Amarin Corp PLC (AMRN) Quote

Have to agree Kiwi. Hopefully “soon” is soon.

Six years post R-IT topline results, and Amarin flounders. Ninth District judges rulings align with Ninth District politics...

Icosapent ethyl (VAZKEPA®) was authorized by the HAS (Haute Autorité de Santé) on December 15th, 2021 in the following condition13, 14, 15: “Opinion in favor of reimbursement only in adult patients on treatment with a statin at the maximum tolerated dose, with very high CV risk due to established CV disease (secondary prevention) and presenting with moderately high hypertriglyceridemia (≥150 and

Great research as always. Hopefully, this helps influence/accelerate a reimbursement resubmission/decision

Thanks, sleven. That update from France should help remuneration there.

In hindsight the old managment should have just sold the company when denners proxy started. Probably could have gotten 5 or 6 a share. Now I doubt denner could even get 1.50 a share do sell this POS. He has ruined the company beyond belief.

All that did was make money for the generics. Now the company is on life support and denner has no answers at all. AMRN is one Italy rejection away from being finished for good. Just sad.

BBI, as I said, this was one tiny snippet from a very lengthy article (nearly 100 pages). There’s like 4 pages of disclaimers.

https://www.sciencedirect.com/science/article/abs/pii/S0890509623006799
Sleven,

Well that's unfortunate, if not tragic, because they're, in essence, offering opinion that we laugh at when we hear it from our doctors: "Oh, just take a fish oil supplement. It's cheaper and it does the same thing as Vascepa."

Also, shouldn't they have a disclaimer in any article mentioning supplements to explain that supplements are not FDA regulated and may not contain what their label says is inside the bottle?

6 years ago today, RI results were released. Without a doubt the biggest screw-up in biotech history. Wildly successful trial results lead to a company on life support. I really have no words. Just glad I unloaded the bulk of my shares before it got this bad. As cheap as it is, the risk of further downside movement is real.

Yup, it’s unfortunate.

BBI, no, ConsumerLabs is legit.

I have subscribed to it for years. Their analysis is very neutral and balanced. In fact, they take down a lot of supplement companies.

Having said that, I don’t always think their scientific analysis is thorough enough. But I am sure they have limitations on how much they spend on research, etc.

The article/research on fish oil is pretty good. They do use scientific studies to back up their analysis. And a lot of it is very good. What I quoted was just a snippet of the larger research.

Is ConsumerLab.com run by the supplement industry, perhaps masquerading as a legitimate testing source when it's actually just a billboard for useless supplements? This is the kind of stuff that causes so many doctors, even cardiologists, to tell their patients to just take a fish oil supplement rather than Vascepa. Doctors read this and think it's a scientific fact: Some supplements have similarly high amounts and concentrations of EPA and DHA as found in prescription omega-3 drugs like Vascepa and Lovaza, but at lower cost than these brand-name medications.

Makes it seem like all the benefits Vascepa provides are just as easily delivered by your over-the-counter bottle of fish oil supplements.

However, (comma) A post hoc analysis that excluded patients who failed to have an increase in EPA levels in the treatment arm and those who had a large increase in EPA levels in the control arm demonstrated a significant advantage for icosapent ethyl on the primary composite endpoint (HR 0.725; 95% CI 0.553-0.951).

In other words, because of the open label, there appears to have been some cheating on the protocol and a large number of dropouts that when accounted for make the PEP Stat-Sig.

https://www.tctmd.com/news/respect-epa-missed-primary-endpoint-hints-benefit-icosapent-ethyl

About to hit another 52 week low with nothing from management. Very disappointing

Now that >90% of Canadians are publicly covered for reimbursement we should see continued prescriber base growth. We should also begin to see this model in Europe and ROW.

3 million Canadians meet VASCEPA's labeled indication!

