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Hickma signaled its position by failing to file a brief initially...and they filed a brief only when the case was approved for oral hearing...They showed their unwillingness to discuss the rule 60 fraud issue in a brief, but chose to depend on the case being rejected for oral arguments on the basis of the rule 24 standing issue.
The present negotiations going on between Amarin and the government health agencies in France and the U.K. are more about economics than science...Nissen is being employed as a "useful idiot"...The government negotiators are well aware of Nissen's reputation...and they are aware that his Strength Study failed and that his MO arguments have been discredited.
It will do very little good to try to discredit Nissen or his MO negative stance...Vascepa has the potential for being prescribed for millions of patients and it is not really cheap for National Health Insurance budgets(especially in this era of financial insecurity)...It will do much more good for Amarin to negotiate with governments on the price of Vascepa...Vascepa's benefits are well documented with many positive studies...and with approvals by the FDA in the U.S. and the EMA in Europe.
Marjac...What would diligence in detecting the fraudulent cropping of the bottom two lines of of the Kura table mean?...It would mean committing the entire table to memory...I will admit that I do not have that kind of a memory...Perhaps that is why I'm not a lawyer...Also I'm naive enough to think that a table presented to the judge, who is in the process of making a decision, is legitimate evidence, rather than having been cropped.
H-W was never intended to become an engine for infringement...but it has become that anyway. The ever increasing costs of R and D and the costs of patent challenges are now being made even less acceptable due to the risks of infringement by generics.
Small pharmas are now being discouraged from innovation...unless they sell out to Big pharmas....This is now the case for Amarin...but the message is not being lost on other Small pharmas.
sstyles...The fact that Amarin chose not to follow up this fictitious fact is irrelevant IMO.
Marjac....There is a subtle difference between a lie and a fictitious fact...The latter is worse.
A lie is the distorting of a fact....The cropping of a table is the constructing of a fictitious fact...and Hikma introduced this cropped Kura table as a significant fictitious piece of evidence to prove their case.
Bolio....Reasons why there are diminishing returns for gV
1.small margins due to expensive API
2.limited supply of API
3.competition amongst 4 generics in U.S. plus branded Vascepa
4.gV not allowed in Europe
5.volume sales of gV dependent on infringing on CVD patents
6.infringement suits already pending and awaiting oral hearing
7.potential FDA review and disallowing of gV as a biosimilar, due to inferior encapsulation of gV with resultant oxidation of EPA
8.potential reversal of the invalidity of the Marine patents due to a fraud on the court during the patent suit
9.potential marketing of Vascepa as an authorized generic
Rose...JT steered Amarin from near bankruptcy after the FDA reneged on its promise to seriously consider allowing the CVD indication for Vascepa, providing that Amarin conducted a well underway R-IT study....
To a near blockbuster success, only to be stopped in its tracks by the ninth circuit decision fiasco...Blame Kennedy, not JT for what has happened to Amarin in recent times.
Jason Marks, Amarin's new chief legal officer, has connections to Novartis..."Mr. Marks also held senior roles at Novartis’s Alcon division, including the head of legal for North America"
Perhaps Marks could play a role in a BO of Amarin by Novartis.
Having had had roles in Bauch and Alcon(two companies noted for their ophthalmic drugs), perhaps Marks might interest an acquiring company in promoting Vascepa for dry eyes.
With China waiting in the wings, the $240/month price of Vascepa might be the "technical issue" which as the Chinese FDA has indicated, needs to be to be addressed before their approval of Vascepa for marketing in China...At the end of the one year moratorium of price negotiations for Vascepa in Germany, the price will have to be negotiated there also.
If we can get quicker approval by NICE in the U.K., the negotiations on price can/should begin on price now....and adjustments made.
The negotiated price can be made dependent on volumes of Vascepa sold.
How about this sexy drug?...Amarin could patent a combo drug with Viagra?...increased blood flow with decreased inflammation....10 mgm of Viagra combined with 1 gm Vascepa taken q.i.d....live a longer and happier life.
