Unfortunately you are not him. Don't know much about Ostroff but there is always a good possibility (since he was appointed to the post) that he is of the same mindset has his predecessors.

We all respect JL's posts, however, in this case AP I tend to buy into you argument because as you indicate not only was it one of the paths forward mentioned by JZ but he had just done the same a few years prior with Omacor.

He said in his last post he has left on vacation.

Your personal study is of course just that, an individual response. But from the figures you post the only thing worthwhile taking is BOTH while individually both appear to work poorly. Of course you did not post any numbers while naive.

I used to prefer the old Sean Penn line: Cut off their head and shit down their neck.

Ray you ask a good question re: 1.8gm dosage. I believe that was also the dosage used in Jelis so for some reason the Japanese zero in on this dosage.

There are many secondary endpoints in the Cherry study that I find interesting and believe can give us insight into R-I. The key of course is MACE, but it will be interesting to see the lipid levels and markers of inflammation EPA/AA and CRP.

About the "when"..... assume like most that it mostly likely only comes after interim or full results of Reduce-It - your idea as well???

Coming before R-I results I would think would need something like Anchor, not to mention that I don't believe your target would be offered without some indication about Reduce It results.

AND if reports are true NCE was possibly the major sticking point preventing a sale of the company back in late 2013.

Very impressive.

Staccani,

Excellent rebuttal - just read it. Great job.

You could very well be right. The posted date on the thing is March 26, 2015 although that does not mean the date it was written.

Poor article from Motley Fool:

http://www.fool.com/investing/general/2015/03/26/should-investors-toss-in-the-towel-on-amarin-corp.aspx


Should Investors Toss in the Towel on Amarin Corp Plc?
By Todd Campbell and Michael Douglass | More Articles | Save For Later
March 26, 2015 | Comments (0)

Investing in biotech is a risky business, and investing in emerging clinical stage companies doubly so. Many investors have jumped on the enticing bandwagon of the next blockbuster drug, only to have their hopes dashed before the promise is fulfilled.

This health care edition of industry focus looks at one such case, discussing what investors hoped for, how the company's progress was derailed, and what potential still remains for the company and its drug to one day become the success story investors hoped they were buying into a decade ago.

A full transcript follows the video.

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Michael Douglass: Amarin Corporation (NASDAQ: AMRN ) A buy? A sell? A hold? This is Industry Focus.

[INTRO]

Hi Fools, health care analyst Michael Douglass here with you today, and I am on the phone with one of our best contributors, Todd Campbell, from New Hampshire. Todd, how are things going this week?

Todd Campbell: Everything's going really well. I appreciate you asking, Michael! How are you?

Douglass: Pretty good! There's always something new and interesting going on. That's one of the things I always love about biotech.

Actually, today we got a question from a listener. Folks, be sure to send us an email -- industryfocus@fool.com -- if you ever have anything on your mind. I don't dispense relationship advice, but aside from that we're always happy to talk about stocks!

One of our listeners, Jim, writes, "I wonder what you guys think about Amarin, my biggest loss to date. I would like to get your thoughts. I just want to understand the huge loss and the volatility in the last weeks, and any info would be greatly appreciated." Jim, thank you for your question. We'll go ahead and try and untangle the company a little bit.

Now, before anything else, I want to emphasize a couple things. First off, we don't give individual investment advice. I think we're always, as Foolish investors, interested in talking about the company and about a company's opportunities, and its competitors and its threats.

And of course we have our own personal opinions about whether a company is a great investment or is not a great investment. But we can't tell you what you should do.

The other piece that I want to highlight is that folks on this program and The Motley Fool may have positions in companies that we're talking about. They may be recommendations in the Fool newsletters, Todd and I may own them -- neither of us owns Amarin.

But you should never make an investment decision based just on what you hear. Always do your own due diligence. I think that's a really critical part of investing Foolishly, and investing intelligently for the long term.

With those caveats out of the way, Todd, let's talk about Amarin Corporation.

Campbell: Amarin is a great example of a stock that had so much promise. It was so enticing to investors a decade ago that it soared. It had the whole world out in front of it. It's the poster child of a high risk/high reward stock that went on the high risk side. As a result, the shares went from $30 about 9-10 years ago, to a low of about $1.

