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An AG at lower prices than brand Vascepa could indeed benefit Amarin...
-Lower prices favor more approvals for payments from National health services, including in Europe and China
-Larger volumes of API favor lower costs to Amarin for acquiring API from wholesalers.
- Larger volumes of sales worldwide for an Vascepa AG give Amarin a competitive edge over other generic Vascepas
I can't imagine that the data from the Brave study will prove important, since it took so long to surface....A somewhat positive trend indicating that Vascepa ameliorates the development of AD is the best we can hope for.
J.R....Ireland tax law..."ANY capital losses that have been incurred on property, shares or ANY OTHER assets, are available to carry forward indefinitely. This means that it can be set against ANY gains that may arise in the future."
Dar53 QUOTE..."not sure why they would want to spend a few billion"...(i.e. for Apple to buy Amarin)
A billion dollar tax break...plus $300,000 dollars in cash in the till ...plus some API already bought and paid for by Amarin...plus good will...plus potential lease revenues from a Big Pharma from sales in U.S. and Europe....all these put together should be worth "a few billion" for Apple to buy Amarin.
Since Apple is not in the pharma business, It could lease Vascepa to a Big Pharma, such as PFE, to continue selling Vascepa around the world...It might do more people more good than even the I Phone did.
QUOTE..."Apple (NASDAQ:AAPL) has faced a significant legal setback as it lost its EU court battle over €13 billion ($14.4 billion), a long-standing dispute concerning its tax arrangements in Ireland."
Could Apple buy Amarin and use its unrealized tax losses to repay some of the tax debt it now owes to Ireland?
A stock price may sometimes go DOWN forever...but it NEVER goes UP forever...I wish I had thought of that when Amarin was in the twenties.
Pfizer has announced PfizerForAll, a new website that will offer vaccines, medical tests and medications to be delivered at home....i.e. to patients who get prescriptions from Docs or nurse practitioners either by phone or on line.
I approve of Pfizer's idea of circumventing the middlemen (PBM's(who have been scooping large percentages from drug prices for themselves)...Its a shame that Amarin doesn't have the assets to enact a similar strategy for their marketing of Vascepa.
sleven...To access the Chinese national health system, the price will have to come down....A lower price will also help in France, Italy, and eventually in Germany.
Why not start the inevitable process of mild price reduction with an AG in the U.S., which can then be further implemented as the volume of EPA sales takes off.
Bird..."banging on the cockpit door while the jet is going through severe turbulence is probably not the best way to get a positive result"...
Pilots going through severe turbulence usually look for a different place to land...In the case of the turbulence Amarin is facing, an AG for the U.S. may offer a safe landing place.
With the increased volumes from Vascepa sales in Europe, Amarin will get a break on price from the EPA suppliers that may cause the generic Vascepas in the U.S. to be at a competitive disadvantage.
DMC...In January of 2023, Amarin settled a lawsuit with Healthnet over infringement of Vascepa CVD patents by Healthnet ...without revealing the terms of the settlement...Thus far, I am unaware of any benefits that accrued to Amarin from that settlement...I hope the case against Hickma is not similarly settled.
Capt...."Bhatt and others have recommended V + Statins in all prior MI or stroke patients."
I don't believe that the FDA has yet specifically approved just a prior CVD as an indication for use of V+Statins...it would be helpful to patients and to Amarin if the FDA made that clear.
For one thing, it would make it clear to Docs and to the public that the MOA of Vascepa can work to reduce CVD, even in patients, who have a normal LDH.
Some patients are unable to tolerate statins...It would be important to evaluate CVD patients who take Vascepa, REGARDLESS of their LDH levels, and WITHOUT taking STATINS...and evaluate their reduction in subsequent CVDs.
Ramfan..."Are you taking a statin? Is your LDL "normal"....yes to both...I am on 80 mgm. of Lipitor and 4 gm. of Vascepa...with a recent LDL of 74mg./dL
IMO Any adult who has had a stroke or a heart attack...(I have had two of each)...should be taking a statin plus Vascepa, regardless of whether their LDL level is normal, as is mine.
A study is begging to be done and then submitted to the FDA...showing that a statin plus Vascepa is safe and effective in reducing an additional CVD in those who have already has a stroke or a heart attack.
If Amarin does not have the assets to do this type of study, it should be sold to a BP that does have the assets.
Any marketing strategies(like that of Lilly and Pfizer) which reduce the extortionary tactics of PBMs on pharmas and increase costs to patients should be welcomed, IMO.
Quote..."Pfizer (NYSE:PFE) has announced PfizerForAll, a new website that will offer vaccines, medical tests and medications delivered at home.
PfizerForAll is designed for patients with migraine, COVID-19 or flu, and adults seeking vaccines for preventable diseases, including COVID-19, flu, RSV and pneumococcal pneumonia.
The platform offers end-to-end services including same-day appointments with a qualified healthcare professional (either in-person or via telehealth), finding and booking vaccines, and at-home delivery of tests and medications or through a preferred pharmacy.
Patients will be able to use existing insurance and pharmacy programs as well as new direct services from partners including UpScriptHealth, Alto Pharmacy and Instacart.
