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Dead on correct. Sarissa is not stupid, and they are not in this to lose millions in their fund. This is not going to happen overnight, and for us very frustrated longs we will have to continue wandering in the desert. Hopefully, in the end patience will be rewarded.
The drug is that good and important.
Hmmm... I wonder if there is a safe drug that stabilizes lipids and trigs to prevent dementia? Sadly, everyone on this board and taking Vascepa will maintain their cognitive abilities to be forever frustrated with Amarin's share price.
https://www.medpagetoday.com/neurology/dementia/105338?xid=nl_mpt_DHE_2023-07-05&eun=g2071419d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=Daily%20Headlines%20Evenin
The Du decision was a pyrrhic victory for the generics. Currently they are executing their usual strategy for a developed market with the net result that multiple companies are literally fighting over the pharma equivalent of table scraps. Yes Amarin is holding its US 60% market share but in a market that is totally stagnant with near zero growth. I historically thought that the Reduce-it data and Evaporate data was so compelling that my colleagues would do the right thing for their patients and write the scripts regardless of the usual big pharma incentives and silly TV ads. I was wrong, and I severely underestimated charlatans like Nissen, Krumholz , and Herper who waged a successful disinformation campaign to destroy Vascepa. Amarin can be 100% faulted for doing nothing to counter them.
Amarin needs a strategic reboot that may include making a deal with one of the devils, namely Teva. Teva has the firepower to bury other generics and combined with Amarin they should be able to squeeze them on price for GV so that they are forced to leave the market. A well structured deal would preserve and potentially increase the US market, leaving ROW for further growth.
Unlike previous management, Sarissa has the ability to grasp Amarin's situation and negotiate a settlement that will will slowly increase SP. When that happens, they can have a realistic discussion about acquisition. Denner historically is very meticulous, anyone expecting fireworks now will be disappointed, but a 1-2 year horizon is a necessity given expiration of international protection.
Sarissa is not in the business of losing millions of dollars. The stock is now a binary that fully depends on them.
Some important points to remember about Teva:
1) They alone have a CV indication for GV in the US (skinny label not in play)
2) They are capable of competing with Hikma, Reddy, and Apotex
3) They have the resources to engage in a prolonged legal battle with the above and sue insurance companies that have prior authorization CV infringement (Health net litigation)
4) The have significant presence in the EU and know the environment and regulators.
5) They were reasonable in dealing with Amarin historically.
An Amarin/Teva alliance or even acquisition has benefits for both companies
Take this for what is worth. Sarissa knows what they are doing and their incentives are aligned with ours. Does anyone think that their 4th biggest position was initiated without a profitable exit plan? Obviously, AD opened up his rolodex and made some key calls to check the temperature of several BPs.
This is not going to play out in the next two weeks, but I will be surprised if in March 2025 Amarin is still independent.
As for the fate of KM and the old board members, they need to go if for no other reason than wasting $7.5 million on fighting nearly their entire share holder base. They did not just lose a little, they got crushed, and this was a resounding referendum on Amarin's overall strategy.
They could have worked constructively with Sarissa but fought them at every step. Another strategic debacle that makes current management unfit to continue in their current roles.
Which is exactly what Sarissa is threatening. No member of the BOD will want this legal action impugning their reputations going forward.
AD is playing hardball, and we will likely see much of current management head to the exits now that they squeezed every last cent.
Reading between the lines of this PR from Sarissa 1) We won, and we know by tracking blue cards "sitting on a powder keg." 2) We are going to clean house including the current BOD and KM. "Breach in fiduciary responsibility" "personally responsible". Bottom line: You can resign now and save your reputation, or lawyer up bitch on your dime....your call.
It does beg the question of why the CFO and Chief Counsel resigned when it became obvious that Denner will get a very good look at Amarin's skeletons in the closet.
