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ILT..."Why not an authorized GV to shake out the Generic's?"
Questions for Amarin for an AG price at $180/month
1.Would generic cos. lower their prices to compete?
2.Would EU and China demand a still lower price?
3.would an increase in volumes make up for the decrease in margins?
I believe its risky, but worth a try...especially if volumes and revenues continue to decrease.
Then, when the combo drug is aproved, the US market will be ready.
Robin..."Amarin needs to launch own brand generics now"
This will happen in 2023 after negotiations with Europe and China have been substantially completed.
lizzy.."After what happened with BIIB I suspect Denner has his hands full with the BS that's going on with the Alzheimer's drug."
The failure of the Alzheimers drug may stimulate interest from a BP to buy out Amarin and to do studies on Vascepa's anti-inflammatory effects in ameliorating Alzheimers.
This would be in the interest of the shareholders, if not in the interests of management.
We need a large study, but Amarin can't spare the cash.
CBB...KM has been with Amarin long enough to speak truth to power.
-Ekman should resign.
-Amarin needs to be sold.
Research and development expenses for the first quarter ended March 31, 2022 were $10.1 million compared to $9.4 million in the prior year. This increase(i.e. of $.7 million) was primarily driven by costs incurred related to the development of a fixed-dose combination of VASCEPA with a statin.
Under U.S. GAAP, Amarin reported a net loss of $31.6 million for the first quarter ended March 31, 2022, or basic and diluted loss per share of $0.08. This net loss includes $6.1 million in non-cash stock-based compensation.
Amarin is spending much more cash on stock based compensation than on a combo drug...while the combo drug is the only thing that can save Amarin from oblivion...Amarin needs to spend $20 million/quarter on the combo development, not $.7 million!...I am disgusted!
There was no corruption in this case..There was a toxic mixture of inexperience and naievite, made worse by lawyers willing to leverage a fraudulent cropped chart on behalf of their client.
The PR heralding the positive findings in the subgroup analysis of R-IT, written up in the JACC, was a step in the right direction...It would be helpful to see PR's like this as often as possible.
Term of Office of Amarin board:
Members of our Board hold office until their successors are elected and qualified or until their earlier resignation or removal. Our articles of association stipulate that, at every annual general meeting, one-third
of the members of our Board (or, if their number is not a multiple of three, then the number nearest to but not exceeding one-third)...must retire from office, with such retiring members of the Board being eligible for re-election.
The members of our Board to retire on each such occasion will be, first, any directors who wish to retire and not offer themselves up for re-election, and second... the members who have been longest in office since their last election.
Ekman, who came on the board in 2008, has been the longest in office....I'm not sure when Ekman was last elected....Will he be standing for election this year?
"Biogen said Tuesday that it booked about $275 million in charges from Aduhelm inventory write-offs in the quarter, and it would essentially shutdown the commercial infrastructure supporting the drug."
It's time for a large study to prove the ameliorating effects of Vascepa on Alzheimers disease(especially in the early stages)...A huge market is waiting in need of an effective and moderate cost treatment.
JRoon..." I think the Du decision completely derailed us because we only have so many resources as a small company, and a lot of those resources were then focused on what to do about the generics issue."
Your view corresponds to my understanding of this shocking event...J.T. had no inkling of the coming loss.
I believe that prior to the Du decision Amarin was ready to spend cash to research additional indications for Vascepa.
J.T.'s big error was in not understanding that his strategy for Amarin had now been thwarted by the unexpected Du decision and that he needed to change course and he should start looking to sell Amarin to a BP with more assets to fulfill his plans.
It is much easier to accept and act on a positive surprise than a negative one.
It is now up to KM to do what should have been done by JT.
Rose..."Are you saying though that if Amarin were to be denied reimbursement that the decision could never be revisited or changed in the future if another Pharma took over the reins?"....
IMO reimbursement depends on the product, not the Pharma...If Nice denies reimbursement for Vaskepa sales, it would be a terrible blow for Amarin.
"I don't believe that a reimbursement decision strictly guarantees success in sales of Vazkepa. We all know Amarin's track record."
Vascepa sales were doing well until gV came along...and in Europe, there will be no gV
"As far as those other studies you mentioned, I think a number of EU decisions will come before those results are published and I am not sure that a year study in a small geographic locale in one country can be weighed as much as a multi-year multi-country study that was prescribed by the FDA to enable approval. I know that you are talking about Mitigate being used to show the slight separation at one year, but it won't be very clear cut."
I agree
Rose...A good part of Amarin's low price is WS's correct perception that Ekman is more interested in Covington than in Amarin.
If Ekman were to resign, it would be a signal to WS that Amarin's management could be once again focused on the future of the company rather than on management's friends!