Pfizer has said it will continue to expand and develop PfizerForAll to address a broader range of needs and conditions.
Back in January, fellow drugmaker Eli Lilly (LLY) launched its own website to offer telehealth access and home delivery of drugs.
WW International (WW) and LifeMD (LFMD), down 0.92% premarket, also operate similar offerings. Meanwhile, telehealth platform Hims & Hers Health (HIMS) lost ~5.23% premarket in reaction."
I seems like a good move to cut out the PBMs...PFE SHOULD USE THE SAME MARKETING STRATEGY FOR VASCEPA!
Rose..." Question is what is there in the near future that could possibly stir a rise in the pps enough to get it over a buck?"
A remuneration for Vascepa sales in China...coupled with an AG for the U.S., could easily get the pps over a buck and start the momentum towards a global acceptance of Vascepa and a sale of the company.
To initiate a suit, the plaintiff(s) must have standing...A group of patients with CVD, who had been denied Vascepa, even though Vascepa had been previously specified in their Rx(s) with a "do not substitute" admonition... and then were given gV as a substitute anyway...only to subsequently have serious CVD events, (even mortal ones), would appear to have standing...or if they were no longer alive, their families or estates would appear have standing.
My family and I were stationed at Camp Lejeune from 1966 to 1968, where the water supply was contaminated with cancer producing agents...My wife was later diagnosed with Lymphoma...A class action suit ensued, which the U.S. government has already settled in some cases.
The case of Amarin vs. gV would seem to deserve a class action suit.
JR..."Zip, you establish a NEW basis at the time of a transfer in kind out of an IRA."....I agree. The amount you paid for the stock when you first bought it for your IRA, whether higher or lower than its present price, is not a factor...The only important price is the price at the close of trading on the day you transferred it into your taxable account.
North..I have, for years, used the practice of "transfers in kind" out of my IRA into my taxable accounts in order to satisfy my RMDs...without any problems from the IRS...I've never checked to see whether my basis for tax purposes, due when I sell the stock from my taxable accounts, was at the price, at the close of the market on the date of my"transfer in kind"...However, I have assumed that my basis for tax purposes was indeed the price of the shares at the close of the market on the day of the transfers from my IRA into my taxable accounts.
I now intend, to sell "specific shares" in my taxable accounts to capture losses....including those shares that have been transferred from my IRA to satisfy my RMD.
Thank you for bringing this to my attention.
The Chinese national health care system will pay for Vascepa in order to lessen massive patient hospitalizations for CVD.
It's why they approved Vascepa in the first place.
CBB...The price in the U.S. and in Europe is now around $170/month....with a 60% discount mandated in China, this reduces the price to around $70/month....With Amarin buying large volumes of EPA from manufacturers, this price could still allow Amarin and Epping to earn a profit.
Quote from 2016 agreement..."Amarin will receive a $15 million payment that will help improve its cash balance. This payment is characterized as non-refundable and up-front, so it appears that Amarin gets this payment immediately upon signing the agreement, and that this payment is not affected by regulatory approval/non-approval. As well, Amarin may receive up to $154 million in development, regulatory and sales-based milestone payments, plus DOUBLE-DIGIT royalties on net sales of Vascepa in China."
Captain...Thank you for your continued work over the years... Vascepa was always intended to be a medicine for the masses...To achieve its mission, it must have lower prices in the U.S. in Europe, and worldwide.
Reimbursement in China and a subsequent AG in the U.S (likely occuring next year) are in the cards...to be followed by global acceptance of Vascepa and better times for Amarin.
CBB...QUOTE...."Can AMRN achieve this or would it take a BP to make
it work." IMO a BP is now, more than ever, necessary to execute a global distribution of EPA with high volumes at low prices.
Also, a BP could further develop Lr-ET-EPA and pursue legal cases against the generic infringers in the U.S. while they're at it.
My takeaways from the Q2 2024 C.C...
1. Decreasing revenues dictate that a $50 million buy back is now off the table
2. An AG for the U.S. is now on the table
3. China reimbursement for Vascepa in 2025 is now a real possibility
My analysis of these developments.... I expect lower global Vascepa prices and higher global Vascepa sales volumes in the near future.
Theme
Drug Development
Abstract
Background: The omega-3 fatty acid eicosapentaenoic acid (EPA) has positive benefits for cardiovascular risk, reducing inflammation and improving endothelial function. Evidence suggests that Icosapent ethyl, a purified form of EPA, can improve cardiovascular outcomes in at-risk patients. Veterans are at higher risk for vascular dysfunction, a risk factor of Alzheimer's disease (AD), thus improving vascular health may be pivotal for delaying or preventing AD among Veterans.
Method: Cognitively healthy VA-eligible Veterans at William S. Middleton Memorial Veteran’s Hospital in Madison, Wisconsin ages 50 through 75 were invited to enroll into an 18-month randomized, placebo-controlled, double-blind, parallel-group clinical trial which assessed the efficacy of Vascepa® IPE. 206 Veterans were screened for exclusion criteria, leading to the randomization of 131 Veterans to either the placebo or 4mg daily IPE. Triglyceride, low-density lipoprotein (LDL) cholesterol, and blood pressure were collected at baseline, 9-months, and 18-months. New adverse events were self-reported at all study visits. Lipid levels, blood pressure, and new adverse events were analyzed to determine any differences between Veterans receiving the study treatment or placebo.
