Amarin Corporation PLC (AMRN) News

Lizzy, I think this has been the game plan since shortly after we lost the US patents. Prior managers initiated it. New management said they would continue with it. I don't think this company is a buy out candidate, at the moment. They are building a multi-national pharmaceutical company. It's going to take some time before Wall Street sees it.
Again all of the above is just my opinion.
Sleven,

Sleven, Indeed your theory is playing out. Kudos. It's so logical I guess it may have taken them a while to realize that if you can't fight the system their way then might as well game the system another way.

Lizzy, It was over two or three years ago that I first posted my theory about how this would play out. Amarin has access to both supply and markets that the generic companies don't. As markets outside of the United States gain traction, we will need to purchase larger volumes of API. Buying in bulk should decrease unit cost. At the moment we are taking a hit on US sales margins. I believe that is a temporary problem. With the return of the exclusive contract through CVS, we have over 50% of the US market again. Multiple generic distributors are fighting over the rest. This gives us a certain amount of leverage when we negotiate with suppliers. None of the individual generic companies will be able to complete with our volume. If you are the supplier who do you want to do business with? If our partner can get Vascepa included in the 2026 NRDL things might change quickly. Lots of eligible patients in China. As always I could be wrong. I think we are seeing my theory of Amarin's plan start to take shape.
Sleven,

The rebate plan now offered by Amarin will eat into margins they will make up the difference with volume.

Someone recently posted this idea or option to increase PBM's coverage for V and drop GV. So, while CVS has changed its formulary as of 7/1/25, Rebates from Amarin to PBM's has turned the tables in favor of brand V.
Copilot reply.

Pharmacy Benefit Managers (PBMs) have recently shifted to covering brand-name Vascepa® while dropping generic icosapent ethyl from many formularies—a move that seems counterintuitive at first glance. But here’s what’s driving it:

💸 1. Rebate Economics Favor the Brand
Amarin, the maker of Vascepa, offers substantial rebates to PBMs in exchange for exclusive formulary placement. These rebates can make the net cost of branded Vascepa lower than the generic, which typically doesn’t offer rebates at all. So even though the list price of the brand is higher, the PBM and plan sponsor may actually pay less.

📉 2. Generic Supply and Pricing Issues
Generic manufacturers of icosapent ethyl have struggled with:

High production costs (due to the complex purification process)

Limited supply capacity

Lower profit margins, making them less competitive on price

This has led to inconsistent availability and higher acquisition costs for some generics, undermining their usual cost advantage.

🧾 3. Patient Out-of-Pocket Costs
Because of the rebate structure, patients may pay less for branded Vascepa than for the generic—especially if the generic is non-preferred or not covered. This makes the brand more attractive from a patient affordability standpoint.

📋 4. Formulary Strategy and Simplicity
PBMs often prefer to streamline formularies by selecting a single preferred product. With Amarin’s aggressive contracting, Vascepa has become the exclusive product for many commercial and Medicare Part D plans.

So while it bucks the usual trend of favoring generics, this shift is a classic case of rebate-driven formulary design. If you’d like, I can show you which PBMs or plans currently list Vascepa as preferred, or help compare out-of-pocket costs across plans.

Good Find! Residual Risk is real, and IPE is at the heart of mediation therapies.

2019 article that needs to be republished......Love this part...............It is a prescription drug that will likely be given to many more patients for the prevention of cardiovascular disease if the FDA goes along with the recommendation of its advisory committee, and it usually does.

LDL-C and lipids are very complex/contextual (way above my paygrade _ Im NP). LDL-C isnt as important when inflammation is controlled (easier said than done). If LDL-C in itself was the full story dropping it to 0 would almost eliminate 5 point MACE which it does not (not even close).

https://www.cbsnews.com/newyork/news/vascepa-super-fish-oil/?intcid=CNM-00-10abd1h

🔎 Residual ASCVD Risk in Statin-Treated Individuals
📌 Insights from EHJ 2025
Summary

🟣 1. Statins Don’t Eliminate All Risk
Even at LDL-C < 55 mg/dL, residual cardiovascular risk persists due to:
✅ Triglyceride-rich lipoproteins
✅ Inflammation
✅ Lipoprotein(a)
✅… pic.twitter.com/Y2yDguvgpe— CME INDIA (@CMEINDIA1) June 17, 2025

Kiwi, I think the cost of this study was estimated at about 1.5 million pounds.
Sleven,

Thanks.  Will check it out when I get home. 

RMB, I provided two colorectal cancer studies. The second one is the linked study. First study doesn't involve issues with the liver. both are completed.
Sleven,

https://clinicaltrials.gov/study/NCT04216251?term=Icosapent%20ethyl&page=2&rank=20
https://clinicaltrials.gov/study/NCT04682665?term=Icosapent%20ethyl&page=3&rank=27
The second study is the one that is linked. Both are relevant.
Sleven,

Sleven, that would be a very interesting read.