Perhaps a study on a combination of Vascepa and Paxlovid could achieve statistical significance in preventing Covid infections in patients who were in contact with people already infected with Covid.
"Announcing topline data from a Phase 2/3 study for Paxlovid, Pfizer (NYSE:PFE) said on Friday that the COVID-19 antiviral did NOT meet the main goal in the trial designed to evaluate its effect in the prevention of infection''
Perhaps a study on a combination of Vascepa and Paxlovid could achieve statistical significance in preventing Covid infections in patients who were in contact with people already infected with Covid.
dogn...Whoever in Amarin management is in charge of Vascepa studies should reach out to Gilead for their opinion on the results of the Vascepa arm of the Nash study.
Dogn....Amarin holds the patent for treating CVD...It doesn't matter whether Amarin calls their EPA product ICPE or brand X...any EPA product issued by a generic company and prescribed to treat CVD is infringing on Amarin's CVD patent.
More patient event studies are needed on the effects of Vascepa on cancers, Alzheimers, arthritides, dry eyes,diabetes, hypertension, depression, obesity, etc.
Who will do these studies?.....certainly not generic companies....Amarin does not have the assets to do these studies....perhaps Big Pharma can do at least some of them.
HDG...You were proven smart to get out when you did...now I hope you'll be proven smart to get in when you did.
We have enough information to see where the ship is going...What we now need to hear from KM on May 2 are how he plans to right the ship.
Kiwi..."AMRN has selling and general admin costs of over $400m a year "
-Reduce SGA to $100 million/year in the US
-negotiate a price for Vascepa 20% lower than the present price in Germany at the end of the first year of sales...when prices have to negotiated between Amarin and the German regulatory agencies
-accept a similar price from NICE and from other European national regulatory agencies.
-accept a similar price for an AG in the US
-await the arrival of a combo stain-MD2119
Amarin will be selling higher volumes of Vascepa globally than the generics and will be paying lower prices for their volume purchases of API... reducing the profit margins of the generic companies, if they wish to lower prices still further.
Duke...I agree about an AG form of Vascepa
The main scientific advantage Vascepa has over gV is its patented capsule that prevents oxidation of EPA...Amarin has not yet produced evidence of this effect...even though there have been compelling reasons for them to have done the studies... Although there have been rumors that research is being done on this issue,,.we have not seen definitive results from these studies.
Until we do hear more about this research, the main distinguishing features between Vascepa and gV remain the slightly lower price of gV and the lack of any clinical trials of gV.
Until we have the authority to market a once a day statin-MD2119 product, we should commence marketing of an AG of Vascepa.
raf...These poor sales substantiate the need for Amarin to redirect its US efforts and its assets towards bringing on the statin-MD2119 combo ASAP in the US.
We need to hear details of the research and regulatory situation at the CC on May 2.
Sabre...Amarin's sp is like that of a start up company with an unapproved drug
The followed is an abbreviated summary of Amarin's positives and negatives.
on the positive side is
-it has an FDA approved, established product
-it has an income stream
- it has $500 million in CASH
-it has NO DEBT
-it has been approved in the EU and is already selling in Germany
-it has an an agreement in Japan(Mochida), which will give it access to a blockbuster patented combo drug in the US
on the negative side is
- the 'skinny label' problem is presently harming US sales
- Dr Nessen's well refuted contentions that the MO placebo used in R-IT produced the extraordinarily great results from the trial
Capt...I'd like to hear more from KM at the CC about the patented Amarin-Mochida forthcoming ,once daily, statin-MD2119 product(now up for approval in Japan) and whether this improvement has the potential to make gV obsolete.
Lizzy...Amarin pps pretty much followed the IBB(biotech index) until 1:00 pm...Then as the IBB went up, Amrn went down for the rest of the day.
The last 30 minutes before the bell saw 40% of the volume for the day, which was not exceptionally large...with Amrn pps on the downside.
My take..There was lots of shorting, but the large stakeholders were not selling...These shorts have to be covered.
Rose...Will NICE now maintain that at least 50% of the excellent data comes from the use of MO as a placebo?
Even if NICE were to defend the preposterous idea that this theory was true, the results would still be excellent.
raf...I wonder how NICE handles this news in MAY 2022 JACC!...Is this also due to MO?
PREVENTION OF CV EVENTS AND MORTALITY WITH ICOSAPENTETHYL IN PATIENTS WITH PRIOR VENTS
"Sudden cardiac death and cardiac arrest were also significantly reduced by 40% and 56%, respectively."
I agree Lizzy....Assuming we see no growth in US sales of Vascepa in Q2, Amarin should IMHO cease marketing expenses in the US and do the R&D for a combo product for the US...and, in the meantime, concentrate on Vascepa for Europe.
The combo product will have appeal for the many millions of patients already on a statin.
