Amarin Corp PLC (AMRN) News

CAPR having all the fun while we languish in hell. Maybe just maybe we have 1 more decent run for this POS stock to get us some of our money back. What a freakin nightmare this turned out to be.

https://www.marketbeat.com/instant-alerts/nasdaq-amrn-analyst-earnings-estimates-2024-10-04/

Kiwi.....Nothing wrong with the numbers as you said. I did have excess body fat thanks to my Ben and Gerry's Covid diet so I managed to melt that off by avoiding carbs and burning fat for energy. That's what happens when you become fat adapted.

I stopped taking the Lisinopryl because my BP normalized

Re Prior to this, my standard American Diet lipids had me at LDL=95, TRIGS=40, HDL=80....what was wrong with that ?
About BP measurements ...you probably know about the white coat phenomenon . Suggest you have the BP measurement done at least twice while in the office ...just after you arrive and again just as you are about to leave . If you can stop by a place like Rite Aid on the way home for a self administered 3rd measurement , all the better .
Why no more Lisinopryl ?
Kiwi

It will be interesting to see what my personal lab rat lipids look like in a couple weeks......as you may recall, I put myself on a super low carb way of eating. Mostly high fat meat, dairy, and eggs. Prior to this, my standard American Diet lipids had me at LDL=95, TRIGS=40, HDL=80. My BP was hanging around the hypertension levels of 140/90 and they prescribed low dose Lisinopryl. At the 6 month mark, I had LDL=200, TRIGS = 48, HDL=89.......no more Lisinopryl as my BP hovers in the 120's/80s....... so I'll see the vampire next week and see what happens

Ram. agree ...good pt . My wife prescribes Statins to her CKD patients ,( has prescribed Vascepa ) but also can't tolerate a high enough dose of a Statin to get her LDL below 70 mg/dl .
Kiwi

Let's not forget, these indications assume a certain level of ability to tolerate statins....... a case can easily be made that a patient does not tolerate something.

N7. You wrote I would imagine they can make the patient fit reimbursement criteria....which indicates intent to defraud ...filing incorrect data ( LDL levels for instance ) in order for Vascepa to be reimbursed.
That activity probably puts the MD at higher risk than prescribing off label .
JMO
Anyway ...if the story out of Italy was great AMRN would have PR'd it already .
Good news hits the wires almost instantly . Less good / indifferent news seems to get lost ...MITIGATE data for instance

Kiwi

It's just paperwork... The reality is very different.

Dead silence from denner and his fund. They have not said a word in six months. That is what I know.

The stock is at .60 cents how much more damage can be done to it that denner has not already caused? The guy has proven to be a complete fraud in over his head. I guess he turned around a company once but its clear his lost his touch. The silence from his firm speaks volumes after they claimed how important communication was. To me they are complete liars who said whatever they had to simply to take control.

Here are some notables from this article:
https://kevinforeymd.com/reverseascvd/

How To Reverse Atherosclerosis: Strategies For Those With Coronary Artery Calcium (CAC)

1. Icosapent ethyl (VASCEPA®) can be effective in the reversal and regression of atherosclerosis (plaque), in statin treated patients regardless of their TG levels.
2. A 1% reduction in plaque volume is associated with an 18% reduction in major cardiovascular events.
3. Icosapent Ethyl plus Statin therapy achieved a greater reduction in total plaque volume as well as fibrous low-attenuation plaques, suggesting an additional plaque-stabilizing effect.

Below is my illustration comparing plaque regression to CVE Outcomes in statin treated patients plus alirocumab (PCSK-9) vs. Statin treated patients + VASCEPA®. You can easily see the relationship expressed in bullet point #2 in the RRR from these two therapies.

JRoon, I stand by that opinion. Reimbursement isn't a label restriction. "If" a doctor wants to put a patient on Vazkepa, I don't believe restrictive reimbursement will create an insurmountable barrier.
Sleven,

I would imagine they can make the patient fit reimbursement criteria.

That's what I was responding to.

