Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Chromosome , isn't the market in Canada split between Cardiologists and Primary Care with PFE only marketing to Primary Care ?
It would seem that since the R-IT trial was mostly secondary prevention CAD patients ...Cardiologists would be the main market .
Primary Care have enough trouble keeping their CAD patients on Statins which are very low cost and in the case of Crestor at least ...small pills and only once a day .
Secondary prevention patients ( prior MI , stroke etc ) are probably more willing to add 4 large caps to their daily med routine .
But IMHO all this is largely irrelevant to AMRN's bottom line .
Their main challenge is to gain more reimbursements in the EU and ramp up sales there before US revenue declines any faster then already seen in Q1 numbers
Kiwi
ORBAPU (or Capt), do we know if Epadel uses the same encapsulation method as Vascepa?
Here is a study of branded EPADEL vs. generic from 2020.
https://www.scirp.org/journal/paperinformation?paperid=103416
Methods and Results: We investigated the differences in the serum levels of EPA, docosahexaenoic acid (DHA) and arachidonic acid (AA), and the EPA/AA ratios through blood sampling six months after daily administration of 1800 mg of EPADEL and a generic EPA drug was initiated for 96 patients with cardiovascular diseases. All patients received these PUFA treatments while continuing with baseline therapy. After 6 months of administration, EPADEL produced better results than the generic (G) product.
This is what I'm hoping for. All of my shares are in taxable accounts, and I have a LOT of shares (200K). I already have significant earned income, so that, plus cap gains, plus my state cap gains (7%), plus NIIT tax (3.8%) is a killer. I'm looking at 31% tax on gains that I would love to defer over a few years (that would help avoid that high cap gains rate and NIIT tax).
Yes the time factor a rep has with a doc is an important mention. A lot of docs are not that fond of rep visits and if they are a busy practice they want to get back to their waiting patients. If it is a practice with no patients then the rep can visit with the doc all day but it won’t matter since that doc is writing hardly any scripts. Like you say a million times zero is 0.
JRoon, that's my point.....we don't know if they've looked into this.
In a tangential note to you mentioning holding shares of a possible acquiring company. If the acquisition price is significant enough (>$5 per share), it would definitely be preferable to have the deal go down as cash + shares, or just shares, as that would enable postponing to a degree cap gains taxes and minimizing higher income effects to other things such as Medicare premiums escalation.
Exactly…I get the rationale for choosing PFE in Canada as a partner but to your point, in the hierarchy of what the reps carry in their bags, V was probably somewhere in the bottom. Given limited time with physicians, reps are lucky to bring up two drugs in their bag. Even an army of sales reps can’t change that dynamic since a million times 0 is still zero (well you get the analogy)
Ram, do you really think that a bunch of Monday-morning quarterbacks on an anonymous internet forum know more about the scientific studies being done on IPE than the scientists that run the largest provider of IPE?
Honestly, that's crazy-talk.
The one thing we do know is that we don't know if they did any research on this already.
Not necessarily. What this highlights is the poor return of partnerships. I believe JT mentioned this dynamic when considering partnerships in the EU. V just becomes one out of a hundred other drugs in the salesperson’s bag. Plus they will usually focus their efforts on pushing the drugs that are most profitable to their company. Only way BP really pushes V is if they own it.
J.T. had intentions of making Amarin into a BP by using Vascepa revenues to develop new indications for EPA meds and to acquire additional meds...Now Denner has intentions of selling Amarin to a BP with more assets
In retrospect, I believe that Amarin could actually have become a BP if everything hadn't came crashing down, due to the judge DU decision and the lack of U.S. courts' enforcement of infringement laws...I hope that Denner is more successful than J.T. was and I look forward to holding shares in the fortunate acquiring BP.
No, just Pfizer no longer selling for HLS.
There’s been a lot of talk on this board and others about the “bioavailability” of generic VASCEPA® vs. the brand. Personally, I don’t believe the end generic product is compositionally equivalent.
