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BOD Inside Buy- David Stack, the director who bought shares, was also at a healthcare venture fund for some time. Only point being, he has a background in valuing a company. So bullish signal not picked up by the ihub board other than a director buying. While he could not buy if he was aware of news pending/inside info, his buy is a signal that there are events coming up (COVID, Europe) and he is bullish.
Timing of this is interesting regarding COVID data in two weeks. At every turn Amarin has known the answer to what its major studies will show. Recall they did a parallel study to Reduce-it. COVID would open a massive near term market that they may need to protect. We will see.
You are the CEO of Hikma or Reddy's; are you really going to tool up a factory and launch with the treble damage sword hanging over your head? For a relatively small piece of a completely immature market on razor thin margins? If it goes south you just lost your job and serious money. They will wait or have a nice chat with JT.
I see no universe with this ruling that a generic combo pill would not be considered infringement on the Reduce-it patent.
Amarin has many strategic options and a BP could litigate the generics, PBMs and anyone else into the ground. The trick is now what is Amarin actually worth which again might be murky? Clearly more than $4.5 for sure which values US at zero.
Combined Statin/Vascepa Pill as a way out of this debacle? I would be curious to hear opinions. To the best to my knowledge Amarin's patent on a combined pill (crestor?) is still very much valid. This would only be appropriate for the Reduce-it indication. In many ways superior from a patient and MD standpoint given one script and probably better medication compliance. It should allow a BP to reboot their Statin patents. As long as the patent is valid, generics could not knock it off. In theory an insurance company could demand a patient take two different drugs but that would be more trouble than its worth depending on pricing. Medicare/medicaid coverage would apply to the combined pill and that just cut an infringing generics company profit in half. Generic Vascepa would still partially own the Marine indication, but compared to population that would take a combined pill who cares? I am surprised that we have heard so little about this path. Am I missing something here? All patients in Reduce-it were on Statins so no worry about drug interactions. The FDA will have some hoops but nothing insurmountable for a BP.
100% correct. GIA is laughable at this point. The Street would not trust current management to run a local CVS, let alone mastermind an EU and ROW marketing and distribution strategy. Anything other statement from Amarin other than "we are employing X to explore strategic partnerships and acquisition of Amarin" will result in another 10% SP drop. There will be no buyers at any SP given current management has ZERO credibility in returning share holder value on one of the most important innovations in all of biopharma.
Lemmiwinks please read below. Hydroxychloroquine (HCQ) has been obscenely politicized by both sides. Like Vascepa, you need to understand the basic science that explains its in vitro antiviral effect. Without getting into details, I have been in this since February. Follow what I am suggesting, it may save your life, it might have saved mine. As long as you don't have a baseline cardiac arrhythmia you will be fine. Dr. Howard Zucker is the Commissioner of the Dept of Health NYS:
Dear Dr. Zucker,
My name is xxxxxxxx, and I am a retina surgeon in the Hudson Valley who the New York Times recently put in touch with Gary Holmes regarding the use of Hydroxychloroquine to treat COVID-19. I wanted to be sure to write you directly about a critical aspect of our findings: Hydroxychloroquine is an effective treatment for COVID-19, but only if administered early enough and at a significantly high loading dose. (This is based on my analysis of worldwide case data and personal clinical experience).
I hope you will consider evaluating the protocol below, which I believe would substantially reduce the number of New Yorkers needing hospitalization and critical care for COVID-19, and also add a layer of protection for HCPs:
Protocol
1) Maintain frontline medical personal on 400mg QD of Hydroxychloroquine. This is a routine Lupus/RA dose and will have minimal side effects. It will create a steady drug level in the lungs that probably reaches EC 50 for SARS-CoV-2.
2) If clinical signs of COVID-19 present the following is done, administer the drug as follows: Day 1-3 800mg QD (EC 90 Levels); Day 4-6 600mg/QD; Day 7-10 400mg/QD, optimally with testing done in the first week. This dosing also addresses potential side-effects specifically Q-T prolongation. I can say with certainty that retinopathy is a total nonissue.
