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For V users - I just checked Medicare Part D plans for 2023 in my state, Elixir Rx Secure PDP price for 0.5 g one month supply is $64.44, Cigna Secure Rx PDP is only $33/mo - that savings for Cigna is $377/yr (deductibles are the same at $505). The 1 g dose is even cheaper, but I didn't look up those prices since I take the 0.5 g caps, but annual savings should be similar.
Clearly they decided to allow their CVD patients to suffer elevated event rates compared to countries willing to pay a reasonable price for V. Ruthless does not belong in the conversation with health care.
The UK should have already set an EU price - didn't they settle on $180/mo or something? Look at CaptBeers net sales numbers in the US over the last 4-5 yrs:
https://charts.stocktwits.com/production/original_472046104.PNG
AMRN went from making ~ $135/monthly scrip down to $100 starting in 2022 - I don't know what "Amarin begins exclusivity contracts" means, but it chopped 26%/script of net revs from AMRN's US sales, and they lost money in Q1/Q2 - clearly that's not enough to support the company. They've never had a profitable quarter in their existence due to non-cash exec comps (~ $80M/yr on free stock to execs and the BOD annually), most they ever made not counting that expense was a few cents - if they were losing money at $135/script, they'll go BK at $100/mo.
Germany asking for 50% off from what the UK is willing to pay, or whatever number AMRN started at ($250?) is not going to happen - AMRN can't sell V at a loss just to sell more volume. This is another case of horrible timing for AMRN - the cost of coal and NG Germany is paying has skyrocketed because of the Russia/Ukraine crisis, and their new austerity plan was in motion even before that happened. Their new proposal to cut orphan drug spending from $50M/yr to $20M/yr per drug is hard to believe - that plus their refusal to agree to a reasonable price for V shows they don't give a damn about helping the unhealthy part of their population, almost like survival of the fittest is the new manta.
They settled on a price with the UK - Germany must want it even cheaper, and AMRN wouldn't budge - asshats.
But AMRN did not get it's 12 month free pricing window, so they won't sell a single capsule of V in Germany until well over a year after the EMA approved it.
AMRN fucks up again - they're closing Germany operations completely because they could not agree on a price - god knows when V will be available in Germany:
So when exactly will AMRN be able sell V in Germany? This is bizarre - could only happen to AMRN, timing-wise and impact to the company.
So why the hell did AMRN spend a DIME on German field reps if nobody could buy the drug w/o reimbursement?
Are you sure that plan went into effect? Appears the bill is still being negotiated:
https://www.globalcompliancenews.com/2022/07/19/germany-german-government-announces-bill-to-drastically-slash-drug-reimbursement-08072022/
On 8 July 2022, the German Health Ministry has officially shared the second edition of a new bill referred to as the Act for Financial Stability of the Public Health Insurance (GKV-Finanzstabilisierungsgesetz, “GKV-FinStG“). The bill is still subject to discussions with stakeholders and several rounds of congress hearings. If ultimately implemented, which is a likely scenario, pharma companies will face several painful cutbacks on the statutory reimbursement of prescription-only (“Rx“) medicinal products. The dawning global economic crises, foreshadowing diminished funding available to the German statutory health insurance (SHI) funds, may accelerate the momentum for signing the bill into law.
Pharmaceutical companies should brace themselves for yet more pressure on revenues, and wherever possible take proactive actions to get adequately prepared.
I'd almost laugh if this weren't so typical for AMRN - as soon as they get approval a disaster occurs - COVID in the US, the DUbacle, now this - Germany decided to enact the Austerity program just when V became available? Unbelievable. Do you know when this was enacted? Meaning we really haven't sold a single dose of V in Germany?
I assume you're referring to AMRN yanking reps out of the field in Germany? Can't believe that's tied to the energy/natural gas problem - the Q2 PR I saw mentioned something about being in the fourth round of price negotiations and that they were pulling reps out of Germany - didn't exactly give a specific reason. I also didn't see any Germany specific sales data - they only mentioned Canada, China, and the ME region - are they really selling no V in Germany yet?
