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KIWI...Its clear that there is disagreement on this important subject...Perhaps Holt could make some comments on this topic to clear some points up for all interested in Amarin.
BEDMINSTER, N.J. and DUBLIN, Ireland, June 12, 2018 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that it has entered into a multi-faceted collaboration with Mochida Pharmaceutical Co., Ltd. (“Mochida”, TYO:4534), an integrated Japanese pharmaceutical company.
The collaboration is focused on the development and commercialization of early-stage drug products and indications based on the omega-3 acid, EPA.
This collaboration seeks to leverage the decades of successful research and development experience at Amarin and Mochida towards expediting the development of new products and indications.”
“Mochida is delighted to partner with Amarin,” stated Mr. Naoyuki Mochida, president of Mochida. “Both Mochida and Amarin have demonstrated strong capabilities in developing and commercializing EPA-based products and we believe that together we can achieve much more to improve patient care in the years to come.”
Among other terms in the agreement, 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.
IMO The ability to develop a FDC with a statin and MND-2119 is a very important development...i.e.
1. a single med given once or twice a day is much better for compliance than a regime of one med given once a day plus a capsule given four times a day.
2. It is easier to have a statin coated on a capsule than to have a blister pack with a statin pill plus four EPA capsules.
3. a single capsule with a statin and EPA would be less expensive than a blister pack with five items.
Nuke...The FDA ignored the Jelis study results because it was not a controlled study, but R-IT was controlled...Also the idea that EPA could make a reduction in CVD was a brand new concept at the time.
Kiwi...Your negative thesis on the approval prospects for MND-2119 by the FDA deals with its potential side effects and its efficacy
The FDA has already given approval of Vascepa for its minimal side effects and considerable efficacy ...
Mochida has been marketing MND-2119 in Japan for some time... Amarin will now be able to inform the FDA about the side effects of MND-2119 (as well as its efficacy) in a large population of users.
I am sure that Mochida has been doing studies on these issues which are available( or will soon be available) to Amarin) for presentation to the FDA.
Based on these studies, Amarin will be able to present, to the FDA, details pertaining to the side effects of MND-2119 (as well as its efficacy) in a large population of users.
As you have said, a once or twice a day formulation of EPA, rather than four times a day, will benefit patients by encouraging compliance and the FDA will take this into its consideration.
The EPA level in the blood is currently understood to be the critical factor in reducing patients' TG's...Blood test studies on patients on MND-2119 would take only a few months to analyze and would demonstrate the effectiveness of MND-2119 in reduce TG's, while not depleting cash assets very much...and could obtain U.S. FDA approval for a drug containing emulsified EPA to reduce TG's....A later study could then be instituted to show that patients, who were on MND-2119, had reduction in their CVD's as well as reduction in their TG levels.
Tal...Thank you for that informative post.
We have been given, long ago, the information about the 2.7 million dollars in upfront fees that Amarin paid to Mochida...This lead to our enhanced expectations of timely MND-2119 products to be marketed by Amarin....but we investors have still not been offered any information by Amarin by either its old BOD or its new BOD...about the very important issues of royalties and milestone payments due to Mochida for MND-2119 products....I assume that a BP, investing in Amarin will ask for this information and will quickly receive it....This is a glaring example, IMHO of the game being rigged against the retail investor and in favor of the institutional investor.
There were two reasons for Amarin not having been being clear about the details of its agreement with Mochida for these past 5 years...One reason was to keep competitors uniformed....The other was to keep investors uniformed ...Which was the main reason for Amarin's radio silence on this subject, in which Mochida's MND-2119 was already being approved and marketed in Japan...with Amarin's sole response being continuance of its 'don't ask,don't tell' policy.
Is it paranoid to believe that we investors were being played by former management?...Can we now expect 'straight talk' on the subject of MND-2119 by present management?
Tal...This agreement was signed in 2015...at which time, Amarin agreed to "collaborate" with Mochida on emulsified products with EPA...for which deal, Amarin paid Mochida $2 MIllion.
This was at a time when Amarin was up to its neck in debt, trying to pay for the FDA mandated completion of the R-IT study.(Amarin had even mortgaged their patents to acquire this debt.
Eight years later, we still have no idea of what this deal truly meant to Amarin's future prospects....The main information given out is that Amarin and Mochida have been "collaborating" on development and commercialization of EPA products(whatever that means)
Capt....Serial spinal taps have severe side effects..
"As many as 25% of people who undergo a lumbar puncture develop a headache afterward due to fluid leaking into nearby tissues. The headache typically starts several hours up to two days after the procedure and may be accompanied by nausea, vomiting and dizziness."...
These are illustrative of some of the less severe potential complications of serial spinal taps.
My question is...Whey would anyone agree to participate in such a study?...The participants have, at the very least, the right to know the results of the study.
