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“Fed. Circ. Won't Question Reviving Vascepa Skinny Label Row
By Adam Lidgett
October 18, 2024, 8:18 PM EDT
The Federal Circuit has said the full appellate court will not rethink a panel's decision reinstating Vascepa maker Amarin Pharma Inc.'s skinny label patent case against rival U.K. drugmaker Hikma....
https://www.law360.com/lifesciences/articles/1891342/fed-circ-won-t-question-reviving-vascepa-skinny-label-row
JRoon71/Zip
IIRC Bhatt said that somewhere around 15% of R-IT pts were not on a statin (stopped their statin early) and the efficacy was the same, so there is some data on V without a statin.
JRoon71
Managing a patient with residual risk: applying recent evidence with EPA to practice
Speaker: Kausik K Ray (Imperial College London - London, United Kingdom of Great Britain & Northern Ireland) X LogoProfKausikRay
Kausik K Ray = president of the European Atherosclerosis Society = Extremely influential
Kiwi
“National health care systems are incentivized to find ways to reduce future healthcare costs.”
You would think so but that is NOT the case. There is a “prescription drug” budget and there is a “inpatient hospital care” budget”. Each has someone whose job/career depends solely on coming in under budget each quarter. If the hospital services budget can save 50M in 5 years by spending 5M more this year on prescriptions the individual managing the prescription budget says “no way, I haven’t got 5M to spare and saving 50M in 5 years for another department does ME no good at all”. He may also point out that a fatal MI saves $ for both of their budgets as well as the seniors pension budget and many other budgets. Once a person stops earning income and paying taxes just about every budget benefits from the pts death.
The ONLY obstacle to reimbursement in all these countries is MONEY. Nobody, except you, needs another study. Delaying reimbursement saves money for the prescription drug budget.
It’s ALWAYS about the money
NS
425,166 bottles of V doesn’t make logical sense.
A shipping company would only want to know the gross weight a client wants to ship when calculating the shipping charge , weight distribution and fuel needed for the ship. They don’t care about the weight of the product.
AI says “The weight of a 40-foot transatlantic shipping container with built-in heating and cooling systems can vary depending on the specific make and model. However, a standard 40-foot refrigerated container, commonly known as a "reefer" container, typically weighs around 8,500 to 10,000 pounds (approximately 3,860 to 4,536 kilograms) when empty. This weight includes the built-in refrigeration unit and insulation.”
The question is how many of these 4500 kg shipping containers were used ?
if one was so motivated, they could measure the height and diameter of a 120 capsule bottle and then calculate how many bottles would fit on a shipping pallet. Then calculate how many pallets fit in a 40 foot reefer container. Then calculate the total mass of these pallets of V. This would give you an idea of how many shipping containers were used then you could figure out a very rough estimate of how many actual bottles were sent.
I don’t have a full bottle of V to measure otherwise AI would figure this out pretty quickly. Come to think of it, AI can probably tell you the height and diameter of a bottle of V.
Bottom line is that Amarin did not import 425,000 bottles,
Lizzy
????
How can that be? St Denner was the saviour for Amarin that you lobbied so hard to have shareholders hand over 100% control of the company. Now we sit at a MC below COH? It’s been a year and a half (previous Board was only given 6 months) and Denner hasn’t done 1 single thing except tank the stock price.
I really hope that there isn’t 1 single retail shareholder that still thinks handing absolute control of the company to Denner was a good idea.
Ride that blue wave!!!!
St Denner is proving his brilliance at running a biotech and his experience at launching a cardiovascular drug in EU.
Thank god we got rid of KM and his 2 decades of experience launching cardiovascular drugs in EU.
I love the constant winning!!!!
Success after success after success- wait, the SP is worse than a year ago, we were flat out rejected in Italy, Germany and France haven’t changed and the US market share is exactly were it was before.
How exactly are we winning?
One year of patent life gone. No BO. No sign of a BO (actually the opposite)
Having a bunch of bankers run a biotech may not actually have been the best choice to make.
