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KIWI...You're beginning to sound like Kaiser Permanente's answer to the Cleveland Clinic.
Joking aside, it would be revealing to see mass testing of serum LDL's and EPA's.
Kiwi...your post misses the point....THE STARTLING FACTOR IS THAT THESE KIDS ALREADY HAD CVD AT AGE 22.
1.You are looking a dead servicemen in Korea"...
These kids were 22 year olds, who were killed in action.
2. "How many of them actually died of heart attacks?"....
These kids had CVD at 22 years of age... with 10% of them having severe occlusion(i.e.90% occlusion) of coronaries at the time of their death. They had no way of knowing that had CVD.... some of them SEVERE CVD.
3. "This was before statins were invented and HeFH ( very high LDL cholesterol) was identified as a risk factor"....
These kids were draftees with no known risk factors.
CVD is ubiquitous in adults...something, which is NOT well understood...and that is why CVD is all too common a reason for death.
You do not need to wait until a person has a heart attack before you start treating CVD.
Life is a risk factor for cardiovascular disease...An autopsy study on U.S. soldiers, whose mean age was 21 years and who were killed in the Korean war, showed this...
QUOTE ..."In 77.3% of the hearts, some evidence of atherosclerosis was discovered. For 35% of the cases, the disease was limited to fibrous thickening or streaking causing insignificant luminal narrowing. For 13.3% of the population, plaques had narrowed the lumina by 10%. For 5.3% of the population, the lumina had narrowed by 90%."
gg...Thanks for correcting my recollection of these figures, which even more impressively paint the picture of potentially increased Vascepa sales in Europe, by not having to compete with these gV and Lovaza inferior products.
The combined total of the volumes of sales of Lovaza and gV in the U.S. is roughly equal to the present total volume of U.S. Vascepa sales...With these sales of gV and Lovaza not in competition with Vascepa in Europe, the potential volume of Vascepa sales in Europe may be presently underappreciated by W.S.
Rose..The potential downside is a buck...The potential upside is many bucks.
Amarin is a going concern with a great product, cash in the bank, and no debt!
If Amarin can retain the market they already have, while they add more markets, and continue to conserve cash, the future remains attractive.
Amarin is now selling like a call option with an unlimited expiration date...
In the past, I bought call options on Amarin that were more expensive than Amarin's present price and profited greatly.
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Since Amarin is said to have collaborated in the Mochida development of MND-2119, would not the royalty on Amarin's; MND-2119 products be set at a reasonable rate which would allow Amarin to sell MND-2119 at a rate as low as or lower than the present price of Vascepa?...Has Amarin divulged the royalty rates?
Do we have any idea of whether Amarin, who apparently collaborated with Mochida in the development of MD-2119, will be paying any royalties to Mochida for their sales of MD-2119 products in the U.S....and, if so, at what percentages of the selling price?
Do we know how much Mochida is charging in American dollars in Japan for 2 gm capsules of MD-2119 ?...I understand it is being sold OTC in Japan.
Pdude...When I was in medical school, diabetics were followed on the basis of their blood sugar levels...I had never heard of A1c levels, which are now emphasized on adds by Jardiance and other meds to treat diabetes.
In the same way, Docs should now be encouraged to test their patients' EPA levels frequently in order to see how well protected they are against CVD events.
I believe Vascepa and especially MD-2119 will prove superior to DS and Lovaza.
I would also be interested in how the serum levels in patients treated with gV stack up against those treated with Vascepa and MD-2119
Capt...Great post...It seems that the patent situation has been taken care of by Mochida...Now Amarin needs to attend to the FDA approvals for MD-2119...plus FDA approvals for the fixed dose combos with statins and MD-2119.
Its all about the serum EPA levels...An Rx for 4 gms/day of Vascepa yields a serum EPA level of 150...An Rx for 2 gms/day of MD-2119 yields a serum EPA level of 200....OR 50% MORE EPA in the MD-2119 Rx than in the Vascepa Rx!
