On a risk / reward basis ....For those at risk ...Statins provide a lot more reward with a lot less risk
With Niaspan ( Niacin )..it's the opposite .. the risk clearly out weighs any reward
I am amazed at how slow moving or perhaps dysfunctional , part of our health system is .
No one should be on Niaspan ( Niacin ) The recent final data from the Thrive trial clearly shows that risks outweigh benefits .....yes ...Risks outweigh benefits . Yet patients or their MD's seem to be on some automatic script renewal program where by these patients are still prescribed Niaspan.
What is frustrating is that Vascepa offers a superior and safer alternative . Hopefully this will change within 30 days , when I expect Dr Jenkins of the FDA to at least expand the label for Vascepa ...and in doing so ,give his blessing for wider use for those with cardiovascular risk ....the same patients now on Niaspan should be on Vascepa
Ps ...I was prescribed Niacin for years ....hated the stuff.
Re Lovaza ...it's was Dr Chowdhurys comment that a similar effect on TG's was seen in Lovaza's clinical trial .
She accepted documentation from Amarin that the lt wt paraffin oil they were using was inert .
This oil was selected because it was colorless and thus matched the appearance of Vascepa .
If you google Dr Chowdhury FDA Amarin or Marine trial ...EPA drug initiative site etc ...you should find her comments . Further digging and you'll probably find the research docs used to support the lt wt mineral oil
I believe it's Dr Chowdhury ( not Chowdury ) and I don't think she is necessarily an expert on light wt mineral oils . Rather , on behalf of the FDA she reviewed the data provided by Amain and noted that the trial for Lovaza showed a similar effect .
Remember , this is the Marine indication approval debate ( no Statins involved )
The issue is now whether lt wt mineral oil will affect the rate of absorption of the Statins in the a Reduce It Trial .....ie make the Statins less effective in the Statin plus placebo arm.....thus making the Statin plus Vascepa arm look better.
As Jesse Livermore has written on IHUB ...it would be fairly easy to run a short trial if necessary to determine lt mineral oil effects on Statins .
If Statin plus Vascepa is more then 20% better then Statin plus lt mineral oil ....I don't think it will matter much
Vascepa is the most patient friendly CV / lipid altering drug I have ever taken .....and I have taken almost all of them at max doses since 1985 .
I'm just stating a fact ....not trying to pump AMRN or it's chances with the FDA
Niacin was one of the worst ( Colestipol) before Statins was no fun either ) for me....Severe flush reactions from Niacin and stomach upsets from Fibrates
Most CV drugs were approved because they improved risk markers ( LDL , TG , HDL ) etc . I took Statin drugs a max dose for years before the Jupiter Trial proved that Statins lowered CV events
Re your comments about the FDA rushing in . Well the drugs improved the risk markers they identified and adverse events were limited ...so on a risk / reward basis it was let's approve and also insist on Outcome trials.
Well the outcome trials came back as showing little benefit ( except for Statins ) so the FDA understandably became more cautious ....first rule " do no harm "
So now comes Vascepa and the FDA are thinking " Hmmm...fish oil ...no proven CV benefit in a US population so why don't we wait this time for an Outcome trial result first "
And that's where we were until the NEJM articles on the role of TG's and APOC3 in heart disease.
That research rocked the boat , even for Dr Nissen ,Chair of Cardiology at the Cleveland a Clinic....
So now IMHO the FDA ( Dr Jenkins in particular ) are thinking that there may be benefit here after all and on a risk / reward basis why not expand the label for Vascepa ( more insurance coverage ) until we get the Reduce It trial results
JMO ...not advising anyone to buy or sell , do your own DD etc etc
Quick note on Niaspan and Tricor.
No one should be on Niaspan / Niacin ....risks outweigh benefits ....final conclusion of the Thrive trial .
Less clear ( from memory ) on Tricor but I believe it's of little benefit to Diabetics who are also on Statins ( Accord trial )
Both these drugs moved surrogate risk markers in positive directions ( lower TG 's , raised HDL ) etc BUT did not lower rate of CV events .
It's their method of action that's the problem. Niacin use saw a rise in La Plaz2 ...an enzyme that's associated with small LDL particles embedding in the arterial wall . Yes you get better HDL and TG numbers but unfortunately you also appear to get more small LDL particles stuck in your coronary arteries.
