Dolsten,at age 66 ,with estimated net worth at over $50 million, is unlikely to be looking for challenging new employment..

"https://seekingalpha.com/news/4123562-pfizer-advances-development-of-once-daily-weight-loss-pill"

Pfizer's ORAL weight loss med IMO, would take significant market share away from the products, which are now on the market...since the competing meds need be taken by weekly INJECTIONS (even if the Pfizer med proves to be slightly less effective)...This would be especially true for patients, who disdain the nuisance and discomfort of injecting themselves on a weekly basis.

'OUSTING' is probably the wrong word...Dolsten is 66 years old...and he probably thought it was time to retire and enjoy his fortune, achieved through being awarded millions of Pfizer shares over his 15 years with the company.

HW is a flawed law, which often entices generic companies to attack pharmas, which have created profitable innovative meds, by infringing on these meds through the use of 'skinny labels'.

NS...I agree!...Good analysis

JR...The case of Amarin vs. Hikma is intended to discourage on going skinny label infringement by generics(often aided by state laws), by pharmacy benefit plans and by insurance companies...If this goal is achieved, the cash awards from this case can wait to be reaped by the BP, which acquires Amarin.

There is some confusion as to what the rights Amarin and Mochida each have to market the products of their collaboration agreement of 2018.


QUOTE..."Among other terms in the agreement, Amarin obtained an EXCLUSIVE license to certain Mochida intellectual property to advance Amarin’s interests in
the United States and certain OTHER territories and the parties will collaborate to research and develop new products and indications based on EPA for
Amarin’s commercialization in the United States and certain OTHER territories."

KIWI... Denner's goal is to sell Amarin to a BP...Catalysts like China NMPA approval of Vascepa for the CVD indication will definitely help towards that goal.

KIWI...Mochida has not, as yet, applied to the China NMPA for approval of Epadel for the CVD indication...Mochida would have to start the process from scratch.

Rose..You are correct...I was conservatively focusing on the Chinese CVD patients, who are prime candidates for Vaskepa..not the entire population of China.

"It is estimated that approximately 330 million individuals in China are affected by CVD, including 13 million strokes, 11.39 million coronary heart disease, 8.9 million heart failure, 5 million pulmonary heart disease, 4.87 million atrial fibrillation, 2.5 million rheumatic heart disease, 2 million congenital heart disease"...actually, many more than 5 million patients in China could benefit from Vaskepa.

There are also over 300 million smokers in China and smoking is a major cause of cardiovascular disease (CVD) and is responsible for one in every four deaths from CVD. These smokers could be protected against CVD by taking Vaskepa.

JR...I figured an off the cuff calculation of Amarin potential earnings on China...

At a price of about $90 per one month supply of Vaskepa(i.e. 60%off of the approx. $180/month that Amarin is now charging in the U.S. and in Europe),
Amarin would charge Epping about $40 for a one month supply per patient... and earn royalties from Epping of about 15% of a $90 per month price tag per patient (or $14)...For one year, it would come to about $170 that Amarin would be earning from Vascepa.

if Amarin could sell to 3 million patients out of China's 380 million population, Amarin could earn approx 500 million per year... in addition to earnings in ROW...

Many nations would more interested in Vascepa at a lower price than at present...National health services would benefit...insurance companies would benefit...and ,most of all, patients would benefit.

Please feel free to criticize and correct.

"According to a recent report on cardiovascular health and disease in China, cardiovascular disease (CVD) accounted for 44-47% of all death in urban and rural areas in China, meaning two out of every five deaths were due to CVD. It is estimated that 330 million patients suffer from CVD in China, and that China has one of the highest CVD death rates in the world.ii According to the World Heart Federation, cardiovascular events, such as ischemic heart disease and stroke, are projected to increase by 50 percent among the population in China between 2010 and 2030 (based on population aging and growth alone)."

