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rose...I agree...A partnership,at this point, might limit which BP could BO Amarin.
There are a lot of potential indications and products, remaining for Vascepa to explore, both in the U.S. and in Europe, but it would take more cash and management expertise than Amarin now possesses.
In an AGM, most shareholders do not bother to to send in their votes and management wins in a landslide...In a "special meeting", there will probably be attempts to inform shareholders by phone on the issues to be voted on...and there will be a greater percentage of shareholders, who submit their votes.
IMO, at the special meeting,the voting would be different from that at the Amarin AGM ...and likely favor the group that called for the special meeting..especially when Amarin stock price has been plunging over a period of years and stockholders sense a need for a change in the BOD.
sleven...QUOTE from Denner..."immediately after the annual meeting, we could call a special meeting and seek to remove and replace some or all of the Amarin directors with the affirmative vote of the holders of a majority of the outstanding shares."
IMO Mikhail has performed well as CEO in a difficult situation,..Otherwise, Amarin now needs different management.
Unfortunately, The adverse ninth circuit court decision changed everything. We now need a new approach to deal with a changed environment and new ways to maximize the value of Vascepa.
It would be good to see the recently appointed members, Enright, Zulueta and Mikhail reappointed...plus Denner (as COB)...and some of Denner's associates also appointed to the BOD.
No one can deny that Amarin has been going through some tough times, but we must give it the best chance we can to recover.
KM has had previous experience with a combo drug with statin to treat CVD at Merck...
KM was able to reverse a sales decline in Merck's lipid lowering business with the launch of an LDL-lowering combo drug, Atozet....This was a Lipitor -Ezetimide combo...The doses of the combo drug were ...Lipitor 10-20-40-80 mgm. with Ezetimide 10 mgm....Amarin should give a high priority to producing a combo statin-EPA drug with the same doses of Lipitor as in Atozet ...together with a 40 gm once a day Vascepa...or, if necessary, a 20 gm twice a day Vascepa..
It would have te folllowing advantages...
--be more effective than Atozet in reducing CVD
--benefit from patent protection
--introduce more Docs and more patients to the benefits of Vascepa.
--
sleven...Thank you for posting this...It may not seem like a big deal, but it is another step for Vascepa getting accepted as a SOC drug for CVD around the world.
HDG...If you're saying that personal relationships aren't important when it comes to getting appointed to boards of directors, I beg to disagree.
I also think that Ekman and PWO had a personal relationship, the extent of which, I don't know for sure....I'm not implying there is anything bad about this, but it makes the firing of Ekman, a long standing COB of Amarin and now a board member, by PWO, who recently advanced to the job as COB, a touchy situation.
HDG...The point is that Ekman and PWO have known each other and it is no coincidence that Ekman hired PWO as a member of the BOD and retired shortly afterwards...clearing the way for PWO to be elevated to the position of COB....This makes it awkward for PWO to dismiss Ekman as a member of the BOD...only a few months after assuming his new position....It would be preferable for Ekman to leave...after a vote at a special meeting
hdg... Ekman and PWO had a relationship through Merck and was instrumental in bringing PWO to Amarin....If not for Ekman, PWO would not be chairman of BOD of Amarin...It would be hard for PWO to dismiss his friend Ekman (his predecessor as COB) from the board.
"Lars Ekman was formerly with Nova Cardia acquired by Merck"
"Per Wold-Olsen joined Merck & Co. (MSD) in 1974. He became Managing Director of the Norwegian subsidiary in 1976 and Regional Director and Vice President of the Scandinavian region in 1986. In 1991, Per Wold-Olsen was appointed Senior Vice President for Worldwide Human Health Marketing of Merck & Co. Inc. in the US, and in 1994, he was appointed President of Human Health Europe of Merck & Co., Inc. In 1997, his region increased to include Eastern Europe, the Middle East and Africa, as well as Worldwide Human Health Marketing. In 2005, he was appointed President of the Human Health Intercontinental Region, Merck & Co. Inc. From 1994 to 2006, he was also a member of Merck’s Management Committee."
