Amarin Corp Plc (AMRN)

[HDGabor]

P-

Didn't think I needed to split hairs to that degree, lol. Okay, sorry, yes Lovaza and its generics.

LOL It looks like you does not have any clue how plans handle generic vs brand.

biggest in the US.

Much better to use the most recent ... (UnitedHealth) Your 2016 Prescription Drug List effective July 1, 2016. Omega-3-Acid Ethyl Esters Capsule (generic L) and Vascepa have a same: Tier 3 with PA. Lovaza isn't covered.

Also, see pg 19

(John Hopkins).
- "Tier 1: Generic drugs have the lowest out-of-pocket cost for members and are placed on Tier 1." ... no brand-name on Tier 1
- "Products are listed by generic name with brand name for reference only ... Generic drugs are listed in bold in the formulary" - omega-3 acid ethyl esters is bold, icosapent ethyl isn't -> generic L *Tier 1( and Vascepa (Tier 3) is covered, Lovaza isn't.

Also, generic Lovaza tier 3, vs Vas tier 4 (pg 37) ... we don't find Vas higher than Lovaza or generic anywhere.

Did you realize that meanwhile O3 is generic it wasn't classified as T1 or T2? Furthermore it has PAR, V does not have. "Prior Authorization: Our plan requires you or your physician to get prior authorization for certain drugs. This means that you will need to get approval from our plan before you fill your prescriptions. If you don't get approval, our plan may not cover the drug.". Meanwhile it is true, V has a same Tier as gL. Furthermore, I think you could find any brand vs generic drug (for the same indication) example where brand has a higher Tier than generic.

You're saying it was (mean?) 220 for the whole group, or for the 1,075 enrolled after the 5k were already enrolled?

Sorry, but you have:
- dyslexia or
- other damage or
- do not know what is mean and median
(I hope you did not continue the discussion without reading the slides ...)

Amarin Presentations for the October 16, 2013 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee is B&W:
- the first 6,075 qualifying TG level was: median 202 / mean 220 (slide CO-70)
- "increased TG enrollment threshold to >= 200 / May 2013" (slide CO-74) - around app. 5,000
- "median TG since amendment is 230 (slide CO-74)

Based on this we KNOW:
- 3,036 w 150-202
- app. 538 w 200-230
- app. 1,915 w 200-500
- app. 1,964 w 202-500
- app. 537 w 230-500

Wrt baseline EPA levels and ANCHOR or MARINE vs R-IT, do you think control in R-IT will have baseline closer to MAR or ANCH? And why? What would you guess it will be?

Are you serious? I have to ask again: Do you have a clue about Amarin's studies?
- MARINE: >= 500 mg/dL and <= 2000 mg/dL, 4g mean: 680
- ANCHOR: >= 200 mg/dL and <= 500 mg/dL, 4g mean: 281.1
- REDUCE-IT: >= 150/200 mg/dL and <= 500 mg/dL, 4g mean (@6,075): 220

So, R-IT mean will be definitely 220+, but more likely (at least) 230+. So closer to ANCHOR than MARINE, which had a lowest limit equal with the highest limit in ANCHOR / R-IT ... OMG. Furthermore, TG reduction is the part of the total only, EPA / V is more than TG reduction.

Lov is better at reducing TG counts anyway ... It also helps that it's tier 1 on most/all plans. I have yet to see a plan that puts Vas higher than Lov (or generics)

Really? For your consideration (Baseline TG / % Change vs. Placebo):
> TG >= 500
- Lovaza: 816 / -51.6%
- Lovaza: 655 / -14.0% (head-to-head study of OMTRYG vs. LOVAZA and placebo)
- Vascepa: 680 / -33.0%

> ANCHOR >= 200 - <=500
- Lovaza: 268 / -23.2.6%
- Vascepa: 281.1 / -21.5%

A lot of plan puts V higher than L, as does not cover L (only gL, mostly in the same Tier - see United Health ... biggest in the US ...)

You would immediately identify what group you were randomized to. If no change, or slight increase, maybe you would drop out (assuming you got mineral oil), maybe you would take additional n-3 supps (despite protocol saying not to), or ...

- Acc. to the protocol: "Blinding

[0116] This is a double-blind study. Patients, investigators, pharmacists and other supporting staff at the Research Sites, personnel and designees of the Sponsor, study administrators and personnel at the organization(s) and vendors supporting the study will be unaware of the randomization code (i.e., they will not know which study participants are receiving the experimental drug and which are receiving the placebo drug). The study medication AMRlOl and placebo capsules will be similar in size and appearance to maintain blinding.

[0117] During the double-blind treatment/follow-up period, everyone (patients, investigators, pharmacists and other supporting staff at the Research Sites, personnel and designees of the Sponsor, study administrators and personnel at the organization(s) and vendors managing/supporting the study), with the exception of the laboratory personnel performing the analysis, will be blinded to individual results of the efficacy laboratory measurements (including lipid values). Individual results from the lipid profile may be unblinded in the event of an emergency for a patient." Unless the patient pay for a test somewhere else (top of the free test), they do not know. Not likely ...
- Significant drop-out affects the study, but the planned number (7,990) wasn't increased. "Before completing the enrollment phase of the trial, i.e. approximately 3- to 6-months prior to the projected enrollment of the 7990th patient, the actual event rate based on pooled, blinded accumulation of primary efficacy endpoint events will be calculated and plotted. If those analyses suggest the number of patients with at least 1 adjudicated, primary event (and appropriately accounting for patients with potential primary events for which the adjudication process is then incomplete) is consistent with projections, then the study could continue toward the protocol-specified target enrollment of 7990 patients."

On Lovaza scripts, they remain much higher than Vas.

Yes, but the difference is smaller and smaller, week by week (off-label marketing takes time). Don't forget: the approved indication is TG >500 for both, targeting TG only, and L affect is faster and looks better (on paper - see baseline TG above) for this purpose.

But I said you guys can have the last word, and I intend to stand by that

It isn't about last word, it is about truth and facts. You constantly post false / wrong information and claim them as a fact ... How could be your opinion seriously taken, meanwhile you aren't know the basic.

Best,
G