Amarin Corp PLC (AMRN) Quote

Yes... I'm happy with my pick....... Robinson's momma looked a bit off.... like she was so afraid of talking on the camera or even had a bit of a demensia thing going on. I felt sad for her. His grandma looked happy though. She couldn't wait to get out of the Michigan cold.....

Can we finally “stick-a-fork” in the notion that Fibrates, Niacin’s & Mixed OMG-3 FA’s have any clinical CVD benefit?

A recent FDA Citizen Petition by HealthyWomen (https://t.co/YMrQ4MHfZs) calls for the FDA to FINALLY revise labeling fenofibrate drugs. It’s the EPA Stupid! pic.twitter.com/SmoNkMlCqi— Mike Everts (@GeoWizz_) April 26, 2024

Indeed! Novo Nordisk is a BP that in the past was focused on Diabetes.
I used to believe they would be interested in AMRN from that angle. No
doubt every Eurocentric BP should be interested in Amarin if they were
aware of what it had and how they could optimize uptake of Vazkepa
in Europe. Of course, Alex Denner has complete control over AMRN
and I believe his game plan is to ultimately sell the company to BP.
When that may happen and at what price we do not know. The only
good thing about the stupid low share price is that more shares could
be bought back for the $50 million should the low price persist.

cbb, Or Novo Nordisk - they got the money and power to make Vascepa - Vazkepa big 'fast' WW ✌️

The Cardinals had 2 First Round picks. The chose Marvin Harrison WR and Darrius Robinson DL. Robinson’s momma didn’t look too happy, when Phoenix was announced. 120 degrees in summer. Awful long commute from Detroit. I really like the look of Robinson. Reminded me of Mean Joe Green. Tall and lean, quick too.

So much talent out there. You got Jared Verse.

Hey Nukem, your Cardinals snagged a superstar receiver so now you have to figure out how to get him the ball......

CBB. No EU pharma co is buying AMRN without a realistic plan to get reimbursement in Germany , France and Italy.
So far AMRN has failed to detail such a plan .
Maybe they will at the May earnings report.
NVS is the most obvious EU Pharma ...especially now that the EU patent life has been extended .

So can Sarissa buy more shares before the buyback ? Doesn't this have to be approved by UK ? regulators first and therefore wouldn't they have inside knowledge of those proceedings ???

Kiwi

I wonder if Roche, Merck, or Bayer would have any issues in getting Germany
to reimburse for Vazkepa? Seems the most important thing that AMRN could
use is a Eurocentric BP acquirer. Of course, Denner is well aware of that so
us long suffering shareholders will simply have to wait until Denner gets what
he wants for the company. Maybe if we can get share price down to a new
52 week low around the start of the share buybacks that would help. I would
be surprised if Sarissa does not pick up more shares before the share buyback
begins.

TalShu, You raise many excellent questions, as always. I wonder
if Mochida's EPA product will compete with Vascepa in China or if
Mochida will pursue their drug (eventually) for CVD in China? Unless
AMRN has some plan to salvage its relationship with Mochida they
could become a problem for AMRN. Given the exclusivity that AMRN
has in Europe until 2039 it may end up that the greatest value AMRN
has as a BO candidate, is the value that Vazkepa has in Europe. My
view remains that only a Eurocentric BP is capable of optimizing sales
of Vazkepa in Europe. In other words, unless AMRN has protected
one-a-day version(s) of Vascepa, a BO deal (sooner rather than later)
makes the most sense. I used to think that AMRN would have some
sort of one a day version of Vascepa, unless they do, they need a BO.

Yep. But he is convinced he’s a comedian. Dumbass at best.

Ins
Ignore
Ralphy’s an idiot

Tal Shu...I re-read your post #423521 and I will be interested in seeing what Amarin is able to divulge, affording clarity on some of the issues raised in your post...at the C.C. on 5/1/24.

You still here trying to be funny? Oh ralphey ralphey u so clever. U funny funny guy…

We 100% need this buyback in the worst way to get any momenteum at all. We are back down to .85 cents with earnings coming up that may not be good. Then you are looking at the stock being driven back down another 20 cents which often happens after bad earnings. The buyback right now is the only thing we got and the sooner the better.

