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I was relatively young when I first bought Amarin shares(or ,at least, I felt that way,, but since that time, I've gotten older in a hurry.
jas...I erred in referring to him as Nessen rather than Nissen...At least I apologized...something which is not in Nissen's playbook, when he errs.
Since Nissen became famous by correctly accessing the dangers of Vioxx, which was taken off the market due to causing serious CVD problems... and, which episode persuaded Merck to pay out almost $5 billion to settle lawsuits, Nissen has been trying mightily to find another drug to criticize in order to retain his new found fame...He has been relatively unsuccessful of late...so he decided to try his luck to take down Vascepa...Unfortunately for Nissen, but fortunately for patients, that effort has mostly backfired, but not before he was able to inflict some serious harm to Vascepa and to patients.
Orbapu...Even though the article was intended to be a hit job by Ridker, it was actually supportive of the fact that whatever small effects the MO placebo may have played in the R-IT study...they did NOT negate the excellent results of the study...This conclusion, which is the antithesis of Nessen's previous hypotheses, meant that Nessen's ego would not permit his name to be on the list of the authors of the study...
i.e....list of authors of the Circulation article
Paul M Ridker,
Nader Rifai,
Jean MacFadyen,
Robert J. Glynn,
Lixia Jiao,
Ph. Gabriel Steg,
Michael Miller,
Eliot A. Brinton,
Terry A. Jacobson,
Jean-Claude Tardif,
Christie M. Ballantyne,
R. Preston Mason and
Deepak L. Bhatt
Originally published28 Jun 2022http
Nissen is probably waiting for the next more damning hit job on Vascepa that appears, to affix his name to it.
Nessen did not like the science that showed that the DHA in Omacor blunted the role of the EPA in reducing CVD...and embarrassed him because of his mistaken advice to AZ to first pay a high price to buy Omacor and then to spend even more to prove that it works...He will forever blame Amarin and Vascepa for his failure...no matter what the evidence has already shown or will shoe in the future.
Nsleven...IMO, The most instructive parts of the article in the CIRCULATION journal were "What net clinical effect the current data, if taken in combination, might have had on outcomes in REDUCE-IT is difficult to estimate."
HOWEVER...
"Regulatory agencies evaluating REDUCE-IT estimated that approximately 3% of the net clinical benefit observed with icosapent ethyl might have been a consequence of adverse biomarker effects on LDL cholesterol and hsCRP attributable to mineral oil....In the context of an overall 25% relative risk reduction in first events and a 30% reduction in total ischemic events observed, a potential bias of this magnitude, even if doubled in size, would be unlikely to fully attenuate the overall benefit of icosapent ethyl observed."....
QED...Vascepa is valuable in lowering the incidence of CVD!
mivan...QUOTE..."The Italian agency has published these updates on vazkepa. It seems it did not fulfill the standard of innovation requested.
The most disappointing thing to me is that the quality of Reduce-it they judged as 'Low' "
Is it really the quality of the R-IT study they regard as low?...or Is it the product itself...?unsafe...?ineffective...?too pricey?
How can Amarin improve the quality?...My guess is that the.. the "quality is low" for Vaskepa...actually means that, in their estimation, the price is high.
Apparently Spain, England, Denmark, Sweden,Israel etc. did Not believe the quality was low.
"In 1928, a chance event in Alexander Fleming's London laboratory changed the course of medicine. However, the purification and first clinical use of penicillin would take more than a decade. Unprecedented United States/Great Britain cooperation to produce penicillin was incredibly successful by 1943."
In the late 1930's, sulpha drugs were still the most commonly used drugs for infections...I myself was, in 1939, treated with a sulfa drug for a foot infection even though penicillin might have been available then...It took years for even a remarkable drug like penicillin to be commonly used....IMO Vascepa will be commonly used in the future....perhaps not like penicillin, but possibly like statins.
jas...Penicillin came from a mold belonging to the Penicillium genus...It was successful because it was effective in treating bacterial infections...Patients and Docs did not care that it came from Penicillium mold.
IMHO, How EPA is produced is less important to me than how it helps CVD...The evidence that Vascepa reduces CVD with almost no side effects is what is important to me and, I think, to most people....i.e. as long as the process to produce Vascepa is as safe as the product is.
