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?

As I said, my knowledge in this matter could stand to be improved, but I assume an AG could compete against GV in the category of generics. Now we have sales of brand V declining and Generics gaining market share. If a PBM or insurance co stops covering brand V then at least an AG could still be viable in that situation and take some of the generics scripts in that coverage scenario. Anyway I will sooner or later read any responses but am currently on a Panama Canal cruise so won’t be posting too often for a while. Getting off the ship now in Puerto Vallarta.

Thanks for posting. Well if it weren’t for the Generics and morons still prescribing L and GL (other than for VHTG), the future would look bright for Amarin. I am sure I am not knowledgeable enough about the dynamics of the situation, but absent a quick legal victory (wiping the Generics from the scene) I wonder if an AG is about the only way to take advantage of the projected growth

Thanks Kiwi. I feel your presence as I am sitting on a bench near pier 39 in Frisco, on the way south thru the Panama Canal. Good luck with Vera

Thinking that with Tang getting involved here big time that big things might happen quickly. He does not appear to be someone with a long time horizon.

Thinking that with Tang getting involved here big time that big things might happen quickly. He does not appear to be someone with a long time horizon.

Well the “exceptional circumstances” peaks my interest. If they are in some position that might lead to say a sale of the company then this may make sense. Otherwise. ……. Waiting to see if we hear anything from Lucien.

If it was Denner I believe we would have to see it reported relatively soon after it happens.

Meant to add, that given all that maybe they should just go ahead and do the BB. My thinking is that if the whole plan is to sell the drug to BP (rest of company is worthless) why do they have to worry about delisting?

Hopefully not, but maybe they are like some of us, not knowing how to get out of this condensed spot between a rock and an even harder rock.

I know way back when, management used to say they wouldn’t start an AG as it could affect reimbursements in the EU, but I think we are past that point (I realize Germany, France, Italy are still on the fence). It would be interesting to see if people like CVS Caremark in their commercial plans would still try to shut out an AG. Can’t believe they wouldn’t be liable if they tried to pull such a thing.

I am just overly concerned with the sp sitting for so long. I realize the market does not reward companies for declining revenues and notwithstanding what Berg said (about having many tools) I am fearful of a RS. We would never get our monies back then.

1 and 3 are great questions. I just don’t enough to speak to the BB while the company is dealing with declining revenues.

"Why do you think the script rate is so low especially for these patients with TG's over 150.."

Kiwi, I know you posed the question to Capt but let me take a whack at it.

First, not sure if you saw my previous post but one of the authors of this paper in question has previously authored another where she says:

""Evidence-based practices take, on average, 17 years to be incorporated into routine general practice in health care. This delay creates an “evidence-to-practice” gap where evidence exists about a particular subject, but no action is taken."

So, you have that. Plus you have to realize that Vascepa is not owned by BP. Betcha that utilization rate would be a lot higher if Vascepa had been owned by BP the last 4 years.

Side Note: Had my second visit with my new primary care doc since moving out west. As I was about to leave he said wait a minute I just want one more look at your meds to make sure we haven't missed anything. Looking at his screen for a moment, then he turns to me and says ALL is good. He just wanted to make sure I was on a statin. He said he was on a statin and went on a long diatribe as to how important and valuable it was for both of us (on my first visit he went on a long diatribe of how happy he was to see me on Vascepa and went on and on about its benefits), but he started by saying (and I can't remember his exact words) to forget or completely disregard the cholesterol lowering effect of the statin. He went on to describe the fibrous cap thickening effect of statins and some other feature with respect to protecting us among other things but I had tuned out after a while.

Saw this post on ST:

:$RZLT Opportunity
BTIG raises target price to $15 from $13
Guggenheim raises target price to $15 from $11"

One of the authors also wrote a piece about how long it takes for implementation of new science in the field of medicine:

"Evidence-based practices take, on average, 17 years to be incorporated into routine general practice in health care. This delay creates an “evidence-to-practice” gap where evidence exists about a particular subject, but no action is taken."

https://www.researchgate.net/publication/380844088_Implementation_Science_Strategies_to_Improve_Adoption_and_Adherence_to_Clinical_Practice_Guidelines

Look it is an extremely valuable molecule. It is an essential fatty acid that is required by humans and other animals for normal physiological function that cannot be synthesized in the body.? We have been shown in numerous clinical studies its value in reducing CV risk. No question.