Reading its earnings reports, it’s apparent that BMY is experiencing the same problems that AMRN faced years ago. Sales of key drugs have fallen, notwithstanding multiple and extensive TV ads directed to patients and doctors. A few of those drugs will have generic competition on patent expiration in addition to negotiated price reduction in light of recent Congressional legislation. 2500 person layoffs are in the future for BMY. Debt accrued for a pair of acquisitions this year also is a problem in light of much higher interest rates in 2024, in contrast to AMRN that has no debt.

BTW, we deliberately purchased those 100 AMRN shares at $0.9638/share AH last evening. I had intended to purchase up to 900 more but a retirement party we attended lasted beyond last trade at 8 pm.

Amazing Opportunity for AMRN ! The Pink market is the easiest exchange to get listed on. All a company needs to do is submit electronic Form 211, which is provided by the Financial Industry Regulatory Authority (FINRA). Usually, this is done on behalf of a company by a market maker.

Well, that didn't last too long.

Well Capt I'll be interested to see what mgt says during the earning release CC on their plans to gain reimbursement in Germany , France and Italy .
Hopefully they will provide details and a time table .
Thx for your charts etc . They clearly demonstrate the risk reduction especially in certain sub groups .
When you look at the cost of revascularisation following a PCI .....The savings to health depts would be substantial even if you reduced RR by only 25% ( to allow for possible overstatement of benefit due to placebo used in R-IT)
According to a study published in JAMA Cardiology in 2019, the median cost of PCI was estimated to be around $35,000, while the median cost of CABG was approximately $45,000.

So if the first PCI fails , to revascularise was around $35,000 and if bypass was the only alternative cost was around $45,000.
If you can reduce that by at least 25% with Vascepa added following the initial PCI I would think its huge $ saving .
The problem probably is that after a PCI most patients are on blood thinners and the interventionist may be hesitant to add V because of its blood thinning qualities
Kiwi

MA5..."Fenofibrate is available in several formulations and is sold under several brand names, including: Tricor by AbbVie. Lipofen by Kowa Pharmaceuticals America Inc. Lofibra by Teva."...The FDA needs to replace these products with meds that are proven effective at reducing CVD.

Thank you for that most informative post.

Thanks for posting. The Fenofibrates would not be the only ones I would petition the FDA about. I know people will say they have no control over it, but if I sold a bottle of fish oil and told people that it will reduce CVD the FDA or FTC would come after me (if they had the resources, etc,) but in essence people who are getting Generic V or Lovaza and have been prescribed that for CVD are getting screwed because those drugs are not approved ( or even proved to be helpful) for CVD.

There is significant off label filling of people's scripts with Generic V for people who are taking it for CVD and Lovaza as well.

Ohhhhh ralphey u so clever. Heheheheheeee clever fella

DUBLIN, Ireland and BRIDGEWATER, N.J., April 24, 2024 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced its support for a petition filed with the U.S. Food and Drug Administration (FDA) requesting that the Commissioner focus on and take further action to address significant off-label prescribing of fenofibrates, due to the fact that multiple clinical trials have proven fenofibrates have no clinical benefit when used in combination with statins to reduce cardiovascular disease (CVD) risk. The filing comes as heart disease continues to be the leading cause of death in the United States, accounting for one in five deaths in 2021.1,2 Approximately 805,000 people in the United States have a heart attack each year, which amounts to one person every 40 seconds.1 The annual treatment cost for CVD is $555 billion, which is expected to double within 20 years.3

Amarin Applauds HealthyWomen’s Citizen’s Petition Urging FDA To Take Further Action On Fenofibrate Prescribing in Patients at Risk of Cardiovascular Event

Why am I excited to see an after market share price of 0.95?

I definitely have Stockholm Syndrome.

