Amarin Corp PLC (AMRN) News

North,

I used the GoodRx codes today at my local CVS and refilled my 90 day script for $295.20.

x BLK BK

Thanks for that TalShu. I have read some of this stuff previously from both you and Laurent. So I understand what they ARE. What I still don't quite get, is if they are somehow related (it seems like the same science). And the question that still remains is if/when/how Amarin intends to use one or both of the technologies at some point.

I have to believe they ARE, or they would not be developing it (specifically Lr-EtEPA). Or they are at least planning to use it as a carrot in a BO.

Please find below some informatin that should clarify the difference between Lr-EtEPA and MND-2119.

Excuse the way am presenting it; I am doing this in a hurry as I have to go out shortly.

LR-EtEPA Patent Timeline

Reference Amarin’s U.S. and international patent applications for an LR-EtEPA technology/invention for “LYMPH-RELEASING COMPOSITION OF FATTY ACIDS AND USES THEREOF FOR LYMPHATIC INCORPORATION AND SYSTEMIC DISEASE TREATMENT.”

Amarin is here claiming, inter-alia, that “Lymph-releasing composition of eicosapentaenoic acid ethyl ester (LR-EtEPA), in some embodiments, increase EPA uptake in tissues and treat various diseases including cardiopulmonary diseases, renal diseases, neurological diseases and cancer.”

A. Applying for patent protection in the U.S.

Being the first applicant for an invention is especially important since there may be other pharmaceutical companies developing similar technologies at once. Since patent rights are granted to the first entity that files a patent application for an invention (assuming all requirements for the issuance of a patent are met), filing an initial United States provisional patent application can allow an applicant to obtain the earliest possible priority date since a provisional application may be prepared in less time and filed in an INFORMAL form.
The benefit of claiming priority is to take advantage of the filing date of the initial provisional patent application and consequently receive protection for the subject matter in the initial patent application.

Consequently, Amarin filed 9 U.S. provisional patent applications as follows:

Patent 63/303,365 filed on 26 January 2022 (01.26.2022)
Patent 63/303,383 filed on 26 January 2022 (01.26.2022)
Patent 63/304,042 filed on 26 January 2022 (01.26.2022)
Patent 63/334,065 filed on 22 April 2022 (04.22.2022)
Patent 63/334,071 filed on 22 April 2022 (04.22.2022)
Patent 63/340,292 filed on 10 May 2022 (05.10.2022)
Patent 63/340,304 filed on 10 May 2022 (05.10.2022)
Patent 63/342,509 filed on 16 May 2022 (0516.2022)
Patent 63/348,908 filed on 03 June 2022 (06.03.2022)

Thanks to StockTwits board member SanDiegoLiving’s post of the 6th instant https://register.epo.org/documentView?number=US.202318472875.A&documentId=LWIIVHGXGREENX5 it is at present known that:

- On 09.22.2023 Amarin proceeded to file a NON-PROVISIONAL or REGULAR patent application under Number 18/472,875.

- USPTO issued a NOTICE OF PUBLICATION OF APPLICATION for
“LYMPH-RELEASING COMPOSITION OF FATTY ACIDS AND USES
THEREOF FOR LYMPHATIC INCORPORATION AND SYSTEMIC
DISEASE TREATMENT” which now has an OFFICIAl Publication No. US-
2024-0165066-A1 and a 05.23.2024 Publication date.

- The patent application now enjoys a “pending” status as certified by the “A1” code at the end of the publication number.

- Accordingly, Amarin is given privileges as if a patent was granted on the date of publication of application. Thus, in case of suit for
infringement, the patent owner can claim damages from the date of publication of patent application or date of infringement whichever
is earlier.

- Publishing a patent application basically announces to the world that innovations in the above-mentioned area of technology may be
covered by patent rights. It puts Competitors on Notice and Discourages New Competitors.

