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I seriously doubt that Judge Andrews will disagree with the decision of Judge Hall...but will decide at the hearing on October 14th to continue the case...the issues pertaining to the case are both complex and important enough to merit a resolution by a trial or by a settlement between the parties....The news that the defendants have hired 8 lawyers to represent them is a reflection of how important they understand the case is.
ggw...Yes...The recent decision in the GSK vs. Teva case, in favor of GSK, should prove helpful to Amarin in this case.
The frequency of 'skinny labels' infringing on existing patents needs congressional review of Hatch-Waxman at this time...Perhaps a win for in Marjac's 20/60 appeal case will generate enough media coverage to bring the problem to the attention of Congress.
Drugs can be made affordable while still preserving the incentive for innovation and, at the same time, not doing great harm to legitimate patents.
ggw, Its not unusual for a district court judge to hold a hearing after the magistrate judge has made a decision not to dismiss a case
"District judges often pass along motions to dismiss or summary judgments to their magistrate judge, allowing them to prepare the report and recommendation. From the magistrate’s report, the district judge will then hand down a decision on a case."
study, the case is not being thrown out...a magistrate judge heard the case and made the decision not to dismiss and judge Andrews now is being asked by Hickma to weigh in.
Raf...QUOTE from the recent plea written by Healthnet to Judge Andrews "I write on behalf of Defendant Health Net to respectfully request that the Court also receive oral argument on Health Net’s Motion to Dismiss (D.I. 30) during the October 14th hearing"
Although Hickma and Healthnet are both conspiritors in infringing on Amarin's CVD patent, the case against Healthnet is the stronger of the two...because there is no way for Healthnet to deny that the prescriptions Healthnet subsidized were being used for treatment of CVD... since the prior authorization they demanded from Docs makes that fact undeniable.
The goal of Hickma in asking for a re-hearing of the case, previously heard by a magistrate judge, is to have the case against both defendants dismissed or, failing that, to at least have their case separated from that of Healthnet.
'Individual patient reimbursement' in a government funded national health plan in Europe seems a lot like 'prior authorization' in a private insurance plan in the U.S.
Apparently governments in Europe are loath to spend money on drugs, just a private insurance companies are in the U.S....However, a big difference is that insurance companies in the U.S. understand that patients may subscribe to them for a short period of time...whereas patients in government funded plans will be with them for long periods of time...so they have a motivation to keep patients well to avoid the long term effects of CVD and save money over the long term.
Sluice...QUOTE "Amarin obtained an exclusive license to certain Mochida intellectual property to advance Amarin’s interests in the United States and certain other territories and the parties will collaborate to research and develop new products and indications based on EPA for Amarin’s commercialization in the United States and certain other territories. THE POTENTIAL NEW PRODUCT and indication opportunities contemplated under this agreement are in relatively early stages of development."
I have concluded that the Amarin Mochida agreement included MND2119(especially after the CEO mentioned "new formulations' at a recent conference)...Do you have reason to believe otherwise?
A phase 3 study has been conducted in Japan and Mochida has applied for approval there....Also combo drugs with a statin are on the horizon.
Kiwi...The volume of sales of Vascepa depends on the Europe Governments paying for the drug and patients and Docs asking for it...Governments will see that they are saving more on medical expenses than they are spending on Vascepa and will cooperate.
As for marketing costs in the U.S., Amarin has already shown that it intends to rein these in... and they will have lesser costs for marketing in Europe....As the volume of Vascepa grows in Europe, news will spread across the pond and the volume will grow in the U.S. as well...For poorer countries, Amarin can reduce the price even further, as they will probably have to in China next year.
JL used to say that Vascepa was a volume play rather than a price play...Vascepa, due to the high price of its API, will never be as cheap as the ineffective Lovaza...but, with increasing volume from Europe, Amarin will be able to cut prices and maintain its profitabilty...This will also be true in the U.S, where the Generics will be non-competitive as they lose any potential price advantage for their gV due their much smaller volume.
Amarin will benefit from the lack of competition for Vascepa from Omega 3's in Europe...This includes Lovaza and generic V and other ineffective drugs...If P-it 2 results are positive, Amarin should immediately apply for approval from the EU, and Vascepa will take off all over Europe...as KM begins to market it in each country.
There is an emphasis on hospitalizations and deaths from Covid, but the long term damage to organs from Covid infection, related to the developing cytokime storm, can eventually be a cause of patient long term misery, disability and expense....The important features of an antiviral drug are that it should be easy to administer,safe, and affordable for the masses of patients, who will need it...The critical factor for efficacy is that the drug shold be administered as soon as possible after the diagnosis of Covid is made, in order to avert or mitigate the oncoming cytokime storm...It may be too late once the patient is on a ventilator...since the crippling damage may have already proceeded too far.
CVD, in the majority of cases, is a silent chronic disease...Covid usually has more urgent and more immediate symptoms...The more acute and the more obviously debilitating a disease is, the more it is likely to be given emergency use authorization, Although both CVD and ALZ can have serious consequences, Covid attracts the attention of the FDA and the public more readily and thus is a better candidate for EUA.
