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I am still awaiting more news from Amarin, fleshing out any new developments in the patenting of LR-Et-EPA or any future plans to market it.
Lymphoma is an all too common, potentially deadly cancer...and this disease could benefit from a treatment with an EPA drug... LR-Et-EPA could be a safe and relatively inexpensive treatment for Lymphoma...along with current treatments...such as Chemo, Antibody drug conjugates and Car-T therapies, which are all not only very toxic, but also very expensive.
I guess what I am trying to figure out is if AMRN were acquired by BP,
and they ran appropriate studies for new indications, lets say they were
able to achieve 5 new indications, would that add 5 years to exclusivity?
In other words how difficult would it be for a BP to continuously extent
exclusivity which would keep their revenues growing for an extended
period of time. Seems to me that any Eurocentric BP would use such
a strategy if they were confident of Vazkepa's effectiveness and utility.
Thanks North. I wonder what PFE's thoughts are of their involvement with V in Canada in the relationshiop through HLS. Do they view Vascepa as a successful drug to promote in the US or in the world? Are they better suited to sell V in EU than say Novo Nordisk who is more Europe centric?
I 'll state the obvious that everyone knows.
We need;
A positive response from the judges regarding the Hikma case to move
Italy and France on board in Europe. And of course Germany but that is 2025 timeline.
Buyback of shares
New indications for V
New US product in either packaging or Mochida product to fight generics
Probably more, but it seems to me that all of this will occur before EOY '24
Exclusivity and patent protection are two different things. New drugs are granted “Exclusivity” according to this formula:
8+2+1 = 8 years without anyone filing, 2 years before any application is looked at, and one additional year for any new indication.
Patents in Europe are generally good for 20 years but can be extended under certain circumstances.
Worth noting regarding Amarin's potential future sometime after early June:
".....In the same note, he listed his critiques of the Pfizer operation. Pfizer has "struggled until very recently" to develop biologic therapies, he wrote, and has failed to extend important cardiovascular businesses beyond its drugs Eliquis and Vyndaqel, whose patents will soon expire...."
Perhaps Dr. Baum and Dr. Denner met while at Morgan Stanley:
https://invest.ameritrade.com/grid/p/site#r=jPage/https://research.ameritrade.com/grid/wwws/research/stocks/news/article?c_name=invest_VENDOR&docKey=1-DN20240506002257-002257
Some say that PFE's M/A activity is not finished in light of Dr. Baum's new position, reporting directly to PFE's CEO, Dr. Bourla.
Does anyone know if EU patent exclusivity could be extended any further to beyond
the current 2039? (I thought in the past I read that certain new trials / new indications
could add on time.) Given that there are so many possible further indications for
Vascepa I wonder how much (if any) additional exclusivity status time could be
earned?
There are two kinds of migraines: chronic which you referenced (CM), and episodic (EM) which was studied in the previously mentioned publication. Those types would have separate indications and claims.
Anyone surprised 😀
Prior Art on EPA for Migraine Relief
Claims of any pending patent application would need to be drafted to distinguish from the related art that follows the blog article cited by DMC8. The blogger himself suggested Vascepa as a suitable med to use for migraines. What have Amarin researchers done with use of Vascepa in the art of treating migraines is my question….anything prior to the publication of the blog? Could Amarin as assignee use the blogger alone as the inventor? That might cost Amarin some $$$$.
Any pending applications?
They don't have any patent protection for use in treating migraines ( no method of action or composition of matter patents ) ...so I'm sure the generics and supplement Co's would love AMRN to waste time and $ on such a study .
Kiwi
They should run a 12-week trial in Europe for this indication -- from design to publication that ought to take a year
Definitely not run another trial for CVD indication (re establish reduce-it outcome), if that is what you want to know.
When selling a new drug, you don't signal a loss of confidence in your research, the results, or the product by doing another trial. If you show weakness in your convictions and product, it will only create further doubt in the minds of the people you are trying to convince. When selling, conviction, persistence must prevail.
