DGAP-Adhoc: PAION AG ANNOUNCES POSITIVE END-OF-PHASE II MEETING WITH FDA FOR REMIMAZOLAM IN PROCEDURAL SEDATION

PAION AG  / Key word(s): Research Update

23.11.2013 15:51

Dissemination of an Ad hoc announcement according to § 15 WpHG, transmitted
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The issuer is solely responsible for the content of this announcement.

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PAION AG ANNOUNCES POSITIVE END-OF-PHASE II MEETING WITH FDA FOR
REMIMAZOLAM IN PROCEDURAL SEDATION

  - FDA offers support to achieve planned label

  - Costs for completion of the clinical procedural sedation development
    program estimated at appr. EUR 20 million

  - US Phase III to start in H2/2014 depending on successful completion of
    current funding and/or partnering discussions

Aachen (Germany), 23 November 2013 - PAION AG (ISIN DE000A0B65S3; Frankfurt
Stock Exchange General Standard: PA8) today announced that it held an
End-of-Phase II meeting with the U.S. Food and Drug Administration (FDA) to
discuss PAION's Remimazolam for the US lead indication 'procedural
sedation' and now received the final meeting minutes. At that meeting, the
FDA laid out its expectations for the remaining development program up to
NDA filing and offered a dialogue to finalise the necessary study designs
together with PAION. A pivotal Phase III program evaluating the safety and
efficacy of Remimazolam is planned to start in H2/2014 depending on
successful completion of current funding and/or partnering discussions. The
cost for completion of the procedural sedation development program is
currently estimated at approximately EUR 20 million and is depending on the
final requirements of the FDA.
Labelling comparable to Midazolam may be achieved if the Phase III studies
are designed and the safety data continue to support such claim. FDA has
agreed to work with PAION on the design of the Phase III studies to support
the desired labelling.  PAION aims at a label similar to that for
Midazolam.

###

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.


23.11.2013 DGAP's Distribution Services include Regulatory Announcements,
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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:       Regulierter Markt in Frankfurt (General Standard);
              Freiverkehr in Berlin, Düsseldorf, Hamburg, München,
              Stuttgart
 
End of Announcement                             DGAP News-Service
 
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