north40000
13 hours ago
For a hint at direction insurers may be going, the CVS where my prescriptions for Vascepa are filled no longer stocks generic V and my GEHA insurance, managed by Caremark, will not cover generic V. See also the posts beginning with JTFM’s post #14794 to last about Medicade, various BCBS plans, on the ANIP IHub board with respect to preference for a different med.
JRoon71
15 hours ago
Don't mistake my comments for thinking that EPA is not effective for A/D. I just think the time period of the study is so short, that it is going to give minimal positive results. I still think the results will be positive. I don't think they will be statistically significant. But then again, as long as they show positive outcomes (with SOME level of magnitude), then the study should be viewed as a positive for future research.
My dad died from ALZ, so believe me, I am rooting for anything that will work. It's why I have been taking EPA for a few years now (I don't qualify for V script).
But I personally believe that the BRAVE results (relative to AMRN as an investment) will be sort of a non-event.
I just wish they would hurry up and release the results!
ilovetech
16 hours ago
North4000 - You might be reading my posts, but they're not sinking in. I didn't mention a word about turning to the courts, as that side of the battle was covered? For the third time, why wasn't the same urgency applied towards approaching the USPTO in parallel? I was very vocal about the idea years ago, before and after Marjac filed the shareholder case. I don't remember your exact response at the time, but let's just say it was dismissive, and to the extent, that I was even more frustrated than I was before I brought it up.
ilovetech
19 hours ago
North4000 - I wonder, like you, why Amarin has not asked for reexamination of its 4 patents in the PTO before the Board of Patent Appeals and Interferences. The procedural effect of FRCP Rule 60(d)(3) “at any time” seems equally applicable in both the Federal Courts(Hazel-Atlas case) and BPAI. Where were you on this option right after members of this board discovered Du's decision was based on a cropped graph? When I repeatedly asked why Amrn wouldn't exercise such an opportunity, "if one exists?" I heard nothing encouraging in response at the time. Just crickets for the last 4 years. It took coming across an article about a rich BP, not a small biotech in the dumps for years, to learn there is a pathway through the USPTO to pursue. If I had that expertise, I would have adapted a Warjac approach in pursuit of that option years ago.
north40000
19 hours ago
ziploc, your observation coincides with MRK’s mixed results at the BPAI and my own observations when I was a member of that Board in 1983-1986 before leaving to enter private practice. But that was long ago. The Undersecretary of Commerce annual report to Congress, budget hearings, may still have statistics on Board results in reexamination proceedings.
One of my last, and longest, cases as an expert witness was a jury case in Arizona. I had been deposed 4 times over a period of 25 years. The jury heard testimony on who was the 1st inventor of the subject matter in the claims of the plaintiff’s patent. The jury found the accused infringer’s witness was the 1st inventor. The Board had found likewise. Both asserted inventors had testified by way of deposition before the Board. The accused infringer’s inventor witness testified at trial. The jury heard no new testimony from the inventor named on plaintiff’s patent because he was dead. Both parties submitted documentary evidence to support respective inventor testimony. I think the parties settled.
JRoon71
20 hours ago
Zip, not necessarily. BRAVE had nothing to do with A/D outcomes (there were some secondary cognitive measures, but I doubt those showed much). The study was purely about bio markers. And it's entirely possible that the study simply wasn't long enough/powerful enough to achieve its outcomes.
This is the weakness of scientific study. It can only produce what you measure. So for something like BRAVE, while it's entirely possible (more likely than not) that EPA does reduce the incidence of A/D to some degree, a study like BRAVE could come to a null conclusion.
I am just hoping that there is ENOUGH evidence (even if not statistically significant) to continue pursuing EPA as an A/D solution. Because realistically, BRAVE was not going to result in a new indication, but rather lead to additional, more extensive trials.
the_kube
20 hours ago
The following is from the Brave study. Based on this, does this mean study’s selected participants are less likely to have any positive response to icosapent ethyl?
“The proposed study is a proof-of-concept, randomized, placebo-controlled, double-blind, parallel-group clinical trial assessing the efficacy of 18 months of icosapent ethyl (IPE) therapy on magnetic resonance imaging (MRI), cerebrospinal fluid (CSF), and cognitive biomarkers for AD in 150 cognitively-healthy Veterans ages 50-70 years with increased risk for developing AD due to parental history of the disease and increased prevalence of apolipoprotein E4 (APOE4) allele.”
ziploc_1
21 hours ago
Conclusions of study...."In conclusion, higher concentrations of EPA were associated with a lower incidence of AD dementia."
