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When KM resigned as CEO of Amarin on March 31, he surprisingly did not give the customary month or two for the BOD to select a new CEO...and then he demanded separation pay....Such "in your face' behavior was not productive and was not welcome to the new BOD...and IMO did not reflect well on him either....even though I understand his frustration at being on the wrong side of the proxy fight, in which he chose to align himself with PWO, who was ineffective and uncaring about Amarin...rather than with the shareholders.
Nevertheless, I wish him well in his new pursuits.
IMO Vascepa needs to be tested for reduction of CVD on adults with NORMAL triglycerides and NO other risk factors...Only then will Vascepa be accepted universally as a med for ALL adults with or without previous CVD...At present, patients, who have already suffered a CVD should all be treated with a statin plus Vascepa or a statin-EPA combo drug.(except those intolerant to a statin)
KM's interest was in continuing as CEO of Amarin...This led him to side with PWO in the recent proxy fight...after Denner won the proxy fight, KM's ego was too fragile for him to now switch his allegiance to Denner, who was obviously going to put Amarin up for sale... and thus eventually end his goal of remaining CEO...This is why, IMO, he decided to quit as CEO.
Rose...QUOTE...The board looks forward to working together with Aaron quickly to further optimize operations and capital allocation for the Company.”
- 'OPTIMIZE OPERATIONS'...i.e...increase volumes of sales by whatever strategies it takes(potentially including lowering prices in China and an AG in the U.S.)
- 'OPTIMIZE CAPITAL ALLOCATION'...i.e...don't throw away cash, as the company did in Germany by hiring and then having to fire reps.
As J.T. was wont to say..."Vascepa is a volume play...not a price play"as e.g. PCSK9 drugs are).
Berg has had previous experience in a company, which was sold to a BP...
QUOTE..."Mr. Berg served as Vice President of Marketing and Sales at Kos Pharmaceuticals (Kos), where he was instrumental in driving annual revenues approaching $1 billion. Mr. Berg worked at Kos until it was acquired by Abbott Laboratories in December 2006 for $3.7 billion."
Amarin strategy has changed from GIA in Europe.
Amarin has gone from a Europe-centric CEO to an U.S.-centric CEO...
QUOTE..."Amarin Corporation plc (NASDAQ:AMRN) today announced that the Company’s Board of Directors has appointed Aaron Berg, currently Amarin’s Executive Vice President and President of the U.S. Business, as INTERIM President and Chief Executive Officer (CEO). In addition, the board has appointed Oliver O’Connor as a new independent Director of the company. Both appointments are effective immediately."
Berg was probably more on board with a sale of Amarin than was KM....The plane is taxiing down the runway and being made ready for a take off to a new destination.
...JR...No matter even if the results of Mitigate are excellent when they are released, the doubters will always continue to be doubters...In the minds of many patients as well as of Docs, Vascepa will suffer from the perception that it is "just a fish oil"...If Vascepa were to be marketed as EpaCVD or if a combo drug were to be marketed as 'StatinEpa CVD' that might help change perceptions somewhat.
Lovaza LOWERS triglycerides but RAISES LDL...This explains why Lovaza is ineffective (or even harmful) in reducing CVD....and this may apply to OTC fish oils as well
From a study on the effects of Lovaza...
"Total cholesterol down 9.7%
Triglycerides down 44.9%
LDL-C UP 44.5%
THROW OUT FISH OIL-GET VASCEPA INSTEAD!
Rose...Vascepa is proven to reduce CVD...while the effect of lovaza on CVD is unknown...
Quote..."Lovaza contains omega-3-acid ethyl esters, mostly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Lovaza lowers triglycerides but may increase LDL cholesterol. Therefore, its effect on cardiovascular disease is UNKNOWN."
Amarin has thus far failed to inform the public about the differences between Vascepa, which has been PROVEN to reduce CVD and Lovaza, which has not...and even without any known effect on CVD , Lovaza still has more prescriptions being written for it than for Vascepa!
Amarin and Moshida agreed to "collaborate" on new products in 2020...including Amarin's marketing Mochida products in the U.S. and elsewhere...but not in Japan.
Quote from Amarin at he time...'We exercised certain rights under the agreement, resulting in payments of $1.0 million in each of January 2020 and December 2020, respectively, to Mochida.
We have never been informed about what royalties, if any, are to be paid by Amarin to Mochida for new products as a part of this agreement.
The new version of EPA by Mochida, which can deliver EPA, which is better absorbed in the bloodstream of patients and can thus be delivered in smaller doses and less frequently than Vascepa while having the same anti-inflammatory effects and reduction of CVD...puts the question of the economic feasibility for Amarin marketing this new product in the U.S. into focus.