If Denner is successful in his negotiations with Amarin's BOD, it will probably mean a seat for him and not for Ekman...PWO's position as CEO is, in large part, due to Ekman...It would be difficult for PWO to agree to the dismissal of Ekman from the BOD...A compromise between Denner and PWO might include the retention of Ekman on the BOD...Failing that, a special election, in which Denner would dismiss Ekman might might be more acceptable to PWO.
alm...QUOTE..."3-act now in terms of -to change the direction of the company and over time see the SP recover and then sell"
This option seems the most beneficial to me....i.e. further development of
1. EU sales
2. China sales
3. Statin Vascepa combo
4. Once a day Vascepa
5. AG Vascepa
6. more indications for Vascepa
When the SP returns to double digits...then SELL Amarin to a BP and let them use their muscle to complete the task of making Vascepa into a world wide standard drug.(like Aspirin or Statin)
Robin...I agree...Results are available about the numbers of patients in the U.S. who have had a MACE within 5 years, which was followed by a second MACE within 5 years...It would be easy to compare those numbers to the numbers of patients taking a statin plus Vascepa, who have had a MACE within the past 5 years and then a second MACE...and evaluate what the differences in the numbers were.
Like most studies, it may not be perfect, but it could still be revealing....and provide evidence that those patients taking Vascepa, have been better protected against additional MACE.
Rose...QUOTE..."Given ongoing discussions, we intend to vote “ABSTAIN” on all matters at the annual meeting."
My translation of Denner's remarks to shareholders is..."We are having discussions with the board for the purpose of making some necessary changes...We would rather not commit ourselves with YES or NO votes at the AGM...However,if necessary, we will call for a special meeting after the AGM and commit ourselves at that time."
HDG...QUOTE..."None of the most discussed topics - ongoing studies, STAT article, management, etc. - are important on a real (long-) term"
Judging from Denner's past history as an activist investor, it is probably his goal to arrange, in the near term, something that should have done years ago...i.e. to sell Amarin to a BP.
The outcomes of the topics up for discussion here are relevant as to the timing and price to be obtained for the shareholders from the sale of the company...
P.S....It was my mistake to interpret AHA as meaning America Hospital Association rather than American Heart Association...and,this led me to report on the wrong dates for the meeting where the Respect study is to be discussed.
Thank you Nsleven for clearing that up...Respect will be reported in November, rather than in July...assuming the study is accepted to be reported at the meeting...The Respect and Mitigate studies should do a lot to quell the recent absurd conspiracy of chronic Vascepa opponents to discredit the Reduce It study by using the mineral oil placebo as the reason for the excellent results achieved by Vascepa in reducing CVD
PFE has already demonstrated an interest in Vascepa by becoming involved with its marketing in Canada...They have had big winners with their CVD drugs, Lipitor and Eliquis....Amarin seems ready for a BO....PFE has plenty of cash and could be a welcome candidate in this regard.
Rose...those "scientific experts",with an axe to grind, ignored the Jelis and Cherry studies...I expect they will choose to ignore Respect and Mitigate too.
Cap...Thanks for the DD...My interpretation of this news is that data from the Respect study, which is currently locked, is scheduled be released at the AHA meeting 7/17/22 -7/19/22....
This will IMO provide confirmatory evidence that taking a Statin plus Vascepa reduces CVD...WITHOUT a mineral oil placebo...ie. much like the Jelis and Reduce It studies already showed.
Additional confirmation by the Mitigate study is due soon.
Feuerstein and Herper , who sell subscriptions to a Wall St. tip sheet, have denigrated Vascepa for ten tears, in every way possible, including by referring to it as just a 'fish oil'
This is a step up for them, who now refer to Vascepa more accurately as a "medicine derived from fish oil."...After all these years of actively discrediting Vascepa, maybe they are ready to cease bad mouthing Vascepa and pay it some deserved respect.
