Amarin Corp Plc (AMRN)

[KCSVEN]

1. DISCUSSION:

In ANCHOR, 12 weeks of treatment with Vascepa 4 g/day led to an estimated median
-21.5% (95% CI, -26.7% to -16.2%; P<0.0001) change in fasting triglycerides, compared
with the mineral oil placebo, among statin-treated patients with mixed dyslipidemia at
high cardiovascular risk. Changes in other lipid/lipoprotein parameters (selected secondary
and exploratory endpoints) are summarized in the table below.

Median % Change from
Baseline to Week 12
Median % Change
(95% CI)
Placebo Vascepa 4g/day Treatment Difference
Fasting TG +5.9 -17.5 -21.5 (-26.7, -16.2)
Direct LDL-C +8.8 +1.5 -6.2 (-10.5, -1.7)
Non-HDL-C +9.8 -5.0 -13.6 (-17.2, -9.9)
VLDL-C +15.0 -12.1 -24.4 (-31.9, -17.0)
Apo B +7.1 -2.2 -9.3 (-12.3, -6.1)
Tot. Chol. +9.1 -3.2 -12.0 (-14.9, -9.2)
HDL-C +4.8 -1.0 -4.5 (-7.4, -1.8)
Apo A-I +3.6 -2.9 -6.9 (-8.9, -4.9)

Please discuss the efficacy results from the ANCHOR trial, including the clinical
significance of the observed changes in lipid/lipoprotein parameters and your level of
confidence that these changes will translate into a meaningful reduction in cardiovascular
risk among the target population.

2. VOTE:

Taking into account the described efficacy and safety data for Vascepa, do you believe
that its effects on the described lipid/lipoprotein parameters are sufficient to grant approval
for co-administration with statin therapy for the treatment of patients with mixed
dyslipidemia and CHD or CHD risk equivalent prior to the completion of REDUCE IT
Please provide the rationale underlying your recommendation.