Twice-rejected Barhemsys finally gets its nod
Following two complete response letters over the past year and a half, and having finally found a reliable supplier for the active ingredient, Acacia Pharma has got Barhemsys over the finish line and on to the US market. The dopamine receptor blocker’s approval as a rescue medication for postoperative nausea and vomiting pushed the UK group’s stock up 27%, though this has not quite made up for the sharp fall last May when Barhemsys was rejected a second time. Acacia intends to launch the drug with its own direct sales force in the second half of this year. Another approval could be on the way; last month Acacia licensed exclusive US rights to Byfavo from Cosmo Pharmaceuticals, at which point the ultra-short-acting sedative was already filed with the FDA. Assuming Byfavo is approved by its PDUFA date, April 5, Acacia will soon be selling two drugs targeting essentially the same market – anaesthesiologists and hospital pharmacists. According to consensus forecasts from EvaluatePharma, both Byfavo and Barhemsys are forecast to sell around $103m each in the US by 2024.