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Thanks so basically patients with too severe disease progression skewed the results in a negative way by showing no improvement between the two groups: treatment arm and placebo?
I went back to look at the press release from Jan 2020. Can anyone explain the baseline imbalance? Trying to wrap my head around why the company thinks this time will be different.....
Is it just a longer trial and no Namenda / mematine this time around?
https://www.prnewswire.com/news-releases/neurotrope-provides-corporate-update-after-completing-bryostatin-1-data-analysis-for-advanced-alzheimers-disease-trial-300991105.html
NEW YORK, Jan. 22, 2020 /PRNewswire/ -- Neurotrope, Inc. (Nasdaq: NTRP) ("Neurotrope" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapies for neurodegenerative diseases, today announced its corporate update.
The Company has completed analysis of the data (Clinical Study Report) from its recently reported Phase 2 confirmatory clinical trial (the "203 study"), examining moderately severe to severe Alzheimer's disease patients treated with Byrostatin-1 in the absence of memantine / Namenda.
"A significant imbalance (4.8 points) in the baseline Severe Impairment Battery ("SIB") scores occurred, by chance, between the Bryostatin-1 treatment group and placebo group," stated Dr. Daniel Alkon, Neurotrope's President and Chief Scientific Officer. "After consulting with our Scientific Advisory Board and statistical experts, we were advised that, in a small study such as this, a baseline imbalance could prevent a definitive analysis of Bryostatin-1 treatment versus placebo in SIB scores at the primary (Week #13) and secondary endpoints as provided in the original Statistical Analysis Plan ("SAP")," stated Dr. Alkon.
"Due to the baseline imbalance observed in the study, and because a clear signal of benefit could be observed in the raw data from the pre-specified Moderate Stratum, we conducted a post-hoc analysis using paired data for individual patients, with each patient as his/her own control," stated Kazem Kazempour, Chief Executive Officer of Amarex, Inc., the biostatistician retained to analyze the data from the 203 study under the SAP. For the pre-specified Moderate Stratum (i.e., MMSE-2 baseline scores 10-15), the baseline value and the week 13 value were used, resulting in pairs of observations for each patient. The changes from baseline for each patient were calculated and a paired t-test was used to compare the mean change from baseline to week 13 for each patient. A total of 65 patients had both baseline and week 13 values, from which there were 32 patients in the Bryostatin-1 treatment group and 33 patients in the placebo group. There was a statistically significant improvement over baseline (4.8 points) in the mean SIB at week 13 for subjects in the Bryostatin-1 treatment group (32 subjects), paired t-test p < 0.0076, 2-tailed.
In the placebo group (33 subjects), there was also a statistically significant increase from baseline in the mean SIB at week 13, for paired t-test p < 0.0144, consistent with the placebo effect seen in the overall 203 study. "This smaller, placebo effect could possibly be due to the imbalance observed even for the Moderate Stratum in the study," stated Dr. Alkon. For the pre-specified Severe Stratum (MMSE-2 baseline scores 4 – 9) patients, there was no statistically significant change from baseline for either the treatment or the placebo group.
If anyone has Karim's email address they should email it to him.
I emailed investor relations in the past but they don't respond so I'm not going to waste my time. Is anyone even working in IR? No wonder there is tepid interest to own the stock.
I haven't seen an Amarin commercial in months.
btw: if you want to see a management team who knows how to launch a product watch this presentation: https://wsw.com/webcast/oppenheimer16/plxp/2825452
Both PLX and Amarin have heart medications...and Dr. Bhatt is involved with both. One company is moving in the right direction and the other seems to be constantly in stealth mode.
Go figure
The market has been on a tear except for Amarin, will management / the Board wake up. They have a fiduciary duty to shareholders.....
The lack of PRs, relative lack of attention on the European launch, Munich conference, etc........ No sales forecast, etc. etc. etc.
Pegged between $5 and $6 for a reason.
Yes, I own the stock.
I'm not surprised we haven't come with a good commercial: we had an accountant as a CEO. not a marketing guy. The Board of Directors probably couldn't identify the M in marketing if they were looking at the word.
I saw Amarin was mentioned in that article.
