DGAP-News: PAION ANNOUNCES CLINICAL DEVELOPMENT PROGRESS

DGAP-News: PAION AG / Key word(s): Research Update PAION ANNOUNCES CLINICAL DEVELOPMENT PROGRESS WITH REMIMAZOLAM BY ITS PARTNER YICHANG HUMANWELL IN CHINA 06.09.2016 / 14:00 The issuer is solely responsible for the content of this announcement. --------------------------------------------------------------------------- PAION ANNOUNCES CLINICAL DEVELOPMENT PROGRESS WITH REMIMAZOLAM BY ITS PARTNER YICHANG HUMANWELL IN CHINA - First Phase I study started in October 2015 has completed recruitment - Yichang Humanwell has started a new Phase I study with continuous infusion - A Phase II study in procedural sedation is in preparation Aachen, 06 September 2016 - PAION AG, a Specialty Pharma Company (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces that its Chinese remimazolam licensing partner Yichang Humanwell has informed PAION that their first Phase I study started in October 2015 has completed recruitment. In addition Yichang Humanwell has started a second Phase I study with continuous infusion in order to prepare a study in general anesthesia. A Phase II study in procedural sedation in China is in preparation. Yichang Humanwell initially planned to develop remimazolam for general anesthesia for the Chinese market but has now decided to develop remimazolam in procedural sedation as well. The rights to develop and market remimazolam for the Chinese market were granted to Yichang Humanwell in 2012. The completed Phase I study tested a range of single bolus doses of remimazolam in healthy volunteers. The next Phase I study will test various infusion rates of remimazolam, again in healthy Chinese volunteers. The Phase II study will be performed with patients undergoing various short procedures where sedation is required and a range of bolus doses of remimazolam will be tested to identify a safe and effective dose for future studies. Dr. Wolfgang Söhngen, CEO of PAION AG, commented, "We congratulate Yichang Humanwell on the progress as they had to go through a repetition of a significant amount of pre-clinical work prior to starting clinical development in China including setting up their own GMP manufacturing. We look forward to learn more about the future progress in China." ### 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. 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. Remimazolam is partnered in the U.S., Canada, China, Russia (CIS), Turkey, the MENA region, and South Korea. 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. --------------------------------------------------------------------------- 06.09.2016 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, Financial/Corporate News and Press Releases. Archive at www.dgap.de --------------------------------------------------------------------------- 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 --------------------------------------------------------------------------- 499243 06.09.2016