At most AGM, the votes are lopsided in favor of management....not with Amarin at this meeting
These proxies amount to a vote of approval for Denner to proceed with necessary changes.
HDG...Without an IPO, Eddingpharm will have inadequate cash to pay for...
1. milestone payments
2. royalties
3. purchases of Vascepa shipments
4. marketing in China
Perhaps it is time for Amarin to look for another partner in China.
Approval of Vascepa in mainland China is long overdue...Amarin management needs to share any information, even if limited, as to what is causing the hold up is and as to whether they have a plan that might assist in expediting an approval .
Potential projects for Amarin...
1. recover patents for Vascepa with a combo drug or a once a day drug or a proof of inferiority of gV
2. develop other indications for Vascepa ...such as Alzheimers, cancer, dry eyes etc.
3. maximize the EU and ROW markets for Vascepa.
These projects take more assets than Amarin has now or will have in the near future...and a BO by a BP is required.
To all shareholders...If you are happy with the current BOD's handling of Amarin since December 2019, vote for them...If you think a change is necessary, vote for Denner.
I, for one, can't wait for a special meeting to be held.
I am assuming that far less than 50% of shareholders voted at all....and that a significant number, who did vote, voted to abstain....If so, Denner can then proceed with negotiations with the BOD or, if this path proves non-productive, he can initiate plans for soliciting proxies for a new meeting of shareholders.
Marjac...The S.C. is presently under intense criticism for some of its recent decisions...They had to choose between what was right and what seemed to be making it more expensive for the public to access an important drug...and they chose to turn their backs on the fraud that occurred in the ninth circuit...in essence, they chose, during these turbulent times, to 'play it safe'.
You were right, but the tenor of the times was wrong...Even the S.C. does not have unlimited political capital.
louie..QUOTE..."Hey....lets make a combo pill..... Oxycodone and Vascepa. Sales will go thru the roof."
Perhaps the compassionate FDA would approve this combo pill...BUT LIMITED...i.e. ONLY for sales to Amarin shareholders.
DTG...I would add another item to your list of future initiatives for Amarin...
i.e....A serious pursuit of evidence that Amarin's patented gelatin capsule protects the efficacy of the EPA within...and makes gV NOT BIOSIMILAR to Vascepa....followed by lawsuits against generic companies for infringement and against the FDA for incompetance.
Amarin management did not think the denial of CERT by the S.C. was important enough to inform the shareholders....Management probably will refrain from discussing it at the AGM...as though it doesn't matter to the shareholders or to Amarin.
QUOTE..."R. Preston Mason, MBA, PhD, is on the faculty of the Department of Medicine, Division of Cardiology, at the Harvard Medical School-affiliated Brigham and Women's Hospital in Boston, Massachusetts."
If Dr. Mason's studies demonstrate that generic "fake Vascepa" capsules have less EPA than branded Vascepa capsules, it becomes incumbent on the generic companies to undertake studies of their own to prove that Dr. Mason's studies were flawed...Until the generic companies can prove that Dr. Mason's findings were incorrect...the FDA should halt the sale of gV.
In the meantime the generics have NO studies to show that their inferior capsulation of EPA does not matter in the effectiveness in reducing CVD
GENERIC V IS NOT BIOSIMILAR TO VASCEPA!!
Chas....Your note on Vascepa is amazingly well reasoned and constructed The details are convincing to anyone with an open mind...I hope Amarin management and Denner are given your convincing thesis to digest....also, EU agencies responsible for reimbursing patients for Vascepa should read this.
JT did an excellent job of shepherding Vascepa through the R-IT trial...working through financial pitfalls ...and achieving an unexpected and important scientific success...only to be blind sided, along with KENNEDY, as well as with outside council, by the fraud occurring in the ninth circuit Marine patent trial.
long ago, I owned a couple of race horses...I knew that when I entered a horse in a race with 12 horses, the numbers were against victory for my horse...but if I had faith in the quality of my horse, the odds were improved.
