DGAP-Adhoc

PAION EXPECTS ONO'S REMIMAZOLM DECISION ON FILING IN JAPAN IN NOVEMBER 2014

PAION AG / Key word(s): Research Update

10.10.2014 14:41

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 EXPECTS ONO'S REMIMAZOLM DECISION ON FILING IN JAPAN IN NOVEMBER 2014

- Filing no longer possible in 2014 given the preparation works for
filing

- Filing decision will also be based on now available PK data

Aachen (Germany), 10 October 2014 - PAION AG (ISIN DE000A0B65S3; Frankfurt
Stock Exchange General Standard: PA8) today announced that its Japanese
partner, ONO Pharmaceutical Co., Ltd. ("ONO") has informed PAION AG, that a
decision on filing will be made in early November. Due to necessary
preparations for filing and the ongoing discussions around PK issues filing
will not be initiated in 2014.

After unclear PK findings in an explorative dose finding Phase II trial in
ICU sedation performed by ONO the trial was halted in 2013 and an intensive
joint pre-clinical programme was initiated to elucidate the unexpected high
plasma levels in a few patients. This joint effort now has been concluded
and no explanation for the findings of high plasma levels could be
identified. The studies included a 7 day study in monkeys as well as a 5
day superfusion of isolated hepatocytes. In addition the PK data of the
Phase II study in cardiac surgery performed in Leipzig were integrated into
the pharmacokinetic modelling.

From PAION's perspective all remaining questions around the PK issue can
only be answered in a new dose finding study in ICU sedation with lower
doses and lighter sedation. ONO may however consider the PK data issue as a
risk for filing in the indication of General Anaesthesia in Japan.
This will not have any effects on PAION's ongoing development program in
General Anaesthesia in Europe and Procedural Sedation in the US.

ONO entered into a license agreement with PAION (formerly CeNeS) in August
2007, acquiring the exclusive right to develop and market Remimazolam in
Japan. PAION had expected that ONO would file in the 2nd half of 2014.


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Information and Explaination of the Issuer to this News:

About PAION
PAION AG is a publicly-listed Specialty Pharma Company headquartered in
Aachen, Germany with a second site in Cambridge, UK. The company has a
track record in developing and out licensing of hospital-based treatments
for which there is substantial unmet medical need. PAION's strategy is to
extend its business model from a pure development company to a specialty
pharmaceutical company with a focus on anaesthesia products. Remimazolam
is intended to be the basis for its future marketing activities.

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.

10.10.2014 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: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
in Berlin, Düsseldorf, Hamburg, München, Stuttgart

End of Announcement DGAP News-Service

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