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MA52TA, It's not off label. Vazkepa is approved for sale. It's just not reimbursed.
Sleven,
Vazkepa is already sold in ITALY off label. I don't think there will be a "launch".
“We are getting approval from Italy?” I thought Laurent wasn’t sure? Isn’t the jury still out?
Study, just wanted to say I likewise appreciate the DD you post (especially appreciate the discussion details you posted on the NICE UK pricing meeting back in 2022).
I do agree we really can't afford another rejection from Italy. Look forward to getting this behind us so we can focus on France/Germany.
Laurent. Thx for keeping us up to date on this process.
Kiwi
N7. thx for the update
Kiwi
We are getting approval from Italy this time. I don't anticipate it moving the share price substantially however since it's all about revenue and cash preservation at this point. We had to make some compromises with Italy (I know cost was one of the compromises but don't know what the other compromises were). I don't know what the determined price was. I need a better sleuth than my poor, limited skills to find that out for us. We are between a rock and a hard place and our hands were tied. We couldn't afford another delay. We've got to get boots on the ground and Vaskepa into the hands of the Italian people with government HC coverage ASAP. Clocks ticking and not on our side. France is still a long way away and Germany is nothing more than a distant dream at this time. At least we've got Italy finally. It will be interesting to see timelines from management for roll out when they get offical announcement of approval from government. I think your time frame for next Friday is spot on. Thanks for all your due diligence for the shareholders. I've learned a ton from you and appreciated.
I think we'll see a pdf posted on the AIFA website upcoming friday 9/27. We'll either see something like "Opinion expressed" or "Subject postponed". If "Opinion expressed" then I think that means it's up to Amarin to PR whether it's a yes or no, but we won't know beforehand.
Kiwi, Don't know about Italy. Was an AIFA meeting this week.. Vazkepa was on the agenda.
Sleven,
N7. where are we in this process in Italy ?...as a reminder ...in the EU and other parts of the world, the dates are written day / mth / yr vs in the US mth /day / yr
Kiwi
Further proof that it’s NOT “just” about TG reduction:
We know from PROMINENT, STRENGTH and from REDUCE-IT EPA Mediation Analysis (https://esc365.escardio.org/presentation/265872)
That TG reduction is not the main driver for residual risk. In this new JACC study (hot off the press), and co-authored by Deepak Bhatt:
“Triglyceride Levels, Alirocumab Treatment, and Cardiovascular Outcomes After an Acute Coronary Syndrome” https://www.jacc.org/doi/full/10.1016/j.jacc.2024.06.035
They sought to examine relations between triglyceride levels and the effect of alirocumab vs placebo on cardiovascular outcomes using prespecified and post hoc analyses of the ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) trial.
They concluded
JRoon71
Thanks for the detailed perspective for UK !!
Looks like we need about “5 more UKs” ($20M in 2026) during the next 2 years to get back to cash flow positive ?
5 possibilities - Spain? China? Italy? ROW? New “deep discount exclusive deals with US PBM”?
Okay thanks N7. On another topic, I work at a Nuke Plant. These are “Baseload” Units, run 24/7 for 18 months. Without our country’s Nuclear Fleet, we would be in serious trouble.
With the coming of AI, there will be increased demand for electricity to run these Data Centers. Microsoft is apparently working a deal with Three Mile Island to purchase all the power produced at the station. Electric Utilities are a great investment going forward. Not only will you get a dividend, but you’ll get share price appreciation. Artificial intelligence (AI) is also the coming thing.
Here’s hoping that Amarin secures Italy. If they can do that, then France would follow suit. Can someone explain to me why Bempedoic acid + Ezetimibe has such a high acceptance rate? GLTA
Nuke,, We just received our preliminary HTA assessment in Ireland. Now we need to respond. This was a different drug going through the process. You can see that there is a fairly quick back and forth toward the end.
Sleven,
Any word on Italy reimbursement? TIA
N7; What is the gist of this article? The other thing that amazes me is where do these drug companies come up with these names? Dang, so many drugs, the naming of which must be “mind boggling?”
Cocaine is great for weight loss, but probably doesn't help your risk of having a cardiovascular event...
https://www.ncpe.ie/fenfluramine-fintepla-for-lennox-gastaut-syndrome-hta-id-23051/
This provides a timeline for moving forward in the HTA process.
Sleven,
and if we don't get Italy on board and make some progress over the pond, there really isn't much to sell to BP. To me, we are in crunch time.
One of NVO’s P2b weight-loss clinical trials is being treated as a failed trial today; NVO share price declined ~ $7.4; VKTX shares are + @ $70.47.
Yes.....I'm a bit soured on trials as you can imagine....... when you have great comprehensive trial like Reduce-It which validates a trial like Jellis and you struggle to get market acceptance by the healthcare industry, it just shows how flawed the system is. Money talks. Do what Big Pharma wants or they stop funding your research or sponsoring your weekend symposiums. If you can't beat them, you have to sell to them.
Ram, and actually for them, safety is probably the bigger concern (thus the trials), where Vascepa really only has one (very small) potential side-effect of afib.
Kiwi, I would say these studies were provided to the world by Captain Obvious. Why would we even need 1 double blind placebo controlled study showing a drug engineered for weight loss would also be associated with reduced risk of cardiovascular events and diabetes?
Should we have a double blind placebo controlled study showing jumping from an airplane without a parachute is associated with higher mortality rates?
And here's a list of the double blinded placebo controlled trials run on GLP-1 drugs
LOL! Ram, that's pretty funny, but true.