Honesty and transparency has not exactly been KM's and the BOD modus operandi. What company spends $7 million fighting their own share holders? They could have worked with Sarissa to save the Company and increase the SP, but instead choose to go full General Pickett with our money.
Why?
Amarin's depressed SP and pathetic 35% institutional ownership is a direct reflection of Wall Street's total lack of faith in KM and the BOD. In the past six months Amarin's Chief legal counsel and CFO have resigned (never a good sign). Clearly they lacked faith as well.
For those voting white do you honestly think that based on past performance the Street will suddenly alter its universal disdain for Amarin that has made it one of the most hated names in biotech? We have no future revenue guidance and the European roll out has been an abject failure with zero significant revenue. How is that changing?
Sarissa has a very difficult hole to get out of, but at least Alex Denner recognizes that a new strategy is necessary to begin to unlock the full potential of Vascepa. That strategy does not involve eliminating the US. GIA under the current management guarantees that Amarin becomes a zombie biotech despite having one of the most important and efficacious drugs to emerge in the past decade.
Like many here , if Sarissa fails, I certainly will move on rather than provide a charity for KM's exorbitant salary and the current BOD pay for lack of performance compensation.
It will be interesting to see what the SP discount for incompetent management is for AMRN. When that tide finally turns we should be back at 4-5. That was before KM's epic fail where he managed to convince the Street that dilution was imminent, the US abandoned, and showed no real plan for Europe.
I suspect there are very few on ihub who support management, but assuming this is an investment and not an ongoing charity for BOD and management, can anyone say that the Street will ever have confidence in this team given the unprecedented dismal execution of the past 5 years? The current SP is not a reflection on Amarin's one stellar asset, but a clear and resounding referendum on the company's governance.
KM was brought in as European specialist, how much money was burned in Germany and in 2023 he still can't even give any guidance? Negotiating Europe for Merck is very different when you have an entire portfolio of drugs to do give and take, giving you leverage. Amarin has one drug, that almost nobody has heard of and patients are not exactly demanding. Ancient history, but I believe JT even said that Amarin would never try to do Europe alone. He got that one correct.
Sarissa has their work cut out for them, but at least they have an actual track record of creating share holder value.
CBB, the fact of the matter is retail ownership is somewhat meaningless in Sarissa's overall strategy. Denner played this perfectly, he waited until tax selling depressed the price, and now we are seeing institutional money pushing up the SP and accumulating shares. He had his soldiers prepped for the proxy war which he would not have initiated if he was not near certain he would win. I was amused that he dropped the hammer at JPM when the entire biotech investment community is fully tuned in.
At this point we are spectators, and Amarin's SP is in Sarissa's hands. Positive Mitigate results will certainly be helpful, but Amarin has nasty way of squandering great clinical data. Years of mineral oil idiocy has created so much FUD in cardiology that nobody actually prescribes the drug. Pfizer would have crushed Nissen/Krumholz long ago.
To see the alternative universe just look north to Canada. Rather than do some version of the HLS/Pfizer deal Amarin's management has allowed the drug to wither on the vine in the US. Karim said US sales have stabilized. Not true, especially with major insurance Co's dropping Vascepa coverage. The silent settlement with HN appears to be useless so far.
Amarin's management and BOD deserves the red wedding that Sarissa has waiting for them.
That business reality is exactly why a real CEO and BOD would have come to a mutually beneficial agreement after the Du debacle. That can still happen, but it will require Sarissa to gut Amarin's pathetic management and think outside the box.
Denner's team can do so or find a pharma that is willing.
Denner/Sarissa are beginning to move and gathering support . Sleven, here is the Sarissa connection:
Simos Simeonidis, PhD, MBA
co-CEO and co-CIO, Managing Partner of Ally Bridge Group (ABG) President and Portfolio Manager of ABG Public Equity Strategy was a partner at Sarissa for four years. Google or see Linked in.
Safe to say this is Alex Denner at work.