JRoon, You are responding to things I didn't write.
Sleven,

You're also making a huge assumption that doctors are so emphatically moved by Vascepa that they are willing to push the envelope on script requirements and documentation in droves.

Since this has not happened in the U.S., Canada, the UK, or Spain, what leads you to believe that Italy is somehow different?

All of EU is approved for use, and more than a handful are approved for reimbursement with ZERO scripts written.

I would love to be optimistic, but there is zero evidence that any significant number of doctors, on ANY continent, are prescribing Vascepa like crazy. In fact, the opposite is happening - there are other drugs that are leapfrogging Vascepa in the standard of care regime.

Did you see what was written about Vazkepa by AIFA?

"Although demonstrated in comparison with a placebo probably not completely inert and in a population not treated on top of the drugs recommended for the reduction of LDL cholesterol, the data of the study seem to configure an important added therapeutic value. The certainty of these data, however, is not sufficient as detailed in the section on the quality of the evidence."

QUALITY OF TESTS: Low
COMMENT: The pivotal REDUCE-IT study, a randomized placebo-controlled trial, was considered in the GRADE_Pro assessment. The lack of reproducibility of the results (the only study with results not consistent with those of other drugs in the same class) and the lack of generalizability (patients not treated on top of the drugs recommended for LDL-C reduction and in the absence of information regarding any dietary control) determine the application of two downgradings to the quality of the evidence which is therefore to be considered LOW.
OVERALL JUDGEMENT ON INNOVATION: The drug is not recognized as innovative in light of its moderate therapeutic need, significant added therapeutic value, and low quality of evidence.

This is what doctors are seeing in Italy

It's just paperwork... The reality is very different.

Kiwi, Is Italy part of the EU? Italian reimbursement decision will not alter the label.
Sleven,

https://kevinforeymd.com/reverseascvd/

https://www.dispensingdoctor.org/news/dda24-reducing-cv-risk/

Absolutely no risk ?

When prescribing off-label medications in Italy, physicians have several important liability considerations:

Legal Framework
The main law governing off-label prescribing in Italy is Law 94/1998 (also known as the Di Bella Law)1. This law allows off-label prescribing under certain conditions:
It must be for an individual patient
The physician must determine that approved on-label medications cannot effectively treat the patient's condition
There must be scientific evidence supporting the off-label use, including favorable results from completed phase II clinical trials
The patient must provide informed consent

Physician Liability
When prescribing off-label, Italian physicians take on increased responsibility and potential liability:
They have a direct responsibility for the off-label prescription3.
They may be called to respond to any problems arising from the off-label use as if they had done something outside the standard of care1.
The burden of proof rests on the physician to demonstrate the off-label use was appropriate1.
Key Liability Considerations
To mitigate liability risks, physicians should:
Thoroughly document the rationale for off-label use and scientific evidence supporting it
Obtain and document informed consent from the patient, clearly explaining the off-label nature of the prescription4
Closely monitor the patient for adverse effects
Stay up-to-date on the latest evidence and guidelines regarding off-label uses

Potential Consequences
If problems arise from off-label prescribing, physicians may face:
Administrative liability
Potential requirement to personally reimburse costs
Professional disciplinary action
Civil liability claims from patients
However, if proper procedures are followed, off-label prescribing is legally permitted and can be an important treatment option2.

The key is ensuring it is done responsibly with appropriate documentation and patient consent.. my emphasis ...just what MD's want everywhere ...more paper work

Kiwi

Absolutely no risk. Completely different from the USA.

I think he has a lot of discretion to prescribe. I know how it works, I am Italian, even if I currently live abroad. Of course, either the doctor or the patient must be informed of the benefits of prescribing VAZKEPA.