Vascepa and MD-2119 are two different drugs...They are NOT bioequivalent... An Rx for 2gms/day of MD-2119 can NOT be substituted for by an Rx for 4 gms a day of Vascepa
Vascepa and MD-2119 are like apples and oranges...They are both fruits, but one is very different from the other..
ILT...You bring up important questions...
1. When did Amarin apply to the US patent office for a patent on MD-2119 and has the patent been awarded?
2. Has Amarin applied to the FDA for an approval of MD-2119 and if so...for which indications and dosages?
3. i.e. Is the MD-2119 application for FDA approval for the CVD indication...or just for the Marine indication?
4. Has Amarin applied to the FDA for a fixed dose combo containing a statin plus MD-2119 and if so...for what dosages of what statins plus MD-2119?
The patent on the new emulsified formulation of EPA will make generic substitution an infringment...Generics can still sell gV, but not MD-2119.
I anticipate that the market would eventually phase out Vascepa in favor of MD-2119
The current situation for Amarin reminds me of the period after the FDA decision in 2013 when the FDA decided not to approve Vascepa for CVD until R-IT could be concluded...The potential that Amarin had with Vascepa did not mean much to the market as long as there was this fear of bankruptcy...At that time Amarin was in debt and had put up their patents as collateral...This is not the case today, but the fear of bankruptcy is hanging like a cloud over the share price...until this fear is lessened, the share price will continue to be in the gutter.
Management needs to continue to make it clear that Amarin is not in debt, has hundred's of millions in assets and is conserving capital(as they have recently stated)...and if they can break even or even show a little profit, that would go a long way to redirecting the market's focus to Vascepa's(orMD-2119's) potential stellar sales and help the share price.
It would also help if they could discuss their plans for MD-2119.
Perhaps they will do this at the AHA meeting in early November
rose...QUOTE from an article in journal of clinical medicie research in June 2012..."sdLDL particles are more easily taken up in the arterial walls and display a high susceptibility to oxidation with their retention in the walls, leading to uptake by macrophages, and thereafter, foam cell formation. The atherosclerotic processes produce oxidative stress"....
My take on this is...It is important to destroy sdLDL particles by oxidizing them...The intact(i.e.non oxidized) EPA particles, when dealing with sdLDL particles, can oxidize these sdLDL particles before their retention in the arterial walls(where they can be oxidized there.. and thus the EPA particles can prevent atherosclerosis and CVD events.
rose...QUOTE" the present invention provides methods of treating and/or preventing cardiovascular-related disease and, in particular, a method of reducing or preventing small dense LDL ("sdLDL") oxidation in a subject, the method comprising administering to the subject a pharmaceutical composition comprising eicosapentaenoic acid or a derivative thereof.
Inventors: Mason; Richard Preston (Bedminster, NJ)"
Wasn't Mason also working on a study to show that Amarin's patented gelatin capsule prevented oxidation of the EPA within?...This would tie into the idea that less oxidized EPA produces less oxidized small dense LDL, which then, in turn, produces a reduction in CVD events....Wouldn't this be evidence that gV, with an inferior capsulation, does NOT have the same effectiveness as Vascepa in reducing CVD events...a defect in gV that the FDA has not dealt with to date....and a reason why I declined to approve my pharmacist's offer to substitute gV for my Vascepa?
They can mention in the adds that Vascepa has patented capsule science to prevent oxidation and preserve efficacy....something that gV does NOT have.
Vascepa's prime competitor is not gV...The prime competitors are Lovaza and DS fish oils(more than twice the market that Vascepa has)...Amarin needs to call out their competitors, in advertisements, explaining why Vascepa is better than the competitors in reducing CVD.
