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Unfortunately, for Amarin and us shareholders, the dispute about generic IPE for VHTG and V for Cardiovascular Protection is entirely a legal question and not a medical question. The patent infringement perspective is entirely a legal situation for which Amarin has no way to enforce the worthless R-IT patents.
Generics can be used off label, just like V was prior to Dec 2019 FDA approval.
Trying to argue with healthcare professionals that one brand can be used for one indication and another brand (or generic) should be used for another indication is an argument very few will listen to.
HealthNet had doctors fill out a prior authorization where they specified it was for cardiovascular disease protection, and the insurance company chose to only cover the generic. After two years of lawsuits it looks like HealthNet walked away with zero penalty, but may have had to adjust some of their formularies. Insurance companies can do whatever they want and they will always choose the cheapest alternative, regardless of technical or legal issues.
My suggestion is that people who are prescribed the generic should take the generic for one month and then tell their doctor and insurance company that they could not tolerate the generic, that it caused stomach problems and diarrhea that you did not experience with Vascepa. They may insist you try a second generic next. Do so and tell them the same thing.
Jasbg
The patents for V may still be technically valid in ROW but they are not always enforceable.
Generic IPE is available in Egypt for example:
http://egyptiandrugstore.com/index.php?route=product/product&product_id=4526
Capt
I think even the Chinese know that if they want quality products they avoid “made in China” labels. I suspect it would be the same or even more so with their healthcare products. Affluent Chinese, a rapidly growing demographic, will likely want the US brand “real” stuff and likely don’t use government insurance for their medications so access through private insurance will be quicker.
I think China healthcare may be somewhat similar to Canada, and less similar to the EU. In the EU government insurance typically covers the majority of people. In Canada and China there is a hybrid of private insurance and government insurance. This also brings up the topic that your recent HLS graph isn’t completely representative EU. Although the CPA was available as of February 2020 it was only covered by private insurance up until one year ago. Even now, two large Canadian markets British Columbia and Alberta still do not have government coverage. The split between private insurance and government plans for patients on V is about 50-50. UK should take off much quicker than Canada. China will be more like Canada - available to private insurance patients rather quickly, but a minimum of two years to get on government coverage
AGORDON
There is one very troubling section in your post:
“Vascepa has no approved competitors in China for its FDA-approved indication for CRR. As of the Latest Practicable Date, only one competing generic was marketed in China with only one approved indication, TG reduction in severe HTG (500 mg/dL) adult patients. This competing generic has not been approved for persistent CRR,”
V’s R-IT patents are completely unenforceable in the US, what makes you think the fact the competing generic is not approved for the CRR indication will have any meaning in China? If there is a competing gV available in China then I foresee a significant problem.
Also, IIRC from research I did a couple years ago, new drugs take at least 2 years before being covered by government insurance (just like in Canada and EU) and they typically get a 60-70% discount compared to US and EU pricing because they know they are offering volume unmatched by any other market.
Amarin has rarely mentioned China in the past 3 years and has never given any financial guidance for China and I suspect that is because the chances that a Chinese sourced, Chinese manufactured and Chinese sold gV is very high. Remember, Teva’s API source is China, unlike all other sources. China built and opened a hospital in 2 weeks, how long do you think it will take them to mass produce IPE?
I give absolutely no weight to Chinese revenue when estimating total global sales.
NS
You would think so.
It sure seems suspicious to me. It also shows that WS has absolutely no interest in Amarin at the moment.
It should be a simple math issue. Ensuring you have quorum is the responsibility of the secretary of Board and is determined prior to starting the meeting. Nasdaq regulations apparently determine Amarin’s requirements although other Boards would have the requirements stipulated in the organization’s bylaws.
I agree!
North
It was a personal conversation. The man has a distinguished career and, similar to KM, sales just weren’t meeting expectations and they needed to blame somebody.
