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Amarin's Underappreciated Breakthrough - Addressing Criticism And A Deep Dive Into Mineral Oil

Feb. 08, 2019 10:26 AM ETAmarin Corporation plc (AMRN) Stock203 Comments
Charles Lyon profile picture
Charles Lyon


  • The REDUCE-IT trial recently proved Amarin’s drug, Vascepa, is a historic breakthrough for prevention of cardiovascular disease, the #1 killer of Americans (800,000 US deaths/year).
  • Major Adverse Cardiac Events (MACE) were reduced 25% (p<0.00000001) in at risk subjects. Heart attacks were reduced 31%, strokes 28%, and cardiovascular death 20%.
  • Risk reduction exceeds other drugs, including statins, for a huge market with no direct competitor. Amarin remains deeply undervalued.
  • Misinformation is addressed with verified facts. Exaggerated mineral oil placebo criticism is thoroughly debunked.
  • Tens of millions of Americans can now reduce heart attack/stroke risk, often for a $9/quarter co-pay, off-label before FDA label expansion.  As word spreads, sales will soar.


Confusion and misinformation remain about Amarin Pharmaceutical’s (NASDAQ:AMRN) unexpected breakthrough clinical trial results released last fall for its cardiovascular drug, Vascepa. My previous Seeking Alpha article reviewed the facts. Here, I respond to criticism of Vascepa and include a deep dive on the mineral oil (MO) placebo issue, which continues to be raised despite clear evidence its impact is very minor.

The trial’s lead investigator, Harvard Medical School professor Deepak Bhatt, a leading authority not known for excessive claims, called it “the dawn of a new era in cardiovascular prevention … looking back in time this will be viewed as a major advance in cardiovascular medicine.”

Response to a Recent Bearish Seeking Alpha Article

A recent bearish Seeking Alpha article by Bhavneesh Sharma gave a $5 price target for Amarin, from a recent price near $16. The author, who disclosed his short position (I’m long), said doctors will advise patients to buy dietary supplements instead of prescribing Vascepa. He said the LDL-C (“bad” cholesterol) increase caused by the DHA many of them contain is small. His evidence for low current sales included chats with 5 local pharmacists. He said the statistical significance of Vascepa’s reported death reduction was too low. He cited mineral oil placebo concerns and said the FDA may ask for an additional clinical trial.

Two Seeking Alpha articles (rebuttal 1 and rebuttal 2) responded and disagreed. I add some remarks. In particular, the mineral oil criticism is so thoroughly discredited as a significant factor at this point that any mention of it ought to explain that its effect is very minor. I address that in the following section.

The REDUCE-IT (RI) trial clearly showed that tens of millions of Americans would benefit from Vascepa. My prior article explained why DHA/EPA blends have less benefit than pure EPA. DHA raises LDL-C, sometimes

This article was written by

Charles Lyon profile picture
Charles Crosby Lyon is a semi-retired electrical engineer who did signal processing algorithm R&D for the intelligence community for many years and more recently has applied his skills in health sciences. He lives in Northern Virginia with his wife Barb.

Analyst’s Disclosure: I am/we are long AMRN. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

I do not intend to trade AMRN for 72 hours after publication.

Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole. Seeking Alpha is not a licensed securities dealer, broker or US investment adviser or investment bank. Our analysts are third party authors that include both professional investors and individual investors who may not be licensed or certified by any institute or regulatory body.

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Comments (203)

Finally mentally and completely exhausted.

I made a promise- an actual promise that this one last trade is the final one I will make until September options expiration. It's fairly pointless anyway.

Sold to open September $14/9 put spread for 85 cents. All in at $14, but probably would just take the loss on the spread if it's under 14 in 6 months because I really feel there is no rational basis for that, and it will show I have COMPLETELY lost the track. Which I think is a given anyway since this trade will either have me down between 96% and 99% on my account from all these machinations. 96% if it's at $9 or lower, 96% if $14 or higher. It will be many, many years to recover and I will need to hit a miracle home run like a bitcoin. So I wish all good luck- and I certainly hope this stays over $14 this year, although a crash that finishes me off is probably the best that could happen to me. Cheers all.
jammastermike profile picture
goodbye lilkanna

While you've been messing around with your option plays you could have almost doubled your money with straightforward share purchases. This was pointed out to you in December when AMRN was under 12.
@Steve__C Absolutely correct sir. Who really knows why I did this dumb crap, but it's too late now- at this point I'm sitting on my hands until September expiration- just waiting to see how far under $14 it dips and if it comes back. Sorry in advance for any pain I cause longs with my needing the stock to do better than -33%, ha. Good luck all!
Will this be the options cycle the stock finally breaks out of the $10-30 range? My guess is NO- it will not be above 30 or below 10 at any time in March (in fact I do not think above 30 or below 10 any time in 2019).

