MA5..."Fenofibrate is available in several formulations and is sold under several brand names, including: Tricor by AbbVie. Lipofen by Kowa Pharmaceuticals America Inc. Lofibra by Teva."...The FDA needs to replace these products with meds that are proven effective at reducing CVD.

Thank you for that most informative post.

I agree...judges, especially younger ones, like many human beings, have their eye on the next potential step in their careers...They don't want to make a misstep, that might mitigate against them in the future....This includes possible advancement to a higher position within the court or even to a higher court.

Even on the Supreme Court, it is not unheard of, to have a justice entertain still higher ambitions.

Tats Mochida agreed, in 2018, to COLLABORATE in the devlopment of new and better EPA meds

Amarin and Mochida Announce Collaboration on Future Development of EPA-based Drug Products and Indications...
June 12, 2018 05:00 ET | Source: Amarin Corporation plc

"BEDMINSTER, N.J. and DUBLIN, Ireland, June 12, 2018 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that it has entered into a multi-faceted collaboration with Mochida Pharmaceutical Co., Ltd., an integrated Japanese pharmaceutical company. The collaboration is focused on the development and commercialization of early-stage drug products and indications based on the omega-3 acid, EPA (eicosapentaenoic acid)."

Amarin paid Mochida $2 million,up front, upon completion of this COLLABORATION agreement....The time has come, after the passage of six long years since this agreement was signed...to have Amarin now begin work to bring to the market patented LrR-Et EPA, a med,even superior to their current Vascepa.

I would rather see Amarin spend $50 million on this project rather than on buying back Amarin stock.

DMC8...."In Hikma’s press release Hikma refered to multiple uses of generic Vascepa....Amarin's lawyer emphasized that physicians observed Hikma’s press release and saw that its drug was the generic equivalent of Amarin’s drug. This, the lawyer argued, creates a question for the jury of inducement of infringement."

Why would Hikma NOT disclose on their generic meds' label that "this med is ONLY to be used for treatment of patients with triglycerides of over 500 mgs/dcl"?...The obvious answer is that Hikma would NEVER do this because...if they informed patients and Docs of that uncomfortable but legal fact, they would then lose 97% of the generic EPA's market share for the U.S.,which they now pull in by infringing on Amarin's CVD patents and which 97% of market share should, by law, be going to Vascepa.

"Amarin has secured a worldwide patent priority claim to a LYMPH-RELEASING composition of eicosapentaenoic acid ethyl ester (LR-EtEPA) technology/invention and methods of using the same to increase EPA uptake in tissues to treat and/or prevent the onset of a number of diseases including:
- Cardiopulmonary, cardiovascular, and cerebrovascular diseases
- Pulmonary disease including sepsis, SIRS, and/or ARDS
- Neurological diseases
- Cancer...including cancers associated with the lymphatic system"(e.g. LYMPHOMAS)

I would hope that some mention of this product will be made by CEO Holt at the Amarin upcoming Q4 2023 results C.C. on 5/2/24

From SA article..."The actual launch of the product took place in Q4 2023. However, the issue of reimbursement of the drug by the government remains open and on this point, it is expected that the process will not be defined before the end of 2025."...

I disagree...The Chinese national health system has had Vascepa under study since before Q4 2023...Medical journals have been reporting on the superior efficacy and safety benefits of Vascepa...The data on Vascepa has been under review since Q4 2023 and probably even prior to that time...Recent articles have informed scientists and doctors the about the positive effects of Vascepa for patients...I would not be surprised to see a report of the approval of Vascepa for patients in mainland China released any time soon...followed by negotiations to be conducted by the Government health system and by Eddingpharm over reimbursements.

