Paion O.N (DE:PA8G) has successfully accelerated recruitment in the confirmatory pivotal bronchoscopy study of its ultra-fast-acting sedative remimazolam in procedural sedation and has raised funds to support filing for general anaesthesia (GA) in Japan, putting it on track to file for approval in both the US (via partner Cosmo Pharmaceuticals) and Japan by mid-2018. It has also outlined a programme that could see it restart Phase III studies in GA in Europe (estimated cost €20-25m). Paion has sufficient cash to fund operations beyond end 2018 but would need additional funds to restart the Europe development programme (potentially from Cosmo milestones and a licence deal in Japan). We lift our valuation slightly to €214m (vs €208m).
Bronchoscopy Phase III close to full recruitment
Paion has successfully accelerated patient recruitment in the confirmatory Phase III trial of remimazolam for procedural sedation in bronchoscopy patients; recruitment is expected to complete shortly. A safety study in high-risk colonoscopy patients completed recruitment in December, with headline data expected soon. Based on consultation with the FDA, Paion will initiate additional Phase I studies to further assess abuse potential. A pre-NDA meeting is planned for the end of 2017, with a US filing by partner Cosmo expected in mid-2018 (pending positive trial results).
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