But big March $25 call buying at 65 cents today makes you wonder if "someone" knows "something." I expect those calls will at LEAST hit $2, so AMRN to 27.
norjud profile picture
I agree with what you say. Like I said I sold Lipitor and then Crestor for AZ. Many of the doc offices do not see reps, and thus no "access". I own this stock, and think this drug is great. I also sold Torpol-XL, and when it was approved for heart failure, outcomes data very good to excellent and back then all offices were open, but many docs still used atenolol and Inderal.
So this product will do well, but many hurdles along the way. Plus pts. take 4 pills a day for how many years. If many pts. are diabetic, they already have boat load of drugs to take. So they pick and choose. Just getting real, as I have diabetics on my wife's side, and they have the money, but are very NON-complaint when it comes to their meds. I like your style!
norjud profile picture
Yes, I worked for Parke-Davis, Sanofi (Marion Labs in 1980's), AstraZeneca.

So, yes they need some BP to help. Docs will use statins first for most pts. as they can get them very cheaply...then Vascepa on some pts. It won't be easy, as many primary care docs, have...STOP...seeing all drug reps. Esp. in big cities with BIG hospitals.
norjud, I'm not worried about doctors NOT prescribing Vascepa.
Most doctors do not want their patients to die or have strokes &
heart attacks needlessly. Peer pressure will do more to get doctors
on board than anything a sales rep can do. With a number needed
to treat of 21, what doctor would want to take the risk of not having
their qualified patients on a medication that is essentially harmless.
What doctor would want to risk having an attorney coming after him
if any of his/her died of or had CV events after a number of years
because he did not have his patients on Vascepa? I still believe that
BP sales reps will result in much faster and broader market penetration.
Most sales reps have an established clientele of doctors who they have
a relationship with. If that rep brings samples of a new Cardiovascular
medication that saves lives and reduces events, along with the literature
to back it up, what doctor would not listen? As to the big hospitals in
big cities, well they don't want to be sued....
norjud profile picture
FYI: I think Vascepa will easily hit your numbers. It will take some time. What do you mean by "BP"?
On the high chol. front if a pts. is over 240 chol. reading the almost all docs will offer something for the pt to take, because if they don't and pt has MI....well it's on the doc then. I know many pts. who should not be taking statins, but the doc convinced them.
I think this stock is easily $30/share by end of year.
norjud, "BP" is an abbreviation for Big Pharma which
includes massive, multi-national corporations such as:
Pfizer, Amgen, Novartis, and Sanofi, to name just a few.
Jeffcad was making the point that if Vascepa were in the
hands of BP, they would be able increase market penetration
of Vascepa far faster and much further than AMRN ever could
in a "Go It Alone" scenario.
Charles Lyon profile picture
BP is big pharma.
norjud profile picture
I launched Lipitor for Parke-Davis. We had head to head trials with the other statins, for lowering LDL. Lipitor clearing won that battle. PLus the NCEP guidelines came out about the same time and said the>>>>>Lower the LDL....the better. It only took Lipitor 6 months to be the market leader. PLus we had NO outcomes data. Only Zocor & Pravachol had data. FDA would not allow other statins to compare against placebo.

That's why Vascepa data is so....GREAT. It is on top on a statin. If I was a diabetic or needed my Trigs lowered this is a NO brainer.
Two major hurdles: Many docs already have a view on Vascepa...not good at reducing Trigs., and second many of these pts. already take many meds., and don't take meds like the doc told them to.
I think it will do well and hope the docs see how good this drug is....
jeffkad profile picture
Norjud, here’s the thing I keep coming back to. Statins penetrated >50% of eligible users. There are now roughly 40M statin users. Vascepa only needs 5% penetration (2M Rx) of statin users to do ~$3.6B net revenue (after discounts, etc). Even at 2.5% penetration (1M Rx), Vascepa will do ~ $1.8B. Even with all the obstacles you and others have pointed out, how in the world do they not hit this low penetration level? And in the hands of BP...?
NDHT profile picture
Good article and comments.

Still hoping to see that AMRN, Esperion and The Medicine Company merge with each other to become a CV powerhouse, not at the mercy of a big pharma.

