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Amarin's downturn can be traced to its loss of patent protection in the U.S....Events have shown that Amarin can't depend on Europe....Amarin should return to a focus on the U.S....with patented MND-2119, replacing Vascepa...and a patented Fixed Dose Combo with a statin and MND-2119...if necessary, with a new U.S.-centric management....The JPM conference on January 10 would be a good opportunity for KM to discuss Amarin's plans for these new products....He has previously stated plans for these products would be announced in Q1of 2023...so now is the right time for this announcement.
Ns....QUOTE from the Jones Day legal analysis on the Amarin vs. Hikma case..."the court reiterated that generics are 'NOT required to include on their labels statements affirmatively discouraging use of a drug for patented indications that have otherwise been carved out of the generic's label."
While this is true, the analysis went on to state that the reason for the case being continued against Healthnet was the previous warning that Amarin had delivered to Healthnet about infringement of their CVD patents...plus the prior authorization that Hikma demanded before filling Vascepa Rx's at a lower tier(and cheaper price) than that assigned to Vascepa.
One reasonable resolution for this problem in the HW law would be for generics to include in their labels....'statements affirmatively discouraging use of a drug for patented indications that have otherwise been carved out of the generic's label.'
I hope that this was the basis for the recent agreement between Amarin and Healthnet...and that the rest of the insurance industry takes notice...If Hatch were still in the senate, he would be pushing for this just correction in the HW law.
North...Algae harvesting is real and can be put to use when the need for EPA explodes.
"HAVANA, Fla. (June 14, 2022) — Today, Northwest Florida Water Management District (NWFWMD) and the US EPA, in partnership with AECOM, UF/IFAS and May Nursery, demonstrated the progress and technology of an EPA 2021 Farmer to Farmer grant awarded project. The NWFWMD was awarded $959,754 for an ALGAE harvesting and biomass reuse project where unused nutrients from agricultural practices are captured and transformed into a biofertilizer to support sustainable nutrient reduction in agricultural runoff."
Amarin was the plaintiff and Healthnet, the defendant...It seemed like a particularly strong case for Amarin, which has been hurt significantly by infringement by Healthnet and others..I assume Amarin gained important concessions in the settlement.
Capt...Don't worry...If you die while taking Lovaza, fepblue will pay for Vascepa for your widow....This will prevent her from suing fepblue...and, if she does sue, they will pay the settlement out of the cash they saved by not paying originally for your Vascepa.
louie...D....Quote..."The Company is pleased with the outcome and believes entering into the Settlement Agreement will provide SIGNIFICANT VALUE in the market with payors."
This is a very upbeat statement from Amarin... I hope we investors will learn what made Amarin so confident about this when Denner takes over the BOD....right now, its such hush-hush good news, they can't tell us about it.
Another good news that Amarin is keeping hush-hush about is, when is Amarin releasing its plans for MND-2119.....Oh, we have to wait for that until sometime in Q1...no rush for that...its only something that could make or break Amarin....
Oh, by the way, where was Craig Granowitz, Amarin's science genius, when Mochida was developing MND-2119?
A study needs to be conducted to show that EPA, alone(without a statin) can yield the anti-inflammatory effects, which are the MOA for the effectiveness of the drug, in multiple acute and chronic diseases.
Bolio...Its my understanding that this is a derivative suit...As a stockholder, Marjac would definitely have an interest in Amarin.
Marjac...I support your efforts...You are doing what should have been done by Kennedy and Ekman after the legal malpractice of Covington at the ninth circuit trial....I hope that Denner will also aid your efforts.
Judge Du was inexperienced and naive...Covington was neither of these, but was glaringly inept...and Kennedy and Ekman chose to protect Covington rather than Amarin.
Ns...Partners have their own axes to grind...J.T. saw what happened with Amarin's failed KOWA partnership and now Amarin is witnessing a difficult situation in their ongoing relationship with Eddingfarm...i.e. in getting Vascepa approved by Chinese regulators...The difference in China is that you must have a partner if you want to have any chance of doing business there.
Lizzy...The monolithic CCP can bend in the face of massive resistance......They bent when the people came out in the streets to protest their draconian quarantine policies...Now they have hundreds of millions of people infected with Covid and millions dying from it.