Aside from that, one critical issue that is seldom mentioned is the fact that pure EPA begins to oxidize immediately and becomes less efficacious the longer it remains apart from its site of uptake in the blood stream. Encapsulation is a method of slowing this process down. However, even this won’t prevent oxidation from eventually destroying the intended use.
Fortunately, Amarin has patented a capsule that inhibits oxidation much more effectively than the standard gel cap.
You may pay slightly less for the generic, but your savings just might be in determent to your life and health.
So now we are out of canada? Man what will it take to even get a hint of good news for AMRN.
Honestly, I don't think one has anything do with the other. The sales/distribution methods in Europe are much different than Canada and the US.
I agree, Vascepa has been a bit of a disappointment in Canada. $17-18M in full-year revenue after this many years is pretty disappointing. I wasn't able to listen to the earnings call today, but am hoping to listen to the replay when available.
I think a lot of this goes back to the GIA strategy. HLS is not a big company. They are tiny, and they are boot-strapping it (hence, why they brought in Pfizer originally).
Vascepa in the hands of a BP probably would have gone much differently.
Ziploc, Just tried searching Google patents - very extensive documentation:
https://patents.google.com/patent/WO2023146984A1/en?oq=WO2023146984
Its disappointing that Pfizer is not able to find marketing leverage for Vascepa in Canada primary care !
How will this impact evaluation estimates for other BP's in Europe ??
Its most likely a Bearish sign, neutral at best, and not what I was hoping for !!
I didn't say it was a waste of time and money. I said I don't think that's the direction Sarissa wants to go.
And how can Amarin claim a patent on research they didn't do, using a product that is not even theirs?
I'm not sure why you and Kiwi think this is such a big waste of time and money..... they don't need to chase a migrane indication..... they have the resources to do a quick patent search and if one doesn't exist, apply for the patent and add it to the portfolio for future use.
Published Today: New US Patent Application US 2024/0148683 A1 for the encapsulation of ultra-pure EPA. This is presumably filed to extend the current patent # US 8,642,077 B2 which is set to expire Feb. 4, 2034.
https://ppubs.uspto.gov/dirsearch-public/print/downloadPdf/20240148683
Just a reminder of one of the reasons why generic versions of VASCEPA® which are not encapsulated by this patented method may not be as efficacious as the Real Deal! Don’t trust your health and life to oxidized products!
I have to agree with Kiwi on this. Amarin already knows about the migraine issue. They are aware of anything and everything that goes on with IPE.
But I also don't believe that Amarin has the time, resources, or interest to chase new indications that are not central to their goal. I believe Denner wants to focus on getting V rolled out in Europe, finish out the litigation efforts in the U.S. (whatever might come of that), possibly do something with the new formulations (LrEtEPA, MND-2119), and get this thing sold.
The other indications and formulations...colorectal cancer, migraines, FDC, etc. are likely something to be dangled in front of a BP as a future opportunity.
I may be wildly wrong, but there does not seem to be any effort or money being spent on R&D right now, which would be the big indicator that something was going on.
As I have stated previously about the lack of traction in Canada, it was only a matter of time before HLS needed to do something.
Pfizer was responsible for less than $6M in revenue annually, IIRC. They essentially weren't selling anything.
On a more positive note, HLS highlights in Canada included:
Vascepa unit demand increased by 54% compared to Q1 2023.
The number of consistent prescribers2 for Vascepa increased 112% compared to Q1 2023.
Vascepa net revenue was C$4.5 million, up 27% compared to C$3.5 million in Q1 2023.
