DGAP-News: PAION'S PARTNER ONO STOPPED ITS DOSE FINDING,

DGAP-News: PAION AG / Key word(s): Research Update PAION'S PARTNER ONO STOPPED ITS DOSE FINDING, EXPLORATIVE PHASE II TRIAL IN ICU SEDATION WITH REMIMAZOLAM AND PLANS TO ADAPT THE DOSE REGIME FOR A NEW STUDY 01.08.2013 / 12:39 --------------------------------------------------------------------- PAION'S PARTNER ONO STOPPED ITS DOSE FINDING, EXPLORATIVE PHASE II TRIAL IN ICU SEDATION WITH REMIMAZOLAM AND PLANS TO ADAPT THE DOSE REGIME FOR A NEW STUDY - ONO initiated the dose finding, explorative phase II trial in ICU sedation with Remimazolam in September 2012 - ONO plans to adapt the dose regime for a new study - The clinical trials in General Anaesthesia are on track - the recruitment of second study of Phase III program is completed (ASA III or higher) Aachen (Germany), 01 August 2013 - PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange, General Standard: PA8), a biopharmaceutical company, announced that it was informed by its partner ONO Pharmaceutical that it has decided to stop the dose finding explorative Phase II trial in ICU sedation. Due to an unclear pharmacokinetic result in long-term administration in the study, ONO has decided the discontinuation of the study. Overall all patients were sedated successfully and no significant Adverse Events were reported. The next step will be to perform a batch of pre-clinical experiments, perform PK modelling based on the plasma samples and consider if dose adjustment (reduced or changed) is necessary for new studies. ONO furthermore confirmed that clinical trials in General Anaesthesia are on track. The recruitment of the second study in the Phase III program (American Society of Anesthesiologists classification III or higher) in more severely sick patients has been completed. No significant Adverse Events has been reported so far. ONO entered into the license agreement with PAION UK Ltd. (former CeNeS Limited) in 2007 to develop and commercialize Remimazolam in Japan and is developing the substance for the Japanese market for both 'induction and maintenance of anaesthesia' and 'ICU sedation'. Dr. Wolfgang Söhngen, CEO of PAION, commented: 'We are again impressed by the fact how fast Ono is driving the anaesthesia Phase III program forward. ONO's decision to discontinue the ICU study shows the diligence with which ONO is performing the program. ONO is committed to the program in ICU sedation and plans to perform a new study. In addition we will be able to collect data in our study in Europe, as part of the patients undergoing Cardiac Surgery will be observed for up to 24h ICU sedation with Remimazolam as compared to Propofol.' ### 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 --------------------------------------------------------------------- 01.08.2013 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 --------------------------------------------------------------------- 223810 01.08.2013