Mitigate question: Will the trial be able to answer the question of MACE risk reduction over the six months following COVID infection? Since the trial was initiated, we have new data that clearly says: 1) Everyone is at far greater risk for a major CV event in the six months after COVID infection. Including young patients with no CV risk.
2) From AHA last weekend we now know that anticoagulation, which is the biggest gun in the prevention of CV events, made no difference in decreasing these events.
https://www.medpagetoday.com/meetingcoverage/aha/101639
That leaves us with nothing as far as I know. If Xeralto failed, aspirin will almost certainly fail as well. I suspect that the Mitigate results will be similar to the smoking study that showed pure EPA took smokers back to the risk of nonsmokers for major vascular events.
If Mitigate matches this result and normalizes events, it will be a big deal and should change standard of care post-COVID. This in addition to addressing long COVID which is characterized by microvascular damage and chronic coagulation abnormalities.
My letter to STAT News:
I am sure that STAT will agree that the integrity and credibility of any publication depends on issuing a correction when data proves past articles to be in error. In the case of of Amarin's drug Vascepa, there have been no less than 10 articles in 4 years that have questioned this life saving treatment for CV event prevention and argued that the results seen in Reduce-It, that led to its FDA approval, were an artifact of its mineral oil placebo.
We now have definitive confirmation that the drug is indeed effective in decreasing CV risk and the mineral oil hypothesis was the creation of a disgruntled aging academic, embarrassed by leading a failed competing trial.
Without a correction, STAT is fully complicit with a campaign of fear and doubt that has repeatedly discredited pure EPA and limited its adoption for CV patients. It is not hyperbole to suggest that this has cost lives. Pure EPA may have treatment indications that include COVID-19, oncology, and ALZs, so it is imperative that STAT now end spreading disinformation and publish a factual article on the results of Respect-EPA presented at AHA last week. If Mr. Herper is incapable of being objective, I suggest you assign another reporter to do the research and write the story.
Discussant of the study at the Late Breaking Clinical Trials session, Pam R. Taub, MD, professor of medicine at the University of California San Diego School of Medicine, said, "Despite being underpowered with a sample size of 2460, RESPECT-EPA shows benefit in decreasing composite coronary events."
"There is benefit with EPA, but the magnitude of benefit is uncertain," she stated.
Taub pointed out that there is a signal across studies for new-onset atrial fibrillation, but the absolute increase is "rather small."
She noted that more mechanistic and clinical data are needed to hone in on which patients will derive the most benefit, such as those with elevated high-sensitivity C-reactive protein or highest change in EPA levels. But she concluded that in clinical practice, physicians could consider addition of EPA for reduction of residual risk in secondary prevention patients.
Two points stand out in my mind:
1) There simply is no way now to argue that Reduce-it's efficacy was an artifact of the mineral oil placebo.
2) Pure EPA is clearly efficacious for major CVA risk reduction beyond statins, and can do so with minimal side effects.
Denner now knows with certainty that the science is fully de-risked and can approach BP with that knowledge. Amarin's SP is now directly dependent on Sarissa's actions as management has shown no ability to execute or even defend the SP from made up nonsense like M.O.
For those waiting for an institutional buying signal, I suspect they will begin harvesting shares when retail dumps for tax selling in the coming month.
Wishing her a speedy recovery. I would keep her on Vascepa for the next three months though. The literature is very clear that this is a critical period for thrombolic events including pulmonary embolism, strokes, and MI's.
Covid/Long Covid is a disease of blood vessels and clotting dysfunction. Vascepa addresses these issues.
Maybe we will one day have a company that is capable of running a RCT to prove it.
If you look at Sarissa's positions they are extremely methodical and do their homework on the science. At this point the fate of our investment is in Dr Denner's capable hands. This will not be quick and given the tax loss harvesting that will begin next month, I doubt we see institutions begin to accumulate now.
