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A long shot possibility is that the Q3 C.C.. is being held earlier than usual in order to afford a platform for the Amarin BOD to announce the appointment of new members to the BOD.
If Q3 earnings are good, the Amarin BOD would prefer them released ASAP to blunt a Denner proxy vote, which might result in changes in the BOD....No guarantees, but possibly a good sign.
Press Release
Amarin and Mochida Announce Collaboration on Future Development of EPA-based Drug Products and Indications
June 12, 2018 at 5:00 AM EDT
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 (eicosapentaenoic acid). Amarin and Mochida are recognized worldwide as the leading, innovation-driven companies committed to the research and development of EPA-based drug products to treat the needs of tens of millions of patients who are at-risk of cardiovascular disease.
At the signing of the agreement Amarin paid Mochida a large fee up front.
“We are excited to enter into a collaboration with Mochida given our common mission to create preventative healthcare solutions on a worldwide basis, and our mutual commitment to continued innovation in the EPA research and development area,” stated John F. Thero, president and chief executive officer of Amarin. “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.
I would certainly like to know more details of this agreement.(? what, if any, royalties for products that the parties collaborated on and ? can the agreement be transferred to a new owner in case of a BO of Amarin})
Tat...Pfizer could definitely make this work...Amarin had a role in the development of MND2119...so I'm not sure the Mochida commision would be as high as 18%
KIWI...The cost of the statin would be minimal...The cost of the combo drug would be mainly the EPA.
Tat...a patent would apply if the EPA were in the form of MND2119
...Amarin could market 2 drugs...one drug, a 20 mgm lipitor combined with a MND2119 capsule containing the equivalent of 4 grams of..EPA... and a second drug with 40 mgm Lipitor combined with a capsule of MND2119.
Paxlovid is a fixed dose combo drug...Why not a fixed dose combo with statin and Vascepa?.... "Each carton of the new dose(Paxlovid) pack contains 20 tablets divided in 5 daily-dose blister cards. Each daily blister card contains 2 nirmatrelvir tablets (150 mg each) and 2 ritonavir tablets (100 mg each), which are separated into morning and evening doses"
Why do we have to wait 3 years for Amarin to market a patented fixed dose statiin-Vascepa drug... and thus reclaim the U.S. market?
The Amarin strategy to GIA in developing a long term sustainable global market for Vascepa has failed, in part due to mistakes by Amarin management and, in part due to events beyond their control...Now Amarin is faced with having to sell the company to a BP, which is more able to execute on this goal than is the current BOD of Amarin.
Denner has much better experience to guide him in executing on this new initiative than does the current BOD...and the sooner Denner takes control, the better.
ONE...I assume the result will be based on 67% of the votes actually cast in the proxy fight, rather than on the number of outstanding shares....I also assume that there is more interest in voting by the group of shareholders who want Denner to make changes, than in the group who do not care to vote due to a lack of interest...Therefore, those in favor of Denner making changes, are more likely to vote then those who, who are neutral or have no interest...i.e. roughly 50% of shareholders)....or those, who want Denner to fail.
Therefore, it is important for each of us, who want change, to vote.
It would be beneficial for Amarin and its shareholders to replace just a couple of board members with Denner and one of his associates...and not have to go through a special hearing...but the BOD has rarely placed the interests of Amarin or its shareholders above their own interests.
From Amarin BOD response to Sarissa....QUOTE..."We remain committed to engaging in constructive dialogue with Amarin shareholders, including Sarissa"
The Amarin BOD could conduct a constructive dialogue with investors, on Zoom, with the purpose of hearing their concerns.
Many have asked why Denner has not been buying more shares of Amarin at its current low prices...I believe he will buy addtional shares once he has more say in the company's future ...The value is there...Denner has ro bring it out.
Who would you rather have in charge of selling Amarin to a BP?....Denner or present management?
Rose...Amatin's main problem is not having enough cash to exploit MND2119 and combo drugs...Selling to a BP ASAP makes sense for both Amarin and the acquiring BP.
QUOTE..." we have interviewed several highly qualified candidates and the Board is in final stages to appoint new independent directors. Throughout the Board’s consideration of these candidates, including Sarissa’s proposed nominees, we have kept Sarissa apprised of the Board’s refreshment process. This process remains ongoing."
