DGAP-News

PAION AG REPORTS CONSOLIDATED FINANCIAL RESULTS FOR THE FOR THE FIRST NINE MONTHS OF 2015 - Seite 2

Development and commercial activities

PAION continues to focus on the development of Remimazolam. In the first
nine months of 2015, a Phase III program with Remimazolam in procedural
sedation was started in the U.S., and a Phase III trial in general
anesthesia has been initiated in the EU.

The first U.S. Phase III study was started in March 2015. This prospective,
double-blind, randomized, placebo- and midazolam-controlled, U.S.
multicenter Phase III trial in 460 patients undergoing colonoscopies marks
the start of PAION's Phase III clinical development program, which also
includes a second pivotal prospective, double-blind, randomized, placebo-
and midazolam-controlled, U.S. multicenter Phase III trial in patients
undergoing bronchoscopies which started in June 2015, and a smaller safety
trial in high-risk patients undergoing colonoscopies for the indication
procedural sedation. In parallel, three Phase I studies are currently being
conducted by PAION.

The start of the multi-national, multicenter, randomized, single-blind,
propofol-controlled, confirmatory EU Phase III study in patients undergoing
major cardiac surgery was announced in August 2015.

Patient recruitment in the Phase III programs in the U.S. and the EU was
initially moderate. Meanwhile, most of the study centers are active and
PAION is seeing accelerated recruitment. Based on the fact that recruitment
typically gains momentum when trial centers have been running for some
time, no significant impact is expected on the previously communicated
timelines. For the U.S. Phase III study in colonoscopy patients, more than
half of the 460 patients have been recruited in the meantime.

Two routine data monitoring committee (DMC) safety reviews have taken place
since the start of the U.S. Phase III program. Both safety reviews led to
the positive recommendation to continue the Phase III trials as scheduled.

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.

In October 2015, the Japanese Pharmaceuticals and Medical Devices Agency
("PMDA") informed PAION in writing that both the active ingredient produced
by PAION in Europe as well as the finished formulation of Remimazolam
fulfill the requirements for filing in Japan. The European and Japanese
product are considered to be of equivalent quality. This clarification was