I feel the pain here. I think anyone who's invested in emerging clinical stage biotech stocks has had one of these in their portfolio; a company that has a lot of promise, but when push comes to shove, despite overcoming all of the hurdles in front of it -- getting an FDA approval, getting their fish oil drug, Vascepa, to market -- this has not been a winning stock.

There are a lot of reasons for that, but it's a great reminder of the risks that are inherent in this space, that face investors.

Douglass: Let's talk about Vascepa. I think I've put out this caveat before, but to everybody listening, pronouncing things in biotech is difficult. Is it Va-seppa? Is it Vis-keepa? Is it Vis-keppa? Not sure, so we're going to go ahead and run with Va-seppa, just for ease.

This is a fish oil pill, and it's for severe hypertriglyceridemia. Try saying that three times fast!

Campbell: Exactly. On the name game, it's tomato/tomahto!

Yes, basically what we're talking about here is a drug that was designed to help reduce the risk of heart disease. The thinking here was that if we can reduce triglycerides, maybe we have a better shot at reducing the number of people who end up eventually having either a stroke or heart attack or some other cardiovascular event.

The thinking here is pretty solid, if you look at the success that statins had. It's hard to blame investors for getting excited about this stock and wanting to own it 10 years ago, when at the time Pfizer's (NYSE: PFE ) Lipitor was raking in $12 billion a year in sales as a statin for lowering cholesterol levels.

There were a lot of reasons to have high hopes that Vascepa would, once it got FDA approval, roll out and become a much more widely used drug than it is today.

A couple problems happened along the way, though. First off, the original approval for this drug was, as you said, in very high triglycerides. You're talking about I think 500 mg/dL or up. That's a very small patient population.

Douglass: Tiny.

Campbell: Yes. According to the company, there are about 3.5 million people that fall into that camp, and about 3.8% of them receive medical intervention or treatment. So, you're only talking about a total addressable market of 130,000-140,000 patients. It's not a big indication.

The hope was to win approval in this, and then continue some studies, and then go and try and get a label expansion that would broaden this drug to a much wider audience.

Unfortunately the game plan went as it should, if you will, until late 2013 when the advisory committee for the FDA was evaluating expanding the label to this larger population, and voted 9-2 against doing it until it had ... we'll call it "unequivocal efficacy data" from that trial.

Basically, Amarin was hoping that they could get the FDA to approve it on a first look at the data. Instead, the FDA said, "No, we want to see the full data set," and that's not going to happen until 2018.

So you went from a potential to expand your patient population by 10 times -- it would have been about 1.4 million people that this drug could have reached -- to now saying, "We don't even know if we can get it approved, and it's going to be at least five years before we can even find out."

Obviously, that's frustrating to investors. It means a tremendous amount of operating expenses have to get spent on these trials, without having any corresponding income coming in.

Vascepa's not a bad selling drug. It's growing. It did $16.5 million in sales last quarter; that's a 70 million run rate, roughly. Analysts think that this drug could do $90 million in 2015. It could do $190 million by the end of '16, maybe even more.

You've got a drug that is going to bring in revenue for the company, but the expenses for these trials are just so high that there's no sign of profitability ahead.

Douglass: Right, and when you look at cash burn, if I'm looking at their balance sheet correctly, they burned $72 million in cash from operations in the 12 months leading up to December 31, 2014, and they ended 2014 with $120 million, I think, in cash and short-term investments.

You do the math there and that runway seems to indicate that they might have to do a capital raise or something like that moving forward, which usually means dilution for shareholders; not exactly a great position to be in when you're a company without any real positive catalysts incoming.

Campbell: Right. We've seen this before. Dendreon's (NASDAQ: DNDN) Provenge jumps to mind. You've got a commercial product which that the market doesn't quite deliver on. Lofty expectations, the company's saddled with a lot of debt. Eventually it becomes hard to keep going in its current form.

I'm not saying that that's going to happen here with Amarin. They have money in the bank. Yes, they have a lot of debt and if you look at cash, as you said it's about $120 million. The debt's about $227, but they can handle that debt for now, and the revenue is increasing.

But there's just a tremendous amount of risk in this stock. It's become incredibly volatile over the course of the last few months, as people start saying, "Yes, but what's the real value?" and "Shouldn't it trade up ahead of the potential data release?" and "What if it can get that expanded label in 2018?"

