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PAION SUCCESSFULLY COMPLETES PATIENT RECRUITMENT IN PHASE III STUDY WITH REMIMAZOLAM FOR PROCEDURAL SEDATION DURING COLONOSCOPY

DGAP-News: PAION AG / Key word(s): Research Update
PAION SUCCESSFULLY COMPLETES PATIENT RECRUITMENT IN PHASE III STUDY WITH
REMIMAZOLAM FOR PROCEDURAL SEDATION DURING COLONOSCOPY

11.04.2016 / 20:56
The issuer is solely responsible for the content of this announcement.

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PAION SUCCESSFULLY COMPLETES PATIENT RECRUITMENT IN PHASE III STUDY WITH
REMIMAZOLAM FOR PROCEDURAL SEDATION DURING COLONOSCOPY

- No safety concerns

- Headline data expected in mid 2016

Aachen (Germany), 11 April 2016 - The Specialty Pharma Company PAION AG
(ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) announces
today's successful completion of recruitment in the U.S. Phase III clinical
trial of Remimazolam, an ultra-short-acting sedative/anesthetic, for
procedural sedation in patients undergoing colonoscopy. No drug-related
serious adverse event has been reported.

This Phase III clinical trial - conducted at multiple sites throughout the
U.S. - was a prospective, double-blind, randomized, midazolam- and
placebo-controlled study in 460 patients undergoing colonoscopies for
diagnostic or therapeutic reasons. Patients were randomized to receive
either Remimazolam or midazolam or placebo in addition to fentanyl in order
to achieve adequate sedation to start and perform the procedure. In this
study short-term procedural sedation with Remimazolam in comparison to the
use of midazolam and placebo was investigated. The primary endpoint was
defined as successful completion of the colonoscopy procedure with no
requirement for alternative sedatives as compared to placebo plus fentanyl.
Non-responders to placebo received midazolam at doses being used according
to current local medical practice. The midazolam study arm was added to
compare efficacy against the labelled midazolam dose including onset/offset
times. It also served as an additional safety reference.

Headline data are expected mid 2016.

"We would like to thank the patients who participated in the trial as well
as the gastroenterologists and their clinical study teams performing the
colonoscopies. I am confident that the excellent efficacy and safety
profile of Remimazolam, as seen in the Phase IIb study, will be confirmed,"
Dr. Wolfgang Söhngen, PAION AG's CEO, commented. "We will now start with
the necessary activities to enable a thorough data analysis. Based on this
we will report headline data. After that the study data will be integrated