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Tats...Let's refrain from making unnecessary, unproductive comments about Denner's personal life.
Amarin has the patent on its superior encapsulation, which affords better lab and clinical results than the encapsulation that generics are using.
This introduces the question of whether generic V is really "biosimilar" to Vascepa!...It is something that Amarin or a BP that acquires should explore.
If PFE were the potential prospective buyer, there would be no reason for HLS to end its Vascepa partnership with Amarin...It would need to be another BP that has expressed significant interest in buying Amarin.
Of course, we retail shareholders would be last to know.
J.T. had intentions of making Amarin into a BP by using Vascepa revenues to develop new indications for EPA meds and to acquire additional meds...Now Denner has intentions of selling Amarin to a BP with more assets
In retrospect, I believe that Amarin could actually have become a BP if everything hadn't came crashing down, due to the judge DU decision and the lack of U.S. courts' enforcement of infringement laws...I hope that Denner is more successful than J.T. was and I look forward to holding shares in the fortunate acquiring BP.
Here is a summary of Amarin's patents on LR-EtEPA
Abstract of patents WO2023146984
"Lymph-releasing compositions of fatty acids and uses thereof for lymphatic incorporation and systemic disease treatment
Abstract
Provided are compositions comprising one or more polyunsaturated fatty acids or derivatives thereof, a source of phospholipid, and optionally one or more additional emulsifiers, as well as methods of using the same to treat various diseases. In some embodiments, provided is a lymph-releasing composition of eicosapentaenoic acid ethyl ester (LR-EtEPA) and methods of using the same to increase EPA uptake in tissues and to treat various diseases including cardiopulmonary diseases, renal diseases, neurological diseases, and CANCER."
EPA is a med that needs development ASAP, not only for the CVD indication, but also for several other indications...If Amarin is unable to perform this task, Amarin should be sold to a BP that has the necessary assets to do it.
I am still awaiting more news from Amarin, fleshing out any new developments in the patenting of LR-Et-EPA or any future plans to market it.
Lymphoma is an all too common, potentially deadly cancer...and this disease could benefit from a treatment with an EPA drug... LR-Et-EPA could be a safe and relatively inexpensive treatment for Lymphoma...along with current treatments...such as Chemo, Antibody drug conjugates and Car-T therapies, which are all not only very toxic, but also very expensive.
IMO the BP that acquires Amarin..will have Vascepa PLUS new EPA meds and new indications to pursue and the time to pursue them.
Jasbg...Thank you for this self aggrandizing video of Nissen...My main take away from it is...that he thinks that badly needing a shave makes him look more like a medical expert.
ramfan...from the C.C...."we are genuinely ready to pivot to an authorized generic strategy and plans should we need to. And that's really simply a matter of us doing that with the partner we have selected."...... guesses as to the partner is?"
My guess is that CVS could supply enough shelves for Amarin to adequately display Generic Vascepa...
Amarin does not need a partner to produce their product, but only to display it for public consumption...if the patient still prefers prescription Vascepa, CVS can fill that request also....(although I assume they would be the same product, possibly with a different name...such as ecosapentethyl and perhaps a different price.
JR..."I would like to see Sarissa buy more shares alongside the buyback (or before it)"....I agree
If Denner's purpose for Sarrissa buying back shares is to to increase its share price, as we must assume it is....then it makes sense for him to be buying Amarin shares NOW or in the near future at these ridiculously low bargain basement prices.
Even Denner's additional purchases will give more credence to the success of Amarin for the future.
The market is NOT taking kindly to the C.C. and that is NOT unexpected...No news on any plans for LR-Et-EPA or comments on the relationship with Mochida...No news on the potential time line for mainland China approval of Vascepa for the CVD indication....
The market is unimpressed with the Amarin $50 million buy back, which we all knew about previously anyway....Amarin price is down over 10% as of the time of this post
Come on Amarin...How about a C.C. or a PR with some REALLY good news!...instead of sad news, which we already knew about.
-pfizer-genmab-cervical-cancer-therapy-wins-full-fda-approval
https://seekingalpha.com/news/4096045-pfizer-genmab-cervical-cancer-therapy-wins-full-fda-approval
I was seated next to my daughter, who lives in D.C. and who was at the meeting, sitting beside me...When we heard the 16 to 0 verdict of the FDA, IN FAVOR of Vascepa, we embraced.
I flew to Washington in 2019,at my expense, to attend the FDA hearing, which lead to the FDA approval of Vascepa for CVD... During the meeting, I noted what seemed to me to be an unusual conservatism on the part of the FDA...possibly because Vascepa was a med, which the FDA apparently realized, had the potential for very wide use and which had not been that widely used, up until that time.
I think that is why the FDA insisted on Vascepa having an indication for patients, who have 150 mgs/dcl. or more...They also suggested that Vascepa have on its label...a "black box warning" due to potential side effects..Thankfully, this idea was dropped by the participants at the FDA meeting and they did not require the label to mention it.
Now that Vascepa has been used by millions of patients, we have greater knowledge of its superior efficacy and its placebo like side effects....so the 150 mgms/dcl. of TG imperative is not as necessary as it was in 2019.
My own TG has been in the range of 50mgs/dcl I and was eventually able to convince my cardiologist to prescribe Vascepa for me.
CAPT... When the FDA, in 2019, approved Vascepa for treating patients for the CVD indication, the approval, at that time, was....ONLY for patients with TG's of 150 mgs/dcl or more...(plus diabetes or other risk factors for CVD).
Amarin now needs to contact the FDA about this NEW information, published after 2019, and petition for a NEW LABEL hearing, which reflects the new information, published after that time...and, for the FDA,to issue their updated approval for Vascepa for the treatment of CVD patients....which does NOT have the over 150 mgms/dcl TG criterion, previously mandated in their decision five years ago.
The Generics mandate for over 500 mgms/dcl of TG for THEIR indication can stay
A simple, but critical question for Holt to answer at the upcoming 5/1/24 C.C....Is Amarin (or a successor Pharma Co. which buys Amarin) committed or NOT committed,by the Amarin 2018 collaboration agreement with Mochida...to pay milestone or royalty fees to Mochida for its patented product, LR-Et-EPA sales in the U.S. or in Europe?
IMHO everything else that Holt discusses at this conference pales in importance as compared with this question...Unless some unexpected bombshell announcement is released.
Tal..." Holt’s narrative is the BOD’s focus on immediate, short-term, execution. To put it in his words: “the focus in the immediate term is really on executing what we have in our hands.”
i.e. In plain English Holt seems to be saying...Do what we can now to get the stock price up..and the sell the company and let the buyer take over and do the rest...e.g. developing LR-Et-EPA...This seems like a risk averse strategy that I'm not sure I'm happy with...Its a little disappointing...It isn't why I got into Amarin over 14 years ago
I could have bought Pfizer instead and benefited from a nice dividend all these years.
Tal Shu...I re-read your post #423521 and I will be interested in seeing what Amarin is able to divulge, affording clarity on some of the issues raised in your post...at the C.C. on 5/1/24.
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)