I am thinking of Vascepa from the point of view of a consumer, not of a chemist.
mrmain..Spain and Europe are now slowly getting to understand the value of Vascepa...and they will buy Vascepa in quantity when the price is right...The greater volumes of sales will lead to greater profits and translate into increases in price of Amarin stock.
ORB...QUOTE "Associating Vascepa with fish oil just because fish oil happens to be the source of EPA, used in its manufacturing processes is misleading".
YOUR STATEMENT has a grain of truth to it...HOWEVER...Most people do not have the background in chemistry needed in order to understand anything about the esterification process that fish oil is subjected to, to convert it into purified EPA by separating the EPA from the other constituents of the fish oil(especially the DHA)....
A few other considerations come to mind...
-Vascepa has always, from its beginnings , been labeled as a fish oil...and it probably always will be.
-most people do have some understanding of what the words, highly purified, might imply.
-Why not embrace Vascepa as a highly purified fish oil since it will forever be linked with fish oil anyway..and fish oil is not really a bad thing(as witnessed by its historic huge sales globally).
JR and Jas...This current huge market for fish oil presents a challenge for Amarin...but even more of an opportunity ...
-Amarin should not run away from Vascepa being a healthy extract from fish oil...
-Amarin should begin emphasizing the fact that Vascepa, as a highly purified extract of fish oil, definitely HAS been proven to reduce CVD...while fish HAS been proven NOT to reduce CVD
-So Amarin needs to ask people why they are continuing to waste their money on fish oil...People should use Vascepa INSTEAD OF FISH OIL!
The market is already established(as it has been in the past for aspirin and statins)... All Amarin now needs is a new and enlightened approach to make it work!
Hundreds of millions of dollars are spent each year, in vain, by patients seeking to reduce their risks of CVD by taking EPA-DHA drugs, such as Lovaza, Omacor, and various fish oils ...Yet the important studies that prove that DHA blunts the action of EPA in reducing these risks... remain unpublished for years...Why??
The FDA is a political body as are the Courts...The judges in the Courts and the supervisors and commissioners in the FDA are political appointees...The prevailing political winds are in favor of the generics...and the Congress, the Courts, and the FDA are aware of this....This leads to the present situation in which there is obvious corruption of the HW law, but no one wants to correct it.
Denner is now easily able to change the "no standing" issue, which was then due to PWO's intransigence... It was the cause of Marjac and Amarin being denied justice in Amarin's "fraud on the court" case...The "no standing"issue,being easily rectified by Denner, could allow Amarin and Marjac, possibly with additional help from other excellent lawyers, to renew litigation of Amarin's case on a contingency basis.
The ubiquitous, nasty corruption of the H-W law by skinny labels, which is presently being tolerated, is HUGE...With very sharp and learned lawyers and with just courts and juries, the damage awards due to Amarin should also be HUGE!
Amarin...If you still have any residual belief in justice after what happened in the Du case, DON'T make any deal with DR in their Sherman anti-trust case...and DO sue Dr. Reddy for their infringement of the Amarin CVD patent!
Correction..."the difference in an increase in the percentage of AF between the two arms is a misleadingly large 72% increase in the EPA arm."...
Error...The difference would be 28%
Jas...An example of Dr. Nessen's biased analysis of the R-IT study is manifested in how he chooses to report the incidence of the atrial fibrillation risk in the EPA arm vs. the incidence of the atrial fibrillation risk in the placebo arm of the study....
The incidence of AF in the placebo arm being 3.9%
The incidence of AF in the EPA arm being 5.4%
There are two ways to report this increase in incidence of AF in the EPA arm over the placebo arm...
First. way---- compare an increase of 5.4% in the number of patients with the AF side effect side effect in the EPA arm as opposed to the to the 3.9% increase in the number of patients in the placebo arm...this difference between the two arms is then reported as relatively small 1.45% increase in the EPA arm.
Second. way----compare the 3.9% increase in the patients in the placebo arm side with the 5.4% side effects in patients with patients in the EPA arm...and to then report the difference as an increase in the percentage of AF between the two arms as a misleadingly large 72% increase in the EPA arm.
This way of reporting by Dr. Nessen leaves the false impression that Vascepa(EPA) has severe side effects, which it DOES NOT!