As far as the Ukraine/Russia NG (and coal) sanctions, Putin is not going to give in - withholding NG is his only bargaining chip with the EU. Germany and other EU countries are learning the hard way that closing down nukes and coal power plants before renewable energy sources were ready to replace them was a horrible idea. IIRC, Germany is going to cut NG supplies to businesses by 50% - that means they're going to have to shutter the factories that absolutely depend on NG, which is probably most of them - even if they're not using NG to make their products they likely heat the factory with NG. Office buildings may suffer the same fate - nobody heats buildings with electricity, way too expensive and inefficient.
Since this energy problem is EU-wide, yes, I expect it to put a huge dent in V sales - governments will be scrambling to cut costs everywhere - LNG costs about 4x more in the EU than it does in the US, and importing LNG to turn it into NG is the only way to escape the stranglehold Russia has on the EU NG market. At least my GLNG stock is benefiting from this, up 84% YTD, most of the gains since Russia invaded - they've sold two FSRU's that had been sitting idle for a few years to Italy - FSRU's take a shipload of LNG and turn it into NG that's pumped into existing NG pipeline systems onshore.
I never believed in that "natural fats" like those found in red meat and butter were bad for you - humans ate those foods for a couple thousand years, we adapted to deal with it, or even need it - what really happened that increased CVD was the explosion of vegetable oils in all kinds of processed foods - humans didn't start consuming those man-made fats until the last 50-100 years. Throw in substituting HFCS for real sugar and you have a massive increase in obesity and CVD.
The low baseline Lp-PLA2 levels are a real puzzler to me, around 130 is only a few points from optimal levels - they went up +25% - but does a level of 163 indicate higher CVD risk? We don't know the answer, because levels in V patients didn't change at all. If something like hs-CRP went from 2.3 to 3.4 that's a large % change, but 3.4 isn't really a high level. I think what Bhatt tried to point out is that the only clear correlation of CVD risk R-IT data revealed was that the level of serum EPA is what matters - they went up 400% in V patients.
No explanation for why the MO group saw changes but the V group didn't , but they mentioned something might have been going on within other inflammatory pathways with biomarkers they didn't measure:
I thought about that, but what are the chances V kept all of those biomarkers from moving up or down over 5-7 yrs? If they moved either direction I think you could say V was doing something, but for them not to move at all is just weird - unless MO was causing the changes in the placebo group.
Lp-PLA2 went up +25% in the MO group - and that's a risk factor for CVD - link shows results of a Google search that brings up tons of articles published by well known health groups and journals for you to peruse:
https://www.google.com/search?q=Lp-PLA2+risk+factor+for+CVD&ei=mcHBYpjLC8GliLMPkoC6sAs&ved=0ahUKEwjY-87ij934AhXBEmIAHRKADrYQ4dUDCA0&uact=5&oq=Lp-PLA2+risk+factor+for+CVD&gs_lcp=Cgdnd3Mtd2l6EAMyBQghEKsCMgUIIRCrAjoECAAQRzoFCAAQgAQ6BAgAEEM6CAgAEIAEEMkDOgYIABAeEBY6BQgAEIYDOgUIIRCgAToICCEQHhAWEB1KBAhBGABKBAhGGABQ5ANY9SRg2SloAHACeAGAAbUCiAHYEpIBCDEyLjcuMC4xmAEAoAEByAEIwAEB&sclient=gws-wiz
First article on the list:
Thanks to North for mentioning that article - link to the full PDF is in the upper left corner of the URL you posted - I just finished reading it, and it's pretty clear MO is not inert as AMRN claimed - even at such a low dose it did something bad - but finding out why would be very expensive and may not reveal a direct cause/affect relationship - metabolic processes are beyond complicated. (see links below).
From your article - shocking that no anti-inflammatory effects were found in the EPA group - almost all of us on V have reported greatly reduced inflammation, like DES being cured with V - for me it relieved a lifetime of chronic lower back pain plus DES - JL claimed DES was an inflammatory disease. EPA must reduce inflammation via a pathway that didn't have it's biomarkers measured in R-IT.