This Amarin PR skirts around the current reality for Amarin...which is the need to orchestrate a sale of Amarin to a BP for the best possible terms...This requires a BOD with many contacts with BPs and experience in getting such such deals done...Denner fits those needs better than most other potential board members....Denner also has a huge investment in Amarin which focuses his attention of what is best for Amarin shareholders.
KM war hired to get Europe moving....Due to pressures on the European economy from the war in Ukraine and the Covid scourge, KM found himself in a very difficult position...I don't blame KM for the EU unwillingness to pay for a drug that is used mainly to treat non acute diseases....I would support having KM continue with his work in Europe and award the U.S. portfolio...including development of MND2119 and fixed dose combos with statins... to a vice president in charge of Europe
Or if Amarin has the intention to return to the U.S. market in a vigorous fashion, hire a new CEO mainly for the U.S. and leave the European portfolio in the hands of KM.
Perhaps if Ekman and Per Wold Olen opted to resign in favor of Denner and one of his associates, the election at a special meeting would not be necessary.... and the time and the expense involved in Amarin having such a special meeting would not be wasted during this crucial time period...The shareholders would be grateful for this move.
Apparently Respect is included as a late breaker at the AHA conference, but not Mitigate.
Pdude...I agree...That is nuts....However, for nutty people like that, perhaps one capsule/day would be better accepted....and also for people, not so nuts.
Pdude...QUOTE..."I see no reason why it couldn’t. "...(i.e.dispense the .5 gm capsule to fill patient's Rx's for 4 gms. Vascepa per day...
Having to take 8 capsules a day is a good enough reason enough for me to not want to take the .5 gm. capsules...4 caps is enough to take daily.
Bolio..My wife used to have similar severe calf pains, often to the point of having to wake me up at nite to rub her calf...These pains have largely disappeared since she has been on Vascepa...However, she says she will now check to see if the occasional recurrences of these pains which sometimes do occur, do so when she has not been rigorous about taking her daily 4 grams of Vascepa.
This is one of the problems with meds for chronic indications...i.e.you may need reminders to take them regularly....one capsule a day(i.e. MND2119) would be easier to have patients maintain compliance in the absence of acute symptoms.
ILT...I hope Amarin cites this case as one of many skinny labels that are presently being allowed to infringe with impunity.
sleven...I agree...Asking for a PA on skinny label drugs would be a good solution to the skinny label problem.
"I don't know nutthin"...i.e.about the reason for which my skinny label drug is being prescribed...is a dodge now commonly being used falsely by generic companies and insurance companies in order to infringe on patented indications without penalties... and to reap unwarranted profits at the expense of "robust labels"
During the ninth circuit trial, judge Du warned Hikma against using Vascepa for the CVD indication...but the warning went unheeded just as for so many other "skinny label" drugs.
The way that HW is now being applied means that those, who have gone through the work, the expense and the risk in raising and nurturing the chickens, now have to stand buy while interlopers sell the eggs...I don't think it takes conservative mindsets for judges to see the unfairness of the 'skinny label loophole' in HW....I would appreciate the SCOTUS judges pondering over this case.
Both Hatch and Waxman obviously wanted to stimulate innovation...NOT to stymie it.
It is my hope that the Teva vs.Glaxo trial showcases the 'skinny label'end run around the HW law, which enables infringing generics to get rich by subverting the law's intention to reward innovation, while preserving price stability...and this case stimulates Congress to reexamine HW with a view to amending it to eliminate the 'skinny label' disincentive to companies to invest in innovation, which is so important to finding superior treatments to help patients.
China was never going to pay anything more than rock bottom prices for EPA products for the millions of their people, who could benefit from those EPA products...So, understanding this situation...was the exclusivity consideration, as it pertains to China, ever really as important as the volume consideration ?
The main tasks ahead for both Edding and Amarin are to seek approval for EPA products in China and negotiate prices with the China regulatory authorities that both parties can live with.
KIWI...QUOTE.."Zip ..regards to China , combos etc ......wont matter IF RESPECT EPA does not confirm clinically significant risk reduction and IF Kaiser follows the CV part of MITIGATE for at least 2 yrs past full enrollment ....which would be Sept 1st 2023 .....and doesn't see the CV event lines separate in a clinically significant manner."
On the basis of JELIS and R-IT success, we can reasonably anticipate success with both RESPECT and MITIGATE.
