DGAP-News

PAION COMPLETED REMIMAZOLAM KNOW-HOW AND TECH TRANSFER FROM ONO

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