I think we're in good shape if Judge Andrews family members have loaded up on a sufficient number of AMRN shares by then..............A CYNICAL LONG WOULD SAY

Have to agree with you Laurent. No other way to read the demeanor and thoughts of the 3 judges. Hopefully the trial judge is not pissed but follows their directives.

I think the reversal of dismissal is pretty much a sure shot. (we got the dream team in Moore, Albright, Lourie and they clearly thought dismissal was premature.) The big question is what happens when it lands back on Judge Andrew's docket. We'd have to survive summary judgement before we get to a jury trial.

I'm agree with the UK approval of share buyback and as for the appeal, we can only stick with the positive tones from the 3 judges, however, even at that, it is not a guarantee.
But, we do need both of these to occur quickly to begin some positive movement of the sp.

Maybe Amarin should get hackers to collate the data on V:

https://www.reuters.com/technology/cybersecurity/unitedhealth-says-hack-could-impact-data-substantial-proportion-americans-2024-04-22/

Someone should also file a CP with the FDA to discontinue the use of LOVAZA and all mixed OMG-3 PUUFA's for the same reason as the CP by Womens Health to discontinue fenofibrates. "There is no clinical benefit for its use."

We need to stay on offense and keeping these press releases top of mind.....

https://finance.yahoo.com/news/amarin-applauds-healthywomen-citizen-petition-180000604.html

One of the big sticking points for the German G-BA was their clinical assessment of the outcomes of the REDUCE-IT trial and their interpretation of the "Level of Evidence" regarding "bias" in those outcomes. IMO, they placed far too much scrutiny on the mineral oil placebo as a contradictor of high-quality evidence while ignoring other biasing risk factors.

For example: The Gold Standard for assessing the risk of bias in randomized clinical trails (RCT's), is the "Cochrane Risk of Bias Assessment Tool." This Tool rates 7 bias risk factors as either Low, High or unclear. The 7 bias risk factors are:
Randomization, Allocation concealment, Participants & personnel, Outcome assessment, Selective Outcome reporting, Incomplete outcome data, and Other.

The REDUCE-IT Trial rated a "Low Risk of bias" in each category. The mineral oil hoax would fall under the "Outcome assessment" category. Furthermore, new data is continuing a steady stream of Evidence Based Medicine (#EBM) that IMO, completely debunks the mineral oil conspiracy. Germany, France and Italy need to get their shit together before MACE gets out of control in their countries.

DAR3

Not sure but I would be betting that the UK approval is a done deal after the share holders approval . What would be a reason to say no ?
Also I am not 100% sure that we will win the appeal case. I remember everyone including out side analysts thinking we had a sure win with judge Du

Michael

Some sad history: New Jersey Rep. Donald Payne Jr. dies from a cardiac episode related to complications from diabetes at age 65. He had been hospitalized, unconscious, since early April, per reports in N.J. newspapers.

Cantor was named as being the company that will acquire the shares for Amarin and then move them to Amarin. Not sure if any of the initial purchases have been made prior to the UK approval for Amarin to use on hand capital for those shares.

Well since you have an email relationship with Denner ...ask him why Germany is not onboard .
Kiwi

Kiwi, you are aware that we weren't rejected in Germany because of not enough supportive studies......we were rejected because there was no comparison drug for what our molecule treats so they just picked one that wasn't a good comparative drug to use.

How many times are you going to rehash the same monologue about Germany? I am done reading all of these supposedly explanation why Germany is not on board.

RMB. This is what Germany wants

In Germany, the level of evidence required for the reimbursement of new drugs is quite stringent and follows a systematic process. The German Federal Joint Committee (Gemeinsamer Bundesausschuss or G-BA) is responsible for evaluating the benefits and cost-effectiveness of new drugs to determine whether they should be reimbursed by the statutory health insurance system.