North
I have it from a very reliable source within HLS that confirms JRoon’s position
NS
Yeah, I am aware of the research you have done showing that the FDA has lowered the bar for getting an approval for a drug to treat or prevent Alzheimer’s. Considering the time it will take Amarin to put together the application and submit it and then the time it will take the FDA to review and approve it, we’re looking at about two years.
Seve333
The primary outcome being measured in the brave trial is actually cerebral blood flow and not a specific biomarker for Alzheimer’s like amyloid plaque. The latest imagery data from the Evaporate trial showed a statistically significant, and in my opinion impressive increase in blood flow in the coronary arteries. It would seem reasonable to me to expect similar changes to blood flow in the brain.
That being said, I do not believe the limited evidence from this small trial will be enough to significantly affect sales.
Keep in mind, Amarin will be prohibited from promoting, or even mentioning anything about the brave trial to
prescribers
Zip
What CaptBeer posted as DRL infringement is nothing more than the “generic” Pt information sheet produced by the local pharmacy software. NOT DRL MARKETING MATERIAL. NOT CONNECTED TO DRL AT ALL. At BEST, it could be used to force the pharmacy to update its software, separating the CVD claim from being printed on gV scripts. The pharmacy is listing the approved uses of IPE.
This is a non issue
Rose
I absolutely agree that Amarin should have been sold long ago. The fact that it was not sold means that 1) nobody made a reasonable offer or 2) that the prior board was asking too much. We will never know which one it was. We do know that JT diluting and raising $400 million is one of the only reason this company did not go bankrupt. We also know that if KM had not secured exclusivity contracts with insurance companies that our US market share would be around 10%, Amarin would have no cash and the company would’ve been bought for about $.50 a share to avoid bankruptcy. US sales is what is financing the very conservative launch in EU because they cannot afford to spend more cash than what they bring in.
There is absolutely nothing that I see happening in the next 12 months that gives me hope the stock price is going to go above $1.50. Considering the incredible potential of this drug, the SP is unbelievable yet I have no hope for it changing.
JRoon71
You posted a few days ago with some research on the qualifications (or lack of) of the new Board and I have to say it really stuck with me. AD did take over the company with no plan, no qualifications, no concerns about anything other than he saw an opportunity to take control and he grabbed it.
A poster from Spain pointed out that even after the national reimbursement decision he says he doesn’t expect to actually see any V on pharmacy shelves for another full year as the 18 regional boards each need to do their own cost analysis etc before covering. It was the same in Canada- National pricing negotiations took a year and a half but it took another full year before the province I live in came to an agreement and started coverage. Two large provinces STILL haven’t started coverage - Alberta and BC.
Germany is, at the very least, a full year before there is any sales. Italy likely has a similar system that delays coverage. In Canada a company like HLS has 8 years of patent protection. Governments typically stall for 2.5-3 years before paying to cut the real patented period to 5. Its all about money. Payers are typically accountants looking at this quarter’s budget, not really concerned about lives saved/lost.
There is NOTHING positive in the next year for Amarin and WS knows this so they are investing elsewhere for now. BP will wait and let Saint Denner sweat it out knowing he is under constant cash crisis.
We went from having a CEO with decades of experience selling and launching cardiovascular drugs in Europe to a CEO who knows nothing about Europe. We had a diversified Board with broad expertise and now we have 3-4 reasonable people and a bunch of puppets waiting for huge options to get rich representing Denner who aren’t qualified for their very high paying part time jobs.
How low can this go?
I am the least optimistic I have been in a very long time.
Kiwi/NS
“How do they justify not covering for VHTG ...doubts about the placebo used over stating benefit of V “
Kiwi
V is not covered for TG over 500 (5.6 mmol) in Canada either. R-IT did not have pts with TG over 500 so their decision has nothing to do with MO or even R-IT. Both fibrates and Lovaza are more effective at lowering TG’s with the HOPE it reduces the chances of pancreatitis. V is for CVD risk reduction - not TG reduction.
As for primary prevention, V is approved in Canada (like EU) but not covered by government plans (although it is covered by private insurance plans) for DM Pts without known ASCVD based purely on cost analysis.