Result: Our preliminary analysis indicated no differences for triglycerides, systolic and diastolic blood pressures, and LDL cholesterol between treatment and placebo at baseline (p-value range: 0.552-0.880). Cohen’s d values for these ranged from 0.026-0.108 at baseline. Individuals in the placebo group reported more new adverse events than treatment group (Fisher test=0.007). Analyses examining if there is any significant change in lipids and blood pressure due to study drug over study duration will be presented at the conference.
QUOTE..."Individuals in the placebo group reported more new adverse events than treatment group (Fisher test=0.007). Analyses examining if there is any significant change in lipids and blood pressure due to study drug over study duration will be presented at the conference"
I would expect a comment from Amarin very soon on the University of Wisconsin-VA BRAVE study results.
I also expect more confirmatory studies to be in the offing, probably by a BP.
IMO the decrease in AD in the EPA treatment group(as opposed to the placebo group) which was just reported in the Brave study, is VERY good news for patients susceptible to this terrible disease.
Hikma seems to be disregarding the Amarin legal action against them...i. e. for infringement on Amarin's CVD patent...and Hikma(and other generic companies) are continuing to infringe full steam ahead, as though there is no real problem they might face for their infringing.
They will continue as long as they are not stopped!
The amount that Hikma profited by infringing on Amarin's CVD patents is more than the devastated market cap of Amarin at present...A just victory By Amarin in their suit against Hikma should command a compensation from Hikma, which is at the very least, equal to, or more than, its present market cap.
JR...QUOTE..."The co-administration of PUFAs (e.g. LrEtEPA) with additives including phospholipids and/or additional emulsifiers facilitates in viva absorption of the fatty acid in the form of phospholipid conjugate. Not only is such compound primed for uptake by cells because phospholipids are a major component of cell membrane, but it is also expected to have a higher efficiency as crossing the blood-brain barrier (BBB), thereby delivering the fatty acid which is the active ingredient of the composition to the brain. The BBB can be a roadblock for pharmaceutical agents to access their therapeutic target in the brain or reach a sufficient level inside the brain. Therefore, the lymph releasing formulation of the present technology may provide a novel strategy and platform for delivering fatty acids across the BBB for them to exert their anti-inflammatory, pro-cognitive, and/or other neuroprotective effects useful in the treatment of a variety of neurological diseases and disorders"
This IMO is grounds for believing that Lr-Et-EPA has a positive effect in slowing of Alzheimers.
Kevin...
QUOTE..."They are the manufacturers of the generic V that I picked up yesterday."
I doubt that CVS Caremark manufactured their own brand of generic Vascepa...Rather they are selling a gV, which has been been manufactured by a generic company and then sold to Caremank for distribution....HOWEVER,Caremark certainly understands that they are infringing on Amarin's CVD patent...and that said infringement does not seem to an issue for them...It is now up to Amarin to make this an issue...first by informing them...and, if necessary, by following with a suite to cease their infringing.
Eagerly awaiting C.C. on 7/31 to hear more from Berg about about China reimbursements for Vascepa...plus news about legal disputes involving Hikma (with Amarin as plaintiff) and DRL (with Amarin as defendant), plus any potential new Amarin EPA products on the horizon( e. g. Lr-Et-EPA...or Statin- EPA combo products)
Docs derive their up to date information mainly from medical journals and from medical meetings...They are largely unaware of whether a medicine has a valid patent,or not, for the condition, for which the med is being prescribed....The same is true of local pharmacies...However, this is definitely NOT true in the case of generic companies, insurance companies, and PBMs...Docs writing on prescriptions the indication for which a med is being used...would go a long way help to minimize the multiple cases of patent infringement, made worse by skinny labels, which are clogging up court calendars.
Rose..."verify the efficacy of the product(Vaskepa) to reduce the risk of cardiovascular events in CHINESE patients"
Effing is a marketing company, not a research company...I doubt that Effing would, by themselves, conduct a post approval study of CHINESE patients after 5 years of treatment with Vaskepa...i.e. in order to maintain continuing government reimbursement in China...That mission of Effing would be probably need to be done by the BP that acquires Amarin, long before the 5 year period elapses...or...by Effing which could just hire another Chinese company that specializes in pharma research in China
C.B...."It’s been estimated that the total Chinese patient population in the REDUCE-IT label is 330,000,000 (about the entire US population)"
This boggles the imagination...If only 1% of the potential Chinese patient population who could benefit by being on Vascepa(a benefit, which was proven by the R-IT study), could be prescribed Vascepa...the entire global fishing industry, as we know it, would soon be unable to supply enough EPA for world market consumption...and instead, we would have resort to algae farms for further supply of EPA.
I anticipate that there will be a market for those patients, who have reached a point, where they are ready to discontinue injections of weight loss meds...but still want to continue with an oral weight loss med.
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.