Amarin Corp Plc (AMRN)

[rosemountbomber]

OT: Reality sometimes stranger than fiction. Read today where the IRS has awarded a 7+ million dollar contract to Equifax for fraud prevention. Come on. I hope someone proves this to be a hoax.

[jessellivermore]

md34...

Quote "What are your thoughts on whether they owe Amarin anything for this mistake and if so, how you think they will “make it up to them"?

These are very good questions and I have spent some time thinking about this..

FDA is a bureaucracy, hierarchical in nature...FDA employs over 15,000 employees so there has to be a good deal of delegation of authority. So what happens when subordinates make mistakes, or in this case when a subordinate makes a colossal blunder and promises or guarantees get reneged because carrying out the promise would lead to unacceptable consequences.

This question goes all the way back to Greek Mythology...In the myth of Phaeton and the Chariot of the Sun...

Please understand there were people (private individuals) on the MBs in early 2013 that said the FDA would not grant the mixed dyslipidemia label without seeing a convincing CVOT (completing RI), Posters like myself thought the FDA would never renege on an SPA simply because it was congressional creature.

So the issue must of come up...Certain BPs would have made certain FDA understood the issues, and how fragile was the proof, if any that EPA, would reduce CVD event risk in this group...And this indeed turned out to be the famous Mary Parks question to the SPA panel..."Considering only the ANCHOR trial results only...How confident are you that Vascepa will lower CVD event risk"...This was a directed question because the ANCHOR trial addressed only blood chemistries and said nothing about the efficacy of the drug...

The FDA made a mistake in offering a label expansion for a drug which no scientific or clinically convincing evidence it worked...

FDA being a bureaucracy did not admit it made a mistake..It did go into CYA mode. It never considered that it owed Amarin anything...because Amarin should have understood the folly of receiving such a windfall not based on solid evidence...

FDA did break their word and like a bully they did use the power of a sovereign agency to stone wall the company and prevent them from seeking remedies in the federal courts...as a shareholder like many others on this board I have been injured like you...

Still I believe the right thing was done...Vascepa needs R-I...If Amarin had been able to force V down the FDA's throat I believe the medical community would have boycotted the drug as the issue of clinical proof would raised over and over again...Better that our proof is beyond the pale...

Patience the time is comming...

":>) JL

[Whalatane]

Concapak well this may surprise you but I largely agree with your post

I was on max statin therapy long before there was a CV Outcome Trial to prove benefit from statin .
Yes Statins reduced LDL and most THOUGHT that it would also reduce CV events ...so we took it in the hope it would .

I feel the same way about ADCOM and Vascepa .

I think V should have been approved at Adcom for the patient population at risk ...and then authorization recinded if R-IT does not show benefit .

If R-IT shows at least 20% RRR then you have to wonder how many patients and familes could have avoided CV events and strokes , if V had been approved for the Anchor indication.
JMO
Kiwi

[rafunrafun]

C - People usually revert to name-calling when they lose an argument.

Anchor was about TG reduction, nothing more. Is there any evidence (even upto present) that reducing TG reduces CVD? NO. So why should ANCHOR (TG reduction, NOT CVD reduction) be an FDA approved indication?

[Nukemtiltheyglow]

I thought it might be a new Sea food using Polyps instead of scallops. You know these Foodies, they always got to try something weird and different.

What kind of wine is suitable do you suppose? Red or White?

[concapk]

Raf:
Are you being a blockhead or just you being you....

SPA'S are conditional contracts to begin with... as long as a company follows FDA proticals setup between the two and monitored for safety throughout... the REDUCE-IT study was already underway...

The ADCOM question was changed to produce a negative response .... the FDA changed from TRIG lowering to an add on to statins producing results that the cvot would show one way or another 4 years hence...the question wanted a solution on the spot, which could only be shown on REDUCE-IT RESULTS 4 YEARS LATER.

[HDGabor]

Black Knight ...

It is not necessary.

Best,
G

[Whalatane]

HDG U seem to be experiencing some confusion today ..

I can forward you her direct email if U like , and you can ask her directly ....provided you do so respectfully .

Kiwi

[Whalatane]

North. Trial is to see if EPA reduces the development of colon polyps
Anyone who is scheduled for a colonoscopy to Chk the re growth of polyps would be interested ...if the trial shows benefit
Kiwi

[rafunrafun]

C - but anchor was simply about TG lowering, and to date, we have not seen definitive benefits of such.

Also, how do we know about its safety without the CVOT?