It’s not uncertainty about the MO placebo, it’s the lack of MITIGATE data that governments are waiting for, remember? The 1 year of data from a respiratory infection trial -that is the answer.
You nailed it
JRoon71/BBI/NS/Duke
I think there is a reasonable chance of success at increased cerebral blood flow at 18 months. The new data from EVAPORATE FFC seems promising, even at 9.
https://drive.google.com/file/d/1m86Nb-CaPL-uuUCm-RfqNopk1w5Sq1ts/view?usp=drivesdk
(NS: couldn’t resist)
(Duke: thanks for the clarification on the 2 legal points - just don’t see it helping us in the next 5 years even if they file suite against Apotex, Teva and Dr Reddy next week). Sadly, I have lost all hope for justice in the “US justice system”
Kiwi
You are the only person looking for independent confirmation of the reduce it data. Did you hear about RESPECT-EPA? Or JELIS, EVAPORATE, CHERRY?
The data is very solid.
The ANY MI data from ESC showed a great and very linear reduction in events correlated to serum EPA levels using only the on-treatment Pts (no MO).
It’s just you and Steve who have doubts and of course anyone that needs a reason to argue for better pricing is going to claim to have doubts as well. BUT, as we saw with KM and the NICE review WHO OPENLY STATED “no benefit” 3 times, KM knew what he was doing, knew the committee was bluffing and held his ground and got $170/bottle. Saint Denner would probably have caved and settled for $120. Berg would probably still be asking if the UK was near England because he is lost and only knows that the map says London England but he needs to find the UK.
Seve
“some judge ruling in other countries will allow generics in and we will be back to a buck again.”
Wrong. In the EU Amarin has REGULATORY EXCLUSIVITY not patent protection (or lack there of). Amarin has a guaranteed market for another 6-7 years (could be extended) and that is a considerable amount of time to sell. Awareness and acceptance of V will grow faster in the EU than it did in the US or Canada because it has a history and Pt years of experience. The questioning of the science (driven and funded by PAYERs) will disappear (with the MITIGATE TRIAL DATA - right Kiwi) when the financial need for doubt disappears.
Yes, we have another year or more to wait but the future is still bright. It is also possible that Pfizer or Novartis (who are very aware of its potential) may jump in early to avoid the competitor getting the drug.
JRoon71
Absolutely agree with everything you stated!
I was excessively harsh in my response to Bob because I find it extremely frustrating when people hold on to old ideas when the facts clearly show they were wrong. There’s absolutely nothing wrong with making mistakes, unless you don’t learn from them.
Sorry Bob for my aggressive response
MrM
“My guess is he positions the company toward profitability and then finds a buyer.”
Do you realize how naive that statement is? The company is on the exact same path as it was before. Absolutely nothing has changed nor is there anything that needs to be changed. Thankfully KM negotiated some exclusivity contracts with US insurers that has kept the cash coming in to allow for the bureaucracy to go forward in EU. There is nothing to change except time, regardless of who owns V.
National pricing agreements need to be reached, and then regional or Provincial or state, or whatever they’re called in that area need to go forward. Every step requires time, and no matter who the payer is there are more accountants then healthcare professionals in the decision making process and so money is the driving factor. Accountants worry about this year‘s budget. Delays are beneficial to the accountants. Healthcare professionals worry about the patient’s life three 5, 10 years down the line. Accountants have absolutely no idea/concern about this concept of preventing MACE. All about $$$$$
Spiky
Thank you. Wish others were able to see as clearly.
You mean dead on accurate in his predictions. Right back to where we were before the proxy, except now we have an idiot for a CEO with zero experience in the EU and apparently doesn’t even know V’s status on international treatment guidelines. Wow, that’s bad!
Bob (and anyone else in COMPLETE DENIAL)
You have no idea what you are talking about. Zero!
Du screwed Amarin aided by an over confident yet incompetent third party law firm.
