DGAP-News: PAION ANNOUNCES INITIATION OF U.S. CLINICAL SAFETY TRIAL OF REMIMAZOLAM IN HIGH RISK PATIENTS UNDERGOING COLONOSCOPY


DGAP-News: PAION AG / Key word(s): Study
PAION ANNOUNCES INITIATION OF U.S. CLINICAL SAFETY TRIAL OF REMIMAZOLAM IN
HIGH RISK PATIENTS UNDERGOING COLONOSCOPY

01.12.2015 / 14:00
The issuer is solely responsible for the content of this announcement.

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PAION ANNOUNCES INITIATION OF U.S. CLINICAL SAFETY TRIAL OF REMIMAZOLAM IN
HIGH RISK PATIENTS UNDERGOING COLONOSCOPY

Aachen, 01 December 2015 - PAION AG, a Specialty Pharma Company (ISIN
DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announced
the initiation of a smaller dedicated safety study of Remimazolam in ASA
III/IV patients (American Society of Anesthesiologists classification III
to IV) undergoing colonoscopy as part of the U.S. Phase III program. This
trial will run alongside the two ongoing pivotal U.S. Phase III trials in
colonoscopy and bronchoscopy.

The trial is part of the development program, which PAION and the U.S. Food
and Drug Administration (FDA) agreed upon for the filing of Remimazolam in
the targeted indication 'procedural sedation'.

Dr. Wolfgang Söhngen, Chief Executive Officer of PAION AG, commented: "ASA
III/IV patients are outlined by their significant co-morbidities and
therefore have a generally poor health status. Hence, they carry a higher
risk for complications during or following medical interventions than
otherwise healthy patients.
Despite the use of midazolam, interventions in these patients are
predominantly undertaken in hospitals and with the presence of
anesthesiologists to account for the significant co-morbidities in this
patient population. Although more than 90 % of colonoscopies are carried
out in healthier patients (ASA I/II), it is very important for an overall
safety characterization of Remimazolam to generate safety data especially
in this more severely diseased patient population."

This prospective, double-blind, randomized, placebo- and active controlled,
multicenter, parallel group study involves about 75 high-risk patients
(i.e. ASA III/IV) undergoing a colonoscopy with Remimazolam compared to
midazolam and placebo . Completion of patient recruitment is expected in
2016.

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About Remimazolam
Remimazolam is an ultra-short-acting intravenous sedative and anesthetic
currently in Phase III clinical development for procedural sedation and
general anesthesia. Remimazolam is a member of the class of substances
known as benzodiazepines. 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 in order to
rapidly terminate sedation if necessary.

In clinical studies, Remimazolam demonstrated efficacy and safety in more
than 1,000 patients.  Confirmatory Phase III programs are now in progress.
Data so far indicate that Remimazolam has the expected rapid onset and
offset of action combined with a favorable hemodynamic stability profile.
 
In the U.S., Remimazolam is initially being developed for procedural
sedation during procedures such as colonoscopies.
 
In the EU and most other major markets, Remimazolam is initially being
developed for general anesthesia in patients undergoing non-cardiac and
cardiac surgery, including sedation in intensive care units (ICUs) for up
to 24 hours after the operation.
 
In Japan, a clinical Phase III program in anesthesia has been successfully
completed, and a Pre-NDA meeting is expected to take place in the beginning
of 2016.
 
Development of an indication for ICU sedation beyond 24 hours is planned
following successful completion of the currently ongoing above-mentioned
Phase III programs.  A pediatric development plan has been agreed with the
FDA and will be implemented following approval of Remimazolam for adult
patients. A similar approach is planned for EU.
 
Remimazolam is available for licensing outside China, Russia (CIS), Turkey,
the MENA region, South Korea and Canada, where the compound is partnered
with Yichang Humanwell, R-Pharm, TR-Pharm, Hana Pharm and Pendopharm. In
the U.S. and EU, PAION focuses on the attractive opportunity of an own
commercialization.

About PAION
PAION AG is a publicly listed Specialty Pharmaceutical Company
headquartered in Aachen (Germany) with operations in Cambridge (United
Kingdom) and New Jersey (USA).

PAION's lead substance, Remimazolam, is an intravenous ultra-short-acting
anesthetic that is currently in Phase III clinical development for
procedural sedation and general anesthesia. Remimazolam is designed to
complement and improve currently available treatment options for patients
requiring sedation and anesthesia.
 
PAION is focusing its clinical development activities on Remimazolam and
has initiated pre-commercial activities according to PAION's vision to
become an acknowledged "PAIONeer" in sedation and anesthesia.
 
For more information please visit www.paion.com 

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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01.12.2015 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.

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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                                                  
 
 
   End of News    DGAP News Service  
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