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CBB "I only hope that KM and his BOD will work with
him and not against him"...
I think Denner has worked with Erickson to help entice Per Wold Olson to come onto the Amarin board...this is good evidence for Erickson already working with Denner...It is a first step in Denner's reconstituting the board...KM will definitely work with Denner, as he and Olson have previously worked together at Merck...I look forward to the EPADI- Marjac case against Hickma...and win or lose, Marjac deserves a place on the board for his acumen and his efforts.
Pdude...Olsen got a very sweet deal from Amarin to entice him to join the board...He will be very supportive of KM...but even more importantly, Olsen will be on the same side as the COB when push comes to shove regarding any prospective changes to the board....Erickson is a smart dude.
KIWI...I would not want to sell the ROW rights for Vascepa.
"Lipitor, the cholesterol-lowering medication that has become the gold standard of statins, continues to generate roughly $2 billion per year in sales for Pfizer, even though its patent expired eight years ago."
Most of the revenues for Pfizer's generic Lipitor come from China.
Mitigate study...
Actual Study Start Date : August 7, 2020
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : February 28, 2023
Kaiser is reporting on the primary completion findings as a 'late breaking report'...I am hoping this is an indication that Kaiser has interesting early results, which led them to apply for to a preliminary report, prior to final completion of their study next year.
The FDA has a history of not having the issue of bioequivilentcy high up on its agenda...It will take a concerted effort from Amarin to bring the factors you mention to the attention of the FDA and possibly to the public...Scientific evidence from Dr. Mason or from other scientists would certainly be a help in doing this.
This is a list of top buys for Sarissa Capital as of 9/30/21...
Top Buys
Name% Change
ALKS Alkermes Plc. 8.84%
*AMRN Amarin Corp. ADR 3.4%
INVA Innoviva Inc 1.84%
*GILD Gilead Sciences Inc. 1.5%
Now that Sarrisa has increased its holdings in Amarin to over 6%, could Denner be interested in merging Amarin with Giliead?
Gilead has yet to announce the results of its Nash studies utilizing Vascepa...together with several other drugs.
We need Dr. Mason to clearly outline why the inferior capsule, used in generic V, makes gV a NON-BIOSIMILAR drug to Vascepa...Then Amarin with Alex Denner as Amarin's new COB, can hire Marjac to pursue Amarin's case with the FDA and, if necessary, patent infringement cases against Hickma et al.
ltro..."Your honors, a grievous mistake was made at the District Court level, by a judge evidently not schooled in some very basic statistical principles. As pointed out in the medical journal article, it was a statistical mistake that is common but one that should never have been relied upon to invalidate valuable patents."
The cropping of the last two determinative lines of the Kura table was NOT a mistake...It was a fraud on the court and thankfully NOT COMMON and should never had been repeated verbatim in the judge's decision.
Consider Amarin as a two market company...Assign a portion of present fixed expenses to each market...Then look at the expenses and revenues for each market.
If/when the expenses of the U.S. market exceed the profits of continuing to sell branded Vascepa in the U.S., Amarin has three options...
1. abandon branded Vascepa in the U.S. market... and
2. commence marketing an authorized generic Vascepa in the US...or
3. abandon the U.S. market ENTIRELY
The third option would mean closing the U.S. offices and moving the entire operation to Europe.
Marjac... The origin of “Drink the Kool-Aid” lies in the 1978 tragedy at Jonestown, where over 900 members of Peoples Temple took 'poisoned fruit punch'.
The Hickma attorneys state that EPADI members are drinking Kool-Aid...The metaphor of the 'poisoned fruit punch' was, in this legal dispute, that the EPADI members are refusing to 'drink the poisonous fraud' of the cropped Kura table, but are instead 'spitting out the fraud' with their appeal.
Bio...There was a clever fraud in the marine patent litigation....Amarin's lawyers did not pick it up...Judge Du did not pick it up...Kennedy did not pick it up...Hickma's lawyers did not pick it up(or if they did pick it up, they kept mum about it)...
