DGAP-News

PAION AG REPORTS RESULTS FOR THE FIRST HALF-YEAR 2015 - Seite 2

started in March 2015. The initiation of this Phase III trial in patients
undergoing colonoscopies marks the start of PAION's Phase III clinical
development program, which also includes a second pivotal Phase III trial
in patients undergoing bronchoscopies and a third smaller safety trial in
higher-risk patients undergoing colonoscopies. In parallel, three
accompanying Phase I studies are currently being conducted by PAION.

In June 2015, PAION has started the second U.S. Phase III clinical trial of
Remimazolam for procedural sedation during bronchoscopy. The bronchoscopy
study is a prospective, double-blind, randomized, placebo- and
midazolam-controlled U.S. multicenter study in 460 patients undergoing
bronchoscopies.

For the European Phase III program in the lead indication general
anesthesia, study protocols have been completed and submitted to the
national agencies and Institutional Review Boards (IRBs) following the
discussions with the European Medicines Agency (EMA) regarding a Phase III
study and based on the scientific advice of the European authorities. In
August 2015, the start of the EU Phase III study was announced.

In the U.S., the operative expansion of PAION, Inc. has been pushed
forward. Two renowned experts joined PAION, Inc. as non-executive
directors. Dr. David Bernstein as a medical advisor of PAION will
participate in building the company's U.S. relationships with the academic
community, regulators, associations and industry. Dr. Bernstein has been
material in composing PAION's recently established medical advisory board
and will manage the dialogue with its members, which are U.S. national
thought leaders in the field of gastroenterology also participating in the
US Phase III program.

Moreover, Timothy E. Morris, a senior management professional in the
biopharmaceutical industry and an experienced financial expert, has joined
PAION, Inc. as non-executive director. Mr. Morris has more than 30 years of
professional finance and accounting experience, of which he spent 20 as
Chief Financial Officer, predominantly with biopharmaceutical companies. He
will support PAION in the expansion and particularly the future financing
of the company's growing U.S. activities as well as in connection with the
upcoming commercial activities of Remimazolam.

In July 2015, PAION announced that the know-how and technology transfer
from Ono has been completed. 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. Thus, ongoing licensing