DGAP-News: PAION AG

PAION ANNOUNCES CLINICAL DEVELOPMENT PROGRESS WITH REMIMAZOLAM BY ITS PARTNER HANA PHARM IN SOUTH KOREA

- Hana Pharm plans to start a Phase III trial in general anesthesia in 2018

- IND approved on 31 October 2017

- Hana Pharm plans to submit a marketing authorization application in 2018

Aachen (Germany), 23 November 2017 - The specialty pharmaceutical company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8) today announces that its South Korean remimazolam licensing partner Hana Pharm has informed PAION that their first Phase III trial in general anesthesia will start in 2018 and will be followed by the submission of a marketing authorization application for remimazolam in South Korea also planned in 2018. The Ministry of Food and Drug Safety (MFDS) in South Korea has approved an Investigational New Drug (IND) application on 31 October 2017.

The Phase III study is a single-blind randomized comparative clinical trial of efficacy and safety of remimazolam versus propofol in 198 patients undergoing general anesthesia and will be conducted at 12 sites including Seoul National University Hospital. The trial will be recruited in South Korea.

Dr. Wolfgang Söhngen, CEO of PAION AG, commented: "This is great news. We are delighted by the strong commitment to remimazolam by our South Korean partner Hana Pharm which they also showed during their participation at our remimazolam symposium in Tokyo. We look forward to learn more about the progress in South Korea."

Mr. Dong Jae Choi, CEO of Hana Pharm, stated: "It is a big step to move forward with remimazolam. Many anesthesiologists in South Korea are very interested in this new drug, and we hope conducting our Phase III study with remimazolam will confirm safety and efficacy seen in other studies so remimazolam will launch successfully and then eventually become the global standard for intravenous anesthesia."

The rights to develop and market remimazolam in South Korea were granted to Hana Pharm in 2013.

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About remimazolam
Remimazolam is an ultra-short-acting intravenous benzodiazepine sedative/anesthetic that has already shown positive results in clinical Phase III
trials. 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. During clinical studies, remimazolam demonstrated efficacy and safety in over
1,700 volunteers and patients. Data so far indicate that remimazolam has a rapid onset and offset of action combined with a favorable cardio-respiratory safety profile.

Remimazolam is currently in the final stage of development for procedural sedation in the U.S. After completion of the ongoing development, the implementation of a pediatric development plan already agreed with the FDA is planned. A full clinical development program for general anesthesia was completed in Japan, and a Phase II study in general anesthesia was completed in the EU. Based on the positive results of the Phase II study, development for ICU sedation beyond 24 hours is another attractive indication.

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

About Hana Pharm
Since founded in 1996, Hana Pharm has been manufacturing various medicines that are strongly needed by customers, like intravenous anesthetics and narcotic analgesics. Hana Pharm is continuing to invest in R&D and production facilities in order to comply with global standards.

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 which is in the final stage of clinical development for use in procedural sedation in the U.S. Currently, PAION is mainly focusing its business and financial resources on successfully completing its development program in procedural sedation in the U.S. Outside the U.S., PAION has so far focused on the development of remimazolam in the indication general anesthesia. A full clinical development program for general anesthesia was completed in Japan and PAION is preparing filing in Japan. In the EU, PAION is currently planning to continue the clinical development program. 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 a further site in Cambridge (United Kingdom).

PAION's vision is to become an acknowledged "PAIONeer" in sedation and anesthesia.

Contact
Ralf Penner
Vice President Relations/Public Relations
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.