To have justice in this case, this key fraud needs a reversal of the decision...or there needs to be a new trial without including any of the lawyers or the Judge, who failed to pick up the fraud or to mention anything about it....Even the judge was so taken in by the fraud that she included the cropped table verbatim in her decision, which, as she said, was a "close call".
sleven.."Inclusion Criteria o the MD2119 study"
1.Participants diagnosed with hypertriglyceridemia.
2.Participants with values of fasting triglyceride level are 150 mg/dL or higher and less than 500 mg/dL"
The second criterion looks like the CVD indication, but I did not see mention of previous CVD as a criterion for participating in the study...I am, however, assuming that Mochida applied for approval of both the HTG and the CVD indications in their submission to the FDA in Japan...i.e. on the basis that Jelis and R-IT had previously proved the efficacy of EPA in CVD.
I would also assume that the U.S. FDA would accept the new formulation for both indications...as will the USPTO
rmb...Mochida has completed phase 3 studies on their new 2 gram and 4 gram versions of EPA.
i.e...."Intervention/treatment
Experimental: MND-2119 2 g
MND-2119 2 g, orally, once daily after breakfast for 12 weeks.
Drug: Icosapent (MND-2119) capsules.....PLUS
Experimental: MND-2119 4 g
MND-2119 4 g, orally, once daily after breakfast for 12 weeks.
Drug: Icosapent (MND-2119)capsules"
These two versions of MND-2119 capsules(2 grams and 4 grams) have been submitted for approval by Mochida to the FDA in Japan...
I expect that Mochida and/or Amarin are now working to combine a statin with each of these versions of EPA.
It may take some time, but, even after the R-IT patents run out, the combo patents should still be in tact.
KIWI...Ezetamide is hardly the same class as Vascepa!
"Ezetimibe is a selective cholesterol absorption inhibitor, whether it has a positive effect on CVD events remains uncertain. Results from clinical studies are inconsistent and a thorough evaluation of its efficacy and safety for the prevention of CVD and mortality is necessary."
KIWI The statin ingredient of the the branded statin-Vascepa combo will be very inexpensive to Amarin... Amarin will also have lower expenses for their EPA ingredients(due to their higher volume of purchases)as opposed to the EPA ingredients sold to other companies...and the branded combo will be still be able to be relatively affordable... The Amarin branded statin-Vascepa combo will be able to compete against separately purchased statins-plus-gV's from other companies.
The branded statin-generic combo may be more expensive than statin and gV bought separately...but not by much....and it will be much more convenient and promote better compliance.
Amarin can introduce an authorized generic next year, when lower prices for Vascepa will inevitably be demanded (in Europe and China and the ROW)..a patented, branded, Statin-Vascepa combo should be ready for release next year and should reclaim Vascepa's sales for the CVD indication, now being lost to infringement by generics...The combo can be sold alongside the authorized generic Vascepa.
It will take a marketing expert to fully exploit the potential of these products. I hope KM is that expert.
There is always the risk that if you mention the failings of an inferior competitor drug, you will simply stimulate its sales...IMO Amarin should take this risk...and let it be known widely that Vascepa is much better than the ineffective drug, Lovaza, in reducing the incidence of CVD.
Marjac...My thought during and after the appeal hearing was that Judge Du was female,from an immigrant family,recently having received a prestigious appointment to the ninth circuit...she had, just a short time prior to the case, lost her husband and her stepson and was still grieving...she now was presiding over her first bench trial in her new position...at the same time, Amarin's attorney had a reputation for being a very experienced and very successful patent attorney...and I thought the panel might be loath to make Judge Du look bad in her difficult and complex first bench case in her new position.
There is NO evidence that combinations of statins plus fish oil or statins plus Lovaza reduce the incidence of CVD more than statins alone.
