In 2013, the FDA demanded a large multiyear clinical event trial before they would approve Vascepa for Rx of CVD(i.e. the Reduce-It study)....Amarin did this study on Vascepa at it's own huge expense and achieved success...and eventually got awarded approval by the FDA.

Generic Vascepa does not have the same patented gelatin capsule as does Vascepa...Yet no event studies were demanded of gV by the FDA like they were demanded of Vascepa...Does this mean that the FDA assumed that the Vascepa capsule made no difference?

Dr. Preston Mason has been doing research on the positive effect on the EPA by the Vacepa patented capsule ....I have been taking Vascepa in preference to gV because of this capsule....Unless we hear some information from Dr. Mason on his research, I/we must assume that the patented capsule does, in fact, make no difference to the amount and/or quality of the EPA in Vascepa.

I was also surprised when KM stated that 3 years were necessary for the development of the combo drug....Both statins and Vascepa have been approved and used safely and effectively by millions of patients for many years...and a combo drug should have quick approval...either in a in a blister pack containing the two drugs...or together in one capsule...The enhanced, once a day Vascepa, has already gone through two clinical trials...and Mochida has submitted it for approval in Japan almost a year ago.

Rose..."other interested parties and who they might be"....At his point, I assume that Dr. Denner is talking to other large shareholders and exploring their suggestions and opinions on potential strategies.

As has been discussed, there are pluses and minuses for Dr. Denner to be on the board....However, the pluses seriously outweigh the minuses.

Some in management don't believe in Amarin revenue growth or profits....The ex-COB is a good example of that...They should resign(as he thankfully did) and be replaced by those, who are believers.

I agree that cutting expenses is of prime importance for Amarin in this environment.

The market is now looking for Amarin to show positive earnings...not looking for scientific endorsements, not national approvals, not sales, not even revenues...but for positive earnings...

With positive earnings, the market will respond by higher prices for Amarin shares and pave the way for an eventual BO by a BP.

The two primary arguments against Amarin at the second appeal were...

1. We didn't have standing
2. the first appeal was denied

The issue of fraud on the court in the original case was never seriously discussed.

Rose..." But we'll have to see where the price of Vascepa monotherapy will be at the time of launch because that's going to be very determining whether we launch or not in the US."

I Think what KM was implying was....that, if all else fails and if the generics succeed in stealing the Vascepa market in the U.S....and compel Amarin to issue an authorized generic Vascepa as a mono drug in order to survive as a a company, we will be forced to skirt the U.S. market and issue the statin-Vascepa combo drug in Europe alone.

"Statins are only used by roughly 50% of secondary prevention patients I believe …. And they have been around since 1987"


Statins have a higher rate of site effects than Vascepa with its near placebo like profile...I would be happy with Vascepa being used for just 5% of secondary prevention patients...This is attainable in much less time...particularly with the advent of combo statin-Vascepa drugs.

FFS..."The false perception regarding the adverse effect of MO is swaying opinions as EU/UK reimbursement negotiations continue."

I agree that the next several months will be critical for Vascepa and Amarin....Amarin needs to minimize current expenses in order to put time on it's side.

Amarin's ace card is the effectiveness of Vascepa in reducing CVD....Once national/provincial health services recognize the cost savings they experience by the reduction of CVD, Vascepa is bound to take off as statins have.

Lizzy...Amarin was paid $15 million up front in 2015 by Eddingpharm upon the signing of a partnership for China with Amarin...In addition, Eddingpharm is a substantial company, being a partner of Pfizer in the distribution of Lipitor in China.

I understand Eddingpharm is having some trouble doing an IPO in Hong Kong, but I hope that an arrangement can be made soon so distribution in China of Vascepa can be started ASAP....If not, Amarin must look for another partner in China.

This project is important to Amarin and I hope KM can give us some details as to why it is taking so long.

The court's decision was that the Marine patents were invalid,..due to obviousness... and then these false results from the cropped Kurabayashi table were copied verbatim into the decision...this was so far below the acceptable norms for judicial practices that some form of redress is warranted.

CBB...That is my understanding also.

HDG....You are correct...IF, and only IF, the exclusivity contracts that the pharmacies and the pharmacy benefit plans have signed with the Generic companies allow them to sell an Amarin AG Vascepa in competition with the Generic companies' own gV.

