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TTE...JT had a plan to ride the waves on Vascepa and eventually parlay Amarin into a BP...Judge Du put a stop to all that and now Amarin is just floundering with a GIA strategy...We need Denner to install a new sensible plan for Vascepa's future.
Capt...The Amarin-HLS deal has up front milestone payments to Amarin...I believe Amarin will have to pay Mochida double digit royalties but NO milestone payments...
QUOTE..."Under the Amarin-HLS agreement, HLS will be responsible for regulatory and commercialization activities and associated costs. Amarin is responsible for providing assistance towards local filings, supplying finished product, maintaining intellectual property and continuing the development and funding of REDUCE-IT. Terms of the agreement include up-front and milestone payments to Amarin of up to US$65.0 million. These payments include a non-refundable upfront payment of US$5.0 million, as well as development, regulatory and sale-based milestones totaling up to an additional US$60.0 million. The agreement also provides for HLS to pay Amarin tiered double digit royalties on net sales of Vascepa in Canada."
Since Vascepa is apparently profitable to HLS, even after shelling out milestone payments as well as royalties to Amarin...perhaps MND-2119 could be profitable to Amarin, either as a solo drug,or even better, as a combo drug with a statin...ESPECIALLY IF AMARIN COULD OBTAIN PATENT EXCLUSIVITY FOR MND-2119 IN THE U.S.
Nuke...A potential advantage of MND-2119(as opposed to Vascepa) is that a combo drug, using a statin plus MND-2119, might need be used only twice a day...or even only once a day....since the EPA in MND-2119 would be more easily absorbed by the patient's body, therefore allowing for a lower dose of the EPA in the gelatin capsule to produce the same effect...Using less EPA might even make the product cheaper to manufacture than Vascepa.
An as yet to be answered is whether Amarin would have to pay royalties to Mochida for the use of their product...in addition to the $2 million they paid up front to Mochida upon signing their collaboration agreement.
Capt...Since Amarin already has a patent for MND-2119 in the U.S., it seems reasonable for Amarin to initiate the process to obtain FDA approval in the U.S. ASAP....I'm surprised that Amarin has not already begun this process.
Now that Amarin has a patent granted for a statin-Vascepa drug combo...I would also like to know....
1. Has Amarin applied for an FDA approval for the combo drug?...
2. Will the combo drug be in the form of be a blister pack or a statin to be coated on to a Vascepa capsule?
3. What will be the dosages of the statin to be used in the combo drug?
4. Which statin will be used in the combo?
5. Does Amarin plan to seek approval from the U.S. FDA to use MND-2119 either alone or in a combo?....i assume that Mochida has a patent for MND-2119 in Japan...Does Amarin also have to apply for a patent for MND-2119 in the U.S.?
Rose...Generic companies often offer "financial inducements(i.e. bribes) to pharmacy chains to dispense their products in preference to the products of another generic company...This would put Amarin, a company with only ONE generic product at a disadvantage even if their generic Vascepa was superior to other generic"biosimilar" products from larger companies with MULTIPLE generic products to sell.
study..."QUOTE..."Why not settle with Healthnet now when we can still get some type of value especially if we have a generic on the market by second half of this year."
I agree that Amarin needs an authorized generic soon...but but it would advantageous for Amarin to be bought by a BP with a generic arm before marketing a generic Vascepa...rather than than to compete against many generic companies with hundreds of other generic products already on the market...and who have been been making deals with insurance companies to insure that their generic products get sold on a preferred basis.
I believe Denner is the person to manage this sale of Amarin to a BP
Study...Amarin has settled the Healthnet case in a manner that specifically excluded the shareholders from knowing the agreements..Also we have had no information about Amarin's plans for MND-2119 or a FDC in the U.S.
I'm happy that Lisa that Lisa answered your questions, but I wished she had commented on these issues as well.
Thank you, however, for your reporting on your conversation.
Life...Quote..."Does Karim risk embarrassment and let this go to a vote?"
IMO PWO is calling the shots for Amarin in this proxy fight, NOT KM.
During negotiations btween PWO and Denner, PWO added a brand new board member at an additional cost to Amarin, apparently just to obstruct Denner's negotiating position(This nefarious move caused Denner to threaten to sue if PWO stacked the board with additional members, who would be loyal to him...This move, in the midst of a negotiation, tells a lot about PWO and whether his interests really lie with Amarin...or with HIMSELF.
Nuke...I don't put the onus for the proxy fight on KM...He is in a delicate position and must show allegiance to PWO...I will vote my shares for him to maintain his position on the BOD, but I will votmy shares against PWO.
Dogn...Thanks for the link...It shows that Denner has nearly twice as much invested in GILD as he does in Amrn...The current ridiculously low prices of Amarin are an inviting buying opportunity for Denner as well as for the Amarin BOD....