This is a very ... I'd call it a "gamey" stock. Investors, for the most part, should avoid those kinds of games because they could just as easily one day walk in and have it up 50%, as walk in the next day and have it down 50%.

Douglass: Right, and as you mentioned with the past, Amarin's been trending on the downside.

This is the kind of stock that I would personally only be confident investing in if I knew and trusted the science, and if I was very sure that it would outdo competitors -- in the case of competitors.

Preferably, you'd have even a drug that has none, and has none on the horizon, and that's really not so much the case with Amarin and with Vascepa. For me, it's definitely the sort of stock that doesn't fit in my brand of investing.

Campbell: Yes. We get $147 million -- just to correct myself earlier -- in analysts, for sales, looking ahead for 2016. That's not horrible, but it's a far cry from the blockbuster numbers that people were hoping for back when the stock was trading in the $20s and $30s.

I think that it's a great opportunity for us to just remind everyone; we've all been there and we've all done that. You have opportunity costs. You get into a trade, it doesn't work out, the stock falls, you've lost money.

You don't want to admit the mistake, but you have to realize too that there are a lot of opportunities out there from here. You have to say, "Okay, from today, is this the place that gives me the best opportunity for the future?"

You have to look at that saying, "That's sunk cost for me. Maybe now I need to look at it and say, 'What can I do going forward?' instead of 'Where have I been?'"

Douglass: Sure. I think, Todd, sometime you and I are just going to have to sit down here and chat about some of our failed past investments. It would probably be useful for folks to hear about them. Cool.

Well Todd, that's all the time we've got for today, but thanks for your thoughts. I think this is definitely a stock that we would both tend to stay away from. It doesn't really fit in with our general framework, particularly for new biotech investors.

Folks, as always, thanks for listening. Feel free to shoot us an email: industryfocus@Fool.com, if you have any questions or any thoughts, or just want to give us some feedback on the show. We're always glad to hear that.

Stay tuned for Industry Focus tomorrow, and Fool on!

Michael Douglass has no position in any stocks mentioned. Todd Campbell has no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.

If what you say is such a certainty you would think we wouldn't have to do the trial. Also one would think our pps would reflect that.

To further add, I would have to say that with all the evidence I have seen my guess is that V will be successful in Reduce-It but no way I can count those chickens before they have hatched as I have seen all kinds of sheet happen.

Thanks for the heads up STS.

Weird - for my mind anyway.

FDA says we cannot even sell V as a help to those trying to lower trigs for those under 500 and need some kind of outcome studies to prove cardiovascular benefit before we can.

I copy the following from a Quest Diagnostics site and they out and out state that higher EPA levels in the body equate to lower cardiovascular risk. Does the FDA know they are saying that?

"Treatment Considerations

The cardiovascular disease risk associated with various omega-3 indices are shown in the Table. The risk levels are based on quartiles of the reference population. Those in the lowest quartile are at high risk, those in the second and third are at moderate risk, and those in the highest quartile are at low risk.

Table: Interpretation of Omega-3 Index Scores

Interpretation of Omega-3 Index Scores

Consumption of foods high in omega-3 fatty acids (EPA and DHA), over-the-counter supplements containing omega-3 fatty acids, and prescription omega-3 fatty acids can increase the omega-3 index. An omega-3 index below the therapeutic target suggests either patient non-compliance or an inadequate dosage in individuals being treated with omega-3.

An arachidonic acid/EPA ratio and/or an omega-6/omega-3 ratio close to 1 suggests a good balance between the prothrombotic/ proinflammatory omega-6 FAs and the more protective omega-3 FAs. High ratios suggest a need for dietary modifications (decrease in meat, eggs, and dairy products and an increase in fish intake) and/or omega-3 supplementation."


Looks like the table did not paste. The link is:
http://www.bhlinc.com/clinicians/test-descriptions/Omega-3

Also does anyone know where I can get an AA/EPA blood test (saw something about a finger prick) and what would it be called? TIA

And even if Reduce-It is a success, she will then say that it was only proven in conjunction with a statin.

Thanks STS,

Interesting but unfortunately not much on the "this might". Just one Australian company mentioned and not sure if they are publicly traded or not.