Speaking of Vazalore.....now this is a commercial.
From this weekend's Barron's: no mention of Amarin or Vascepa.
Pills to Battle Covid are coming: These Companies Stand to Gain
In the earliest days of the Covid-19 pandemic, when an effective vaccine seemed too much to hope for, investors and drug developers looked to antivirals to blunt the impact of the disease.
They didn’t have much luck. To date, the only antiviral authorized by the U.S. Food and Drug Administration to treat Covid-19 is Gilead Sciences ’ (ticker: GILD) Veklury, also known as remdesivir. It is expected to earn $3 billion in revenue for Gilead this year, despite its effectiveness being debatable, and it being administered as an inconvenient intravenous infusion.
Today, the next generation of Covid-19 antivirals is on the way, and a pill to treat—or even prevent—Covid-19 could be available by the end of the year. Merck (MRK), Pfizer (PFE), and the biotech Atea Pharmaceuticals (AVIR) each expect late-stage data on an oral Covid-19 antiviral in the coming months. If the data are positive, the drugs provide a major opportunity for the companies—one that investors should not ignore.
The antivirals may not be effective enough to stop a Covid-19 infection in its tracks.
Still, if they show even moderate efficacy, they will play a major role as the global fight against the virus shifts to a long-term grind against an endemic threat. A prescription Covid-19 antiviral that could be taken at home as a pill would be in great demand around the world.
Read more:
FDA Panel’s Vote Against Boosters Deals a Blow to Biden’s Covid Plan
Commentary: Enough Hand-Wringing Over the Science. Bring on the Boosters.
Vaccines for Children Are Moving Closer. Pfizer Will Seek FDA Go-Ahead Next Month.
Sanofi Is Finally Catching Up. How a Covid Vaccine Could Lift the Stock.
Analysts at Jefferies have said that an effective, convenient treatment for Covid-19 could be a $10 billion-a-year drug. That treatment will compete with monoclonal antibody therapies for Covid-19 from Regeneron Pharmaceuticals (REGN), GlaxoSmithKline (GSK), and others, which work well but, like Veklury, are generally administered as an intravenous infusion, making them challenging for widespread use.
The U.S. government has already signaled an interest in stockpiling oral antivirals, signing a $1.2 billion contract with Merck that will go into effect if its drug receives emergency-use authorization from the FDA.
Some analysts are more skeptical of the role the pills will play.
In a recent note, Jefferies analyst Michael Yee wrote that he expected antivirals to be only incrementally effective. Still, he says there will be a need for them “for the foreseeable future.”
Given the potential size of the market, positive data or an emergency-use authorization for any of the three oral antivirals could give the shares of its maker a tremendous boost.
The Coming of the Covid Pill
Four leaders in the race for a Covid-19 antiviral
Company / Ticker Recent Price YTD Change Market Value (bil) Covid-19 Antiviral
Pfizer / PFE $44.77 22% $251.0 PF-07321332
Merck / MRK 72.81 -7 184.3 Molnupiravir
Atea Pharmaceuticals / AVIR 25.98 -38 2.2 AT-527
Roche Holding / RHHBY 46.86 7 331.5 Partnered with Atea
Source: Bloomberg
For Atea, a biotechnology company developing a range of oral antivirals, the effect on the share price could be the most significant of them all. Its Covid-19 antiviral, AT-527, is being studied in a number of trials, including a Phase 3 trial in nonhospitalized patients expected to produce data later this year. The company has teamed up with Roche Holding (RHHBY), which will have the rights to sell the drug outside of the U.S. SVB Leerink analyst Roanna Ruiz recently set a $60 price target on Atea shares, more than double their recent price of around $26.
The drug, AT-527, targets an enzyme called RNA polymerase, part of the coronavirus’ replication mechanism. The drug uses a sort of two-pronged attack, which could make it effective across a range of Covid-19 variants.
“Our drug, to our knowledge, is the only drug that has a dual mechanism,” Atea’s CEO, Jean-Pierre Sommadossi, told Barron’s. The world will need a range of therapeutics to treat Covid-19, he adds. “It’s a major unmet need,” says Sommadossi. “And it’s going to be a significant and large market on a global scale.”