Thanks for digging up that R-IT data! I've been waiting with baited breath for several years for AMRN to publish a smoking gun link between Lp-PLA2 and CVD/stroke risk they found in R-IT, but now I know I'm not going to get one - the data shows no correlation. Color me surprised, if not shocked - I explain below:
I'm not surprised there was very little change in Lp-PLA2 in R-IT in the V group - but a level of 134 is almost normal - sorta throws shade on my long held belief that Lp-PLA2 is a significant risk marker for CVD - perhaps it's just a marker for stroke risk? Most of these patients should have had inflamed arteries - that's part of heart disease - very odd that levels were so low at baseline - but the MO group's levels went up by 25% during the course of the trial - to me that shows disease progression, but still doesn't explain why levels were so low to start with. I would love to see a breakout of data between patients with established CVD and those who were in the trial for primary prevention (risk factors but no CVD) - wonder if the latter group, being healthier, artificially lowered the baseline number.
Interleukin-6 and hs-CRP are or can be transient responses to acute trauma or infection - 5 years ago when a tooth with an old root canal got infected, forming a massive abscess, that required pulling the tooth and installing an implant***, my hs-CRP soared from 2 to 9. I'm not concerned with those results, too many things can make them go up or down. Results for homocysteine were unremarkable for both groups, very little change - but as I wrote, I would not expect EPA to affect levels - homocysteine is almost totally controlled by the intake and absorption of several crucial B vitamins, and the body's ability to use those B's is directly related to the MTHFR gene, and I have a defective allele on that gene (it's only half functional). I take methylated forms of 3 B vitamins (6, 9, 12), but it's hard to impossible to take enough B-12 to overcome the MTHFR defect - the amount contained in DS is extremely tiny, as in 3 to 5 micrograms (6 and 9 are mg's). Several years ago I tried doubling my B-12 doses but it caused intense itching of the skin of my back - the keep you awake at night kind of insane itching, and it was not dry skin - I tried applying moisturizing creams plus almond oil several times per day - nothing worked - but the itching went away when I went back to my prior dosages. There's a medical cause for that B-12 itching but I forget what it is.
**** I saw a holistic dentist to treat that abscess - we attempted to keep the tooth with injections of ozonated water and antibiotics, but they only reduced the abscess size a little bit, tooth had to come out - that infection could have gone into my brain or heart because it had direct access to my bloodstream. When he pulled the tooth the stench was unbelievable, almost made me retch - he said there was a mass of infected tissue the size of a small gumball attached to the roots. When he walked out of the room into the hallway with his assistant to dispose of it he whispered to her "that's why we don't do root canals" - it's hard to remove all of the live tissue, and if any remains it can get infected if the root sealant leaks. In this case I had been using a wrench to try to remove a stubborn bolt from something in my shop, and when it suddenly broke free my hand snapped straight back into my mouth, smacking the gums above that front tooth with the end of the wrench - ouch! Ended up costing me $5k - implants are EXPENSIVE!!
Median baseline Lp-PLA2 levels in ANCHOR were extremely low for people with established CVD (70% of total) or multiple risk factors for CVD, including diabetes (30% of total) - I'm assuming ANCHOR enrolled the same %'s as they did in R-IT - actual number of people with CVD could have been even higher, but Lp-PLA2 of 180 is barely into the "High" category.
I started V in 2013 because I had my Lp-PLA2 tested after reading about what it represents here (level of arterial inflammation and nothing else) because of family history showed my risk of developing CVD was high (I'm now the only male who hasn't had an MI and/or multiple stents) - my levels were a scary high 497! Risk of stroke was 4x the normal population - after 6 months on V mine were down to optimal level of < 123 at 115, and it's gotten as low as 93 over the years. I don't have high LDL-C, I do have high TGs (250-500), but my CAC scan was clean as a whistle, BP is high normal - I basically have/had no CVD risk except for Lp-PLA2 and homocysteine, although the latter is tied to mitochondrial dysfunction I have due to some genetic damage and V hasn't budged it (wouldn't expect it to either).
So why was my Lp-PLA2 so high compared to ANCHOR patients when I have no other CVD risk factors? Periodontal disease can elevate it, but I've never had anything beyond some mild gingivitis episodes as an adult that disappeared after a thorough dental hygienist cleaning (I've always been a lousy flosser, fingers are too big to hold floss in my mouth and reach the molars).