What's sad is that Vascepa is almost like that - beneficial for almost everyone (most populations have Omega3 deficiencies), and has a safety profile close to water.
This is why the FDA and drug claims crack me up....... of course a weight loss drug if it works can say "Reducing the risk of major cardiovascular events in patients with type 2 diabetes and established cardiovascular disease".........
That's like me coming up with a pill that contains either air or water and claiming "Reducing the risk of major cardiovascular events in patients with type 2 diabetes and established cardiovascular disease if taken while on a whole food diet with moderate exercise" In addition, my pill would have an incredible safety profile across all populations inclusive of Male's, Females, and all Genders in between.
I will set up a go fund me page and and am open to all investors. Bitcoin accepted.
Re GLP's approval for heart health in the US
That's a great question. I don't really know the answer. The unfortunate part is that Vascepa (and EPA in general) is so good for most people's health with such a great risk profile, but the challenge is getting the world to accept that (and pay for it).
Our world is all about the "quick fix" in healthcare.
It’s been reported that drug manufacturers commonly get about 70% of the Actual NHS price in the UK.
Will the approval of GLPs in Europe for heart health and eventual approval in US impact Vascepa sales?
Capt what kind of revenue do you estimate this represents?
Actually given there were three more working days in July than June, this isn’t that great although July/August is summer holidays so there is that.
Unfortunately, it looks like BA/EZ combo is taking off as the drug of choice. We need some of the recent conferences to move the needle over there. We're currently annualizing at $2.7M per year in UK (£3.6M). There is a LONG way to go.
The trajectory is very similar to that in Canada, and Canada is currently annualizing at about $17M. But they are about 5 years into commercialization. Granted, the dynamics there are different because of the tedious and time-consuming provincial approval process they needed to go through. But the trajectory is fairly similar so far.
So if nothing really changes in terms of uptake, I would assume the trajectory would look something like this:
2024: $2M
2025: $5M
2026: $10M
2027: $20M
2028: $35M
2029: $40M
And it would likely level off around there. This would be similar to the current uptake in the U.S. (per capita).
Obviously, they need to do something to convince the industry to adopt Vascepa as a legitimate CVD solution, and not just a "niche" drug.
Thanks Captain. Slow and steady, at least the trend is good and compounding will give a value on the UK market. If we could get a bit of a bump in scripts around London/South east area that would help greatly.
Much appreciated Capt'n
Thanks for sharing Capt…this is an encouraging monthly bump
North. Apologies on my quick scan . Yes Naz Co's often get longer than the initial 180 days to regain compliance ...and we are near that 180 day pt now .
Don't know of any that have been given more than a year tho.
Kiwi
Thx for the detail Capt
Kiwi
Why ask that question, kiwi? The question misconstrues what I said.
Monthly English Prescribing Data (EPD) is provided by NHS England for all approved and reimbursed prescriptions. The portal for that data is found here:
https://opendata.nhsbsa.net/dataset/english-prescribing-data-epd
The data is recorded as individual doses. In the case of VAZKEPA® or the three other drugs that I track it would be individual capsules or tablets. The drugs that I track are:
• Icosapent ethyl (VAZKEPA®)
• OMEGA-3 FA EE (OMACOR)
• Bempedoic Acid (NEXLETOL)
• Bempedoic Acid + Ezetimibe (NEXLIZET) combo drug
This report contains data from Jan 2022 to Jul 2024. You may view and download the three slides here:
https://drive.google.com/file/d/19MAuuGeQgu5Hly7kB2qUfitO2SNwMkdF/view?usp=sharing
Summary:
Slide #1: Monthly Line Graph for Total Capsules/Tablets of each drug Jan 2022 – Jul 2024
Slide #2: Same as Slide #1 as a “stacked” cumulative column.
Slide #3: Table 1, VAZKEPA® Monthly Caps and the NHS Actual Price paid. Bar Graph: Quarterly
Hi North ...any examples of longer than 1 yr to regain compliance ?
I have seen pharm companies get further extensions beyond that given with original notice. Haven’t you?
Slow day Ram ? Actually a very good day thx to my position in EWTX
EWTX is also in the Cardio space and aims to treat a very common heart condition ...thickening of the walls of your hearts ventricles ...a condition I found I was developing after failing an echo stress test several years ago . And no Vascepa doesnt cure it ....and neither does a low or high carbohydrate diet :--)
Anyway we await Capts UK script data which sounds encouraging .
How many months does AMRN have left to get the PPS over $1 ......at most Co's get 12 mths from the initial delisting notice
Kiwi
antibluechip, I have CVS Caremark as well and on medicare. When I recently spoke to a rep covering the part D portion of my coverage I found out that if I switched to mail order instead picking up at the pharmacy I can save another $10. for 100 days of Vascepa for $125. Instead of a 90 day supply I'm getting another 10days additional supply for less money.
Captain, Thanks.
Sleven,
Yes, I explained that process. NLM must review first before posting. But they will post within 30 days even if the review is not complete.
Extensions can be granted beyond the deadline. This happens regularly.
The 12-month deadline is for submission by the responsible party (U of W). It's not a deadline for when it gets posted to the public on ClinicalTrials.gov. They have now met the deadline. Theoretically, it could get posted after 9/29, but I expect they will have it up before then.
JRoon,
https://fdaaa.trialstracker.net/trial/NCT02719327/
I understand that the data has been submitted. It has not been reported. There is a reporting deadline.
Sleven,
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