DGAP-Ad hoc: PAION AG

DGAP-Adhoc: PAION SUCCESSFULLY COMPLETES PATIENT RECRUITMENT IN PHASE III STUDY WITH REMIMAZOLAM FOR PROCEDURAL SEDATION DURING COLONOSCOPY

PAION AG / Key word(s): Research Update

11.04.2016 20:54

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.

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PAION SUCCESSFULLY COMPLETES PATIENT RECRUITMENT IN PHASE III STUDY WITH REMIMAZOLAM FOR PROCEDURAL SEDATION DURING COLONOSCOPY

- No safety concerns

- Headline data expected in mid 2016

Aachen (Germany), 11 April 2016 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) announces today's successful completion of recruitment in the U.S. Phase III clinical trial of Remimazolam, an ultra-short-acting sedative/anesthetic, for procedural sedation in patients undergoing colonoscopy. No drug-related serious adverse event has been reported.

This Phase III clinical trial - conducted at multiple sites throughout the U.S. - was a prospective, double-blind, randomized, midazolam- and placebo-controlled study in 460 patients undergoing colonoscopies for diagnostic or therapeutic reasons. Patients were randomized to receive either Remimazolam or midazolam or placebo in addition to fentanyl in order to achieve adequate sedation to start and perform the procedure. In this study short-term procedural sedation with Remimazolam in comparison to the use of midazolam and placebo was investigated. The primary endpoint was defined as successful completion of the colonoscopy procedure with no requirement for alternative sedatives as compared to placebo plus fentanyl. Non-responders to placebo received midazolam at doses being used according to current local medical practice. The midazolam study arm was added to compare efficacy against the labelled midazolam dose including onset/offset times. It also served as an additional safety reference.

Headline data are expected mid 2016.

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PAION 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.

11.04.2016 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 ---------------------------------------------------------------------------