Not sure if anyone has access to this journal. Critique of statin studies:

http://informahealthcare.com/doi/abs/10.1586/17512433.2015.1012494

So is that "total event number" communicated to them on an as it happens basis, or monthly or what?

TIA.

You are sure correct about the form of vitamin D.

My wife was put on a prescription version of vitamin D (ergocalciferol -vit D2) and it has raised her vitamin D level very slightly. My doc, who happens to be the wife of my wife's doctor, simply called me one day after looking at my lab report and told me to start taking vitamin D and left the details up to me as she knew I knew my stuff. Needless to say I started taking the cholecalciferol D3 form and by the next time I had my blood work done my levels had zoomed way up actually a bit past the upper limit.

Asked her why her husband put my wife on the D2 and she just got defensive, flustered or whatever and I never did comprehend her answer. Oh well.

Could, not sure where you have been but there have been a plethora of great buying opportunities. I believe most long term holders here are hoping for no more buying opportunities.

Zu would you say that there was not a very big difference between their low and high EPA/AA ratios?

0.29 vs 0.39. I would think the epa/aa ratio in the Japanese is considerably higher. Anyone have any ideas how much EPA incorporated daily would raise the ratio to the 0.39? Obviously it depends on where the starting level is and what amount of AA they consume.

Expansion of use of statins -- more customers by treating younger people. They would need an outcome study for me to buy in.

Reminds me a little bit of how high blood sugar has been treated. I can easily remember when a fasting blood glucose reading of anything below 140 was considered OK and no meds required. Then they lowered the threshold to 126 and now I have heard physicians say that if you blood sugar is above 100 they would start people on meds. Just get them to eat right and exercise.

Can Bavi have a role here?

http://www.dailymail.co.uk/health/article-3005816/Is-miracle-cancer-vaccine-Scientists-hail-breakthrough-treatment-game-changer.html

So what happened? I mean was the last sentence ever followed?

" “I am sure that those of us who have responsibility for drawing up the next CHF guidelines will pay a lot of attention to the results of this trial,” he said. "

Of course statin supports will point to other studies to validate their case. But ultimately Big Pharma can push a lot of stuff. The wide variability in study outcomes has me thinking that Reduce-It is not as slam dunk as everyone here thinks. I take fish oils (and eat oily fish) but one never knows about A particular study.

I remember back I believe in the late 90's reading about a study ( I believe NEJM) which showed that Plavix was such a miniscule amount better than aspirins the authors concluded that when including cost of drug into the picture that it would be folly to take Plavix. I surely thought that was the death knell for Plavix. HA. Since then Plavix sales have grown immensely.

Raf,

This is the situation. The cholesterol screening that you were subjected to was one in which the LDL was not DIRECTLY measured. There are labs that measure LDL directly and others that use what is called a "calculated method".

Under the calculated method, it is taken that TRIGS divided by 5 equal your VLDL.

Then your LDL = Total Cholesterol - HDL - VLDL.

In your scenario with Total = 276, HDL = 34 and Trigs = 406 the calculation would yield LDL = 161, so your doc's calculation or estimate is off.

BUT BUT here is the thing. When TRIGS are HIGH (like yours at 406) then that relationship of VLDL equal to 1/5 Trigs does not hold very well. In that case there would not be much confidence in the calculated value of LDL.

Stay completely away from simple carbs and alcohol for 2 to 3 weeks and redo the blood work.

Rafun,

My first question would be what was the last triglyceride reading you go on your previous bloodworm and how long ago was it? Does it jive with this 406?

Secondly there are a lot of BCBS. Mine is the federal version and in the basic plan they have Vascepa listed as Tier 3 which means there is a 50% copay.

I would call them.

North,

I think you are both right in regards to the statement. The label is currently as they say, but you are also correct that the doc can do as he/she pleases.

Motley Fool story this morning. They talk to say nothing.

http://www.fool.com/investing/general/2015/03/17/why-amarin-corporation-plc-burst-today.aspx


Why Amarin Corporation Plc Burst Today
By Todd Campbell | More Articles | Save For Later
March 17, 2015 | Comments (2)

Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.

