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Good point. It's a shame when we have to rely on another company's CEO to be forthcoming than our own. It is what it is.
Thanks. This the Exhibit A that AMRN needs help selling/promoting Vascepa.
Will be interesting to hear what KM has to say on the earnings call. If it's more of the same, I will reevaluate if I stick around.
makes a lowball buyout offer more acceptable to shareholders....
shareholders are fed up with the low stock price. will be quick to agree to something in the teens.....
just my opinion
The $5 pin has Goldman Sachs written all over it. Would not be shocked if Goldman bankers are the ones advising Pfizer.
Certainly management's silence helps too.
Excellent point.
that's when JT was the CEO. what pie in the sky number was he asking for....
boy did he do us a disservice. smh
Also keep in mind deals take 4 to 6 months to close.....It's not like when a company is acquired you hand over keys to the acquirer the next day. Deals take months to close.
Again regulatory clock in Europe has started this past March......
Time is elapsing.
Timing of when Pfizer could approach Amarin is an interesting question....
What is the hold up now...?
By March of next year we are already looking at one year of exclusivity in Europe gone. One would think having years of exclusivity is important.....in essence the sooner this is in the hands of BP more value could be maximized.....but we are dealing with Amarin's management and BOD. Do they see the same thing.
Too bad we don't have an activist like Icahn to speak for shareholders.
Back to the $10s.....we hit $14 and now back here we are.
Waiting on the next catalyst or perhaps research published....
LBL--anyone heard from larrybirdlegend ?
Apotex---does anyone recall the settlement with them? Were they granted rights to sell under the CV label if we lost the appeal?
They have not launched yet so maybe they are not interested.
Thoughts?
Agree. If this case is not dismissed, I'm not certain Hikma would want to continue because of the potential for damages and we haven't even discussed discovery. Who knows what would turn up in discovery (emails, etc.). Even if Dr. Reddy's is not party to this suit they would likely come to the same conclusion. For the insurance companies I could see them not wanting to be bothered with the games of covering the generic for this one drug Vascepa because this is opening up too many cans of worms.
btw: I encourage everyone to reread pages 81 - 83 where Kane drives home the point how HealthNet is actively participating /inducing infringement by requiring doctors to get a prior authorization and then still paying for the generic. He closed out with a banger. The generic is not covered for that indication (CV risk)....HealthNet got caught here by preferring the generic over Vascepa.
From Kane:
That's why they're inducing infringement. They're confirming that it's being used for CV risk reduction. They're making the doctor prove it's being used for CV risk reduction, and then they're using -- they're paying at a preferred rate to encourage the generic use for that infringing use. That's inducement.
So if the case survives....Hikma may just pick up its ball and go home (exit this market) because there is too much to lose.
That's why they are fighting so hard to get the case dismissed.
The problem is there is a case called GSK v. Teva that has provided Judge Andrews with a roadmap.
Hikma likely didn't see the GSK v. Teva case coming. And then of course Hikma's own actions with their label and website have not helped either.
I really think these sides (Hikma & Amarin) hate each other and it has become personal or at least it was when JT was at the helm.
Got it. I think he sees that someone is infringing here.
He is the judge and not the trier of fact here since this is a jury trial so one would think he would want to let it proceed to let a jury decide if there is enough to merit infringement as opposed to putting himself in the seat of the jury at this early stage. Doing so, he would be denying Amarin its day in court.
How do we reconcile this with the current $5 pin of us at this constant $5 stock price level.
Surely these hedge funds have lawyers at their disposal who must have read this transcript too.
Who is keeping us pinned at this level?
Yet continued silence from management.
Interesting tidbit from the judge: page 77
THE COURT: But, you know, I mean part of the reason -- well, you know, it's a strange situation, and again, one that I don't really think Congress had intended or, you know, the law intended when it was passed, that the way the system is set up, you're going to have doctors prescribing the generic for these methods. And you know, I just listened for a long time on the generic's not responsible, and you're saying you're not responsible, and so I think, in fact, there is going to be, you know, a significant amount of use of the generic drug to perform the patented method. And essentially everyone is saying nobody's responsible. Well, that seems to me -- maybe that's the way it is, but it seems to me to be not what was intended. I mean, the point of the law was intended to allow them to exercise, including, you know, not in returns on their branded drug for their -- you know, for their -- for the CV use.
Thanks so much.
Thanks. Curious to hear your thoughts on this once you have a chance to review it.
Can you repaste the link?
Could you skip to the end or close to it to try to glean the way the judge is leaning with his questions?
Oh the irony.....JT needing KM to create value for him/his shares since he couldn't do it himself.
You can't make this stuff up.
So is KM stupid? Is our Board stupid? Are the Baker Brothers stupid?
Large hedge funds have a direct line to the CEO.
