DGAP-News: PAION STARTS PHASE II STUDY WITH REMIMAZOLAM IN

DGAP-News: PAION AG / Key word(s): Research Update PAION STARTS PHASE II STUDY WITH REMIMAZOLAM IN THE INDICATION ANAESTHESIA 09.09.2013 / 07:30 --------------------------------------------------------------------- PAION STARTS PHASE II STUDY WITH REMIMAZOLAM IN THE INDICATION ANAESTHESIA - Initiation of European development program in general anaesthesia - First patients successfully treated in Heart Center Leipzig - Study results expected in H1 2014 Aachen (Germany), 09 September 2013 - PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange General Standard: PA8) a biopharmaceutical company, announced today the start of a Phase II clinical trial with the short-acting anaesthetic/sedative Remimazolam in the indication 'anaesthesia' in patients undergoing cardiac surgery. The Phase II study is a randomized, propofol and sevoflurane (standard treatment) controlled Phase II study to evaluate the efficacy, safety and pharmacokinetics of Remimazolam during general anaesthesia in patients undergoing major cardiac surgery. After surgery a follow up sedation in the recovery room or the intensive care unit (ICU) for up to 24 h will take place. A total of 90 patients will be treated. Results of the study are expected in the first half of 2014. The study is carried out at the Heart Center Leipzig, which follows the 'fast track' approach in anaesthesia. The aim of the concept is to restore the patient as quickly as possible i.e. a rapid weaning from mechanical ventilation (extubation) within 6 hours after surgery. This concept provides a significant clinical and health economic benefit through shortening extubation times after surgery leading to better patient outcomes, reduced stay on the ICU and in the hospital. Next to the benefit for the patients this leads to a substantial reduction in resource use for the hospital. The aim is to establish Remimazolam as a key component of this approach. The study is 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 clear insights on early and predictable offset of its effect as well as easy titration of sedation in the postoperative phase. Two doses of Remimazolam will be evaluated against each other and against propofol during induction of general anaesthesia. In addition, Remimazolam will be tested during the maintenance phase of anaesthesia against the combination of propofol and sevoflurane with respect to efficacy and safety. Data in the postoperative sedation phase in the recovery room or ICU will also be obtained for further exploration of the ICU sedation indication. The study was designed such that the data can be compared with the anaesthesia study conducted by Ono in Japan. Dr. Wolfgang Söhngen, CEO of PAION, commented: 'Based on Ono's impressive progress we can now jumpstart the European lead indication anaesthesia. We are pleased to be able to do this in a center of excellence for cardiac surgery as this highlights the high expectations of Remimazolam's profile. We firmly believe that the current study in an area of high medical need will enhance the perception of Remimazolam's potential.' Dr. Stefan Probst, study director from the Heart Centre Leipzig, commented: 'In the field of anaesthesia and particularly in cardiac surgery and intensive care there is a need for well-tolerated controllable anaesthesia drugs due to the increasing life expectancy of the population and the associated increase in the number of elderly patients. Remimazolam has a great potential to cover these requirements. ' ### 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 and South Korea, where the compound is partnered with Ono Pharmaceutical and Yichang Humanwell, and Hana Pharm has an exclusive option. 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 --------------------------------------------------------------------- 09.09.2013 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 --------------------------------------------------------------------- 228979 09.09.2013