Amarin Corp PLC (AMRN) News

https://www.sciencedirect.com/science/article/pii/S104366182500060X

Yep that is high.  Most weight loss encompasses 20-25% loss of non-fat, so ultimately down the road these people GLP-1 inhibitors will have poorer health outcomes. 

40% of weight loss via GLP-1 inhibitors are lean mass (muscle loss and bone density loss). Seems like significantly greater risk than the wonder drug impacts I have heard about to date (at 2:24 in the video below).

Learning for the first time about insulin levels and ketogenic states. Seems as though beneficial impacts of EPA may be significantly related to helping to maintain insulin sensitivity / avoid insulin resistance? "According to current research, fish oil, which contains EPA (eicosapentaenoic acid), may have a positive impact on insulin levels by potentially improving insulin sensitivity, suggesting that consuming EPA from fish could help regulate blood sugar levels and potentially decrease insulin resistance, particularly in individuals with metabolic issues; however, the exact effect can vary depending on individual factors and study design." EPA may contribute to ability to burn both visceral and subcutaneous fat (produce ketones). The brain favors energy from ketones over glucose. Ketones are energy available from fat (processed by ingested or body fat) and are muscle protective (including heart). Body will not generate ketones / burn fat, until insulin / glucose (carb) levels are low. People suffering form Alzheimers have improved brain function when in a ketogenic state that allows the body to send the brain ketones (energy favored by the brain).

N7. Not intending to throw sh#t on it . Just pointing out that they have 4. 5 yrs to complete this trial and show efficacy ...if they want to keep marketing authorization in China .
Thx for bringing it to my attention
Kiwi

Interesting story about how a non FDA approved product will be marketed during the Super Bowl:

https://www.yahoo.com/lifestyle/a-super-bowl-ad-about-weight-loss-drugs-takes-on-americas-broken-health-care-system-health-experts-and-2-senators-arent-happy-about-it-012203206.html

Kiwi, You finally have the confirmatory trial you have been begging for. I bring it to your attention and you throw shit at it. Do you think results would be faster in another country?
Sleven,

Well the fact we know nothing about a trial required by the Chinese govt to be completed within the next 41/2 yrs ..
The success of this unknown trial being critical to continue the sale of brand Vascepa in China
That should concern anyone thinking huge $ from China is in the bag
JMO
Kiwi

Kiwi, I'm not going to debate this with you. We have no information about the nature of the Chinese clinical trial.Are you relying on AI to do your thinking?
Sleven,

Its from date of approval in China July 24 .
Here's Perplexities idea

To design the smallest and shortest trial to confirm the REDUCE-IT findings in a Chinese population, the following elements would be essential:
Key Design Features
Population
Sample Size: A smaller trial could focus on high-risk patients with established cardiovascular disease (CVD) or diabetes plus additional risk factors, similar to REDUCE-IT, but limit recruitment to Chinese participants.
A sample size of approximately 2,000–3,000 participants may suffice if the trial is event-driven and targets a high-risk population to ensure sufficient endpoint events within a short duration.
my emphasis

Eligibility Criteria: Include patients with moderately elevated triglycerides (135–499 mg/dL) and controlled LDL cholesterol (41–100 mg/dL) on stable statin therapy, reflecting REDUCE-IT inclusion criteria

Endpoints
Primary Endpoint: A composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or hospitalization for unstable angina, as in REDUCE-IT.
Secondary Endpoint: Focus on CV death, nonfatal MI, or nonfatal stroke to align with REDUCE-IT’s key secondary outcomes.

Comparator
Use an inert placebo (e.g., corn oil) to avoid confounding effects seen with mineral oil in REDUCE-IT.

Follow-Up Duration
Shorter Follow-Up: Limit follow-up to 2–3 years by enrolling a high-risk population likely to experience events sooner. Event-driven trials can reduce the required time by focusing on reaching a predefined number of primary endpoint events (e.g., 400–600 events). my emphasis

Geographic Focus
Conduct the trial exclusively in China to account for genetic, dietary, and healthcare system differences that may influence outcomes.

Mechanistic Insights
Include biomarker studies (e.g., hs-CRP and other inflammatory markers) to confirm whether the mechanism of benefit in Chinese patients aligns with findings from REDUCE-IT.

Feasibility
A focused trial like this would minimize costs and time while providing robust evidence for IPE's efficacy and safety in a Chinese population.
By targeting high-risk individuals and using an event-driven design, it could achieve statistically significant results within a few years.


Kiwi

Kiwi, Amarin entered into the agreement with Edding in 2015. They know what the Chinese government requires. The trial may have started years ago. We have limited information.
Sleven,

edited

Well what kind of trial would you or anyone reading this...... design to comply with this directive
to confirm Vascepa's efficacy in reducing cardiovascular events
Kiwi

Is this NEWS' - for US Tax payers ?

