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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
North.With respect . You should know the answer to your question by now ( will a 227 patient Greek trial suffice ?) Maybe poster Laurent will be willing to spend some time explaining to you the importance of.... size of clinical trials , powering of clinical trials and P values .
Don't know North. It would have to be some profound noticeable effect for the researchers to delve into it, as the study protocol and goals don't encompass such:
"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 50-75 years. The overarching goal of this trial is to assess whether icosapent ethyl beneficially affects intermediate physiological measures associated with onset of AD in order to evaluate whether larger, multi-site, longer-duration Alzheimer's prevention trials are warranted to assess more definitive clinical outcomes. The proposed study aims to: 1) investigate the effects of 18 months of IPE vs. placebo on regional cerebral blood flow as measured by arterial spin-labeling MRI; 2) determine the impact of 18 months of IPE vs. placebo on CSF biomarkers of AD pathology; and 3) evaluate the effects of 18 months of IPE vs. placebo on cognitive performance." https://www.clinicaltrials.gov/study/NCT02719327?cond=Alzheimer%20disease&intr=Icosapent%20Ethyl&rank=1&tab=history&a=16
NORTH, I take all that BACK.. I found this on an Univ. of Wisconsin Department of Radiology website:
"In addition, data collection from this trial will allow for exploration of the impact of previous TBI and/or PTSD on response to therapy. We hypothesize that in this population, IPE will beneficially affect mechanisms central to AD pathology by: 1) increasing rCBF within the sROI; 2) reducing CSF A-beta-42; and that these neurobiological changes will be associated with 3) an increased ADCS-PACC cognitive composite score. While recognizing that the proposed trial is not addressing all potential effects of IPE, such as changes in measures of inflammation or oxidative stress, we will store neuroimages and blood and CSF samples for future analyses of other potential mechanisms." https://radiology.wisc.edu/research-projects/brave-epa-brain-amyloid-and-vascular-effects-of-eicosapentaenoic-acid-epa-in-adults-at-risk-for-alzheimers-disease/
Wouldn’t the 227 patients Greek trial suffice? See CaptBeer’s post this evening. Does Greek population differ from populations of France or Germany significantly?
See 60 minutes tonight, CBS-TV at 7:00 pm. Reports veteran-acquired PTSD can be “contagious” in the sense that veteran brings back and repeatedly tells wife and child horrific stories of explosions wiping out comrades in same location near him. The wife becomes despondent herself in constant caring of a now suicidal husband. Much caring of both is now in the hands of older child…and the story continues with child also becoming depressed. This husband eventually recovers, finds a job, and is able to support the family. The wife and child are interviewed, and relate the above story.
I wonder whether investigators in the BRAVE trial are seeing signs of the above developments in the veteran population studied and interviewed. Are family members also interviewed?
The article that I posted a few minutes ago describes a short biomarker study conducted in Greece similar in design to MARINE & ANCHOR. Several key biomarkers were significantly improved in a consistent dose dependent fashion like they did in MARINE/ANCHOR.
The authors have concluded that It’s the EPA Stupid and they are currently running a “placebo controlled” study which aims to evaluate EPA levels. They report that the results will be “available soon.”
BTW $AMRN has already submitted a dossier for approval in Greece.
Actually Monk I've been buying AMRN. Last purchase
I figure I'll just tail alone on all the options handed out that vest next April at roughly that price...after this share buyback goes thru of course .
What better use of $50m then do buy back shares ( which should cause the remaining shares to go up in price ) so that the insiders ( and myself ) can make some $ here. Seems to be the current opinion anyway ...or at least what they have sold U on.
Of course if we really want to make some serious $ we need generous reimbursements in Germany , Italy and France ...and your ideas on how to achieve that ???? Please detail Thx Kiwi
North. Unless AMRN gets some relief from the courts in the US ( reversal of judge Du's decision , restraining generic infringement etc ) ...the US market is going nowhere. Break even at best because AMRN will be very unlikely to spend $ expanding this market .
So that leaves the EU where we now have patent protection until 2039 ( from memory ) One approach to gain access to Germany , Italy and France is to engage those Health Depts in a short trial for a specific sub group where the economic benefits of risk reduction can easily be quantified.
Consider that " out to lunch " if you like but in the mean time what your ideas for gaining market share in these 3 key EU markets ...the same ol same ol ? Kiwi
You are correct, and kiwi continues to be out to lunch in failing to acknowledge a line in one of DMC8’s links today that the Vascepa market is being retained because freedom from pancreatitis has not been shown by a generic clinical trial. The generics have the burden of proof.
