Update: A setback in Europe, but US on track
Paion has discontinued its European Phase III trial of remimazolam for general anaesthesia in patients undergoing cardiac surgery due to slow recruitment. The US Phase III in colonoscopy is still on track to complete recruitment in the current quarter, but completion of the bronchoscopy Phase III may be pushed into 2017. Paion remains on track for a potential US filing in 2017, while a pre-NDA meeting with Japanese regulators in Q116 could clear the way for a filing in Japan, ideally with a partner. We delay our forecast launch date for general anaesthesia in Europe by two years to 2020 and lower our valuation to €182m from €230m.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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