The EU launch HAS TO FOLLOW A SPECIFIC PROCESS/BUREAUCRACY. Each step takes TIME - often a year or more. This is standard for EVERY new drug. They staggered the launch by country because they ARE NOT PFIZER or Novartis. They expected Germany to allow an unobstructed first year launch BUT GERMANY instituted a NEW LAW and an “austerity budget reform” and invoked an unprecedented halt in approving new drugs (except cancer and new treatments that are acutely life saving- ie: preventative therapies don’t count). When the GERMAN GOVERNMENT decided ezetimibe was the comparative molecular (clearly an inappropriate choice but one that was made to ensure they would not have to pay for the drug BECAUSE GERMANY WAS MORE FOCUSED ON BALANCING THEIR HEALTHCARE BUDGET than adding V and saving lives in 5 years).
Germany didn’t want to pay! End of f@&$ing story! Nothing KM or Saint Denner could have done to change that unless they were willing to drop the price to equal generic ezetimibe ($30). THAT IS WHAT THE NEW LAW MANDATES.
Saint Denner hasn’t done a single f@&$ing thing since taking over BECAUSE THE PREVIOUS BOARD AND KM WERE DOING EVERYTHING POSSIBLE and they DESPERATELY NEEDED KM TO STAY. HOLY SHIT IS Berg a MORON, correction, USELESS UNINFORMED MORON.
If there are still people on this board who have not COMPLETELY ACCEPTED the FACT they were played by a very skilled and greedy HF manager then they need to find a new place to put there disposable income because biotech investing is obviously NOT your best choice.
People were frustrated and angry and Saint Denner jumped on that to take 100% control of the company because he saw the opportunity and took it. Now it’s his personal little toy that he can do what he pleases and retail’s opinion and prosperity aren’t of the SLIGHTEST CONCERN to him.
There will not be any SIGNIFICANT revenue from EU in the next year NO MATTER WHO OWNS V.
Also, if it’s true that there are 40-50 Amarin rep jobs posted for US positions then that is clear evidence Denner is thinking GIA for at least 2 years because that is how long it will take for new, inexperienced, unconnected reps (because with zero job security who else would take the job) to develop a relationship with prescribers and influence prescribing. I believe it’s 5 encounters that are needed on average to get a prescriber on board.
Don’t bother responding, this board is rarely factual or knowledgeable in their responses anymore (excluding the obvious: NSleven, Dogn, Capt, BBI and a few others)
JRoon71
Excellent point. There is a timeframe for the standard bureaucracy to run its course. Denner can’t change that. KM had the experience needed and proved himself capable with his $170 reimbursement in the UK in spite of NICE declaring “no benefit” 3 times before giving in to KM.
A Spanish poster on ST (evila) just posted that even after the “reimbursement decision” in Spain he expects a full year to go by before V appears in pharmacies and sales actually begin. After reimbursement is negotiated with the country each of the 18 regions have to individually finalize the details for their region.
Amarin is still at least another full year away from any noteworthy revenues from EU. WS knows this and knows Amarin will be struggling with their balance sheet for that timeframe so they have better places to put their money until Amarin has a stable future.
Kiwi
Didn’t BARD say anything about the well known fact that the CARDIOVASCULAR data from JELIS, CHERRY, REDUCE-IT, EVAPORATE and RESPECT-EPA must first be confirmed by supporting data from a recently completed RESPIRATORY INFECTIONS trial called MITIGATE?????
Dave
You are the exception to the rule. 99% of Pts take whatever brand is the least expensive to them. Insurance companies go with whichever brand/generic gives them the lowest net cost.
Ziploc
Maybe it was a condition by Amarin????
Ziploc
If they settled out of fear of large monetary damages, why wasn’t there any significant revenue in the financials indicating HealthNet paid at least small damages?
My GUESS: HealthNet told Amarin that if they lowered their price to equal of gV they would switch to V so Amarin dropped their lawsuit. No winner, no loser. It just went away and Amarin maintained some revenue.
There is NO LEGAL teeth to the patents or “approved indications”.
People need to accept this to understand the SP and understand the direction of the company.
