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PAION AG REPORTS RESULTS FOR THE FIRST HALF-YEAR 2015
DGAP-News: PAION AG / Key word(s): Half Year Results
PAION AG REPORTS RESULTS FOR THE FIRST HALF-YEAR 2015
12.08.2015 / 07:30
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PAION AG REPORTS RESULTS FOR THE FIRST HALF-YEAR 2015
- Key financials for the period in line with plans
- Initiation of U.S. and EU phase III program of Remimazolam
- Built-up of PAION, Inc. pushed forward
- Know-how and technology transfer from Ono completed
- Cash and cash equivalents of EUR 47 million
- Conference call (in English) today at 2:00 pm CEST (1:00 pm BST/8:00 am
EDT)
Aachen (Germany), 12 August 2015 - The specialty pharmaceutical company
PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8)
today reports its consolidated financial results according to International
Financial Reporting Standards (IFRS) for the first half-year 2015.
The first half-year results were as planned. Research and development
expenses increased significantly to EUR 12.0 million compared to EUR 4.3
million in the first half of 2014 due to intensified development activities
with Remimazolam, particularly in connection with the preparation,
initiation and conduct of the Phase III programs. General administrative
and selling expenses increased from EUR 1.9 million in the prior-year
period to EUR 2.7 million as a result of the increase of staff and higher
selling expenses due to the conduct of pre-marketing and market access
activities. In total, a net loss of EUR 11.3 million has been incurred in
the first half-year 2015 (prior-year period: net loss of EUR 3.8 million).
Cash and cash equivalents decreased as planned by EUR 12.0 million in the
first half-year 2015 compared to 31 December 2014 and amounted to EUR 47.0
million as of 30 June 2015.
Dr. Wolfgang Söhngen, CEO of PAION AG, commented: "PAION is increasingly
focussing on the attractive option of an own commercialization of
Remimazolam. With the start of the Phase III programs in the U.S. as well
as in the EU and the completion of the know-how and technology transfer
from Ono as planned, we have reached important milestones."
Development and Commercial Activities
In the first half of 2015, PAION focussed on the development of
Remimazolam.
The comprehensive dialogue with the FDA (Food and Drug Administration) has
defined approval requirements for Remimazolam in the indication "procedural
sedation". The FDA commented on the study protocols and other aspects of
the development program such as the production of the substance and some
accompanying preclinical and Phase I protocols.
Following the discussions with the FDA, the first U.S. Phase III study was
- Key financials for the period in line with plans
- Initiation of U.S. and EU phase III program of Remimazolam
- Built-up of PAION, Inc. pushed forward
- Know-how and technology transfer from Ono completed
- Cash and cash equivalents of EUR 47 million
- Conference call (in English) today at 2:00 pm CEST (1:00 pm BST/8:00 am
EDT)
Aachen (Germany), 12 August 2015 - The specialty pharmaceutical company
PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8)
today reports its consolidated financial results according to International
Financial Reporting Standards (IFRS) for the first half-year 2015.
The first half-year results were as planned. Research and development
expenses increased significantly to EUR 12.0 million compared to EUR 4.3
million in the first half of 2014 due to intensified development activities
with Remimazolam, particularly in connection with the preparation,
initiation and conduct of the Phase III programs. General administrative
and selling expenses increased from EUR 1.9 million in the prior-year
period to EUR 2.7 million as a result of the increase of staff and higher
selling expenses due to the conduct of pre-marketing and market access
activities. In total, a net loss of EUR 11.3 million has been incurred in
the first half-year 2015 (prior-year period: net loss of EUR 3.8 million).
Cash and cash equivalents decreased as planned by EUR 12.0 million in the
first half-year 2015 compared to 31 December 2014 and amounted to EUR 47.0
million as of 30 June 2015.
Dr. Wolfgang Söhngen, CEO of PAION AG, commented: "PAION is increasingly
focussing on the attractive option of an own commercialization of
Remimazolam. With the start of the Phase III programs in the U.S. as well
as in the EU and the completion of the know-how and technology transfer
from Ono as planned, we have reached important milestones."
Development and Commercial Activities
In the first half of 2015, PAION focussed on the development of
Remimazolam.
The comprehensive dialogue with the FDA (Food and Drug Administration) has
defined approval requirements for Remimazolam in the indication "procedural
sedation". The FDA commented on the study protocols and other aspects of
the development program such as the production of the substance and some
accompanying preclinical and Phase I protocols.
Following the discussions with the FDA, the first U.S. Phase III study was
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