Positive Mitigate results, which point to less deaths from Covid, may change their policy with respect to approving Vascepa.....perhaps the CCP could redirect some of their funds from building up their military might...to providing funds for the health care of their people.
We need more information about any Amarin plans for MND-2119...Thus far, management has been giving out vague minimal details on the subject, even as Mochida has already begun marketing this more convenient and more cost effective new form of EPA in Japan.
Vascepa has stalled in both the U.S. and in Europe...Its time for a new approach.
Lizzy and bird...Don't give up on China...With the huge outbreak of Covid presently occurring in China, the government may become receptive to the vital help that Vascepa could afford...especially if the Mitigate study illustrates the advantages that Vascepa offers to their Covid patients.
With the increase in volumes, Amarin could afford to lower their prices for Vascepa.
Pdude...Informed, scholarly posts, like those of yourself and others...by continuously reminding us of the many advantages of Vascepa, have made make the long, difficult journey of investing in Amarin, very worthwhile.
duke...If necessary Vascepa could be better sold OTC as a drug rather than as a DS. Prilosec is an example of a drug, which is now being sold OTC with the name, Omeprazole.
Prilosec and and Omeprazole sit adjacent to each other in the same display at Costco...with the Omeprazole at an about one third lower price than the Prilosec.
Duke...QUOTE..."Many here already take or have taken DS like Omega Via EPA 500. Fast nickels! IMHO."
When/if China approves sales of Vascepa for the mainland, it will a high volume-low price market...In that event, Amarin could issue an AG at first...and then, if sales take off and wholesale prices become lower due to increased sales volumes...I would agree that a DS would be a worthwhile consideration to encourage its use globally for most adults, even those with no CVD diagnosis.
Vascepa is like climate change...No one wants disasters in the future if we don't take care of environmental challenges now... but most governments are unwilling to pay currently for future benefits...Vascepa will save lives in two to five years from now...but regulators in national health programs in Europe and insurance companies in the U.S. are unwilling to spend currently for future benefits.
Rose...Fish burps are real undeniable evidence to patients, who are experiencing those unpleasant burps, that whatever the FDA says about gV being equivalent to Vascepa... gV and Vascepa are NOT the same and Amarin needs to call attention to that fact...to patients and Docs as well as to the FDA.
If the FDA does not deign to respond to Amarin's concerns, perhaps they might be more apt respond to patients' concerns.
No gV has been approved for reducing CVD....Amarin needs to get this information out to Docs.
One way to do this is to have an independent group run a randomized study of a group new patients, just starting Vascepa, and comparing that group to a group of patients just starting gV...to determine which group has more fish burping...When Vascepa proves to be superior in this study, Amarin can discuss the patented gelatin capsule as a reason for the decreased fish burping, presenting this information to Docs and reminding them that ONLY Vascepa has been approved by the FDA for reducing CVD...and that gV is NOT THE SAME as Vascepa.
The solution to the Vascepa four doses a day problem may lie with MND-2119 and a FDC with a statin(reducing five pills a day to one per day)...Thus far, we have not been made privy to any details about the Amarin agreement with Mochida, which would make such products practical for Amarin to produce and market worldwide...nor do we really know much about Amarin's intentions along this line.
We do know that MND-2119 can be marketed worldwide except in Japan...but we don't know whether Amarin would be on the hook for royalties to be paid to Mochida.
A problem for Amarin has been that Vascepa is TOO EFFECTIVE in reducing CVD for adults...An argument could be made that nearly ALL ADULTS (except those with arrythmias or bleeding tendencies) should be taking Vascepa...This would appear to very expensive to governments, which support national health care systems, especially during difficult financial periods....Of course, in the long run, cash paid out by governments for Vascepa would have to be spent in even larger amounts for hospital bills{not to mention those countrymen, who would die from avoidable CVD)
The logical solution to this conundrum is for such a safe and effective drug as Vascepa to be marketed to as large population as possible for as low a price as possible...In order to accomplish this, Amarin should....
-Put Vascepa in the hands of a large Pharma with multinational marketing abilities, that would...
-Market an authorized generic Vascepa in the U.S.