Capt. I linked data from the supplemental section of the Revasc analysis but it didn't format easily ....If you look you will see a dramatic reduction in needing a repeat revascularisation for those on Vascepa Kiwi
The risk reduction ( and therefore potential cost savings ) in this subgroup is dramatic . The event lines separate very early and separation is very evident at the 3 yr pt. Yes we would need buy end to some extent from the Health Depts in Germany , France and Italy.
My understanding is that CAD patients are a lot more adherent to taking their meds after being admitted for a CV event . Recruiting should be a lot easier and quicker then R-IT since theres a lot of followup with these patients in the first months following a PCI
Capt. I was thinking of a short trial for a specific subgroup recruiting recent PCI patients in Germany , France and Italy. This would require the co operation of the health depts of those 3 countries . Say 1,000 patients in Germany with 500 each from France and Italy . . Unless theres a change in the US regarding generic infringement ...reversal of Judge Du's decision etc the US market is break even at best .
Because of the patent extension in the EU ...it's IMHO the only market we should spend $ developing at this time. To do that we need a buy in from the 3 major EU health dept markets mentioned above.
Why focus on Revasc rates following a PCI ? Because it's one of the sub groups with the largest risk reduction and the economic benefit of this risk reduction is easily quantified. Example ... assume there are 20,000 revasc cases following a PCI each year in Germany , Italy and France combined ...at an average cost 10,000 Euros each case ( less expensive then in the US ) = 200m Euros each year in cost to these 3 healthcare systems combined.
If SOC plus Vascepa reduces that event rate by 25% vs SOC alone in this patient population thats a savings of 50m Euro's . Would this 50m Euros savings cover the cost of providing all PCI patients with Vazkepa following their initial PCI procedure ? I don't know ...I'm just using this as an example of how AMRN could use a small focused trial like this to gain access to these markets ...assuming there was at least a 25% risk reduction in revasc rates
I'm not thinking of a rerun of the Reduce It trial . Simply a small focused trial in the 3 EU markets we need access to . JMO Kiwi
Obviously your post was to highlight the fact that Epadel in Japan maintained market share for a long time. Much of the stuff above is of course not very applicable now since the sales force was disbanded. If Amarin can hold onto sales in the U.S. (unfortunately it is a stagnant market) while conserving cash (other than share BB) long enough to get some traction in the EU, then there may be some hope staring us at the end of a very long dark tunnel.
HIKMA/generics, can you also explain why you refused to state in your marketing statements that you have a generic version that can be used for the approved indication in the same fashion as the branded version?
Whale you pretend to be knowledgeable, you pretend to know medicine, you want to know everyone's business, your slippery comments about amrn are clearly negative. Rather than back up your stupid comments about share buybacks you go searching for anything else to avoid proving your lack of intelligence. Viet du caused amrn harm but at least stupid obese yanks have less access to Vascepa which their legal system caused. Is your wife still financially supporting you ??
RMB as a follow up re acquisitions . Acquisitions happen for several different reasons. Some Co's may have excellent P 2 trial results but are unable to fund a final pivotal trial(s ) needed for FDA approval or simply receive an offer to good to refuse from a larger Co. ...recent sales of Co's developing drugs for IgaN ( kidney disease ) for instance Other Co's like UNCY are not set up to launch the sales of their drug and will almost certainly look for a buyer if their final trial succeeds....same with TLPH . AMRN is an economies of scale situation ...as presented in Denners sales pitch . NVS has the economies of scale Kiwi
RMB. Denner's argument is economies of scale . A pervious poster had linked the pages in their presentation . NVS has economies of scale because they already have a sales force in the EU promoting Inclisiran ( their PCSK9 ) for CAD patients . IMHO the ideal combination for CAD patients is Inclisiran plus Vascepa .I wish Kaiser would allow me to do it .
Inclisiran is 3 shots for the first yr and 2 shots per year after that ...dramatically lowers LDL cholesterol ...done in a clinic. . First shot would be at annual physical so after that its just getting the patient back 6 mths later for their second shot . Likely far better adherence The problem with Statins is that roughly 50% drop them after the first year ( so adherence is poor ) and theres an increased risk for diabetes. PCSK9's like Repatha that I'm on ...require a trip to the hospital pharmacy once a month ( can't be shipped as its refrigerated ) and relies on my rather poor ability to self inject myself ( sub Q ) every 2 weeks.