Amarin has never capitalized on this agreement with Mochida...The time may have come.
Thus far, Amarin shareholders have been kept in the dark about many things relative to Mochida...
-what are the royalty arrangements(if any) to be paid by Amarin to Mochida for Mochida products?
-what is the potential of the new Mochida EPA product, especially as it pertains to the US?...especially in FDC with a statin?
- does Amarin have any plans to seek approval for the new Mochida EPA product...either alone or in a FDC in the US or in Europe?
Year 2022 was thought to be the year, in which China might initiate sales of Vascepa on the mainland...That didn't happen...The science supporting Vascepa continues to be solid, but price may be a deterrent...it is time for Eddingpharm to approach the Chinese national Health agency with a plan for a low price for Vascepa in return for a high volume of sales.
This could be followed up with a similar plan for European and ROW countries and an authorized generic for the U.S.
The original deal between Amarin and Eddingpharm for cash payment on approval of Vascepa by China and royalties can be renegotiated to be advantageous for both parties and for Chinese patients.
Amarin has partnered with Eddingpharm since 2015 with no China approval of Vascepa as yet for the mainland....Perhaps its time for Amarin to look elsewhere....
PFE: Pfizer collaborates with Sinopharm to expand in China
From: SA Breaking News @seekingalpha.com>
Date: Thu, Apr 13, 2023 at 11:18?AM
"Pfizer collaborates with Sinopharm to expand in China
Pfizer (NYSE:PFE) announced Thursday a strategic corporation agreement with Shanghai-based Sinopharm Group (OTCPK:SHTDF) (OTCPK:SHTDY) to expand its market presence in China.
Per the terms, the two companies will join hands to seek approval to market as many as 12 innovative drugs in China through 2025, Reuters reported citing a statement from New York-based Pfizer (PFE).
At the launch of the partnership in Shanghai, Sinopharm (OTCPK:SHTDF) president Liu Yong said that the collaboration aims to speed up the deployment of Pfizer’s (PFE) new treatments to patients.
Rival Merck (MRK) has a partnership with Sinopharm (OTCPK:SHTDF) to commercialize the oral COVID pill, molnupiravir, in China, while Pfizer (PFE) has joined hands with local drug maker Zhejiang Huahai to manufacture its oral therapy Paxlovid in the country."
Capt....This is very good news...I bet that a statin plus Vascepa would reduce CVD in HIV patients even further.
Nsleven...QUOTE..."the 2007(teva) release included Coreg®’s total revenue, demonstrating Teva still intended to capture the entire heart failure market. In fact, Teva included heart failure revenue despite personnel explicitly questioning whether it was right to do so."
This paragraph is reminiscent of the Hikma strategy after the invalidation of the high triglyceride patent but with the Reduce-It patent still in tact...As I recall, Hickma predicted at a medical meeting that that they expected prospects for marketing gV would be a million prescriptions a year....an outcome which could only be achieved if Hickma added the 7% of the gV Rx's, which were prescribed for the high trig indication to the 93% gV Rx's, which were prescribed for the CVD indication.
Sleven..IMO legislators may be not stepping in to correct the inequities brought about by skinny labels...because the they incorrectly may feel that the patients are benefited by skinny labels...Legislators may think they can more easily get re-elected and even judges may think they can more easily be promoted if they come down in favor of skinny labels...even when these labels unfairly flout patent laws.
I hope the S.C. accepts the Glaxo- Teva case and deals with the illegitimacy of skinny labels, guided by what is actually legal...rather than the "I didn't know I was infringing" farce by generic companies and insurance companies that currently rule the law relative to skinny labels.
From SA :QUOTE..."The deal(in which Pfizer bought Seagen for $43 billion) will hurt near term earnings; in fact, a neutral impact to adjusted earnings per share is only seen three or four years post closing, and that is after the anticipation of a billion in costs synergies at such a point in time!"
A $4 billion investment in Amarin by Pfizer would have a POSITIVE impact to earnings in LESS than 3 or 4 years....especially with a statin-EPA combo in Europe...and possibly one in the U.S.
john...A buy back at this point does NOT seem to me to be a crazy idea...a $60 million investment by Amarin in their stock would result in a buy back of about 30 to 45 million shares at current low prices, while elevating the Amarin sp...and still not breaking the bank.... It would discourage the shorts and start the process of making Amarin more acceptable for a BP buy out.
Its a lot less risky use of cash than KM's strategy when he hired a sales force of reps in Germany before receiving agreement from the government on price...and PWO 's strategy when he opted to embark on an expensive proxy fight.
