Two Scientific Remimazolam Presentations Are Accepted for ASA and ACG Meeting in October 2014 - Seite 2

In this study the total norepinephrine dose used was 36.7 % lower in Remimazolam treated patients when compared to the Propofol/Sevoflurane group which can be regarded as a clinically significant differentiation.

The ASA meeting is the largest international anaesthesia congress. Remimazolam's lead indication in Europe is to be presented also to U.S. Anaesthesiologists because after successful approval in Europe the NDA (New Drug Application) for the indication "General anesthesia" will be also applied for in the U.S.

PAION will be available for discussions at booth 343 in the exhibition hall.

During the ACG meeting Dr Daniel J. Pambianco, the lead investigator of the Phase IIb trial, will present the results of the colonoscopy study during the session "Endoscopy/Colorectal Cancer Prevention on 21 October 2014 between 8.30 am to 10 am. The title of the abstract is: "A Phase IIb Study Comparing the Safety and Efficacy of Remimazolam and Midazolam in Colonoscopy Patients." The presentation will be available for download on the company's website www.paion.com. In connection with ASA a kick off meeting with potential investigators for the Phase III program will also be held.

PAION will be available for discussions at booth 751 in the exhibition hall.

The Phase IIb trial was a double-blind, randomized, parallel group study examining three dose regimens of Remimazolam compared with Midazolam in 160 patients undergoing a colonoscopy. The patients received either one of three different initial doses of Remimazolam or Midazolam followed by "top-ups" (i.e. multiple doses) as required to maintain an adequate sedation level to undergo a standard colonoscopy procedure. The study -- conducted in multiple sites in the U.S. -- was designed to evaluate the success of the sedation under Remimazolam and the time to peak sedation as well as the time to full recovery and discharge, and safety, in comparison to the gold-standard agent, Midazolam. In addition, based on the results of the successfully conducted Phase Ib and IIa studies, this study was designed to further refine the optimal dose regimen before moving into Phase III.

The primary objective of the trial, to assess the success of a colonoscopy procedure in comparison to Midazolam, was met, and showed success rates ranging from 92.5% to 97.5% with the 3 Remimazolam dose groups, compared to 75 % with Midazolam. Thus Remimazolam was clinically superior compared to the current gold standard Midazolam. The primary endpoint was a composite consisting of the following: "sedation sufficient to initiate and complete the procedure, no mechanical or manual ventilation and no rescue sedation."