N7. Theres plenty of risks...to the MD .... in doing what you appear to be advocating .
I wouldn't count on it
Kiwi

JRoon, I agree that reimbursement is the important piece. If doctors want the patient to receive the medication, they will work the system. I have no doubt they have experience.
Sleven,

RMB, If an Italian doctor wants his/her patient to be on a particular therapy, how much latitude do you think they have. I would imagine they can make the patient fit reimbursement criteria.
Sleven,

RMB, I also agree with this. As I had posted the other day, with such specific and restrictive criteria, it is hard to imagine a significant amount of scripts being written. BUT...it gets our foot in the door. There is always the possibility that criteria are reduced in the future if RWD confirms positive outcomes.

The critical piece is getting reimbursement in place in Italy and France.

Sleven, that's a reasonable assumption.

On World Heart Day, it's important to recognize that over 40 million deaths were attributed to cardiovascular diseases (CVD) across six world regions, with 3.4 billion confirmed cases in 2021, as reported by the Global Burden of Disease Database. Fortunately, cardiovascular events can be reduced by 25%, and cardiovascular deaths by 20%.

Have to agree with your reasoning Sleven.

Having said that, the restrictions imply to me anyway, that scripts will be meager there. I remember many years ago how most of us here ridiculed the analysts who put such very little value on the EU. Obviously they knew that the road there was going to be a tough slog.

I share that opinion and we will see.

Always, I don't read Italian. That said, looking at the documents available, I have an opinion. I see a list of restrictive criteria. I think that list would be unnecessary if reimbursement was denied.
Anyone disagree with that opinion?
Sleven,

AW1, I think it's ambiguous right now. Hard to tell from what's been released on the AIFA website. I have to believe we will know either way shortly.

The safe answer is no one knows for sure and best to wait for company to announce one way or the other…

Has this damn thing been approved in Italy OR NOT?!? So sick of all the misinformation and trickery by our naysayers and paid bashers.

I’m still optimistic that it’s approved, and something has just been lost in translation.

We’ll presumably find out soon.

Huh. I was hoping Italy was one of the reasons they scheduled this upcoming investor call. There must be some impetus to put pro-active comms on the calendar.

Yeah, we looked at that, and it is vague, as there are two different documents that seemingly contradict each other.

One did say "Card Approved". But I don't know if that means approved for USE, or approved for reimbursement. It SEEMS that it should mean approved for reimbursement, because it was approved for use quite a while ago. "Card" refers to the Italian national healthcare card.

Then this spreadsheet today seems to indicate otherwise. We don't seem to have anyone that can confirm either way.

I thought Laurent found something that show reimbursement was approved last week.

NLM states that results should be posted by October 18th

No updates have been posted on the site as of today.

Yeah, that's a great idea Seve. Fire the entire board, have Denner dump 30M shares onto the open market, and let him find a way to manipulate the stock into oblivion. Then half the management team resigns because they know where things are going.

For good or bad, Denner is really our only hope at this point. We can't afford another "transition". So you best hunker down for the ride, or get off the train.

If Denner botches Italy again its time to show him the door and show it to him fast.

Breaking news for AMRN !!!

AMRN believes that Vatican CIty, Greenland And Moldavia will approve Vascepa. This will add at least 100 scripts and will save the company from Bankruptcy. But wait there's more ! LUxembourg may come on board as well. Buy stock now before its too late !!!

By October 18th

It will likely be a disaster with the loss of the USA revenue. Good job Denner.

If Denner botches Italy again its time to show him the door and show it to him fast. I mean that would be beyond terrible for the company and likely mean France and Germany will also be no go's. Its sad the company is now in a position where and approval will likely make or break them. You notice Denner and his crew do not even put out their the stock is undervalued letters anymore. Instead they are dead silent.

Are we supposed to get the BRAVE results posted on the NIH website by end of September? Are there any updates?

Ram, I saw that in the translation as well. But this document is dated May 2022. So I can't reconcile what that means, since they denied reimbursement last year.

Reimbursed indication: Icosapent ethyl is reimbursed in the treatment of patients aged 18-80 years with established cardiovascular disease and BMI ≥27 kg/m2, on treatment with a high-potency statin at the maximum tolerated dose + ezetimibe, who have achieved target LDL cholesterol levels (