So replace Statins and the other PCSK9's with Inclisiran and Vascepa ...both sold by NVS. . But NVS will want AMRN to get full EU reimbursement in place first ...which so far AMRN has failed to do .....and we await details on Wed as to any plans they may have in that area to be divulged .
Sure, there may not be any interest by any big EU Pharma but imo it would not necessarily be because of reimbursements, since there are many acquisitions made well before even drug approvals, never mind reimbursements.
So AMRN sees no benefit in even doing a fairly short ...say 3 yr revascularisation trial like the following ..especially in light of the EU patent extension.
Based on the graphs Laurent / Capt have posted , there should be very clear separation in event lines by 3 yrs , in revasc rates following a PCI between SOC and SOC plus Vascepa . There probably a lot of RWE data already on this waiting to be analyzed .
Whala, Always - for now years and years ALWAYS highlights barriers rather than opportunities.
Hard to understand what you are doing here (tens of thousands of posts) - always aiming to undermine trust in Amarin and Vascepa. ---------------------------------------
Please GO AWAY - and let the new BOD and MGT have the time it needs to turn this ship around !
Kiwi, I don't disagree that the Big 3 Euro countries are a problem. However, I don't see Amarin choosing to do any trials that would be "necessary" to approve V in these countries. It would take too long and be too costly. Not to mention, there is always the risk that something goes wrong with the trial.
I believe they will eventually succeed in Italy and France. But it will just take more time, and more data coordination (ie. RWE data, as well as additional R-It cohort analysis). I have no idea what will come of Germany. But in any event, I don't think additional trials will be the answer. So, I'm not sure where all this extra cash will be needed.
exwan…i need clarification…are you saying that the EU patent is for the “reduce-it” (heart) indication and therefore the coast is clear (i.e. the patent Wall is sound)?
No, there is no "same concern" in the EU as the Anchor patent has held and that is the only one that matters for the EU.
The issue in the US is that generics have been approved for the Marine indication as that patent has failed. That would be a minor issue if not for the fact that they are selling into the Anchor market. That still has a valid patent, but has been almost impossible to effectively enforce.
In the EU there is no Marine indication approved. Thus there are no Marine generics.
In theory somebody could run trials in the Marine indication in the EU and garner an approval for that. In reality that will never happen for economic reasons.
Irishpaddy ...well at least we have one thing in common .....I worked in sheep shearing gang in my youth . Hope U sold a big chunk of your AMRN after posting this Irishhpaddy
Irshpaddy ...I expect the share buyback to go through . As regards UK regulators concerns ,a simple search would have shown you the following Here are some key points on how UK regulators view share repurchases:
A simple, but critical question for Holt to answer at the upcoming 5/1/24 C.C....Is Amarin (or a successor Pharma Co. which buys Amarin) committed or NOT committed,by the Amarin 2018 collaboration agreement with Mochida...to pay milestone or royalty fees to Mochida for its patented product, LR-Et-EPA sales in the U.S. or in Europe?
IMHO everything else that Holt discusses at this conference pales in importance as compared with this question...Unless some unexpected bombshell announcement is released.
Zip….as another longtime holder, I agree…this company has been looking for a big pharma buyer for at least 10 years…BP knows the Patent wall didn’t hold up in the U.S. and likely has the same concern about EU…need a new EPA based product…
Nice find DMC..... I doubt Kiwi will believe this of course because the purity level of the oxygen some of the patients were breathing may or may not have been placebo controlled
TalShu, Outstanding reply to my post. What I found most interesting is how entrenched Novo Nordisk is in China. Of course, Europe is the most important market for a potential acquirer. China is an enigma. However, if an acquirer of AMRN (mainly for what they could do with Vazkepa in Europe) also had a way to optimize (or should I say to help Eddingpharm optimize) the uptake of Vascepa in China, that could be a real bonus. Of course, once China approves Vascepa for CVD that would be major step forward. If Eddingpharm were to work with a BP owner of AMRN that could provide greater distribution & other support (maybe with IP) that could be a win-win. Thanks again for well thought out and carefully documented comments!
Tal..." Holt’s narrative is the BOD’s focus on immediate, short-term, execution. To put it in his words: “the focus in the immediate term is really on executing what we have in our hands.”
i.e. In plain English Holt seems to be saying...Do what we can now to get the stock price up..and the sell the company and let the buyer take over and do the rest...e.g. developing LR-Et-EPA...This seems like a risk averse strategy that I'm not sure I'm happy with...Its a little disappointing...It isn't why I got into Amarin over 14 years ago
I could have bought Pfizer instead and benefited from a nice dividend all these years.