There is POSITIVE evidence that statins plus Vascepa reduce the incidence of CVD....Amarin needs to advertise this fact...
Billions of dollars are being wasted by the public each year on fish oil supplements, which have too small amounts of EPA and the public needs to know these facts
In The EPADI appeal to the ninth circuit court, Judge Du cited two issues in her decision in favor of Hickma.
1. the issue of standing
2. the issue of the EPADI claim of fraud being "unsubstantiated"
In the subsequent EPADI appeal to the CAFC, The court determined that one or both of these issues justified the hearing of oral arguments in the case.
The facts that the fraud in the original case was blatant, and obviously instrumental to Judge Du's decision... may have played a role in the CAFC decision to allow oral hearings.
Marjac..."she stated that our fraud claims were "unsubstantiated"
What could be more substantiated than two pictures of the cropped and uncropped Kura documents, shown together side by side...and then, the judge's verbatim copy of the cropped document in her decision?
Some discouraging factors for generic companies...
1.The 4 generics in the market are competing for only 7% of the EPA market, which they are legally entitled to,(unless they choose to infringe on Amarin's CVD patents).
2.Their costs for EPA are high and their margins are low.
3.They risk facing lawsuits for infringement, incurring legal costs and potential damage award costs.
lizzy...Hickma threw at Vascepa, in the ninth district court trial,every pitch they had in their armamentarium...including some curve balls.
If Marjac wins, Amarin will be wielding a strong bat to hit every pitch, that may come afterwards, out of the ball park.
Rose..."even with a Marjac win that the stock price will not automatically jump to $13."
With a Marjac win, Amarin will receive a BO bid of $13/per share or more from BP.
I doubt we will get an answer as to how the cropping happened or who was to blame, but it did definitely effect the verdict...and without the fraudulent cropping of the vital bottom rows of the Kurabayashi table, the decision, which was close, would NOT have been in favor of the Marine patents being invalid...due to CLEAR and COMPELLING evidence of obviousness.
Hatch and Waxman, neither of whom were scientists, compromised and agreed on the H-W legislation...They depended on the FDA to determine the validity of generic drugs' statements that generics are are actually equivalent to brand drugs....The FDA has since seen fit to take a casual attitude towards generics' equivalence to brand drugs... and the FDA and the courts seem to have no concerns about the issue unless a catastrophe occurs and a public scandal ensues.
I have long believed that Amarin's best argument for the current infringement of their R-IT patent is the prior authorization that insurers have demanded, which shows Vascepa being used for the CVD indication...and the insurers making the COST for branded Vascepa higher and the COST for generic Vascepa lower, thus favoring the use of the infringing generic Vascepa over the branded Vascepa for the treatment of CVD.
e.g. "The Court denied Health Net’s Motion to Dismiss, finding that Amarin pled enough facts to allege that Health Net knew of Amarin’s CV patents, made affirmative acts to induce infringement by placement on the formulary, and had specific intent to induce based on the listing of the patented indication on the insurer’s generic icosapent ethyl capsules prior authorization form. Thus, the court concludes, “Health Net’s placement of generic icosapent ethyl on a preferred tier encourages the substitution of the generic for the branded drug, including for the patented indication.”
Over 90% of the prescriptions issue for Vascepa are for the CVD indication and yet insurance companies are steering these prescriptions towards generic Vascepa.
Canes...You make a good point...In retrospect, KM should have been at NICE, rather than at JP MORGAN on Feb 11....Amarin has some powerful enemies in the medical world, like Nissen, who continue to object to the mineral oil placebo used in R-IT...against all the accumulated evidence that it did NOT play a significant role in the excellent results of the study....KM should have done everything in his power to have medical experts like Deepak Bhatt and Preston Mason come to attend the Nice conference...to counter these false claims....and this needs to be done in the future for major European conferences, which will evaluate Vascepa and what they are willing to pay for it.