You "little" guys can do this. You can grow bigger and beat those Goliath's!
NDHT, What Vascepa needs most of all is Big Pharma
sponsorship (with the FDA & European Authorities) and
Big Pharma distribution. There should be no doubt that
Vascepa is a future blockbuster drug which in time could
rival Humira as the best selling drug in the world...but to
get there will require a massive, worldwide distribution
network. The runway is 10 years as of this August. Just
imagine what BP could do with thousands of reps detailing
Vascepa just in the US (compared to the 400 reps that AMRN
has right now.) Think of how many more lives will be saved
and devastating Cardiovascular events prevented if BP gets
on board sooner rather than later. Ultimately, Vascepa will bring
health care costs down as the total number of at risk patients on
Vascepa increase reducing the number of costly procedures to
treat strokes and heart attacks. If John Thero decides to "Go
It Alone" it will be a costly blunder not just for AMRN shareholders
but for patients who would otherwise die or have odds of more
events without the drug. Hopefully, Mr. Thero will do what is best
for patients, employees, and shareholders. Yes, very real human
lives and health are at stake.
sts66 profile picture
If people die because of lack of awareness of V it will be the responsibility of their doctors for not keeping up with medical advancements, not AMRN's fault for not advertising it enough - and if ACC/AHA guidelines aren't updated with R-IT after formal FDA approval there will be blood on their hands as well.
Great script numbers again! Almost certainly they will have to increase the guidance.
west281356 profile picture
Drop the Mic. Wonderfully thorough article.

I can’t wait till this gets approved so that my wife can take it.
Charles Lyon profile picture
Thanks. An open minded doctor would prescribe it off-label now, before the FDA label expansion. Given them a copy of the NEJM paper, and point out that the benefits were consistently strong over the whole range of trig levels and for different intensities of statin, indicating very probable strong benefit even for those without high trigs and for those not taking statins. The anti-inflammatory effect is also worth mentioning for many other ailments. Most insurance will cover it. I've taken it for years off-label for $9/90 days with Amarin discount card available on their website.
sts66 profile picture
"Most insurance will cover it."

Definitely not true - and especially wrt to Medicare Part D - either on expensive T4 or not covered at all.
Lee Briggs profile picture
@sts66 - I have United Medical's Optum drug coverage and it covers off label, no questions asked.
jammastermike profile picture
my penny pick up 211% today... made some bank, baby!
@jammastermike which stock is that? Looks like AMRN will hit $21 by Friday so the $18 calls for this week that I touted at 18 cents will be $3- 1500%!
I would skip the pps predictions. You lose a lot of credibility when they don’t come true.
jammastermike profile picture
CR144 Research profile picture
Bhavneesh failed to bring down Amarin price. On the other hand he lost large part of his credibility. So it was not really worth it.
@cr144 Check out the volume in this week's $18 calls, HUGE volume, something big is up, I think those go from 18 cents to $2 in the next 4 days. 11 bagger!
10 Feb. 2019
I have a medical degree and I am a practicing physician. I own amrn. I have no idea if it will pay off or not. I do know it lowers triglycerides significantly. Whether it benefits my pocket remains to be seen. I am very happy for the results it provides my patients. It dramatically reduced levels beyond what fish oils ever have such as the Res-q products that cost so much more. For this I am thankful.
sts66 profile picture
You have patient who had lower TGs on V than they did on Lovaza? That's a bit odd if true, since EPA/DHA is better at lowering TGs than EPA alone - perhaps there was better compliance given the zero side effects of V compared to the fish burps and GI problems L can cause?
Charles Lyon profile picture
In an expert panel discussing the REDUCE-IT trial, they noted that the trig reduction was only a fraction of Vascepa's benefit, and other factors (inflammation, plaque reduction, etc) provided the majority of the benefit.


The Amarincorp.com website has a FAQ page that discusses the many modes of action.

Ive been taking V for 4 months 1gm BID, my trigs went from 328 to 198, Ive increase to 3gm daily and went on Crestor 10mg for hight LDL. The pain is my damaged knuckled gone. We need the snda
teachamantofish profile picture

Potential catalyst there of course. I've asked on other boards if and when an early result might be forthcoming. The "rumor of March" mentioned above is difficult to trade on. . . 3rd Q 2019 is the projected timeline for full results. Please post if you have info other than a guess that 9 month results might be released in March.

My DD started here: www.sciencedirect.com/... Interesting year ahead. Profitable too I hope.
Charles Lyon profile picture
Hard to guess about EVAPORATE timing. CHERRY results give a pretty good idea results are likely to be positive. I consider it to be important but less so than the REDUCE-IT results, which showed that Vascepa works. EVAPORATE will help explain how/why it works.
jeffkad profile picture
EVAPORATE named a P4 trial. Not sure the significance.
teachamantofish profile picture
They're going to study the existing data and get more data from existing subjects. For example, the effect on certain populations, ethnicities, sex and other factors. Could possibly lead to the discovery of more benefit and label expansion. There are more knowledgeable posts over on Ihub.
astute pathways profile picture
Insider selling tells you no buyout is near

That's a reasonable assumption but how would they know that? I sold most of my shares when the R-it results were published but I'm still holding some in case of the unknown. Unless I missed something, none of the AMRN execs have sold all their shares.
Insider sales are automatic sales and have nothing to do with any BO or not,imo. GL
sts66 profile picture
"In a careful review of media coverage, I found no claim to the contrary by any scientist, including Sharma."