HDG... Amarin creating their own AG, in competition with Generic companies , which offer exclusivity to pharmacies and pharmacy benefit plans for their large stable of generic drugs would mean the necessity for Amarin to drastically lower their prices for Vascepa.

At that point, Amarin creating Vascepa as a dietary supplement...and distributing it globally as such, might be a better choice.

Vascepa is up for approval in China, with it's population of 1.4 million people, this year....opening up a huge market....Prices will need to be negotiated by Amarin's partner , Eddingpharm.


Amarin is unlikely to issue an AG until the European and Chinese markets come more into focus with decisions needing to be made about pricing and supply.

A suggestion for Amarin to reduce XS inventory if necessary...

Amarin could send free samples of Vascepa to Docs in the U.S.A. with the note..."Vascepa is the ONLY EPA product which, when taken along with a statin med, has been PROVEN by extensive clinical testing to reduce CVD, including heart attacks and strokes, and approved by the FDA for this indication.

This could also be sent with a post card for the Docs to request more samples.

JROON...."why not strike a deal with the generics to become their suppliers, in exchange for their agreement to limit their distribution to MARINE indication"

I doubt the generics would agree to that deal.

CBB...I agree this is good news...

Regarding China...If it will help facilitate approval of Vascepa in China, Amarin can modify it's contract with Eddingfarm and delay milestone payments until certain volumes of Vascepa have been sold, thus making it easier for them to spend their available cash on building a market ASAP in China.

ditmus...The current evolution of the BOD speaks to the fact that more needs to be done to assist in the EPADI appeal...I sincerely hope the BOD sees a way to assist in the pending appeal to SCOTUS by issuing an Amicus.

I believe the EPADI appeal is an important case worthy of Cert.

The issue of potential fraud in the recent election for president is foremost on the minds of many Americans.... The appeal of the flawed ninth circuit decision presents SCOTUS with a case of indisputable fraud on the court and it is incumbent on the justices to make a decision as whether flagrant fraud on the court can be ignored or dealt with in a democratic society.

Rose...The recent do over at the BOD was the first shoe to drop...The next shoe would be for Amarin to hint that it is open to negotiations for a BO by a BP.

Now that Amarin has new appointments to the BOD and a new COB, perhaps an Amicus letter to the SCOTUS in support of our recent appeal might be of help.


"DUBLIN, Ireland and BRIDGEWATER, N.J., May 19, 2022 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced a series of appointments and leadership changes to its Board of Directors, including:
Appointment of Erin Enright and Alfonso “Chito” Zulueta to the Board, effective IMMEDIATELY...

Per Wold-Olsen, a director since January 2022, has been named Chairman of the Board, effective IMMEDIATELY."

You may disagree with Judge's opinions , but you can't disagree with established facts...The Kurabayashi table WAS CROPPED..The verbatin quotes from the table by the Judge, as cited in her decision, establish this fact, without any doubt.

Quote from Hickma
"This meritless claim has previously been dismissed by both the district and circuit courts, and we are confident the U.S. Supreme Court will also deny plaintiff's baseless assertions."

Hickma would prefer not to deal with the issue of fraud on the court....They would rather not dispute it...and instead just rely on an arrogant assertion that it was 'meritless' and 'baseless'.

Hikma would rather not embarrass themselves by disputing the indisputable fraud on the court....unless they absolutely have to.

Charles, I am glad to see you have kept up your interest in Amarin through the years....Thanks for this interesting piece.

Biopa...I would rather patiently wait for Amarin to reach $5/sh on it's own next year ...and then to have a BP buy Amarin for over $10/sh.

Since we know that only 7% of the total volume of Vascepa sales plus gV sales are for the very high triglyceride indication.... and we learn that Dr Reddy volume for gV is 17.9% of total volume of Vascepa plus gV sales, it becomes obvious that Dr. Reddy is infringing on Amarin's CVD patents....much more obvious that of the finding in the Hickma suit in the ninth circuit court case.... in which the Marine patents were found to be obvious according to the judge's decision.

i.e..."Generic Vascepa by Manufacturer
Hikma - TRx 9,892 Total V share 9.5%of total
Reddy - TRx 18,636 Total V share 17.9%
Vascepa + Generic Vascepa- TRx 104,052"

Long Covid is affecting 30% of patients AFTER they 'recover' from Covid...