[concapk]

Raf,

Vascepa was safer than an aspirin..... the FDA could have put a condition of approval to maintain the SPA to protect the consumer if any side effects were to occurr.... thus the SPA contract could have been maintained....
The FDA so stated that a conditional approval would be hard to rescind...thats "BULL"... the FDA almost bankrupted Amarin and in doing so would have possibly kept one new drug from coming to the market...a drug that hints of various outstanding results.

The FDA was manipulated by internal and external forces to keep Vascepa from coming to the market...the ADCOM was a setup to rescind the SPA... I have been in the market for 40 years and AMARIN'S survival is a miracle...

[HDGabor]

K-

She said "being used as the active EPA oil in a phase III clinical trial ongoing in the UK (the SeAFOod polyp prevention trial)" , now she said: "Pharmepa RESTORE is a 90% rTG EPA that is identical to one that was formulated specifically for use in the SeaFood Polyp Prevention trial".

The trial is using 500 mg gastro-resistant capsule formulation of EPA as the free fatty acid (FFA) ... ALFA™ capsules [SLA Pharma AG]. The available info about ALFA is limited, but ..."ALFA is a 99% pure, oral formulation of the omega-3 polyunsaturated fatty acid, eicosapentaenoic acid, (EPA) as the free fatty acid"

How could be 90% rTG EPA identical to 99% pure (EPA) as the free fatty acid?

If you see these as identical: just for you, just for now ... I have an identical Mona Lisa for $100.000.

Don't be the Black Knight ...

Best,
G

[dmlcento]

His reply will be something along these lines, "I don't have time right now to explain, but can you tell me why the earth isn't flat."

[north40000]

"SeaFood Polyp"..what is that, if you know?..Doesn't sound like a medical use.

[Whalatane]

HDG right ...PharmEPA RESTORE is only identical to the one formulated for that trial

that is identical to one that was formulated specifically for use in the SeaFood Polyp Prevention trial.

Other then that they have nothing in common

Kiwi

[ziploc_1]

D:........ "But here is where the FDA went astray . Instead of acting like adults , they went all cloak and dagger . They should have been honest , up front , and admitted they made a mistake".

Eric Coleman and Mary Parks wanted a promotion, not a reprimand, and thus, instead of admitting a mistake,they planned the Adcom ambush to cover their tracks......They made plenty of additional "mistakes" in this fiasco......As is often the case,the cover up is worse than the crime.

[HDGabor]

K-

I am a little bit "confused" ...

You "really don't know if these "DS" are drugs or not", but you know
-"an obvious remedy is that they will be forced to change their labeling"
- "The FDA now permits this statement: “Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.” for (e.g.) OmegaVia

Please explain ...

Best,
G

[HDGabor]

K-

I think Dr Nina Bailey answered your question, no more doubt exist ...

STS Are you saying Dr Nina Bailey is lying ?

Yes, she is lying ... trial is not using PharmaEPA RESTORE

Best,
G

[sts66]

Jesus H....I cannot believe Niacin is still even allowed to be sold based on the SAEs from that trial - it can cause diabetes!

Effects on Other Adverse Events

Assignment to niacin–laropiprant, as compared with assignment to placebo, was associated with a highly significant excess of participants with fatal or nonfatal serious adverse events (7137 [55.6%] vs. 6762 [52.7%], P<0.001), with many participants having more than one serious adverse event (Table S5 in Supplementary Appendix 1). The largest excesses in serious adverse events (nonfatal and fatal combined) were related to effects on glucose metabolism (Table 2Table 2Effects of Niacin–Laropiprant on Selected Serious Adverse Events and Diabetes., and Table S6 in Supplementary Appendix 1). In an analysis of the 8299 participants who had diabetes at the time of randomization, assignment to niacin–laropiprant, as compared with assignment to placebo, was associated with a 55% proportional increase in disturbances in diabetes control that were considered to be serious, most of which led to hospitalization (11.1% vs. 7.5%, P<0.001). In an analysis of the 17,374 participants who did not have diabetes at the time of randomization, assignment to niacin–laropiprant, as compared with assignment to placebo, was associated with a 32% proportional increase in the diagnosis of diabetes (5.7% vs. 4.3%, P<0.001).

[Danburydude]

I agree the FDA realized too late they made a bad agreement with the AMRN SPA . But here is where the FDA went astray . Instead of acting like adults , they went all cloak and dagger . They should have been honest , up front , and admitted they made a mistake . They should have gone to AMRN and renegotiated a new SPA . AMRN has suffered damage because of how the FDA acted . Imagine how much healthier the stock price would be today if investors knew an iron clad renegotiated SPA was in place when the results of REDUCE - IT are announced . Instead , investors are a rightfully skittish because the FDA did a bumbling hatchet job to cover the fact they are the ones that screwed it up in the first place .