The problem we have is that in the most lucrative market -the US- V cannot grow. It can’t grow because docs, pharmacies, PBMs, and insurers are using Generic V to steal scripts from brand V. Because of the Generics the company has given up spending trying to drum up sales here.

The future (unless something positive on the legal front here in this country happens) lies in the EU and ROW. Unfortunately growth there is very slow. Some important countries have delayed reimbursement and of course those places also have restrictions against DTC making it that much harder to increase usage quickly.

So the molecule is fabulous. The business ramifications of trying to get it to many patients is another story altogether as the situation stands now.

Saw this but it is a few days old:

“(Bloomberg Intelligence) - Ardelyx, Akebia Therapeutics and other makers of oral-only, end-stage renal disease (ESRD) drugs will likely see Congress pass legislation during the lame duck session
that blocks an administrative proposal to move the therapies out of the Medicare Part D program. Some lawmakers have expressed concerns with the regulatory decision, and a delay won't impact federal finances. Passing the bill would remove some near-term uncertainty around utilization and
pricing for newer drugs. (09/04/24)
1. Lawmakers Ramp Up Scrutiny of Regulatory Change Ramped-up congressional oversight of Medicare's implementation effort to incorporate oral-only drugs into the ESRD payment bundle should generate enough headline noise to keep the issue front-and-center for action during the lame-duck session. Lawmakers continue to raise concerns about the regulatory change, and have requested information from the Biden administration on the implementation process. But with only a handful of legislative weeks scheduled in September, major policy changes won't make it to the president's desk before Congress adjourns for election
campaigns. The policy change will likely be folded into a broad-based year-end omnibus bill with other member
priorities such as PBM regulation changes and legislation curtailing biotech research with China.
(09/04/24)”

Thanks Kiwi. I unfortunately have been running around today and just got home and am now going back out to cut the grass. Will listen if I can find a replay.

Going on a Panama Canal cruise in a couple days and of course the stuff always hits the fan when I leave.

Zip, I think you are correct in terms of the value Amarin brings, but this industry is far from the expertise that Apple has, and such an acquisition would never cross their minds.

Absolutely correct JRoon. These pharma don’t spend 100’s of millions unless they knew what they were getting in return.

No question that he was sincere as it is unquestionable that you know Vascepa forwards and backwards. So wonder if you or anyone else remembers whether the Mason (or maybe it was Budoff) study on V and plaque reduction (yes soft plaque) was done only on patients with trigs over 150 or were there some patients under 150.

Saw a heath answer where it was indicated only for those with trigs over 150:

“Another drug, icosapent ethyl (Vascepa) has also been shown to reduce plaque, but only in people who have elevated triglycerides (higher than 150 milligrams per deciliter). Since your triglycerides are normal, it's not clear that this would help.”

https://www.health.harvard.edu/heart-health/treating-persistent-angina

Thanks Sleven. I knew someone would have the correct terminology.

Am I just as dumb as rocks or there a reason that HealthNet is still listed as a defendant in the petition for en banc review? Is it because they were part of the original lawsuit and then they were separated out (not the proper legal term) and then of course Amarin settled with them. Anyway was just surprised to see them listed.

Very good post TCI1. I want to add to this sentence of yours:

“Otherwise, why would 6 generics was a share of 7% of the IPE market? “

At the beginning there were only two, but as the others could quickly see, GV was readily being filled for CV scripts. That encouraged them to join the fray. Everyone can plainly see that GV is being used relatively massively to fill scripts for the CV indication but it seems that will be a Herculean task to try to stop it. Classic example in my book for instance is the commercial plans with CVS Caremark. Vascepa is NOT covered at all but GV is. Anyone filling their script (VHTG & CV indications) through them will only be given GV. Can it be any clearer than that?

North,

“A preliminary injunction might be issued against Hikma, pending investigation/resolution of discovery and any trial that relates to those questions? A final order reinstating the patents invalidated in that first suit could issue, as Hazel-Atlas makes clear.”

You are getting me excited.

Thank you. You are a scholar and a gentleman.

Sleven, ain't it something that we can't seem to find that en banc rehearing petition anywhere? Could it be such items are not posted online? Anyway this is the closest I could come - an article about it. And even though it has a disclaimer that it was previously incorrectly titled, there are still some mistakes (having Amarin and Hikma reversed in some areas) in the body of it:

https://patentlyo.com/patent/2024/08/amarin-review-inducement.html

First of all, DMC8, thank you for posting. Isn't this something like what Kiwi has been asking for?

