Amarin Corp Plc (AMRN)

[dogn]

North, what I understand about MND-2119 is that it's the same API (active pharmaceutical ingredient) in a new formulation that adds something (a surfactant?) to render it "self-emulsifying," perhaps as described in this paper "Self-emulsifying drug delivery systems (SEDDS): formulation development, characterization, and applications"

https://pubmed.ncbi.nlm.nih.gov/20136631/#:~:text=Self-emulsifying%20drug%20delivery%20systems%20%28SEDDS%29%20possess%20unparalleled%20potential,yielding%20micro-%20or%20nanoemulsions%20containing%20the%20solubilized%20drug.

Abstract

Self-emulsifying drug delivery systems (SEDDS) possess unparalleled potential in improving oral bioavailability of poorly water-soluble drugs. Following their oral administration, these systems rapidly disperse in gastrointestinal fluids, yielding micro- or nanoemulsions containing the solubilized drug. Owing to its miniscule globule size, the micro/nanoemulsifed drug can easily be absorbed through lymphatic pathways, bypassing the hepatic first-pass effect. We present an exhaustive and updated account of numerous literature reports and patents on diverse types of self-emulsifying drug formulations, with emphasis on their formulation, characterization, and systematic optimization strategies. Recent advancements in various methodologies employed to characterize their globule size and shape, ability to encapsulate the drug, gastrointestinal and thermodynamic stability, rheological characteristics, and so forth, are discussed comprehensively to guide the formula-tor in preparing an effective and robust SEDDS formulation. Also, this exhaustive review offers an explicit discussion on vital applications of the SEDDS in bioavailability enhancement of various drugs, outlining an overview on myriad in vitro, in situ, and ex vivo techniques to assess the absorption and/ or permeation potential of drugs incorporated in the SEDDS in animal and cell line models, and the subsequent absorption pathways followed by them. In short, the current article furnishes an updated compilation of wide-ranging information on all the requisite vistas of the self-emulsifying formulations, thus paving the way for accelerated progress into the SEDDS application in pharmaceutical research.

This would suggest no need to stockpile new API. This is of course still a ways down the road, part of lifecycle management, leading to once daily "Vascepa-2" and/or combo IPE-statin pill, and future hope of regaining US market share.

dogn