[sts66]

The cynic in me says the insurance company[bean-counter actuary] would rather see you dead immediately[despite losing the insurance premiums you might pay for the next 20 years], rather than bearing the cost of the psck9 for perhaps the next 20 years

Perhaps.....but these days you're much more likely to survive an MI than drop dead from one, so in reality not keeping patients as healthy as possible with any drug that can reduce CV/stroke risk should theoretically save money in the long run. PCSK9's aside, of course, at least until they are proven to prevent MI's instead of just reducing LDL-C to ridiculously low and potentially brain-harmful levels.

[rafunrafun]

I am confused how he found the time, because according to him, he doesn't have the time to read the complaint in full.

[Biobillionair]

ITC and FDA workshop regarding prescription drugs...
Here:https://www.ftc.gov/news-events/press-releases/2017/10/ftc-conduct-workshop-november-8-examining-competition-issues

No doubt Amarin ITC action got this issue moving forward.

Meeting pertains to generic drugs and not DS...I think the FDA will take enforcement action with Amarin respodants if Gottleib is involved early.

BB

[north40000]

Perhaps that will be a source of raw material for use in Amarin's patented compositions and methods of making and using V. What else would they contemplate?

[north40000]

Your propensity to truncate or skim- read quoted material is = to NOT truthful and misleading information being imparted to readers of this message board

[Dancing in the dark]

opinion re calibration underway, thank you.

[dmlcento]

Well, we might as well all sell now. Whal has done it. He has cracked the code. He has found the smoking gun. There is no coming back from this. AMRN is doomed. Congrats Whal, but so sad for the rest of us.

[Whalatane]

STS Dr Nina Bailey ..PharmEPA responds

-----------------------------

Thanks for getting in touch. Our product Pharmepa RESTORE is a 90% rTG EPA that is identical to one that was formulated specifically for use in the SeaFood Polyp Prevention trial. ( my highlight )

The lead investigator of that trial was responsible for gaining the Investigation al Medicinal Product Dossier (IMPD) required for the approval of the product in clinical trials by the competent authorities in the EU. The trial product was awarded the IMPD in 2014 and the study I believe is now complete with the result expected to be published next year.

Hope this clarifies things for you

Best wishes

Nina
--
Nina Bailey BSc Hons, MSc, PhD, RNutr
Nutrition Scientist
Registered Nutritionist (UKVRN 6624)

Igennus Healthcare Nutrition - Manufacturers of specialist EPA fatty acid supplements

--------------------------

[G550driver]

Not to mention L raises LDLs and can cause AFib !!

[Whalatane]

STS I was referring to Pharmaepa RESTORE

but never mind .

Re Omegia Via EPA 500 .....so an obvious remedy is that they will be forced to change their labeling to

..." restore EPA levels that are deficient due to our western diet ....not intended to treat disease etc beyond the FDA notification that consumption of high quality " fish oils " supports improved cardiovascular health "

In case you missed it


The FDA now permits this statement:

“Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.”

Kiwi

[HDGabor]

r-

if I ff you correctly

??? I could not be wrong ... I copied / pasted the published results ...

LOvaza has 45% reduction Vascepa 27%

What a "surprise"..., you compared the result from baseline 816 vs 680 and missed the 655 vs 680 ... Lovaza has 26.8% reduction Vascepa 26.6% in this case ... meaning Lovaza is 0.75% more effective in lowering trigs than vascepa - yea that is not very significant ...

Best,
G

[ralphey]

SO if I ff you correctly in trigs >500-

LOvaza has 45% reduction Vascepa 27%

Meaning Lovaza is on a rough guess about 66% more effective in lowering trigs than vascepa - yea thats not very significant

[ralphey]

Of course not that's like patients who are treated for htn come back and say well my pressure is now under control so i dont need the med

[HDGabor]

h-

I suspect they’ve tried to get something approved in this arena. Since nothing has come of it, I suspect FDA is again keeping AMRN from promoting anything other than high TGs.

I do not suspect anything, but I do not think that new element of off-label promotion (if any(thing was requested)) should be disclosed (PR or 8-K).

I am certainly sure that if FDA is trying to keep Amarin from new, requested off-label promotion (acc. to the settlement agreement) Amarin will go back to the court w/o any hesitation.

Furthermore, the outcome of the ITC won't affect the off-label promotion / settlement.

Best,
G

[ralphey]

A funny story ...