Saw this unfortunate update in ConsumerLab.com. I don't think they are interpreting the RESPECT trial correctly. They are ignoring the fact that results were positive, just not statistically significant.

https://www.consumerlab.com/reviews/fish-oil-supplements-review/omega3/#epa-plus-statins

A large, open-label study in Japan among 2,460 adults (average age 68) with stable coronary artery disease and a low ratio (<0.4) of blood levels of EPA to arachidonic acid (which has been linked with an increased risk of atherosclerotic cardiovascular events) who were already taking statins (mainly atorvastatin, pitavastatin, or rosuvastatin) showed that also taking 1,800 mg of icosapent ethyl (the form of EPA found in prescription Vascepa) daily for five years did not significantly reduce the combined risk of heart-related death, non fatal heart attack, nonfatal stroke, unstable chest pain (angina) requiring hospitalization, or need for treatment to restore blood flow to the heart (coronary revascularization) compared to those in the control group, who took statins but did not receive EPA. Furthermore, the rate of new-onset atrial fibrillation, a heart rhythm problem, was about twice as high in the EPA group than the control group (3.1% vs. 1.6%,respectively), and this difference was statistically significant (Miyauchi, Circulation 2024). https://pubmed.ncbi.nlm.nih.gov/38873793/

JRoon, The remark was not meant to be "snarky". Earlier today you made comments about insurance formularies without understanding that they are controlled by the pharmacy benefit managers. Now you are addressing preliminary injunctive relief without understanding the requirements for a grant. I don't know if Amarin would make That request. It's a few jumps forward. En Banc request. Return to district court. ECT.... Rulings at this point have opened the other generic companies to litigation that can go beyond the pleading stage. If Amarin would request and receive injunctive relief, it would have a profound effect on the other generic companies. Check the requirements for injunctive relief.
I actually have explained this before.
Sleven,

Thanks for your top notch analysis Sleven.

Rather than snarky remarks, you could give your opinion on how an injunction against Hikma would shut down all 7 generics.

JRoon, Your thought process is impressively linear.
Sleven,

Ram, an injunction would only impact Hikma. There would be 6 more generics to fill the gap.

Orbapu, thanks for posting. I know that at the top of the article there is a disclaimer stating that it is the opinion of the author but I don’t see anyone rebutting the claims made. Scum those PBMs - and of course that makes sense because they are the creation of insurance companies in their current. Had some time since port and shore excursion for tomorrow cancelled because of tropical storm John. You guys steer this board better than our captain as it has been rocky today.

O. thx, good article
Kiwi

C'mon Sarissa.......do it!

Denner/Sarissa could take 20% of he float off the market if they did their BB at these levels.

PBM’s are a scheme to circumvent profit caps set by the Affordable Health Care Act. PBM’s aren’t profit capped.

https://thehill.com/opinion/healthcare/4768725-drug-prices-pbm-rebates/

Kiwi, Thanks. I have read that information before. It's useful but vague.
Sleven,

Whats on the table in PBM negotiations ?


Drug rebates: PBMs negotiate rebates with drug manufacturers, often for expensive brand-name and specialty drugs. These rebates can serve as a tool to promote the use of certain expensive drugs in exchange for lower costs or preferred placement on formularies.

Formulary placement: Drug manufacturers may offer rebates or other incentives to get their drugs placed in favorable positions on PBMs' formularies (lists of preferred drugs). This can impact which drugs are more easily accessible to patients.

Market share: Manufacturers may offer better deals to PBMs in exchange for increased market share for their drugs.

Clinical programs: Some negotiations may involve implementing clinical programs that encourage doctors to prescribe certain drugs.

Pricing structures: PBMs can use various pricing models, including "spread pricing" where they charge payers more than they reimburse pharmacies for drugs.

Generic vs. brand-name drugs: PBMs may negotiate for increased use of generic drugs to lower overall costs, or in some cases, may be incentivized to favor brand-name drugs due to rebate structures.

Prior authorization and step therapy: Negotiations may involve implementing or adjusting these cost-control measures for certain drugs.

Out-of-pocket costs for patients: Negotiations can impact copays and other cost-sharing structures for patients.

Overall net costs: While rebates are a major focus, the ultimate goal should be to achieve the lowest net cost for payers and patients, though this isn't always the case in practice.

