DGAP-News: PAION AG / Key word(s): Research Update PAION AG: GERMAN REGULATORY AUTHORITY APPROVED PHASE II STUDY OF REMIMAZOLAM IN INDICATION ANAESTHESIA 05.08.2013 / 11:41 --------------------------------------------------------------------- PAION AG: GERMAN REGULATORY AUTHORITY APPROVED PHASE II STUDY OF REMIMAZOLAM IN INDICATION ANAESTHESIA - Final preparations for the start of the study - Study results expected in H1 2014 Aachen (Germany), 05 August 2013 - PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange General Standard: PA8) a biopharmaceutical company, announced today, that the BfArM, the German regulatory authority has granted approval for the Phase II clinical trial with the short-acting anaesthetic/sedative Remimazolam in the indication 'anaesthesia' in cardiovascular 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 cardiac surgery patients. After surgery a follow up sedation in the recovery room or the ICU for up to 24 h will take place. A total of 90 patients will be treated. Currently, final preparations for the official start of the study are ongoing. Results of the study are expected in the first half of 2014. Dr. Wolfgang Söhngen, CEO of PAION, commented: 'I would like to thank the entire internal and external international team of over 30 people who were involved in the planning of this highly complex study. Now it is time to perform the last logistical steps so that the study can begin quickly. Once the recruitment has started, we will inform about further study details.' ### 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 --------------------------------------------------------------------- 05.08.2013 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 --------------------------------------------------------------------- 224199 05.08.2013
DGAP-News: PAION AG: GERMAN REGULATORY AUTHORITY APPROVED PHASE II STUDY OF REMIMAZOLAM IN INDICATION ANAESTHESIA
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