As a reminder, in the United States, examination is requested automatically when filing a regular or non-provisional patent application (done on 09.22.2023). USPTO must accept or reject it within a period not exceeding 12 months. By issuing the 05.23.2024 NOTICE OF PUBLICATION OF APPLICATION USPTO has given the non-provisional application a final/regular status within the legally imposed time framework.

Next, the non-provisional application will be examined by a patent examiner who typically issues at least one Office Action. An examiner’s Office Action is a detailed report that outlines objections to the form of the application and/or the substance of the patent claims. It usually includes citations of prior art, often of 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 (on 09.22.2023). The USPTO may request a new cycle of argumentations that would lead to a second and final Office Action stating allowance or rejection of the patent application.

As a reminder, Amarin has in the past used USPTO’s TRACK ONE Prioritized Examination that allows it to get a final disposition within about twelve months.

B. Applying for patent protection in the rest of the world

The World Intellectual Property Organization’s (WIPO) Patent Cooperation Treaty (PCT) is a mechanism that enables an applicant to file a single regular patent application and have that application flow through to its chosen countries and regions as a regular patent application through either a national or regional phase entry filing made at a later date, once those countries and regions are identified. The time limit for entering the national or regional phase is generally 30 months from the priority date. For the EU it is 31 months.

Amarin proceeded with an application for LR-EtEPA on 01.26.2023.

WIPO/PCT issued an International Publication on 08.11.2023 with a priority date of 01.26.2022 corresponding to the first provisional application made in the US.

It remains Amarin’s strategic decision to designate the countries or regions in which it would like to proceed with filing a national or regional phase entry patent application, and to choose the paths to fast-track the processes and reduce their costs.

While a provisional patent application does not provide any immediate legal protection from infringers, it can preserve Amarin’s future patent rights in the United States and in foreign countries by establishing an earlier priority filing date.

In short, Amarin had secured priority claim for its LR-EtEPA technology/invention in the US and the remaining 156 members states of the Patent Cooperation Treaty. Yet, whether Amarin has proceeded with national and regional applications or not remains an unknown given the BOD’s silence.

In fact, much to shareholders’ regrets, Amarin has never talked about LR-EtEPA. Were it not for poster Laurent Maldague’s due diligence they wouldn’t know of its very existence. And were it not for the DD poster SanDiegoLiving digged up regarding the 05.23.2024 NOTICE OF PUBLICATION OF APPLICATION shareholders would not know where LR-EtEPA application stands today on the patent allowance timeline.

Sincere appreciation and thanks to both Laurent and SDL.

Finally, all that shareholders can hope for is that Amarin has extra diligent patent lawyers helping BOD and management in devising Amarin’s strategy. According to the above exposé Amarin appears to be very close to the U.S. finish line and must have initiated patent applications in the ROW before the WIPO/PCT deadlines come into effect.

How important is this correspondence in the BOD’s decision-making matrix remains to be seen.

All of the above is IMHO. I am not a lawyer. Any corrections are most welcome.

Best.

================

Mochida Pharmaceuticals’ MND-2119 (Epadel EM) is a self-emulsifying formulation of highly purified EPA to treat cholesterol and triglyceride. It also prevents blood from clotting and suppresses blood clod sticking to the vessel walls.
Mochida presents it as follows:

Epadel (generic name: icosapent) is a highly purified EPA ethyl ester formulation developed by Mochida as the world's first medical drug. The product is available in Epadel Capsules, Epadel S, and Epadel EM Capsules forms. Epadel S is indicated for "Hyperlipidemia" and "Ulcer, pain and chilliness associated with arteriosclerosis obliterans" in Japan. The active pharmaceutical ingredient is supplied by Nissui Corporation, which has advanced EPA purification technology and mass production capability. Since its launch in 1990, it has been taken by many patients.
For your information:
A. Announcement of Submission of New Drug Application for Epadel in China

