Biotech Values

[DewDiligence]

AGN/MOLN.SW—Won't the less frequent dosing (particularly quarterly) allow them to compete to a degree in spite of the numerically higher rate of inflammation, particularly if they discount the price relative to Lucentis? Is the incidence of ~15% of intraocular inflammation events truly a big issue for abicipar?

The 15% inflammation rate renders the current formulation of the drug commercially nonviable, IMHO. AMD drugs coming soon from NVS and REGN will have quarterly or longer dosing intervals, so that in itself won’t be able to make AGN’s Abicipar competitive.

…the other interesting thing from the [AGN] PR is the reference that: "We will continue to review these data including inflammation findings and are working on further optimizing the abicipar formulation.” Are they planning an additional Phase 3 trial with a new formulation?

AGN is running an open-label safety stuffy with the new formulation, with the goal of to getting the inflammation rate down to low/mid single digits. Thus, the Abicipar BLA will consist of efficacy data from the old formulation and safety data from the new formulation, which may ruffle some feathers at the FDA.