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Wednesday, 02/27/2019 6:52:12 AM

Wednesday, February 27, 2019 6:52:12 AM

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New Lipid Compounds and other Preclinical Programs
We are also considering development of other next generation compounds based on our internal lipid science expertise, including potential
combination and derivative therapies.
In August 2013, we completed dosing of AMR102, a fixed dose combination of Vascepa and a leading statin product. The study is a randomized,
open-label, single-dose, 4-way cross-over study to continue testing of the relative bioavailability of AMR102 capsules, Vascepa capsules with the selected
statin taken concomitantly, Vascepa taken alone and the selected statin taken alone. The results of this study support the feasibility of AMR102. We have
suspended additional development of AMR102 pending FDA approval of label expansion of Vascepa, anticipated to occur no sooner than after FDA review
of the results from the REDUCE-IT study.
We believe that Vascepa and other lipid-based compositions may have an impact on a number of biological factors in the body such as antiinflammatory mechanisms, cell membrane composition and plasticity, triglyceride levels and regulation of glucose metabolism. Currently all other
development activities are at formulation or pre-clinical stages
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