I blame Dr. Nissen...He knew better, and had no reason to spout out all the nonsense that he did about the MO placebo in the R-IT study being the reason for the success of Amarin's R-IT study....
Except that Nissen had previously advised to AZ to buy Omacor(which contained DHA as well as EPA), for an large amount of cash, as a potential competitor to Vascepa...and then Nissen convinced AZ to do very expensive studies on Omacor...
When AZ ultimately turned out to be an expensive and an embarrassing failure, it did great harm to Nissen's reputation...
After this very embarrassing episode, Nissen blamed Amarin because it had done a very successful R-IT study on Vascepa....This episode has seriously hurt Nissen's reputation as a medical wizard, inducing him to continuously discredit Vascepa by implying that Vascepa would have also failed, as did Omacor, except for the R-IT MO placebo making the R-It study make Vascepa look superior to Omacor on reducing CVD...
Nessen's argument concerning the importance of the negative effects from the small quantities of MO used in the R-IT study placebo study, has been conclusively proven to be false.
Tal... "A party cannot be compelled to arbitrate a dispute unless it has agreed to arbitrate it."
Since DR is the plaintiff here, I assume that DR initiated the arbitration request...If not for judge Du's adverse decision on the Marine patent in Marcn, 2020... which then allowed DR and others to infringe on Amarin's CVD patent, Amarin would NOT have had enough API to satisfy their current needs...IMO this suit by DR should be followed by a counter suit for infringement, with DR as the defendant and Amarin as the plaintiff, .
I would have preferred it... if Amarin had not agreed to the mediation and, instead, gone directly to a counter suit.
Tatsumaki...If, as you believe, Amarin's patent application for LR-EtEPA is a MOA(method of action) patent, and it is eventually approved by the patent office and by the US FDA , do you think that Amarin can market this new formulation(e.g.for Lymphoma) in the US without making payments to Mochida...and that Mochida can market it in Japan and China without making payments to Amarin?
JR...Tatsumaki professes to believe that Dr. Mason's new formulation of EPA, LR-EtEPA, will not fly because it is not enough different from Mochida's MND-2119(EtEPA drug)...Do you agree?
We already know that Amarin has applied for a patent on this new, potential blockbuster drug, but we are sorely lacking further information on it it from Amarin.
During the past decade, we have seen more remissions and even cures with the development of new, more effective, anti-cancer drugs and, recently, we have seen development of genetically engineered antibody and antigen treatments...Now, anti-inflammatory drugs, which have minimal or no side effects have an increasing a role to play in the successful treatment of cancer patients.
Keeping patients healthy, by reducing inflammation, during and after their treatments for their cancer, is a continuing challenge.
DAR53...I am not an oncologist, but I assume that this patient has a metastatic cancer or some systemic cancer such as a lymphoma....To have a chance for a cure,he probably needs infusions with cancer killing meds, which would produce systemic inflammation, too severe to be managed by EPA alone....e.g. he would need high dose steroids.
EPA could be used as an adjunctive therapy to this treatment.
JR...Thanks for the heads up...How about I propose the name for Amarin's product to be EPA-L(the L being for the new drug's importance to lymph, lung, and life)
JR...I thought of the name, 'EPAMAX' for Amarin's new EPA formulation...as far as I know, there is no copyright on the name, EPAMAX...therefore Amarin is free to use that name for their new product with my blessing, if they wish.
Tal...Thank you for this fantastic, comprehensive analysis of EPAMAX.
Jasberg...I think that by collaboration", Mochida actually means outsourcing....Amarin may decide to outsource EPAMAX to Mochida in return for payments by Mochida of an upfront fee, royalties and milestone fees, in addition to marketing rights in "specified territories"...or it may decide not to do that.
From your post...
"MND-21 ethyl icosapentate Phase ? Hypertriglyceridemia Oral "Collaboration" with Sumitomo Pharma (Suzhou) Co., Ltd.<China>"
The only question is who will have the patent rights to EPAMAX...and I think it will be Amarin . Mochida's patent on Epadel does NOT give Mochida any rights to EPAMAX...nor can Mochida give EPAMAX rights to Sumitomo Pharma.
Tats...That's BS The FDA would not grant the CVD indication for Vascepa until completion of R-IT. .