You can access the U.S. Supreme Court’s Orders List at the following official link:
👉 https://www.supremecourt.gov/orders/ordersofthecourt.aspx

This page contains all recent and archived Orders Lists, typically released on Mondays and after conferences. The Orders List for the June 18, 2025 conference will most likely appear on the June 23, 2025 entry.

Kiwi, I'm glad you appreciated the information about the study. This trial also has a separate linked observational study. If you would like I will find and post that. It relates to potential MOA.
Sleven,

Michael, I think the standard thought would be that oil stocks should be up. I do have some oil stocks so if the rest of the market suffers (it could actually be massively up as well) then those oil stocks should buffer the portfolio.

rosemountbomber

How about oil ?? Israel just cleared the way for the US bombers Go USA
Michael

Well 2 weeks came up quick. We attacked Iran today. Anyone have any idea about impact on the markets?

Yep. I did some follow up . Risk is not as bad as I thought . My impression tho was that Kaiser is not in favor of it over 75 .
How are you doing with high blood pressure ...I think you had mentioned that here before .
Kiwi

Well because I've had polyps removed in the past ....so they say no Coleguard
By mid 70's its a risk / reward issue due to the risk of perforating the colon during the procedure .
Kiwi

Interesting that you bring up the colonoscopy. As you know I have a new doctor since a year and a half ago.

On my last visit I guess he was looking at my records that he may have gotten from the previous practice and said something about being due for a colonoscopy. I did bring up perforation, etc., but he seems to defend much of the medical practices - can't bitch too much since he was very laudatory of Vascepa on my first visit with him. When he does blood work for his patients he typically doesn't check for cholesterol.

Anyway I diverted the conversation a bit by asking about Cologuard, and then eventually I turned the conversation elsewhere and then I bolted. But my ideas are like doc's. If they find cancerous polyps it will be at least 5 or 10 years before they kill me. I have other things that might be more of a priority. Not sure if family history is important, but I am not aware of any colon cancer going back a few generations.

Why not do Coleguard? 

N7 ...related..... debate on colonoscopy's .. When I turned 74 I was supposed to have another colonoscopy . On discussing with the MD on risk / reward .
His view was
1) higher risk of perforating the colon at that age
2) If I was developing cancerous polyps I'd probably live to early 80's anyway .
3) Since I was secondary prevention CAD with He FH ( baseline LDL at 312 mg/dl ) I'd probably be dead anyway ...so dont worry about it .
He didn't use those words ...more like your life expectancy etc etc .
Reminds me to take my Vascepa ...I reduce my risk of colon cancer ( or at least may increase my DFS ) and may exceed my estimated life expectancy

Kiwi

N7. thx for bringing this trial to our attention .
Its an important trial for patients and anyone owning shares in AMRN .
Because its a P 3 trial with over 400 patients theres significant expense in recruiting , follow up , blood tests etc .
They will want to chk and double chk the data before releasing anything .
I notice they have follow ups every 6 mths at which time they probably ask those enrolled if they stuck to the dosing schedule and then do random blood tests , probably to chk for EPA blood levels to see if they have , then dispense the next 6 mths of Vascepa or placebo .
The issues raised by Dr Nissen re the placebo ..if using mineral oil ....dont really apply for the first 2 yrs IRRC from the R-IT data .

Theres long been a belief that those on mainly fish / vegetarian diets have a lower incidence of colorectal cancer then those on red meat diets .


Studies suggest that diets high in fish, particularly fatty fish rich in omega-3 fatty acids, are associated with a lower risk of colorectal cancer compared to diets high in red meat. A 2019 meta-analysis found that higher fish consumption was linked to a reduced risk of colorectal cancer, with a relative risk reduction of about 12% for each 100g/day increase in fish intake. Omega-3s may have anti-inflammatory and anti-carcinogenic effects that contribute to this.
In contrast, high red meat consumption, especially processed meats, is consistently linked to an increased risk of colorectal cancer. A 2015 World Health Organization report classified processed meats as a Group 1 carcinogen and red meat as a Group 2A probable carcinogen, citing evidence that 50g/day of processed meat increases colorectal cancer risk by about 18%.


EPA ( Vascepa since AMRN is involved in this trial ) may be the secret sauce !!!