This also would auger success with a fixed dose combo with statin-Vascepa or, even better, with statin-MND-2119....Look at Amarin as a super charged start up....currently selling at close a buck.
KIWI...This is an interesting proposition...
QUOTE..."The rebates are to the large healthcare providers like Kaiser ….It’s a volume discount with a commitment purchase"....i.e. We ( Kaiser ) will purchase ( as example ) 100,000 bottles of Vascepa (1 mth supply per bottle ) for 2022 as long as it’s at least 1 c lower per bottle then the cost of the generic option"
Could this be the basis of a deal with China, which has a very large population, which could benefit from Vascepa?....i.e. We will give a very cheap price in return for enormous volume...As J.T. was wont to say...Vascepa is a volume play...not a price play.
Also. if China agreed on such deal, Amarin could then lower its prices for Vascepa in Europe and the U.S.
study...Your post covers most of the salient points about Amarin's current situation...but as I reflect on it, it omits mention of MND-2119 products and fixed dose combo drugs, especially using MND-2119 with statins..., which could be game changers in 3 to 5 years...For those willing to wait that long, it could still turn out to be be a successful investment.
study...thanks for this insightful discussion
Denner has paid a major chunk of money for his 24 million shares, which is lot of shares. but still makes him a minority shareholder...Even if Denner were to buy another equal amount of shares and thereby average down, he would still be a minority shareholder...and as such, still be at the prerogative the BOD to enact whatever policies they wished...even some policies, more in their own interests rather than in the interests of the shareholders...i.e. like the decision not to support Marjac's and the EPADI's appeal of the questionable ninth circuit court decision...at little or no cash cost to Amarin, but at a potential blow to the reputations of their faulty legal help and to themselves.
IMHO,before Denner makes further investments in Amarin, he must have more input on board policies.
Denner invested $100 million in Amarin because he saw Vascepa as a transformative drug...and IMO he was correct...but not just right now...and not in the hands of current management.
JR..."And V2.0 (MND-2119) could potentially push generics out to some degree."
We are still waiting for information on Amarin's plans for MND-2119....hopefully at the AHA conference in early November or, even better...before.
golf...The Brave study may have been continued for another 6 months to attain statistical significance.
In my personal experience with family members with Alzheimers, the most noticeable symptom is a defect in recent and past memory...It should be relatively easy and inexpensive to do objective tests for these symptoms to evaluate the status of the disease.
Serial CAT scans for amyloid deposits and CSF studies are valuable, but expensive and/or intrusive.
JRoon...If the results of the Brave study are positive, Amarin will be taken over by a BP in a flash at a healthy premium.
You are correct...Amarin is not presently able to both execute on further scientific studies and expand on marketing for current and prospective Alzheimers patients.
JRoon..If an expensive intravenous drug for AZ with potential serious side effects can drive up the Biogen price one hundred points in one day, just think of what a successful result from the Brave study could do for Vascepa.
CAPT....from your QUOTE on Stocktwits...A clear and concise explanation of the MOA of Vascepa...
"When it comes to LDL-C, the lower the better. Statins and new LDL-C lowering therapies like PCSK-9’s can’t eliminate all cholesterol formation, nor would you want them to because they are essential for many cellular functions. However excess cholesterol particles lead to the formation of Cholesterol Crystals which is the cause of inflammation and plaque formation. EPA BLOCKS this propagation, NOT DHA. This may be the hidden MOA for VASCEPA® which is separate and distinct from the LDL-C lowering pathway.
We now know why R-IT was so effective in reducing CVD ...and it was certainly not because of the MO placebo!
"
gozips...I agree...I search daily on the internet for Amarin PR's on their plans for MND-2119...and instead I see trivial PR's on the ethnicity of the BOD...If they could show some profits, I wouldn't care if they were Martians.
KIWI...My Cardiologist has me get a lipid panel every six months...It includes...
HDL
CHOLESTEROL
TRIGLYCERIDES
LDL
CARDIAC RISK RATIO
NON-HDL CHOLESTEROL
Thus far, my lipid panel has never included EPA, which I have recently come to consider an important factor in the assessment of my CVD risk for another event...I will ask him about this on my next visit.
A low EPA value might be a stimulus for docs to prescribe more seqential EPA tests... perhaps just as important or more important than the currently prescribed lipid panel tests.