Here is a summary of Amarin's patents on LR-EtEPA
Abstract of patents WO2023146984
"Lymph-releasing compositions of fatty acids and uses thereof for lymphatic incorporation and systemic disease treatment
Abstract
Provided are compositions comprising one or more polyunsaturated fatty acids or derivatives thereof, a source of phospholipid, and optionally one or more additional emulsifiers, as well as methods of using the same to treat various diseases. In some embodiments, provided is a lymph-releasing composition of eicosapentaenoic acid ethyl ester (LR-EtEPA) and methods of using the same to increase EPA uptake in tissues and to treat various diseases including cardiopulmonary diseases, renal diseases, neurological diseases, and CANCER."
HLS in Canada has terminated their agreement with Pfizer effective May 1st!!
"We have been closely examining the performance of our go-to-market model in primary care. We have concluded that the ROI for this model remains unprofitable and, despite best efforts, there are not enough signs of improvement to justify continuing at our current level of investment. As a result, we have provided Pfizer with a notice of termination of the Agreement between the two companies. We are working with them on an orderly wind down and transition back to HLS of all primary care related activities which we expect will be completed during the second half of 2024. We thank Pfizer for the commitment and effort that they have made towards trying to make this go-to-market model successful."
Yep, could have used VASCEPA 16 years ago when I had my prostate removed!
You are by far the best advocate for AMRN.
Captain,
Thank you for keeping us abreast on PREPARE RCT (PRevention Using EPA Against coloREctal).
As a reminder, Amarin’s Form 10-K 2022 for the year ending December 31, 2021 asserts that the Company "owns" "one additional patent related to the use of VASCEPA to treat prostate cancer with a term that expires in 2037."
Trust me, there’s going to be enough heart disease to go around for everybody.
Then they better get moving, don't you think! ...... they just need to apply for it Kiwi...... get the app in first...... they won't even own the company by the time it's approved so who cares? BP will follow up.
Nope ...good news for the new weight loss drugs
Now if Vascepa could be proven to reduce obesity ...then you're talking
Kiwi
Good news for the future of Amarin and Vascepa I guess.
https://www.nbcnews.com/health/heart-health/adults-us-heart-diabetes-syndrome-risk-research-rcna151215
Ram. it typically takes 1-5 yrs to get a patent on a drug . You're dealing with prior art and USPTO actions .
IIRC in the 2010 / 2011 period the patent office originally rejected the Marine patent . Eventually it was approved because AMRN could prove that Vascepa ( AMR101 at the time ) was DEVOID of DHA . Epadel by contrast has up to 10% DHA .
Poster North may have a better memory of this period.
AMRN doesn't have this time if they continue on their current path and especially if they use $50m on a share buyback.
The reality is that revenue in the US is crashing and revenue growth in the EU is minuscule .
And so far mgt has yet to come up with an effective plan to convince the market , they can change that .
Which is why the PPS is under $1.
JMO
Kiwi
Ramfan, Does anyone else have a method of use patent, that covers icosapent ethyl, for migraine treatment?
Sleven,
Why wouldn't they spend time and money on a patent....... it's not that much time and it's not that much money. They don't have to do any lengthy study either..... just get the patent and add it to your patent portfolio to increase the value of the company.
I hope that management is well informed and aware of the opportunities that this study will provide.
Because Dr Ketchum probably knows this already ...and knows AMRN will not spend time and $ on pursuing this since for one thing they would need to prove it better than an EPA/DHA combination .
A network meta-analysis study provided compelling evidence that high-dosage EPA/DHA (omega-3 fatty acid) supplementation can be considered a first-choice treatment for migraine prophylaxis.
Another study found that high-dosage omega-3 fatty acids, including EPA/DHA, outperformed existing pharmacological options for migraine prophylaxis. The researchers concluded that EPA/DHA supplementation can be considered as a first-choice treatment for migraine prevention.
A review article discussed the potential therapeutic role of omega-3 fatty acids, including EPA, in the treatment of migraine through their anti-inflammatory effects. The review highlighted several clinical studies examining the use of omega-3 fatty acids, either alone or in combination with other substances, for migraine treatment.
