PAION AG / Key word(s): Research Update
05.11.2014 06:26
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'S PARTNER ONO DECIDES NOT TO FILE FOR REGULATORY APPROVAL OF
REMIMAZOLAM IN JAPAN AND WILL RETURN ITS REMIMAZOLAM RIGHTS FOR JAPAN TO
PAION
- Ono has decided to discontinue the project on strategic reasons
considering issues in pharmacokinetic features, while no adverse events
of concern were observed during clinical trials
- Ono will return its license for Japan and initiate the process of data
and Know how transfer to PAION
- Remimazolam is now available for licensing in Japan
- PAION is exploring an alternative filing strategy in Japan
Aachen (Germany), 05 November 2014 - PAION AG a Specialty Pharma Company
(ISIN DE000A0B65S3; Frankfurt Stock Exchange General Standard: PA8) today
announced that its Japanese development partner, Ono Pharmaceutical Co.,
Ltd. ("Ono"), has informed PAION AG that they have decided today "to
discontinue the project on strategic reasons considering issues in
pharmacokinetic features, while no adverse events of concern were observed
during clinical trials".
Ono successfully completed the Remimazolam development program in
anaesthesia - the lead indication in Japan - in November 2013. The primary
efficacy endpoint of effectiveness as a general anaesthetic was achieved by
100% of patients with no adverse events of concern and a clinically
meaningfully less cardio depressive effect as compared to Propofol. After
that the remaining development for a filing in Japan was finished including
further studies to elucidate the pharmacokinetic findings seen in another
development program ICU sedation, which supported PAIONs view that the data
package can be filed for general anaesthesia.
Ono now has decided to stop its development activities and to return the
license. There will be no repayment for received milestone payments.
Remimazolam is now available for licensing in Japan to other parties.
PAION is evaluating an alternative filing strategy for Remimazolam in Japan
in the indication general anaesthesia through PAION or another partner.
PAION has full access to all data generated by Ono. The parties will
closely work together in order to make the transition as fast as possible.
PAION expects no impact on its ongoing development programs in General
Anaesthesia in Europe and Procedural Sedation in the US.
Ono entered into a license agreement with PAION UK LIMITED (formerly CeNeS
Limited) in 2007, acquiring the exclusive right to develop and market
Remimazolam in Japan.
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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.
05.11.2014 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: +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 (Prime Standard); Freiverkehr
in Berlin, Düsseldorf, Hamburg, München, Stuttgart
End of Announcement DGAP News-Service
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DGAP-Adhoc: PAION'S PARTNER ONO DECIDES NOT TO FILE FOR REGULATORY APPROVAL OF REMIMAZOLAM IN JAPAN AND WILL RETURN ITS REMIMAZOLAM RIGHTS FOR JAPAN TO PAION
| Source: EQS Group AG