'Follow The Money' ✌️
-------------------------------

https://rumble.com/v6hmruj-they-fell-right-into-trumps-trap-ep.-2417-02062025.html

https://rumble.com/v6i1ffg-doge-uncovers-more-corruption-than-we-ever-thought-possible-ep.-2418-020720.html
-------------------------------

Could this all being exposed' - lead to a better 'More Honest' World in the future ? My hope is that it actually Will' 🙂

Kiwi, We have no information beyond the highlighted text you just posted. That and a deadline.
Sleven,

Thx Lizzy If the PPS is still under $1 by that date ( 3/3/25 ) they will probably be forced to have a vote on a reverse split anyway .
Once a reverse split is approved it usually takes about 2 mths to complete and have the SEC review all the paper work ...so they would be right up against the delisting deadline

. The company now has until May 19, 2025, to regain compliance by ensuring its stock closes at or above $1.00 per share for at least 10 consecutive business days
Kiwi

Well we can guesstimate how long their trial will take
The trial is a post-approval study mandated by China's National Medical Products Administration (NMPA).
It aims to confirm Vascepa's efficacy in reducing cardiovascular events in Chinese patients

To confirm efficacy they need a properly powered trial to generate stat sig reading of a P value preferably of .01 or better .
So my guess is they need 2,000 patients followed for at least 2 -3 yrs .

Look at the charts poster Capt presents . Event lines usually separate at 1.5 yrs . The separation needs to be maintained long enough so that theres preferably less than 1 chance in 100 that the results are due to chance. .

So to design , get approved and recruit a trial with 2,000 patients ......amazing if they can do that in 1 yr
Run the trial for a min of 2 yrs ...preferably 3 ( longer you run the trial more chance of stat sig results ) ....now you're up to 3-4 yrs ...then 6 mths to collect , clean and publish results .......total 31/2 to 41/2 yrs .

Remember ...they have to confirm efficacy and we dont know what is required by the Chinese health authorities for that ....but doubt its a short 100 patient open label trial

Note .. poster Laurent knows more about clinical trial designs than moi ...so it would be interesting to get his take on what the Chinese authorities might require
Kiwi

Monk4444, I poked around on their website but it's not user friendly. It needs to be cleaned up. I'm on medicare but certain scripts are cheaper for me to use GoodRX. I don't use Blinkrx but maybe with more investors involved they'll have the funds to update the website. I was surprised that a few very sophisticated investors have funded Blinkrx e.g. Bill Ackerman & Joe Lonsdale (Palantir co-founder).

kiwi, publicly traded companies have a 90 day window from the last day of the year to file their year end earnings and the 4th qtr earnings are contained within the 10K (Annual report). 10Q's have a 45 day requirement but if not prepared to report the company can ask for a 15 day extension known as a 10QN.
AMRN hasn't announced a filing date yet although Fidelity says it's 3/3/25.

Kiwi, 4.5 years is the deadline. Without any more information about the trial, there is no way to know how long it will actually take.
Sleven,

N7. Thx for the DD
Kiwi

Kiwi, I don't. I couldn't track the first Chinese study either.
Sleven,

Re One is being conducted in China.
Interesting , thx Any details on it yet ...trial design , has it started etc
Here are the details I've found
The clinical trial required as part of Vascepa's post-approval process in China focuses on verifying its efficacy in reducing cardiovascular risk among Chinese patients.
Here are the key details:

Purpose: The trial is a post-approval study mandated by China's National Medical Products Administration (NMPA).
It aims to confirm Vascepa's efficacy in reducing cardiovascular events in Chinese patients and provide data for a life-cycle benefit-risk assessment during the product's renewal, which is due five years after its approval in July 2024

Design: Specific details about the trial's design, such as whether it will be randomized or placebo-controlled, have not been disclosed yet. However, it is expected to focus on patients with elevated triglycerides and cardiovascular disease or diabetes with additional risk factors, reflecting the approved indication.

Management: EddingPharm, Amarin's partner in China, is responsible for conducting the study. Amarin supports the trial by supplying the finished product and providing development assistance.

This study builds upon prior research, including a pivotal Phase 3 trial conducted in China that demonstrated Vascepa's efficacy and safety profile in reducing triglyceride levels among patients with very high triglycerides.

Only 4.5 yrs to wait ...a blink of the eye in AMRN time
Kiwi

Approval of Vascepa by the China National Products administration will mean many things
-
-Edding will pay double digit % royalties on net sales of Vascepa in China
-Edding will pay a $15 million milestone payment to Amarin now
-Prices worldwide will have to come down post negotiations with China
-Volumes of sales of Vascepa will increase markedly
-An AG in the U.S. is now more likely than ever

Kiwi, My post wasn't about the Chinese market. You have been obsessed with the need for additional outcome studies. One is being conducted in China.
Sleven,

https://www.aace.com/files/patient-summary-dyslipidemia-guideline.pdf

Maybe their plan is to announce on February 29 this year too 😊

Is the ER due a qtly or end of yr report ?
If its qtly
Quarterly Reports: Companies must file Form 10-Q within 40 days after the end of each quarter for large filers, or 45 days for smaller companies35. These reports provide updates on financial performance for the first three quarters of the fiscal year.

