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A PR on the subject of the emulsified EPA by Amarin...or a comment from Dr. Preston Mason would be most appreciated.
Tats...IMO, Under your "sky is falling scenario",Holt would forego all new expenses for any new products...rather than diluting the stock any further and, especially, he would avoid borrowing from Sarissa....(It would look too shady)
JR...In 2015, Amarin had not yet completed R-IT and did not have 300 million dollars in cash assets.
This might be a reason why Amarin has not yet moved ahead with MND-2119 efforts...They were waiting for the patent approval of their own superior self-emulsifying EPA drug by the U.S. patent office...Now they can now move ahead with the necessary lab studies on patients, followed submission of their new product(s) to the FDA for approval.
This important patent is for a new form of EPA that has the potential of being quite useful in cancers, due to it's anti-inflammatory qualities...Relatively common cancers like lymphomas need to be treated with chemotherapy,which has severe accompanying inflammatory components...
High doses of prednisone are currently being used in conjunction with chemo Rx ..despite the dangerous side effects of prednisone...Perhaps the side effects of the prednisone could be reduced by the concurrent use of this new form EPA.
Dr.Preston Mason, who is a respected researcher at Brigham and Womens hospital in Boston and Harvard medical school...filed this patent on behalf of Amarin.
This patent being for an emulsified form of EPA, it might be a prelude for Amarin to initiate the marketing of MND-2119 products for high triglycerides, CVD, cancers, and still more diseases, which have an inflammatory component....It could even become a superior successor to Vascepa.
Holt could have gotten his shares by being given RSUs or options... but It was decided it would be better to increase his salary and then have him buy his shares on the open market...Frankly, I agree with this idea... I'm glad he has a stake in Amarin....His buying had the affect on increasing the the price of the shares by a few pennies...I'm in favor of anything that increases the price of the stock, even if only by a few cents....Lets now see more actions that increase the price of the shares by much larger amounts.
Thank you Canes for putting this misinformation to rest....There's a lot of FUD going around.
Pdude posted this yesterday...
"Preferred shares going to Sarissa???? Denner sells himself 100M shares at $1 and ups his ownership to 25% of a very diluted company???"
Tats posted yesterday..."Denner telling retailers to 'ante up' when he converts"
what BS!!!...Be wary of these misleading panic posts and you'll sleep better at nite.
north...Yes..i meant FTC, not FDA.
Pdude...KM was not to blame for Germany changing it's rules...However,KM does have to bear some of the responsibility for his critical failure to be unable able to convince the German health authorities that Vascepa was, in fact, superior to Ezetimibe.
Perhaps if KM had been better versed in the science of lipids and of CVD, he would have been better able to better convey that message to the German authorities.
KM's failure established a very bad precedent, which has been presently continued in Italy and possibly in other nations of Europe.
Pdude...With respect...You seem to have a lot of animosity towards Denner...Would you care to illuminate us as to why that might be?...Did you really like Ekman and PWO better...when they almost ran Amarin into the ground?
Ramfan...Pfizer is waiting for it's Seagan deal to be approved by the FDA before they entertain any further buy outs...Incidentally, the Pfizer 43 billion dollar purchase price of Seagan was only 17% above the previous market price of the stock....They financed this with 30 billion cash on hand, plus mostly long term debt....The deal is expected to close this year or early next year...Maybe then, they'll be ready to buy Amarin...Their patents are running out soon and they'll need new products.
Tats..."The last item on the proxy was rights provision allowing shareholders to purchase those new shares to avoid dilution. Essentially Denner telling retailers to "ante up" when he converts."
I don't understand how this dilution would take place?...I don't understand what Denner could do in his interest...and what retailers could then do to protect their interests?....I'd appreciate it if you could explain...Thanks.
Denner could have bought Amarin stock in the market these past few months at a low rock bottom price, thus keeping the share price well above $1/sh and helping the stock price by demonstrating his commitment to Amarin ...Perhaps the message from this episode is...You'd be better off to sell your Amarin stock and invest the proceeds in Sarissa...When it comes to a choice between conflicting interests between Amarin and Sarissa, there's little question as which side Denner takes.
100 million dollars more cash for Amarin...That's nice, but management needs to why it was important for Amarin to acquire this extra 100 million for Amarin's coffers(ABOVE THE 300 MILLION THEY ALREADY HAVE), and for what purpose was it necessary? ....Is this part of Amarin's fiscal austerity program?...How will it benefit Amarin in the short term or in the long term?...For whose benefit was this capital raise?
KM' s strategy in Germany was to shoot first and think later...He did the same thing on leaving...when he quit in a huff and then demanded severance pay...He was good at selling, but not so good at planning...as he demonstrated by his failed GIA strategy after Europe was obviously in a dire economic condition .
Amarin has needed a CEO with a legal, scientific, financial and marketing background....Except for the legal aspect, Holt seems to fit Amarin's needs.
Unfortunately, as it has turned out, the legal aspect has been Amarin's biggest pitfall...They need Marjac on the board.
European countries could care less about KM...It was the bad economy that they were concerned with...as they still are today...This too will pass and will make way for better days ahead.
Amarin is selling for the amount of cash in its till...plus millions of dollars in inventory, plus a great product with nearly 60 thousand sales per week and producing positive cash flow and profits in sight...with zero chance of reneging on its debt...because it doesn't have one....I wish I were in such great shape.
KIWI...If a stock trades below $1.00/s for 6 months, it gets delisted from the Nasdaq.
Kube...A strong growth trajectory would be dependent on new products for EPA and/or new indications...This would require some cash(but not like what Amarin had to spend on R-IT), and Amarin's prime consideration at this time is to preserve its cash. ..A BP would be able to expend that cash and change the trajectory of EPA, which is, as you say, a great product.
Craig Granowitz was appointed chief medical officer of Amarin in Jan of 2016..He was aware of the deal between Amarin and Mochida in 2015, which provided opportunities for Amarin to work on new products containing EPA...Granowitz and Ketchum were definitely aware of MND-2119...and yet, even after the Marine patent was invaldated in 2020 allowing Generics to infringe on its CVD patent, Amarin has still done nothing to 'collaborate' with Mochida on a clearly superior, emulsified form of EPA....IMO, this alone was reason enough to necessitate the recent change in management...I hope that this policy of inaction does not persist with present management.
Pfizer could well employ Vascepa to help REDUCE THE CYTOKINE RESPONSE RATE, which occurs with its drug Elrexfio...
"PFE: Pfizer wins FDA nod for multiple myeloma therapy...
Pfizer (NYSE:PFE) announced Monday that the U.S. FDA granted accelerated approval for its immunotherapy Elrexfio for adults with relapsed or refractory multiple myeloma who have received at least four lines of therapy.
However, the company will have to prove its clinical benefit in confirmatory trial (s) for continued approval of the therapy....Elrexfio, a B-cell maturation antigen (BCMA)-CD3-directed bispecific antibody, comes with a Boxed Warning for safety concerns, namely cytokine release syndrome (CRS)"
Kiwi..The problem is we small investors don't have security clearance...Only large institutions have security clearance.
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.