This material is an English translation of the press release to be issued on July 2, 2024 in Japanese, and the Japanese release is given priority regarding content and interpretation.
July 2, 2024 Mochida Pharmaceutical Co., Ltd.
Mochida Pharmaceutical Co., Ltd. (Head office: Tokyo, Japan, President: Naoyuki Mochida, hereinafter: Mochida) announced that Mochida submitted a New Drug Application to the China National Medical Products Administration (NMPA) for Epadel S (development code: MND-21), a highly purified eicosapentaenoic acid (EPA) ethyl ester formulation that is being jointly developed in China by Mochida and Sumitomo Pharma (Suzhou) Co., Ltd., a Chinese subsidiary of Sumitomo Pharma Co., Ltd.
As the clinical phase III trial conducted in patients with severe hypertriglyceridemia in China has shown positive results, Mochida has submitted a New Drug Application for Epadel S.
Additionally, Mochida has entered into a distribution agreement for Epadel S in China with Meiji Seika Pharma Co., Ltd. (hereinafter: Meiji) in 2024. After approval, Mochida will supply the product to Meiji, which will distribute it through its affiliated partner in China, MAXMIND Bio-Technology (Hainan) Co., Ltd.
Mochida is committed to contributing to the improvement of the quality of life for Chinese patients with hypertriglyceridemia through Epadel S.
B. “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.”
C. Since 2020 Mochida dropped its prior reference to Amarin as a strategic partner. In fact, it no longer mentions it at all.
D. Meanwhile, Amarin continues to mention its collaboration with Mochida in its SEC reports.
E. Mochida started commercialzing Epadel EM in Japan in 2022.
F. Questions arise:
- who will commercialize it in the U.S.?
- how will Epadel EM compete with Vascepa/Vaskepa in China?
As a reminder, Mochida has never claimed a CVD indication.

No way to know anything they do not communicate at all. All you can do is make your best guess because I guess the Denner plan is to just stay dead silent and let the shareholders be kept in the dark on everything.

Monk, I think you are referring to LR-EtEPA or MND-2119.

I have been hoping that this was their way back in to the U.S. market. But like everything else Amarin, we have no idea.

Still not clear on the difference between LR-EtEPA and MND-2119

At this rate I think if we could get 5 a share most of us would do cartwheels. The days of thinking we would get 10-15 a share seem like a pipe dream now given the slog in Europe

LR-EtEPA

Nope I just want to know what Denner's master plan is to get the stock over a buck since he took over the company with promises of increased shareholder value. Where is this Italy approval? Denner is supposed to be this master of turning around companies so what is he doing to fix this mess? Nobody knows because they do not say a word. Right now AMRN is just known as the company who got a drug approved so everyone else could sell it. Not having any other products at all right now just kills AMRN. I will never understood that most companies have three or four things they are at least working on to get approved.

Capt
I was referring to the "more rapidly absorbed" version of V
What is that called?

Doesn’t MAT9001 belong to Matinas Bio?

Research on MAT9001 has been discontinued.

Could MAT9001 be AD's silver bullet?

Amarin posted registration for Investor's Day on LinkedIn

Amarin post:
https://www.linkedin.com/posts/amarin-corporation_welcome-you-are-invited-to-join-a-webinar-activity-7250209251078418432-rcDv

Link to registration:
https://us02web.zoom.us/webinar/register/WN_vCgwhxnTT8WKy6o748HTrA#/registration

They may ultimately prevail in court, but not anytime soon. And even if they file an injunction/CDO sometime in the next year or so, that won't necessarily dissuade the other 6 generics from selling IPE. And there is certainly no way there's a settlement soon.

There's all kinds of things that Amarin could do, that Hikma could do, that the other generics could do, that Amarin could do to the other generics, etc. But it all takes time. Tremendous time.

The original question was about what could be done before the SP needs to be above a buck, which IIRC is late May 2025. I highly doubt that anything will have an impact on the SP as it relates to the lawsuit, by then. Although I will acknowledge that if they DO succeed with a CDO before May, that may be enough juice to actually move the stock price.

But I am still doubtful that they get a CDO.