Last report filed Oct 30th
Sooooo 45 days past end of Qt brings us to Feb 15th ...end of next wk ...unless its an end of fiscal yr report in which case they have more time .

Aaaah relax Amarin filed its 2023 end-of-year financial report on February 29, 2024, as announced in a press release and discussed during a conference call on the same day1.

Going to be an interesting day if PPS is still near where it is now .
Lets have an earnings report and a vote on a reverse split .
That Kangaroo warned you all ...remember that :--)
Kiwi

Of course price decline has nothing to do with AMRN failing to announce the date of their earning report yet , obvious threat of stock split by end of month ( allowing 2 mths to process before actual delisting date ) and the over all sell off in the market and biotech .

Its all because of that kangaroo
Dang it ...tie me kangaroo down Sport ...tie me kangaroo down . ( a popular song when I was a kid )
"Tie Me Kangaroo Down, Sport" is a popular Australian folk song written and performed by Rolf Harris in 19576. The song tells the story of an old Australian stockman who is dying and giving instructions to his friends8. It became a hit worldwide in the 1960s6.
The chorus of the song repeats the phrase "Tie me kangaroo down, sport," which is a request to restrain a kangaroo. Throughout the verses, the stockman gives various instructions to his mates, each followed by the chorus.
The song incorporates Australian slang and references to native animals like wallabies, koalas, and platypuses. It also mentions cultural items such as the didgeridoo, adding to its distinctly Australian flavor.
The song gained additional popularity when it was performed by Rolf Harris with The Beatles, though their version included some intentional mistakes and improvisations that added humor to the performance4.

Kiwi

N7. Thx ...a July 24 PR
Whats interesting is
As part of the approval, NMPA has requested that EDDING conduct a post-approval study after the product is marketed to further verify the efficacy of the product to reduce the risk of cardiovascular events in Chinese patients and provide a post-approval study report to conduct a life-cycle benefit-risk assessment at the time of product renewal.

Product renewal is required five years post the approval of the product.

So they have 4.5 yrs left to produce verification of the efficacy of Vascepa .
So assuming they do a large enough study to be powered properly ...say 2,000 patients .
Take up to one yr to get the study designed , approved and recruited .
Run the trial for at least 2-3 yrs ...to ensure separation of event lines ....hopefully gain stat sig results
6 mths at least to process , clean then publish results

By my calculation ...they started yesterday
How they doing ?

On the other hand ....there are a lot of wealthy people in China who will pay best in class ...brand Vascepa ...so it's not a market to ignore

Kiwi

Kiwi,
https://www.amarincorp.com/news-and-media/amarin-partner-eddingpharm-receives-regulatory-approval-0
China.
Sleven,

The Kaiser MITIGATE trial was probably the last chance to independently confirm to some degree R-IT results in the US .
Then Kaiser was still IIRC prescribing brand Vascepa ...now its generic and AMRN would obviously not pay for a RWE with generic V .
So next best hope for RWE with at least 2,000 patients is Spain ( Catalonia area ) or a deal with the German Health dept ....but so far no action on those fronts .
Kiwi

Agreed Kiwi but that’s the exception…Kaiser patients tend to be in the Kaiser system for longer time your average patient. I guess the other single payer is Medicare but that’s not until you hit 65

How I do actually hate this stock for many reasons..... replace the last part with I still hate Sarissa and this stock




Now if they sell at a fair price above $5, I can find love again

I think Kaiser is very proactive on preventive care
Kaiser Permanente does not publicly report a specific retention rate exclusively for patients with coronary artery disease (CAD).
However, its integrated care model and programs like the Prevent Heart Attacks and Strokes Everyday (PHASE) initiative suggest strong engagement and outcomes for CAD patients.
For example, the PHASE program in Northern California has been effective in managing cardiovascular risk factors, which likely contributes to patient retention through improved health outcomes and satisfaction15.
In general, Kaiser Permanente's retention rates are high, with California members staying enrolled for an average of 14 years compared to four years for competitors, indicating strong loyalty across its patient population1.

Kiwi

Well no . If you are a health provider like KP you drive down the cost you pay to the generics or AMRN in exchange for increased volume ....say down to $80 a month WAC and then you say to your highest risk , lowest NNT patients ...we'll split the cost with you
$40 a mth co pay for the patient , $40 a mth cost to KP which would easily pay for itself in fewer ER visits for their highest risk patients .