Ziploc
An FDC or “new and improved self-emulsifying formulation” would definitely be a better product BUT insurance companies will simply refuse to cover it if it is 1 cent more than gV. The company has been very clear, old and new management, the FDC is only of value in EU as a way to extend the market once patents expire or to negate inevitable price reductions by offering the FDC for the same price as V in later years.
The US market is 100% completely GONE beyond competing with generics on price. Nothing can put the genie back in the bottle. If they successfully sue Hikma, then Apotex will pick up all their generic prescriptions and nothing will change for Amarin. Apotex launched silently. No PR, no marketing, nothing. They make a product to serve the VHTG market and if the consumer decides to violate the patents and use for CVD because their choices were gV for $10 or V for $300 then the Pt needs to be sued (or maybe their insurer), not Apotex.
Gone, gone, gone.
The company, old and new, KM and Saint Denner, have both CLEARLY said the future is the EU. They need to maintain US sales long enough to fund EU roll out until they are cash flow positive in EU, which will be at least another year (or 2)- which is why the SP is $1.30 (just like when the old Amarin was in charge) and will remain there until reliable revenue.
It took 2 1/2 years from Canadian V approval until government coverage and the start of revenue. EU is following the same timeline
(Disclaimer, Canada has a slightly different system where private insurance also covers a substantial percentage of people. Most employed people between 25 and 65 are covered by private insurance and 90% of private insurance plans covered V almost right after approval. In Canada, private insurance is required to cover all medications once approved so not at all like US private insurance that, 12 years later, still frequently doesn’t cover V)
Duke
? What CVD indication? R-IT patents are completely worthless. Whether the pt gets gV or V completely depends on exclusivity contracts negotiated with the Pt’s payer (insurance/PBM). Indication is 100% (not even 99%) irrelevant. Generics are being used “off label” for CVD regardless of any technical FDA indications.
Are there still people on this board who think either the patents or “approved indications” has ANY relevance or significance? The insurance company decides what the Pt gets and they ONLY care about price. HealthNet might have been pushed (via lawsuit) to chose V but I’m sure Amarin gave them a better price as part of the deal.
Exclusivity deals negotiated by KM is the only thing keeping market share over 10%.
Duke/NS/Rose
The last time I calculated, Amarin had about 4 years of sales sitting in inventory and were paying 10s of Millions to get out of commitments to purchase more API. If Teva made an AG they would use up Amarin’s excess inventory and no way Amarin would allow them to use API from an additional supplier, especially CHINA.
I calculated Teva brought in about 400,000 bottle’s worth of IPE just in the month of January.
It’s a concern. It will hit the US market as a gV, and probably soon. They will have to offer it at a discount to current gV to penetrate the market and get sales. The other generics will drop prices to keep sales. Amarin will have to drop their price to keep sales. Margins all around drop.
Generics made from standard chemicals in a lab, like Lipitor, Crestor, ramipril, metformin etc are cheap and easy to make. Lots of generic manufacturers make them. They cost a few cents to make. These have low margins because of heavy competition, where volume makes then worthwhile. IPE requires fish, high tech processing and is not easy to make. Amarin’s cost is under $30/bottle and they sell for over $100. Generics costs may be 50% higher (for example, no evidence to support that) but they are selling for a few dollars cheaper. That is still a good margin for generics. I doubt Teva is thinking of getting out of gV market. They will be exiting the small molecule business.
I talked to my Apotex rep who launched generic Janumet XR (Januvia and Metformin). It used to be they got 70% of brand price as first to launch, after 6 months other generics could launch and the price reimbursed by government dropped to 40%. New law passed that generics get 50% at launch, then 25% when others generic’s launched, which will be gradually reduced to 18% over the next 5 years. He was very pissed off. Payers everywhere are starting to squeeze generics. That is why Sandoz and Teva are changing their business plans. It won’t help Amarin.
