Paion

Investment summary

Paion is moving closer to commercialisation of remimazolam, its ultra-short-acting IV sedative/anaesthetic that combines the best features of approved agents midazolam and propofol. Partner Yichang Humanwell filed for approval of remimazolam in procedural sedation in China in November, and Mundipharma filed for approval in general anaesthesia (GA) in Japan in December. Cosmo filed for US approval in April, after Paion successfully completed clinical development in procedural sedation. R-Pharm plans to file for approval in GA in Russia by end 2019. The primary target in the US is to replace midazolam as the sedative of choice for procedures such as colonoscopy and bronchoscopy; faster induction and recovery with remimazolam reduces total procedure time and should increase throughput. Paion has initiated a Phase III in GA in Europe; full recruitment expected by the end of 2019. Cash of €15.6m at 31 March plus €7.5m in milestones for the US filing is sufficient to report top-line data from the European Phase III.