources.
Conclusion
Importantly, IPE has been endorsed by 20 international medical societies as a statin add-on treatment in patients with dyslipidemia and high CV risk. Robust medical evidence supports IPE as a pillar in the management of dyslipidemia.
dogn
Icosapent Ethyl Decreases Cardiovascular Event Risk in Metabolic Syndrome Without T2D
Jessica Nye, PhD | November 30, 2023
https://www.thecardiologyadvisor.com/home/topics/metabolic/icosapent-ethyl-decreases-cardiovascular-event-risk-in-metabolic-syndrome-without-t2d/
Bibliometric analysis of residual cardiovascular risk: trends and frontiers
J Health Popul Nutr. 2023; 42: 132. Published online 2023 Nov 28. doi: 10.1186/s41043-023-00478-z
Lin Wang, Sutong Wang, Chaoyuan Song, et al.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10683255/
Professor Bhatt DL reported the research results of Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial (REDUCE-IT) in 2019. Patients who were treated with 4 g daily of icosapent ethyl had a significantly lower incidence of major adverse cardiovascular events compared to those who received a placebo, with a risk reduction of 25% [57].
The 2020 American Diabetes Association (ADA) standard of care for diabetes no longer recommends fibrates to reduce cardiovascular risk [89]. More importantly, the recently held AHA 2022 announced the results of the PROMINENT trial: pemafibrate reduced TG levels in patients with type 2 diabetes, but did not reduce the risk of cardiovascular events and death [90]. In contrast, there have been some breakthroughs in the area of Omega-3 fatty acids. The REDUCE-IT study demonstrated a significant reduction in the incidence of cardiovascular events in patients with elevated TG levels who were already receiving statin therapy, following treatment with Icosapent Ethyl [57]. Subgroup analysis showed that the same results were obtained in the secondary prevention population [91]. These results suggest that Icosapent Ethyl may be an effective strategy to further reduce cardiovascular risk in high-risk patients beyond standard statin therapy.
deleted
[had posted MND-2119 paper https://doi.org/10.5551/jat.64135 that appeared new but was posted here previously in early August]
New generic entry by Strides
https://www.bqprime.com/business/strides-pharma-jumps-over-8-after-us-fda-approves-drug-to-reduce-heart-issues
https://www.businesstoday.in/amp/markets/company-stock/story/strides-pharma-science-shares-rise-usfda-nod-icosapent-ethyl-capsules-399552-2023-09-25
AMRN makes the American Association of Individual Investors (AAII) list of 4 Undervalued Biotechnology & Medical Research Stocks for Thursday, September 14
https://www.aaii.com/investingideas/article/86607-4-undervalued-biotechnology--medical-research-stocks-for-thursday-september-14
Someone needs to let the author know about the Reduce-It CVD indication!
dogn
If you’re not a robot you can read:
Featured Tickers:
AMRN
BWV
NEXI
SYBX
Based on key financial metrics such as the price-to-sales ratio, shareholder yield and the price-earnings ratio, the following 4 stocks made the list for top value stocks in the Biotechnology & Medical Research industry. Those looking for value stocks to add to their portfolio may want to use this list as a starting point for further investment research.
Amarin Corporation plc (ADR)’s Value Grade: B
Metric Score AMRN Industry Median
Price/Sales 40 1.16 7.89
Price/Earnings na na 20.6
EV/EBITDA na na 0.8
Shareholder Yield 68 (2.4%) (7.4%)
Price/Book Value 18 0.71 1.54
Price/Free Cash Flow na na 22.7
Amarin Corporation PLC is a pharmaceutical company. The Company is focused on the commercialization and development of therapeutics to improve cardiovascular (CV), health and reduce CV risk. The Company operates through the development and commercialization of VASCEPA. Its lead product, Vascepa (icosapent ethyl) capsule is used as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. This indication for Vascepa, known as the MARINE indication, is based primarily on the results from the MARINE study of Vascepa in this approved patient population. The Company sells Vascepa principally to wholesalers, as well as selected regional wholesalers and specialty pharmacy providers, or collectively, its distributors, which in turn resell Vascepa to retail pharmacies for resale to patients and healthcare providers.
Stocks with a Value Score from 81 to 100 are considered deep value, those with a score between 61 and 80 are value and so on.
Amarin Corporation plc (ADR) has a Value Score of 62, which is considered to be undervalued.
When you look at Amarin Corporation plc (ADR)’s price-to-sales ratio at 1.16 compared to the industry median at 7.89, this company has a lower price relative to revenue compared to its peers. This could make Amarin Corporation plc (ADR)’s stock more attractive for value investors.
Shareholder yield is the sum of a stock’s dividend yield (paid over previous 12 months minus special dividends) and the percentage of net share buybacks over the previous 12 months. Amarin Corporation plc (ADR)’s shareholder yield is higher than its industry median ratio of (7.45%). Value investors may look for an attractive shareholder yield because it can be a powerful tool for identifying if the company has a good management team.