After being invested in Amarin for close to 15 years, my current conclusions are that...the main upside for Amarin now depends on catalysts such as...
-reimbursement for Vascepa in mainland China
-reimbursement for Vascepa in major European countries
-court decisions discouraging further infringement on Vascepa CVD patents by generics
-a patented new EPA product being introduced into U.S. market
-new evidence of effectiveness of Vascepa in other diseases in addition to CVD...such as in Alzheimers or cancers

Waiting for these catalysts to materialize, it would be well for Amarin to preserve its cash, in order to withstand any negative catalysts that might arise....and, if the opportunity arises, to spend the cash on something that might increase its revenues


for those reasons, I am not eager for Amarin to spend $50 million on the buy back of its stock.

One of the good things about Amarin's current situation is that it has plenty of cash and no debt.

Colchicine has many serious side effects and would be dangerous to pair with Vascepa for long term use.

Amarin to Report First Quarter 2024 Financial Results and Host Conference Call on May 1, 2024

DUBLIN, Ireland and BRIDGEWATER, N.J., April 15, 2024 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that it will host a conference call with Patrick Holt, President & CEO, and members of Amarin’s senior management team to discuss its first quarter 2024 results followed by Q&A on Wednesday, May 1st, 2024, at 8:00 a.m. ET.

The conference call with management will follow the release of the Company’s first quarter 2024 financial results in the pre-market hours.

To enhance engagement with the company’s shareholder base and facilitate connections with its investors, Amarin is partnering with Say Technologies to allow retail and institutional shareholders to submit and upvote questions, a selection of which will be answered by Amarin management during the earnings call.

Starting on April 15th at 8:00 am ET, all shareholders are encouraged to submit questions by visiting: https://app.saytechnologies.com/amarin-2024-q1. This Q&A platform will remain open until 48 hours prior to the start of the earnings call. Shareholders can email support@saytechnologies.com for any support inquiries.

Conference Call and Webcast Information:

Access to the live call:
Go to the investor relations section of the Company's website at?www.amarincorp.com
Dial in within the United States: 888-506-0062
International dial in: 973-528-0011
Access Code: 207947

Access to replay:
Dial in within the United States: 877-481-4010
International dial in: 919-882-2331
Access Code: 50260

A replay of the call will also be available through the Company's website shortly after the call

A problem for Vascepa is that , in the eyes of the public, it is just another healthy supplement, much like fish oil...Oncology drugs have massive price tickets and are still in demand because patients understand that they make the difference between life and death(or at least can extend life).

Amarin needs to make clear that Vascepa makes a difference between life and death, not just CVD.

Studies of Vascepa discuss reduction of CVD in patients, but they usually don't emphasize the difference that Vascepa can make in long term survival...By now, world figures on years of survival with Vascepa, as opposed to no Vascepa, must be available.

I personally believe that Vascepa has helped me to live to the advanced age that I have attained...I think about Vascepa in terms of my mortality instead of solely dwelling on my reduction of CVD rate.

HW was intended to allow prescriptions to be used,off label, for non patented indications...It was not intended to allow prescriptions to be used, off label, for patented indications...Generic companies have abused the law. The simple remedy for the abuse...is for labels on prescriptions to be clearly marked with the indications for the use of the RX...That will stop this abuse...That is not a negation of the section eight of the HW law.

BB...The combo pill fueled speculation as to whether a combo with Lipitor plus Vascepa would be available in a blister pack or in a single capsule form, containing both meds...were the future products for Amarin...The present speculations are about MND-2119 and LrEt-EPA, which Amarin has not discussed publicly...as to whether these new meds are owned exclusively by Amarin or jointly by both Amarin and Mochida...and as to whether studies have been or will be done by Amarin on these meds, before presentations to the FDA.

Advertising in the U.S. should only be resumed for the purpose of promoting a new patented product(even more effective than Vascepa)...such as LrEt-EPA or MND-2119...and could be initiated by either Amarin or by a BP acquirer.

Rose..."These studies( i.e. from the ACC.24) highlighting the wonders of V" were discussed with my wife...Her response was..."Does that mean the stock is going down again"?