-Keep the price of Vascepa low worldwide
-Start to investigate sources of supply of API from other sources than just fish(e.g.algae)
sleven...The generic companies aren't infringing. They didn't know
-The Docs aren't infringing. They didn't know
-The pharmacies aren't infringing. They didn't know
-The insurance companies aren't infringing. They didn't know
-Hatch-Waxman weren't facilitating infringing. They didn't know
-Sam Bankman Fried wasn't embezzling. He didn't know
Amarin has the Healthnet fish on the hook....Now all they have to do is to reel it in!
I am surprised by the Amarin Agreement in principle" with Healthnet....IMO the Amarin case against Healthnet is "obvious" since Hickma certified that they were infringing through their PA's indicating use of gV for CVD ...and I will surprised and disappointed if Amarin does not get a good settlement.
As for the Dr. Reddy case, how can Dr. Reddy claim that Amarin is monopolizing supply when generics have 40% of the market?...This case should be thrown out.
KIWI...Thank you for your interesting perspectives...I have taken note of them and I will definitely keep them in mind.(especially if we have another chance in the case of Amarin) ....However, to quote Dew Diligence, a respected poster..."The efficient market hypothesis may be the foremost piece of BS promulgated in any area of human knowledge"
KIWI...QUOTE..."I always force myself to " sell the news " some of my position ..AMRN on R-IT approval , RXDX on their win and sell some.... no matter how much you love the Co and its product .....if it FALLS 20% BELOW its recent high"
I agree that this is a useful policy for vulnerable small pharmas...but would you also apply this strategy for well established big pharmas?(e.g. PFE)
Its an interesting question as to why Jason Marks, Amarin's general counsel, left after little more than a year on the job...to take a position with an obscure biotech??
-Was he uncomfortable with Amarin's present legal strategies?
-Was he uncomfortable with upper management in general?
- Was he disillusioned with progress in Europe?
- Did he disagree with the BOD's policies toward Denner?
Inflammatory disease in the brain is NOT the whole answer to Alzheimers Disease...but it may be lurking in the background, triggering the other factors that cause AD...I am optimistic that the Brave study, which will show whether slowing inflammation in the brain, by administering oral EPA in order to slow AD, will be successful.
Even though Brave is a small study, it is a thorough one and should it show a tendency for patients to be improved on Vascepa, IMO the FDA should approve this safe, relatively inexpensive drugs, with other larger confirmatory trials to be done afterwards.
KIWI...QUOTE..."he(JL) decided not to take the risk of a negative ruling even tho he thought chances of a -ve ruling were low ...and then sold the rest after the Judge Du ruling.
J.L. had a daughter, who was a lawyer, who understood the probability that the high triglyceride patent loss would result in generic skinny label infringement on Amarin's Vascepa CVD patent label...which scenario has unfortunately come to pass...and J.L. took her advice and sold.
J.T., then the CEO of Amarin, failed to take the necessary steps to defend Vascepa and was fired by Eckman, who also failed help with any plan to support Amarin ...resulting in Amarin falling to the position it is presently in...The rational for my holding my shares is because I feel that that Denner will soon take the necessary steps to restore either Vascepa (or MND2119) to its deserved status in the U.S. and the ROW as a companion of statins in the prevention and treatment of CVD.
Golf...A statin-EPA combo drug makes the most sense if it contains MND-2119 as the form of EPA...This may take over a year to develop and market... and it is another good reason for Amarin to be in the hands of a BP for developing it and marketing it in the U.S. and ROW
Also, Amarin or an acquiring BP could get FDA approval for MND-2119 before a combo drug is approved and it could replace branded Vascepa in the U.S. with branded MND-2119
Politco article on PFE on 12/9/222..."On Wednesday, a U.S. district judge dismissed tens of thousands of claims that Pfizer, along with GSK PLC (NYSE: GLC) and Sanofi SA (NASDAQ: SNY), pertaining to heartburn treatment Zantac, caused cancer. The judge ruled that the claims failed to show legitimate links between Zantac and several types of cancer, including bladder, gastrointestinal, esophageal, pancreatic and liver cancers. ....There are still more cases pending around the country, but Wednesday’s ruling means remaining litigation will occur in various state courts; the number of cases has dropped significantly.