As one of the most common value metrics, the price-to-book ratio evaluates a company’s current market price relative to its book value. Amarin Corporation plc (ADR)’s price-to-book ratio is lower than its industry median ratio of 1.54. This could make Amarin Corporation plc (ADR) more attractive to investors looking for a new addition to their portfolio.
Higher triglyceride levels are associated with the higher prevalence of layered plaques in non-culprit coronary plaques
Journal of Thrombosis and Thrombolysis, Published: 13 September 2023
Kiyoshi Asakura, Yoshiyasu Minami, Takako Nagata, Masahiro Katamine, Yusuke Muramatsu, Daisuke Kinoshita & Junya Ako
https://link.springer.com/article/10.1007/s11239-023-02888-6
Highlights
+A high TG level was associated with the presence of layered plaques.
+High LDL-C levels and low EPA/AA ratios were associated with the presence of TCFA and macrophages.
+These results showed TG-specific effects on coronary artery plaques.
Cardiac magnetic resonance biomarkers as surrogate endpoints in cardiovascular trials for myocardial diseases
European Heart Journal, ehad510, https://doi.org/10.1093/eurheartj/ehad510
Published: 13 September 2023
2nd citation of paper is to M. Budoff et al.’s EVAPORATE study:
Wisconsin Alzheimer’s Institute at the University of Wisconsin (directed by BRAVE lead researcher Cynthia Carlsson) recently has been awarded a five-year, $35 million renewal grant from the National Institutes of Health for The Wisconsin Registry for Alzheimer’s Prevention (WRAP) program, enabling continued in-depth study of biological indicators of Alzheimer’s disease that may signal the disease decades before the symptoms.
With its academic home within the WAI, the NIH-funded WRAP study is one of the largest and longest-running family history studies of Alzheimer’s disease in the world.
https://wai.wisc.edu/
Cynthia Carlsson, MD, MS, is director of WAI. Dr. Carlsson is also the Clinical Core leader and co-leader of the Biomarker Core for Wisconsin ADRC. Dr. Carlsson is a faculty member of the division of geriatrics and a geriatrician who treats veterans with dementia and memory issues. She is co-director of the memory clinic at William S. Middleton Memorial Veterans Hospital.
https://wai.wisc.edu/staff/carlsson-cynthia/
https://wai.wisc.edu/2023/06/28/wrap-study-receives-35-million-renewal-grant/
http://www.adrc.wisc.edu/brave-study
WAI is quite a bustling international hub for AD research… well positioned to interpret, understand, leverage and promote findings of the soon to be completed BRAVE study.
https://clinicaltrials.gov/study/NCT02719327?tab=history&a=5
dogn
PD, thanks for sharing this.
dogn
My recollection: For Marine indication generics are approved for, TG must be >=500, but Reduce-It CVD indication drops that to >=150 with other conditions of diabetes or prior CVD. Flowchart looks correct to me…a check for infringing use… & Reduce-It RX skips requirement for Fibrates trial.
dogn
My recollection: For Marine indication generics are approved for, TG must be >=500, but Reduce-It CVD indication drops that to >=150 with other conditions of diabetes or prior CVD. Flowchart looks correct to me…a check for infringing use… & Reduce-It RX skips requirement for Fibrates trial.
dogn
From Texas Health and Human Services
HHSC Updates Clinical Prior Authorizations Criteria Guides
July 27, 2023
HHSC reviewed the following clinical prior authorization criteria guides and made the updates shown below. These clinical prior authorizations are optional for the MCOs. HHSC will notify providers when we implement any of these prior authorizations for Medicaid fee-for-service.
Omega-3 Fatty Acids
Clinical prior authorization criteria guide (PDF): https://paxpress.txpa.hidinc.com/lovazapdg.pdf
Vascepa (icosapent ethyl) 500 mg
Added GCNs for Icosapent Ethyl (33238, 42365).
https://www.txvendordrug.com/about/news/2023/hhsc-updates-clinical-prior-authorizations-criteria-guides
Generic Code Number (GCN) - A GCN is a standard number assigned by a drug pricing service called First DataBank. The GCN identifies each strength, formulation, and route of administration of a drug entity. Each drug has its own unique GCN.
(From https://www.findacode.com/articles/drug-classification-systems-35806.html)
Texas is HUGE, right Capt. Beer?
dogn
Texas Prior Authorization Program Clinical Criteria updated Aug 17, 2023
Drug/Drug Class: Omega-3 Fatty Acids
https://www.uhcprovider.com/en/resource-library/news/2023/tx-medicaid-prior-auth-certain-medications.html
https://paxpress.txpa.hidinc.com/lovazapdg.pdf
Revision Notes: Added GCNs for Icosapent Ethyl (33238, 42365)
Generic Vascepa requires prior authorization to confirm non-infringing use (for TG>500); Reduce-it indication authorizes brand Vascepa.
Publication History last page shows:
07/05/2022 Added [Reduce-it] criteria for Vascepa…
12/20/2022 Clarified criteria for Vascepa …
1/03/23 Renamed the guide to Omega-3 Fatty Acids (formerly Lovaza)
7/17/2023 Added GCNs for Icosapent Ethyl (33238, 42365)
Perhaps changes related to Healthnet settlement? Appears patients meeting Reduce-it CVD indication are indeed approved to receive brand Vascepa only.
