PAION AG, DE000A0B65S3

PAION AG, DE000A0B65S3

14.11.2017 - 10:40:37

FDA CONSIDERS CURRENT HUMAN ABUSE LIABILITY PROGRAM WITH REMIMAZOLAM IN THE U.S. AS SUFFICIENT; NO SECOND INTRANASAL STUDY REQUIRED

FDA CONSIDERS CURRENT HUMAN ABUSE LIABILITY PROGRAM WITH REMIMAZOLAM IN THE U.S. AS SUFFICIENT; NO SECOND INTRANASAL STUDY REQUIRED

- The FDA has determined that the available studies are sufficient to provide necessary data regarding the abuse potential of remimazolam in humans

- No second intranasal study required

- PAION assumes clinical development program for remimazolam in procedural sedation in the U.S. as completed

Aachen (Germany), 14 November 2017 - The specialty pharmaceutical company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8) today announces that the FDA informed PAION last night that no additional study is required based on the submitted data. The FDA further informed PAION that it determines the abuse liability program conducted by PAION as sufficient to provide the necessary data regarding the abuse potential of remimazolam in humans. PAION therefore assumes the clinical development program for remimazolam in procedural sedation in the U.S. as completed and will now focus on finishing the respective reports.

The results of the abuse liability program will be part of the New Drug Application (NDA) for remimazolam in procedural sedation in the U.S., which partner Cosmo Pharmaceuticals currently expects to submit in the second half of 2018.

Based on the results of preclinical and Phase I studies and in consultation with the FDA, PAION had initiated additional Phase I studies to further assess the abuse potential of remimazolam. Two aspects were studied: if remimazolam could inappropriately be used as a knock-out cocktail in combination with alcohol and if it could be abused intranasally. Recruitment of a trial evaluating the oral administration of remimazolam with alcohol was completed in the third quarter of 2017. Recruitment of the first trial evaluating the intranasal administration of remimazolam was completed in the second quarter of 2017.

Dr. Wolfgang Söhngen, CEO of PAION AG, commented: "I would like to warmly thank our team who have mastered this challenge with great dedication and with a very well considered study design. We are very excited about the surprising news we have received last night from the FDA. With the completed recruitment of this probably last clinical development part we have achieved a significant milestone on the way to market approval for remimazolam in the U.S."

###

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 clinical 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 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.

14.11.2017 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

628847  14.11.2017 

@ dgap.de

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