I have been saying or asking the same thing for some time. They have a product that ultimately they have to sell. Not sure they need to be listed to access stuff as some companies that want to be a going concern. Time to get revenues up and reimbursements in place and then sell to a BP.

And definitely not before we need to get the SP above a buck.
Who says this ticker has to stay listed?

JRoon, If you wouldn't mind, explain your position in detail. I only ask because you stated it as an an absolute.
Sleven,

I did that on two previous occasions thinking that the stock price was at a low point. Needless to say those didn’t work out very well for me, but to be fair, we only have 60 cents more to lose so you are probably right.

As I said earlier - Amarin has cost me the value of now 6 new Tesla 3 electric cars !

Actually the KM period is what I blame myself the most !

PS were at $ 6.63 - when he took over - but has fallen like a rock ever since.
-------------------------------------

Will we recover (partly / with profit) from this - that is as uncertain as who will be new President in US :)

Seve, you need a drink

If they do a reverse split they may as may fold up shop. A reverse split is nothing more than an invitation to shorts to destroy what little value is left in a stock price. And I mean unless denner is shorting the crap out of this his shares would also take a tremendous hit in a reverse split. I doubt the company would ever recover form it as most do not. Why would you do a reverse split on a 100 milllion dollar investement when you could actually do a buyback instead? The buyback is probably all they got to get it over a buck because the non usa sales are moving far too slow to make a difference. I dont recall when they have until but I thought it was May. If they cannot get it over a buck jn 7 moths then they are really really bad at this.

No.

For anyone with significant AMRN shares in their IRA, now would be an ideal time to do a Roth conversion on those shares.

Shado, there is nothing from a legal perspective that is going to change anything in the next few years. And definitely not before we need to get the SP above a buck.

Shadolane, What's the time frame?
Sleven,

Unless something significant happens in the litigation arena a reverse split may be the only way to salvage the pps from a compliance perspective within the time frame that Amarin has.

I doubt sales in other markets or studies for other uses will intervene in the near term.

We've encountered significant negative effects since the largest one......the Du decision.

And some of us may not be able to survive long enough to see how this all turns out.

IMO

xblkbk, are you of retirement age?

Wow! As a follow up to this post:
---------------------------------------------------------------------------

I just checked and it shows $98.40 for 30 day supply.

One thing that is frustrating is when I put “Vascepa” in the search bar, it comes back with:
Vascepa (generic)
Vascepa (brand-name)
icosapent ethyl (generic Vascepa)

---------------------------------------------------------------

I later saw that this came up when I selected Vascepa (generic):


So basically, when I selected "generic Vascepa", a pop-up box came up and told me that I could find BRANDED Vascepa for cheaper.

But then I also saw this description under generic Vascepa:
About generic Vascepa
Vascepa (icosapent ethyl) is used to reduce cardiovascular risk and treat high triglyceride levels.

I just checked and it shows $98.40 for 30 day supply.

One thing that is frustrating is when I put “Vascepa” in the search bar, it comes back with:
Vascepa (generic)
Vascepa (brand-name)
icosapent ethyl (generic Vascepa)

Exactly as typed, and in that order

North, I wonder if it is possible that this discounted price on GoodRx has only been put into effect very recently and was not in effect 30 days ago.

That exclusive “discount” did not work or was “not available” when I refilled a 90 day brand Vascepa prescription at CVS a month ago, as previously reported. We will try again in another supply 2 months at the same or different pharmacy. Thanks for the news.

That suit filed by Express Scripts and CVS/Caremark against FTC in Missouri is meritless as far as I’m concerned. My usual co-pay cost of $9 or $15 for a 3- month Vascepa supply had disappeared as of 7/01, replaced by over a $1000 cash payment even with a GoodRX coupon.

That's great news. Makes sense that Amarin probably will be in better position to adjust U.S. prices once it is finished negotiating most of its deals in Europe.

Europe worth more than Italy, France and Germany combined 🙃

We have already been creamed under denner That does sound like him

Interesting. I use GoodRx all the time and it's legit.