Transparency: There's often a lack of transparency in these negotiations, making it difficult for employers and other payers to fully understand the terms and compare plans effectively.
It's important to note that the dynamics of these negotiations can sometimes create misaligned incentives, where actions that increase rebates or PBM profits may not always result in the lowest overall costs for payers or patients.

Kiwi

AMRN new 52 week low

Amarin would need to have some indication of legal progress (well beyond CAFC giving them back their day in court) before any injunction is to be considered. Long ways down the road, and so far, not something Amarin is publicly calling for.

Some sort of injunction Rose would be a beautiful thing..... we'd jump to $10 on that news.

I have never seen a formulary that states ‘we will drug ABC only from XYZ manufacturer. Maybe this is communicated to the pharmacy when filling the script - as to which manufacturer’s drug is permitted but I have never seen that. If a person, for instance has say Aetna insurance with CVS Caremark PBM there are still a myriad of pharmacies that the insured can bring their script to be filled. Odds would say that there would be various manufacturers of the drug from which the various pharmacies would fill the script. Like I said I have received GV from multiple different manufacturers. Only time will tell if I still will continue to see that variety. There must be a reason Amazon is holding off introducing an AG (other than the one we have heard about worrying that it could impact negotiations in the EU or ROW) so it could be that you are absolutely correct about the fact that an AG would be useless. Time will tell. There have been posts here with links to stories about how successful other drug companies have been with their AGs so I find this an intriguing question. Best scenario, though, would be to gain some legal advantage and some sort of injunction against the Generics opening up the US market again for us.

I also heard from CNBC Squawk Box this morning that neither of the presidential candidates want FTC to have this much power to go after companies and Lina Khan's days are numbered. These corporations know how to handle and cover up the findings. What a sad state we are in.

SO much hope, so much pain, so little insight. The Fat lady is beginning to sing. Momma makin that pink sheet pudding. 57 pennies and yet its a great stock to buy !! ANOTHER BUYING OPPORTUNITY RIGHT !!

JRoon, I don't know enough about that to have an opinion. I'm not sure what's on the table during a PBM negotiation.
Sleven,

Ah, got it. Ok.

It would still seem that Amarin is at a disadvantage due to their size and lack of multiple medications to negotiate with.

JRoon, The pharmacy benefit managers control the formularies. They are the ones who decide what drugs will and won't be covered by the majority of insurance plans. PBM agreements are at the center of the fight for the US market.
Sleven,

I also wonder if it is a demand issue. Amarin ceased all sales and marketing efforts a few years ago, so there is little demand for branded Vascepa in the U.S. Generics do not market (that I am aware of), so outside of docs adopting Vascepa based on their exposure at conferences, even PBM deals don't move the needle tremendously. And at the same time, insurers have to be willing to reimburse. Even if PBM's cut deals with Amarin for branded V, if insurers don't put them in the formulary, it just sits on shelves at CVS (Walgreens, Rite-Aid, etc.).

It seems that the challenge for Amarin goes much wider and deeper than simply cutting a deal with PBM's.

This is where it would be helpful to understand what/if Sarissa has a real plan for the U.S. market. Because I don't really see one.

JRoon, I agree. Until recently Amarin had managed to maintain an exclusive arrangement with CVS. I/we don't know how they did that. This leads me to believe that we can compete with the generic companies. Pharmacy benefit managers are cutthroat. We still have other PBM agreements that are intact. It's possible that we could regain our exclusive contract in the next negotiation cycle.
Sleven,

Yeah, originally the "idea" of PBM's was a good one - be the "expert" between the pharmacy and the drug supplier. Negotiate prices, bring prices down, etc.

It was not unlike the origins of health insurance and HMO's. But, like them, profit motive got in the way of a good thing, and they constantly find ways to chip away at the "savings" they are providing.

One point of interest, however, is that PBM's actually will sometimes mark generic drugs higher than branded drugs, and manage the cost and profits through a rebate system.

It all seems very shady.

I think one of the biggest challenges that Amarin faces with PBM's and insurers is that they are a "one-trick pony". They are small, and provide only one drug.