Merck, which is developing an antiviral called molnupiravir in collaboration with the private firm Ridgeback Biotherapeutics, could be the first with Phase 3 data on its Covid-19 antiviral.
This past week, Merck CEO Robert Davis said at Morgan Stanley’s industry conference that FDA authorization could come by the end of the year.
In a recent note, SVB Leerink’s Daina Graybosch wrote that molnupiravir could be worth $3 a share to Merck, which recently traded around $71. Like AT-527, molnupiravir interferes with the replication of the virus that causes Covid-19.
“It would be very challenging to mutate around,” says Merck’s vice president of infectious diseases discovery, Daria Hazuda, of molnupiravir. What’s more, she says the drug has been shown in preclinical tests to be active against other coronaviruses beyond Covid.
“It would have the potential not only to be an important contributor to this pandemic, but also future zoonotic transmissions [those transmitted from animals] of other coronaviruses,” Hazuda says.
As for Pfizer, its experimental Covid-19 antiviral, known as PF-07321332, is also in studies that could produce data later this year. Pfizer’s drug is what’s known as a protease inhibitor, similar to antivirals used against HIV, among other diseases.
Pfizer’s Chief Financial Officer Frank D’Amelio said at the Morgan Stanley conference that Pfizer could submit the drug for FDA authorization in the fourth quarter of this year. “We think this could be another really nice tool in the arsenal relative to our fight against this virus and this pandemic,” D’Amelio said.
That's the enigma tho....management is not really taking external steps (more PRs, bullish revenue guidance, etc.) to get the share price to creep up to support a $20 BO offer and there does not appear to be much in the near term horizon in terms of news to move the SP on its own.
Some have said prepare-IT 2 but I'm not holding my breath for Dr. Pablo Corral in November. He seems to be more interested in the focus on him and the big stage but that's another discussion. Spare me with the results need to be released at a conference for validity.
So here we are back to the SP that is stuck between $5 and $6. A $20 BO would be nearly a 4x from here. Not sure how we bridge that link stuck between $5 and $6 and seemingly silence from management.
The FDA meeting today from the WSJ:
Multiple members of the committee also voiced concerns over the limited data so far about whether a third dose increases the risk of myocarditis, an inflammatory heart condition that has so far been found to be a rare side effect primarily in young men. FDA officials told panel members that the risk of the condition is unknown so far, and that more research needed to be done.
And would the combo be something the generics could not take advantage of?
Curious as to what strike price you were selling your calls?
You were never worried about getting your shares called away if something unexpected was announced?
Got it. My point tho is Scott Gottlieb is on the Board of Pfizer. He used to run the FDA.
I will tell you who has a lot of influence: Scott Gottlieb. Look at how much air time the media gives him. He still has influence with FDA.
Could that be helpful if Pfizer were to acquire Amarin and needed help with this generic thorn in the side situation.....???
That and when you don't have much to lose....there's no downside to going to trial: generics in the Marine indication case.
This is completely the reverse: risk of trial for Amarin is not much...the status quo....for generics risk of loss is......you get the picture.
Great post.
Lipitor + Vascepa = Vastor.....
Combo pill?
Perhaps Pfizer will work its leverage with the FDA to get a workaround to the generic problem. If anyone has leverage it is Pfizer. Former head of FDA is Chairman of Pfizer. When Pfizer talks the FDA listens.
so you're saying....PFE does not want to draw the market attention to Vascepa / Amarin at this juncture?
No need to run the deal price up?
But why would PFE want to wait to pay more if those events bump up AMRN's share price....the blue light special (discount) is now....
That is one hell of a discount....$20 bn wow. Pfizer is probably laughing at JT and so glad he is gone.
Great post.
As we speculate about PFE and Amrn this is an interesting backdrop on how PFE acquired Trillium from Endpoints News:
https://endpts.com/how-jan-skvarka-and-trillium-talked-their-way-into-biotechs-hottest-vax-summer/
How Jan Skvarka and Trillium went from down and out to buyout with Pfizer
Jason Mast
Editor
How do you pull off one of the most lucrative biotech turnarounds in history?
