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Either:
Route A- ( Supreme Court- shellacking, likely IMHO-so much for the luck of the Irish!)
$10-15 on China approval+ CVR based on US sales of say $5-10.
The supreme court judgment is the block on a BO at present although Amarin can make a good back up argument on scarcity of API supply to protect the US market its hard to put a value on that- maybe an earn out/CVR based on US sales over say 3-5 years?
Route B- (Supreme Court- victory, unlikely.)
$30+ ( to 'da moon as those pesky kids say)
And either route within a year.
Thanks Raf, interesting the Generic V numbers remain "choppy" behaving like they are having issues with supply.......perhaps. We hope.
that's big news. Thanks.
The FTC investigation. Interesting Amarin hasn't mentioned this yet as far as I have seen. I would have thought Hikma instigated the investigation but it doesn't read like that though.
hint of sour grapes perhaps...Johnny T wont let me play with the train set so I had to tell teacher, haha....
yep, probably.
Well 90 minutes , seems like an awful long time to tell us its failed......
( emoji side eyes!!).
Thanks for the effort and worth asking the question then I see as we may get nothing until Monday.
ok understood, that's what we are looking for the " meeting highlights" for the January 2021 meeting(with minutes of meeting some way behind that time wise) and yes it appears to be the Friday of the week of the meeting each month. So the MB knows its apples from its onions.....never in doubt....!
And of course, thanks!
Excellent work. Pretty blatant!
Might be worth sharing with Marksman Advisors also as no doubt they are putting together their analysis as we speak.
CHMP. Looking at this the CHMP only put up minutes for the October and November 2020 meetings earlier this month and the minutes for the CHMP December meeting aren't even up yet. Why are we all convinced we will know the outcome from the January (...Monday) meeting this Friday out of interest. Is there some other publication route?
Apologies if I am being a little slow, but always best to ask and then understand......
https://www.ema.europa.eu/en/committees/chmp/chmp-agendas-minutes-highlights#agendas-section
Deep fried pangolin is highly calorific apparently and a little chewy.
BB, I think a deal ($ + CVR) post European approval is probable.
China.
worth a re read at this point. I note that not only does Amarin receive milestones and royalties but it also supplies V to Eddingpharma for China. Presumably with a margin on sale?
https://investor.amarincorp.com/news-releases/news-release-details/amarin-and-eddingpharm-announce-agreement-develop-and
Haha. Looks like you're right STS. Almost comical. Looks like Amarins dealings in China will be......… shall we say "interesting". (...the lack of emojis on this site I find debilitating at times BTW....)
My thought is that the threat of the litigation itself, the soliciting of potential claimants in the press, the publicity arising in the trade and actual press etc,etc would have a large impact on 'scrips and would cause a switch to V. Whether the claimants win it in a couple of years down the line ( without sounding too sociopathic...) is neither here nor there. Question then being is there some sort of case not whether it is a winning case.
well I'm a lawyer Raf but not a US one nor a litigator.....
that said the definition of negligence in the US looks very similar to the one we have on this side of the pond:
"A failure to behave with the level of care that someone of ordinary prudence would have exercised under the same circumstances. The behavior usually consists of actions, but can also consist of omissions when there is some duty to act"
So to your question re an off label scrip, I think yes there's potential for litigation there as I think the ordinary level of care should extend to knowing what a drug is indicated for and for that matter what other drugs are on the market which could help the patient. Which V could and the cost of V not being a barrier also.
All IMHO.....and I defer to those US lawyers with more direct and relevant experience. It's as much a gut feel that its not right. Which often isn't a bad place to start with legal matters.
Raf- I take the point that Lovaza is lowering TGs as per the label but given the link between high TGs and heart/CV problems generally surely the Docs acting in a clinically responsible way should be prescribing Vascepa.
I'm not saying the Pharma companies are doing anything wrong as their claim in their label only relates to lowering TGs ...it's the Docs themselves who should know a lot , lot better IMHO. Even a non-specialist general practitioner should see enough people with CV/high TGs on a daily basis to get some degree of specialism and they should actively acquire knowledge of the latest science in this area( inc. V and Reduce-It !) .....these aren't rare diseases after all.
p.s and yes, I would agree perhaps pancreatitis sufferers taking Lovaza are a sub set that is removed if viewed as not being within Vs proven reach.
Litigation….and not to take anything away from all your noble efforts on the Rule 60 litigation. But another thought and one I have had for a while.
Every Friday I get more than irked, when I see the ‘script numbers, by all the idiots still prescribing Lovaza ( generic or otherwise) notwithstanding every study so far indicating it has no long term impact beyond “lowering very high triglyceride (fat) levels in adults”, that is there is no scientific basis for Lovaza reducing CV events. Whereas Vascepa is clinically proven to both reduce TG and lower CV events. And V is cheap! So surely its negligent for Doc’s not to cover both linked ailments at the same time and prescribe V over L.
So I wonder how many people have had a CV event whilst on Lovaza post the Reduce It results being published? Presumably a lot. My thought is that one of those mildly rabid ambulance chasing law firms could have a lot of fun running a class action in gross negligence against those prescribing bodies, insurance companies etc,etc still pushing Lovaza at its punters where the punters have either subsequently died or suffered some other significant CV event whilst on Lovaza. Point being that they may not have died, had a heart attack etc,etc if they had been properly prescribed Vascepa.
Just imagine the impact that action would have on the sales of Lovaza and in turn Vascepa in short order.
Anyone know someone in one of these firms as I am sure this would merit a conversation and these guys could I believe run a class action on a contingency basis so no cost......