Pfizer had more good news Wednesday. According to the company, the U.S. Food & Drug Administration accepted for priority review a Biologics License Application (BLA) for a respiratory syncytial virus (RSV) vaccine candidate submitted by Pfizer. The treatment should prevent respiratory tract disease caused by that particular virus in people ages 60 and older....
Priority review designation by the FDA cuts the standard BLA review time period by four months.
In a statement issued by Pfizer, Annaliesa Anderson, senior vice president and chief scientific officer of vaccine research and development, said, "With no RSV vaccines currently available, older adults remain at risk for RSV disease and potential severe outcomes, including serious respiratory symptoms, hospitalization, and in some cases, even death.”....
She noted that the FDA’s acceptance of the BLA for the company’s vaccine candidate is an important regulatory milestone."
Michael Kasanoff supported Amarin in its appeals of the ninth circuit decision with great expertise...He would be a superior general counsel for Amarin.
Large scale Infringement on Amarin's CVD patents is being facilitated by generic companies and insurance companies...This is due to flaws in the HW patent law, which will not be fixed by congress any time soon.
IMHO Amarin's best course of action is to concentrate its attention and cash on getting approval of new patented drugs, such as MND-2119 or a FDC with a statin and NMD-2119....and stop swimming against the tide with lawsuits, which are destined not to succeed...at least, not to succeed in a timely fashion to help Vascepa.
Lizzy, This is infringement on Amarin's CVD patents....pure and simple
Bolio...QUOTE..."It's another "does not help Alzheimer, only keeps you stable at the same level". We've had those for years."
We have a safe, relatively inexpensive drug(Vascepa), administered orally, which can keep AD stable and and can also potentially prevent AD from ever gaining a foothold in predisposed patients(like relatives of AD patients)...The Brave study at the U of Wisconsin is now attempting to successfully prove this...and the results of the study, which has been going on for five years, will be reported out within a year.
This was an invasive study with serial spinal fluid taps and IMO would have been already discontinued if there were no promising results along the way.
Lizzy...When the buyer establishes an open order to buy X amount of shares from his "go to guy" on the third market...and the price keeps changing upwards from the time the order was placed, at what price is the order finally executed at, between the "go to guy" firm and the buyer?
e.g.....If the "go to guy" is sitting on the bid and the bid keeps going WAY UP, beyond what the buyer originally intended to pay, is the buyer still committed to pay the total price for the open order?...TIA
Vascepa was NOT approved for CVD by the FDA until after a contentious and thorough Adcom was conducted by the FDA with well known cardiologists and Amarin attending ... After the hearing, the FDA then demanded that Amarin complete the very expensive R-IT study...Only upon the successful completion of the study, did the FDA drop its skepticism and approve Vascepa for CVD...and now HN is threatening to sue for invalidity of the CVD patents on the theory that Vascepa's success was "obvious" to a "person of skill in the art"?....That suit would be dead on arrival and should not be a bargaining chip for anyone in any other litigation.
The Amarin vs. Healthnet case points out a potential problem with the HW law...
Off label prescriptions are legal...However, where there are two or more indications for a drug in which one of the indications is patented, it is illegal to infringe on the patented indication...If there is evidence that an insurance company has knowledge that Vascepa is being used for the CVD indication and also the insurance company been using price or other means to induce infringement, there should be monetary penalties awarded to the drug company by the insurance company.
It can be clearly shown that Healthnet was guilty selling of generic Vascepa, which they knew was for the CVD indication from their own prior authorization requests and...in addition, they were selling it for a lower price than branded Vascepa.
If there is a settlement of the Amarin vs. Healthnet case, it should include monetary compensation.
An approval in China would mark a big change for Amarin...It would herald a drastic increase in the volume of sales for Vascepa and an equally drastic decease in price...After that, Vascepa might be replaced by an AG in addition to an eventual statin-MND2119 fixed dose combo for patients willing to pay extra for a once a day drug.
Topics that shareholders would like to be more informed about from Amarin Press releases...
-questions about a settlement with Healthnet
- questions about the need to pay royalties to Mochida for MND-2119 and if/when to apply for FDA approval of same
-questions about differences between the gelatin capsule and ingredients of Vascepa as opposed to gV