Our commercials have not aired for a long time.
They all must see what we see.
We understand this. But does Karim and our Board? Send your message to him and the Board.
I'm convinced you can trade around a small core of your holdings. Sell when it hits the highs and come back later and repurchase.
Like clockwork.
Today would have been a great day for Amarin to generate free publicity on top of this aspirin news about heart attacks and strokes.
I mean we have the reduce-it data.
But nothing. Smh.
I wonder if Amarin management even saw the aspirin news today?
It’s been on all the major networks this evening.
Just saw on CNN Anderson Cooper and Dr. Gupta discussing aspirin and heart attacks and stroke. Not one word about Vascepa. The public by and large is still in the dark with respect to Vascepa. If there was ever a day, Vascepa should have been mentioned…today was that day.
https://www.google.com/amp/s/www.nytimes.com/2021/10/12/health/aspirin-heart-attack-stroke.amp.html
This is fascinating. On Sept. 21st 3 days before the article appeared in Bloomberg volume and price picked up significantly. The deal "leaked" somehow or folks on the Street were in the know.....
Thanks for sharing. I pasted the article below so others could see. The CEO acted in the best interests of shareholders. Let's hope Karim does the same and does not get greedy like the former CEO.
You could see something like that happening with us to get the stock price out of the $5s.....leak of a potential deal....I imagine we would start moving up quickly.
Inside the deal: As leaked details goosed its stock, Acceleron's CEO pumped Merck for more cash
Kyle Blankenship
Managing Editor
As leaked details of its potential merger with Merck were splashed across the internet, Acceleron behind the scenes used newfound interest from investors and a last-minute Hail Mary from an unnamed suitor to ply the drug giant for an even more pricey buyout, according to a play-by-play of the deal in an SEC filing.
After weeks of negotiation, Merck late last month agreed to acquire Acceleron and its lead rare cardiovascular disease drug sotatercept for $11.5 billion, confirming days of leaked details on the companies’ negotiations.
Those earliest reports began swirling on Sept. 24, the day Bloomberg published an article announcing Acceleron was in “advanced talks” for a buyout. The Wall Street Journal followed that news up days later with a report confirming Merck as the top bidder in those negotiations.
Rob Davis
On the heels of that reporting — and as the company’s stock was ticking up — Acceleron CEO Habib Dable reached out to Merck CEO Rob Davis on Sept. 28 to talk about “the market reaction to rumors regarding the proposed transaction,” according to Merck’s version of events, and asked Merck to up its offer of $180 per share. Davis declined to move on the price, and the partners signed the paperwork the following day.
It’s an odd bit of gamesmanship on Acceleron’s part and paints a picture that Acceleron looked to leverage leaked information to drive up its share price in anticipation of a deal. But in Acceleron’s telling of the story, a last-minute push from another potential partner could have perked the biotech’s ears on a potential bidding war. On Sept. 24, that suitor — dubbed “Party B” in the filing — reached out to Acceleron to express its interest in a buyout and discuss terms.
But just days later, on Sept. 28, the same day Dable asked Merck to up its offer, Party B backed out of the race, saying it “could not be competitive with the price that was speculated in the market and was unwilling to make the regulatory clearance commitment the Company’s financial advisors had indicated would be required,” Acceleron said.
That left Acceleron with Merck, a company with a new CEO and CSO looking to make a splash. Sotatercept could prove just the ticket as a potential blockbuster in the making with winning Phase II data in pulmonary arterial hypertension, or PAH, a rare CV disease.
Sunil Patel
Merck initially reached out to Acceleron in July to inquire about potential partnerships, but Dable made clear early that Acceleron wasn’t interested in out-licensing deals. Sunil Patel, Merck’s head of corporate development, locked down a meeting on July 19 during which he notified Acceleron that Merck planned to submit an offer of $160 per share to buy the biotech outright.
There was only one other company in the mix — “Party A,” or Bristol Myers Squibb. Bristol Myers turned down discussions on an acquisition but did propose another arrangement with Acceleron, which it partnered with on both sotatercept and anemia drug Reblozyl. The drug giant offered to waive all royalty rights Acceleron would owe if sotatercept was approved in return for waiving its own royalty rights to Reblozyl sales.
Acceleron mulled the offer over before determining “that the proposal, taking into account the significant tax obligation it would create, would not deliver value to the Company, increased the risk profile of the Company by reducing the diversification of its revenue opportunities and was not in the best interests of stockholders.”
I just cannot fathom that Pfizer would be that naive or lack the requisite knowledge regarding how well Vascepa would fit with Pfizer's portfolio.
This is Pfizer we are talking about not some small pharma company.
The CFO indicated it speaks to the science behind Vascepa. This tells me Pfizer understands the science and if they understand the science then they understand the commercial opportunity.