And with the relentless attacks on anyone who doesn’t post positive news people here are probably surprised by the current situation. Only being open to 1 side of the story has its down side.
Keep pumping!!!!
We have to come clean
NS and I were spreading the anti-Denner crap and constantly spreading FUD for the past year as we shorted the stock from $2.00 down to $0.65. Then, we came up with the story the BRAVE trial was a dud to create panic and get retail to sell us their shares cheap to cover our short. Once we closed our positions we left the board with millions of your dollars.
Thanks suckers
JRoon71
It would appear that the information I provided NS 3 weeks ago has now been verified by a number of sources.
I reached out to NS because he is a gifted researcher who has only ever posted facts and good information. When he couldn’t confirm my information he reached out to iHub seeking help in searching.
All we got for our efforts to try and inform our fellow investors was abuse and insults, just like when I warned people Saint Denner was no Saint and he wasn’t going to be able to do any better than KM and his qualified Board. A year later we are at $0.87. KM could not possibly have done worse than this.
There is no longer any useful information being posted here, just a bunch of children having a tantrum when they don’t get sunshine blown up their ass.
I have a follow up meeting next week but any information I get will be kept off this board.
I’m done
Good luck, JRoon71, you were one of the good ones. You know how to reach me.
For others:
Remember, if you don’t learn from your mistakes you are bound to repeat them. Many on this board still refuse to admit they made a mistake. A fool and his money are soon parted.
Completely hypothetical question
What if I called the VP of Amarin, HLS or Pfizer and told them I wanted to discuss BRAVE. What if I had an hour meeting and laid out the clinical data suggesting BRAVE could be positive and that changes to FDA guidance suggests it could lead to a new indication. Maybe this would perk their interest and the guy would say “Let me look into the BRAVE trial, make some calls and get back to you.” Now, if that person were to contact me a few days later and say that although the science I presented was intriguing the BRAVE trial failed to meet either the primary or secondary endpoints. Hypothetically, I haven’t seen the data, I don’t know if the p value was 0.06 or 0.5, so I don’t know much and I don’t have any “proof”, just some incomplete information from a reliable source. Do I post this on a message board a few days before Christmas and once again become the evil villain of iHub? Maybe I would reach out to a great researcher with a perfect record of always posting factually correct information and ask him to see what he can dig up, given the new information. Maybe he comes up with nothing so he reaches out to the iHub community without pointing the finger at me- and HE becomes the evil villain because anything other than positive information is forbidden on the AMRN page.
It is really pathetic how quickly the mob turns on anyone who doesn’t post positive information.
JRoon71
You nailed it!
If it’s good news then the source and facts don’t matter. If it’s bad news then even with facts the individual that posts it becomes the enemy.
Pathetic emotional investors that don’t have the stomach for Biotech. Just a matter of time before they go broke.
NS/MarkRoth2
Not true. The cerebral vasculature has what is called the “blood/brain barrier” or BBB. The blood vessels in the brain are less porous and allow fewer chemicals to pass through, thereby protecting the brain from potentially toxic chemicals. Most relevant is that LDL cholesterol (the lipoprotein vesicles that carry cholesterol and triglycerides, which are fat soluble, in the aqueous plasma) can not penetrate the BBB and therefore the brain must produce 100% of its cholesterol needed and the brain must rely on blood glucose for energy. In spite of its reduced permeability to LDL cholesterol, you still get cholesterol driven plaque accumulating in the cerebral vasculature in the same way as you get in the coronary vasculature. Once the plaque develops the inflammation follows and plaque rupture can cause a stroke. EPA reduces that inflammation as well as causes an increase in nitric oxide production, which is a vasodilator, and opens blood vessels.
Therefore, fundamentally, there is good reason to expect the same benefits we see with EPA in the coronary arteries to happen in the cerebral arteries. This is the primary outcome being measured in BRAVE - increase in circulation.