As of the 13F in 9/30/22...Sarissa owned...
-GILD
-number of shares)...(in millions)1,273,100
-value in dollars ...(in millions) $78,538,000
-AMRN
- number of shares...25,210,000(in millions)
-value in dollars( $43,361,200(in millions)
jasberg...GS was angry at JT and Ekman...They are both gone.
Bob...As I recall, GS became angry at J.T years ago because JT had failed to inform them prior to GS investing in Amarin's secondary raise of funds that Amarin had begun to push the FDA to allow approval of Vascepa for the CVD indication before the completion the R-IT study....Amarin failed in this strategy, when the FDA insisted on an Adcom, in which they demanded that Amarin finish R-IT before they would approve the CVD indication.
The FDA eventually did approve V for CVD at the second Adcom, but only after the results of R-IT were already in...When the price of Amarin stock went down after that first failed Adcom, GS and their investors lost money that they had invested in the secondary...and GS has had it in for Amarin ever since.
CBB...PWO is asking investors to approve a strategy for a small company with a single drug and with an excessively large overhead... and which has lost its patent exclusivity in the U.S., (and with the company now experiencing difficulty in Europe)...to continue a GIA policy....This makes no sense to me either.
J.T. was an accountant and he knew enough to retire from the GIA strategy...Does PWO know more..or even care about Amarin?
In 2018, I held onto my Amarin shares, even the price was low (but higher than it is now)...because I was waiting for R-IT results...Now I'm holding my shares...waiting for proxy results.
The primary disadvantage with gV would be the oxidization of EPA in its inferior gelatin capsule...as compared with the oxidization of EPA in Vascepa....It would have made sense for Amarin to store gV on its shelves for x number of years and then to do tests to compare the oxidization of the EPA in gV compared to that of Vascepa.
The bad odor and bad taste of gV, alone, might not be enough for the FDA to take action.
J.T. had been mainly focused on the U.S. when he passed the baton to K.M. on 8/12/21...At that time the stock of Amarin was selling for $4.95 per share...During this time, KM has been focused on Europe...Its been two and a half years of frustration since then... Now Amarin needs to return to a strategy to market a patented FDC with Vascepa...or an FDC with patented MND-2119 in the UNITED STATES...Thus far, KM has refused to mention either of these two potential strategies...and he wont even discuss the reasons for his turning away from this policy.
Amarin's moment to GIA has passed...J.T. eventually came to realize this...Apparently PWO and KM have NOT.
If you still want Amarin to GIA, vote for PWO...If you don't, vote for Denner.
If Amarin had 3 billion in cash today, instead of 300 million, I, also, might want Amarin to GIA.
Nsleven...Denner obviously wants to sell the company....He can negotiate in private with many companies before he gets a suitable offer...as he senses a potential offer at a good price, he may buy even more Amarin stock...I am OK with that....First he has to fire PWO, who obviously wants to continue to GIA, which is becoming an exceedingly risky strategy.
JRoon...Denner came in at 4 and change...He is not selling out for 5 bucks.
Dancing...The main purpose of a FDC(preferably with MND-2119), is NOT in Europe... an FDC would, however, be very important for the U.S. if Amarin could get U.S. patent protection for it...An FDC would not solve any Amarin problems in Europe, which is presently starved of cash.
Amarin is apparently unwilling to make clear why they have no interest in MND-2119....This is material information for Amarin to release...information that investors have a right to be informed of.
I would like more transparency from Amarin re material facts , which influence the company's future...e.g.
In June of 2018...QUOTE..."Amarin Corporation (NASDAQ:AMRN) has entered into a multi-faceted collaboration with Mochida Pharmaceutical Co.
Under the agreement, Amarin obtained an exclusive license to certain Mochida intellectual property to focus on the development and commercialization of early-stage drug products and indications based on the omega-3 acid, EPA (eicosapentaenoic acid).
FINANCIAL TERMS ARE NOT DISCLOSED."....
This agreement was signed before the release of the R-IT study findings and Amarin took a chance to pay $2 million to Mochida, up front, at a difficult time for company when they were facing a lot of unknowns.
In the case of MND-2119, which may well be a drug Amarin eventually used to replace Vascepa, we remained uninformed about whether Amarin will need to pay royalties to Mochida for its use, or, if they do, at what percent of the sales revenues.
Rose...I will vote for Denner's full slate...to give him a free hand to decide which old or new board members are most critical to Amarin...He has more at stake than any of the BOD present members.
CBB...One thing I strongly believe is that Denner has more interest in making Amarin a valuable asset than either Ekman or Olsen.
Thanks sleven...Interesting resolution to a difficult impasse.
Chrome...This avoids the basic divide facing Amarin...Should Amarin invest more in a GIA strategy or should the company be groomed for an eventual sale to a BP?