The main issues, which remain to be dealt with by Amarin...
1. Will China rely on Vaskepa  fom Edding (via Amarin) to treat CVD....OR switch to a home grown EPA knock off to keep their costs down?
2. Will China insist on prices too low for Amarin's Vaskepa to maintain profitability?
3. How much lower will Amarin need to adjust worldwide prices for Vascepa...after agreeing to lower prices in China?

China approval of Vascepa for CVD patients presents an impressive worldwide sales volume opportunity for Vascepa...but it also carries with it the aforementioned risks...
in addition, it introduces the probablity of an AG for the U.S.

Chromosome..."Terms of the agreement( i.e. in 2015) include up-front and milestone payments to Amarin of up to $169.0 million, including a non-refundable $15.0 million up-front payment and development, regulatory and sales-based milestone payments of up to an additional $154.0 million. Eddingpharm will also pay Amarin tiered double-digit percentage royalties on net sales of Vascepa in the territory escalating to the high teens."

With the anticipated large volume of Vaskapa sales in China, the sales base volume should reach $150 million briskly.

As J.T. said..."Vascepa is a volume play...not a price play."

Triple...Great good news...Now we await important forthcoming announcements from Edding about reimbursements for Vascepa...as they talk with the NMPA (Chinese National Products Administration)....These developments could influence Vascepa prices worldwide and lead to an explosive growth in sales volumes.

It could result in a lower number of shares in the $50 million buy back by Amarin being acquired...but that would be a small price to pay in view of the anticipated increased volume of sales of Vascepa worldwide.

North...I did see the article on taking Semaglutudes being associated with NAION...


"The precise pathogenesis of NAION remains unclear, but it has been hypoth­esized that transient HYPOPERFUSION of the short posterior ciliary arteries causes acute ischemia to the optic nerve head (ONH), resulting in axonal swelling. This swelling compromises the axoplas­mic flow, which subsequently increases the axonal swelling, contributing to the compression of ONH microcirculation, exacerbating the ischemia. This vicious cycle creates a compartment syndrome, eventually leading to infarction and apoptosis of the retinal ganglion cells "

I believe that studies that will now need be done by Sematutide companies to show whether there is any lessening in the risk of developing NAION...

1. for diabetic patients, who are NOT taking Samaglutide meds as opposed to those, who are.
2. for diabetic patients, who taking Semaglutide meds, but also taking Vascepa
3. for diabetic patients , who are taking NEITHER Semaglutides nor Vascepa.

DMC...Thank you for posting this interesting article...For those us, who are less familiar with the scientific terminology in the article, I took away the following message...

1. Loss of endothelial function is associated with inflammation which, in turn, is associated with a DECREASE in the availability of nitrous oxide
2. EPA INCREASES the availablity of nitrous oxide...and is the mechanism, whereby systemic inflammation is DECREASED...along with endothelial function being INCREASED....This factor consequently results in healthier arteries throughout the body..(including the mechanism, which explains the reduction in CVD for patients using EPA.
.

Rose, Vascepa is approved for sales in China for the HTG indication but not yet accompanied by any current reimbursement by the Chinese national health service.

The present prices for Vascepa are far too high for many Chinese patients to afford...The prices in China will have to be lowered when the Chinese national health service approves reimbursement for Vascepa...If approved for the CVD indication, as it is in the U.S., the volume of sales would be large enough to make the lowered prices worthwhile for Amarin and worthwhile for China to save the large amounts of cash that they currently spend on patients with CVD.

KIWI...individual Kaiser Docs may not be aware that they are infringing on Amarin's CVD patent...by prescribing gV for patients for the CVD indication....but Kaiser management is certainly aware of these infringing Rx's...and, thus far, they don't have any qualms about it.

It seems to me that a conspiracy to infringe on Amarin's CVD patent exists among...generic manufacturers... pharmacy benefit plans, pharmacy chains... and insurance companies, which all seem to be working together to undermine the HW law in order to reap their mutual profits.