Anybody know if Amarin holds any European patents on this indication (headaches)?
Do you know if CNC GELCAPS produces branded EPADEL or a generic?
No surprise that a systemic anti-inflammatory would help with migraines
Add joint pain, gastrointestinal issues, maybe gout, who knows…
JR, If you say the same thing 5 times each month - year in and year out - you can still call 'debating' !
If you repeat it 2.000 times a year - it is like Coke adds - deliberate 'Brainwashing' atemth.
---------------------------
Over the years ? - You been here since early 2022. You missed like 17.000 post: "Amarin need more trials" - because Whala says so !
The science is very clear, Vascepa does wonder for heart and brain, the 2 most important organs of human body.
We need a scientist to comment ….but looks like primary endpoint is a 5x increase in fatty acid post-use….which I believe is positive as the higher level is better wrt cancer…..🤔
Capt
Thanks for sharing !!
Looks like this would be worthy of a Press Release if our partnership with Mochida covers Epadel & patents for this potential indication ??
Interesting that they have not updated ClinicalTrials.gov for the outcomes.
Thanks for the post. Here's a recap + ClinicalTrials.gov website:
$AMRN More info on the Taiwan RCT to reduce migraine frequency & severity with high dose EPA (EPADEL):
Here is the Peer Reviewed Publication:
https://www.sciencedirect.com/science/article/pii/S0889159124003003?via%3Dihub
Here’s the ClinicalTrials website:
https://classic.clinicaltrials.gov/ct2/show/NCT04572789
The primary outcome was the decrease in migraine attacks over a 12-week period & the severity. Several Secondary Outcomes are listed in the publication.
It appears that many Outcome measures were met with significance including the Primary:
Comparing baseline values to those at week 12, the EPA group displayed significant improvements in various parameters within the group, including a marked reduction in monthly migraine frequency (7.4 ± 5.0 days vs. 3.0 ± 2.0 days, p < 0.0001), decreased usage of acute headache medication (2.9 ± 3.2 days vs. 1.6 ± 1.7 days, p = 0.013), lowered headache severity (VAS score: 5.5 ± 2.0 vs. 4.2 ± 2.6, p = 0.004),
They took only 2gm daily; half of the Vascepa dose for the heart problems. And it still helped the migraine patients. Interesting.
Seems like a study that might give doctors favoring fish oil supplements even more ammunition to support their bad choices since the study used a product, "crafted by CNC GELCAPS CORPORATION—an entity accredited with ISO 22000, HACCP, and GMP standards—(which) incorporates an orange flavoring agent to conceal the taste of EPA."
Amarin to Present at H.C. Wainwright 2nd Annual BioConnect Investor Conference
Date/Time: May 20, 2024, 4:30 p.m. ET
Webcast: https://journey.ct.events/view/a719062a-400f-406f-82d4-2463ef546624
https://www.marketscreener.com/quote/stock/AMARIN-CORPORATION-PLC-1658813/news/Amarin-to-Present-at-H-C-Wainwright-2nd-Annual-BioConnect-Investor-Conference-46636316/
A 12-week randomized double-blind clinical trial of eicosapentaenoic acid intervention in episodic migraine
May 2024
https://www.sciencedirect.com/science/article/pii/S0889159124003003
The 1.8g capsules described in this article tells me that the drug used in this trial was EPADEL. I also assume Mochida has a MOU patent on this indication? Would this indication fall under our IP sharing contract with Mochida in the US or other territories? I’ll do some homework on this today.
That’s a new one. Thanks for sharing.
EPA in fish oil prevents migraines
By: Dr. Mauskop
05-05-2024
https://www.nyheadache.com/blog/epa-in-fish-oil-prevents-migraines/
No problem, I guess I wasn’t following all of your posts. IMHO, I think Denner & Holt are working hard to wright the ship.