Please post any updates on this trial that you become aware of
thx
Kiwi

Kiwi,
https://ctru.leeds.ac.uk/emt2/
From the trial website, it looks like your right. Early/mid 2026.
Sleven,

Kiwi, That's possible. I was making a timeline guess based on the estimated primary completion date. Disease free survival shouldn't take much time to calculate.
Sleven,

https://www.sciencedirect.com/science/article/abs/pii/S0952327816301284

Highlights

•
Individual red blood cell (RBC) and tumour polyunsaturated fatty acid (PUFA) levels have not previously been reported in a randomised trial of omega-3 PUFA supplementation in cancer patients.
•
Our data highlight the high inter-patient variability in eicosapentaenoic acid (EPA) incorporation in cells that occurs during oral dosing in colorectal cancer (CRC) patients.
•
Importantly, we demonstrate, for the first time, that the RBC EPA level predicts CRC liver metastasis EPA exposure during EPA treatment, suggesting a role for RBC PUFA analysis as a non-invasive biomarker of tumour EPA exposure in future phase III trials.
•
A fascinating preliminary observation is that RBC EPA content, irrespective of randomisation to either EPA or placebo, was related to post-trial overall survival.
•
Future trials of omega-3 PUFA supplementation should incorporate secondary analysis of blood omega-3 PUFA levels as a predictor of clinical outcomes, especially as background dietary intake of omega-3 PUFA can vary significantly and widespread use of ‘own’ omega-3 PUFAs may ‘contaminate’ the placebo group.


From the phase 2 trial

EPA Incorporation: Analysis of red blood cell (RBC) and CRCLM tissue confirmed that orally administered EPA was incorporated into target tumor tissue, with a mean 1.26% increase in RBC EPA content during treatment (p<0.001), not observed in the placebo group.

So looks like an increase in RBC ( red blood cell ) EPA content, may increase disease free survival

Kiwi

N7 they record no longer recruiting at 12 /23 . So minimum 2 yrs followup plus 6 wks min to clean / chk data on 400 patients ...you are probably looking at late Jan into Feb 2026 for top line data
JMO
This is an important trial ...Amarin listed as collaborator
I might take a spec on this trial ( gasp ...buy some AMRN ) on any sell off, as we get closer

Kiwi

N7. Good find


The Phase II randomized controlled trial (RCT) of eicosapentaenoic acid (EPA) 2 g daily in patients (n=88) undergoing liver resection surgery for colorectal cancer liver metastases (CRCLM), known as the EMT study, yielded the following results:
Primary Endpoint (Tumor Proliferation Index): There was no significant difference in the histological tumor proliferation index between the EPA and placebo groups.

Secondary/Exploratory Endpoints:
Tumor Vascularity: Metastases from the EPA arm showed a lower vascularity score, suggesting potential anti-angiogenic activity compared to placebo-treated tumors.

Disease-Free Survival (DFS): Median DFS was 22.6 months in the EPA group compared to 14.7 months in the placebo group, indicating a potential benefit, though this was an exploratory endpoint.

Overall Survival (OS): OS was also specified as an exploratory endpoint, with preliminary observations suggesting a possible prolonged survival benefit in the EPA group, though specific data were not detailed in the provided references.

EPA Incorporation: Analysis of red blood cell (RBC) and CRCLM tissue confirmed that orally administered EPA was incorporated into target tumor tissue, with a mean 1.26% increase in RBC EPA content during treatment (p<0.001), not observed in the placebo group.

Safety and Tolerability: EPA at 2 g daily (as EPA-free fatty acid) was safe and well-tolerated during the preoperative period.

Study Limitations: The trial intervention was limited to the preoperative period, and tissue samples were only obtained at surgery, preventing longitudinal analysis of EPA incorporation and washout in CRCLM tissue.

The trial provided preliminary evidence of EPA’s potential anti-angiogenic effects and possible survival benefits, supporting further investigation in the larger Phase III EMT2 trial.


The P 3 trial ClinicalTrials.gov ID NCT03428477
Randomisation will be 1:1 to receive either IPE capsules or placebo capsules. 4 capsules per day containing IPE (equivalent to 4 g EPA-ethyl ester [EE] daily) or 4 placebo capsules per day.
Participants will start treatment a prior to CRCLM surgery and will continue to receive treatment for a minimum of 2 years and a maximum of 4 years post-liver resection.


So double the dose of EPA ( I'm assuming its Vascepa ) from prior to surgery for at least 2 yrs following surgery .

I'll be a big deal if this prolongs DFS ( disease free survival ) significantly
Kiwi

My spirits here have recently been buoyed particularly by some of the PBM changes that posters have provided. 180 degree from the last couple of years where Vascepa was being shut out by some PBMs and insurers. That change of heart has not yet affected my insurer (FEHB BCBS with Prime Therapeutics as PBM).

But thinking about how Hikma et al are suing Amarin for supposedly cornering the API supply, I wonder if anyone has any thoughts on whether these Generics would be entertaining the idea of suing PBMs if the PBMs drop GV? About a year ago the FTC and some states sued PBMs but from what I gather there big beef was that PBMs were removing lower cost options for patients. For example this is the Vermont case:

https://ago.vermont.gov/blog/2024/07/17/attorney-general-clark-sues-pharmacy-benefit-managers-illegally-driving-prescription-drug-costs

Have no idea if the Generics would have any leg to stand on or whether they would simply not entertain such action since I assume they would not want to alienate the PBMs since they probably have many other drugs being covered and the GV market so small for them not to mess with it.