Here are the slides to the article Dr Bhatt is referring to:
https://docs.google.com/file/d/1EbmPZacAJiDXPO9OQy1GjH1mz1T_HUMH/edit?usp=docslist_api&filetype=mspresentation
They use a new AI assisted technology to assess blood flow in the coronary arteries.
Zip
HOLY CRAP!!!
Ozempic is at most $250/month in Canada.
The US system with all its middle men, kickbacks, rebates etc is a profit driven ripoff.
I would bet you the actual cost to the insurance company is less than $250/month, probably even under $200. All the other numbers thrown around are bogus upcharges and hiding kickbacks and payoffs.
Ontario
JohnH
Denner bought this stock and scammed shareholders to get complete control of the company for the same reason we bought stock- he sees the long-term potential of this incredibly important drug.
Patience is the key. Stop watching the price every day. The stock will likely follow XBI for the next couple months at which point I suspect a positive presentation at the end of March for the BRAVE study.
Alzheimer’s is an absolutely horrendous disease for both the patient and all their loved ones. Most people don’t worry about having a heart attack because they think they’re invincible and it’s natural to procrastinate. CVD prevention gets very little attention especially when giving the drug causes no noticeable changes like V. Alzheimer’s is different. People are terrified of the idea they may get Alzheimer’s. There are people that would drink their own piss if they thought it would prevent them from developing Alzheimer’s. The sales will go up with positive brave data. Denner is a smart guy, as well as an asshole, and he likely suspects a positive outcome with brave as well. Everyone needs to just walk away and come back at the end of March.
JRoon71
I am not in the US system, so I do not know how PBM’s affect selection and what is carried. From an inventory cost perspective the pharmacy just can’t afford to be carrying triple and quadruple products not to mention the physical space is limited.
John
“Unfortunately, he duped us all.”
Wrong. He duped 90%. Several members on this board like NSleven, Dog, JRoon, myself and others could see right through his BS and tried to warn people. See post 402838 for a clear and accurate warning given to all. Instead of objectively assessing my warning I was labeled the enemy.
We are in a far worse situation now than we were with the previous board. We no longer have anyone at all that has any experience in launching a cardiovascular medication in Europe, or the rest of the world. All we have is a bunch of bankers.
We are approaching one year where Dinner has had 100% control of the company, and he has achieved absolutely nothing other than losing Italy, which, unlike Germany, was a specific rejection of Vascepa and not the result of a change in government regulations like Germany was.
And yet, there are still posters on this board who thoroughly endorse Denner and refuse to accept that they were played. Those people should get out of the stock market because if you can’t recognize your mistakes, you certainly can’t learn from your mistakes.
North/JR
A pharmacy will not carry more than one or maybe two generic versions of a drug. Generic drug companies grow their sales by having a broader range of products and offering package deals. For example, if generic a has 15 products, they can ask the pharmacy to choose their company to carry those 15 products in exchange for some type of rebate . If company B is someone like Apotex and has hundreds of products they can make exclusivity agreements with the pharmacy where the pharmacy will only buy Apotex generics for an agreed upon list of products in exchange for some type of discount or deal. These small generics are adding gV as a way to increase the number of products they can group together when trying to get the contract with individual pharmacies or more often sign a deal with head office. The deals that are set up are competition between generics and don’t affect the Pt (if anything they benefit from lower pricing). The insurance company is the one that decides brand vs generic then generics fight amongst themselves for that gV market. More competition does drive down prices and the insurance companies will jump on that to get the brand to offer bigger discounts otherwise they switch to generic.
The 3 key factors are: 1) what it will cost the insurance company 2) what it will cost the insurance company and 3) what it will cost the insurance company.
Label indication - meaningless, physician preference- meaningless, Pt preference- laughable. $$$
Golf dud
I don’t drink, I just state facts. Try it, at least once.
Golf dud
May i suggest you do a little research for the first time ever instead of just asking dumb questions.
I wasn’t able to find a single post of yours with any value at all and certainly never a new fact posted by you.
