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The problems with an AG for Vascepa....
1.It makes Amarin accept a lower margin
2.It sets a maximum price for Vaskepa in Europe
3.It competes with multiple other generic EPA's
4.It competes with larger generic companies, which lower their prices to pharmacies for their own gV...in return for exclusive deals for their own gV together with their other drugs
5.It potentially harms other patented Amarin products in the future... when concentrated, (once a day)Vascepa and a combo statin-Vascepa are ready for the market.
A buyback by Amarin of 20 million shares would cost only a little more than 10% of cash on hand and would be an eloquent statement by management of its faith in the company's future.
Amarin has lots of cash, no debt, and is earning enough to break even or even to show a profit in the near future...with the the stock price so low, it may be time for Amarin to buy back a sizeable amount of their stock at a tremendous discount.
A buyback would attract attention and might even raise the price enough for a BP to seriously consider a BO.
The roll out of Vascepa in Europe should soon start paying for itself and generating profits....In the meantime, Amarin's cash sitting in the bank doesn't seem to be doing much good for them.
I would love to hear monthly updates from Amarin management on any progress on the patented Mochida concentrated EPA and Amarin statin-EPA combo products.
Long term retail shareholders are withering on the vine and may not be able to hold on to their shares long enough to see the price spike up from these new patented products ... we may have to sell our Amarin shares just to keep alive....and only then, witness the option holders and the new owners reap the profits.
IMO Ekman, as COB of Amarin AND director of Sofinnova, was duty bound to resign one or the other of his posts when he sold off the Sofinnova stake in Amarin....His failure to do so represents a conflict of interests as well as an insult to Amarin shareholders, who remain holding their shares and hoping for a better future.
A COB should care deeply about his company and its future...apparently Ekman distains Amarin and its future.
It didn't help Amarin's price when Ekman sold out Sofinnova's stake in Amarin and his remaining tenure as COB is one of the reasons why Amarin's price is so low....Why should W.S. have faith in Amarin when its COB does not?
Ekman did not support the Amarin rule24/60 appeal which might have made a difference in the result.
J.T. resigned...Kennedy resigned...and now, Ekman should resign.
Re Markman comments..."The decision(to decline the en banc appeal for the GSK vs. Teva case)opens the door to the possibility that a generic will be liable for infringing a method-of-use patent despite expressly carving out that indication from its label. That liability will be determined ultimately by jury verdicts, which often come years after a generic has invested CONSIDERABLE TIME, MONEY, AND RESOURCES towards bringing a generic drug to market.
The investments by generics pale in comparison with the investments of the inventor of the drug...Also, once a drug faces generic infringement, the inventor is discouraged from exploring other worthwhile indications for its drug....something generics will not do...and the public is the loser.
Amarin is a good example of this...Amarin would be now exploring other uses for Vascepa, but the infringing generics have prevented Amarin from having the assets to make these investments.
Retired..."I cannot fathom how Amarin's COB can sell out of his (Sofinnova's) Amarin position with the stock at $3."
This tactic of Ekman could be(should be) a portend that we are close to a change in the management of Amarin,and the sooner, the better.
There is a future for Amarin, but new management is required...or a sale to a BP.
CBB...I agree...If we are correct in our conviction that AMRN shares are severely undervalued,KM could indicate his support by spending some of his own money to buy AMRN shares on the market in addition to the ones he is getting for free....as could other members of the BOD.
Gusman..."Followed by a BO at 30!"...The negotiations could start there, but be concluded at a lower price.
Lizzy...Ekman has demonstrated a conflict of interest in his dual positions as director of Soffanova and COB of Amarin...He should resign as COB from Amarin and pave the way for a new COB.
Gusman..."Amarin will leave the US market once EU is established."
IMO Amarin will remain in the U.S. market anticipating the introduction of a patented statin-Vascepa combo product.
KIWI...Lipitor went generic in 2011...In 2020, Pfizer paid 90 billion dollars to buy Warner Lambert...Its blockbuster drug was still Lipitor(even with competition from other statins)....Pfizer had 2 billion dollars in sales from Lipitor last year...If managed correctly, Vascepa could be a blockbuster drug, even as a generic.
One...A combo pill could introduce 700,000 Docs, who are now prescribing a statin, to the idea of prescribing Vascepa along with it...It's the best advertising Vascepa could ever do.
Kiwi...Pfizer is now selling Vascepa in Canada...What is their purpose?
Is it to give their reps employment?
Is it to to make a few pennies in Canada?
Is it to help reduce CVD for Canadians?
Is it because they are interested in HLS?
Is it because they are interested in Amarin?
