DGAP-News

PAION RECEIVES POSITIVE FEEDBACK FROM JAPANESE AUTHORITY PMDA ABOUT PRODUCTION OF REMIMAZOLAM FOR JAPAN

DGAP-News: PAION AG / Key word(s): Research Update
PAION RECEIVES POSITIVE FEEDBACK FROM JAPANESE AUTHORITY PMDA ABOUT
PRODUCTION OF REMIMAZOLAM FOR JAPAN

14.10.2015 / 14:00

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PAION RECEIVES POSITIVE FEEDBACK FROM JAPANESE AUTHORITY PMDA ABOUT
PRODUCTION OF REMIMAZOLAM FOR JAPAN

- PAION expects to use product produced in Europe for commercialization
in Japan

Aachen (Germany), 14 October 2015 - The Specialty Pharma Company PAION AG
(ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today
announced that the Japanese Pharmaceuticals and Medical Devices Agency
("PMDA") has informed PAION in writing that both the raw materials produced
by PAION in Europe as well as the finished formulation fulfill the
requirements for filing in Japan because the European and Japanese product
are considered to be of equivalent quality and the differences are seen as
having no direct impact on the pharmacokinetics of Remimazolam. This
clarification was necessary for the filing dossier in Japan because PAION's
former partner Ono Pharmaceutical Co., Ltd. (Ono) is no longer available as
a producer. In the case of a negative opinion, it would have been necessary
to set up a new production process based on Ono's manufacturing process,
which would have led to a significant delay in the Japanese filing.

"With this result, we have successfully managed a further important step
towards market entry of Remimazolam in Japan. Our internal team and our
Japanese experts who have accompanied us on this journey deserve the
highest recognition," said PAION AG's CEO Dr. Wolfgang Söhngen. "We can now
prepare for the Pre-NDA meeting with the Japanese authority expected in the
beginning of 2016. This clarification will also be an important signal for
the ongoing licensing discussions in Japan."

As part of the validation campaigns of the manufacturing processes, PAION
will collect more data to support the data package in Japan. These data are
also required for the approval in the EU and U.S.

A Japanese clinical research organization ("CRO") is currently preparing
the draft Dossier for the Pre-NDA meeting expected in early 2016. This
meeting with the authority is a prerequisite for filing Remimazolam in
Japan.

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About Remimazolam
Remimazolam is an ultra-short-acting intravenous sedative and anesthetic
currently in Phase III clinical development for procedural sedation and
general anesthesia. Remimazolam is a member of the class of substances
known as benzodiazepines. In the human body, Remimazolam is rapidly
metabolized to an inactive metabolite by tissue esterases, and not