If RWE or additional trials confirm ( as Statin trials have done ) a 25% risk reduction in MACE ....I doubt if many would have a problem with a $40 a mth copay for Vascepa ( brand or generic )
My co pay for Repatha averages $120 a month . I pay it because I'm HeFH and Statins alone won't drive my LDL cholesterol below 100 mg/dl

So I dont agree with your opinion .
By the way R-IT had 2 interim analysis ...the first I think at 29 mths that was stat sig at around .0005 .
That trial probably achieved a p value of .01 by 24 mths ( One chance in 100 that the results were due to chance )
So why not do a REW using EHR ( Electronic health records ) for at least 24 mths
Kaiser's MITIGATE was using EHR ....they have the data on Vascepa ...but apparently AMRN isn't interested in paying them to retrieve it and independently analyze it .
By the way NVS is doing a 2 yr trial using Leqvio ( their PCSK9 ) with the German Health Dept ....2,000 patients IIRC for 2 yrs ....compare results SOC vs SOC plus Leqvio.
What can't AMRN do the same thing with the lowest NNT ( numbers needed to treat ) patients .

Anyway Pdude ...good to see you posting again ....
Kiwi

That’s probably more specific to the US system, especially since people change insurance all the time, there is limited incentive for insurance companies to cover preventative care when the longer term benefits don’t necessarily accrue to them.
In Europe and other single payer markets, chronic diseases management and HEOR arguments are taken more seriously by governments.

It seems $1 is a good price at this point.

And there are people here who want to keep going with this status quo and think RFK is a weirdo for trying to MAHA. The entire house needs to be burned down.

Seems like the odd of a RS are going up by the day. I have owned alot of stocks but as far as silence goes Denner and his boys are near the top of the list of any I have ever owned. I cant see how he ever has another successful proxy win again after this.

You are correct. Very good insight. The medical industry business model needs people to stay sick. There is little to no incentive for wellness. 

Chart update: In the previous post I highlighted the price reversal at ice line resistance and warned to watch for a MACD bearish crossover.



An Inverted Kangaroo Tail has traced on the heels of that bearish crossover (red highlights) - confirming selling pressure and the likelihood of lower prices in the days to follow.

This is a very reliable pattern that resolves downward, the distance of the length of the tail.

Second Chance short entries should be targeted in the yellow highlighted area, with a PT near the December low.

I love it when people post this all over the internet, "TA doesn't work for this stock." That tells me they are upside down and TA is shouting it in their ear.

Kiwi
Let's say you are an insurance company like KP. You do a real world data analysis of V pts and show 25% reduction in MACE. Now you have a couple hundred thousand pts that your own data says should be on V, but aren't. Now what? You put all those pts on V at $100/Pt/month and blow your budget by $20 MILLION/month, $240M/yr? For 1 drug. Sure, 5 years down the road KP starts to see a net savings and their pts live longer (costing more healthcare dollars because sick old pts spend KP cash while younger healthy people pay the premiums) but it doesn't help you because your ass was fired as soon as the VP of finance heard what a stupid idea you had pointing out how they don't provide "optimum care", they provide the least expensive care they can get away with. 

Absolutely no insurance company is going to agree to have their pts in a RWE review unless it's a cheap drug like statins where they can afford to cover the cost of properly treating the Pts.

There is no question in the informed medical community about the benefits of V. It's always ONLY about the $

Any Medicare people here using Blink Rx for V or GV?

I agree with you. That is why I sold half my position and put it in other things. I have almost made back all I lost on amrn so far . I still have about 25k in shares but I will certainly not buy anymore even at these prices. Heck they have not even announced an earnings date yet which is maybe for the best they usually say nothing and the stock tanks. I am all for them just saying nothing honestly

https://vascepa.copaysavingsprogram.com/
Yes, Amarin Pharma still has a partnership with Blink Rx. Through this partnership, eligible patients can access Amarin's medication, VASCEPA (icosapent ethyl), at a reduced cost. Blink Rx helps patients find the lowest price for their prescriptions and offers free home delivery2.

Would you like more information on how to use the Blink Rx service or details about VASCEPA?

https://x.com/JTLonsdale/status/1887914035397427310

Wondering if AMRN still promotes Blink RX for Vascepa coupons? Maybe cost of V will decrease??
https://x.com/DonaldJTrumpJr/status/1887863899208470674

https://openheart.bmj.com/content/9/1/e001900 This is a Real World study on statins using EHR ( electronic health records ).
Patients prescribed statins at baseline were propensity-score matched to those eligible for statin therapy (low-density lipoprotein >2.5?mmol/L) without a statin prescription
AMRN could do the same with Vascepa
Kiwi

I'm kinda over it. Whether it's called "fish oil" is beside the point. It's emphasized by people addicted to banal satire (and I'm over those people too).