Amarin Highlights Key Data Providing Mechanistic Insights into Eicosapentaenoic Acid (EPA) at ACC.24
Data Further Advance Understanding of VASCEPA®/VAZKEPA® Potential Mechanism of Action

DUBLIN, Ireland and BRIDGEWATER, N.J., April 08, 2024 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today highlighted three data presentations at ACC.24 showcasing the mechanistic activity of Eicosapentaenoic acid (EPA), including the potential effects of EPA on endothelial cell dysfunction and on oxidation of samples enriched with Lp(a).

”The data presented at ACC.24 provide new evidence surrounding the mechanism of action for VASCEPA/VAZKEPA, including the effect of the compound in combination with high-intensity statin on endothelial cell function during inflammation and the compound’s effect on Lp(a) levels,” said R. Preston Mason, Ph.D., Brigham and Women’s Hospital. “These learnings further advance understanding of how EPA and VASCEPA/VAZKEPA work to reduce cardiovascular events in at-risk patients.”

The studies and their key findings are outlined below:

Eicosapentaenoic acid (EPA) and a High Intensity Statin Enhanced Expression of Proteins for Detoxification of Reactive Oxygen Species during Angiotensin II Challenge in Endothelial Cells

This analysis measured the separate and combined effects of EPA and rosuvastatin on expression of proteins involved in detoxification in vascular endothelial cells under inflammatory conditions with angiotensin II (Ang II).

The combination of EPA and rosuvastatin favorably modulated the expression of proteins related to oxidative stress and detoxification under disease-like conditions. These findings indicate that the net benefits of a high intensity statin and EPA, compared to statin alone, on expression of detoxification proteins during inflammation may contribute to reduced atherothrombotic risk in outcome trials.

Eicosapentaenoic Acid (EPA) and Rosuvastatin Modulate Expression of Endothelial Proteins that Regulate Function and Platelet Activity during Angiotensin II Stimulation

In this analysis, investigators compared the separate and combined effects of EPA and rosuvastatin on expression of proteins that regulate platelet signaling and nitric oxide (NO) levels in human umbilical vein endothelial cells (HUVECs) subjected to angiotensin II (Ang II) stimulus.

The combination of EPA and rosuvastatin favorably modulated proteins involved in platelet degranulation and NO bioavailability in HUVECs under inflammatory conditions to a greater extent than their separate treatments. The beneficial effects of a high intensity statin and EPA on endothelial dysfunction may contribute to reduced atherothrombotic risk in outcome trials.

Eicosapentaenoic Acid (EPA) Inhibits Lipoprotein(a) [Lp(a)] Oxidation due to Scavenging Mechanisms In Vitro

Elevated Lp(a) levels are an independent and causal risk factor for cardiovascular (CV) disease with limited treatments available. Oxidized Lp(a) stimulates foam cell formation, endothelial dysfunction, and inflammation. ?

In this analysis, investigators tested EPA effects on oxidation of samples enriched with Lp(a) compared to the fully saturated eicosaenoic acid (EA; 20:0) and Trolox, a water-soluble analog of Vitamin E.

Investigators found that EPA inhibited oxidation of Lp(a) enriched plasma in a time-dependent fashion consistent with a free radical scavenging mechanism. The potent antioxidant actions of EPA may contribute to reduced CV events in REDUCE-IT, including among those subjects with elevated Lp(a).

This last post should have stated that EPA reduces CVD by limiting oxidization of Lpa

Capt....Thanks for the interesting links...I humbly offer a precis of 1054-07

-Lpa is a causal factor in producing CVD
-OXIDIZED Lpa is the culprit
-EPA reduces CVD by limiting oxidization of EPA

Nsleven...In 2018, Amarin and Mochida inked an agreement to"collaborate" on new EPA meds...

"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. The potential new product and indication opportunities contemplated under this agreement are in relatively EARLY stages of development."

This 2018 PR does not indicate..
-what the "new" products are?

It is of interest that Amarin chose to commit $100 Thousand to a Mochida study of MND-2119 that started on 2022 and is slated to end in Q4 2024.