What: A week after announcing a marketing deal for its fish-oil drug Vascepa with a Chinese distributor, investors decided that Amarin Corporation plc (NASDAQ: AMRN) has run a bit too far, too fast. After more than doubling so far this year, shares in the company tumbled more than 15% earlier today.

So what: Investors' pessimism exiting 2014 has turned to optimism in 2015 on hopes that lackluster sales for its triglyceride lowering drug Vascepa can turn a corner.

Following news that the FDA had tabled a potential label expansion for Vascepa in October 2013 that would have significantly enlarged its addressable patient population, shares in Amarin had collapsed from $6 to less than $1 exiting 2014.

Sales of Vascepa climbed 17% quarter-over-quarter to $16.5 million in the fourth quarter, bringing full year sales to $54.2 million, up 105% from 2013. Importantly, the company's cost-cutting helped reduce its year-over-year losses too. SG&A dropped by $44.5 million last year, leading to a drop in net cash used in operating activities from $190 million in 2013 to $72.3 million in 2014.

Investors have also cheered news that the company had locked up an important deal with Eddingpharm ltd to develop and commercialize Vascepa in China. As part of that agreement, Amarin got a $15 million upfront payment and could eventually earn an additional $154 million in milestone payments, plus royalties.

Now what: Clearly, Amarin has had a remarkable move, but investors may want to pause before jumping in and using today's drop to buy. Although Vascepa's sales are growing, they're limited by the narrow label for use in hypertriglyceridemia, a rare form of high triglyceride levels. Amarin is also hamstrung by high expenses tied to the ongoing REDUCE-IT trial that it's conducting to eventually try to win that important label expansion. As a result, while the company's expenses have fallen, it's still burning through cash. For that reason, while things have been going Amarin's way so far this year, I'm content to keep watching this one from the sidelines.

Thanks Zu,

I wonder if anyone knows how their high EPA (>56 micrograms/ml) stacks up against what Reduce-It active group would have since they are taking 4 gm per day?

Yes Zu good find. Although I wonder if this also lends credence to the idea that ultimate market share for Vascepa will not be as high as some of the wild predictions here?

Unfortunately nothing above my neck (and probably below) working very well this Monday morning, so I can't seem to find the criteria of subjects in this study but the event rate for the placebo arm is seemingly much lower than what we are expecting in Reduce-It so are these very healthy patients compared to sicker subjects in Reduce-It?

What gets my goat the most are those supplement companies that market their fish oils as "pharmaceutical grade". As far as I know (I haven't checked the last couple of years) the United States Pharmacopeia has no specifications for such.

If stock price bounce back exceeds which fibonacci level do we then think the downtrend is over.

I am assuming after the retrace -either 50% or 61% then the downtrend resumes.

Bio,

I'll second that motion on the sardines. Used to eat them as a child and then for decades never had any and now I am back to my old childhood habits. Not cheap but cheaper than salmon .

Zu,

I understand that olive oil has about 10% omega-6 and a tiny amount of omega-3 fats but I assume that the monounsaturated fats (of which olive oil is mostly made up of) are not considered either an omega-6 or omega-3. Is that correct?

I wonder if we could get at least the same benefit from V in the Reduce-IT study as this one for the Med Diet. Of course different since it was not versus a statin:

http://www.nejm.org/doi/full/10.1056/NEJMoa1200303?query=featured_home

Whalatane,

To piggyback onto your comment about statin users, a portion of those on statins are on generics.

You talking Par Pharmaceutical?

STS,

Thanks for your input and testimony. I have long been familiar with DHEA and its nature of being a precursor hormone. Unfortunately it seems that clinical data is mixed - insofar as increasing testosterone in older guys - women yes. Here is one:

http://www.ncbi.nlm.nih.gov/pubmed/9876338

Now there are so many variables one does not know if there was something particular about this group of men that did not show an increase in testosterone. (or at least they did not say how much of an increase).

Your testimony runs counter to that and it seems that the biological cascade in the body leads to DHEA before becoming testosterone. It could very well be that some individuals have trouble with the conversion. I have not had my DHEA or DHEAs measured only T. When things calm down a bit I plan on having them checked. Thanks for the info.

Whalatane,

You were lucky.....only one winter in Montreal!!

I was born and raised there. Left in my mid-twenties for warmer climes.