This is an additional heads up that the final evidence from Brave study will show at least a positive trend in favor of minimizing AD, even if the study does not reach statistical significance(due to the small sample of patients in the study).... in reducing the incidence of AZ or ameliorating it.
As the authors suggest, more studies are indicated...In the meantime, millions of patients are growing old with Alzheimers with no safe, affordable medicines available to help them cope
Giovinco
22 hours ago
EPA Associated with Decreased Incidence of Alzheimer’s Dementia in the Oldest Old
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7912244/
5. Conclusions
In conclusion, higher concentrations of EPA were associated with a lower incidence of AD dementia. In addition, we observed that higher concentrations of EPA were associated with a decreased risk for all-cause and AD dementia among APOE e4 non-carriers but not among APOE e4 carriers. Furthermore, a higher percentage distribution of EPA, DHA, and ALA was not associated with incidence all-cause and AD dementia. We recommend future studies to analyze both relative fatty acid profiles and absolute fatty acid concentrations. In addition, we encourage existing and new studies to prioritize their research on the oldest old and to investigate the interaction between PUFA and APOE e4.
Scientists hope that their research will encourage future clinical studies to determine the potential benefits of EPA in Alzheimer’s disease
https://nutrition.org/omega-3-fatty-acid-rich-diets-potential-benefits-in-lowering-risk-of-alzheimers-disease/
dogn
1 day ago
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
dogn
1 day ago
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
ilovetech
1 day ago
Yes, according to the article I read, and unsuccessfully linked, Merck chose not to go the legal route, and instead, chose to petition the USPTO. When Du adapted a falsified doc and testimony to declare that the USPTO's bases for granting the Marine patent was "weak," I sounded off. I asked, "why Amrn wouldn't just ask the USPTO to notify the court, that it had reviewed the study which Du relied upon, and mischaracterized as Stat Sig, when the Study actually stated APO B reduction was Not Stat Sig? I didn't get from you at the time, that this option was actionable. Amrn management/BOD had no skin in the game. They were like sheep, those bastards. I figured when Denner saw his invest take a dive, that he might at the very least, try to get creative, I.e. approach the USPTO. I would have went straight to their offices asking for a meeting if it was me. This was a case of FRAUD. Bureaucracy be damned. LOVAZA is still ripping. No balls out there.
CaptBeer
2 days ago
PREPARE Clinical Trial:
I sent an email to one of the PI’s in this trial:
Hello Dr. Song,
I see that the results of your PREPARE Trial have been posted at ClinicalTrials.gov. It appears that the Primary Outcome Measure (Change in Marine Omega-3 PUFA Composition in Colorectal Tissues as a result of the AMR101 Treatment) has been met. Do you plan on publishing the results, and what are the clinical implications for treating patients with the drug?
Here’s the reply I got back:
Hi Mike,
The posted results are only part of the full data, because a subset of the samples failed the lab assays due to technical issues.
We do plan to publish the full results, hopefully by the end of this year. Thanks for your interest!
ilovetech
2 days ago
North4000 - Thanks for your reply. In case I wasn't clear in my prior post, I'm referring to the loss of the marine patents for obviousness. Where Amrn clearly earned the patent after earlier rejections "due to an unexpected decrease in APO B." BUT Du adapted Generic's citation of an underpowered, inappropriate trial population study, to claim a stat Sig reduction in APO B, when in fact, the author of that paper said the opposite! It led to Du disagreeing with the PTO, when she stated that the PTO's finding of a reduction in APO B was "weak." At the time we had posters here who quickly uncovered that fraudulent citation, and I kept pressing for getting the USPTO to step in to clarify the record. Your response to that suggestion, and I don't remember the exact wording, but let's just say, it was a huge damper on any hope I held for exploring that option at minimum. It's one thing to ask perhaps, supporting an issue which is not well defined reasoning, that schedules are hectic and resources stretched, but we have a falsified court doc and purjurious testimony. What's wrong with asking the USPTO to step in to correct the record? If you can't ask them to do something that rises to a moral obligation, then the USPTO is a worthless. Inept at best. Period. Full stop.
dogn
2 days ago
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