However, can someone please explain the Results table to me? I am not sure if there is something pertinent in the small print that I am missing, but are those numbers the events in each group? Seems like more events per 100 patient years in Vascepa group, but obviously that is the wrong interpretation by me so I wonder what I am missing? TIA

I hope that they haven't delayed the buyback because of a thought of a potential RS. I know, I know, on the day of the actual split it would make no difference, but we all know that within a few weeks, months of a RS, in 90%+ of the cases, the stock drops again. So these guys I assume are market savvy and might be thinking of that and that they could retire even more shares. I certainly hope not.

I guess sitting here at 60 cents for what seems forever is making me paranoid.

“ safe approved drug, no debt, and $300 million in the bank. “

You are right but the market is focused on growth and for the time being sees very slow EU script uptake being negated by decelerating US scripts. US scripts which up till now had been decelerating slowly but might start showing more precipitous drops with the CVS BS. I know that you and I would take $5 a share and not look back, (which would have been poo-pooed as way to low not long ago), but even that target seems shaky now.

If we could somehow jump to the future 5 years, prospects would be much better, but can the company (and we shareholders), last that long. A RS and we are cooked.

Would be subtracting $3,000 on line 7 of form 1040 every year till I take my last breath.

Could, Japan approval is a possibility, since the news of the dosing of the first patient in the AUR200 trial was yesterday so it shouldn't be that. Of course we are always last to know.

Maybe it is investors seeing the video that Kiwi posted about a few days ago?

You were saying?

Seems to corroborate:

"Conclusions
Our analysis indicates that among primary prevention-type patients without diabetes aged 50–89 years and not on statin therapy, the lowest risk for long-term mortality exists in the wide LDL-C range of 100–189?mg/dL which is much higher than current recommendations. Our analysis also shows that lower T-C/HDL-C and triglycerides/HDL-C ratios are independently associated with lower mortality risk, whereas LDL-C appears to be of limited to no predictive value. Collectively, these observations suggest that adult patients without diabetes counselled for primary prevention of ASCVD be apprised of their estimated future risk of ASCVD with minimal consideration of their LDL-C concentration and more consideration of the T-C/HDL and triglycerides/HDL-C ratios along with other established causes of ASCVD (eg, high blood pressure, smoking, physical inactivity) and potentially coronary artery calcium scoring."

https://bmjopen.bmj.com/content/14/3/e077949

““The threat of protracted litigation through fact and expert discovery is enough to deter generic competition,” Hikma warned,”

Okay, if this case proceeds I want to see Hikma stop selling GV

Thanks Kiwi. That seems like a pretty good chunk of the CHD population.

Thanks. Anyone know when time limit for a ruling on this? TIA

Does anyone what percentage of people have high sdLDL?

I guess whether the FDA accepts it (60 days?), and ultimately approval would mean more to the sp

Well yes and no. Ozempic and Wegovy are the same drug but slightly different strengths. Ozempic is approved for people with diabetes and Wegovy is approved for weight loss. Semaglutide.

Nuke, glad to hear that you are doing so well. I will turn 73 in March (if I make it that long) and although I seem to estimate myself better than the average 73 year old that I see around me, I don't feel that I am anywhere near as good as you. Bravo.

As far as Vascepa knocking down your cholesterol in half, I would have to say that scientifically, through the thousands of subjects that Vascepa has been studied clinically, that is not a degree of cholesterol lowering shown by V.

This is why all the years Amarin lost could come back to bite us in the ass. There is always something new coming around the bend. Studies now beginning to show that these new weight loss drugs might slow down aging and all the concomitant diseases. And of course as the medical community gets excited about these, we get left in the dust:

“
"These ground-breaking medications are poised to revolutionise cardiovascular care and could dramatically enhance cardiovascular health," he said.
The studies - part of the Select trial - tracked more than 17,600 people, aged 45 or older, as they were given either 2.4 mg of semaglutide or a placebo for more than three years.
Participants were obese or overweight and had cardiovascular disease but not diabetes.
Those who took the drug died at a lower rate from all causes, including cardiovascular issues and Covid-19, researchers found.
People using the weight-loss drug were just as likely to catch Covid but they were less likely to die from it, with 2.6% dying among those on semaglutide compared with 3.1% on the placebo.
And while women experienced fewer major adverse cardiovascular events, the drug "consistently reduced the risk" of adverse cardiovascular outcomes regardless of sex.
It also improved heart failure symptoms and cut levels of inflammation in the body regardless of whether or not people lost weight.”

https://www.bbc.com/news/articles/ce81j919gdjo