Many people have had a CVD event or have a family member, who has had one...If they were informed of why Vascepa is superior to the competition, they might be willing to pay somewhat more to switch to a drug with more efficacy...and pressure their Docs to give them an Rx for it.
rose...QUOTE..."measuring serum levels of EPA can give you an idea of the amount of benefit that can be obtained from EPA. We are not even sure what a saturation level might be above which no extra benefits can be obtained."
I have been thinking along the same lines...I take Eliquis twce a day in addition to Vascepa four times a day...Would two grams of MD- 2119 taken twice a day, substituted for 1 gram of Vascepa four times a day, make it safe and effective enough for me to stop my Eliquis twice a day?
We need event studies on this question.
Capt...I agree...The evidence is abundant that the MOA of Vascepa in reduction of CVD events is dependent on the level of serum EPA
As the graphs depicted in your post 388844 clearly illustrate, the serum level of EPA is associated with reduction of CVD events...Serum EPA should now become standard in metabolic testing.
It took a while for penicillin to be accepted by MD's.
I remember as a child, in the 1930's, having a leg infection...A local MD was called and he had not heard of penicillin and gave me a sulphur drug instead.
"Although Fleming published the discovery of penicillin in the British Journal of Experimental Pathology in 1929, the scientific community greeted his work with little initial enthusiasm. Additionally, Fleming found it difficult to isolate this precious ‘mould juice’ in large quantities. It was not until 1940, just as he was contemplating retirement, that two scientists, Howard Florey and Ernst Chain, became interested in penicillin. In time, they were able to mass-produce it for use during World War II."
Dr. Bhatt's interest in Vascepa is akin to Dr. Florey's interest in penicillin.
Capt.....QUOTE...." Effect of Low-Dose Statin Compared With Placebo and Six Dietary Supplements on Lipid and Inflammatory Biomarkers: The SPORT Randomized Clinical Trial"...
SPORT is essentially composed of the same group that has made a hobby, in the past,of denigrating REDUCE-IT
Among those are..."Luke J Laffin, Dennis Bruemmer, CLEVELAND CLINIC FOUNDATION Cleveland, OH; Michelle Garcia, Danielle Brennan, CLEVELAND CLINIC, Cleveland, OH; Ellen McErlean, CLEVELAND CLINIC, Cleveland, OH; Astrazeneca Biopharmaceuticals, Wilmington, DE; Steven E Nissen, CLEVELAND CLINIC FOUNDATION, Cleveland, OH"
I note that biomarkers used in the study include LDL, but NOT EPA.....Inclusion of EPA might be counter to their narrative.
bigka...QUOTE..."But what I can say is we are very committed to stand behind VASCEPA in every way."
IMO this was a slightly ingenuous way of KM saying that he can't, at this time, say more about Respect(now a late breaker at AHA) or Mitigate(hopefully to be admitted as a late breaker at AHA) until the results are released at the meeting.
Respect and Mitigate will open the doors...Brave will blow the doors off!
Amarin's primary market for Vascepa is for CVD reduction...The market for other conditions can wait...IMO Amarin should develop the statin-MD-2119 combo market even before developing the V2 market, thus keeping the Vascepa market they already have...while waiting for the combo market to develop
The patented method of encapsulation used in Vascepa to protect the pure EPA from being oxidized...thereby preventing its loss of effectiveness in preventing CVD events... distinguishes Vascepa from gV, which does not use it.
Mochida's MD-2119 does not make use of Amarin's patented method of encapsulation, but I'm sure Mochida and Amarin could reach an agreement for both of them to use it...for both the mono drug and the combo drug.
These are vital questions and investors deserve answers NOW!
Skipper....QUOTE..."Cash crunch completely dictates direction and pace that Amarin is able to move"...
I agree...and that is why Amarin needs a BO from a BP with expendable cash....This was made necessary by the adverse ninth circuit decision...Otherwise Amarin would have had a chance of making it to being a BP itself.
Lacking a BO, Amarin should consider shifting gears and concentrating on MD-2119 for the U.S. market.