Agree and worth listening to the CFO around the 38 / 39 minute mark.
Said Pfizer is experienced with prescribing audience of Vascepa and it speaks strongly about science behind Vascepa and importance of drug clinically.
Provides validation of commercial opportunity of the product / Vascepa.
Thanks for posting. It's refreshing to hear how transparent the HLS CEO is with respect to the Pfizer partnership.
Meanwhile with AMRN it's always a guess to figure out what's truly going on.
$5 ping. Who would have guessed it? LOL
This is groundhog day and oh what do you know also happens to be Goldman's price target $5. Just a coincidence huh?
When it's all said and done.....I would not be surprised to find out Goldman was the financial advisor to the big pharma that buys Amarin out.
And there is supposed to be a Chinese Wall between Investment Banking and Equity Research.......
Wall Street is still Wall Street.
Can't wait to see how this all plays out.....
Larrybirdlegend.....talk to us.....morale seems to be at an all time low. Stock is sub $5 and we are in Q4. What do your spidey senses tell you?
So where do you see the stock going? Is this bullish?
When do you plan on lightening? $25....$30....?
Good thing is you can buy now and still sell half at $20 and pretty much be playing with house money.
Unlike JT hopefully the new CEO understands that maybe one can accomplish more with a BP than so called "forces" erecting road blocks each and every way: bad press, fish oil moniker, Nissen, etc.
So it appears from Raf's earlier posts, the parties will have 10 minutes for oral arguments. And the Magistrate Judge has already recommended that the motion to dismiss be denied. I imagine the magistrate judge would have spent more time on this case than the sitting judge and given the high bar for a motion to dismiss...I would think the sitting judge would defer to the magistrate judge's opinion.
Just my two cents....
Why Merck's covid pill could be riskier than people think---from Barron's.
Why Merck’s Celebrated Covid Pill Could Be Riskier Than People Think
By Josh Nathan-Kazis
Updated Oct. 5, 2021 8:50 am ET / Original Oct. 5, 2021 4:30 am ET
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Merck's Covid-19 antiviral pill molnupiravir
Merck ‘s announcement that its antiviral molnupiravir had halved hospitalizations in a trial of high-risk Covid-19 patients was met with enthusiasm on Friday, inspiring a vision of a world in which treating a Covid-19 infection could be as trivial as swallowing a few pills.
Some scientists who have studied the drug warn, however, that the method it uses to kill the virus that causes Covid-19 carries potential dangers that could limit the drug’s usefulness.
Molnupiravir works by incorporating itself into the genetic material of the virus, and then causing a huge number of mutations as the virus replicates, effectively killing it. In some lab tests, the drug has also shown the ability to integrate into the genetic material of mammalian cells, causing mutations as those cells replicate.
If that were to happen in the cells of a patient being treated with molnupiravir, it could theoretically lead to cancer or birth defects.
Merck (ticker: MRK) says it has run extensive tests in animals that show that this isn’t an issue. “The totality of the data from these studies indicates that molnupiravir is not mutagenic or genotoxic in in-vivo mammalian systems,” a Merck spokesperson said.
read more
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Pfizer’s Vaccine Loses Effectiveness Against Infection Over Time
Scientists who have studied NHC, the compound that molnupiravir creates in the body after it is ingested, however, say that Merck needs to be careful.
“Proceed with caution and at your own peril,” wrote Raymond Schinazi, a professor of pediatrics and the director of the division of biochemical pharmacology at the Emory University School of Medicine, who has studied NHC for decades, in an email to Barron’s.
Scientists are split on how serious a risk this is, and in the absence of detailed data on Merck’s animal tests, and long-term human safety data, it’s difficult to know for sure.
The safety concerns suggest that the stock market’s reaction to the positive molnupiravir data on Friday might have been overblown. Shares of Merck jumped 8.4% Friday, while shares of Covid-19 vaccine maker Moderna (MNRA) fell 11.4%, and shares of Regeneron Pharmaceuticals (REGN), which developed one of the leading monoclonal antibodies for Covid-19, fell 5.7%. Vir Biotechnology (VIR), which developed another of the monoclonal antibodies in partnership with GlaxoSmithKline (GSK), was down 21.1%.
“It was sort of, in effect, wishful thinking,” says SVB Leerink analyst Dr. Geoffrey Porges of investors’ reactions on Friday.
Investors saw Merck’s pill as a pandemic panacea that would sit in everyone’s medicine cabinet, he says, adding, “that’s just not going to be the case with this drug.”
Porges says that when the Food and Drug Administration authorizes molnupiravir, he expects regulators to impose severe limitations on who can use it. The agency, he says, will have difficult questions to answer about what conditions to put on access for people who may become pregnant. “I think it is effectively going to be a controlled substance,” he says.