The need for a safe, inexpensive, orally administered antiviral is now, not nest year...If the results of Prepare-it 2 are as good as we think they are, Corral needs to discuss the results now and apply for emergency authorization...regardless of any embargo by the AHA.
This was made clear by Merck not only not waiting for a meeting to discuss their anti-viral results...they didn't even wait for completion of their study.
FDA emergency authorization is more important than a discussion at the AHA meeting.
The FDA approved Biogen's Aducanumab in the wake of a nearly unanimous negative vote by its Adcom...This drug is expensive, has to be administered by injection and has numerous severe side effects...e.g.
"adverse safety events were noted, the most common involving brain edema, which can cause headaches, changes in mental state, confusion, vomiting, nausea, tremors, and gait disturbance."
With this in mind, a positive result from Brave, a safe drug such as Vascepa, which is orally administered and relatively inexpensive, should receive quick approval from the FDA.
IMO the FDA would ask for larger studies while granting emergency authorization to Vascepa much as they did with Covid vaccines.
Don't ignore the value of MND2119 for Europe...After the exclusivity for Vaskepa runs out, there will still be more than 10 years of exclusivity for this once a day EPA formulation.
MND2119 is ethylated EPA... It should not be significantly more expensive than Vascepa...and Amarin can absorb any extra cost and keep the price about the same as Vascepa to keep it competitive....It's once daily regime makes it more convenient than Vascepa and promotes higher patient acceptance for longer periods of time.
Mochida has already completed an 18 month phase 3 study in June of 2021 and is in the process of applying for approval in Japan...I am anticipating that Amarin will soon apply for FDA approvsl in the U.S.and eventually for approval in Europe.
Vaskepa should be sold for other applications in addition to CVD, but this requires more R and D assets than Amarin presently has at its disposal(thanks to Judge Du)...and this is a major reason why Amarin needs a BO by a BP.
lettruth..."we have been so unsuccessful in selling our very effective product, we are sure you will want us to sell your lesser product too.
I'm not picturing it."
I agree...Why would A small company not prefer a world famous company, ike Merck or Pfizer, to sell their product instead of Amarin?...IMO this would be a distraction from Amarin's main goal in Europe, which is to popularize Vaskepa.
In my experience as a physician, I had barely enough attention to give to a single product, being marketed by a pharma...and definitely not enough attention for two products.
Look at what happened with Kowa, a mid sized sized company, which Amarin partnered with to market Vascepa...Kowa then preferred to emphasize their own product(Lovostatin) over Vascepa, leading to JT having to end the arrangement with Kowa.
I believe that this policy would also not end well for Amarin.
Meoza...IMO a BP BO deal for Amarin is more likely when when the SP of Amarin gets to be much higher than where it is at present...e.g. with a premium of about 100% or less.
meowza...CEO's are sensitive to blow back from their shareholders if they pay a 400% premium for company they are buying...Even if the deal turns out to be a good one for the future of the company, it can be detrimental to the CEO if the price tag of the BO is so unpopular with his shareholders that it undermines his position as CEO.
Pfizer may have done the partnership deal with HLS in order to co-opt other BP's from doing a similar deal with HLS to market Vascepa...thus making it messy for an eventual Pfizer buy out of Amarin.
By doing this deal with HLS, Pfizer has preserved the inside track for an eventual deal with Amarin...Now its up to both sides to agree on a price.
Even before Pfizer got involved with HLS, sales of Vascepa in Canada were doing well...they can only do even better with the addition of reps from Pfizer...Amarin's SP will go up with news of sales in Europe and Pfizer will then proceed with a realistic BO offer.
KM announced at the Cantor meeting that he intends to enlist smaller companies to market Vascepa in smaller markets...the HLS experiment, put into place under JT's leadership, demonstrated the potential of this policy.
This in no way indicates that KM has lost interest in a BO by a BP, which has the assets to manage any and all markets on its own.
KM's Cantor presentation was impressive, esp. his predictions of Vascepa markets in Europe.
QUOTE from SA on Pfizer,which could have relevance to Amarin.
"CEO Albert Bourla recently recruited McKinsey's Senior Partner Aamir Malik as the company's Chief Business Innovation Officer and deal-making lead. Pfizer hopes to capitalize on Malik's 25 years of M&A experience, as PFE looks to strike a new growth phase by investing in Biotech opportunities. As CEO Bourla emphasized: "Pfizer is blessed right now to have a very, very strong balance sheet and a lot of cash. We have an opportunity to reinvest all this capital.
Pfizer is looking for an oral drug to treat Covid patients...to go along with its Biontech vaccine....If the results of Prepare-it 2(to be reported out this November) are positive, they might make Vascepa just the drug Pfizer is looking for.
"The field of Alzheimer's research has proved so difficult that it was dubbed by some with the macabre nickname of the "Valley of Death."
The last I heard was that the Brave study at the University of Wisconsin, utilizing Vascepa for the treatment of Alzheimers, was to be completed by November of this year...Positive result from the Brave study would breath additional life into Vascepa and Amarin.