I think the last reason is the most likely....Their Eliquis patent expires soon...They need a blockbuster drug to replace it.
Rose...Purified EPA is extracted from esterified fish oil....The statin would need to be soluble in EPA, not in fish oil. ..
Lizzy...I assume that Eddingpharm needs to file an IPO so that it can attain the funds to make milestone payments as specified in their contract with Amarin....i.e."Under the agreement, Eddingpharm will be responsible for development and commercialization activities in the territory and associated expenses. Amarin will provide development assistance and be responsible for supplying finished, and later bulk, product. Terms of the agreement include up-front and milestone payments to Amarin of up to $169.0 million."
If this is the holdup, Amarin can let Eddingpharm delay their upfront payments to Amarin in order to get the ball rolling.
Nsleven...Vascepa is presently a liquid in a gelatin capsule...The statin would have to be powder made to dissolve in the liquid Vascepa and have the same gelatin capsule.
Regarding the combo bill...The main holdup is in adding the solid statin to the liquid Vascepa...After that, finding a manufacturer and commercialization should proceed in short order...Finding chemists to work on this should not be difficult....KM's announced time line of 3 years seems too conservatively long.
"today statin users in the US are 700,000 prescribers, while VASCEPA prescribers(of Vascepa) -- because we only had a couple of years of launch for cardiovascular risk reduction,we have maybe 30,000 subscribers. So all of a sudden, by putting a statin in your product, you appeal to 20 times more physicians who can now prescribe you, because you put a robust statin in your fixed dose combination."
IMO this was the most positive discussion of the C.C...Not only will we have patent protection with inexpensive statin combined with Vascepa plus attractive margins for both the the consumer and for Amarin ,the combo can attain huge sales volumes worldwide and become standard of care for prevention of CVD...just as statin is now.
KM said that China approval will come in 2022...He previously stated it would occur in 2021.
"the applications for drug approval of VASCEPA were formally accepted by the National Medical Products Administration (NMPA) in Mainland China and the Department of Health in Hong Kong, stated James He, chief medical officer, Edding.Feb 9, 2021"
When will we hear from KM his take as to why this critically important China approval has been held up?...It will affect the volume of API purchases and the pricing of Vascepa.
raf...I interpret..."laid the foundation" to mean...doing the research to compose, manufacture, and commercialize a combo product.
It will eventually come to fruition, but not this year...It would go faster and better in the hands of a BP.
The regulatory aspect is not the problem...The incorporation of a solid pill into a gel is the main problem.
Amarin to Participate in Cowen 42nd Annual Health Care Conference
February 25, 2022 at 8:00 AM EST
These conferences seem to be followed by a downward move in Amarin price...Lets see if this one breaks the cycle.
Reasons for lower prices for Vascepa...
-pressure from generics
-pressure from Europe
-pressure from China
-pressure from high inventories
Fortunately Vascepa margins are high enough for Amarin to be able to lower prices and still grow profits...all the while reaching more patients and becoming increasingly well known and accepted...and eventually achieving a volume of sales, similar to that of statins.
Another advantage for Vascepa is that the are many different types of statins, but there is only one Vascepa.
From SA..."Vascepa will likely be approved in China by the end of 2021, based on several clinical studies confirming the efficacy and safety of this medicine."...
What's up with the delay?...Is price holding up the approval of Vascepa in China?...With over 100 million people in China able to profit from taking Vascepa...i.e. by having a reduction in CVD, Amarin can afford to negotiate a lower price for China.
ILT..."Can the same case be filed again with a different party who satisfies the "standing" smoke screen?"
I wondered the same...Rule 60 was never addressed by the recent panel...i.e. as far as we can tell from their rule 36 decision... which you have to assume,from hearing the oral arguments, was on the basis of standing alone.
Role 60 fraud was the crux of the case and was never seriously considered...I would love to see the case re-opened with Amarin as the plaintiff...although I suppose Denner would have to convince Amarin to take that tack.
The profits from selling Vascepa exclusively to the very high trig population are minimal...The reason for the Amarin lawsuit against Healthnet is to reduce profits for infringing players and increase their risks...Amarin can wait for a trial and even and for Healthnet appeals if Healthnet loses.
Amarin has definitely more invested in this case than Healthnet has...Amarin is much more interested in stopping infringement for CVD than in getting compensatory damages from anyone.
IMO Amarin should prove infringement by Healthnet and exact a price for their infringement.
The risk of infringement costs to the insurance companies(as opposed to profits) is the best way to discourage their future infringement.
The transcript of the Anchor Adcom must be available and should be acquired by Amarin for introduction into a court if needed.