Administering HCQ in the early stages of COVID-19 is essential. Like Tamiflu, HCQ’s clinical efficacy will be maximized early in COVID-19. There is a window of maximum effect. Endstage/ICU patients are likely in the throws of cytokine storm. At that point HCQ (or even Remdesivir) will be minimally effective, and could even be deleterious due to the amplification of side effects as organs begin to fail.
Based on PCR data from now several independent international studies, which I would be happy to detail further, this protocol should eradicate COVID-19 within a week among many patients. This would have a profoundly positive effect on community transmission and hospital overflow in New York.
I am eager to discuss further and can be reached at any time at xxxxxxxxxx.
Sincerely,
xxxxxxxxxxx, MD
The Chloroquine/COVID-19 op-ed we submitted to the NYT two weeks ago. Dr Andrea Savarino was the first to publish on Chloroquine as an antiviral in The Lancet 2006 after SARS. (google him) We need to use Chloroquine as prophylaxis. Waiting for a clinical trial now is total idiocy. Forward please:
https://medium.com/@savesightmd/an-old-drug-for-the-new-virus-a6fd6a0843bc
Do not forget about Evaporate. I am going to predict that 2000 Cardiologists gasp simultaneously when the before and after imaging of plaque reduction is shown at AHA. Nothing is as powerful and irrefutable to an MD. We are visual learners.
Frankly, I find ad hominem attacks childish and beneath the dignity of our profession. I think we can all agree that no matter the medical specialty there is enormous inertia to create a completely new treatment paradigm. This is especially true now with the intersection of Big Pharma financial interests and academia largely deciding the direction of many clinical trials.
On the cusp of what I believe will be a seismic change for multiply specialties, it is much more productive to use bandwidth here and our expertise to explore both the commercial and medical future of Vascepa, than to attack one another.
Could this all be about Evaporate? 1) The FDA wants to see the data as this potentially answers the MOA question and puts mineral oil to bed. 2) or Amarin asked for a label WITHOUT TRIG LEVELS. The FDA would certainly want an Adcom for that question. Recall Amarin ran an internal study to reduce-it. They knew the answer before the results. Why would they have not done the same for Evaporate? Not trying to be glass 1/2 full here, but this just does not make sense. We don't have the data to understand what is going on.
I think you are underestimating MD's, specifically CV Surgeons and Interventional Cardiologists using the drug off label. They usually follow the literature very closely and will do what it takes to give their patients a survival edge after a stent or bypass. If Evaporate is positive (the Japanese equivalent was), than it is not crazy to think that anyone pre or post these procedures should be on Vascepa. I would for sure want it. That market is enormous BTW
Thanks Sam. IMHO Evaporate is a huge potential catalyst that the Street has essentially ignored. Patient's can easily visualize the concept of a 'liquid stent" (think Drano for your coronary arteries). The data is purely objective and irrefutable. I agree that every CV patient that is a potential candidate for surgical intervention (stent or bypass) or has historically undergone these procedures will be put on Vascepa based on this study. Cherry was done with a much lower dose and its results were still very robust.
Dig a little deeper on Gwen Fisher. She has been involved in some very large pharma M&A deals for Shire and Pfizer. I am somewhat agnostic to GIA or B.O. , but this is certainly interesting:
https://www.linkedin.com/in/gwendolyn-fisher-74624b8/
Evaporate and Cherry
Does anyone know when Evaporate reads out? I recall this fall but I cannot find the reference. Like Reduce-it and Jelis, I think we already know the answer. This should end all discussions on MOA and put mineral oil idiocy to bed for good.
https://www.investorvillage.com/smbd.asp?mb=2294&mn=3804&pt=msg&mid=19126707
JL noted that the answer to Reduce-it's outcome could be found in Jelis' results. SImilarly, I think EVAPORATE can be predicted as well. Doing a little homework I found this nugget. Like most Japanese papers it is dense with data and has meticulous methodology.