In my case, I stayed 2 nites for one stent 20 years ago and one nite for 2 stents 7 years ago.
Hickma's lawyers either committed a fraud or a mistake was made by someone in the cropping of the Kura table....either way, it was instrumental in the decision in the case, which now needs to be reversed by the rule 60 appeal panel.
It is also possible that Kennedy chose not to make an issue of the fraud with a rule 60 appeal...due to the fact that he, himself, had failed to recognize it during the case.
It is fitting that Kennedy has now left Amarin.
IMO Covington erred in failing to pick up the fraudulent cropping of the Kura table, which showed that the change in APO-B was NS(i.e. non significant)...
Then, in deference to Covington, Kennedy chose not to make an issue of it with a rule 60 appeal...even though the fraudulent table was quoted verbatim in Judge Du's decision.
IMO This fraud was instrunmental in winning the case for Hickma.
There are 2 arguments for and against patents
1.For patents...They encourage innovation of new drugs, which can save lives
2. Against patents...They encourage high prices so that patients may not be able to afford them
H-W was an attempt to resolve this problem
"Skinny Labels" are a corruption of H-W...The Democrat Waxman may not agree...but I think that the Republican Hatch would agree....some judges have agreed and some have disagreed.
New legislation is needed by Congress.
Webster...Levin wouldn't have had to wait for 5 years to experience the effect of Vascepa on the coronary arteries...QUOTE "The EVAPORATE trial showed that icosapent ethyl 4 g/day reduces low attenuation plaque volume at 18 months compared with placebo among patients with known CAD, as assessed by cardiac CTA.
Principal Findings:
The primary outcome, change in low attenuation plaque volume, for icosapent ethyl vs. placebo, was -0.3 vs. 0.9 mm3 (p = 0.006).
Secondary outcomes for icosapent ethyl vs. placebo:
Change in total plaque volume: -9% vs. 11% (p = 0.002)
Change in total noncalcified plaque: -19% vs. 9% (p = 0.0005)
Change in fibrofatty plaque: -34% vs. 32% (p = 0.0002)"
No one can dispute the fact that the Amarin-Kowa marketing partnership was a flop...However, this does not definitely mean that an Amarin-Pfizer partnership for the marketing of Vascepa would not be a success....On the contrary, a partnership might better determine the future value of Vascepa, both in Europe and in the U.S....and act as a preliminary step to a BO of Amarin.
The FDA experts refused to approve Vascepa for CVD Rx in their Anchor Adcom in 2013 and instead, they demanded from Amarin a long and expensive R-IT trial to prove Vascepa's effectiveness against CVD...If any Generic company insists that the R-IT patents were obviousness to a POS (i.e.(a "person of ordinary skill in the art") this should be strong and convincing evidence for Vascepa's CVD patents' non-obviousness as a treatment for CVD.
Marjac, I have great respect for North but, by the time the appeal trial occurs, I hope (and I feel that North also would agree)...that Pfizer will own Amarin by that time...and will send their most experienced patent honcho to Washington to back you up you up...as you masterfully present your case.
Unfortunately, the rumors of layoffs of reps are probably correct...
U.S.sales have been flat for a while and Amarin has been patient. They now need to husband their cash for expansion into Europe...This fiscal austerity was a necessary, but a sad, move....The biggest losers are the American public.
Chalk it up to the 'skinny label' conundrum...Perhaps when things turn up...,either in Europe or in the U.S., many of these sales reps can be hired again.
KIWI... QUOTE "What are the less expensive oral alternatives for those already vaccinated
Will P-IT 2 give us that info ?"
Yes!...I believe that P-it 2 will confirm what Cardiolink has already told us.
Cardiolink's impressive results were largely and IMO unfairly, ignored due to the Canadian study's small sample size.
I expect Mitigate, with its larger sample size, to seal the deal...but I believe that, if we get positive P-it 2 results, we should not have to wait before we get approval to use a drug like Vascepa, which has been proven safe after years of use in large populations...in order to reduce hospitalizations and lingering cardio-vascular and thoracic events in Covid patients even after they are discharged from the hospital.
The China Evergrand real estate crisis and the U.S. debt limit crisis have something in common...They are both too big to fail.
In both cases, their respective federal governments are likely to step in soon to avert their crisis.
The result will be that this drop in the markets will be short term.
The broad market will suffer until congress passes an increase in the debt ceiling, which will happen by the end of September...or, at the latest, in early October.
Amarin should be bot on any weakness in the SP during this period.
sleven... The results from the Cardiolink study in Canada continue to give me an expectation(in Covid 19 infections) that Prepare It 2 will also be positive...
QUOTE from Cardiolink "Giving patients icosapent ethyl, or Vascepa, led to a 52% reduction of the total patient-reported symptom outcome prevalence score as compared with a 24% decline for outpatients who received usual care."...This was outsanding good news when so many other treatments have failed to show benefit.
Even with Cardiolink having a small patient size, these results point to at least some positive trends to be expected from Prepare It 2...Perhaps Prepare it 3 is being run in the expectation that the trends may become statistically significant figures.