Porges later clarified his comment, saying that he expects that distribution and access to molnupiravir will be limited, not that it will be treated as a “controlled substance” under U.S. law, as are some addictive and illicit drugs.
Molnupiravir came to Merck through a partnership with a private firm called Ridgeback Biotherapeutics, which licensed the drug from a not-for-profit biotech concern owned by Emory University. Molnupiravir is what’s known as a prodrug, which metabolizes in the body to create NHC, which has been studied for decades.
Schinazi, who is a professor at Emory but did not work on molnupiravir, has a long history with NHC, and has written a number of papers on the compound. He was a founder of the biotech Pharmasset, which he says considered developing NHC as a treatment for hepatitis C in 2003, but chose not to because of the risk that it could cause mutations. Pharmasset created the hepatitis C drug Sovaldi, and Gilead Sciences (GILD) eventually bought the company for $11 billion.
Schinazi told Barron’s that he did not believe that molnupiravir should be given to pregnant women, or to young people of reproductive age, until more data is available. Merck’s trials of molnupiravir have excluded pregnant women; the scientists running the trial asked male participants to “abstain from heterosexual intercourse” while taking the drug, according to the federal government website that tracks clinical trials.
A paper published in the Journal of Infectious Diseases in May by Schinazi and scientists at the University of North Carolina reported that NHC caused mutations in animal cell cultures in a lab test designed to detect such mutations.
“The risks for the host may not be zero,” the authors concluded. “Evaluating the utility of this drug should be done in those likely to receive the greatest benefit, with monitoring provided to assess potential long-term genotoxic side effects.”
One of the paper’s authors, Dr. Shuntai Zhou, a scientist at the Swanstrom Lab at UNC, said that he and his colleagues had flagged their initial findings to Merck in July 2020, roughly a year before his paper was published.
“There is a concern that this will cause long-term mutation effects, even cancer,” Zhou says.
Zhou says that he is certain that the drug will integrate itself into the DNA of mammalian hosts. “Biochemistry won’t lie,” he says. “This drug will be incorporated in the DNA.”
What impact it will have when it’s there is unknown, given the various systems human cells use to limit the impact of mutations.
Merck scientists responded to the UNC paper in a subsequent issue of the Journal of Infectious Disease, saying that their tests of molnupiravir in animals had not found higher mutation rates. The Merck scientists also took issue with details of the UNC authors’ methods. In a reply, the UNC scientists stood by their methods, and wrote that they believed that molnupiravir should only be used in people at high risk of serious illness from Covid-19 until its long-term risks are better understood.
Some experts have advised caution on the part of Merck and regulators.
“Given the possibility that the drug could be incorporated into cellular DNA, it will be very important to demonstrate a lack of cancer in animal models and in humans,” says Nathaniel Landau, a professor in the department of microbiology at the NYU Grossman School of Medicine who is not involved in any of the NHC or molnupiravir research. “Even though it looks good in preliminary animal models, it will be important not to rush this into clinical use before being very confident that it does not cause cancer even at very low frequencies.”
Molnupiravir’s first brush with public attention, long before Merck began its collaboration with Ridgeback, came in May 2020, when the former head of the U.S. government’s Biomedical Advanced Research and Development Authority said in a whistleblower complaint that he had been pressured to provide funding for molnupiravir, then known as EIDD-2801, but had objected, partially due to safety concerns. The former BARDA head, Dr. Rick Bright, told Bloomberg this past March that the involvement of Merck had “softened” his concerns.
Indeed, Merck’s reputation for rigor has eased some observers’ worries. SVB Leerink analyst Daina Graybosch notes that the data on molnupiravir released last week came far later than some investors had expected. “Merck took a really long time to develop this,” Graybosch says. “They haven’t necessarily said this explicitly…but I think they’ve been doing a lot of work to get comfortable around this risk.”
Graybosch, who covers Merck for SVB Leerink, raised her target price on the stock on Monday, to $104 from $101. Still, her outlook on molnupiraver is muted. “The continued halo effect provided by molnupiravir in the eyes of the public and investors could be more impactful than its direct effect on P&L [Merck’s profit and loss statement],” she wrote in a Monday note.
Merck said it ran two separate tests in animals in which it gave monulpiravir at higher doses, and for longer, than it would in humans. The tests showed that monulpiravir is not mutagenic, the company said.
“Patient safety is at the forefront of our company’s joint mission and vision: to save and improve lives,” Merck said in a statement to Barron’s. “Our top priority is to ensure the safety of the patients who receive our drugs and vaccines. In everything we do—from research and development to the manufacturing and distribution of our medicines, vaccines and other products—safety, quality and efficacy are our primary considerations.”
Merck shares closed up 2.2% Monday, while Moderna shares fell another 4.5%, and Vir shares dropped another 0.8% on the day.
Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com