Look up some other completed trials and see what their funding was like.
There is a great website and search engine called Google. Search clinicaltrials.gov.
Try to contribute something for once.
Rose
It will if the general press print a story about V being proven beneficial in a phase 2/3 clinical trial run by the preeminent Alzheimer’s researcher. I bet literally 1000’s of website hits for “what the hell is Vascepa” and insurance formulary websites searches for V.
JRoon71
“But what would be the prescribing indication that a doctor would give?”
This is irrelevant. Drugs are commonly prescribed “off-label” just like most V scripts pre Dec 2020 were for CVD prevention while there was no label. Just like gV scripts are all for CVD. Indications are meaningless and there is nothing the FDA/Amarin/courts can do about it.
Insurance companies will avoid paying any way they can. It is only once people start shopping around for a new insurance provider who covers V that the providers become motivated to include it in their formularies. Their website formularies track searches and they know what people are looking for.
rdhitchcock
Great find! Very useful and encouraging information!
Thanks for sharing
BBI
“I'm just saying that the trend with trials involving Vascepa has not been good, even when results are good.”
I think it’s important to point out that all the trials mentioned showed a benefit for the V pts.
“The trend is your friend” as they say analyzing charts. There is an overwhelming trend that pts taking V have less disease progression, almost regardless of disease studied.
Agreed that the messages have worthless but I think, to a large degree, FDA regulations prohibit claiming benefits on a prescription drug prior to FDA blessing. But, like you said, with the KOL of Alzheimers running the trial can attract a lot of attention and say things that Amarin just won’t be allowed to say.
I like our chances. As always - more waiting (likely until late March IMO)
Capt
We have several “method of use” patents for CVD as well.
Laurent
Great find.
Makes complete sense to those that have read Dr Barry Sears’ analysis on EPA/DHA in the brain.
Laurent
Exactly.
Cholesterol can’t penetrate all the way through the BBB but assuming it does penetrate into the endothelial lining then we still have the same MOA as coronary arteries with plaque and inflammation. Elevated cholesterol levels are an increases risk factor for vascular dementia and I believe (but can’t quote a source from memory) Alzheimer’s.
The ApoE4 allele issue is a ??? That gene allele likely produces a protein/enzyme/? that induces Alzheimer’s or produces a protein that is incapable of defending the neuron from Alzheimer’s. That could be such a specific MOA that EPA levels have no effect, thus the German study results. EPA may still affect biomarker levels, as NS has suggested, but ultimately have no benefit on disease progression. Total unknown here.
JRoon71/Laurent/NS
Great discussion
This slide from Barry Sears (Author of the Zone Diet and a pioneer in Omega 3 research) may be of interest. I’ve posted before but it’s a good reminder of EPA vs DHA in the brain
https://docs.google.com/file/d/1S3S4vZJEaotKmRROybBKRKEvywaeH54l/edit?usp=docslist_api&filetype=msword
Kiwi
We’ve both been on this board and conversing for over a decade. IMO your years of reduced doses and use of DS may have reduced the benefits of slowing cognitive decline :)
Kiwi/Laurent/NS
As you may recall, EVAPORATE FFRct was a trial of a total of 47 people (22 IPE, 25 placebo) studying coronary artery blood flow. It provided stat sig beneficial results. BRAVE is a larger Pt population, although not as sick, studying cerebral blood flow. It is entirely reasonable to expect similar pharmacodynamics in the endothialium of the cerebral vasculature as the coronary vasculature. The “blood-brain-barrier” makes it more difficult for molecules to penetrate into the CSF but the relevant issue isn’t penetrating through and into the CSF but merely penetrating the endothialium to deposit plaque which becomes inflamed. We know that “vascular dementia” proves that cerebral blood flow is affected by narrowing of cerebral blood vessels.
I believe we have a reasonable chance of stat sig results from this small trial.
NS
Great news!!
