DGAP-News: PAION AG: POSITIVE REMIMAZOLAM PHASE III COLONOSCOPY RESULTS PRESENTED AT THE 2016 AMERICAN COLLEGE OF GASTROENTEROLOGY ANNUAL SCIENTIFIC MEETING

DGAP-News: PAION AG / Key word(s): Research Update
PAION AG: POSITIVE REMIMAZOLAM PHASE III COLONOSCOPY RESULTS PRESENTED AT
THE 2016 AMERICAN COLLEGE OF GASTROENTEROLOGY ANNUAL SCIENTIFIC MEETING

19.10.2016 / 07:30
The issuer is solely responsible for the content of this announcement.

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POSITIVE REMIMAZOLAM PHASE III COLONOSCOPY RESULTS PRESENTED AT THE 2016
AMERICAN COLLEGE OF GASTROENTEROLOGY ANNUAL SCIENTIFIC MEETING

Aachen, 19 October 2016 – PAION AG, a specialty pharma company (ISIN
DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces
that data on the clinical results of remimazolam’s U.S. Phase III
colonoscopy trial were presented in the Colon/Stomach oral session at the
2016 American College of Gastroenterology (ACG) Annual Scientific Meeting
in Las Vegas. Remimazolam is an innovative, ultra-short-acting
benzodiazepine anesthetic/sedative for which positive topline data from
this trial were published in June 2016.

Douglas Rex, M.D., Indiana University, Indianapolis, IN, U.S., principal
investigator of this Phase III trial, presented the results.

The Phase III trial enrolled a total of 461 patients at 13 U.S. sites and
was designed to evaluate the efficacy and safety of remimazolam compared to
placebo (with midazolam rescue) in patients undergoing proceduralist-
administered sedation for colonoscopy.

The primary outcome measure was a composite endpoint defined as: no need
for rescue medication, completion of the procedure and no more than 5 top-
up doses within any 15-minute window. The primary endpoint was reached in
91.3% of the patients in the remimazolam arm and 1.7% in the placebo
(including midazolam rescue) arm. Important secondary endpoints in the
remimazolam arm showed a median time from start of medication to start of
procedure of 4.0 minutes (placebo 19.5 minutes) and a mean time from end of
procedure to return to full alertness of 7.2 minutes (placebo 21.3
minutes). Additionally, time to “back to normal” as reported by patients on
remimazolam was 331 minutes (placebo 572 minutes).

There were no treatment-emergent serious adverse events in the trial.
Hypotension was 44.3% with remimazolam and 47.5% with placebo and accounted
for most of the adverse events in all study arms. Hypoxia occurred in 1.0%
of patients given remimazolam, 3.4% in the placebo arm.

On the Hopkins Verbal Learning Test administered five minutes after
reaching the fully alert status, the total raw score, delayed recall,
memory retention, and recognition discrimination scores were all better
with remimazolam compared to placebo.

Patient satisfaction was similar in all arms of the study.

In addition to the detailed analysis of the primary and secondary endpoints
of the Phase III trial (comparison to placebo), Dr. Rex also presented data
for the open label midazolam arm. These results will not be part of the
label claims. They will however serve as valuable data to plan future
studies and perform pharmacoeconomic modelling. Midazolam patients showed a
median time from start of medication to start of procedure of 19.0 minutes
and a mean time from end of procedure to return to full alertness of 15.7
minutes. Midazolam patients took 553 minutes to be back to normal.

Hypotension was 67.3% with midazolam and hypoxia occurred in 1.0% of
patients given midazolam.

Overview procedural results:

Remimazolam Placebo Midazolam
(Open Label)
Procedural success 91.3% 1.7% 25.2%
Use of rescue 3.4% 95.0% 64.7%
sedation
Average fentanyl 88.9 mcg 121.3 mcg 106.9 mcg
dose
Start of medication 4.0 minutes 19.5 minutes 19.0 minutes
to start of
procedure (median)
End of procedure to 7.2 minutes 21.3 minutes 15.7 minutes
fully alert
(mean)
Mean time 1st dose 58 minutes 86 minutes 75 minutes
to discharge

Dr. Rex concluded: “Remimazolam, given under supervision of an endoscopist,
appears to be safe and effective for procedural sedation in colonoscopy
based on the results from this Phase III study. We saw significant
differences in onset and recovery times as well as restoration of cognitive
function and fewer adverse events when compared to midazolam or placebo. In
addition, the need for fentanyl was lowest in the remimazolam group. If
these data could be translated into medical practice, this would result in
a meaningful gain in efficiency and patient comfort, which are important to
achieve our goal to increase the overall colonoscopy screening rate.”