I am thinking about about the research going on in the scientific development of the combo product(i.e. a blister pack containing a gelatin capsule of EPA plus a statin tablet...or a statin sprayed onto the exterior of a gelatin capsule of EPA.
Also, I am thinking about whether the FDA will accept studies of Mochida done in Japan or demand lab or event studies to be done in the US.
Rose..." the caveat is if there is some fundamental change to what we are experiencing now, then anything could be possible."
The fundamental change I am awaiting is the FDA approval of a once daily statin-MD2119(EPA) combo to restore our patents for the US market.
With that in mind, I would hope that Amarin immediately directs its time, energy and assets towards effecting the approval of that product...while we continue to grow our market for Vascepa in Europe and also grow our market slightly in the US.
I am also awaiting Vascepa approval in China....We need to negotiate with Eddingpharm and with Chinese regulatory agencies to make that happen.
Apparently public reimbursement for Vascepa in Canada has two stages.
First stage... "The completion of pCPA’s assessment regarding reimbursement represents an important milestone towards advancing the potential reach of therapies across Canada"....I assume this means that there is now agreement on the price of Vascepa....This removes the main obstacle to commercizalation of Vascepa in Canada.
Second stage....HLS now has announced(by a letter of intent) that they intend to reach out reach out to provincial regulatory bodies to add Vascepa to their formularies....This should happen in short order.
Rose...my impression from KM's talk at the Cowens meeting was that Amarin was working on the combo drug right now...Perhaps he will speak more about this important development at the CC on May 2.
Rose....This is a critical time period for Vascepa.
If Europe (and possibly) China become profitable and Amarin can at least continue to break even in the U.S., Amarin can afford to wait until a once daily statin-EPA combo is available to market in the U.S. and the 'skinny label problem' at that time becomes an irrelevance.
Then Vascepa can resume its destiny to become a blockbuster drug, which was interrupted by the ninth circuit 'skinny label' decision.
The difference between the recent outcomes of the errors of John Thero (CEO) and Lars Ekman (COB)....
J.T. was wrong not to object to the Hickma vs. Amarin case being played out in the ninth district, in which Amarin lost the case due to fraud....J.T. lost his job due to that mistake.
Ekman was wrong not to support the EPADI appeal, in which Amarin lost the case due to standing.... Ekman kept his job in spite of that mistake.
Quote from 'Due Diligence', respected poster on I-Hub"
“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”
China has numerous cases of CVD and Covid...Vascepa can help with both.
Eddingpharm is having problems with Vascepa winning approval in China...Perhaps it might help for Amarin to send to a member of their team to China to discuss the problem with Eddingpharm and with the Chinese Health regulators.
Will Ekman sell his Amarin share perks in May, issuing form 4's, just as he sold out of Amarin shares at Sofinnova, where he is managing director?....Does the still sitting COB of Amarin have no shame?
The 'Game of mineral oil Chicken' that NICE has played with Amarin has hurt. It should help when that is resolved.
CB...Thanks for this excellent piece on a potential statin-EPA combo drug.
"MOCHIDA MND-2119....
Another potential option is a technology developed and LICENCED TO AMARIN by Mochida Pharmaceutical Company called MND-2119. The MND-2119 product is a PATENTED(# 9,801,843), “selfemulsifying” capsule that can deliver twice the EPA content to the bloodstream as the regular capsule, making the administration a “once-a-day” option instead of twice a day. Two clinical trials have already been conducted in Japan on this product:"
Since ,as you say, Mochida has already conducted two clinical trials on this product and already applied for approval in Japan ten months ago, it seems that KM's recent estimate of 3 more years needed to develop a combo drug seems on the conservative side.
Pdude..."If, by year end, generics are producing 90,000 bottles a week and scripts remain stuck at 100,000/week (zero sign of any growth for 2 years now) then Amarin will start to hemorrhage cash while rolling out in EU and continuing to amass a bloated inventory (10M bottles at the end of 2021 IIRC). I would guess at least 2 years in EU to hit break even."
Reasons why Vascepa price will come down;
1. Amarin has made commitments to buy more bottles of Vascepa from wholesalers than they can now sell in the U.S. at the present prices....They now need to move their excess inventory.
2. Even though branded Vascepa is of higher quality than gV, it will be price that determines which sells best.
3. As you mention, rollout in Europe will take some time, unless the price of Vascepa comes down.
4. China is unpredictable as to when they will approve Vascepa, but, when they do approve, Vascepa will definitely need to have lower prices for the Chinese market and for markets in the ROW.
5. a once a day statin-MD2119 product is 3 years away and Amarin can not afford to wait.
6. It was previously stated by J.T. that Vascepa was a volume play...not a price play...Now is the time to put that policy into place.