Amarin Corp PLC (AMRN) 뉴스

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175887676

If not being like you makes one liberal, count me in.

Amarin attorneys in Arizona (Perkins et al) filed a petition in Supreme Court on March 4 to extend time to file a response to Hikma's Petition
for Writ of Certiorari that was filed on February 14, 2025.

https://www.supremecourt.gov/docket/docketfiles/html/public/24-889.html
Sleven,

https://www.linkedin.com/posts/michael-everts-34799334_the-pleiotropic-effects-of-ipe-residual-activity-7303042029205209088-yWNy?utm_source=social_share_send&utm_medium=member_desktop_web&rcm=ACoAAAdDmycBzT_CwLIulyFqANe8SLMF4KH2Odo

R3i:

https://www.linkedin.com/posts/r3ifoundation_r3i-residualrisk-residualriskreduction-activity-7290005794429779968-R-U-?utm_source=social_share_send&utm_medium=member_desktop_web&rcm=ACoAAAdDmycBzT_CwLIulyFqANe8SLMF4KH2Odo

https://www.ncpe.ie/icosapent-ethyl-vazkepa/
Sleven,

https://stocktwits.com/SanDiegoLiving/message/606646103

Our Friend Peter Libby has just been named the new President of R3i Foundation (Residual Risk Reduction) https://www.linkedin.com/company/r3ifoundation/posts/?feedView=all

$AMRN This is Interesting:
Today, Esperion announced a partnership with CSL Seqirus to commercialize NEXLETOL and NEXLIZET in Australia and New Zealand. This is the same partner $AMRN uses in Australia & NZ. Hummm

JRoon, Some supply from CCSB in Taiwan.
Sleven,

Sleven, that would be ideal. I wonder if ALL of the generics obtain supply from China. It appears so from the shipping manifests you post, but not sure if that includes all of them or not.

JRoon, This will probably give Amarin an advantage in negotiations with providers.
Sleven,

I wonder if any of the generics have "backdoor" channels where they could funnel API or finished product through other countries, versus delivering straight from China to the U.S.

If nothing else, it will either be costly, or highly disruptive to their supply chain (I hope!).

Nuke, don't forget, in Italy (like Canada), all 20 of their "Regions" must first go through their own individual approval processes before being approved in their regions for reimbursement. This could be a 12-24 month process to see approvals in all of them (it was not clear from what I read back then about regional approvals and timing).

I would expect this approval process to look somewhat like Canada. And also, with the current restrictive criteria on Vazkepa in Italy, the target population is actually quite small (I think CaptBeer indicated 250,000 people nationwide?).

While a pharmaceutical medication must be approved by the national agency (AIFA) for reimbursement in Italy, each individual region can then decide whether to include it on their own regional list of reimbursable drugs, meaning not every region is required to reimburse the same medications; this can lead to variations in patient access depending on where they live in Italy....

After national approval, each of Italy's 20 regions can then decide whether to include the drug on their own regional formulary, potentially leading to discrepancies in access...

This regional review can further delay patient access to new medications as each region may have different criteria for inclusion...

Once the national evaluation is completed, a new drug is usually not immediately available in every hospital or pharmacy, except for innovative drugs, which receive immediate access to regional formularies. Otherwise, the drug’s approval process needs to undergo further steps that are different from one region to another. Even within a single region these steps may vary among the different health districts and hospitals. The regional drug access is a fragmented and complex process; both the timing and the number of drugs available for patients are widely different from region to region. Due to these different procedures and to regional decision-making autonomy, discrepancies and inequalities between different regions in the timing of patient access are created.

https://www.usnews.com/news/health-news/articles/2025-02-18/trumps-tariffs-prompt-fears-for-cost-quality-of-critical-medications
Wonder how this will impact our generic competition?
Sleven,

The study says 2029

You are right Nuke. Numbers the only thing in considering traction.

I am slightly curious about the study DMC8 posted a link to yesterday (via ST) where Novartis and Amarin are Collaborators. Are they just collaborating individually with the study or are they collaborating with each other? It could mean absolutely nothing or maybe???? Denner did the deal for Medicines Co with Novartis.

Italy gaining some traction? Guess we'll have to wait for the numbers.

Overall market looking ugly this morning.  

https://stocktwits.com/SanDiegoLiving/message/606646103

https://x.com/JAHA_AHA/status/1896757236057133447

Kiwi, no question that Amarin's V scripts stalled in the 2nd half of 2020 and continued spiraling downward since then. How much was related to Nissen is debatable. First, Amarin ceased marketing. And we know you can't sell drugs in America without marketing. Secondly, although V's sales started to tank, the overall scripts for V + GV have continued to rise - albeit at a rather slow pace - NO marketing. If you look at Capt. Beer's post #429059, you will see that scripts in Canada, as small as they may be, are on a constant and steady rise. So, I don't know, could it be they have blocked all commentary by Nissen in Canada?