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About Remimazolam
Remimazolam is an ultra-short-acting intravenous benzodiazepine sedative/
anesthetic, currently in Phase III clinical development for procedural
sedation in the U.S. The first of two pivotal Phase III studies was
completed successfully and reached its primary endpoint. In the human body,
remimazolam is rapidly metabolized to an inactive metabolite by tissue
esterases and not metabolized by cytochrome-dependent hepatic pathways.
Like other benzodiazepines, remimazolam can be reversed with flumazenil to
rapidly terminate sedation and anesthesia if necessary.

In clinical studies, remimazolam demonstrated efficacy and safety in over
1,000 patients. Data so far indicate that remimazolam has a rapid onset and
offset of action combined with a favorable cardio-respiratory safety
profile.

A pediatric development plan has been agreed with the FDA and will be
implemented by Cosmo following completion of current development of
remimazolam for adult patients. A full clinical development program for
general anesthesia has been completed in Japan, and a Phase II study in
general anesthesia has been completed in the E.U. Based on the positive
results of the Phase II study in Japan, development for ICU sedation beyond
24 hours is considered following successful completion of development in
procedural sedation and general anesthesia.

Remimazolam is partnered in the U.S., Canada, China, Russia (CIS), Turkey,
the MENA region, and South Korea with Cosmo, Pharmascience (Pendopharm),
Yichang Humanwell, R-Pharm, TR-Pharm, and Hana Pharm, respectively. For all
other markets, remimazolam is available for licensing.

About PAION
PAION AG is a publicly listed specialty pharmaceutical company developing
and aiming to commercialize innovative drugs to be used in out-patient and
hospital-based sedation, anesthesia and critical care services. PAION’s
lead compound is remimazolam, an intravenous, ultra-short-acting and
controllable benzodiazepine sedative/anesthetic drug candidate. Currently,
remimazolam is in active Phase III clinical development for use in
procedural sedation in the U.S., where PAION is focusing all its business
and financial resources on successfully completing its ongoing clinical
development program in procedural sedation. Outside the U.S., PAION has so
far focused on the development of remimazolam in the indication general
anesthesia. Development of remimazolam in the indication intensive care
unit (ICU) sedation is also part of the longer term life-cycle plan for
remimazolam.

PAION is headquartered in Aachen (Germany) with further sites in Cambridge
(United Kingdom) and New Jersey (USA).

PAION’s vision is to become an acknowledged “PAIONeer” in sedation and
anesthesia.

PAION Contact
Ralf Penner
Director Investor Relations / Public Relations
PAION AG
Martinstrasse 10-12
52062 Aachen – Germany
Phone: +49 241 4453-152
E-mail: r.penner@paion.com
www.paion.com

Disclaimer:

This release contains certain forward-looking statements concerning the
future business of PAION AG. These forward-looking statements contained
herein are based on the current expectations, estimates and projections of
PAION AG’s management as of the date of this release. They are subject to a
number of assumptions and involve known and unknown risks, uncertainties
and other factors. Should actual conditions differ from the Company’s
assumptions, actual results and actions may differ materially from any
future results and developments expressed or implied by such forward-
looking statements. Considering the risks, uncertainties and other factors
involved, recipients should not rely unreasonably upon these forward-
looking statements. PAION AG has no obligation to periodically update any
such forward-looking statements to reflect future events or developments.

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19.10.2016 Dissemination of a Corporate News, transmitted by DGAP – a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements,
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Archive at www.dgap.de

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Language: English
Company: PAION AG
Martinstr. 10-12
52062 Aachen
Germany
Phone: +49 (0)241-4453-0
Fax: +49 (0)241-4453-100
E-mail: info@paion.com
Internet: www.paion.com
ISIN: DE000A0B65S3
WKN: A0B65S
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated
Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich,
Stuttgart, Tradegate Exchange

End of News DGAP News Service
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