Among the factors that politicians run on is the financial integrity of their government run programs....such as national health services...These politicians, running for office or, holding tight to their present office, may be interested in short term fiscal results and, in some cases...even more interested in the short term than in the long term.
This is especially true in the case of Vascepa, a drug which has the potential to be prescribed for millions of patients, thereby adding short term costs to the national health system...and possibly making politicians, currently in offfice, look bad.
Alzheimers studies have shown that reduction of amyloid does not bring a reduction of symptoms.
Alzheimers is due to:
1. inflammatory disease of the brain, leading to
2. disruption of nerve dendrites, leading to
3. secretion of amyloid in the brain from the disrupted dendrites
Amyloid is a symptom of Alzheimers, not the cause...
Anti-inflammatory modalities such as Vascepa can help Alzheimers...The Brave study at The University of Wisconsin is a small first step to demonstrating this effect.
The need to lower the price of Vascepa will eventually come from pressures from Europe and China...I'm therefore not concerned about lowering the price in the U.S....Vascepa was always intended to be more about volume than about price.
The market and the indications for Vascepa are so large, that Vascepa can be quite profitable at a lower price point...We do have to get the volume up first before this can happen.
I can see Vascepa being sold in lower income settings like India and Africa at lower prices in the future...At that point, the challenge will be to increase the supply of EPA...This will take a large investment to explore new avenues for the production of EPA.
Perhaps many of the top officials in China are away from their desks, attending the Olympic games. It is possible that everything is on hold in China until after the completion of these games.
bidmark...I agree.... "Laurent Abuaf, Karim Mikail's hand picked man to head Europe should be held accountable for the UK NICE"
Amarin should not have to absorb one blow after another...without making necessary changes to top management....In the future, KM must represent Amarin in important events like Nice, with Abuaf as his assistant.
J.Z. and J.T. also left after debacles, which occurred on their watch.
What happened at Nice was avoidable....if done with the proper planning....as was also what what happened in the Marine patent loss.
Sluicebox and PDude...You're right!...All the issues brought up by Nice were also brought up the FDA in the Adcom of 2018...and the vote was 16 to zero in favor of approving Vascepa for the CVD indication...also, the use of Vascepa in millions of patients since then has only strengthened the case for its life saving efficacy and for its side effects being benign.
The Nice meeting seem to be setting the groundwork for a debate on the price that the U.K. National health service will pay for Vascepa.
Nevertheless, we need to be better prepared for a skirmish than we were at Nice.
KM spoke at JP Morgan when he and Ketchum should have been speaking at Nice....It is not difficult to imagine that Amarin, a company based in Ireland, with important detractors in the U.S. such as Dr.Nissen...and serious competition from BP in Europe, could run into some opposition at Nice...Dr. Bhatt and other knowledgeable Doctors could have/would have made a difference at the meeting.
Wake up Amarin!....You are working in an environment, marked by intense competition and resentments...Vascepa is a lifesaving product, but you have to roll this stone uphill.
As has been said...next time send your 'A' team.
Some day, when Johnathon Singer, who was Amarin's attorney during the first appeal of the ninth circuit decision,writes his memoirs, we will know why the Amarin BOD instructed him not to mention the rule 60 fraud during the oral arguments...He was too good a lawyer to have taken this course without instructions from the board not to do so.
Perhaps the BOD felt they could win the Amarin appeal on the basis of the Graham principles and statistical errors on the Mori and Kura studies... without having to embarrass Covington and the in house counsel, Kennedy for not picking up the fraud during the trial.
Thank goodness, we now have a lawyer, who does not have to obey instructions from the Amarin BOD.
Marjac "If there was hard evidence, meaning the appropriate scientific testing proof of such impurity"...
This would be of importance for the FDA to take action to remove gV from the market.
If there was hard evidence(through scientific studies of patients being harmed by taking gV rather than Vascepa), it would be a matter for the courts.
At this time, we are awaiting release of scientific testing proof of impurities...presumably being done by Dr. Mason and others.