In the past J.T. made what turned out to be the wrong decision...Is Olsen going to make the wrong decision again?
If Amarin is to be eventually sold to a BP, wouldn't it be best,at this time, not to enter into many partnerships?
one...Circa 2011 and still today, I had a significant position in Amarin, recognizing that Vascepa had the potential to be a great drug for masses of people...At that time, I was in the GIA camp...as was my friend,J.L.,who first introduced me to Amarin....I felt even more confident when the R-It studies were released.
After the ninth circuit case, my friend got out, but I stayed in. I remain a believer in Vascepa, but NOT in Amarin GIA...It is my that hope Denner succeeds where current management has failed.
A reason that V is superior to gV is that the that the pure EPA in the patented gelatin capsule of Amarin is resistant to oxidization of EPA and that increases its effectiveness over the generic capsule of gV... Amarin should acquire some generic capsules and fill some of them with pure EPA and test for comparative oxidization of the EPA in the two capsules to demonstrate that the generic capsules cause increased oxidization of the EPA as compared with Amarin's patented capsules.
Rose...Erikson refused to support the EPADI appeal because it brought attention to the negligence of Covington in its handling of the ninth circuit case, which he was loath to do...He always put his own preferences ahead of what was advantageous for Amarin and its shareholders.
Nsleven...For Denner to publicly announces his plans for Amarin would be counterproductive...He needs more room to maneuver.
We can however, assume he intends to...
1. get Amarin's selling price up and...
2. sell the company
For Dennner to give more details would be a dumb move.
The alternative to voting for Denner would be to have Amarin management continue to GIA....I would want Amarin management to more release details about the settlement with Healthnet and their plans for MND-2119 before I would support them...Amarin has already shown bad faith by their recent appointment of a new board member without any input from Denner, who has been negotiating with Olsen for many months
Do you trust Olsen or do you trust Denner?...I trust Denner and will vote my shares and the shares of my family for him.
Nsleven..."Germany was an understated risk"...I don't fault KM for failing to get reimbursed by Germany, but I do fault him for hiring reps prior to German approval for Vascepa reimbursements...I also fault him for not being more open about the Healthnet agreement and the deal that Amarin has with Mochida...especially his plans for MND-2119.
I want Denner to make the deal,not JP Morgan, not the BOD...not even the shareholders.
This is another example of Olsen not being interested in Amarin or its shareholders, but just in himself.
Skipper..Denner recognized that when Olsen recently appointed a new board member, Olsen's reason was mainly to strengthen his own bargaining position... Denner then recognized that he was not really in a negotiation, but in a war...That is when Denner decided to proceed with a proxy fight...As a long term investor, Amarin has been my largest investment ever(it is substantial, but a lot less shares than Denner has)...I intend to vote all my shares including those, held by my family, for Denner.
Nsleven...IMO Excess API, which Amarin has already contracted for, will be soon a huge problem...Amarin is depending mainly on Europe for an increase in sales and revenues rather than an increase in the U.S market....It may be necessary for Amarin to issue an AG in the U.S., if only to avoid having to have to eat its oversupply of API...A buy out by a BP would solve this problem handily.
Sleven..Marketing a FDC in the U.S. would require more of an advertising budget than in Europe....probably with more reps than Amarin would want to hire.
Nsleven...It would be too much of a strain on Amarin's present budget to introduce a FDC in the U.S. at this time.
The FDC has to be has to be first cleared with the FDA....If it were to contain MND-2119, that would also need FDA clearance.
In the hands of a BP, a FDC could be introduced in the U.S. as well as in Europe and consist of a statin plus MND-2119 rather than Vascepa.
If not for judge Du, Amarin would,by now, have had the cash to do this themselves.
J Roon...QUOTE..."We know ZERO about his intentions with the company."...I believe Denner's intentions are to sell the company...something that should have been done long ago. We are at a dollar and change...and destined to stay that way unless Denner takes over.
Thank you...After two months of negotiations between Denner and Olsen, the gloves have finally come off... IMO it would be serious mistake for shareholders to let Denner fail in his mission to increase the value of Amarin, which has been inherent in its product, Vascepa, but has gone unrecognized. Despite the valiant efforts of KM, the time has come for Denner try his expert hand.
Ns...Amarin could essentially give away the statin and charge only for the Vascepa in a combo for the U.S....The patented combo would present a formidable challenge for the generics to infringe on. I look forward for work on this to now proceed rapidly.
A combo with MND-2119 might even be better....but KM must have had some good reason for not mentioning MND-2119 at the JPM conference yesterday....I'm not sure why we investors should not be privy to this reason....Amarin paid Mochida $2 million at the time of their agreement to share patents, but it might be that Amarin would still have to pay royalties to Mochida for the use of their inventions.