Despite Observa’s best efforts to keep its lead project going nolasiban has finally run out of road. Today the oxytocin antagonist flunked its confirmatory European Implant 4 trial, prompting a halt to all work in IVF and a 43% share price fall. It had been hoped that adding nolasiban at day five of IVF embryo transfer would increase the number of pregnancies reaching the 10 week mark. Instead, the rate with nolasiban was roughly similar to that with placebo. Current low IVF success rates – only 29% of IVF-treated women under 35 celebrate a live birth – mean there is a real need for products that assist fertility. This could explain the $106m of sales forecast for nolasiban in 2024, despite ongoing questions around its efficacy. Nolasiban had previously failed a phase II trial and in February 2018 a phase III trial only showed benefits in patients undergoing embryo transfer at day five and not day three, prompting the confirmatory Implant 4 trial. With nolasiban now on ice in IVF, Obseva’s focus will switch to linzagolix in uterine fibroids, but given the competition here from Abbvie’s Orilissa and Myovant’s relugolix any further missteps with Obseva’s pipeline will not be taken kindly.
|Sales by indication uterine fibroids|
|WW sales ($m)|
|Relugolix||Myovant Sciences||Phase III (marketed by Takeda in Japan)||33||194||438|