Paion - US and Japan filings and EU Phase III on track
Paion remains on track to file for approval of Remimazolam in 2018 for procedural sedation (via partner Cosmo Pharmaceuticals in the US) and general anaesthesia (GA) in Japan. Remimazolam’s excellent safety profile and shorter procedure times than midazolam are expected to drive uptake if it gains market approval. Preparations are underway for an EU Phase III study for GA in general surgery patients to start in 2018 (subject to funding). Recently granted formulation and dosing patents will strengthen market exclusivity in the EU and Japan until 2033, which sees us lift our valuation to €260m (vs €245m) or €4.25/share.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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