Dancing
Thanks for these ai posts. Some potentially positive possibilities here.
When do you [or ai] believe the actual BO of the company will occur?
tia

https://www.researchgate.net/publication/347293910_Omega-3_Eicosapentaenoic_Acid_Reduces_Prostate_Tumor_Vascularity
Sleven,

From Claude.ai this time:
**Implementation Timeline:**
**Phase 1 (2026-2027)**: EMT2 success creates temporary branded advantage**Phase 2 (2027-2029)**: Enhanced formulation development and regulatory approval **Phase 3 (2029-2032)**: Payer policy implementation and market differentiation**Phase 4 (2032+)**: Sustained competitive separation from generics
**Buyout Valuation Impact:**
**If Generic Exclusion Succeeds:**- **Platform value**: $400-800/share (restored premium)- **Acquisition rationale**: Genuine competitive moats- **Big Pharma interest**: Maximum willingness to pay
**If Generic Competition Persists:**- **Platform value**: $100-200/share (commodity pricing)- **Acquisition rationale**: Portfolio integration only- **Big Pharma interest**: Moderate strategic value
**Bottom Line:**
The most realistic path to **functional generic exclusion** combines:1. **Enhanced formulations** (LR-EtEPA) with superior efficacy2. **Companion diagnostics** requiring specific products3. **Payer policy differentiation** based on medical necessity4. **Combination products** that can't be substituted

Sleven, this is a good trial. If you have other data, I'd love to see it.

Sleven,
Thanks for your offer; but SDL had put me in the picture based on his thorough investigation of the matter.

TalShu, Yes we are. Disease free survival was roughly 22 months in the active arm versus 14 in the placebo. That's fairly significant. I have been digging into the clinical research that proceeded this phase three trial. Some interesting stuff. If you would like I can post some of the findings.
Sleven,

Sleven,
And now we’re talking “cancer”.

TalShu, I am expecting top line data before year end.
Sleven,

Thank you Sleven,
Completion next November, readout in April 2026.

Yup, I understand that FDA withdrawing the Marine indication is impossible without some safety issue with the drug. Safety issue is something none of us want to be associated with Vascepa in form.

But PBMs have the ability to obliterate the generics by not covering IPE for >500 TG. As you rightly mentioned PBMs not covering IPE FOR >500 TG will save them money. At the same time if AMRN can sell them vascepa at a price which is very competitive or even little bit less than what currently generics are charging, PBMs will have added advantage of paying less for IPE for reduce it indication and at the same time no liability for patent infringement.

With economy of scale, Amrn can also afford to sell vascepa at a lower price to PBMs.

A perfect synergy purely based on business fundamentals, which could be sustainable.

Some weekend reading. https://www.propublica.org/article/fda-drug-loophole-sun-pharma

https://clinicaltrials.gov/study/NCT03428477?term=Icosapent%20ethyl&page=2&rank=16
For anyone following possible upcoming catalysts. This trial has e better than average chance of producing a positive result. Look at the phase 2 exploratory results.
Sleven,

You are correct---there are days when a sleepy, fat thumb hits the wrong key on an I-Pad,  and I ignore any correction that appears

I like your sale of the July puts assuming you have the cash to cover the purchase of the shares if they are put to you. I give this outcome a low probability (unless you give high credence to FFS's interpretation of his charts). If you sold 10 puts at $0.22 (the last quoted sale price), that's $220 against the risk that the price declines to $10 in a month. A nice way to create a synthetic dividend. $10,000 is at risk, so using rough numbers that's ~$220 for 1 month which would be about 26% annualized.

Snd101, FDA will only withdraw an indication if, new evidence calls into question issues of safety or effectiveness. That is unlikely. The insurance business might be a different story. Not providing coverage for the MARINE indication would save them money. Conversely covering the generic for the CVD indication, exposes them to potential litigation. It's a situation that we should pay attention to.
Sleven,

North, is the date you list as 7/23/25 correct? Should it be 6/23/25?

I looked into this a couple years back...... I believe that they would have to show there is an issue with the drug whereby it is not safe to use.......... so, unless there is another way, we fight the way we are fighting.

RMB, the reason I was curious, is because I was one fo those people that asked about it, probably a year or so ago. When I asked if it was possible to withdraw an indication, I was told "yes", but that we could only withdraw our own product from the indication, but unless the FDA somehow rescinded approval of the drug for the indication, that generics could continue to sell into it.

I honestly don't know who told me that, but recall it may have been Chromosome or Kiwi, or possibly Tatsumaki.