The conclusion that EPA stabilizes plaques based on direct imaging of vessels is a completely objective finding. Hopefully we can dismiss the argument against JELIS that you cannot generalize these results to westerners.
https://www.jstage.jst.go.jp/article/jat/advpub/0/advpub_25593/_pdf
Scripts in January are sort of meaningless to follow. Patients do not go to MD's voluntarily due to not meeting their deductibles (true of pharma benefits too). Add in lousy, snowy weather for most of the country this month and that explains this week's numbers. A very small data point that allows no overall conclusions.
http://www.visionmonday.com/latest-news/article/shire-reports-sales-growth-of-6-percent-in-q2-as-xiidra-hits-100-million-in-sales/
DES is big money and a reoccurring revenue stream. Unlike Reduce-it this would be a very easy/quick study for Amarin to do. This is Zip's expertise, but the results of tear film production and composition are quantifiable. I would think all you would need is 6 months at most on Vascepa to see changes.
I hope someone at AMRN is mining the Reduce-it data for diabetic retinopathy, macular degeneration, and vein occlusion data. The association of mac degeneration with C- reactive protein is absolute, and is likely serving as an inflammatory marker as trigs did in reduce-it.
Eloquently stated.
Academic medicine has become so dependent on BP for financial support in the face of reimbursement austerity, that clinical scientific inquiry and innovation has been stunted and curtailed. Saying I don't understand the MOA, therefore the results are suspect is simply pathetic.
On another note, I received a text today from my local CVS that Vascepa is in short supply and do I want to renew early?
And so it begins.....
Happy Thanksgiving to all.
Zip,
Not how this will get done.
I already have started the discussion with the National Eye Institute and they are going to look at Vascepa as a preventative measure for the development of Wet AMD and progression of diabetic retinopathy. Will the study get funded? I have no clue and it will certainly take awhile. Depriving a patient of an injection of a standard of care medicine is essentially almost never done, most studies look at adjuvant therapy to standard of care. Maybe a small pilot of treatment naive patients in Phase 2 with immediate rescue if things go south.
Amarin would be far more interested in the larger preventive market in any case. No competition except AREDS vitamins and a totally different bar. Simple study of treatment vs placebo and see who develops wet mac degeneration. It would take a few years, but relative to reduce it would not be huge.
For all we know, they may have some data from reduce it and might be able to collect it post facto.
I had an interesting email exchange with the Deputy Director of the National Eye institute. She ran the NEI's AREDS trial on macular degeneration (vitamins for mac degeneration). She had indeed read Bratt's NEJM paper and assured me that the NEI was very intrigued with the results and would evaluate the possibility of initiating studies in AMD and diabetic retinopathy. I sent the email exchange to Amarin so they can reach out when they have a moment to breath. Will it happen? I have no idea, given the NEI is a branch of the NIH and deals with budget constraints and government red tape. The point is that all of medicine, including oncology, rheumotology, and neurology are suddenly looking at Vascepa. This may not mean much in the short term, but in the longterm, CVD is just the beginning for Vascepa. The science is not over as someone posted, it is just beginning. How that translates to PPS now and later I will leave to posters who actually understand business.
Elegantly stated.
This is Gottlieb's FDA, there will be no repeat red wedding, and "you know nothing Jon Snow" certainly does not apply to JT and Amarin management now. Winter is coming for BP and they know it. It's their choice what to do about it now, but erasing Reduce-it is not an option.. The PPS may not be stable in the short term, but those of us who have been here for 6 years really do not care and will be patient again.
I trust you did not bother to read the article? If you had grasped the nuances of the author, you would than understand why the editorial in the NEJM was written. The editorial author (and Bratt for that matter) are both saying that Icosapent ethyl's full mechanisms need to be elucidated and understood. Modern medicine is very uncomfortable when it can't fully parse a mechanism. It makes MD's feel stupid.
That is not mutually exclusive from my strong belief and probably theirs that Vascepa works dam well, it should be approved ASAP by the FDA, and there is real statistical proof that MO is a nonissue.
The FDA's job is not to determine mechanisms. Three questions have been answered resoundingly by Reduce-it 1) Vascepa is enormously safe 2) It is efficacious for preventing deadly ischemic events in a nearly untreatable patient population (academics will debate how efficacious, but since Vascepa has no competing therapy, nobody can say it is not more efficacious than drug X). 3) It meets an unmet medical need and addresses a major public health problem.
The label will be expanded, and this all becomes background noise.