RMB,
https://www.techtarget.com/healthcarepayers/feature/How-Payers-and-Pharmacy-Benefit-Managers-Work-Together-to-Lower-Costs#:~:text=PBMs%20negotiate%20drug%20prices%20with,price%20and%20receiving%20a%20rebate.
This is quick worthwhile read.
Sleven,

I understand that CVS has joined Express Scripts in its Missouri law suit against the FTC.

Last night, CBS “60 Minutes”(Stahl, I think) interviewed FTC chair Khan for about 20 minutes, asking questions about food and prescription drug inflated prices/costs that consumers have experienced and cannot afford to pay. Those consumers apparently did w/o the prescribed medication and substituted something else that didn’t necessarily work like the prescribed medicine. Video was shown of 2 persons—DOJ’s Kanter and FTC’s Khan—sitting together and discussing their respective law enforcement problems. Both want fair and effective competition.

I haven’t repeated a search of Kanter’s and Khan’s speeches or appearances to see if the above can be retrieved. A CBS podcast of above might be available.

See Louisiana Senator Cassidy (a doctor) on CNBC-TV discussing PBMs, about 7:50 a.m. this morning

North, Pharmacy benefit managers are under some scrutiny at the moment. They control the prescription drug trade in our country. It is debatable if they actually benefit the consumer in any way. I'll see what I can find concerning how they negotiate with "manufacturers". I'm not sure what I'll find. These organizations are immensely powerful. I would imagine that they make the major South American drug distributors jealous.
Sleven,

RMB, I don't have access to a signed contract between CVS and a generic manufacturer. I would be surprised if anyone could find that. It is possible that multiple generic companies could have engaged in a form of collective bargaining. That is beyond the scope of my knowledge. My point still stands. A PBM will provide the product that offers them the best profit. I am speaking simply about a complex financial system. Just calling our product a generic isn't going to provide CVS with a financial incentive.
Sleven,

north40000, thanks for your posts, and specifically this one related to CVS. And, I am especially impressed with your willingness to stand up for V and to pay the ~$1000 for approved V instead of accepting an AG. Then, per RMB's follow-up response that CVS offers various AG's and not V for the CVD, it seems to me there is a legal issue of direct infringement that could / should be brought against CVS Caremark. I am with you 100% and if you and marjac want to fight that fight, I again will support through a go fund me account. Amarin needs to get off their collective butts and do something but as experienced in the past have done very little on the legal front to preserve their only drug.
Thanks again for all you do for this board.

Does the following remind Blue voters of a Sarissa proxy-war promise?

Financial Times

NHS lunches 'suscription' scheme for antibiotics with Pharma sector.

Drugmakers will Receive flat fies for new medicines in push to avoide overuse.

By Ian Johnston in London August 12 2024


The NHS will agree subscription-style deals with drugmakers for antibiotics, as the UK seeks to encourage the development of new medicines and curb antimicrobial resistance caused by their overuse.

The NHS on Monday said it would negotiate fixed fees to pharmaceutical companies of up to £20mn a year per drug, working alongside the National Institute for Health and Care Excellence, the health spending watchdog.

The first-of-its-kind scheme was designed to “break the link between the payments companies receive and the number of antibiotics prescribed, removing incentives for overuse”, the NHS said.

The health service issued tenders for the subscription contracts on Monday, with an estimated total value for the programme worth up to £1.9bn over 16 years. The plans will apply across all four nations of the UK.

David Glover, NHS assistant director of medicines analysis, said the plans were “a major step forward in making sure it is financially viable for pharmaceutical companies to develop next-generation antimicrobial drugs to keep the spectre of drug-resistant superbugs at bay”.

Developing new antibiotics has historically been an unattractive investment for pharmaceutical groups because novel treatments must be used sparingly to avoid exacerbating antimicrobial resistance (AMR) — when organisms causing infection evolve to survive drugs.

This has contributed to a dearth of new treatments, with no new classes of antibiotics discovered since the 1980s.

Without the development of new drug classes, drug-resistant infections could kill 10mn people globally a year by 2050, according to a UK government-commissioned report in 2016. Some 1.3mn deaths were attributed to AMR in 2019.

The global cost in lost GDP could amount to $1tn-$3.4tn a year by 2030, according to World Bank estimates.