Long Covid is due to lingering inflammation after the cytokine storm has abated or continued inflammatory over-reaction of the autoimmune system.

Vascepa, as an anti-inflammatory med, needs to have studies done for it's affect on the symptoms of long Covid, which include tiredness and cognitive decrease.

Amarin, at present, does not have the assets to do these studies.

Kiwi..I agree that our market share now seems to depend more on insurance companies rather than on Docs...We need to adjust our strategy to deal with our new main problem(i.e. lowering the cost of Vascepa to the insurance companies by increasing rebates)...Otherwise , they will be motivated to continue to push gV ahead of Vascepa....This means reducing our sales force in favor of rebates to insurance companies.

Sadly, what's best for patients seems to be lost in this scenario.

Nsleven..."Most interesting in Erin Enright's background as new BOD member..."MERGERS and acquisition experience"

Rose...."Generic medicines use the same active ingredients as brand-name medicines and work the same way, so they have the same risks and benefits as the brand-name medicines. The FDA Generic Drugs Program conducts a rigorous review to ensure generic medicines meet these standards."

IMO this statement is not true in the case of gV.

In the case of gV, the FDA has never done a lab or a clinical study to evaluate the effects of the differing capsule that gV has, as opposed to Vascepa's patented capsule..on the vital ingredient(EPA).

HDG..."Was the Generic Vascepa tested for the approved indication ...?

gV was approved by the FDA as as a 'biosimilar' for the very high triglyceride indication....gV does not have the same patented capsule as Vascepa and has not been tested to see whether the essential EPA in the product is preserved and available for use to the same degree as in Vascepa....The main usage for gV currently is for CVD, for which it has neither been tested...nor approved by the FDA.

With a new board, is it too late for Amarin to assist EPADI with the SCOTUS appeal?....If Cert is given, but no summary judgement is decided...could Marks(Amarin's chief legal counsel) assist Kasanoff in the oral arguments?

JRoon..."Prettybrook has approximately 20 active investments in a variety of companies, typically as a co-investor with institutional private equity."

Private equity often invests in small companies, OFTEN WITH AN AIM TO SELL TO A LARGER COMPANY.

This would be presently be a good strategy for Amarin to explore.

rose...I am not a lawyer, but it seems that the issue of fraud on the court is flagrant and indisputable...Therefore, Hickma will be relying on the standing issue for its defense.

Marjac has stated there is evidence from past legal cases that, in the unusual case of fraud on the court, we do have standing.

The cropped table performed a critical role in the District Court's decision

"The District Court’s decision was tainted by fraud
on the court, because the District Court relied upon a
“cropped” version of Kurabayashi Table 3, which omitted
supplying critical material information to the District
Court. C.A.J.A. 347. The District Court copied this same
cropped table directly from Respondents’ Post-Trial
Proposed Findings of Fact and pasted it verbatim into
the District Court’s Opinion. App. 62a."

This paragraph says it all in a nutshell....
"In order to appreciate the fraudulent nature of
Respondents’ misrepresentation, one need only compare
the cropped Table in the Court’s Opinion (App. 62a),
with the identical cropped Table in ¶280 of Respondents’
Post-Trial Proposed Findings of Fact (C.A.J.A. 347),
with the uncropped original Kurabayashi Table. C.A.J.A.
343. Respondents cropped the Table to disingenuously
corroborate Dr. Heinecke’s misleading expert testimony
which was diametrically opposed to Kurabayashi’s stated
conclusion regarding their own statistical analysis of the
data."

Ekman should not continue with his job as COB of Amarin once he decided to eliminate Amarin shares held by Sofinnova,where he was managing director....I'm surprised he did not do the decent thing and resign as COB of Amarin after that surprising move....IMO this action of Ekman represents a conflict of interest....Why not turn the reigns over to someone who has a real interest in Amarin?

Ekman had a choice of resigning as managing director of Sofinnova or as COB of Amarin...but keeping both jobs borders on unethical.