DGAP-News: PAION COMPLETES PHASE II STUDY WITH REMIMAZOLAM

DGAP-News: PAION AG / Key word(s): Research Update PAION COMPLETES PHASE II STUDY WITH REMIMAZOLAM IN INDICATION ANAESTHESIA 11.02.2014 / 07:30 --------------------------------------------------------------------- PAION COMPLETES PHASE II STUDY WITH REMIMAZOLAM IN INDICATION ANAESTHESIA - Recruitment for Phase II study in Heart Center Leipzig - University Hospital successfully completed within 5 months - Study results expected in H1 2014 - No safety concerns Aachen (Germany), 11 February 2014 - PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange General Standard: PA8) a biopharmaceutical company, announced today the successful completion of the recruitment of the Phase II clinical trial with the short-acting anaesthetic/sedative Remimazolam in the indication 'anaesthesia' in patients undergoing cardiac surgery. No drug-related Serious Adverse Event has been reported. The Phase II study was a randomized, propofol and sevoflurane (standard treatment) controlled Phase II study to evaluate the efficacy, tolerability and pharmacokinetics of Remimazolam during general anaesthesia in patients undergoing cardiac surgery using a heart-lung machine. After surgery a follow up sedation in the recovery room or in the intensive care unit (ICU) for up to 24 h has taken place. A total of 90 patients have been treated. Results of the study are still expected in the first half of 2014. The study was carried out at the Heart Center Leipzig - University Hospital and was designed to provide detailed information about the cardiovascular safety profile of Remimazolam as an anaesthetic during general anaesthesia for cardiac surgery. Furthermore it is expected to deliver further insights on titration of sedation in the postoperative phase. Two doses of Remimazolam have been evaluated against each other and against propofol during induction of general anaesthesia. In the maintenance phase of anaesthesia Remimazolam was tested against the combination of propofol and sevoflurane. Furthermore data in the postoperative sedation phase in the postoperative care unit or ICU against Propofol were obtained and can be used for further exploration of the ICU sedation indication. The study was designed such that the data can complement the anaesthesia study data conducted by Ono in Japan and could then be used together with the Japanese studies for filing. Dr. Wolfgang Söhngen, CEO of PAION, commented: 'Great recognition goes to the entire study team at the Heart Center Leipzig for the rapid and smooth study conduction in compliance with the care required in the context of a clinical trial. We will now carefully analyze the data package in order to use the data obtained for the scientific advice meeting with the European regulatory authority (EMA) to prepare the European Phase III trial.' Dr. Stefan Probst, principal investigator from the Heart Centre Leipzig, commented: 'We are extremely satisfied with the course of the study. The inclusion and treatment of 90 patients was carried out very quickly. Here's my special thanks to my study team which have ensured with their tireless efforts and their enthusiasm to carry out the study very quickly and with a high quality and care. The anaesthesia and sedation with Remimazolam has been very well received by our patients. Our team has been able to gather important data for the optimal dosing of this anaesthetic and it could be quickly included in the daily routine.' ### About PAION PAION AG is a publicly-listed biotech company headquartered in Aachen, Germany with a second site in Cambridge, UK. The company has a track record in developing hospital-based treatments for which there is substantial unmet medical need. PAION AG is transforming its business model from a pure development company to a specialty pharmaceutical company with a focus on anaesthesia products to take advantage of the unique profile of its main compound, Remimazolam. About Remimazolam Remimazolam is an innovative short-acting general anaesthetic/sedative. Due to its short duration of action and good controllability, it has a preferable efficacy and safety profile relative to other currently marketed anaesthesia compounds. The rapid offset of Remimazolam's effect is due to its metabolism by tissue esterase enzymes that are widely distributed throughout the body. Remimazolam has potential in three indications: - Procedural sedation - General anaesthesia - ICU sedation Remimazolam is available for licensing outside Japan, China, Russia (CIS) and Turkey, as well as South Korea, where the compound is partnered with Ono Pharmaceutical, Yichang Humanwell, R-Pharm and Hana Pharm. 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. End of Corporate News --------------------------------------------------------------------- 11.02.2014 Dissemination of a Corporate News, transmitted by DGAP - a company of EQS Group AG. The issuer is solely responsible for the content of this announcement. DGAP's Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and 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: Regulierter Markt in Frankfurt (General Standard); Freiverkehr in Berlin, Düsseldorf, Hamburg, München, Stuttgart End of News DGAP News-Service --------------------------------------------------------------------- 251222 11.02.2014