When we first discovered that ASA was useful I was working ER. I had a gentleman come in with massive ST elevations in the throws of an MI. I looked at the EKG turned to the nurse and said give him an 81 mg aspirin immediately and went out to write more orders.

The guys eyes widened and I could read his face - 'the ole take two aspirin and call me in the morning routine he thought " he was in shock and thought I was a quack . After getting orders written nitro drip going morphine etc etc I sat and talked with him about the rationale for the ASA and he felt more at ease after our discussion

Unfortunately I have been around long enough to remember the days before stenting . When UK went to nationalized health the standard of care was if you walked into an ER with a stable MI you were given an aspirin and sent home !!

[HDGabor]

r-

OTC's should be required to perform double blinded studies

Please try to use OTC and DS (dietary supplements) words correctly, since your posts are confusing for members who know what is OTC and what is DS ... since the two aren't the same, OTC is a drug.

What are over-the-counter (OTC) drugs and how are they approved?

OTC drugs are drugs that have been found to be safe and appropriate for use without the supervision of a health care professional such as a physician, and they can be purchased by consumers without a prescription. These drugs are sometimes approved under applications like new prescription drugs, but more often they are legally marketed without an application by following a regulation called an OTC drug monograph.
An OTC drug monograph tells what kind of ingredients may be used to treat certain diseases or conditions without a prescription, and the appropriate dose and instructions for use. OTC products that meet a monograph’s requirements may be marketed without FDA review. OTC products that do not fit under an existing monograph must be approved under an application like the applications for prescription products.

Best,
G

[HDGabor]

B-

If the FDA felt that lowering trigs in the 200-500 range was worthless ... no credible science in the period after the SPA came out which would refute the clinical benefit of lowering trigs ... allow the FDA the "out" they used

Please note: As I am not a "medical person" (maybe) my words won't ne medically / scientifically correct ... but the meaning will be.

To consider TG as a valid / confirmed surrogate marker the relation between TG reduction and event reduction should be unquestionable ... independent from the type of the drug(s) and / or the MOA of the drug(s). TG wasn't a valid / confirmed surrogate marker ever, but was a "candidate / suspect" at the time of the SPA. The extent to which TG directly promotes CVD or represents a biomarker of risk has been a subject of long-standing debate, result of the studies have been mixed (low or non TG reduction resulted in event reduction, meanwhile stat. sig. TG reduction did not come together with event reduction).
I am not aware of any proven result about "clinical benefit of lowering trigs". The ACCORD-Lipid, AIM-HIGH, HPS2-THRIVE weren't relevant regarding EPA (Vascepa), but were as TG reduction and / or as add-on therapy to statin (see previous paragraph above). The result of these studies increased the level of uncertainty re. TG as a surrogate ... "moved" the answer toward "less likely" ... it was enough for the FDA to change their mind / require more evidence for event reduction. Please note: meanwhile ANCHOR / SPA was about TG reduction, the target had not been a TG reduction ever ... it was the event reduction ... nobody would like to reduce TG just for fun ...

I do not think R-IT will decide the status of TG (is it a surrogate or not), since it will be one additional result only, among others (to avoid any confusion: I mean it strictly about TG reduction) it won't change the TG science significantly.

To avoid any doubt: I did not like FDA action ... but I see / understand them ("fair is fair, science is science" ... it was not personal or political implications and complications) and the SPA rescission was a logical (more evidence is necessary ... unfortunately I did not see it in advance) and legal (they are authorized by the law to do it ... and the law does not require "new clinical evidence", lack of evidence - and it is / was the case - is enough) action.

I agree w u: None of this matters of course. What happened, happened and we're waiting on ITC and RI now

Best,
G

[ziploc_1]

J.L......."You and BB feel it was personal...I don't...The FDA did what they had to. It was never about Amarin or JZ...It was a "business decision"

I agree with you, but I'm reminded of Mafiosos, who kill someone, saying "it was nothing personal, just business".....Just because it was nothing personal just business, doesn't absolve the FDA from the crime.

[md3434]

What are your thoughts on whether they owe Amarin anything for this mistake and if so, how you think they will “make it up to them“?

[heysfguy]

An ITC/1A connection? Thinking "aloud" here for your input:

Since AMRN has settlement about negotiating up to two off label promotions per year with the FDA, I suspect they’ve tried to get something approved in this arena. Since nothing has come of it, I suspect FDA is again keeping AMRN from promoting anything other than high TGs.

Rather than take this back to court, AMRN looks at what DS companies are allowed to promote, and files an ITC complaint. This forces the FDA to publicly declare its position on supplements vs. drugs. Once settled - either way - AMRN may have a clear path for taking this 1A promotion back to court - or at least forced FDA’s hand to approve an off label use.