KIWI...Jelis was a large trial without a mineral oil placebo...It was confirmed by R-IT...I am sure that Mitigate will also be confirmative, but I wonder if equally excellent results from Mitigate will satisfy those, who may have a vested interest in doubting Vascepa?
Just as a football team often calls a time out just before a game changing play, in order to shake up their opponents,I hope that Hickma does not try the same technique in our appeal to the CAFC...and make a last minute request to delay the case.
The difference in follow up in the active vs. the passive group makes the comparisons between the groups, as to symptoms and hospitalizations, difficult to evaluate...Among other things, we don't know who in each group has Delta or Omicron infections.
However, once patients are admitted to the hospital, we can assume that they will have equal follow ups and results will more meaningful as to a potential reduction in the death rate in the active group vs. the passive group.
iryokabu...This was also my thought....i.e. if Kaiser didn't give the same instructions(in the Mitigate study)for both the active and the passive group to get tested for Covid, the active group would be tested more,and would report more cases of Covid than in the untested passive group...This would skew the results of the study AGAINST the efficacy of Vascepa in the active group in reducing the number of symptomatic and hospitalized patients with Covid infections...as opposed to the passive group.
Kiwi...It seems to me that Kaiser has put more emphasis on part one of the Mitigate study(CVD) than on part 2(Covid)...On the other hand, the large volume of patients being involved in the study is a positive development.
capt..."10 Euro Co-Pay is the best bargain on the European Continent!"
I agree...This figures to about $14/month copay in Germany for Vascepa...My copay in U.S. for Vascepa is about 10 times that figure...and this is after a $450 dollar deductible on my insurance plan is paid each year....But its still better than my having another heart attack or a stroke.
My vision for the future of Vascepa...
High volumes with low prices are the keys...Eventually the prices for Vascepa will be cut in half and wholesale prices will also drop...European and China sales will boom...Competition in the CVD market will be unable to match the effectiveness, safety, and price of Vascepa.
Volume is the key to Amarin's success...New methods to increase the supply of EPA will come on line in order to satisfy the demand...This is just the beginning of a long ride for Vascepa and for Amarin.
KIWI...The Mitigate study details have been confusing...My present understanding is...
1. 3000 patients, who match up well, have been randomized out of the 16500 patients.
2. 1500 randomized patents have been put on Vascepa and been closely studied
3. 1500 randomized patients have been remained on usual care and have been closely studied
4. 15,000 patients who did not match up well and were not picked for randomization, have remained on usual care and have not been closely studied.
IMO there would be a greater chance of the results of part 2 of the Mitigate study to be statistically significant if the randomization of the 3000 patients, chosen to be closely studied, was started early in the study(when Delta was the prevalent Covid infection)...the reason is there would be more hospitalizations and deaths in both groups...with the Vascepa group having less of each than the usual care group.
The first cases of Omicron in the U.S. started on Dec 1. 2021...The Mitigate study started enrolling on August 2020... I assume the majority of Covid cases in the study are of the Delta variant...The 2000 randomized cases in the study may be sufficient cases to provide statistical significance for the prevention and hospitalization (part two of the study) when they stopped enrolling new patients on Jan 11, 2022.
The Mitigate study is a 2 part study...
Part 1 is a CVD study to add further data to the previously reported results of the R-IT and Jelis studies...There is no urgency to release the results of this part.
Part 2. is a study on the prevention and/or mitigation of Covid infections...Since we are in the middle of a Covid pandemic, it is incumbent on Kaiser that the part 2 results be analyzed ASAP and, if they have positive statistical significance, be released to the public in time to assist with the pandemic.
I agree, but I would suggest you patent it yourself first.
Capt...I hope the U.S. FDA will accept the results of the Moshida phase 3 studies in Japan on their 'self-emulsifying' version of purified EPA.
"Reduce the dosage to half and get the same results in a self-emulsifying capsule (MND-2119)".
This would suggest the possibility of two different combo dosages...containing either a low dose of a statin or a higher dose...thus covering the majority of patients.