...but who are Eton Pharmaceuticals to Amarin BB? Eddingpharm are the local distributor/licensee in China. This could well be bogus. Although why go to all those lengths to mock something up and not put in Eddingpharm......it is a little weird.
If it is true then it's surely PR'able.
China. A little perplexed - Amarin's Chinese partner is Eddingpharm not Eton Pharmaceuticals.
https://investor.amarincorp.com/news-releases/news-release-details/amarin-announces-commencement-vascepar-clinical-development
Thanks T. So according to my school boy maths Generic V has 5.95% of the Vascepa market.
Isn't that still below the Marine/high trigs % of the whole?
i.e. perhaps the litigation has at least slowed them down a little in the meantime. Although I would much prefer it that they just can't source API to make their crappy product.
Great, that should kick any potential bad news ( unlikely but possible) beyond the highly important CHMP opinion for the European approval. Limits downside risk for a while and should help the stock price in the run up to CHMP.
Hopefully...........
I think with the pandemic and the generic entry this isn't great but could have been a lot, lot worse Skip. I would be interested to see numbers on how quick and hard generics hit the market in a non-skinny label scenario like we have here.
Is that where JT keeps his gold HDG?
https://www.bbc.co.uk/news/health-55312505
There you go Kiwi. Like I believe most (..if not all?) Coronaviruses, it mutates.
FFS, I'm a big supporter of your graphs, your volcanoes and your rocket ships. Above all your sense of humour and dry wit. Has been much needed over the last few months- so cheers!
BTW, as a general rule of thumb, I think anyone resorting to aggressive behaviour and caps lock has probably already lost the argument. Fun to watch you play matador with these raging bulls....( ...raging bears?!).
Haha, generic Vascepa. Have they run out already?
Perhaps they were just drawing our fire with their "limited ( ....and crappy!) quantities"?
...and thanks as ever T!
ok understood, thanks M!
.....but its a jury trial right so whilst he may lead the jury somewhat it is the jury who decides not the judge or am I being thick?
Long covid is a big thing in the UK and presumably elsewhere for those who have had C-19 with Docs just starting to understand those after effects. Wonder what impact V would have on that.....
I spent all my formative years in the UK thinking the Dukes of Hazard was a bawdy knock about escapist bit of larger than life TV. After the Du decision, the Court of Appeal shambles ( 10 minutes or so, no legal reasoning , clearly not studied the briefs in detail ( Mr Du- huh?) and no written judgment)- I’m starting to wonder - was the Dukes of Hazard a fly on the Wall documentary. I have no faith in the US legal system.
Thanks for your efforts Marjac and to everyone else who tried.
I was discussing this the context of the AZN v Apotex case and potential patent infringement of the R-IT patents down the line by Hikma, with Hikma needing to be very careful. That is of interest.
En Banc looks like a slow walk to hell (or back to a US court, as they are I believe one and the same!) as far as I can see.
Star witness Z?
So on Dec 13 2019, Reduce it approval day (...remember that folks!) -VASCEPA total net revenue guidance increased for 2019 to a range of $410 to $425 million and for 2020 is newly guided to a projected range of $650 to $700 million.
So $410 million p.a was a base marine figure ( ......probably much less with off label for reduce it type patients at the time) after 6 years of being on the market for marine.
slide 17 of presentation also of note for sales both pre and post R-It.
https://investor.amarincorp.com/static-files/d6b5bb48-f4f6-4d84-b565-37abd27d3f6a
.....wasn't quite as technically able as you HK. Thanks.
Couple of points arising the number they cite appears to be more that just a marine indication number and they have a solid record for settling cases with other pharmacos.
https://www.hikma.com/media/2676/38th-annual-jp-morgan-healthcare-conference-presentation.pdf
yep I see it Raf. Page 12 I also see their record for settling cases.
ok so not mad, just a little forgetful. Wonder did anyone manage to screenshot this before Hikma took it down? Context would be interesting.
Did I dream it or didn't Hikma put a slide up at a conference presentation with large, large numbers showing for its prospective sales of generic Vascepa, only for somebody to point out that this would clearly include the reduce it population, not just marine. They then amended the presentation rapido.
If that was the case, and I'm not going mad, then that is pretty damning evidence as far as any subsequent analysis of intent and in turn infringement is concerned.
Having watched the US legal system throw a judge with a non science/pharma or patent background at this at first instance ( suggestion- specialist patent court with specialist judges) I raised an eye brow.
Then at the OA Judge Dyk didn't even know Judge Du was female and asked Singer to distinguish the Novo case ( erm....read the relatively short brief we provided to you some time ago Judge Dyk -which does just that)-conclusion he hadn't read the pleadings or studied the case that hard; and then 25 minutes or so of semi-engaged "analysis" of something with thousands of lives and billions of $$ at stake.....
.....may as well make it a drive 'thru appeal and add fries.
What a mess.
Novo case was distinguished. See page 4 of the Singer brief. This should all be viewed in the round.
https://investor.amarincorp.com/static-files/b99a2ce7-5fe4-4eea-bea0-963bab4f12d8
But your “ I’m much wiser than you” thesis rests on a flawed judicial decision. Everything else flows from that. Being a contrarian in this sector ....you get to be right most of the time. Well done you........
Other that that I was always GIA once the opportunity arose and they would have been good to go if Du knew her arse from her elbow.
As to the appeal, yep I’m twitchy. Have fun trolling the masses and watch out for that karma, it’s a bitch.
Moderators....any chance of you guys taking all this off topic reactionary political crap off the MB?