As a comparison, for two decades we essentially amputated the retina in severe diabetics with laser to prevent blindness (FDA approved of course). We did not understand the mechanism until the mid 90's when Judah Folkeman found the growth factors that cause neovascularization.
As for being a FUDster, thank you for prompting me to finally search the acronym asI had thought it had something to do with the hapless Elmer Phfud.
I don't post often, but if you can't tell that I am long time Amarin supporter and shareholder, and that I believe that Vascepa's utility goes far beyond CVD, you are welcome to continue to call me silly names.
The Tao of Cholesterol. An interesting article on why Vascepa has had such an uphill climb. Medicine has become far more concerned with causation mechanisms than actually curing the patient. Thought provoking if you need a break from M.O.
https://www.wired.com/2011/12/ff-causation/
Clinically negligent is a somewhat amorphous concept. It has to do with malpractice risk and the knowledge that you are not practicing at the standards of the community. That being said no physician wants to needlessly put themselves in a situation where they directly harmed a patient by using an antiquated drug with a black box warning from the FDA.
The plaintiff lawyer questioning would go something like this:
Q: Did your patient die from a myocardial infarction?
A: Yes
Q: Does raising LDL increase risk of M.I?
A: Yes
Q: Does Lovaza raise LDL?
A: Yes
Q: Were there any alternatives that you could have place the patient on?
A: Yes
Q: I have your open payment data from CMS showing payments received from GSK. Was this your reason for putting your patient at unnecessary risk and not prescribing a safer more effective drug?
Jl, I think you are actually hitting on an incredibly important observation that would also explain BP's worst fears about Vascepa. As of yet nobody, including JT , has raised the possibility that Vascepa may obviate the need for statins in a segment of the population. In the tradition of stupid MD's doing experiments on themselves, I have an N of 1 to back up your point. Several years ago my Total Cholesterol was a borderline 220. My Internist threatened me with Statins and Aspirin to which I negotiated a recheck in 6 months. I put myself on a Jelis dosage of Vascepa. Net result: my TC dropped to a respectable 180 and has been there ever since. Maybe the 220 was an aberrant lab, or maybe Vascepa successfully decreased my TC to a safe level. In the near future, a study will look at what Vascepa's role should be in a low risk normal triglyceride population. We do know one answer for now, Vascepa is far safer than daily aspirin therapy, and likely more efficacious since aspirin's bleeding complications outweigh its potential benefits.
Medical reality 101 from the trenches. Most patients have little or no coverage for part D drugs. High deductible plans are the most common for private insurance. A year of Vascepa equals approximately one macular degeneration shot. MD's like to keep their patients alive and actually do read the NEJM. They will prescribe off label, and patients will buy it. Any patient intolerant of Statins will get Vascepa. Bad diabetics will get Vascepa. Wall Street puts far too much emphasis on labels when a drug is already approved. We are not robots, and think independently. MO nonsense will be an academic argument of angels dancing on pins. The drug works, it saves lives, patients will demand it, the prescriptions will be given.
Regeneron did a mixed self offering last night. I am told that kind of raise is done prior to a large deal. No knowledge here other than this fact.
New AF Stat+ article. He is sending somewhat of a dogwhistle that Amgen may be on the hunt to acquire Amarin. Hard to say if this is pure conjecture on his part or he has an inside source.
I doubt I get an answer to this tweet
Professional courtesy to give Dr Weiss the benefit of the doubt:
A simple question for you: Now that you have had a chance to review the @NEJM article and have carefully examined the full $amrn data set (evidently you had done neither prior to your comments in @statnews), would you prescribe Vascepa to appropriate patients in your practice?
— Oreo the dog (@savesightMD) November 11, 2018
Dr. Ethan J Weiss (AF's "objective" commentator) has received more than $100K from Pfizer and other conflicted pharmas. His parent organization, Cardiovascular Research Institute, has also received extensive BP funding.
Have we learned absolutely nothing from the Sloan Kettering's conflict of interest debacle?
Here it is in black and white:
https://openpaymentsdata.cms.gov/physician/1031578/payment-information
This should have been fully disclosed by AF and Statnews.
Comic relief while we wait......A close friend and fellow 6 year AMARIN veteran was confronted by his wife today on why he seems to be so obsessed with someone called " tasty the elf". A strange cover name for a mistress for sure.