Its one thing for a product to have a rotten smell...Its another thing for a product to have a rotten result.
Marjac...potential Amarin arguments against these Healthnet's claims...
Healthnet claim 1."a Declaration that they(Healthnet) are not infringing"...
Prior authorization requests to Docs show that Healthnet has been definitely infringing on Amarin's CVD patents.
Healthnet claim 2."even if they(Healthnet) are infringing, a Declaration that the patents are invalid"...
Judge Du already found the R-IT patents for CVD to be valid,i.e. in the Hickma vs. Amarin patent suit.
Hickma originally sued to have both Amarin's Marine and Reduce-It patents invalidated, but Judge Du, to her credit, refused to invalidate the R-IT patents...This attempt by Healthnet to invalidate the R-IT patents is more evidence of the conspiracy between Hickma and Healthnet to infringe upon the R-It patents....They both had to cooperate or the infringement would not work.
Judge Hall ruled that the Hickma and Healthnet cases could advance...Judge Andrews allowed the Healthnet case to advance, but dismissed the Hickma case...with the proviso that Amarin could make an amended claim later...and this now seems to be Amarin's amended claim....I'm hoping Amarin can secure a jury trial.
Rose...J.T.'s specialty was accounting...He was neither a marketer or a lawyer.
lizzy...This lease was signed prior to J.T. being blind sided by judge Du...J.T. expected to have a blockbuster revenue drug in Vascepa and wanted to provide a hub for future sales globally...For the same reason, J.T. was signing long term contracts for EPA with suppliers...Then the Generics moved in with their stealthy mischief... and started to cut into Vascepa, thereby doing damage to patients and to J.T.'s plan.
Rose,I agree...there are many issues that Marjac could argue, but he is constrained by having only 15 minutes...this means he he will have to concentrate on the cropping of the Kura table...As for Hickma, it is difficult for them to argue that there was no fraud...or if there was, that it was not important for the judge's decision...Hickma will have to base their argument mainly on standing.
If EPADI wins its appeal, EPADI should have a meeting/celebration at a venue chosen by Marjac and invite Marjac to be our guest of honor.
If the CAFC felt that EPADI had no standing, they would not have scheduled oral arguments...so I believe the main issue to be argued on February 11 is: Was there a fraud on the court, which influenced the judge's decision?...This is an issue which is literally spelled out sufficiently in the documents of the court, to provide a basis for a win by EPADI.
We know that Vascepa has an anti-inflammatory effect in addition to its effect in lowering triglycerides...This effect is important in reducing the incidence of CVD...and in helping with other diseases.
e.g....in the Cardiolink study..."Treatment with VASCEPA led to a 25% reduction in the inflammatory biomarker, high sensitivity C-Reactive protein (CRP), which was statistically significant."
Amarin needs to publicly emphasize the importance of this MOA in Vascepa, a drug,which has been proven safe in the treatment of millions of patients....If necessary, Amarin can do additional large scale, short term biomarker studies to emphasize this point.
Liver disease was the side effect that caused Pfizer to drop development of Vupanorsen...and,in that process, lose 250 million dollars...Vascepa has the advantages of having phase 3 studies, which have shown no serious side effects and great effectiveness in reducing CVD...Pfe was hoping for a 3 billion dollar market for Vupanorsen...Vascepa, in the right hands, could replace Pfizer's hoped for,but now lost market, and introduce Pfe to a far larger market.
dmicento...I see this 2020 article as being a plus for Vascepa.
“Almost 20 million people in the U.S. take fish oil supplements, mostly because these products are advertised to reduce cardiovascular risk and claim unproven health benefits,” observes Dennis Bruemmer, MD, PhD, Director of Cleveland Clinic’s Center for CardioMetabolic Health. “The STRENGTH trial adds to the increasing evidence that fish oil supplementation, particularly when added to recommended statin therapy in high-risk patients, has no beneficial effect on cardiovascular risk."
Vascepa is NOT fish oil. but is over 96% EPA, a purified derivative of fish oil that has undergone a chemical process to extract the esterifed EPA and leave the rest behind...
