PAION AG / Key word(s): Research Update 09.02.2016 20:07 Dissemination of an Ad hoc announcement according to § 15 WpHG, transmitted by DGAP - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement. --------------------------------------------------------------------------- PAION DISCONTINUES EUROPEAN REMIMAZOLAM PHASE III TRIAL IN CARDIAC SURGERY PATIENTS DUE TO INSUFFICIENT RECRUITMENT - Low recruitment of cardiac surgery patients - No drug-related serious adverse events have been observed - New EU Phase III trial subject to further funding - Focus on U.S. Phase III program Aachen, 09 February 2016 - PAION AG, a Specialty Pharma Company (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8), announces today's decision to discontinue the European Remimazolam Phase III trial in cardiac surgery. The European Phase III Remimazolam clinical trial in cardiac surgery faced recruitment challenges due to the complex study design. Despite intensive efforts to enhance study recruitment, the trial proved to be difficult to implement in practice. PAION decided to discontinue the trial in order to avoid a long and expensive study with the existing design. No drug-related serious adverse events have been observed. Accordingly, PAION will work together with recognized experts on setting up an alternative design in general surgery patients. The EU decision will have no impact on the U.S. program. The company will now focus on the ongoing U.S. development program in procedural sedation with highest priority. The Phase III colonoscopy trial is on track and completion of patient recruitment is still expected in the first quarter 2016. Patient recruitment in the Phase III bronchoscopy trial remains moderate which could possibly extend the completion into 2017. Conditional on successful implementation of ongoing counter measures, PAION expects filing for approval in 2017. ### Contact Ralf Penner Director Investor Relations / Public Relations PAION AG Martinstrasse 10-12 52062 Aachen - Germany Phone: +49 241 4453-152 E-mail: r.penner@paion.com www.paion.com Disclaimer: This release contains certain forward-looking statements concerning the future business of PAION AG. These forward-looking statements contained herein are based on the current expectations, estimates and projections of PAION AG's management as of the date of this release. They are subject to a number of assumptions and involve known and unknown risks, uncertainties and other factors. Should actual conditions differ from the Company's assumptions, actual results and actions may differ materially from any future results and developments expressed or implied by such forward-looking statements. Considering the risks, uncertainties and other factors involved, recipients should not rely unreasonably upon these forward-looking statements. PAION AG has no obligation to periodically update any such forward-looking statements to reflect future events or developments. 09.02.2016 The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and www.dgap.de --------------------------------------------------------------------------- Language: English Company: PAION AG Martinstr. 10-12 52062 Aachen Germany Phone: +49 (0)241-4453-0 Fax: +49 (0)241-4453-100 E-mail: info@paion.com Internet: www.paion.com ISIN: DE000A0B65S3 WKN: A0B65S Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart End of Announcement DGAP News-Service ---------------------------------------------------------------------------
DGAP-Adhoc: PAION DISCONTINUES EUROPEAN REMIMAZOLAM PHASE III TRIAL IN CARDIAC SURGERY PATIENTS DUE TO INSUFFICIENT RECRUITMENT
| Source: EQS Group AG