The reason for the existence of patents is to encourage innovators to develop better meds for patients...The reason for the existence of generics is to encourage cheaper prices of meds for patients...there is a place for both...but skinny label infringements by generic companies have skewed the compromise in favor of the generics.

We need BOTH innovation of newer and better meds...PLUS lower prices for patients.

The recent decision of the appeals court is intended to restore some balance for both sides.

Rose...Most patients have a good idea of why they are taking a medication...When the label specifies a different condition, the patient will ask the pharmacist or the Doc...IS THIS MEDICATION RIGHT FOR ME?

Not being a lawyer, I need to go on my common sense...My common sense tells me that...a skinny label medication should include, on the label, the indication, for which the medication is legally approved.

Simple label changes could avoid law suits over skinny labels.

Most reverse splits are in companies on the verge of bankruptcy...Amarin is NOT on the verge of bankruptcy...In the absence of solid good news to propel the stock to over one dollar/share, I expect a reverse split to accomplish that goal.

Section 8 of the Hatch Waxman act has resulted in many infringements by generic cos. with consequent lawsuits

"Section viii of the Hatch-Waxman Act permits an Abbreviated New Drug Application (ANDA) applicant to obtain FDA approval to market a generic version of a drug for a non-patented use where the reference listed drug (RLD) has multiple indications, not all of which are covered by a method-of-use patent."

The obvious simple solution to this plethora of lawsuits is...for congress to amend the HW law so that...
medical insurance companies would be required to...
1.make lists of medicines with multiple indications in their formularies...declaring that they will provide coverage ONLY for the approved indications
2. require that prescriptions for medicines must always specify a particular indication in order to have insurance coverage for that patient prescription

Governments and medical insurance companies should approve of this amendment to HW...since it would reduce their costs while enabling patients to get the medicine they need for the correct indication.

As well as strengthening patent law..and reducing patent lawsuits

NS....Amarin is a competitor of generic Vascepa companies...If Amarin would just leave the U.S. market to them, they would have 100% OF THE icosapentethyl sales in the U.S....rather than just the 50% that they now have...through their infringement on Amarin's CVD patent.

Anything the generic companies can do to hurt Amarin, helps themselves....They would like it if they could induce Amarin to just retreat to the EU and leave the U.S. market to them entirely...Even if/when the generic Cos. lose their Sherman act lawsuits, they can still damage tiny Amarin by having them deplete their cash by instigating meritless law suits against Amarin.

NS...Hikma, Teva, Dr. Reddy, and Apotex (manufacturers of generic Vascepa), are involved in an illegal conspiracy to cripple Amarin and thereby protect their aim to continue infringing on Amarin's CVD patent, though which they have stolen millions of dollars in revenue, which rightfully belong to Amarin.

The purpose of a counter-suite by a defendant can be to induce the settlement of a suit initiated by a plaintiff.

However, in the case of Amarin's "monopolizing " the market through large orders of EPA from suppliers, those orders were clearly made by Amarin in anticipation of larger markets...before the infringement of Amarin's CVD patents by Hikma and other generic companies, made possible by the Du decision.

Capt...Vascepa is like a firecracker with a slow fuse... The fuse has been lit and it is smoldering...making its way towards the moment when it explodes.

Dar53...Amarin is a company, which depends on a volume of sales from its ONE product...Generics are companies, which depend on volumes of sales from their MANY products...When generic companies assess their balance sheets, they tolerate a small volume and a small margin from any ONE of their MANY products.

Generic companies then insure their profits by NOT advertising and NOT innovating(while they don't hesitate to cheat on patented products).

Some politicians(and some judges) think generic companies are a force for good...but are they really?

DMC....QUOTE..."In this prospective, multicenter, randomized, open-label, blinded end-point study, patients with stable coronary artery disease and a low EPA/AA ratio (<0.4) were randomized to EPA (1800 of icosapent ethyl administered daily)"

This study demonstrates that the dosage of EPA is important...In the RI study, the daily dosage of EPA was over twice as much as in this study....i.e. 4000 mgms. of EPA daily in R.I. as compared with 1800 in this study.

