Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Nsleven..."KM said they were going to develop a combination pill.
It does certainly indicate product development or label expansion."
If the combo pill were 3 years off as KM said, perhaps Amarin is hiring people for MD2119, which could be marketed earlier.
Although the price for Vascepa of $175/month is below the current price in Germany(and in the U.S.), it is still a fair price...and should serve as a template for prices in other countries in Europe.
"a price of 1,640 SEK per month (equivalent of approximately 160 EUR or 175 USD per month)"
KIWI..."I think most in MITIGATE will be on statin therapy."
I'm hoping that those patients on Vascepa, but not on statins, will still experience a reduction in CVD and complications from Covid.
I have been on Vascepa plus heparin for 7 years...My cardiologist switched me from heparin to Eliquis about a year ago...I've never had a problem with bleeding.
There are no TOTALLY NEW inventions....Prehistoric Neanderthals used rocks to kill animals...Does that mean that guns and ammunition are not new inventions, unable to be patented due to the prior art being 'obvious' to Neanderthals of skill in the art?
KIWI...In addressing the value of Amarin, its partnership with Mochida and the prospects for Amarin to release a patented once daily EPA drug in the U.S. should be factored in....Its been over 8 months since Mochida filed for approval of MD2119 in Japan and they should hear soon... approval in Japan will be quickly followed by an Amarin request for U.S. approval, which should be a slam dunk.
"Mochida Pharmaceutical said on June 22,2021 that it has filed for the Japan approval of MND-2119, a once-daily soft capsule version of its high-purity ethyl icosapentate (EPA) agent Epadel (ethyl icosapentate)."
nsleven...I don't know what the FDA would require, for a once daily version of Vascepa, to get a CVD label."
nsleven...I would assume that the Jellis and R-IT studies provide sufficient data for the statin-MD2119 combo drug to be approved by the FDA for the CVD indication....The MD2119 is purified concentrated EPA.
The combo drug is truly biosimilar to statin plus Vascepa.
The FDA had no qualms about approving generic V as biosimilar....even though it has inferior capsulation, which allows for oxidization of the EPA in the gV drug.
Nsleven...IMO The best way to clear up this infringement mess is to market a patented, once daily statin-Vascepa combo drug.
If Amarin were owned by a BP, this project would have been expedited and taken place in little more than a year...just as work on vaccines was expedited.
Rose..."We know rosuvastatin became available as a generic in May 2016....And Amarin only entered an agreement with Mochida in June 2018"
The concentrated EPA drug(MD2119) by Mochida has only recently been produced and the statin-Vascepa combo can now being envisioned as a once daily drug...This patented drug could re-establish the U.S. market for Amarin's Vascepa.
The Amarin-Mochida agreement has not received enough weight on Wall St...Apparently, Mochida is better at research than Amarin.
Abe.."So it seems like they are still about Combo Pill aftr 9 years. What have they been doing between 2013 till now?
They have been waiting for Mochida to come along with the a concentrated, once a day EPA product...that can be used as a combo drug with a statin.
In the meantime, they oversaw the R-IT study and acquired 500 million dollars in assets to fund research.
Pfizer's Paxlovid cost to the U.S. government is about $530 per course...It would be interested to know what the Chinese government is paying for it.
I'm going to make a guess that its half of that or less.
Vascepa is a volume play rather than a price play...Amarin doesn't need to wait for negotiations with multiple European nations, which will inevitably lead to a lowering of Vascepa price in Europe...Amarin can take `take the initiative and lower its price for Vascepa in the U.S., in Europe, and in China and expand its market...and then start working seriously on other indications for Vascepa.
With an established market at lower prices, a once a day Vascepa and a combo statin-Vascepa will be readily accepted worldwide to make it one of the largest selling drugs of all time.
14:00 CET is equivalent to 2:00PM ET.
"Mochida Seeks Japan Approval of Once-Daily Epadel"....
Jun 23, 2021 — Japan's health ministry announced new NHI prices to be applied in April under the FY2022 drug price revision in the official gazette on March 4...
We should be hearing more about once daily EPA soon...when it starts selling in Japan.
Lizzy..." a good faith move would be for upper management to buy stock in the open market."
I agree...It is disheartening that none of the managers have deigned to spend their own cash to buy shares at these low prices.
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.