Thanks for the unnecessary and undeserved insult - expect better from you. How else do you interpret this statement except for "MO did something bad to placebo patients and we don't know how it could have affected R-IT results"? Don't give me reversion to the mean - we're not talking about LDL-C levels here.
They're hiding in shame - Herpes says AMRN funded that research paper - it shouldn't have been published, throws some real shade on R-IT results. There is no way AMRN can defend this and say MO did nothing bad - their own research shows it did.
There is a smoking gun in that damn research paper - it basically says MO caused those biomarkers to go up and even questions R-IT results - it doesn't get worse than this, and they were backstabbed by their own experts, including Bhatt.
You don't call AMRN in it's current state a fail? The short bashers won, with huge assistance from bungling management.
She posted the link already:
https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.122.059410
I'll bet that's the new analysis Matt Herpes from Statnews used to diss V again today - he said an AMRN sponsored analysis was used to question R-IT results. It shows MO had a negative effect on certain biomarkers, and the diff was not because the V group had lower levels - the V group's levels stayed the same. Why the hell would AMRN publish a study that actually shows MO had bad effects on the placebo group?!?
Sickening - GV now has 40% market share, but might they stop at 50%? IIRC the API supplier for Hickma and maybe DRL was expanding their facilities to be able to fill 50k scrips/wk - GV now is 38k/wk, V 63k/wk - unless more API capacity comes online, V and GV will end up splitting the market at 50k scrips each. Total O3 market has basically flatlined, GL is flat, which means V/GV scrips are flat at 100k/wk - a fraction of the people who should be on V will actually ever take it - how many lives will be lost because of Du's decision?
Yeah, and the pigs continue to feed at the trough of handing out free shrs to execs - they want to add 10M new shrs to the kitty for distribution, and claim 'tutes back this crap - what about revoking the RSUs given for breaking $500M in US revs now that they're below that number?
https://investor.amarincorp.com/node/21961/html#toc651622_13
The second I read the first link saying “Mineral Oil plays no role in the absorption of statins and changes in LDL-C nor in outcomes.” one of Nissen's complaints popped into my head - and I'm talking about it only took a split second for me to recall this - hs-CRP in the placebo group doubled - that was part of his proof that MO was interfering with statins, because they lower hs-CRP. AMRN claimed reversion to the mean I believe, I don't recall if the V group's levels went down or not, but I think not by a stat sig amount - rise in placebo group was definitely stat sig.
The EPADI doc is extremely well done (as usual, you guys rule), but it apparently didn't change the minds of the NICE committee - which makes me wonder something - is it possible there's and egotistical dominant member of that group that strongly believes MO affected R-IT results, and he's intimidating the other members into going along with him? Meaning they have a Nissen on their team? Don't forget the ACC/AHA still haven't put V on their CVD guidelines, saying the MO issue clouds R-IT results and a 2nd trial using a different placebo has to be run to confirm them.
If he only hit it 203 yds on #1 he probably bogeyed it - that hole is 445 yds long, he'd have a longer shot in than he hit his tee shot - and it's almost a straight hole, no dogleg that calls for a short lay up. #2 is a 575 yr par 5, he's also in trouble if he hit it 203 on that hole. Looks like he did ok, finished 1 under par, leader in the clubhouse shot a -4 in the first round with TWO double bogeys - he must be hopping mad. Frankly, after wincing while watching Tiger and his son play in that charity tourney end of last year I can't believe he actually made through an entire round on that hilly course - it's known as one of the hardest courses to walk in the entire world, TV doesn't give it justice as far as elevation changes.
Same thing goes for probably the most (in)famous par 3's in all of golf, #17 at TPC Sawgrass, where they hold the PGA championship. There's a company that builds golf courses called "Renditions", where they duplicate some of the most famous hole in golf - one of them is Sawgrass #17, the island green - on TV it doesn't look like there's much elevation change, but when you play it for real (there's a Rendition's about half an hour from me) it's unbelievable how the heights of the three parts of the green are - you hit it long middle or left when the hole is in the customary lower right location, when you're standing over your putt you have no clue how you can get it over the edge of the hill and get it to stop before it rolls into the water off the right side of the green - that's how steep it is - like 15 ft below you. Amen Corner is also duplicated, and boy is that part a real treat! Best I ever did there was bogey #11 (a real bitch of a hole), birdie the par 3 12th, and birdie the par 5 13th - playing those holes in 1 under during the Masters is a good score for the pros - the green on #12 is so skinny, maybe 10 yds from front to back, it's unreal.