PFE recently bought Seagen for $43 billion when they could have bought Amarin for about one tenth of that price..It would have fit in well with their other CVD meds...and Vascepa is patent protected in Europe for at least 10 years
Vascepa has a smaller cost to the public than Seagen's cancer drugs, but, with PFE promotion, Vascepa could still have made an important contribution to PFE revenues and earnings at a very reasonable cost to them...during the next few years, as several of their present meds are scheduled to lose their patent protection.
After the proxy fight ,in which K.M. supported PWO, K.M. had a choice...
He could either work for the best interests of the shareholders...or he could be ruled by his frustration at not winning...and he could resign....K.M. chose to resign...and now is small-mindedly attempting to further punish the shareholders...I thought better of him.
Amarin may be going through a change of direction(mercifully)...but NOT had a change of control...
Control remains, as it always has been, in the hands of the Amarin BOD.)
The BOD will soon vote on the new CEO...and at Amarin's annual meeting, the shareholders, will vote on the BOD, as is the customary practice.
This is a frivolous suit IMO and K.M. should pay the legal expenses incurred by Amarin in defending it.
Sleve...Thanks for the link...definition of a "change of control as defined in the link...QUOTE...
"a change in the ownership or effective control” of the Company or a “change in the ownership of a substantial portion of the Company’s assets"
Sarrissa owns only 6 % of Amarin....This in no way represents a 'change in ownership of a substantial portion of the company's assets '...The effective control of the company is still fully in the hands of the COB and the BOD of Amarin and they will vote on the hiring of the new CEO to succeed K.M. after his resignation.
IMO, Unless "change of control" was a phrase, which appeared in KM's employment contract, KM's claim is without merit.
It was made clear in the proxy fight that was supported by KM...the COB would be replaced, but there never any mention that KM would be replaced...the only other mention was of the new board members, who remained free to vote on strategies as they thought best(as were the old board remaining board members).... KM feared the BOD would have strategies would differ from KM's strategy(but this was not guaranteed by anyone)...KM disagreed with a change in strategy and decided to resign before the BOD ever voted.
A win by KM would mean that anytime there is a board change the CEO could resign and claim severance pay.
As a non-lawyer, the first thing that comes to my mind is...Did KM quit or was he fired?...If he quit by himself, I don't see how he has a case.
KM's longevity was only 18 months and...either because of, or in spite of his leadership, a new board became necessary after an expensive proxy fight supported by him.
A super majority of the shareholders voted in a new board...This situation does not reflect well on KMs leadership....I am surprised that KM chooses to call attention to this.
In the past, my interpretation of a medial embargo means that the results will be released at a conference...and must not be released before the conference.
This means that the results will interesting to the attendees at the conference and usually means that the results are at least somewhat positive.
If that were not he case, Kaiser would have already stopped prescribing Vascepa for their patients.
duke... QUOTE... "I argue that the only meds that should require a PA is skinny label medications to keep them in their lane of use."...I agree with this concept.
When a product has a valid patented indication plus another non patented indication(i.e. a 'skinny label"), it should have, after the name of the med in the insurance company formulary, the initials O.C.(for other condition) so the insurance companies could recognize it as a "skinny label" and ask for a Prior Approval from the Doc(to make sure that it it is not being used in a manner,which infringes on the patented indication.
An example would be an insurance company formulary listing of BOTH Vascepa plus Icosapentethyl O.C...with the latter unpatented med needing a prior authorization for the prescription to be covered....Otherwise, the current situation of insurance companies' constantly violating patent laws, and claiming ignorance, will continue.
It has been 8 years since Eddingpharm took on the job of getting approval for Vascepa in mainland China...When can Amarin expect this to happen?...The new Amarin CEO will be anxious to look into this...It possibly can happen this year.
CVD is a problem in China, but Amarin will have to lower its price for Vascepa in return for the expected huge volume of patients, who will be helped to reduce their heart attacks and strokes....
Vascepa can not only be effective in reducing patient's health problems in China, but can also be effective in reducing hospital costs in China.
Amarin needs a V.P. for China.
In addition to the DNA contained in the French drug, having been been proven through studies to be a negative factor the prevention of CVD, their gelatin capsule is probably less effective than Vaskepa's capsule in preventing oxidization of the all important EPA ...and thus it is probably less effective than Vascepa in reducing CVD.
JR...I agree...Kaiser will need to be out in force to defend Mitigate against the naysayers, who will surely come on to the scene again, including the Lovaza and Omega 3 fans....It is not the inferior generics, who are Vascepa's largest competitors...It's these other useless drugs, whose main reason for support by patients and Docs is that they are more cheap.(even if ineffective)
if the Mitigate trial were extended or stopped for futility, we would have heard about it by now...IMO the trial has had some success and the results are now being complied and readied for presentation at a conference...The fact that KIWI is still being prescribed Vascepa by Kaiser is a plus...since Kaiser is not known for wasting money.
