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ILT..."I wonder if there have been two consecutive rule 36 cases followed by a reversal?"
The second appeal was denied on the issue of standing....Fraud on the court during the ninth circuit case, which plainly played an important role in the decision, was never seriously considered during either appeal.
If the SC agrees that we have standing, the issue now becomes fraud on the court in the ninth circuit case, which is ostensibly indefensible.
fg..."As far as declining scripts, unfortunately that's what happens when you don't advertise, even for a drug that will "sell itself".
Vascepa has always suffered from the perception that it is just 'another fish oil'...That perception is held by patients, Docs, and even the courts.
That is another reason why a statin-Vascepa combo will help educate the public as to the life saving value of this drug.
J.T. had left Amarin and K.M. was new....Ekman was, at this time, calling the shots, selling all of the Amarin shares in the fund ,Sofinnova, where he was managing director and refusing to join in EPADI appeal...Now, for the first time, KM is in the driver's seat.
In the wake of the critical loss of the Marine patent, followed by the gV skinny label infringement on Vascepa's CVD indication, cutting expenses to the bone was an obviously necessary strategy and KM is doing just that.
I don't blame KM for the past management mistakes of JT, Kennedy, or Ekman.
Rose...An upside to an AG is that, in states that require that a generic must be dispensed over a brand, icosapentethyl would gain an advantage.
A downside to an AG is that the price is usually set lower than that of a brand...However Vascepa will have to lower its price anyway in order to sell in EU and ROW including China.The goal for Amarin is to determine a price for Vascepa and their AG so that higher volume will triumph over lower price....This will require some deft handing as to whether and how to market and how to price.
If worked out correctly, EPA could rival statins for sales and pave the way for a statin-EPA combo drug.
Rose...I did not mean to imply that an Vascepa AG would be good for the EU at this time.
My point was... together with the larger volume of sales produced by an AG Vascepa in the U.S., plus the volume of Vascepa sales in the EU and in the ROW, EPA would become much cheaper for Amarin to buy in large quantities from wholesalers, than for the generic companies to buy wholesale...This would make it much more difficult for gV companies to compete on a profitable basis with Amarin AG Vascepa and branded Vascepa prices in the U.S.
For this reason I would support an AG Vascepa
Lizzy..."Kalb didn't warn KM as to what was coming and he blind sighted KM."
Apparently he didn't blind sight Erikson.
Duke...I agree...With Amarin volume purchases for an AG Vascepa for its markets in U.S., Europe and ROW, they will be able to buy EPA at a lower price than the generic companies and compete profitably on price alone....especially with several generics dividing up the generic market.
PFE has been grossing $2 billion/year from Lipitor despite having many generic competitors and Lipitor has a much lower price than Vascepa.
Amarin is a text book example of the outcomes when a one product drug company loses its exclusivity for it's primary indication to a skinny label...theoretically marketed by a generic only for a for a secondary indication...but, in reality, the generic company counting on making most of its sales for the primary indication.
The case of Amarin vs. Hikma points out some serious flaws in the H-W law.
In retrospect, this move was necessary two years ago.
Rose...Du should also be fired...She could easily find a job as a computer technician for generic drug companies, which are interested in cropping tables from drug studies before they are presented in court as evidence in favor of their generic drugs.
HDG......" massive layoffs...YES
• buyout / partnership ...NO...not yet
• authorized generic / acquisition of a new product"...NO...not yet
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"