Yes they do. Look at CATT Study or AREDS Study. They only get involved when it will be a significant question of public health. Vascepa as a preventative for AMD progression would fit this criterion.
Ferretmoney, this timely article in the NEJM directly answers your question about aspirin for diabetic patients..
https://www.nejm.org/doi/full/10.1056/NEJMoa1804988?query=recirc_curatedRelated_article
I would discuss it with your doctor.
Regeneron/Sanofi?
No idea if this is even possible to structure. Both had a big win Friday after hours, when they received a asthma indication for Dupixent.
They often collaborate on projects. Vascepa essentially leaves Regeneron's cardiology program in ashes.
I completely agree. Aspirin is the enemy of the retina except when a patient has a real cardiac need to be on it. All the epidemiology studies presented in Europe this summer showed no benefit and actual harm in populations that are not truly at risk. EPA has very minor anticoagulation effects. However like AMD, diabetic retinopathy also has a significant inflammatory component. We use intravitreal steroids all the time to address diabetic macular edema.
Going along with the SI mechanism, every diabetic I have ever treated with extremely elevated trigs needs the kitchen sink to save their vision with constant anti-VEGF injections to minimize the macular edema.
If your friend needs a second opinion in the Boston area have him see Elias Reichel at Tufts.
https://www.neec.com/our-doctors/elias-reichel-md/
Vascepa could conceivably prevent blindness in millions and save CMS billions.
There is powerful evidence to suggest that Vascepa could prevent the progression of macular degeneration.
Mac Degen is an inflammatory disease and their have been multiple subsequent studies that have confirmed the findings in this critical paper:
https://jamanetwork.com/journals/jama/fullarticle/198183
Vascepa of course significantly decreases C- reactive protien, and many other inflammatory markers.
Treatment of Mac Degen has the dubious distinction of the biggest spend in all of Part B drugs (5 billion last year) . One dose of Lucentis or Eylea almost equals a year supply of Vascepa.
Hey Amarin if you are listening?!, approach the National Eye Institute with the idea. They already did a large study (AREDS) which to my knowledge is the only study that showed vitamins have some benefit on pretty much anything. They know how to do an oral drug study, and nobody can scream commercial bias when the results come out.
From a vision perspective the public health benefits would be enormous. I also would not mind the side effect of my patients not dying of an MI or Stroke :)
Is Vascepa not only cardioprotective but also antineoplastic? A question for AVII or anyone intimately knowledgeable about reduce-it study design. Given 8000 patients and 6 years, and the fact that a new cancer of any kind would be reportable event, could Amarin have data that suggests Vascepa may prevent the development of GI Cancers? The numbers are probably too small to hit statistical significance since the study was not powered to look at this question.
Yet, it is certainly Intriguing that Amarin initiated this study with Mass General Hospital before revealing reduce-it's data.
https://clinicaltrials.gov/ct2/show/NCT03661047?term=vascepa&recrs=abdf&rank=5
Great find Chris2125.
It sure would be fun to watch the reaction at AHA if one of the secondary endpoints was an anti-neoplastic signal.
Big pharma would have to add some more zeros to their check.
My bet is that the big firms start their upgrades to gain favor for involvement in the M&A business that is yet to come.
They simultaneously drive the price up along with their underwriting fees.
Just my cynical view
The deafening silence of no secondary offering.
As we get closer to AHA, I think JT is telegraphing that Amarin is holding all the cards. IMHO the fact that they have not done a secondary yet to raise money for GIA and ramping production leads to only one conclusion: JT knows with near certainty that the share price is going much higher.
A week before AHA I think the stock is without risk, as doing a secondary then would make no sense.
My investment strategy for what its worth coming from an MD (likely not very much)
1) Accumulate more shares on silly day trading dips
2) A week prior to AHA short term options slightly OOM. You are only paying for volatility and not time premium.
3) Maybe a small amount of idiot insurance calls at a > 30 strike price.
4) Positive FDA action per BB would accelerate this timeline
After AHA if JT does a secondary it is he way of telling BP either pay up or we GIA.
Just for chuckles-Amarin and JT are the new Honey Badgers of the Nasdaq...