In experiments by Pfizer,using their vaccine for Covid...on experimental animals, which they subjected to Covid viruses, Pfizer found that inflammation of the heart and lungs in the animals was NOT improved in the animals with Covid,which had been previously subjected to immunization with Pfizer vaccine(and still got Covid)...as apposed to the inflammation in the group of animals, which had been subjected to having Covid infections and had not not been previously immunized by Pfizer vaccine
"Almost similar microscopic lung inflammation was observed in both challenged control and immunized animals after the peak of infection (Days 7/8)."
i.e. In the animals which got Covid after immunization...those inflammatory effects from the Covid infections might have been reduced by administering Vascepa to the infected animals, either before inducing them to have the Covid infections, or after the infections took hold)... i.e. Vascepa might have lessened the inflammation induced by the Covid infections with previous immunization or without it.
The S.C. justices are aware that 'skinny labels" award the generics with an opportunity to reap profits by skirting patent law...and they weaken innovation, as even the solicitor general must be aware...I would not be surprised if the S.C. refuses to take this new suit...A reversal would not be good for the public's interest in the short term by making branded drugs more expensive...and, in the long term, by making new innovative branded drugs less available.
I think most of us understand that the "skinny label" is really a loophole in the HW law, being taken advantage of by generic companies.
I think you have hit the nub of the problem....Vascepa is purifed EPA...NOT a fish oil...When Vascepa is connected to a statin, it can seriously reduce the incidence of CVD...and OTHER DISEASES with an inflammatory element...This connection should be emphasized in PR's, in literature and in adds.
STATIN, ALONE WILL NOT DO THE JOB THAT STATIN PLUS VASCEPA WILL DO!!!
Thus far, Amatin has failed to make this connection in the minds of Docs or of patients.
A one product biotech can be sold on a concept only...It can be sold on a successful phase one study...It can be sold on a phase two...or phase three study...it can be sold with a product already being successfully marketed...It SHOULD be sold...and SHOULD NOT GIA IMO with a product now being challenged by generics in the U.S.
.
The continuing policy of former Amarin management to GIA seemed, at least to me, to have been a misguided policy... and a change in management seemed in order.
My hope is that Denner will work to get share price up, followed by a sale of he company.
Capt....Quote from articled you linked your post 406444 "Inflammation and hyperlipidaemia jointly contribute to atherothrombotic disease. However, when people are treated with intensive statin therapy, the relative contributions of inflammation and hyperlipidaemia to the risk of future cardiovascular events might change, which has implications for the choice of adjunctive cardiovascular risk"
The linked article goes on to illustrate that hsCRP is reduced by 40% using Vascepa vs. placebo!
It's the lipid lowering effect of statin TOGETHER with the anti-inflammatory effect of Vascepa that are responsible for the remarkable reduction of CVD.
Sarissa needs to make this fact known...Right now, patients and Docs think the statin does the whole job.
A FDC might help illustrate the necessity of adding Vascepa to a statin to achieve the desired results.
My mistake...KM's salary was about $6 million in total...I'm sure that would have been less under Sarissa.
KM was earning base salary of about $6 million/ year plus options and he didn't think he deserved a pay cut...Denner didn't agree...so KM submitted his resignation.
As for KM working with PWO, he had no choice.
KM became CEO in August of 2021, barely a year a half after Amarin lost the Judge Du case...He did his best in a bad situation...He was focused on Europe and, with the exception of his failure in Germany(which has a reputation of being a tough nut to crack) he did a good job...Ekman and PWO are the ones who I have gripes with.
Apparently the EMA is more concerned with bioequivilance than the U.S. FDA
"• A panel of the European Medicines Agency (EMA) said that Viatris (NASDAQ:VTRS) withdrew an application for a generic HIV therapy Raltegravir Viatris on Feb. 22.
• The EMA's Committee for Medicinal Products for Human Use (CHMP) said that based on review of data and the company's response to the agency's questions, at the time of the withdrawal, the regulator had some concerns.
• The EMA considered that BIOEQUIVILANCE with the reference drug was not shown as the study results showed differences in the absorption rate."
The FDA seems to have zero interest in the fact that the capsule of gV is less resistant to oxidation of the vital EPA than the Vascepa capsule...all of which makes gV less effective than Vascepa.
Its time for a new CEO to adopt consider some new strategies...
-lower prices for higher volumes in Europe and ROW
-an authorized generic for U.S.
- a FDC for the U.S.
- a FDC for Europe