Tats...I believe that Amarin's legal department has more understanding of Mochida's MND-2119 patent and the details of the Mochida- Amarin agreement of 2015...than either you or myself...and, with that in mind, Amarin made the decision to fund Dr. Mason to do the research on EPAMAX to show its superiority to MND-2119...and then spent additional time and money to file a new patent for it.
I will continue to believe that EPAMAX is Amarin's unencumbered drug unless Holt or Denner informs me otherwise.
Tal....Amarin's patent filing for EPAMAX on 8/3/2023 was 232 pages long..IMO Amarin would not have spent all this time and money if they didn't think they had a reasonable reasonable chance of success in getting the patent approved and then developing the product....They probably also assumed that a patient this important and potentially profitable would eventually be challenged by other pharmas and would withstand the challenges. (hopefully better than the Marine patent)
Since the ?provisional patents were filed from January through May of 2022, this would, almost but not quite fit the timeline for the ?non provisional patent filing in August 2023....So it is still possible that these latest filings are provisional....We won't know for sure until next August.
"Under the PCT(Patent Coordination Treaty), you can file one PCT application in one language at one patent office, within 12 months from the date of the earliest patent application that you have filed for the same invention (the “priority date”)."
The Amarin patents for the new drug, EPAMAX, were first filed in the U.S. in January through May of 2022 as provisional patents... and, as such, they were due to expire in one year...so these new patent filings in August of 2023 are probably non provisional(or permanent) patent filings.
The patents for EPAMAX were never filed by Mochiba and were not part of the "collaboration" between Amarin and Mochiba as they were funded solely by Amarin.
Two serious diseases that come to mind as potential treatment targets for this new Amarin drug would be lymphoma and lymphatic leukemia....in addition to any diseases which produce swollen, inflamed lymph glands.
Amarin apparently disagrees, having filed an application on 8/3/23 for a NEW patent on "LYMPH REDUCING composition of fatty acids and uses thereof for LYMPHATIC INCORPORATION and systemic disease therapy"
The deal between Amarin and Mochida was one in which Mochida outsourced certain rights to collaborate with Amarin on the development of EPA products and for Amarin to market them in "specified territories such" as the US. and "other territories".... In return, Amarin paid Mochida 2.7 million dollars up front and agreed to pay Mochida royalties and milestone payments.
To my knowledge, Amarin does not have an agreement with Mochida, in which Amarin has outsourced to Mochida the rights to market EPAMAX in the U.S. and "other specified territories" and not paid any upfront fees to Amarin for such rights...nor has Mochida agreed to pay royalties or any milestone payments to Amarin on the marketing of EPAMAX....Also. I am not aware of any role that Mochida collaborated in Dr. Mason's research to develop EPAMAX...Therefore, in lieu of other information to the contrary, which emerges on the subject, I believe that Amarin is the sole, unencumbered owner of EPAMAX.
I don't think we should underestimate the potential significance of this newly invented formulation of EPA by Dr. Preston Mason, both to patients and to Amarin...
It merits the name..."EPA MAX".
Tal Shu, I agree...The new and improved version of EPA, researched by Dr. Preston Mason, is an important addition to Amarin's drug list for a host of reasons...I hope we can learn more details on Amarin's plan for patenting and marketing of this new drug.
As a clearly superior new form of EPA, it could lead to the introduction of an AG for Vascepa alongside the new improved version of branded EPA.
CBB...Cancer Rx is a new focus for drug companies...
e.g....."Antibody-drug conjugates (ADC) are a rapidly expanding class of anti-cancer drugs, with twelve agents in current clinical use. Despite recent successes, many ADCs fail during clinical development due to excessive toxicities and unfavorable risk-benefit profiles. Even for those ADCs that have been approved for clinical use, a substantial fraction of treated patients require dose reduction, treatment delays, or treatment discontinuation due to intolerable ADC-associated toxicity."
e.g. Car-T Rx's are immunotherapies, in which T cells are collected from the blood and genetically engineered to fight cancer cells....The reactions with cancer cells produce huge inflammatory effects.
Both of these newer therapies(in addition to older CHEMO therapies with a longer history) produce inflammation, which must be dealt with in the course of treating cancer patients..Vascepa is an anti-inflammatory drug with practically no side effects...Hence it's usefulness as an adjunct to newer and older anti-cancer therapies.