UnitedHealthcare is in partnership with Health Net at least in some states https://www.unitedhealthgroup.com/newsroom/posts/2022/2022-03-15-partnering-with-healthnet-expanding-access-384928.html
https://www.healthnet.com/static/provider/unprotected/pdfs/national/close_announcement_provider_FAQs.pdf
https://www.uhccommunityplan.com/missouri
dogn
Eddingpharm activity
Seeing some new updates on Eddingpharm website at https://www.eddingpharm.com/EN/ since last I looked and since they received approval to Launch Vascepa from NMPA in May.
At top under "Our company" they now list
3 Therapeutic Areas ... 6 Core Products ... 16000+ hospitals ... 770+ sales representatives.
And under Our company/history/2023 now show
· The NMPA has [granted] approval for VASCEPA as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia (≥500 mg/dL)(VHTG)."
Under "Core Therapeutic Areas" and "Cardiovascular" they note the Reduce-It results and FDA approved CVD indication as well as:
In May 2023, Vascepa® received approval from the NMPA for the treatment of severe HTG levels (≥500 mg/dL). As of June 14, 2023, Vascepa® had already been recommended by seven clinical guidelines in China, including the 2023 China Guidelines for the Management of Blood Lipids.
Under "Full Value Chain"
Vascepa® is a single-molecule product. It is a highly purified omega-3 fatty acid (EPA) ethyl ester.
Vascepa® is the only drug approved by the FDA as an adjunct to maximally tolerated statin therapy for reducing persistent CV risk in targeted high risk patients. Based on cross trial comparisons, Vascepa® demonstrated significant efficacy advantages over evolocumab (one PCSK-9 inhibitor) and ezetimibe (one cholesterol absorption inhibitor) on top of statin therapy for reducing the risk of cardiovascular events.
We launched Vascepa® in China in 2023.
and an updated Vascepa timeline showing in 2023 NMPA has approved Vascepa for the treatment of severe HTG levels (≥500 mg/dL)
Under Career tab, Talent recruitment learn more link redirects to https://eddingpharm.zhiye.com/Social which using Google chrome translation to English shows a total of 135 job openings, many in "SC" and "CV" areas (presumably supply chain and cardiovascular), majority (over 80-90) posted since May. Looks like they are in growth mode.
dogn
Probability Of Bankruptcy of LESS THAN 2.0%.
https://www.macroaxis.com/invest/ratio/AMRN/Probability-Of-Bankruptcy
Crazy FUDsters. Geesh.
Added to my position.
More evidence that “it’s the EPA, stupid”!
New 12 week study from Australia
“Improved arterial inflammation with high dose omega-3 fatty acids in patients with elevated lipoprotein(a): Selective effect of eicosapentaenoic acid?”
dogn
https://www.lipidjournal.com/article/S1933-2874(23)00249-0/fulltext
Highlights
•Patients with elevated Lp(a) are at an increased risk of atherosclerotic cardiovascular disease partly due to pro-inflammatory effects of elevated Lp(a).
•High dose ?-3FAs lowered arterial inflammation, as measured by SUVmax using 18F-FDG PET/CT, in patients with elevated Lp(a).
•Reduction in arterial inflammation was inversely associated with on-treatment plasma levels of EPA, but not DHA or triglycerides, suggesting a favourable direct effect of EPA.
Amarin-Hikma Appeal filings from FedCircuitBlog
A “brief” post
-dogn
See links for all filed briefs at https://fedcircuitblog.com/other-cases/amarin-pharma-inc-v-hikma-pharmaceuticals-usa-inc/
Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc.
APPEAL NO. 23-1169
OPINION TBD
SUBJECT Patent
AUTHOR TBD
Issue(s) Presented
1. “Did the district court err by failing to consider the combined weight and effect of evidence demonstrating Hikma’s repeated extra-label encouragement of using their generic version of Amarin’s patented drug for both the approved skinny-label use of treating severe hypertriglyceridemia and the non-approved and infringing use of reducing cardiovascular risk in patients who do not suffer from severe hypertriglyceridemia when it dismissed Amarin’s complaint for failure to state a claim?”
2. “Did the district court err by implicitly making a factual finding on the pleadings regarding what Hikma’s conduct communicated to prescribing physicians, a key element of induced infringement?”
3. “Did the district court improperly analogize Amarin’s allegations to Grunenthal, a label-only case where the asserted patent covered a use narrower than the generic label instructed, whereas Amarin alleged extra-label inducement activity by Hikma in the context of Amarin’s patents, which are directed to a use broader than Hikma’s approved use?”
DATE/ SELECTED PROCEEDINGS AND ORDERS
March 21, 2023 Appellants' Opening Brief
May 31, 2023 Brief for Defendants-Appellees
June 7, 2023 Brief for the Association for Accessible Medicines as Amicus Curiae in Support of Defendant-Appellees and Affirmance
July 12, 2023 Appellants' Reply Brief