It is interesting that Amarin committed $100
-is one of the "new" products RMND-2119?
-will royalties need to paid by Amarin to Mochida for commercialization of RMND-2199?
-Are there any royalty payments due to either party in connection with the med, LR-EtEPA...which Amarin recently patented?

Dar...I think you are correct" The following statement should be in a decision by the court...either by a judge or by a jury in the context of a trial...

"the simple step that all generic Vascepa companies should take to avoid infringing... is to simply indicate on their label that..."icosapentethyl is biosimilar to Vascepa, but only for use in very high triglycideremia"...That easy solution would solve Amarin's infringement dispute as to Vascepa.

Hikma might agree to this to avoid triple damages and other infringers might also agree, in order to avoid damages emanating from their own cases.

Dar..."IF the Generics (Hikma or others) were found to be guilty of infringement"...That is the whole point in favor of a of a settlement prior to trial"...i.e. the word "IF"

I wrote a post arguing against John Thero settling with Hikma prior to the judge Du trial, because I was so convinced that Amarin would win...I learned a bitter lesson from that trial.

Going to court is like walking a mountain in the dark...you feel pretty safe, but you never know whether you might unexpectedly take a fall and break something.(e.g....your neck)

Rose...Insurance companies could easily solve this problem by requiring prior authorization for prescriptions for Icosapentethyl....indicating that this Rx is for very high triglycerides.

Incidentally, insurance companies should be doing this, even at present.

The insurance companies should not be immune from infringement suites.

IMT...Amarin could forego the treble damages...in return for such a concession from the generic companies to cease their infringing on Vascepa.

Amarin does not seek to destroy the generic companies in the fashion that the generic companies seek to destroy Amarin.

What the appeals court indicated yesterday.... was that...the simple step that all generic Vascepa companies should take to avoid infringing... was to simply indicate on their label that..."icosapentethyl is biosimilar to Vascepa, but only for use in very high triglycideremia"...That easy solution would solve the infringement problem...Unfortunately, it would be a solution that infringing generic companies would be very hesitant to take, since it would severely impact their profits from Vascepa.

CBB..The news of Amarin's Vaskepa patent extension by the EU until 2039 should give the shorts, who have been active every day, something new to think about.

As the appeals court said...the wording on the generic label is very important...If a med is to be legally used for one indication and not legally used for another indication, the label must state so...e.g. "icosapentethyl is biosimilar to Vascepa but only for use in very high triglycideremia"

This will restore the illegal profits that the generics have been making through their infringing on a patented med...back to the inventor...in return for the inventor's expensive research.

Important Amarin news from the EU..."AMARIN(AMRN)- GOT DECISION TO GRANT FROM EUROPEAN PATENT OFFICE FOR NEW PATENT COVERING VAZKEPA,EXTENDING VAZKEPA EXCLUSIVITY 8 ADDITIONAL YEARS INTO 2039"

Rose...The business model of some generic companies is to seek out products, where there are potentially huge profits to be made....(e.g.... as in Vascepa)
-then the renegade company makes an attempt to invalidate one or more of the inventor's patents, which pertain to the product
-then, if possible, to sell the inventor's lucrative product, off label, legally
-however, if necessary, to infringe by selling the still patented product off label
-then to hire expensive lawyers to defend you...if necessary

I speak from experience because I was once urged to participate in just such a plot by a wealthy friend...and I refused the offer.

P.S....My friend, who has since passed away, became even more wealthy before he died.

Make no mistake...Triple damages would be very important to Amarin....as they might enable Amarin to restart advertisements for Vascepa again...but it would be MUCH MORE IMPORTANT for generics to cease their infringement on Amarin's CVD patent NOW!

Unfortunately neither a settlement with Hikma, nor even treble damages would solve the damage done to Vascepa and to Amarin....In the long run, after Amarin's CVD patent runs out, Vascepa might even prove to be more profitable for generics rather than the paltry sums they are now making from Vascepa.

This is not taking into account the damage that infringement is doing to the health of millions of patients, who have never been able to hear about Vascepa because the financial difficulties of Amarin which are directly due to the infringement policies of the generics.