This article is more evidence that fish oil supplements like Lovaza, are ineffective and should be removed from the market...as they have been in Europe!
KIWI "Marjac pulls off his Hale Mary ) THEN PFE might be interested"...
I agree...but, if we win the rule 60 case, Amarin should not be willing to be receptive of any offers that are under the high double digits.
Capt...good strategies for companies awaiting potential BO bids...Amarin has all the boxes checked.
1.demonstrate financial strength
2.demonstrate demand for their product
3.demonstrate catalyts for future growth...i.e.
a.outcomes of legal cases
b.improvements in their products...higher strength EPA capsules
c. potential new products...combo with Statin-EPA
d.new markets...China, ROW
e. new indications for Vascepa...cancer, colitis, Covid, Alzheimers dry eye etc.
dogn...The article you cited is deficient in many ways...but the best point in the article, which I agree with, is this is this...
"The last resort for the company would be to build out the sales forces in Europe and the U.S. and distribute the drug itself. This would be an incredibly expensive, time consuming and risky option to be avoided at all costs."
Yet this appears to be the current direction, which Amarin is taking at this time....Perhaps Denner can orchestrate a change in course with a sale of Amarin to a BP...KM could stay on as the CEO of Amarin...but as a subdivision of Pfizer, Novartis , or Merck.
Vascepa has demonstrated ant-inflammatory effects in multiple disease including CVD....therefore it makes sense that it would help blunt the Covid Cytokine storm syndrome. The Cardiolink study was statistically positive in showing this effect of Vascepa and the Prepare-It study was trending positive, although not statistically significant...The Mitigate study should add to the positive evidence for Vascepa mitigation of Covid symptoms...and also buttress the Reduce-It and Jelis evidence of Vascepa reducing CVD and help stop the misinformation madness out by the mineral oil miscreants.
We have scientific evidence that EPA is the essential factor in Vascepa that is responsible for reducing the incidence of CVD.
If Dr. Mason's scientifiuc studies show evidence that oxidization reduces the amount and/or quality of the EPA in gV...the obvious conclusion would be that gV is NOT as effective as Vascepa...Since the FDA has declared gV to be bioismilar to Vascepa (though the capsule of gV is definitely NOT biosimilar to the capsule of Vascepa, the onus should rest with the generics to prove that their product is as effective as Vascepa...although the evidence would seem to point in the opposite direction....Otherwise patients are being deprived of the benefits they are expecting.
Lizzy..In my layman's experience, SPACS are mostly interested in cash poor start ups...I don't believe that Amarin, with an established business, a large carry forward tax loss, foreign registration and $500 in cash would be the ideal candidate for a SPAC.
In July of 2019, GS brokered a secondary offering from Amarin for $400 million...The FDA,at that time, was expected to give its approval for R-IT very soon...The FDA then announced in Nov of that year they they would be holding an Adcom to determine approval of Vascepa for CVD.
GS's impression was that John Thero knew about the chances for an Adcom delay in approval and had kept it from them... The FDA held an Adcom four months later in November,2019 and the FDA approval did not come until December,2019...In the meantime, the Amarin selling price went below the secondary price...and GS and its investors lost a lot of money on that secondary...It is well known on W.S. that GS hates to lose money.
GS seems to have held it against Amarin and J.T. since that episode and has been constantly negative on Amarin and, IMO hurting their share price.
Now, with J.T. departed from Amarin, Perhaps GS will be willing to forgive and forget and take a more positive stance towards Amarin...Their investment in Sarissa may be an indicator of this.
lizzy...These laws present a potential negative inducement for an acquiring company. On the other hand, Amarin could be a subdivision of the acquiring company and profit from favorable taxation laws.
CBB...Pfizer recently lowered their Lipitor price in China by 30% in order to reach more patients...Vascepa could benefit millions of Chinese patients, but it needs management by a company, like Pfizer, that has the assets and the know how to distribute a low cost, high volume drug to eventually save China money and lives.