Amarin Corp Plc (AMRN)

[HDGabor]

mrmainstreet & jimmyb & Danburydude & zumantu & ggwpq

I woke up now, to avoid ’jet-leg’ on Sunday evening

Scripts:

First of all, to understand my approach: the TRx contains 3 elements: refills (1st and 2nd,, 1 and 2 months after the previous script), renewal of scripts (3 months after the original script, inc. in NRx) and new scripts (inc. in NRx).

I am a little bit confused, what is going on. The refill was disappointing during the first 2 weeks (last week is not really relevant since effected by Christmas week), meanwhile the NRx’s trend is good. (btw: I am expecting lower refill for next (this) week as a result of Christmas and year-end week.)

The total O3 (V+L+gL) number is - more or less - flat: 06/21 – 91k, 12/19 – 90k, 01/16 – 88k

The next five weeks will give some clue / answer. I see a chance to reach 5k next week and 6k -6,5k by end of February (NRx).

KOWA:

They are dealing with low volume writers and 250 reps are visiting 60k physicians, meanwhile 130 V reps are visiting 20k. Both suggest that the effect could not be imminent and significant from one week to the other. AMRN / JT is happy with their performance and they have much detailed info than us.

I did not use the Symphony Health Solutions’ system, but based on its description PrescriberSource™ provides a very detailed information to measure V and K reps’ performance.

Outlook:

Depends on script# and NCE we could see $4-7 pps, on a short term (till R-IT interim), however I do not think it is relevant. The important things are:
- patents and
- R-IT interim result

Patents:

AMRN has 40+ patents. Meanwhile, not all of them equally important, I think at least one key will hold, since
- the USPTO check the validity before grant it
- AZN did not challenged the patent itself

R-IT interim result:

Meanwhile we do not have the proof for V eff. and especially for eff.%, we know a lot of data / info about the key element (EPA, 4g, TG, population) and we could guess / assume the result, i.e.:
- EPA: JELIS confirmed the eff.
- 4g: ANCHOR (and Marine) confirmed that 2g is not enough, 4g is necessary, so previous studies with 2 or less gram are not really relevant
- TG: Life-long low TG was resulted in lower CVE
- Population: Acc. to FDA in May, 2011 – “Accord-Lipid’s subgroup and some subgroup analyses from other fibrate cardiovascular outcomes trials also raise the possibility of cardiovascular benefit in patients with elevated TG (+ low HDL-C) levels at baseline.”
- R-IT’ SPA: was changed due to lower than expected event rate. The placebo anticipated event rate (5.2%) was based on previous studies placebo or active arm, so I assume it is a precise rate, so the lower event number could be the result of higher eff.% (more than 15%)

Based on these I expect at least 20% eff. (p < 0.001, power 93%) and it will be enough for DMC to recommend the stop. 25% is much better, since in this case the power will be 99%.