Regulators are taking steps to incentivise investment. Drugmakers that make new classes of antibiotics would earn “vouchers” under an EU proposal, where they would be offered longer regulatory exclusivity for other drugs in their portfolio.

Companies could use these vouchers to market their drugs for longer without facing competition or sell the vouchers to rivals.
Health minister Karin Smyth said the UK was “leading the way” in the development of new antibiotics. She added that antimicrobial resistance was “not a challenge we can tackle on our own” and that the government would seek an “ambitious agreement at the UN general assembly next month for co-ordinated action”.

The UK’s subscription scheme comes after a 2022 pilot phase between the NHS and Pfizer and Shionogi, the US and Japanese drugmakers, for their sepsis and pneumonia medicines.

Huw Tippett, chief executive of Shionogi Europe, said the new scheme was “the kind of sustainable solution we need to tackle the very serious and urgent issue of antimicrobial resistance”.

The maximum annual payment the UK will make per drug is £20mn over no more than 16 years, with spending decisions controlled by the Nice watchdog.

The UK will prioritise products that treat infections caused by pathogens identified as “critical” by the World Health Organization, including so-called Gram-negative bacteria, which are among the leading drug-resistance threats.
However, the £20mn maximum sum could remain unattractive compared with the billions of pounds in sales that drugmakers hope to earn from leading assets in their portfolios.

Paul Catchpole, head of value and access policy at the Association of the British Pharmaceutical Industry, a trade body, said the plans to offer a “guaranteed return on investment” were a “positive step?.?.?.?to ensure the availability of effective antibiotics for future generations”.

https://on.ft.com/4gAR2on

Sleven, if everything is as you say, then of course it would seem there would be no benefit to an AG. But my experience seems to run counter to what you have laid out. I have been with federal BCBS for many years. I was on brand V from before R-I results. CVS Caremark has been the PBM. Once GV was introduced my BCBS covered both brand V and GV. A couple of times the pharmacy tried to switch me to GV but quickly gave me brand V when I hollered. At some point (I think Jan 23?) BCBS through the CVS Caremark formulary stopped covering brand V. Since then I have been forced to take GV. But I can’t say that happened because they made a deal with one Generic company, as I have received GV from at least 3, if not 4 different manufacturers. So when you say that CVS has dropped brand V from their formulary are you sure it is because they made a deal with one and only one Generic company? If it turns out that CVS Caremark is covering a variety of Generic Vs, and not just one GV then an AG might still be of some value. Do you have information that CVS made a deal with only one GV manufacturer?

I will respond to the issue you raise, sleven. I had paid $9-15 co-pay, with GEHA insurance, for a 3-month prescription for Brand Vascepa, prescription on file with my local CVS, for many years prior to 7/01/2024. As of that date, Brand Vascepa was not on the formulary at CVS with my GEHA insurance at that price; I was informed by a joint GEHA/Caremark letter that, as of 7/01/2024, I would have to pay full, uninsured price for a 3-month supply of Brand Vascepa. GEHA had apparently lost a competitive bid to supply CVS with any Brand Vascepa to Express Scripts(?). I have not obtained any other insurance, having been with GEHA since ~1961 when I entered U.S. government employment. I paid ~$1000 to fill that prescription for Brand Vascepa at CVS earlier this month, even with a coupon furnished by GoodRX.

I will not accept so-called generic Vascepa to fill that prescription for substantially the reasons expressed in that recent Fed. Cir. opinion—Hikma’s product has not been shown to be therapeutically equivalent to Brand Vascepa, nor has FDA approved any ANDA or sANDA filed by Hikma for its product to be used to treat or reduce risk from CVDs.

I do intend to investigate whether I can obtain a prescribed Brand Vascepa from PFE’s newly established consumer pharmacy— “any” prescription drug, and at what price.

Meantime, I am going to explore any interest DOJ or FTC may have in investigating Brand and/or generic Vascepa, false advertising issues that may be present re “generic Vascepa” being offered for sale and actually sold, or other deceptive, collusive practices that may have occurred that permit so-called generic Vascepa to be in any of Amarin’s market for Brand Vascepa in the first place.