Tal...My take is that...according to the commercialization agreement with Neopharm, Amarin's profits from Vaskepa in Israel, would seem to be mainly dependent on volumes of sales.(unless the transfer price builds in a sizeable profit margin for Amarin).
Bob..Will Neopharm be responsible for negotiations with Israel authorities on pricing... plus being responsible for the marketing of Vaskepa in Israel, keeping its profits over the transfer price it paid to Amarin...or does Neopharm just receive a percentage commission on the sale price and return the rest of the profits to Amarin?
Duke... Important Items, which remain for us been informed about by Amarin, pertaining to the deal with Neopharm...
-does the deal begin early or late in 2024?
-the potential pricing and reimbursement for VAZKEPA in Israel?
- any upfront payments due to Amarin?
- any milestone payments due to Amarin?
JR...IMO, Brave will show that Vascepa can slow the onset of Alzheimers and/or slow its progression, but not cure it once it is established, since Alzheimers is a chronic disease.
Its analogous to Vascepa's effect on atherosclerosis, in which Vascepa can slow the progression of atherosclerosis and the ills brought on by it...but not completely stop it or CVD....It is also similar to the aging process...in which Vascepa has anti-inflammatory effects on many conditions, which have to do with aging...but not to cure them...and in the end, we all have to die.
Unfortunately , the picture is not as clear to patients using Vascepa, as when penicillin is used by them to end their infections.
Tal....Lequembi has many problems including as severe side effects...such as intracranial bleeding, large expense, unimpressive results... and the need to be given IV by a Doc or a nurse.
The Brave study uses Vascepa as an oral, inexpensive safe alternative treatment for Alzheimers ...The study starting on June 2017, and utilizing serial spinal taps... is due to be completed by the University of Wisconsin by the end of next month....Vascepa could be outstanding competition for Lequembi in the slowing of the progression of Alzheimers.
Even if there are only moderately good results from the Brave study, the FDA would seem likely to look favorably on Vascepa as a treatment for this terrible debilitating disease.
Diabetes was one of the risk factors that the FDA identified in their Adcom in their unanimous approval of Vascepa for the treatment of CVD.
Pdude...KM hired his friends at Biologics, a company which turned out to be missing in action...then he wasted Amarin millions of dollars by hiring a large number of salesmen prematurely, all the while, failing to recognize Germany's well known history of not providing adequate reimbursement for drugs for their patients....Then PWO, following his own interests, failed to grant standing to Marjac's appeal to SCOTUS even when was working gratis...on on a very convincing over 200 page brief, pointing out the fraud perpetrated by Hickma on Amarin in the ninth circuit case...
KM and PWO constantly were putting their own interests ahead of Amarin's...Sure his goal has been to profit from his investment in Amarin... but I have confidence that we retail investors will also participate in those profits.
Unlikely that Holt traded today since he had information, not yet known publicly.
ILT was making antisemitic remarks and I was directing my post to him.
YOU ARE FULL OF CRAP!!! NUF SAID
ILT "If I were Denner, I would go after the fraud with standing. We didn't have it the first time, cough cough, but Denner does"
I Agree...Marjac(i. e. attorney Michael Kasonoff of New Jersey) wrote an excellent legal brief of about 260 pages for the consideration of SCOTUS, which rejected it due to lack of standing...There is no time limit for fraud on the court... and justice for the fraud is still waiting.
CBB..I believe it was an unfortunate confluence of Judge Du's inexperience, along the poor performance of Amarin's lawyers...that allowed Hikma to defraud the court and that lead to the tragic error, which has resulted in the occurence of so many CVD's, which could have been prevented.
One..."As part of the agreement, Amarin will receive an upfront payment as well as pricing and reimbursement and sales milestone payments based on net sales of the product.
-what is the upfront payment?
-What is total amount of the milestone payments?
-What is the status of approvals in these counties?
-Its probably too soon to ask about reimbursements.
KIWI...Increased volume feeds on itself...i.e by word of mouth.
1000 sales at $10 profit/sale is preferable to 100 sales at $20profit/sale
So..even with decreased prices, profits can grow....
As the old saying goes...You can lose a little bit on every sale, but you can make it up on the volume.
KIWI...Tony(JL) was fortunate enough to have a lawyer daughter, who explained to him that Hikma's real goal was not to just break Amarin's high trig patent for its measly rewards, but to infringe on Amarin's CVD patent with its handsome rewards...
We now know that Hikma was able to fraudulently manipulate the court through an inexperienced judge and achieve their goal of cashing in by a 'skinny label' infringement of Amarin's CVD patent...The result has been to cripple Vascepa and Amarin, thereby, diminishing their assets, and, with it, diminishing Amarin's ability to tell patients about Vascepa and save the lives of many patients, who might have been able to survive a CVD had they been able to know about the drug...and prevented Amarin from further developing Vascepa by a FDC.
Canam...I disagree...
Denner is a relatively young man with many more battles to fight...He has his reputation on the line...as well as his cash.
