DGAP-News: PAION AG / Key word(s): Research Update
PAION COMPLETED REMIMAZOLAM KNOW-HOW AND TECH TRANSFER FROM ONO
23.07.2015 / 14:20
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PAION COMPLETED REMIMAZOLAM KNOW-HOW AND TECH TRANSFER FROM ONO
- IP, data, know-how and tech transfer from Ono to PAION completed
- Pre-NDA meeting with the Japanese Authority in preparation
- Two scientific abstracts about Japanese clinical data of Remimazolam
accepted for presentation at the ASA conference in San Diego in October
2015
- Partnering process for Remimazolam license for Japan ongoing
Aachen (Germany), 23 July 2015 - The Specialty Pharma Company PAION AG
(ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today
announces that PAION has completed the Remimazolam know-how and technology
transfer from his former partner Ono. In the meantime, Ono has also
returned its Remimazolam rights. PAION has received most of the data in
electronic form and has access to the paper versions. PAION has
successfully been assigned all IP that was generated in Japan on an
exclusive and worldwide basis and has full access to all data generated by
Ono. All investigational sites and the Japanese Pharmaceuticals and Medical
Devices Agency ("PMDA") have been informed by Ono that the development by
Ono has been stopped "due to strategic reasons" and that PAION will be
responsible for the future development and activities in Japan.
In June 2015, PAION requested an informal meeting with the PMDA to discuss
the project status. The PMDA informed PAION that the company could directly
apply for a Pre-NDA (New Drug Application) meeting. A Japanese CRO is
already preparing the draft dossier that is required for this Pre-NDA
meeting which is expected to take place in the beginning of 2016. The
framework of the future production of Remimazolam for the Japanese market
will be discussed with the PMDA in advance. The timing of a potential
filing will be subject to the outcome of these meetings.
In the meantime, PAION has held very productive meetings with Japanese Key
Opinion Leaders ("KOL") involved in the general anesthesia studies as well
as in the ICU sedation study. All KOLs confirmed that Remimazolam is
regarded a needed innovation for the Japanese anesthesia market and that
the improved cardio stability and the availability of a reversal agent are
significant improvements over existing alternatives.
Two scientific abstracts based on the Japanese Phase I/II studies and the
Phase III data have been accepted for oral presentation at the upcoming
"Anesthesiology 2015 Annual Meeting" ("ASA") in San Diego, USA, in October
2015. Full publications of these trials are in preparation.
"We acknowledge a very constructive support by Ono in the transition phase.
Remimazolam is now available for licensing in Japan. Based on the data
package, the interested parties can now have a deeper look into the vast
data set and we can intensify the already ongoing discussions with several
parties. The response of PMDA supports our view that the existing data
should be sufficient for filing", CEO Dr. Wolfgang Söhngen commented.
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About Remimazolam
Remimazolam is an innovative ultra-short-acting general
sedative/anesthetic. As a result of its short duration of action and good
controllability, it has a preferable efficacy and safety profile relative
to other currently marketed anesthesia compounds. Remimazolam's rapid
offset is a consequence of its metabolism by tissue esterase enzymes that
are widely distributed throughout the body. Remimazolam has potential in
three indications:
- Procedural sedation (Lead indication U.S.)
- General anesthesia (Lead indication EU, Japan)
- ICU sedation (Phase II Japan)
Remimazolam is available for licensing outside China, Russia (CIS), Turkey,
MENA Region, South Korea and Canada, where the compound is partnered with
Yichang Humanwell, R-Pharm, TR-Pharm, Hana Pharm and Pendopharm.
About PAION
PAION AG is a publicly-listed Specialty Pharma Company headquartered in
Aachen, Germany, with further sites in Cambridge, UK, and New Jersey, U.S.
The company has a track record of developing hospital-based treatments for
which there is substantial unmet medical need. PAION's strategy is to
participate in the commercialization of Remimazolam and extend its business
with a focus on anesthesia/critical care products. Remimazolam is the
building block for its future marketing activities.
For more information please visit www.paion.com
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.
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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: Regulated Market in Frankfurt (Prime Standard); Regulated
Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich,
Stuttgart
End of News DGAP News-Service
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380481 23.07.2015
DGAP-News: PAION COMPLETED REMIMAZOLAM KNOW-HOW AND TECH TRANSFER FROM ONO
| Source: EQS Group AG