On track to file in US and Japan by mid-2018
Paion has successfully accelerated recruitment in the confirmatory pivotal bronchoscopy study of its ultra-fast-acting sedative remimazolam in procedural sedation and has raised funds to support filing for general anaesthesia (GA) in Japan, putting it on track to file for approval in both the US (via partner Cosmo Pharmaceuticals) and Japan by mid-2018. It has also outlined a programme that could see it restart Phase III studies in GA in Europe (estimated cost €20-25m). Paion has sufficient cash to fund operations beyond end 2018 but would need additional funds to restart the Europe development programme (potentially from Cosmo milestones and a licence deal in Japan). We lift our valuation slightly to €214m (vs €208m).Paion is a holding company. Through its subsidiaries, Co. is a biopharmaceutical company focusing on developing and commercializing drugs to be used in out-patient and hospital-based anesthesia, sedation and critical care services. Co.'s key compound is Remimazolam, an intravenous ultra short-acting and controllable anesthetic/sedative drug candidate in advanced stages of development for use in procedural sedation and general anesthesia.
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