PAION is a specialty pharma company developing anaesthesia products. Its lead product, remimazolam, is partnered with Mundipharma in Japan, Yichang in China, Hana Pharma in S Korea, Cosmo in the US, Pendopharm in Canada and R-Pharm in CIS, Turkey and MENA.
Paion is approaching 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 procedural sedation in April and the FDA accepted the submission for review in June; we expect an FDA decision in April 2020. R-Pharm plans to file for approval in GA in Russia by end 2019. The main aim 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 should increase throughput. Paion has initiated a Phase III in GA in Europe; full recruitment is expected by end 2019. Paion is well funded with cash of €15.6m at 31 March, plus €7.5m in milestones due for the US filing and a €20m loan facility with the European Investment Bank.
Remimazolam has important advantages over competing products, including fast onset and offset of action with lower risk of cardiopulmonary events than the standard-of-care midazolam and propofol, and a reversal agent exists if there is over sedation.