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 moving closer to commercialisation of remimazolam, its ultra-short-acting IV sedative/anaesthetic which combines the best features of approved agents midazolam and propofol. Partner Yichang Humanwell recently filed for approval of remimazolam in procedural sedation in China. Cosmo is on track to file for US approval in Q418 or Q119, having successfully completed clinical development in procedural sedation. Mundipharma is on track to file for approval in general anaesthesia (GA) in Japan towards year-end, and R-Pharm plans to file for approval in GA in Russia in Q119. 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 throughout. Paion has initiated a Phase III in GA in Europe, with top-line data expected in 2019. Cash of €19.8m at 30 September and anticipated milestone revenue is sufficient to report top-line data from the European Phase III.
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.