The G-BA typically considers evidence from clinical trials, health economic evaluations, patient-reported outcomes, and real-world data. The level of evidence required includes:

Clinical Trials: High-quality, randomized controlled trials (RCTs) are often required to demonstrate the efficacy and safety of a new drug. These trials should follow rigorous methodologies, including appropriate blinding, randomization, and control groups.
Health Economic Evaluations: Cost-effectiveness analyses are crucial to assess whether the new drug provides value for money compared to existing treatments. This involves comparing the costs of the new drug with its benefits in terms of improved health outcomes.
Patient-Reported Outcomes (PROs): The G-BA also considers patient-reported outcomes, which provide insights into how patients perceive the impact of the drug on their quality of life, symptoms, and overall well-being.
Real-World Data (RWD): Evidence from real-world studies, such as observational studies and post-marketing surveillance data, may also be required to evaluate the long-term effectiveness and safety of the drug in routine clinical practice.

So at least bring on the Real-World Data .
Kiwi

Ram. I agree that we are very unlikely to see another EPA trial the size and length of R-IT .
A trial of a high risk sub group ...say 2,000 PCI patients followed for 3 yrs for rate of re vascularization ? What's the patent life in the EU now with the new extension ?
If thats what it takes to get reimbursement in Germany and France it might be worth it . At least more / larger RWE studies.
Amarin Corporation plc (NASDAQ:AMRN) today announced that the Company received a Decision to Grant from the European Patent Office (EPO) for a new patent covering VAZKEPA® (icosapent ethyl) that will extend VAZKEPA exclusivity eight additional years into 2039
Kiwi

alwayswatching

Congratulations another low for you !!!! What are you hoping for .50 cents ? IMO your thinking is just stupid !

Michael

Yeah, that was definitely one of the most birdbrainery things I've written now that I reflect on it. Haste makes waste!

The Amarin-Mochida Collaboration

1. Seen from Amarin’s viewpoint:

a. Amarin’s 10-K 2018 states:

“In June 2018, we entered into a collaboration with Mochida Pharmaceutical Co., Ltd., or Mochida, related to development and potential subsequent commercialization of drug products and indications based on the active pharmaceutical ingredient in Vascepa, the omega-3 acid, EPA (eicosapentaenoic acid). The potential new product and indication opportunities contemplated under this agreement are currently in early stages of development.”

b. From 2019 till 2023 all Amarin’s 10-K have reported the following INVARIABLE text:

“In June 2018, we entered into a multi-faceted collaboration with Mochida Pharmaceutical Co., Ltd., or Mochida, related to the development and commercialization of drug products and indications based on the active pharmaceutical ingredient in Vascepa, the omega-3 acid, EPA. Among other terms in the agreement, we obtained an exclusive license to certain Mochida intellectual property to advance our interests in the United States and certain other territories. In addition, the parties will collaborate to research and develop new products and indications based on EPA for our commercialization in the United States and certain other territories. The potential new product and indication opportunities contemplated under this agreement are currently in early stages of development. Upon closing of the collaboration agreement, we made a non-refundable, non-creditable upfront payment of approximately $2.7 million. In addition, the agreement provides for milestone payments from us upon the achievement of certain product development milestones and royalties on net sales of future products arising from the collaboration, if any.”

c. Nota Bene: Amarin 10-K 2019 also confirmed at the end of the above statement: “In January 2020, we achieved certain milestones under the agreement, resulting in payment of $1.0 million to Mochida.’

2. Seen from Mochida’s viewpoint:

a. Mochida Annual Review 2018 stated:
“In June 2018, Mochida also entered an agreement with Amarin Corporation Plc Group to develop and
commercialize high-purity EPA products in the US and certain other countries under Mochida’s intellectual properties, including new EPA formulation.”

b. Mochida’s Annual Review 2019 affirmed:
“Mochida also entered into an agreement with Amarin Corporation Plc for the development and commercialization of EPA-based drug products in the United States and certain other territories by Amarin Corporation Plc.”
c. Nota Bene: Mochida’s 2019 wording replaced:
- “high-purity EPA products” by “EPA-based drug products” and,
- “under Mochida’s intellectual properties, including new EPA formulation” by “certain other territories by Amarin Corporation Plc.”

d. Mochida Annual review 2020 specified:

“Mochida also entered into an agreement with Amarin Corporation Plc for the development and commercialization of high-purity EPA formulations in the United States and certain other territories by Amarin Corporation Plc.”