You begin, it seems, by calling up the chief business officer of a Big Pharma sitting beneath a $30 billion-plus windfall and asking if he might want to get in on a modest investment in an up-and-coming company.
John DeYoung
At least that’s what Trillium CEO Jan Skvarka asked Pfizer global business vice president John DeYoung in early summer 2021. Trillium was valued at a couple of shades under $1 billion at the time, an astronomical valuation from the penny stock mire it sat at when Skvarka arrived in October 2019.
But they could still use some cash, so Skvarka asked DeYoung if Pfizer, which had already invested $25 million, would chip in another 25. It was less than a thousandth of their Covid-19 vaccine revenue, barely half of what a star athlete like Kansas City Chiefs quarterback Patrick Mahomes made in a season.
By Aug. 21, Pfizer had agreed to buy out all of Trillium for $2.3 billion, or roughly what it would cost to buy the Kansas City Chiefs.
It was a rapid close for a company with an almost unprecedentedly rapid rise. The valuation surpassed even the estimates the company’s own financial advisors, Clearwater, provided. It was more than triple Trillium’s closing price-per-share and more than 200 times the value of the company when Skvarka arrived.
For all that value creation, the Slovakian ex-investor and financial advisor will earn a Mahomesian sum, taking home just over $25 million from his Trillium stock options, according to SEC filings Monday.
How much credit Skvarka deserves for the turnaround remains an open question. Unlike Pharmacyclics and other previous biotech cinderellas, Trillium does not owe its turnaround to any disease-changing data or molecules nearing approval.
On the contrary, even some of their results from earlier this year have been a mixed bag.
Instead, Trillium began trading up in the winter of 2020 for well, no clear reason. The company had to actually put out a statement that February just to make clear it didn’t know of any undisclosed info that could account for its surging stock.
Soon, though, Trillium would rise for a different, clearer reason: the broader interest in CD47, a target many executives hoped could expand and turbocharge the reach of immunotherapies — and one that Trillium had been working on since at least 2013. That March, Gilead bought out Irv Weissman’s Forty Seven for $4.9 billion, and Trillium’s stock jumped from $4 to $7 amid speculation that they too might be bought out.
The speculation, it turned out, was accurate. According to the new documents, Trillium was already exploring a partnership with a company. It hired Centerview two days after Gilead announced its buyout.
That June, after Trillium released promising but not overwhelming data for its CD47 antibody, executives began their first talks with Pfizer. The first $25 million investment came in September 2020, days after AbbVie bet $200 million on I-Mab’s CD47 antibody.
The only data it released between that investment and the buyout were met with mixed reviews.
At the same time, though, Skvarka, a veteran of Bain and PureTech, made key decisions on the path to the acquisition. He all but ended development on Trillium’s main preclinical molecule and slowed development on one of their CD47 antibodies, while accelerating another.
And when he reached out to Pfizer over the summer, he told them he wouldn’t settle for a price-per-share below $13 — a gutsy ask, given Trillium’s stock would fall to as little as half that in those months.
Deborah Baron
But Pfizer was game. After only a couple of exchanges DeYoung and Deborah Baron, Pfizer’s SVP of business development, called Skvarka to say they wanted to buy out Trillium for $15 per share, or roughly $1.8 billion. And they said they wanted to close by Aug. 23.
After that, only two other companies were involved, as Trillium tried to gauge the industry’s broader interest — one biopharma that never showed much inclination and another that eventually decided Trillium was too early stage. Trillium’s board didn’t even bother reaching out to the first company executives had spoken to in 2020, deciding it didn’t have the capabilities to pull off such a bid.
After a few back and forth negotiations, Pfizer and Trillium agreed to a $2.3 billion buyout — $18.50 per share — on Aug. 21. They announced the deal two days later, precisely on the New York pharma’s schedule.
It's amazing how Big Pharma wins isn't it. $6 bn.....and pre-DU trial folks would have scoffed at $6 bn.....of course we still had the patents / IP but to think that one day shareholders would be willing to part with Amarin for $6bn.....very few would have seen that coming.
In fact one of the main bulls....swore that Vascepa would sell itself and that BP is not needed. Fast nickels beats slow dimes remember...