EPA ( Vascepa ) benefit IMHO appears to be its method of action where by it gradually reduces the amount of coronary arterial plaques or at least makes them less prone to rupture
Remember that Reduce It is an event driven trial ...All that matters is , Does Vascepa and a Statin reduce events more then just Statin alone .
Whether the surrogate risk markers are goosed one way or another , won't matter ( IF they are goosed at all )
I suspect that a modified label might say some thing to the effect that " available evidence suggest benefit for diabetics , those on dialysis, those with precious MI's and those with hetero FH etc ....beyond that we await the results from Amarins Reduce It trial to confirm wider benefit "
Thanks for the detail
Note .. in light of ALL the available evidence ( ie including , I would assume, the recent NEJM research on TG's and APOC3 )
What are the chances of getting $ from the govt over a corrupted Adcom ...lets see ..snow balls chance in you know what . Sorry I can't think of a better metaphor..
Since this thread is on the bear thesis ...I'll put forward that perspective .
Amarins management were over confident prior to Adcom. Joe Z had been quoted as saying the FDA had never rejected an application for wider approval once an Outcome Study was sufficiently underway....implying that Anchor was a done deal .
In fact , those that bothered to read the tea leaves ..in the form of comments by Dr Nissen Chair of Cardiology at the Cleveland Clinic ..would have read that the FDA was unlikely to approve a new drug for the 24m mixed dyslipidemia market solely on the basis of lowering high Triglycerides , without evidence that that actually lowered CV risk .
So whats changed ?
The NEJM articles on TG and APOC3 and their role in CV risk.... Dr Nissen now comments in referring to this research " This is a big deal he says. Both his study and Amarins have a better chance of success ...." indicating a shift in attitude ...that evidence was accumulating that lowering high TG's in those at risk would lower CV events
Yes we have learn't the hard way not to take anything for granted...especially with small cap biotechs and the FDA...which is why I'm only 70/30 in favor of at least an expanded label ( as opposed to 90/10 )
I think there is a "harm by omission " concern possibly creeping into the FDA's thinking.
ie .....If we agree that there is no harm in allowing wider prescription to those most at risk ...we must recognize thats there is then potential harm in NOT allowing wider use for those at most risk ...harm by omission....if we believe there could be potential benefit .
My probability of the FDA allowing at least an expanded label for Vascepa ( ie may be of benefit to Diabetics etc ) is 70 /30 in favor . Part of my reasoning has to do with the fact that at least 30,000 patients currently use Vascepa every month and there are another 7,000 currently enrolled in the Reduce it trial.
To date , no adverse events have occurred. Now I agree that the possibility of an adverse event was extremely low but Dr Haitt ( going from memory ) had raised the issue of risk of bleeding , particularly cranial bleeding ...whether that might occur in some one ,once large numbers started taking 4 gms of Vascepa.
That concern should hopefully be laid to rest ...so on a risk / reward basis alone ...its hard to argue against some expanded approval.
Regarding the Marine indication ( TG's over 500 ) . Here I disagree with most who are long AMRN.
When patients have a high risk of pancreatitis ( usually TG's over 750 ) ...getting the TG's down the most is the prime concern . Lovaza at max dose , lowers TGs more then Vascepa at max dose . Many of these patients will also be on Statin therapy that mitigates the rise in LDL to some extent .
So only those patients with very high TG's and who are intolerant to Statin therapy or have uncontrolled LDL levels still ,despite Statin therapy ....are likely to be prescribed Vascepa ....when Pancreatitis NOT Cardiovascular disease is their immediate concern.
So I doubt if you will ever see $500m in sales for Vascepa in the Marine ( very high TG ) indication alone.
There is only one reason to be long AMRN IMHO ..and thats for the Anchor indication ...reducing Cardiovascular risk ....and even then I doubt you will see anywhere near $25 a share unless we have extremely generous insurance coverage enabling patients to get 4 gms of Vascepa for under $2 a day .
And now the Bear Thesis
Amarin is in a slow financial death spiral that they will only escape if the FDA allows Vascepa to be prescribed on label to at least high risk patients such as those with previous heart attacks , diabetics or those on dialysis ,
OR the Reduce it trial is stopped for efficacy before they run out of $ , which at present ( without a huge jump in sales ) is IMHO early 2016
Amarin will never survive on the Marine indication ( very high triglycerides ) alone . This is largely due to their debt obligations , principally the $100m they "borrowed " from Pharmakon to launch the sale of Vascepa .