This is one of the last charts of scripts in the US by Capt Beer:
https://drive.google.com/file/d/1q2Gq20XdYCJ1IfXHN-O943forVFbf5Sj/view

As forecasted AMRN TA was in a bounce or break mode as resistance was approached last week. At the time, volume was anemic - indicating likelihood of a price reversal at the ice line. The updated chart below displays a threatening break of the trough low support between the A-B peaks.


That the 200DMA was breached in the General market today, means AMRN prices continue to plummet towards the .43 low.

The Kangaroo is a better price forecaster than Puxatony Phil!

When do you expect published results ???
Kiwi

https://stocktwits.com/SanDiegoLiving/message/606582922

RMB. just wondering ...R-IT indication was approved late Dec 2019 and scripts surged .
When did Dr Nissen start trashing age R-IT results as being over stated due to placebo used ?

Here you go ...courtesy of our president's best buddy's AI


Dr. Steven Nissen began challenging the results of the REDUCE-IT trial prominently following the presentation of findings from the STRENGTH trial, for which he was the principal investigator.

The STRENGTH trial results were presented at the American Heart Association (AHA) meeting in November 2020, showing no cardiovascular benefit from omega-3 carboxylic acid (containing both EPA and DHA) compared to a corn oil placebo. This contrasted sharply with the REDUCE-IT trial, published in 2018, which demonstrated a significant reduction in cardiovascular events with icosapent ethyl (a purified EPA formulation) against a mineral oil placebo.

Nissen's challenge escalated after STRENGTH's full results were published in JAMA Cardiology on May 16, 2021. He argued that REDUCE-IT's positive outcomes might be a "false-positive" result, attributing the difference to the mineral oil placebo used in REDUCE-IT, which showed increases in LDL cholesterol and inflammatory markers like hsCRP, potentially exaggerating the treatment effect.

He suggested that the corn oil placebo in STRENGTH was a more neutral comparator, casting doubt on REDUCE-IT's findings.
This critique was notably articulated during his presentation at the American College of Cardiology (ACC) meeting in May 2021, where he called for further randomized controlled trials with a neutral placebo like corn oil to validate REDUCE-IT's claims.

Thus, Dr. Nissen started challenging the REDUCE-IT trial results in late 2020, with his skepticism gaining significant traction in 2021 following the STRENGTH trial's detailed outcomes and subsequent debates.


---------------------------
How were scripts trending after late 2021 ?...... 2 yrs after the R-IT indication was approved


Kiwi

Austria (our latest P&R approval: IHD & Stroke Stats show a huge potential patient population for VAZKEPA

Pretty amazing Capt. I worked for Checker Auto 2000-2003 approximately when my youngest daughter was born. I needed the money. Checker fell on hard times (management stupidity) and was bought out by O'Reillys. They can be really good jobs, you meet a lot of nice people. There's always exceptions however. Keep sending those slides, you never know. Good luck. 

agreed

Nuke, Thanks for the kind words. I actually started a job for O'Reilly Auto Parts (ORLY) as a "Parts Runner thanks to my retirement fund. Check out their stock! Every now and then I send AMRN some of my slides with a subtle hint about employing me. Nothing yet.

Or to use Thero's language : Robust.  Ha. 

Yes..... the ad campaign was a major cause of raising drug awareness but I agree they shouldn't spend another dime on ad campaigns in the US until they either get back their patent protection via some miracle of law or a new formula or perhaps the launch of a generic but who knows how effective that will be. We just need to tread water until further penetration of the EU, China, and ROW. Then find a way to get some BP bids for the drug and all it's patents. Coming up with a new indication wouldn't suck either.

I won't argue that point but only offer an example. In the 3 months after label expansion, and marketing was in full swing, script increase was dramatic.   

FYI: There are nearly 2.3 million existing cases of adults with IHD or a stoke survivor. This is clearly an unmet clinical need. Slowly, but surely European regulatory agencies are recognizing the unique and distinct benefits of VAZKEPA®

RMB Insurance co pays ...or lack of coverage ...ultimately determine which drugs patients get or can afford .
Some drug companies set unreasonably high prices for their drugs and health providers use tier ratings to make patient copays unaffordable for many .
As example ...my Cardiologist will prescribe me Inclisiran ( a PCSK9 thats 2 shots a year ) but Kaiser insists I pay the full amount ...around $6,000 a year if I want it , or stick with Repatha ( a shot every 2 wks ) which they will cover with a $1,500 a yr co pay .
For CKD patients , as you are aware , Insurers usually want LN patients to fail on Benlysta before they will consider covering Lupkynis ...Benlysta being around 1/3 rd less cost .
MD's usually try to treat their patients with the best drugs available ...wether insurers will cover them is a whole different matter .