JRoon, Good advice. I doubt he takes it.
Sleven,
Is anyone familiar with how this would be handled with a potential acquirer from another tax jurisdiction (country)?
Jasbg, just because people disagree or don't get on board with whatever you believe, or don't worship at the feet of Denner, does not necessarily mean they are shorts or have nefarious motives.
I don't necessarily agree with everything Kiwi says. I also don't agree with some things that a lot of posters say (And i know plenty of people don't like what I say). But sometimes you can learn something from people you don't agree with. Even if it's just small nuggets of wisdom. I have learned quite a bit from Kiwi over the years, despite not necessarily being on board with all that he says.
I don't believe that more trials are the answer right now (for EU). Kiwi does. But it doesn't mean I ignore him or bash him.
If you don't agree with what someone says, either give your constructive feedback, seek more explanation, or simply don't respond.
Chromosome And I completely agree with your analysis , assuming they mine the data Kaiser etc are accumulating .
Make the economic argument in the EU for the reasons you mentioned.
The RR in select subgroups such as Revasc doesn't have to be as high as R-IT in the RWE study ...it just needs to be clinically relevant and a cost effective use of the Health Dept funds. ...( ie The Health Dept will save Euros by reimbursing for the sub group studied )
Kiwi
Sure Kiwi,
Amarin will conduct/fund trial to get the so called real world data (same data acquired via reduce-it trial), just because it is your fantasy.
Similarly Santa will deliver a unicorn 🦄 to me this Christmas, that I will ride to work every day. And yes, this unicorn will be very special as it poops pure gold.
All very practical.
He gets under your skin because he’s right on many counts and you know it. He remind you, monk, caddied, etc. of what a colossal mistake this investment has become.
To think honoring a down trendline could have avoided all this. Wow.
Kiwi yes I think you are making my point. It doesn’t have to be exactly the same outcome as the trial; this is an economic argument and works better in European countries because there is a single payer systems and people don’t change insurance. In the US, economic incentive is more focused on short term for insurance companies as people are switching insurance more of term (at least for the commercial insurance). You can argue Medicare is a single payer system for the elderly. They can easily compare two cohorts; one on V and one not on V and look at the last say 5 years and see how many CABG’s or PCI’s each cohort got (have to be pretty similar patient characteristics). I think with RWE mounting, even Germany will come on board, eventually. Just my opinion
So what would constitute a stronger dossier ...Real World Evidence studies that the previous mgt once floated ?
As you probably know ..Real World evidence studies rarely show the same degree of RR as the original trials.
This is well known and the reason is that in most CV trials the patients that enroll are often more health conscious than the general public and are more likely to adhere to the dosing schedule.
So knowing this you focus on that subgroup with the highest RR thats quantifiable and can easily translate into healthcare cost savings .
Even if the Revasc subgroup only showed a 20% RR vs the over 40% reported in R-IT ...its still a huge saving in healthcare cost .
Ask posters here who have had a PCI what they cost ?
My angiogram / angioplasty in 2016 was $18,000 ...no over night stay and no stents
This didn't include the ER costs ...just the Cath Lab costs
One of my business partners had several stents , in hospital for 2-3 days I think ...close to $100,000
Kiwi
If my suggestions counted for anything I would be the CEO. They’re the experts and we pay them to move the ball forward. I won’t back-seat quarterback. They’ve resubmitted in Italy and France (which have already passed the technical assessment) and they continue to gather evidence for Germany.
I don’t think the answer is more trials…the answer is better promotion, stronger dossier for reimbursement and patience. Just my opinion.
Capt. The issue is how to obtain reimbursement in the remaining big 3 EU markets and spark an increase in script numbers in the existing EU / UK markets .
The current strategy ...same ol same ol ...isnt doing it ( Spain being the possible exception ...but still only 2,000 scripts IIRC )
So what's the boards ( and your ) suggestions for gaining reimbursements and increasing script number in these markets ?
Kiwi
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