Summary
AbbVie announced that elagolix met its primary and secondary efficacy endpoints in the first of two Phase III studies for uterine fibroids.
Uterine fibroids is another potential multibillion-dollar indication for AbbVie and Neurocrine given the large, underserved patient population and the combination of elagolix’s efficacy and safety.
This clinical success pushes my fair value to $95 and there could still be meaningful long-term upside to my elagolix estimates in both patient penetration and pricing.
Good news continues to stack up for Neurocrine Biosciences (NBIX), with the company’s partner AbbVie (ABBV) announcing on Wednesday that its first of two Phase III studies of elagolix in uterine fibroids met all of its efficacy endpoints. This continues a pretty good run of success with Neurocrine’s late-stage pipeline and brings another potential multi-billion-dollar drug that much closer to approval and commercialization.
While there are still more steps to go through with elagolix in uterine fibroids (namely, full results from both studies, including safety data), the similarities between the Phase III and Phase II results thus far would suggest that there’s not much reason for worry (then again “surprises” are by their nature not expected…). Approval of elagolix in 2019 or 2020 would bring another important revenue generator to market for Neurocrine and this incremental step does modestly boost my fair value.
A Partial Success In Uterine Fibroids
AbbVie did not report all that much data on Wednesday morning (hence, I call it a partial success), but what it reported was encouraging. In the ELARIS UF-I study, more than 68% of women met the primary endpoint of menstrual blood loss (or MBL) of less than 80mL and a 50% reduction in MBL at month six from the baseline. With a placebo response rate of just under 9%, elagolix achieved its primary endpoint with a strong p-value (p<0.001), and AbbVie reported similar statistical significance for all of the secondary efficacy endpoints.