"$1.15 to $2.50 is a significant move to anyone not 'hollering' about Amarin being $20+ once"...
I don't 'holler" as sometimes tornado do...I speak with quiet calm and confidence in the future of Vascepa and Amarin.
"Denner would NEVER engineer a way to take control for pennies on the dollar, it's not his MO"
I do agree with you there...even though I understand you were only being your old 'tornado' self.
Your advise was appropriate for the time when Amarin's price was over $20/sh, but not at this time...When the price rises significantly, I will reconsider it.
Tats...When I took the name Ziploc, it was because I thought a bright future for Vascepa and for Amarin was "in the bag"..I still do.
Tatsumaki...I looked up, on Google, the meaning of your IHUB moniker...It is "tornado of terror"...
IMO you are certainly living up to that name....You are obviously intelligent but I believe you are playing this board... We shareholders are serious investors with serious money at stake...Please keep your comments equally serious and equally rational....Dr Denner is NOT invested in Amarin to make some interest on a loan...nor is he interested in taking over the company himself and then selling it for pennies...It is not his style, nor his reputation.
JR...You may be correct...and, if so, A BP, which owns Amarin, can better afford the wait than Amarin can.
JR...In the short term, I expect Amarin to get approval for Vascepa in China along with a decision on remunerations for Vascepa in China at low prices...i.e. through Amazon's partner. Eddingpharm...This may lead Amarin to issue an AG in the U.S....Amarin,with the added income from sales in China and from the U.S. AG, will be able to have the assets to market Vascepa globally at low prices and high volumes...I have long thought that this is the future path for Vascepa.
CBD...I agree your thinking about the benefits of Amarin's partnering with a large generic company for an AG of Vascepa in the US...
A generic company, which partners with Amarin on an AG of Vascepa in the US, could compete well on pricing to patients with the pricing to patients from other competing generic companies...which are also marketing a gV in the US at the same time ...and Amarin and Amarin's generic partner could benefit from the advantage of having greater purchasing power for their EPA from their manufacturers...due to the larger volumes of EPA, used to supply markets in Europe as well as in the US...This would lead to lead to lower prices for the supplies of EPA for Amarin and for its generic company partner...than the prices for the supplies of EPA for competing generic companies, which also need to also buy EPA from the same manufacturers.
At the same time, Amarin could continue with its sales of branded Vascepa in Europe...and Amarin could continue to benefit from lower prices for its EPA due to their higher volume purchases of EPA for the AG IN THE US and for their branded Vascepa IN EUROPE.
A BP, with many drugs on the market, has an advantage over a small company with one drug...when it comes to negotiating with governments....A BP, with bountiful assets, can accept lower prices for a certain drug and higher prices for another of their drugs...as benefits the interests of both parties in the areas of supply and pricing.
In the case of Amarin, they have too much supply, but they can't lower their prices for Vascepa, in return for increased volume...because they can't sustain a temporary loss of income from Vascepa...A BP would be better able to deal with problems of this nature.
What Vascepa needs now is credibility, especially after the fiasco with German refusal to pay a reasonable price for the drug...Each approval in Europe and assignment of a reasonable price contributes to that credibility...Eventually this process will pay off for Vascepa and for Amarin.
I do believe that a BP could speed up this process
Denisk... "Mitigate was never intended as a clinical trial to reveal additional positive medical results for using Vascepa/ Vazkepa was only done to promote the distribution and sale of Vascepa to KP customers and patients.Total waste of time to talk about it." ...WRONG!!
IMO KP cares little to nothing about the distribution and sales of Vascepa to their customers...except as this might relate to KP's saving money by preserving the health of their customers.
Amarin, which provided the Vascepa to KP for for the study, as well as we investors, deserve to know the reason for it being stopped...and I am confident that the results will become known soon.
I wonder whether Hikma filed its false Sherman antitrust complaint against Amarin in the expectation that the filing might then induce Amarin to compromise and agree to withdraw its substantive CVD infringement complaint against Hikma.
Amarin's destiny changed after the judge Du debacle...Prior to Judge Du, JT planned to capitalize on Vascepa's future earnings and make Amarin into a BP... and GIA had made sense until then...But after the invalidation of Amarin's high trig patent, JT failed to understand that GIA was no longer practical...and therefore Amarin's best future prospects lay with a BP..rather than a GIA policy....I believe Denner understands this well...as does his BOD.
KIWI...QUOTE..."They can afford to run their generic V as a loss leader ...until AMRN drops out of the US market ."
Generic companies are not doing so well lately. Therefore...
-Generic companies will be hesitant to sell large volumes of gV at a loss to them.
-Vascepa will not drop out of the US market...It will, in any event, be taken over by a BP, which will continue it on a global scale...with new EPA configurations and new EPA products, as previously discussed.
Vascepa is not going away..although Amarin will eventuall be bot by a BP
Amarin currently has no debt and $300M in cash...Why would Denner and the board want to take on debt now?