The GOAT cardiovascular-inflammation Dr Peter Libby (arguably the best known cardiologist in the world) is giving the plenary speech at ESC next week and his brief promo for his presentation clearly endorses IPE! This will get attention and respect in EU. When he talks cardiologists listen. I doubt even Steve would be dumb enough to contradict him.
Professor Peter Libby will be participating in EAS Congress 2023 with us. In this teaser, he introduces key messages covered in his presentation: Modern approach to dyslipidemia. If you want to experience it live, you can register for: https://t.co/TpzJuEZrWy pic.twitter.com/CZuDoGmxzx
— European Atherosclerosis Society (@society_eas) May 17, 2023
Thanks Mike
The new book by Peter Attia “Outlive” is really good! A must read for health conscious people looking to be healthier in their later years.
Although he did write a bit of a hit piece about the inflammatory biomarker study by Ridker, he mentions Vascepa in his book (although technically incorrect because he claims it is FDA approved to lower LDL in Pts with high TG).
If we could get a huge podcast guy like Peter Attia to support V it would be huge.
Dr Thomas Dayspring is mentioned by Peter several times as a key mentor in his life. I have been going back and forth with Dayspring on LinkedIn and Twitter about Vascepa (Dayspring is DrLipid) but Dayspring believes that all you have to do is lower cholesterol under 40 and inflammation won’t be an issue. He is incapable of approaching ASCVD by any other method that ultra aggressive ApoB lowering. I haven’t been able to get through to him at all that a 2 prong approach should be considered.
When your a hammer, every problem is a nail
Antibluechip
I can’t say with 100% certainty without the full document and more information BUT I believe what you are showing is the PHARMACY’S automated drug information handout (aka Pt information sheet) that the pharmacy’s software prints out. This is not the Hikma label, which is an FDA approved lengthy document detailing all the drug information as presented by the manufacturer to the FDA.
Lab test isn’t covered and costs about $150
JRoon71
“Nearly half of older patients stop taking statins within a year, study finds
BMJ 2018; 363 doi: https://doi.org/10.1136/bmj.k4700 (Published 07 November 2018)
Cite this as: BMJ 2018;363:k4700
Nearly half of older patients prescribed statins stop taking them within a year, a large observational study1 has found.
Researchers analysed data for all adults aged 65 years and older who were dispensed at least one prescription for a statin over the two year period from 1 January 2014 to 31 December 2015. The data came from the Pharmaceutical Benefits Scheme, which collects information on the type, quantity, and timing of drugs dispensed to a randomly selected 10% sample of the Australian population covered by the country’s universal healthcare scheme.”
With statins you get a measurable reduction of a well know, well documented, biomarker like “bad cholesterol” that everyone knows about. Imagine what it’s like when it’s a drug that “does nothing” to anything. Retention rates are very poor. I think this is what BP knew long ago and retail are just realizing. To you and I “25% reduction in MACE” is a no brainer, to many others it’s just a number.
Capt
I’m seeing a significant percentage of Pts who just quit taking it because they don’t see/feel any difference. I tell them about the significant drop in MACE and how brutal a non fatal stroke would be and they respond: “yeah, I guess, but they are big and 4/day and I hate taking pills blah blah blah” and they get to the time to refill and they just don’t.
It’s a tough sell and just as tough to keep the Pt motivated to stay on it
Capt
You do realize that HLS’s CEO was “forced out” recently due to poor Vascepa sales? They called it “retiring” but that is the public spin.
On your chart, can you see the inflection point when Pfizer joined? Didn’t think so. Their partnership hasn’t had the effect HLS had expected. Hmmm, not even Pfizer can change the fate of V.
There is massive resistance to paying for a drug that doesn’t change biomarkers nor do the benefits occur in any measurable way. With no way to tell that an “event” DIDN’T” happen, that otherwise would have happened, it’s a very difficult drug to sell.
Alzheimer’s would change everything (almost as significantly as Kiwi thinks MITIGATE will)
Nuke
$1.20 and falling.
You tell yourself whatever you have to to help you sleep at night.
I’m pretty comfortable with how much I know, what I don’t know, and how my predictions have played out.
GL