This $100 m loan is actually a $150m loan when all the payments are considered and is supposed to be paid back on an agreed on schedule ending in 2017 .
Rather then paying back the loan at the agreed payment schedule , it appears Amarin is forced to take the least painful option and pay a lot lower rate based on % of sale .
This basically converts this " loan " ...to a credit card type loan with an interest rate of 12-14% ...which they warned could happen in their 8K filed 12/12/12. So in 2016 , unless the SPA is reinstated or Reduce it comes in early ...Amarin will still owe $100 on this loan and facing interest payments ALONE of $12-$14m with little reduction in principal. Failure to make payment means they are in default and Pharmakon gets to sell Amarins patents ( which they are holding as collateral )
JMO ...appreciate informed opposing views , do your own DD , not advising to buy or sell ...etc etc etc
First the Bull Thesis.
At a $1.65 a share AMRN is basically a speculative bet on first , the FDA re-instating Amarins Anchor SPA which may lead to some comprise allowing on label prescription for diabetics , those on dialysis and other high risk patients. Second , Amarins Reduce it Trial being stopped for efficacy in late 2015 .
The most immediate issue for AMRN longs are the chances that Dr Jenkins , head of the FDA's Office of New Drugs reinstates Amarins Anchor SPA . IMHO based on the recent New England Journal of Medicine articles on the role of triglycerides and APOC3 in cardiovascular disease and a change in language in response to letters that I and others in the EPAdrug initiative group have recently received from the FDA
Recent communication indicates that the FDA are now reviewing ALL the scientific evidence rather then limiting themselves to the 3 trials cited in Adcom ,that they used to state that no current evidence supports CV benefit from lowering high triglycerides..
Add to that the constant barrage of citizen petitions , fax's to the Senate and Congress and finally a demand from Congress that the FDA explain their guidelines for revoking an SPA ( Special Protocol Assessment ) especially if no new health hazard has been identified .... add it all together and you have a speculative bull thesis why the FDA will reinstate Amarins Anchor SPA and AMRN would go a lot higher.
Next the Bear Thesis ..... Do your own DD , not recommending either buying or selling ...appreciate informed opposing views
Oh I'm still here .
I'm not interested in any stock fraud and I agree with Adam Fuersteins recent article that a bullish argument can be made for a speculative bet on AMRN at these levels.
But like I have always said ...do your own DD , dont risk more then you can afford to loose , stay diversified.
And you can call me anything you like ...except Sue ( and old Johnny Cash line )
Amarins Vascepa is FDA regulated as a drug. Your dietary supplement is FDA regulated as a food ..quantity and quality of the EPA will vary
With Amarins coupon and great insurance coverage , Vascepa is costing many as little as $19 a month ..ie about $54 c a day
The closest dietary supplement alternative EPA will cost you about $2.50 a day for an equal amount of EPA
Dietary supplement EPA is delivered by mail ...in my case when I tried them ...left on my driveway all afternoon on a hot day ...care to guess the quality of that EPA . It was returned to Amazon .
Vascepa I get from Walgreens ...stored in a protected cool environment.
So Vascepa is the gold standard .....BUT now a kind word on dietary supplements .
Without insurance or Amarins coupon Vascepa , 4gms daily , cost about $8 a day .
No one , including myself , will be paying that price when good quality EPA dietary supplements are avaliable , such as Omegia Via EPA for about $2.50 a day for 4 gms .
Amarins success depends on getting wider FDA approval AND generous insurance coverage to make Vascepa affordable.
You are correct in that most fish oils off the shelf will have some effect in lowering Triglycerides .
OK ..so now identify which ones have any clinical evidence in reducing heart attacks and at what dose .
That takes you to the GISSI trials and the JELIS trial
Both trials have their problems ...GISSI because many were not on Statin drugs to begin with but many were by the end ...Jelis because it was open labelled and patients were not a max dose Statins
So here we have Vascepa at 4gm daily dose of EPA .
This is far more intensive then anything you will find "off the shelf " and has far ranging effects then simply lowering triglycerides
As an example ...recent clinical trials have shown that those entering dialysis that have a low EPA / AA ratio are at far higher risk of a heart attack then those with higher EPA / AA ratios.
Vascepa and EPA at 4 gm doses is about a lot more then simply lowering triglycerides