Sarissa did not jump into this blindly, they have undoubtedly had conversations with BP and allied institutions. They also know they have the votes to execute their strategy.
The chess game begins and Amarin's inept BOD and inexperienced CEO are about to get schooled. In six months management will look very different.
Killing MO idiocy with the smoking study. I think there is potentially a significant finding buried in Bhatt's study. Instead of comparing the smoking group to placebo, compare it to a matched cohort of nonsmokers who were taking Vascepa. Smoking now is the only variable. If the unquestioned increase in smoking related CV events is again significantly negated, it can only be explained by the efficacy of Icosapent Ethyl and not that the placebo group was made more susceptible.
RTC purists will argue that using a historical control is not acceptable. However, the numbers are very large in the Vascepa treated cohorts, and CV risk associated with smoking has been studied endlessly and has widespread acceptance.
Thoughts?
I can't comment on the FDA /legal complexities of the new formulation. But like Ziploc, I am 100% certain that this will be huge for patient compliance and adoption. Amarin has numbers about patients discontinuing Vascepa and it is certainly an issue. These patients are on multiple pills daily and anything that gets rid of four horse pills will be a significant net positive.
Combine this with a Statin, and that really could be a block buster.
This is really bad and frightening. Long COVID patients lose approximately 40% of their capillary capacity.
🚨 Absolutely stunning #LongCovid findings:
— charlos (@loscharlos) August 11, 2022
"Compared with healthy controls, the capillary density of #LongCovid patients was decreased by 41%"
"Our data strongly suggest that COVID leaves persistent capillary rarefication even 18 months after infection" https://t.co/f8BmW0EJ9k
This would be another huge indication for Vascepa. Not a difficult pilot study to run, and all you would have to look at is the photographic progression of macular degeneration. Meanwhile in addition to preventing these patients from going blind, you also avert serious CVD events.
https://www.medpagetoday.com/meetingcoverage/asrsvideopearls/100153
Revisiting biomarkers in Cardiolink-9. Read slides at end.
https://www.acc.org/-/media/clinical/pdf-files/approved-pdfs/2020/12/14/15/55/vascepa-covid-19-nla-slides.pdf
Vascepa MOA COVID
How does Covid heighten the risk of clotting?https://t.co/WT96lC9dyB@NatRevImmunol @emconway99 @JHMorrissey pic.twitter.com/DkXwSpUbRB
— Eric Topol (@EricTopol) August 10, 2022
Just superb.
Might as well start drafting the gentle “ I told you so” for when Mitigate hits. Hopefully that gets this into the NYT, WSJ and other major outlets.
My condolences for your loss Capt. So senseless and sickening. I can't imagine what your family is going through.
The real damage that Nissen/Krumholz do is that for community cardiologists they do not see Vascepa as now standard of care, given these big academic guns have raised doubts about the legitimacy of Reduce-it.
These docs are Amarin's bread and butter and they are not writing the Rx's.
I think Mitigate will read out positive. Like Reduce-it we have several leading indicators. Cardio-Link 9, and a recent paper on success in several long Covid patients. COVID is a vascular disease and unquestionably has a significant associated coagulopathy. (remember COVID toes?). It is also not in dispute that survivors are at increased risk of a major vascular event post COVID for up to six months.
Vascepa is a mild blood thinner and that alone could drive a positive result. Add in its endothelial cell protection and I think you will see the Reduce-it results replicated or exceeded.
So then what happens? Does STAT news, Nissen, Krumholz finally fall on their swords? Somehow I doubt it. Will Vascepa become SOC for post-COVID? Does BP wake up and now take notice? Sarissa gets into the game?
Mitigate is a seismic event that like Reduce-it may radically change Amarin's fortunes.
One can hope that Vascepa's real efficacy finally wins the day.
I actually was not suggesting it was them. They are a multi-billion industry that should be the real target here for ethical journalists as their product is useless or even harmful for the millions who take it. Why the FDA has not acted is beyond me.