FYI: you could have mentioned that a while ago :)
Bouf
Outside the US the chemical IPE has regulatory exclusivity. The US relies on “method of use patents” which the courts don’t recognize or enforce.
EU will only have Vascepa until at least 2031 (I believe)
Zip
It was only 111 pts doing a proof of concept trial.
“We conducted a proof-of-concept investigation into the efficacy of an FDA approved high dose EPA in improving cerebrovascular function in healthy, cognitively unimpaired Veterans.”
“ Trial outcomes will be completed in Sept 2023. Here we report on mean baseline values for the pre-specified outcomes. At baseline, N=127, 119, and 129 participants had an MRI scan, LP procedure, and complete cognitive battery, respectively (N=111 participants had both successful baseline MRI and LP); to date, 110 participants completed all study visits.”
“Conclusion: The impact of IPE on cerebrovascular health in cognitively unimpaired Veterans will be presented at the conference.”
Laurent
Although I agree with the validity of the points you mentioned, clearly the author wrote the abstract before trial completion and knew the conference dates. The author must have anticipated the challenges of presenting so quickly after trial closure and felt it could be done.
Maybe they submitted the abstract “in case” they were prepared but were unable to present. It is odd that AF didn’t jump on the chance to slam and ridicule fish oil’s failure. I honestly think he would have if he could have.
Golf
“Conclusion: The impact of IPE on cerebrovascular health in cognitively unimpaired Veterans will be presented at the conference. Key words: Veterans, omega-3-fatty acid, cerebral blood flow, cerebrospinal fluid. Clinical Trial Registry: NCT02719327; https://clinicaltrials.gov. Disclosures: The authors have nothing to disclose.”
The conference ended last Friday. The quote above is from the abstract.
Bout
Generics would definitely steal the indication just like they did with CVD. The benefits would be that all suppliers of IPE would gain sales.
Zip
Stock Twits info suggests it was released last week at an Alzheimers meeting in Boston.
Still trying to find out more info but the fact we don’t hear about it implies nothing significant found.
jfmcrr/zip
My best guess for presentation of BRAVE results:
Option 1:
Based on:
“A major event for Alzheimer’s disease research is the NIH Alzheimer’s Research Summit, which is organized by the National Institute on Aging every two years. The summit brings together experts from various disciplines and sectors to discuss the progress and challenges of the National Plan to Address Alzheimer’s Disease, which aims to effectively treat and prevent Alzheimer’s disease by 2025. The last summit was held on March 1-2, 2022 in Bethesda, Maryland”
So maybe in March 2024. Note: BRAVE funded by NIH so this seems the logical place to present trial results. Five months after trial completion is certainly enough time while not being an excessive delay (although we may feel differently)
Option 2:
Based on
“Alzheimer Society International Congress™ (ASIC 2024™)
ASIC 2024™ will be held on May 21-23, 2024 in San Francisco. ASIC 2024 is a leading forum in Alzheimer research and dementia care. The Congress will highlight the latest accomplishments in Alzheimer research and best practice in patient care.”
So maybe May 2024
They could also make an announcement next week - but I highly doubt that.
Vascepa has been available since 2012. A large insurance company like KP surely has enough Pt data over the past 11 years to do a statistical analysis of the prevalence of Alzheimer’s amongst V users vs similar pts who did not get V (a massive pool of these placebo pts)
LBL
Did you notice one of the co-authors is none other than Dr Cynthia Carlsson- aka BRAVE primary investigator (although in that paper she goes by Cindy Carlsson).
The section on BRAVE would have been written by her.
Interesting little piece of trivia
Beyond cardiovascular medicine: potential future uses of icosapent ethyl
Deepak L Bhatt,s1 Mark A Hull,s2 Mingyang Song,s3,s4,s5 Carol Van Hulle,s6 Cindy Carlsson,s7,s8,s9,s10 M John Chapman,s11,s12 and Peter P Toths13,s14
JRoon71
I have absolutely zero concern that they will burn through inventory. They have way too much.