This is further evidence that OTC omega 3 products, containing lesser amounts of EPA than Vascepa(together with unhelpful DNA) are not as effective as pure Vascepa.

Capt...."Reasons for the seemingly peculiar effects of EPA when administered alone are unclear, but appear NOT directly related to the decrease of triglyceride levels"

The FDA indications for Vascepa, as promulgated in the Adcom of 2019, included patients, who have triglycerides of "equal to, or over 150 mgms./dcl."

Amarin should (in view of this new information having been just released)...return to the FDA and ask for a new Adcom for the purpose of approving Vascepa for patients, who do NOT have have triglycerides above150 mgms./dcl, but who do have have cardiovascular risks such as previous heart attacks, diabetes, or hypertension ??

Generic companies are selling gV ostensibly on the basis of high triglycerides rather than on the basis of reduction of CVD...Now we know that high triglycerides are NOT the reason why Vascepa is so effective in reducing CVD...This could be a game changer for patients and for Vascepa.

IMO the G-BA focus on Vaskepa is primarily interested in the price more than in the science...When an AG for Vaskepa comes to Germany... at lower prices than at present, the attitude of the G-BA will change and the German market will become open.

As the old saying goes...You can lose a little on every sale, but make it up on the volume.

djiks...National health systems depend on federal budgets, which, in turn, depend on tax collections...This introduces political considerations into the equation...which may, at times, override scientific medical considerations.

About an Amarin AG for Vascepa...Profitability could be achieved by...

-really high sales volumes of Vascepa sales by Amarin due to lower Vascepa prices and (Amarin) generic V prices in the U.S. and elsewhere...This would be made possible by...really low prices of API to Amarin from its suppliers...This would, in turn, be made possible by
-really increased EPA sales volumes in Europe, together with the ROW(which other generics could not match)

Its a challenge, but what other options are available to Amarin?

LOTS...From my point of view, these PBMs dropping Vascepa from their formulary, are just begging Amarin to sue them.

cloudera...I assume that Amarin might continue to market branded Vascepa while marketing the same product as a generic V....BUT marketing generic V with a different label from Vascepa, calling the generic V Icosapentethyl, but that is just an off the cuff guess.

The generic companies use an inferior capsule, which causes more oxidization of the EPA, but I'm not sure how Amarin would handle that issue.

Denisk...We have no information on the exact reasons or the exact terms of Holt's resignation, but it seems to have been on good terms.

an AG is an authorized generic

It is now my belief that we will see an announcement of an AG for Vascepa by the end of June...Holt had no experience in dealing with the U.S. FDA and with marketing in the U.S... and he graciously ceded the CEO position to Berg in this critical time for Amarin....Berg does have experience with the FDA and with marketing...The CEO job for Amarin has now switched from getting Vascepa approved in Europe...to getting Vascepa approved by the FDA in the U.S...and then to market an AG in the U.S....both formidable challenges.

It is a job that was more suited to Berg's skills and experience than to Holt's...Holt understood the situation and appropriately resigned.

Berg's long affiliation with Amarin as a marketer will be helpful in accomplishing Amarin's goals.

Vascepa has an exclusive for many years in Europe (where there is no gV)...Amarin can attain high volumes of Vascepa sales in U.S through lower prices with an AG.... combined with their sales in Europe, where there is no gV....thus Amarin can afford to lower their prices even further in the U.S. and around the world in order to enhance these volumes, thereby surpassing the volumes of gV in the U.S....These lower prices and enhanced volumes for Amarin will lead to lower costs to Amarin for their API...and can make the lower priced Vascepa profitable for Amarin, while making gV less profitable for gV companies, who will have to pay more for API their own gV product.

John Thero said years ago..."Vascepa is a volume play...not a price play." Now is the time to enact his idea.

We know Vascepa is the right product...Perhaps it is just the price, which is wrong!