Marjac...The past denial of your petition to the U.S. Supreme Court for a writ of certiorari, to appeal the decision of the ninth circuit, signified only that the Supreme Court had chosen not to accept the appeal due to lack of standing(by Amarin)... and did not express the Court's view of the merits of your(our) case....If so, is there a chance you that you would consider renewing this case, as a part of the legal team representing Amarin?

Hikma first issued a generic Vascepa in November 2020...It is time for Amarin to obtain a bottle of generic Vascepa, issued two years age... and compare the level of unoxidized EPA per capsule.... against the level of unoxidized EPA per capsule from a bottle of branded Vascepa...It would be a quick and relatively inexpensive test.

The FDA should be very interested in this information.

"Biosimilar"=BS ....Rancid butter is biosimilar to butter...but they are far from the same!

ROSE...The API shipped to the U.S. from abroad is processed here in the U.S....The manufacturing facilities in the U.S. must pass inspection to be certified by the FDA... and, occasionally these manufacturing facilities are not approved of by the FDA for one reason or another.

It is curious that the FDA says that the generics are "similar" to Vascepa...even though the generics lack the patented Vascepa encapsulation, which prevents the oxidization of the EPA in the Amarin branded Vascepa...despite the fact that the lack oxidation of the EPA is a very important element in the efficacy in Vascepa's reduction of CVD.

Why has the FDA chosen to ignore this important factor, which distinguishes Vascepa from generics??

IMO it is possible that the DRL anti-trust suite against Amarin...is likely a mechanism for DRL to persuade Amarin to agree to a settlement....wherein Amarin would eschew potential future claims against DRL for infringement(as have been already filed in the Amarin vs. Hickma) suite)....in return for DRL dropping its anti-trust suite against Amarin.

If this is true, it would imply that DRL might be concerned that the Amarin suite against Hickma may be successful for Amarin.

Amarin is pursuing Hikma for infringement of their CVD patents...while DRL is pursuing Amarin for anti-trust violations that deny sufficient supply of API to them.

Which of these suits, if any, is more likely to end with success?...I believe Amarin has a good chance to be successful in both....but then again, I also thought Amarin would be successful in the judge Du case.

JR...From courtlistener.com...."Jury Demand: Both"

The case will be tried in front of a jury, which Amarin and DRL BOTH demanded..A jury of reasonable people should understand the hypocrisy demonstrated by DRL in this matter.

Prior to the judge DU decision Amarin was anticipating a huge demand for API and making contracts, which were sufficient to fulfill that demand...Post the judge DU decision, infringing generic companies immediately came on strong....This caused a marked reduction in expected Vascepa revenues, thus forcing Amarin to fire reps and to essentially cease advertisements of Vascepa...The market that Amarin had previously anticipated for Vascepa and that had stimulated Amarin to seek large amounts of API, had evaporated due to the generics infringing on the CVD indication and the consequent loss of revenues for Amarin.

JR..."exclusive contracts that reduce competition may also violate the Sherman Antitrust Act and are subject to civil enforcement. "

The PBM's (pharmacy benefit managers) negotiate exclusive contracts with generic companies, which stipulate lower prices for the generic company's product...in return for the PBM refusing to list a competitor's product...

This common practice seems a clear violation of anti-trust laws...When Amarin eventually tries to list an AG( authorized generic) for Vascepa, Amarin's sole drug) with a PBM, this illegal practice of exclusivity will present a formidable challenge to Amarin....as opposed to generic companies that which have many products to list with a PBM.

The hypocrisy of the DRL anti-trust suite against Amarin is SURREAL... They are actually complaining that they are not getting enough API to satisfy their infringing, 7% of the market, needs....while Amarin is using their API to satisfy their legitimate, 93% of the market needs.

DRL's model for success seems to be to "copy and litigate rather than to do research and develop"

Controlled cancer studies on animals (e.g.monkeys), fed a red meet diet, as opposed to animals fed a diet lacking in red meet, might yield interesting results.