Two Scientific Remimazolam Presentations Are Accepted for ASA and ACG Meeting in October 2014

AACHEN, GERMANY--(Marketwired - October 01, 2014) -

• Presentation of the Phase II trial results in anaesthesia at „The Anesthesiology 2014 Annual Meeting" (ASA) on 13^th October 2014 in New Orleans, USA
• Presentation of the Phase IIb trial results in procedural sedation at „American College of Gastroenterology Annual Scientific Meeting" (ACG), 21^th October 2014 in Philadelphia, USA

PAION AG, a Specialty Pharma Company (ISIN DE000A0B65S3) (FRANKFURT: PA8) announces today that scientific abstracts about clinical data of Remimazolam were accepted for presentation at two major US congresses. The lead investigators will present the clinical results and PAION the hypothetical product profile of its innovative, short acting anaesthetic/sedative to professionals; consisting of gastroenterologists, anaesthetists, surgeons and intensive care professionals. The booth in the commercial exhibition is part of the planned pre-marketing activities.

The presentation by lead investigator Dr Stefan Probst at ASA will be during the session "Drug Disposition, Metabolism and Elimination" at ASA on 13th October 2014 from 3 pm to 4:30 pm. The title of the abstract is: "Phase II Study of an Ultra-Short Acting Benzodiazepine (Remimazolam) Versus a Standard Regime of Propofol/Sevoflurane in Patients Undergoing Cardio-Surgery." The presentation will be available for download on the company's website www.paion.com. The Phase II study in anaesthesia was conducted at the Heart Center Leipzig/Germany from September 2013 to February 2014.

The Phase II study was a randomized, Propofol and Sevoflurane (standard treatment) controlled Phase II study to evaluate the efficacy, tolerability and pharmacokinetics of Remimazolam during general anaesthesia in patients undergoing cardiac surgery using a heart-lung machine. After surgery a follow up sedation in the recovery room or in the intensive care unit (ICU) for up to 24 h was part of the protocol. A total of 90 patients have been treated.

The primary efficacy endpoint as a general anaesthetic (defined as successful anaesthesia not requiring sedative rescue therapy) was achieved in 98% of patients in the two Remimazolam dose groups and 96% in the Propofol/Sevoflurane group. Therefore, an excellent efficacy rate across all treatment groups was shown. The safety profile was generally very good in all treatment groups.

One of the key targets of this trial was to assess the cardiostability during cardiac surgery with Remimazolam when compared to Propofol/Sevoflurane, both of which are known to cause cardiac depression. During cardiac surgery norepinephrine is routinely used to maintain blood pressure in the normal range and counteract pronounced blood pressure decreases.