It also listed Amarin as part of its “alliance partner” group.

e. Nota Bene: Mochida went back to using “high-purity EPA formulations” in lieu of “EPA-based drug products” but continued to ignore “under Mochida’s intellectual properties, including new EPA formulation.”

f. Strangely, the Mochida Integrated Report for 2021, 2022, and 2023 NO LONGER MENTIONS Amarin in any way.

3. In summary:

a. It is clear that Mochida had had second thoughts as early as 2019 regarding Amarin’s ability to fulfill its part of the 2018 Agreement “to develop and commercialize high-purity EPA products in the US and certain other countries under Mochida’s intellectual properties, including new EPA formulation.”

b. Mochida has been concerned by Amarin’s inability to promote Vascepa in the U.S. and avoid the erosion of its market share in the face of generics. Cutting off its nascent advertising spending, completely eliminating its sales force, and offering rebates to maintain 75% of the market at the expense of margins only corroborate this assessment. Moreover, declarations by Karim Mikhaïl and Per Wold Olsen that the U.S. market is lost could hardly have reassured the Japanese partner. To the contrary, these will back up future attempts by Mochida to have the 2018 Agreement declared legally void and nil.

c. What concerns Mochida most is the reference to the terms “intellectual property” which were erased in its Integrated reports for 2019 and 2020. Worse, Mochida no longer mentions a word about Amarin altogether since 2021. Gone are the short days when it was looked at as a collaborator and ally.

d. In this perspective, Mochida reasserted its attachment to and defense of its “intellectual property” rights by applying for U.S. patent protection for its MND-2119 (Epadel EM) product on July 17, 2020. The latter was granted on February 27, 2024.

e. Amarin, for its part, insists yearly on stating: “Among other terms in the agreement, we obtained an exclusive license to certain Mochida intellectual property to advance our interests in the United States and certain other territories.”

f. Questions impose themselves here:

- What is the state of relationship obtaining between Amarin and Mochida and where is it heading?

- Can the “exclusive license to certain Mochida intellectual property to advance our interests in the United States and certain other territories” be valid if Amarin is unable to put them to good use as well as promote its only product in terms of publicity/awareness (educating doctors, pharmacists, insurers and patients), and sales?

- To what extent is Amarin dependent on Mochida’s R&D capabilities? Does this reliance in a deteriorating relationship explain why Amarin scraped its Fixed Dose Combination program which KM and Executive Vice President, President R&D, Chief Scientific Officer Steve Ketchum had touted so much before?

- To what extent is LR-EtEPA’s development linked to Mochida’s R&D capabilities, and hence affected by this blurred and strained relationship?

- As Mochida obtained U.S. patent approval for Epadel EM who will eventually commercialize this product in the U.S. and “certain other territories”? And with what sales force?

- Mochida’s products being limited to the VHTG indication, can Vascepa’s 4mg compete against Epadel EM one-a-day in this market segment in the U.S., Europe, China and ROW?

- What do “certain other territories” cover?

- Is/are litigation(s) next to clarify the Mochida-Amarin collaboration?

g. For information:

- Mochida has 17,000+ employees.

- Mochida declared in its Integrated Report 2023: “We are also leveraging our alliances to globally expand our EPA drug with high purity in China, Thailand, Vietnam and the United States. In Thailand, the subsidiary of Meiji Seika Pharma Co., Ltd. obtained approval to import and market our EPA drug for the treatment of hypertriglyceridemia in October 2020 and commenced sales in April 2021. In Vietnam, an alliance partner of Meiji Seika Pharma is in the process of applying for approval to import and market our EPA drug.” It is worthwhile noting here Mochida does not identify who are its high-purity EPA drug marketing partners in the U.S. and China.

- Meiji Seika Pharma Co., Ltd (Japan) promotes and sells, inter alia, Mochida’s products overseas through a network of consolidated subsidiaries that cover India, most of the Far East (4 in China), Oceania (Australia & New Zealand), Europe and Africa. Production facilities are also found in India, Thailand and Spain.