In 2013, it was disheartening to hear the panel of cardiologists refuse to approve Vascepa for CVD.
The FDA also gave Vascepa a hard time during the R-IT Adcom before approving it for CVD by a vote of 16 to zero...We are going through the same test of fire in Europe now...even though the results of Vascepa, since approval, have been even more impressive than they were in the FDA approval in 2019.
Amarin must be under some kind of a "fish oil curse"
EPA-PURE would be a better name for the product than Vascepa.
ggw...Even Judge Du found the R-IT patents to be Non-obvious.
In the FDA Anchor Adcom in 2013, the panel of very distinguished cardiologists voted 11 to 2 NOT to approve Vascepa for CVD until more evidence could be shown...It was definitely not obvious to these POSA( people of skill in the art) until Reduce-It showed it to be effective.
The pharma landscape is filled with dinosaurs...There is no longer any chance for a guinea pig to avoid being trampled on.
If a guinea pig wishes to survive in this era, it needs to crawl into a dinosaur pouch.
-Eckman is a managing partner of Sofinnova
-Sofinnova recently divested itself of Amarin shares
-Eckman is also chairman of the board of Amarin
-Eckman needs to resign and be replaced by someone more committed to Amarin
With Amarin shares down over 80%, this is an urgent matter and should not have to wait for an annual meeting...A search for a replacement needs to be conducted without delay!
Amarin is a firm of interest to venture capitol investors, even if Eckman has decided otherwise.
North...This is a convincing case, illustrating that where a fraud has occurred, timeliness of appeal is less important...However, alleged lack of standing was the purported issue that lost us the EPADI appeal...It was Amarin's obvious legal responsibility to appeal this case....and they reneged on that duty...The shareholders were not uppermost in management's interests.
JRoon...The large volume/minute trades have been more on the buy side rather than on the sell side for the last few days...so your idea is interesting, but seems unlikely.
I believe there is accumulation going on.
Rose...If we were owned by Pfizer, they would have one hundred researchers already working to show that gV was not biosimilar to Vascepa.
Rose...There is a difference in the odor and color of gV that has been noted in recently purchased capsules, as opposed to odorless and clear Vascepa, so I assume that gV is NOT biosimilar to Vascepa right from the shelf.
We await studies by Dr. Mason to prove this is true.
Nissen is the kind of a guy, who disagrees with everything and everybody...He is,indeed, a disagreeable guy.
Marjac...Amarin's attempt to get Cert from SCOTUS was mainly based on the Graham Principles being improperly interpreted by Judge Du... The argument was laid out impressively by Singer...and still the SCOTUS denied Cert.
Errors in the Ninth circuit case include misunderstanding of the Graham principles, mistakes in Mori and Kura and fraudulent cropping of the Kura table.
If we couldn't convince Newman to reverse Du, what makes you think we can convince SCOTUS?....
Why not move on to more potentially productive pursuits, like e.g. lawsuits against Healthnet and Hikma for infringing and complaints to the FDA for approving gV, which does not have the Vascepa patented capsule to protect the EPA from being oxidized..The pure EPA is the reason for the reduction of CVD...People are wasting hundreds of millions of dollars on fish oils and now on gV and not getting the benefits they are paying for...We have a new chief at the FDA...He is a cardiologist and may be receptive to this.
I have been offered gV at my pharmacy and refused it, demanding Vascepa
Marjac...Amarin owes you for the work and energy you put into this case...They could repay you by creating a position for you on the board....You know what it means to be a retail investor and you understand our problems.
Unfortunately you would probably no longer be able to post on any board, but we would know that we had someone representing our interests on the board and speaking up for us....at this point, we retail investors feel we have no representative on the board.
You could be a vice-chairman in charge of investor relations and legal affairs....These are two areas where we, as retail investors, see the major need for improvement....You would still have an investor relations person and general counsel to do the detail work and consult with you....You would attend board meetings and give management a sense of where the shareholders are.
IMO the chances of being granted cert by the SCOTUS are near zero...The liberal judges like the idea of generic drugs and the conservative judges like the idea of not having courts swamped by shareholder lawsuits.
As for fraud or mistakes in handling evidence, the courts are more sensitive to to those factors in criminal cases than in civil cases.
Even if a Hickma attorney came forth at this point and admitted that he cropped the Kura table, I doubt the SCOTUS would grant cert...on the basis that it was obvious enough for the Amarin attorneys to pick it up...and, in fact, THEY SHOULD HAVE!...That's what Covington and Kennedy got paid the big bucks for.
And SCOTUS would also ask:...why didn't Amarin participate in the CAFC appeal?...This was the point that Dyk made that torpedoed EPADI's case.