I have to assume that KM has been in contact with the FDA...asking some of the same questions we investors have been asking...I anticipate a timely PR from KM relating to these questions and an application for FDA approval of MD2119, which could be the game changer Amarin has been awaiting since the adverse ninth circuit decision on Vascepa....The cat is already out of the bag, so there is no futher need for secrecy to protect trade secrets.
Capt....IMO Amarin should drop plans to investigate the fixed dose combo with Vascepa and switch to the fixed dose combo with MD-2119.
Capt.....WOW!...The vital serum EPA 1 year level with V at 4gms./day(i. e. the R-IT study) was exceeded by 70% by the serum level in the MD-2119 1 year study at 2 gms./day.
What is Amarin waiting for before deciding to make a move to MD-2119?...Reclaiming the U.S...market for pure EPA could become Amarin's first priority...Lovaza and gV could be left in the dust!
CBB...I agree...I suspect Denner has already been in discussions with BP's...Now he needs cooperation from the BOD.
Things that Amarin can do now that would not deplete their cash assets.
1. apply to the FDA for approval of MD-2119 for CVD
2..apply to the FDA for approval of of a fixed dose statin-Vascepa combo
3. apply to the FDA for approval of a fixed dose statin MD-2119 combo.
If there is to be a problem with these requests, it would be beneficial to know ASAP so Amarin can do whatever is necessary to rectify the situation.
JRoon..."QUOTE...Zip, what exactly has the BOD done/not done that makes you believe they "don't care"?
The BOD didn't care to support the EPADI , appeal, which stood a chance of overturning the decision by judge Du...thus restoring the U.S. market for Vascepa to Amarin....Their lack of support, predicated on their own interests not to be embarrassed by the mistakes made by their outside lawyers and their own in house lawyer, doomed the case.
Marjac's brilliant appeal brief, to which the EPADI investors had contributed, was ignored by the court...mainly because the Amarin BOD had not supported it.
The BOD does not seem to care about the present roadblock...How does Denner feel about it?
Rose...Amarin has already done much of the work in building the house...Now they need a BP to help fill the house with furniture.
KM was remarkably open in his recent talk at the H.C. Wainright conference...QUOTE
"So fixed dose combination is a very significant initiative. It is supporting the diversification element on our side. When you get a product like VASCEPA with 25% or 30% outcome benefit, it would be a shame not to imagine a full portfolio of products around it....Now because of the cost reduction, and we are very, very cash prudent today, we decided to focus on 1 statin in terms of development and really go sequential in terms of planning....meaning NOT TAKE RISKS to run different phases in parallel."
It is clear that deficient cash is the main factor holding up Amarin's development of a fixed dose combo of Vascepa with a statin or MD-2119 with a statin.
Amarin can not raise cash by selling their low priced stock or by borrowing at high interest rates...one solution is to sell to a BP flushed with cash....IMO pure EPA would have a much greater greater future in the hands of a BP than in the hands of a small cash poor Pharma.
Perhaps my most important consideration for supporting Amarin to be under the aegis of a BP...is that Vascepa is a potentially powerful drug for many conditions, other than just CVD...and Amarin, after the decision of the ninth circuit, has been deprived of enough cash to properly pursue the R&D for these indications.
KM does not intend to talk about fixed dose combos until 2023...QUOTE...(thanks to ggwpg)
"we decided to focus on 1 statin in terms of development....and really go sequential in terms of planning, meaning not take risks to run different phases in parallel because you can do that and save time....
But we are encouraged by the progress we're making. So far, we have made very, very little -- very few public statements because we believe the minute we talk about this, THERE IS COMPETITIVE RISK. But some time in 2023, we will talk not only about the product, what it will bring and the value, but what sort of protection can come with it and so on...
So we are very encouraged with the fixed-dose combination, and it's a significant part of our future fixed-dose combinations in general."
I am betting that the fixed dose combo with statin and MD-2119 makes the most sense.