(Reuters) – Apellis Pharmaceuticals said on Thursday a panel of the European drugs regulator was likely to vote against approving its chronic eye disease treatment, sending its shares down more than 20% in early trading.
If the panel’s opinion is negative at its next meeting on Jan. 22-25, the company said it would appeal the outcome and seek re-examination.
“It’s an uphill battle to go through an appeal process, but one that we look forward to engaging into,” Apellis CEO Cedric Francois said on a call with analysts.
Apellis has applied to the European Medicines Agency (EMA) for use of the drug, a form of pegcetacoplan directly injected in the back of the eye, in patients with geographic atrophy (GA).
GA is caused by the growth of lesions, which destroy the retinal cells responsible for vision and leads to progressive and irreversible vision loss.
The disease affects more than 2.5 million people in Europe, according to the company.
Apellis’ marketing application was based on data from two late-stage studies that showed pegcetacoplan reduced lesion growth with increasing treatment effects over time.
The discussion with the EMA panel centered around the functional benefit of reduced lesion growth in patients with GA, which is “really hard to measure”, Francois said.
The drug, branded as Syfovre, is already approved in the U.S. where it competes with Astellas Pharma’s drug Izervay, which was approved in August.
Syfovre has had strong demand in the U.S. since its approval, recording more than $75 million in sales.
Last week, BofA Global Research upgraded Apellis’ stock to “buy” from “neutral”, partly due to the “strong launch trajectory” of the drug. The brokerage said there is still “room for upside”.
(Reporting by Leroy Leo and Mariam Sunny in Bengaluru; Editing by Shilpi Majumdar and Arun Koyyur)