In summary, the search results indicate that multiple studies have investigated the use of EPA, either alone or as part of omega-3 fatty acid supplementation, for the treatment and prophylaxis of migraine.
So, why are you telling me all this? These things I already know. Again my point to relaying this to Amarin is to inform them of a possible patent they could get priority on. Indications which already have studies on the drug you own are low hanging fruit. Don't let the competition snag an IP that you should get the first crack at.
Capt. I believe thats a lot of Prior Art regarding Omega 3's and migraines ...so patent protection might be a challenge.
The exclusivity route ...see previous posts .
Great graphics tho
Kiwi
So I'll answer my own question about lack of patent protect for the migraine indication...exclusivity is an option
Based on the search results, the key differences between patents and regulatory exclusivity for drugs are:
Patents are granted by the U.S. Patent and Trademark Office and protect the intellectual property of the drug inventor, typically lasting 20 years from the filing date. Exclusivity is granted by the FDA upon drug approval and prevents competitors from submitting generic or similar versions for a specified period of time.
Patents can be obtained at any stage of drug development, while exclusivity only comes into play after the drug is approved by the FDA.
Exclusivity periods are typically shorter than patent terms, ranging from 3-12 years depending on the type of exclusivity (e.g. new chemical entity, orphan drug, pediatric).
Patents can be challenged and invalidated, while exclusivity is more secure and guaranteed as long as the statutory requirements are met.
Patents and exclusivity can run concurrently, but exclusivity often expires before the patent term ends. The expiration of the later of the two is what determines when generic competition can enter the market.
In summary, patents and exclusivity serve complementary but distinct purposes in protecting drug products, with exclusivity providing an additional layer of protection beyond just the patent term. The interplay between the two is complex but critical for understanding the timing of generic drug entry.
There's a plethora of indications that could be studied. What would I have Amarin do? Figure out which indications are hanging fruit and get those patent applications submitted. My reason for pointing these things out to them is because I'm not sure they're even aware of this stuff. Maybe they'll see the good work I do and offer me a job in PR? lol
CaptBeer
Yet another reason for the 10 % drop for us When will it ever end ? I mean OMG we cannot even be at 1 dollar so sad . Less then 2 million shares traded what happens when its 40/50 million shares ?
Michael
EPA is a med that needs development ASAP, not only for the CVD indication, but also for several other indications...If Amarin is unable to perform this task, Amarin should be sold to a BP that has the necessary assets to do it.
My apologies for my mistake. I was looking at JAMA Network link, not the link you had referred to.
JR, You are an Ok guy 'some days' - when your not focusing on Sarissa and Denner 'cheating everyone' in the market 🙂
---------------------------------
Here trying to solve the confusion - olive oil / EPA Vascepa for North - 'no spring hare' !
Capt. What would you have AMRN do with this info ?
AMRN doesn't have any patents covering composition or method of action for treating migraines that I'm aware of .
The trial was run using Epadel ...and it only enrolled 70 people using a drug not FDA regulated
Studies a U.S. FDA-regulated Drug Product: No
ralphey, You seriously are in need of psychological help.
You spending time on a random financial forum - where you clearly have no idea of what is actually going on - calls for a serios mental problem !
--------------------------------
You go find a qualified psychiatrist - who know which best drugs to help you - and in a few months - you will again be able to appreciate being alive 🙂
Captain, Let me know if you get a response.
Thanks.
Sleven,
Followers
|
1111
|
Posters
|
|
Posts (Today)
|
9
|
Posts (Total)
|
425939
|
Created
|
03/12/07
|
Type
|
Free
|
Moderators ziploc_1 zmanindc golf stud Number sleven |
AMARIN TICKER RELATED LINKS
Amarin Webpage
NASDAQ AMRN Quote
Y! Finance AMRN Landing Page
Seeking Alpha AMRN Landing Page
FinViz AMRN Landing Page
Volume | |
Day Range: | |
Bid Price | |
Ask Price | |
Last Trade Time: |