DGAP-News: PAION DISCONTINUES EUROPEAN REMIMAZOLAM PHASE III TRIAL IN CARDIAC SURGERY PATIENTS DUE TO INSUFFICIENT RECRUITMENT


DGAP-News: PAION AG / Key word(s): Research Update
PAION DISCONTINUES EUROPEAN REMIMAZOLAM PHASE III TRIAL IN CARDIAC SURGERY
PATIENTS DUE TO INSUFFICIENT RECRUITMENT

09.02.2016 / 20:11
The issuer is solely responsible for the content of this announcement.

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PAION DISCONTINUES EUROPEAN REMIMAZOLAM PHASE III TRIAL IN CARDIAC SURGERY
PATIENTS DUE TO INSUFFICIENT RECRUITMENT

  - Low recruitment of cardiac surgery patients

  - No drug-related serious adverse events have been observed 

  - New EU Phase III trial subject to further funding 

  - Focus on U.S. Phase III program 

Aachen, 09 February 2016 - PAION AG, a Specialty Pharma Company (ISIN
DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8), announces
today's decision to discontinue the European Remimazolam Phase III trial in
cardiac surgery.

The European Phase III Remimazolam clinical trial in cardiac surgery faced
recruitment challenges due to the complex study design. Despite intensive
efforts to enhance study recruitment, the trial proved to be difficult to
implement in practice. PAION decided to discontinue the trial in order to
avoid a long and expensive study with the existing design.

No drug-related serious adverse events have been observed. Accordingly,
PAION will work together with recognized experts on setting up an
alternative design in general surgery patients.

The EU decision will have no impact on the U.S. program. The company will
now focus on the ongoing U.S. development program in procedural sedation
with highest priority. The Phase III colonoscopy trial is on track and
completion of patient recruitment is still expected in the first quarter
2016. Patient recruitment in the Phase III bronchoscopy trial remains
moderate which could possibly extend the completion into 2017. Conditional
on successful implementation of ongoing counter measures, PAION expects
filing for approval in 2017.

Dr. Wolfgang Söhngen, CEO of PAION AG, commented: "Following intensive
discussion and consultations, we decided to discontinue the trial. Together
with our business partners around the world, we continue to see great value
in the General Anesthesia indication. We will develop a clinical plan in
Europe that builds on the insights we gained from the cardiac surgery
trial, once funding is available.

In the meantime we will be allocating additional resources to the U.S., our
biggest market opportunity. "

###

About the EU Phase III trial in cardiac surgery
The Phase III study is a multi-national, multicenter, randomized,
single-blind, propofol-controlled, confirmatory study in patients
undergoing major cardiac surgery. A total of 530 patients were planned to
be treated in several European study centers. Results of the study were
expected in 2016.

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.  A confirmatory Phase III program is currently 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 general and cardiac
surgery, including post-operative sedation in post anesthesia care or
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.

Development of an indication for ICU sedation beyond 24 hours is planned
following successful completion of the 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 or co-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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09.02.2016 Dissemination of a Corporate News, transmitted by DGAP - a
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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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