I remember how hyped up Brave was on here a year ago and hyped for a long time. I never understood the hype people were acting like it was going to be huge and drive the stock to 50 bucks. Some said Denner knew what he had in Brave. I think it is safe to say at this point Denner doesn't and never had any secret weapon or master plan. He is doing the exact same thing the old management did to a T. I guess maybe he is a little better at controlling costs but other than that there are no differences that I see. It makes you wonder what the point of the nasty proxy battle even was for especially given we get even less communication from denner.

Noticed that as well. Again, this is why we need RW data. Man, I wish MITIGATE gave us something.

With all the talk about IPE and an AFib adverse side effect, I found it interesting that in this study there were 2 AFib events, both of which occurred in the placebo arm.

Monk, what are you asking? There was essentially no difference between Vascepa and placebo. In fact, the placebo group actually did slightly better (which was not statistically significant).

IMO, the trial is too short, and I'm not even sure the outcome measures were appropriate. But in a short trial like this, it's all they could really measure.

As CaptBeer stated, I believe that EPA is effective over long periods of time, which is why populations with high fish intake have lower incidence of dementia. Vascepa is not an acute medication.

But outside of meta-analysis, I don't believe a long-term trial could ever be conducted like this. It would have to be VERY long, and it would have to start earlier in life.

Monk, couple things:

1. The report is not "final". The NLM does a review process on the submission, with comments. But they are required to publicly post the submission within 30 days of original submission, even if all questions have not yet been answered. You can see their comments in the results tab. So, nobody would likely "announce" results until the submission was "final".

2. This is not Amarin's study. So since the results didn't say anything positive, Amarin has zero reason to PR this. Same with U of Wisc. No need to make a major announcement.

3. The results are not "buried". They are displayed exactly how the NLM requires it to be displayed. They have a standard format that all trials follow.

the differences between V and the placebo were not significant. That’s not to say that IPE isn’t beneficial in the long run ( really long, like 10 years), but it does say that no one will be doing a study like that any time soon. I’ve been on VASCEPA for 10 years now and I’m still doing fine.

https://clinicaltrials.gov/study/NCT02719327?tab=history&a=17#version-content-panel

Capt. B.
Your thoughts on this report from Jroon that Brave was a bust???

Rose, Roon
Something does not seem right here.
Why do you have to dig for the results?
I thought this would be more of an "announcement"
than a technical piece with results buried??

Thanks for posting. Good to know. Of course those with insurance would still pay less than that for GV.

BbI,

Don’t know if this has already been posted, but GoodRx is saying switch from generic V to brand V for less money!!!

Per their “exclusive manufacturer discount”:

30 day, branded V, retailing for $406.65, is $98.40 with GoodRx

90 day, retailing for $1216, is $295.20 with GoodRx

I know management had talked in the past about the problem that an USA authorized generic’s pricing would disadvantage reimbursement negotiations in the EU. So maybe this “exclusive discount” is a backdoor for the near term??

My script is up for renewal in a few days. Since I’m stuck on Obamacare, where V isn’t covered, I’ve been paying $680 for a 90 day supply with the current Amarin discount. Will use the GoodRx codes and see if they work!!!

You have to expand those results sections to see it.

Meantime, take a look at bfiest’s latest message on the CDMO ticker symbol, and the Biosecure Act summary discussion there. If that bill passes the Senate and is signed into law, Medicare ability, VA hospital ability to contract with foreign jurisdiction producers of meds/drugs may be affected. What effect on Hikma, Dr.Reddy et al? Do they already produce their generic for Vascepa in the United States, or do they import from abroad…..?

JR
Could not find any of this verbiage.
"The average ASL at 18 months for the IPE group was slightly lower than the placebo group, but this difference did not reach significance.

On average, there was a slight increase in pTau181 in CSF after 18 months of IPE compared to placebo after controlling for age at baseline Visit and pTau181."