My point was Amarin's sales are a rounding error compared to them, yet the company always seems to be on the receiving end of awful press. If Nissen, Herper, Krumholz etc really cared about patients they would actually take the fish oil industry to task for peddling snake oil.
I have no idea if the past month is just coincidence, but for a small biotech that has minimal sales it sure manages to be lightning rod for hit pieces that consistently kill the SP.
Someone called the Atlantic with an agenda. They did not just stumble on this story.
I am not one for conspiracy theories but the forces that have conspired to destroy and discredit Vascepa are clearly winning. In the last month we have had negative press in the following: The Atlantic, two Stat articles, a tik tok video from the head of cardiology at Yale. Negative Tweets from other B list academic cardiologists. Etc. what is next, the National Enquirer?
As all of us know all too well, Amarin is a tiny player that barely has any market share. This compared to the fish oil industry that is several billion dollars and has zero data to say their product actually works, and more likely is causing real harm.
So who whispered in the ear of the Atlantic that this is a legitimately important story?
Amarin is vital to the stake holders on this board but the amount of attention suddenly on the company and the reemergence of MO has someone's fingerprints on it.
Who and why?
For those interested on what is possible:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5433516/
The NIH could do this as well.
Data mine the Medicare or Kaiser data base.
I think we are all agreed that Amarin is no financial position to run another clinical study. The one interesting point from the Atlantic article was the mention of a possible future NIH study, which unsurprisingly the academic cardiology world favors. Draw your own conclusions as to the motivation.
A road that Amarin has not considered is to look at gross patient data since Reduce-it. Yes, this is not the gold standard RCT, but the numbers would be huge and that washes out many confounding factors. All it would take is small team of biostatisticians. Care would be needed to compare apples to apples, as I bet the patients on Vascepa are sicker, but that is certainly doable.
I despise electronic medical records, but supporters of these systems are correct that the data they contain is pure gold.
ALZ's studies are among the most fraught in all of biotech. The trash heap of failed drugs is huge and any "success" will be dissected endlessly. Kiwi is correct that the best conclusion will be further study needed. These trials are incredibly difficult, ask Biogen. Focus on CV, that indication is big enough if the company can actually execute.
The only consistent factor throughout Amarin's pathetic history has been the 100% success of EPA in all clinical trials big and small.
Dr. Denner would not touch this if he had any doubt about the science. Sarissa has very few positions and they would not invest if they thought Reduce-it was a statistical artifact.
If Mitigate and Respect are well designed they will be confirmatory. I think Kaiser already saw the signal in their vast electronic medical records, and that is why they initiated Mitigate. COVID is a vascular disease, and Vascepa will emerge a viable treatment that should be standard of care.
The drug works. The company, not so much.
If only we had a safe drug to address this problem and save lives.....
https://www.nature.com/articles/d41586-022-02074-3
Kaiser is extremely data driven. It would not be difficult for them to mine their electronic medical records, which is uniform throughout the kaiser system, to get a rough idea of Vascepa's efficacy.
I believe Kaiser already has this data, and it was one of the factors that prompted Mitigate. Just conjecture, and Kiwi would know better.
Fish oil lobby at work?
The coordinated hit on Amarin is unlikely at this point to be short selling hedge funds. Stock is just too low. I would love to know who is paying Herper's greek chorus of academic MD's. Always the same names who when Mitigate is positive will just stay silent or invent a new issue.
Nothing happens until Mitigate comes out. Denner will also likely not act until after earnings.
No buyers until those events unfold and an easy target for FUD nonsense like a biomarker study to drop the stock 20%.
Long COVID and Vascepa
Hmmm...if only there was a drug that protected endothelial cells and vessel walls. This mechanism is probably at work in ALZ and many other diseases. BP just can't be this stupid not to see the big picture.
https://www.healthrising.org/blog/2022/07/16/endothelial-cells-brain-inflammation-long-covid/