That clown is not a scientist - no evidence he even participated in clinical trials, especially given his lack of understanding of p values and the incorrect belief that all cause mortality has any importance in a CVOT like R-IT.

What's with all the double and triple parenthesis around certain terms and acronyms? Made reading this a tad irritating to the brain, which kept asking "WTF is up with that?" - you do not need parenthesis around FDA or SPA - the oddness goes on whether the term is a hot link or not - very weird - I assume some artifact of the software editing you used, although this issue was missing from your first SA article. Not trying to nitpick,but I did quite a bit of proofreading and editing in a prior life and mistakes like that stick out like a sore thumb to me.
Charles Lyon profile picture
Sharma presumably has a medical degree, but doesn't seem to know the difference between OTC drug and dietary supplement, which is disturbing. Had a formatting problem I think is fixed now, sorry about that. I was mortified it went out that way, took a while to fix. Still getting used to Seeking Alpha, and not great help for new authors re nuts and bolts. Getting the hang of it though.
sts66 profile picture
The number of people, from medical types to layman, who don't understand the difference between OTC drugs and dietary supplements is staggering - even after being informed of the diff when the subject comes up again they make the same mistake time and again - it's like their brains refuse to learn or remember, a sort of mental block. Glad you got the formatting problem fixed!
CR144 Research profile picture
I've seen many Bhavneesh's articles in 2016 and at that time he was extremely bullish on many biotech stocks. It seemed like almost everything was a buy. Obviously many of those stocks performed quite badly, some even being a total failures (eg Cempra).
So now I was quite surprised seeing Bhavneesh as a cheerleader for shorters on Amarin.
minddeal profile picture
Initially my comment was great article, old data, but the comments and your responses have cleared up several questions I still had about Vascepa. Up until now I was a little worried about what could stop Amarin/Vascepa from becoming a blockbuster drug. Now I'm convinced it will be even bigger than some of the original pie in the sky claims and it is just a matter of waiting it out.
After reading numerous reviews by Vascepa users I find that there are many other applications for Vascepa and expect more label expansions by the FDA.
The only thing I can't find is the weekly prescription data. Where is it?
Thanks again.
Charles Lyon profile picture
I get my scripts updates from the iHub AMRN message board on Fridays. A couple links:




Note that there was bad weather and a 3 day meeting of all sales staff recently that may impact the numbers. I expect increasing momentum for sales, although, of course, FDA approval of the oabel expansion will be a big factor. Probably no DTC ads with trial results until then.
minddeal profile picture
jeffkad profile picture
As I mentioned in comments to a previous article, the metrics around Vascepa are pretty encouraging. It is likely that V will become the standard of care as a bolt-on to statin use. There are ~78M Americans who are statin candidates. Roughly 40M use statins. Since V’s results appear to actually be trig level agnostic, there is value to pretty much every stain user. AMRN only needs 5% penetration of the US stain user population to do 2M prescriptions. At roughly $1800 annual net to AMRN per Rx, 2M Rx means $3.6B. This does not include Canada, Europe (another 30M+ statin users), and India and China (and the rest of Asia). Certainly outside the US, net will be significantly lower as gross prices are much lower plus partnership cuts, but the numbers are still compelling. For all the non-believers (MO objectors, and any-fish-oil-supplement will do), there is still 95% of the market to point to in order to justify your position. While you do that, AMRN will be racking up $Billions in revenue. Not a bad story.
Charles Lyon profile picture
Thanks for contributing those relevant facts and insights.
So,in conclusion,Sharma was wrong,is wrong, and will be wrong in any future hit piece...just saying,facts matter,not fear and lies.Good job Mr.Lyon:)
Charles Lyon profile picture
ganj1948 profile picture
Great article! I just wanted to add another fact about the mineral oil red herring. LDL-C has been proven to rise with age, so it makes sense that it would increase in the placebo arm of a trial that lasts several years. Vascepa has been shown that it can reduce LDL-C, so the treatment arm did not experience this increase.
Charles Lyon profile picture
Thanks. Good point about LDL rising with age. I think I mentioned that in my first article and may have forgotten it in the second in an attempt to streamline. It's a small factor since the controversial LDL increase is over the first year, but it's one more piece of the puzzle.
javings profile picture
A well constructed article CL, taking into account recent events.....look forward to additional updates, as hard data come in, but be prepared for a rocky ride.
Charles Lyon profile picture
Thanks. Since I weathered the 2013 adcom, I'm hard to shock.
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