DGAP-Adhoc

PAION DISCONTINUES EUROPEAN REMIMAZOLAM PHASE III TRIAL IN CARDIAC SURGERY PATIENTS DUE TO INSUFFICIENT RECRUITMENT

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.

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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: [phone]
E-mail: [e-mail]
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

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Language: English
Company: PAION AG
Martinstr. 10-12
52062 Aachen
Germany
Phone: [phone]
Fax: [phone]
E-mail: [e-mail]
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

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