It appears that manufacturing of the product is the challenge for MDCO as it was for PFE. So is the required IV administration.
A recombinant apoA-I Milano/phospholipid complex (ETC216; Pfizer) showed antiatherosclerotic effects in animals and produced significant regression in coronary atherosclerosis in humans as measured by intravascular ultrasound (IVUS).[3] However, apoA-I is a large protein consisting of 243 amino acids, so it is necessary to administer it intravenously. In addition, manufacture of apoA-I to date has been difficult and expensive. Research has therefore been directed toward finding smaller peptide mimetics that produce similar results to those seen with apoA-I, but that are easier to manufacture and administer.
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