The hardest hole at Renditions is actually the replica of the Scotland's Inverness Club #12 - a short par 3, plays about 140-150 yds, but the green is steeply sloped from front to back and left to right - the only way for most amateurs to keep the ball on the top front of the green, where the hole is usually cut, is to bounce your tee shot into the slight slope in front of the actual green - if you hit the green you're going to end up long right no matter where your ball lands - it's impossible to hold the green unless you can put a ton of backspin on the ball, which most amateurs cannot do, especially off the tee.
I read the NICE page to say they're taking public comments until April 16 - I don't think AMRN gets another bite at the apple to try to convince NICE of V's benefits - I'd have to go back and read the first review's text, but IIRC they were even harsher on V as far as possible MO effects on R-IT results - I don't remember seeing 7%-13% before. The 2nd review release was after AMRN reps met with NICE again, and they failed to change their minds. Don't think there's anything anyone can do at this point, but if you think flooding their website with comments disagreeing about their conclusions will help go for it - though it would be better if potential Brit patients were the ones complaining rather than US investors.
What I really don't understand with the UK's position is something like a dozen EU health organizations have blessed V for R-IT patients - UK is saying "you guys have been hoodwinked, we know better"? I really think this is just about money, plain and simple - UK knows it will cost their healthcare system > $26M/yr if they cover V, and that's sort of their breaking point - they actually ration drugs over their by cost/benefit, like only a certain number of patients per year can get Hep C cured by drugs. I don't know how the real doctors on that decision team sleep at night knowing many people will die because they couldn't afford to pay for V out of pocket.
TGs 150-499.
I doubt the UK's ICER folks and NICE members are listed publicly - and what would you do if you had their names anyway? I read here that after the 1st UK review there was a meeting between AMRN reps and NICE, and whomever watched and wrote notes about the meeting was raving about how well AMNR did to rebut the 1st review's problems - but there was zero movement by NICE in this 2nd review, and this is the last one - it's over - V is not getting UK coverage. How many other countries will also discount R-IT results over MO BS and refuse to cover V because cost is more than benefit in their eyes? If that asshole Dr. Nissen was standing in front of me right now I'm not sure I could control my temper and keep my hands off him.
Don't know if this has been posted here already - 2nd review of V by UK's NICE again says no insurance coverage for V because of the MO bullshit - UK is one of the top 3 EU countries for potential V sales - AMRN is going to lose a huge % of future EU revs:
https://www.nice.org.uk/guidance/gid-ta10736/documents/129-2
Thank you! So Hikma will not be part of the trial, and AMRN cannot appeal them being dismissed from patent infringement until the case against HN is concluded and a ruling made, correct?
Were you surprised Hikma was dismissed, or why the judge refused to sever?
Nevermind - I see marjac posted about what this means.
What's the diff between dismissing the case against Hikma and in not being a final ruling? Did you read the CC transcript where KM says:
In any case, he dismissed Hikma entirely, correct? Otherwise what would AMRN be appealing? They definitely did not want to sever the cases.
Tried to edit my reply to sleven but it took too long, so I have to make a new post.
OT question - has anyone besides me noticed that IHUB is working differently than it was about a week ago? I suddenly cannot find replies to my posts by clicking on the "Mailbox" link - I sent this PM to the admins:
D
I agree with your assessment, although it's not exactly logical - the court declined to sever the claims filed against Hikma and HN, but he dismissed the claims against Hikma. Read the CC transcript - KM even says they are going to appeal the dismissal of Hikma. What's illogical is how can you dismiss Hikma w/o severing the claims? Only way that make sense is if there were zero overlapping claims. How the judge could dismiss Hikma just from reading briefs is beyond me - that means they had an overwhelming defense that they were not infringing - also points out the any attempt to connect this case to GSK/Teva were misguided, the behavior of Teva was obviously infringing, and Hikma was not that stupid.