In requesting CERT. at the S.C., the numbers are against us...but due to the quality of the EPADI brief written by our lawyer the odds for CERT. and a victorious finish are improved.
M... the only way to validate that would be with a CVOT trial"
The efficacy of Vascepa correlates with the quantity of pure unoxidized EPA in the Vascepa patented gelatin capsule...
Because the EPA in the inferior capsule of gV is being oxidized over time...and is less in amount, when used by the patient, than is the EPA in the oxidation-resistant capsule of Vascepa, then the patient is not getting what he is paying for...and his health may be suffering as a result.
gV has been approved by the FDA as a 'biosimilar" to Vascepa but has never been submitted a CVOT trial...and gV may not be truly biosimilar to Vascepa because gVs are employing a less protective and effective capsule for their EPA.
The patented gelatin capsule makes a difference...The billion dollar questions is.... how much of a difference?...It is incumbent upon Amarin to answer this important question ASAP.....and to publish the results for all to see...including the FDA.
If what I suspect is correct, gV may be dealt a mortal blow.
Right now it seems to be a two against one stand off...i..e. PWO and Ekman against Denner...I'm not sure how this impasse can be resolved in the short time left before the ASM....Perhaps Enright and Zulueta could pitch in to assist in negotiating a compromise.
Also, a delay in the date for the ASM might be a helpful step towards reaching a resolution.
It seems as though the present BOD will be inevitably be re-elected at the annual meeting, as is almost always the case...However those, who are now voting to abstain, are really casting a vote for change.
It would be advantageous for a new meeting to be called by Denner ASAP after the ASM and for a new roster for the BOD be presented to the long suffering shareholders for a vote.
If the dilemma surrounding Vascepa patent infringement by generic Vascepa could be successfully put to rest, I believe that a larger study than the small Brave study would be promptly initiated by either Amarin or by a BP to test Vascepa's efficacy in ameliorating the AD problem, which is crippling millions of Americans' lives and those of their families.
KM has expertise in EU marketing and regulatory affairs...If Amarin is to remain as an independent company, it would be optimal to have someone with expertise in marketing, regulatory affairs, and legal issues, as they pertain to the U.S., share the helm with KM.
PWO was hand picked by his friend, Ekman, the former COB, to replace him as COB...However,Ekman remains as a member of the BOD after resigning as COB....PWO has been with Amarin for less than two quarters.
That should give us a hint as to who the prime decision maker/s are at Amarin at this time....and IMHO they are not KM.
I can not envision a company more in need of a different management structure, which I hope Denner can provide.
It would be optimal if PWO, Ekman, and KM could see this and clear the way for Denner to right the ship.
KM entered a dire situation a year ago and has performed well...
1. He introduced Vaskepa to the German market.
2. He arranged for government payments for Vaskepa in Sweden at a fair price...and got approval in the U.K.
3. He has made good progress on approval in France and other EU nations.
4. He has taken necessary steps to cut overhead.
5. He has also taken necessary steps to stem the tide of generic infringement by offering rebates to insurance companies in the U.S.
Having recently assumed the job of CEO, he was no position to correct the errors of commission and omission that the entrenched BOD had made over a period of years.
He could be faulted for continuing the GIA policy, but it was in force when he was appointed as CEO...and he had little authority to turn it around in the less than a year that he was on the job.
QUOTE..."LARS EKMAN - BOD COB SELLS ALL OF HIS STOCK IN THE $3s (1,070,000 SHARES) BEFORE Q1 22 EARNINGS ARE ANNOUNCED".....
Two doctors, who have shown zero interest in the products and goals of Amarin are...Steve Nissen and Lars Ekman...IMO neither of them should be nominated for, nor elected to, a position on the BOD of Amarin.