DGAP-News

PAION AG REPORTS RESULTS FOR THE FIRST HALF-YEAR 2015 - Seite 3

discussions with interested parties can be intensified.

Outlook
Outlook on Development and Commercialization Activities

PAION's focus for the second half of 2015 are the Phase III development
programs with Remimazolam in the U.S. and the EU, the production
development for Remimazolam, in particular the validation of the production
at market scale, as well as further pre-marketing and market access
activities. Moreover, PAION expects the development activities of its
Remimazolam cooperation partners Yichang Humanwell, Hana Pharm, R-Pharm and
Pendopharm to continue. PAION benefits from the progress of the development
of Remimazolam in the form of additional development data as well as
financially in form of milestone payments and royalties from launch
onwards.

In order to exploit Remimazolam's full potential, PAION will implement
measures to allow the immediate commercialization of Remimazolam after a
possible market approval in the U.S and EU. This particularly includes the
early establishment of a supply chain and securing the preproduction of
market material (stock piling) for the launch phase. In order to be ready
to sell at approval, these activities have already been initiated.

For all territories outside the U.S. and EU it is aimed to find license or
distribution partners. For Japan, PAION is currently evaluating a strategy
for filing Remimazolam in the indication general anesthesia itself or by a
new partner. Presumably in the beginning of 2016, a Pre-NDA meeting will be
held with the Japanese authority in the course of which the details of a
possible market approval will be discussed. In parallel, PAION is in talks
with several parties regarding a Remimazolam license for Japan.

The completion of patient recruitment for the first pivotal Phase III trial
in the U.S. is expected end of 2015/beginning of 2016. Conditional on
successful study results and dependent on interactions with the FDA, PAION
currently expects filing for approval in 2017.

For the EU, results for the Phase III trial are expected in 2016, and
filing for Remimazolam in general anesthesia is expected in 2017.

Financial Outlook

PAION further concentrates on the development of Remimazolam and does not
expect significant revenues in 2015.

Due to the investments in the development of Remimazolam, research and
development expenses will be higher than in 2014 and amount to
approximately EUR 25 million to EUR 30 million dependent on the progress of
the development. In this context, tax credits on parts of the research and