One can wonder what JT could have sold the company for immediately post REDUCE-IT.....I have to think it was higher than $6bn.
Yet, here we are......The psychology here is so interesting because shareholders are so fed up they are on the verge of saying just take my shares for as little as nothing and end this madness for me. BP always wins.
Always take profits with biotechs.....because things can change on a dime.
It's a cold game. LOL
so you think this is all being done to try to shake out retail?
the only issue is that europe is already on the clock.....started in March. at some point these games will also cut into the exclusivity in Europe....time is of essence
Good to know you are still here and holding strong with us AMRN longs!
Go AMRN.
Until it is not and you are no longer the CEO.
Shareholders own the company. What do you think the Baker Brothers want.....
The time to do the secondary if they were truly GIA was right after the european label approval when the stock broke $9......
That fact they didn't pull the trigger then speaks volumes.....
Like LBL said....it's GIA until it's not....
clock is ticking.
Is LBL still here?
I think your thoughts are spot on! Likely a preemptive move / strike to ward off another BP from striking a deal with HLS in Canada post any other PFE and Amarin arrangement.
Great DD lizzy as well. So we know Pfizer is interested.....and we also know Karim is not a dummy and has a big pharma background. The Company has been eerily silent as of late especially leading up to the European launch. We also know the clock has already started ticking in terms of European exclusivity. It started back in March.
We also know the Baker Bros are not dumb and they are still holding here.....
Investing is about sleuthing and putting the bread crumbs together...to discern as much as you can. Thus far......the roads appear to lead to PFE. We shall see how this all plays out.
Clock is ticking....
btw: this is Pfizer we are talking. They already know they can sell Vascepa. LOL. The science is not the issue. Res ipsa loquitor...the science speaks for itself.
Even more reason for Pfizer to get involved. If anyone can work a label change or regulatory fix via combo drug it is Pfizer. Generics would be left with all that supply for the high trig indication. Lol.
Chairman of Pfizer is the former fda commish. If they owned Vascepa, I bet they would get what they want from the FDA to preserve the cvd indication.
Great insight and comments today. The best thing is that Karim unlike JT likely realizes what big pharma can do and will be motivated to get a deal done.
Great points. Would also reveal why PFE did deal with Canada in advance to prevent HLS from increasing its negotiating leverage subsequent to PFE going after AMRN and of course even though they are different markets PFE gets any ancillary benefit from word of mouth / advertising etc that accrues to Canada from USA.
Now what would really be interesting is if Merck or another big pharma deemed $15 to $17 too low and also made a play at AMRN. One can dream but let's not get greedy. $15 and run for the hills. LOL
Very interesting. Thanks for sharing your thoughts. So you think this happens within the next 2 weeks?
If this happens would you holdout 6 months for deal to close to get the CVR? or sell immediately at $15?
Let's remember that Bristol Myers paid $13.1 billion to buy MyoKardia for its heart drug that is expected to bring in $1.5 billion in revenue by 2025. I repeat by 2025.
I saw the post about Europe potentially bringing in $2.4 bn so thought I would add this for context.
Our stock is $5.29....$2.1 bn market cap.
What will Karim do......
8 months from now tho LOL. Hope AMRN is in the hands of another entity long before then......
Great. Another wait till Mid November. SMH.
Hope AMRN doesn't wait for such data to make strategic moves.....
You think it's just a coincidence?
So when does it happen......by end of November? end of December? by end of Jan 2022?
Time is ticking....
If you've been in touch with Karim or have his email you should let him know.
JT let these attacks go on without batting an eye. Go figure.
LOL....this line of thinking is exactly why we are still here. It's the same line of thinking shareholders and management had pre-DU trial....$50 $60....$100 per share....
Vascepa will sell itself.....
$18 to $20 get the deal done.
Idk....we hit a high of $26 in Dec in AH trading...pre the loss of the patents in March perhaps we could have been taken out around $40 to $45....some I'm sure would say higher but it's water under the bridge now.
never get too greedy especially with biotech....always take some profits off the table. it's one of the hardest things because you sell and the stock keeps running you have regrets.....
some posters were saying $100 and others were saying the drug would sell itself and GIA was best.....we all know how that turned out.