DGAP-News

PAION REPORTS POSITIVE HEADLINE DATA IN U.S. CLINICAL SAFETY TRIAL OF REMIMAZOLAM IN HIGH-RISK PATIENTS UNDERGOING COLONOSCOPY

DGAP-News: PAION AG / Key word(s): Research Update PAION REPORTS POSITIVE HEADLINE DATA IN U.S. CLINICAL SAFETY TRIAL OF REMIMAZOLAM IN HIGH-RISK PATIENTS UNDERGOING COLONOSCOPY 27.03.2017 / 07:30 The issuer is solely responsible for the content of this announcement. PAION REPORTS POSITIVE HEADLINE DATA IN U.S. CLINICAL SAFETY TRIAL OF REMIMAZOLAM IN HIGH-RISK PATIENTS UNDERGOING COLONOSCOPY

- Remimazolam administration appeared safe

- Efficacy and efficiency gains comparable to confirmatory U.S. Phase III pivotal trial

Aachen (Germany), 27 March 2017 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces that remimazolam, its ultra-short-acting benzodiazepine, appeared safe in a study comparing remimazolam sedation to placebo with midazolam rescue in high risk (ASA III/IV) patients (American Society of Anesthesiologists classification; ASA III: patients with severe systemic disease, ASA IV: patients with severe systemic disease that is a constant threat to life) undergoing colonoscopy.

In addition the efficacy and efficiency gains were comparable to the first pivotal U.S. Phase III trial in colonoscopy patients. As ASA III/IV patients can develop symptoms that require immediate stabilizing interventions, these patients are mostly treated in a hospital environment. The classification of the patients' ASA status was checked by an external anesthesiologist who was not otherwise involved in the trial.

This Phase III trial is part of the U.S. development program agreed upon between PAION and the U.S. Food and Drug Administration (FDA) for the filing of remimazolam for market approval in the targeted indication procedural sedation.

This prospective, double-blind, randomized, placebo- and active controlled, multicenter, parallel group study enrolled 79 high-risk patients (i.e. ASA III/IV) undergoing a colonoscopy into a remimazolam, midazolam or placebo (including midazolam 'rescue' sedation) treatment group. The disposition for ASA III and IV were equally distributed for the remimazolam and control patients.