- Amarin made the following payments to Mochida:

• “a non-refundable, non-creditable upfront payment of approximately $2.7 million” “upon closing the collaboration agreement” in June 2018.
• $1.0 million for “certain product development milestones achieved under the Agreement” in January 2020.
• $1.0 million for “exercising certain rights under the agreement” in December 2020.

- Amarin filed 9 U.S. provisional patent applications for LR-EtEPA during the period January 26 – June 2, 2022. It could not have done so if LR-EtEPA were the same product as MND-2119 for which Mochida had applied on July 17, 2020 – both priority claim and prior art would have impeded this.

- We do not know the status of these applications. After one year the United States Patent and Trade Mark Office (USPTO) must inform Amarin as quickly as possible if it is allowed, or not, to pursue the process. If allowed, Amarin must file a “final” so-called ‘regular” non-provisional application.

- Once the regular application is examined by a patent examiner, it is typical for the patent examiner to issue at least one Office Action. An examiner’s Office Action is a detailed report that outlines objections to the form of the application or the form or substance of the patent claims. It usually includes citations of prior art, often prior patents and published patent applications, that the examiner alleges to be relevant to the patentability of what’s claimed in the subject patent application.

- An Office Action is usually received by the applicant within 17 months of filing a regular patent application in the United States. The USPTO may request a new cycle of argumentations that would lead to a second final Office Action stating allowance or rejection of the patent application.

- Noteworthy, it took 43 months for Mochida to be granted USPTO protection for its MND-2119.

- As regards the rest of the world, Amarin used the PCT process on January 26, 2023 to ensure worldwide priority claim for LR-EtEPA based on the 9 non-provisional U.S. applications. This became effective with WIPO’s international publication of Amarin’s application on August 3, 2023.

- It is up to Amarin to move forward with applications for patent protection in certain individual countries and/or regional groupings as recognized by the PCT. Unfortunately, we lack total information regarding Amarin’s moves and intentions in this regard.

Vazkepa sales are disappointing in Europe so far. Why?
Which areas are the key reasons for the very slow start:
- Price??
- Awareness??
- Science and belief that it works??
- Better alternatives??
Anyone have a strong data based opinion ??
TIA

More Great News for Amarin! AMARIN has been voted as the number one stock for providing buying opportunities ! If you invested just $10,000 in AMRIN in 2007 today it would be worth, not quite $10,000 today. The desperate housewives of Investors HUb continue getting pumped and dumped . After being jilted by the loser Thero, who absconded with all of their money in their desperation they turned to the CAD AMRN. Yet every week hope springs eternal. Lets take a peak at the Fat Lady's pudding . Drum Roll Paaaaleeeze ta dum ta dum ta dum BOOM Its 96 pennies !! That's right its amazing, 96 pennies. Tune in next week where this the story line will be repeated as it has been for over 10 years. There is a secret coming out about AMRN that is going to make it boom. Buy more stock now while its cheap because buying opportunities like this don't occur often. Just almost every day for 17 years.

Rose - Ram, Whala made til argument OVER and OVER hundred of times since I joined here 2018.

That is why several posters over the years has suggested that he is somehow "related" to - S Nissen of Cleveland 👇️

Exactly Rosem....... I also remember one of the Adcom doctors commenting that he was worried that this would become cardio candy...... to me, that's a comment that smells like he was afraid too many prescriptions would be given out. I mean, that's the whole point. The evidence was too strong not too vote for and it was 16-0. He was probably Nissen's secret lover..... who knows!

Ram, you are definitely correct about that. I believe that Kiwi though has mentioned easier things like some RWE that insurers might already have from people being on V for a number of years now.

All those statin studies were not done by one company. The FDA vigorously defended R-I at the Adcom, and although It is my opinion that there is sufficient corroborating evidence for V (Jelis, Respect?, Evaporate, etc) what is the point of a p value if studies have to be redone a myriad of times.

311 shares moves it up $.08 in PM. Just insane this stock is!