Anyone else feel there’s a strong connection here?

[ralphey]

This has been going on for years - more snake oil is being sold today than at any other time - if the FDA wants something to do they should crack down on all these claims being made by the OTC's OTC's should be required to perform double blinded studies to prove what they say. Right now they are making billions and need prove nothing.

There are people advertising magic crystals on ebay to "help" with cancer, magic copper strips, magic foot pads that suck the 'poisons' out of your body and detoxify you - and oh dont forget those horrible 'chemicals' (as if your body and everything around you is not a 'chemical'). I find these people to be vile taking advantage of peoples desperation to line their own pockets

[sts66]

what you wrote says "Can I make claims about...disease prevention?" And the answer is "Yes...as long as the statement doesn't imply that your product can... prevent a disease." Anyone else see the problem?

Yeah, if he copied *exactly* what that FDA reg says (don't have time to verify), that's a really strange statement - contradictory beyond comprehension. If a DS mentions that EPA has been shown to be helpful in managing high TGs, and the product contains only EPA, what other conclusion can you come to but that the DS is claiming to treat or prevent the disease of high TGs, even if they don't specifically say "our product will lower TGs"?

[UFO]

Is there a drug on the market that's just purified DHA?

UFO

[sts66]

So the DS that states that their supplement is to restore appropriate EPA levels since our modern western diet is deficient in them .....and then goes on to state in bold print
" This product is not intended to diagnose , treat , cure or prevent any disease "

But that's not what OmegaVia 500's website says:

https://shop.omegavia.com/products/omegavia-epa-500

EPA-only formula is ideal for:

Mood health
Manage inflammation
Triglyceride management
Skin health
Helps with children's behavior

Specific Health Conditions

For triglycerides: Take 6 capsules a day
For inflammation: Take 4 capsules a day
For mood disorders: Take 4 capsules a day
For skin health: Take 2 capsules a day

They're clearly making claims for treating disease states.

And the statement "This product is not intended to diagnose , treat , cure or prevent any disease" appears nowhere on that page - even if it did, it would be similar to that Star Trek episode with Harry Mudd that ends with the classic "Liar's Paradox" scene where Kirk tells an android "Everything Harry says is a lie", then Harry tells the android "I'm lying", making the android's head literally explode from the endless loop of the paradox.

[rafunrafun]

B - pretty certain he's talking about that this enabled him to buy him more (cheap) shares. He would not have had these shares if not for the rescind.

[rafunrafun]

B - yes, CVOT had to have been substantially
(or 50%) enrolled. But I strongly believe that it (the SPA rescind) was not about face-saving but about doing the right thing. And to them (whoever 'them' is, whether its the WH, FDA or Congress), the right thing was not to have the drug available for 36 million people until there is undeniable proof of its effectiveness.

[Bolio98]

raf as far as I recall ANCHOR had nothing to do with CVOT. So no face saving required if it went forward.

[sts66]

The FDA now permits this statement:

“Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.”

"EPA and DHA omega-3 fatty acids" = the naturally occurring form of fish oils, FFA-EPA and FFA-DHA. It does not say "EPA and DHA omega-3 ethyl esters" or refer to rTG form either. This is further confirmed when they mention "improve their health by identifying foods that contain these important compounds (EPA and DHA)" - clearly they are talking about foods and food additives (GRAS), a determination which EE-EPA and rTG-EPA have not been granted by the FDA. In contrast, the EE forms *have* been approved by FDA in V and L, as drugs, not GRAS.

[rafunrafun]

B - I am positive that there were political implications and complications at stake - we obviously don't know the specifics. I cant defend the FDA's move of granting ANCHOR SPA - could simply be because different people were charge. But lets go to the step where someone (FDA? WhiteHouse? Congress?) has realized that the FDA should not have an approved indication for 36 million people until they have definitive evidence (CVOT). When that realization has occurred, what should have been done?

[Bolio98]

one rag

For me at least, it's (ANCHOR SPA rescindment) the best thing that could have happened. Hopefully someday you will feel the same.

You'll have to explain that one to me. I see no way that was the best thing. All you have is a depressed stock price since that time and probably greatly reduced scripts as well.

The outcome study being "substantially underway" was always part of the process as I remember. I did not think of the competition aspect, but it does not matter to me. The SPA is a contract and, to me, there was no new clinical evidence, which would allow SPA action, that had any bearing on what ANCHOR was supposed to be reviewed for.

None of this matters of course. What happened, happened and we're waiting on ITC and RI now.