Jeff $AMRN Doc Call Takeaways: More Utilization Likely
Given Strong Data Despite the Noise

We hosted a call with two CV experts to discuss the REDUCE-IT data. Conclusions:
1) Strong view on efficacy and safety, 2) understandable questions from some
on minor if any impact of placebo and 3) increasing utilization given broad
enrollment across populations. The experts viewed the data as outstanding
although we appreciate the stock has been up significantly recently and there
is some investor uncertainty on the data. (*Email us for replay info*)
Overall, the docs' high level take on the study and data were summed up in
using the words ￿superb￿ and a ￿grand slam￿.....The key positive from the doctors'
point of view, was that Vascepa is no longer just a lipid modifying drug, but more importantly
a broad CV-risk lowering drug, since the data demonstrate a clear and beneficial reduction
in CV events and across both a primary and secondary prevention population. Notably, the
experts were encouraged by the fact that there was benefit in patients irrespective of TG
levels (both high and lower). In terms of safety, the experts were not worried about minor
incidences of atrial fibrillation etc, and characterized it as ￿not clinically meaningful in terms
of utilization.￿ They both stated the data was almost ￿as good as it gets,￿ and the only thing
that could have topped it would have been a stat. sig. reduction in all cause mortality.
Some biomarkers moving around and the debate around control arm mineral
oil isn't overly concerning and wouldn't have driven a big impact versus overall
large 26% MACE improvement......The 2 KOLs were not overly concerned with any
impact of the use of mineral oil in the control arm as a placebo and laid out several points:
1) LDL fluctuates over time, especially in the course of a long trial such as REDUCE-IT and in
previous outcomes trials such as ODYSSEY, there was an increase in LDL in the control arm of
larger 10% and in others you see a decrease, so it's difficult to draw any definitive conclusions;
and using the LDL/CVOT linear slope r'ship, this minor LDL change would have only a minor
impact if at all; 2) In terms of hsCRP, the correlation with reduction CV risk is imperfect as previous
trials such as CANTOS showed an association when at high levels but in others such as ACCORD,
the trial failed. The marker can change with a variety of different things and is not a a validated
CV marker. In REDUCE-IT, the elevation of hsCRP in absolute terms was small and minor if using
the log-hsCRP scale which was pre-specified and accepted which removes outliers in the noise of
the measurement....also, when looking at relative change it appears much greater because the
baseline levels (denominator) were very low to begin with; 3) Concomitant and subsequent drug
use such as the use of diabetes drugs, may have contributed to some of these fluctuations,; 4)
Changes in patient weight and diet would also impact hsCRP; 5) The experts felt the magnitude
of changes in biomarker parameters in the control were minimal relative to the overall CV risk
reduction. Separately, on the AZN STRENGTH trial, KOLs stated they looked forward to the
results (likely early 2020) in order to shed more light on the omega-3/fish oil mechanism
and to answer questions on the effect of EPA vs DHA, given Epanova is a mix of EPA/DHA,
whereas Vascepa is pure EPA...They agreed that colleagues and respected KOLs who may
appear bearish may have various agendas or biases that may impact their views. *We note
separately, the co has issued an 8K addressing some of these similar questions
w/ similar information the docs noted earlier*.
Clinical use and scripts should start going up over 2019 (we've already seen
some bump up since the initial press release)... One expert cited he had already
started prescribing more since the topline came out and details at AHA further motivate him.
On the other side, the experts discussed some of the hurdles around adoption including
pharmacy store omega-3/fish oil and co-pays for patients (though co-pays might be same
as Amazon purchased product). In terms of OTC omega-3/fish oil, the way the company
positions this drug and the broader community messaging will be key in order to differentiate
Vascepa from other mixtures The experts cited Vascepa of course is an FDA approved drug,
as opposed to supplements which are largely unregulated and manufacturing purity of the
product matters a lot for unregulated fish oil products on the shelf due to oxidation and
other issues for fish oil handling,etc.

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