DGAP-News

PAION AG REPORTS CONSOLIDATED FINANCIAL RESULTS FOR THE FIRST HALF-YEAR 2014 - Seite 2

licence agreements, which will secure the funding for the development
programme of Remimazolam and the planned approval process. We are currently
in further consultations with the authorities in preparation for the Phase
III programmes in the EU and the United States. We now concentrate all our
efforts on starting the phase III programme later this year - probably
first in the U.S."

Development and commercial activities

In the first six months of 2014, PAION continued to focus on the
development and out-licensing of Remimazolam. In February 2014, only five
mths after the start, the company was able to announce the completion of
recruitment for the Phase II clinical trial with the short-acting
anaesthetic/sedative Remimazolam in the indication of general anaesthesia
in patients undergoing cardiac surgery at the Leipzig Heart Centre. The
study was a randomised, controlled Phase II trial to evaluate the efficacy,
tolerability and pharmacokinetics of Remimazolam during general anaesthesia
in patients undergoing cardiac surgery using a heart-lung machine, compared
with the standard treatment of Propofol/Sevoflurane. After surgery, a
follow up sedation for up to 24 hours took place in the recovery room or in
the intensive care unit (ICU). A total of 90 patients were treated. The
primary endpoint (efficacy) as a general anaesthetic was achieved in 98% of
patients in the two Remimazolam dose groups and 96% of patients in the
Propofol/Sevoflurane group. This demonstrated an excellent efficacy rate
and in addition a generally very good safety profile was observed across
all treatment groups. One of the key targets of this trial was to assess
the cardiostability of Remimazolam during cardiac surgery when compared to
Propofol/Sevoflurane, both of which are known to cause cardiac depression.
During cardiac surgery, Norepinephrine is routinely used to maintain blood
pressure and a variety of cardiac parameters as close as possible in the
normal range and thus counteract a pronounced decrease in blood pressure.
In the trial, the use of Norepinephrine was 36.7% lower in Remimazolam
treated patients when compared to the Propofol/Sevoflurane group, which can
be regarded as a clinically meaningful differentiation.

In terms of marketing, a number of successes were achieved in the first six
months of 2014 as well. In June 2014, PAION and R-Pharm, Russia, expanded
the scope of their licence agreement concerning the exclusive rights for
the development and commercialization of Remimazolam to include the MENA
region (Middle East and North Africa). Based on this expansion of the