Treatment protocols are often driven by the heads of the various departments in hospitals . So if you have a head of dept thats a fan of Dr Nissen ...dont expect a huge push to prescribe Vascepa

Kiwi

FYI: Some smaller (Population wise) countries that have approved VAZKEPA® for P&R. Ischemic Heart Disease & Stroke INCIDENCE Numbers for 2021 reached over 273,000. This is clearly an unmet clinical need. Slowly, but surely European regulatory agencies are recognizing the unique and distinct benefits of VAZKEPA®

Capt; with your skills at making pie charts and graphs, you're wasting your skills here. You should be the head of Marketing somewhere? My goodness. 

FYI: Some smaller (Population wise) countries that have approved VAZKEPA® for P&R. Ischemic Heart Disease & Stroke Death Numbers for 2021 reached nearly 100,000. This is clearly an unmet clinical need. Slowly, but surely European regulatory agencies are recognizing the unique and distinct benefits of VAZKEPA®

I still think this is a sad commentary on the medical community. Isn't it their jobs to treat patients. Has that responsibility morphed into awaiting marketing campaigns to guide their treatment protocols?

Look at the guidelines, and look at what is covered by insurance. We can't place all the blame on doctors. Spend some time reading opinions on Vascepa within the healthcare industry. Most of what I see is "well, it's really just fish oil...it's for high trigs...bad placebo...". Plus, when you've got statins, PCSK9, Ezetimibe, and BA, there is not really a "need" for another solution. Look at how EZE+BA combo pill is doing in the UK compared to Vazkepa.

Most docs have their "go-to" authorities in the industry. And if they follow someone like Nissen (and there are many others), then they will have a natural skepticism towards Vascepa and fish oil in general.

The fact is, Amarin stopped trying in the U.S. years ago. New Medications don't just "sell themselves". You think GLP-1's just "magically" fly off the shelves? No. Their companies SELL them. They MARKET them. You can't watch TV for 5 minutes without seeing a commercial for them.

As the Godfather would say "Maybe they made him an offer he couldn't refuse"

Hmmm, with only two jobs posted, the Ol Chipper seems to not stay very long in one place? Teva =11 months, Amarin =9 months, it's coming time to switch jobs maybe? We'll see, maybe working for Teva wasn't his thing? I would imagine Teva is harder to work for and to get ahead career wise? 

Being delisted would be better than the dreaded reverse split for your investment

I likely wont stick around to find out. When it becomes clear they are going to do a split will unload all I have I am not sticking around for the massive dilution that will follow. Its really blows my mind what denner did tot this stock price.

Bull, Jroon, in a way, I still think this is a sad commentary on the medical community.  Isn't it their jobs to treat patients. Has that responsibility morphed into awaiting marketing campaigns to guide their treatment protocols?

From your mouth to God’s ears
Bullrunner!

it is no longer an evidence problem but rather a marketing problem.

Precisely. All this stuff that Capt and SDL post is wonderful, but the truth is, none of it really matters. It's just fluff. We all know the "evidence". Amarin knows all the "evidence". And it's great information for us to keep up to date on the company, since Amarin, the Board, and Sarissa have made the conscious decision to withhold all information that is not required to be dispensed per SEC rules. But why the hell are we getting more information from random shareholders than from the company or the board?

I have said this numerous times - Denner has made the decision to end all public marketing and communications.

You have to ask yourself why. And I no longer accept the "the generics are the ones who will benefit" line.

We aren't fighting the market or the medical/science community. We are fighting Denner and Amarin. They don't WANT all this information out there.

The only thing I hold onto is that maybe Denner is waiting for the new formulation to be ready, or some other development. I really don't know. Because they don't share anything. I have wondered for quite some time why we have all these approvals in Europe, yet we aren't selling a single script in most of the EU countries. UK and Spain. That's it. I'm sure there's a reason. Maybe it's financial. Too costly to launch in countries that are too small to make a difference. And maybe they are waiting until they have a stronger foothold in Europe and can support a cashflow-negative launch in the smaller countries. Maybe? But again, we don't know because they don't say shit. They just meekly announce that another country has been approved. And that's exactly why the stock price doesn't move when we have a new approval - because the "market" knows that we aren't going to sell a single script in any of these countries (yet?).

The stock price wouldn't bother me so much if I had any idea what their plan or their goal was.

EDIT: And I should also say, that despite this, I (we) appreciate the efforts of Capt, SDL, Sleven, DMC, etc. Without their efforts, we would be flying TOTALLY blind.

Vazkepa/Vascepa needs to be in bigpharma hands for the good of humanity. It's a shame how many people die because they don't even know about it or taking a generic which is not equal. In big pharmas hands we would be a 1bill revenue company quickly.

https://stocktwits.com/SanDiegoLiving/message/606460233

A poster on ST stating that it is no longer an evidence problem but rather a marketing problem. I don't disagree - particularly when it comes to the U.S. market. BUT, how do you spend millions upon millions for a marketing budget when you know much of the benefit will go to the Generics. A very tough situation.

There is as good a chance as any with RFK Jr., but there is also a great chance with his anti-drug mindset that he just proclaims "go get fish oil".  We just have to see.