DGAP-News: PAION AG REPORTS HEADLINE DATA OF ONO'S PHASE

DGAP-News: PAION AG / Key word(s): Study PAION AG REPORTS HEADLINE DATA OF ONO'S PHASE II/III TRIAL - REMIMAZOLAM MEETS PRIMARY ENDPOINT AND SHOWS GOOD SAFETY DATA 14.11.2013 / 09:16 --------------------------------------------------------------------- PAION AG REPORTS HEADLINE DATA OF ONO'S PHASE II/III TRIAL - REMIMAZOLAM MEETS PRIMARY ENDPOINT AND SHOWS GOOD SAFETY DATA - Completion of phase II/III study in 375 patients - Primary Endpoint successfully met - Excellent cardiovascular stability confirmed - Excellent safety profile of Remimazolam confirmed Aachen (Germany), 14 November 2013 - PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange General Standard: PA8) today announced that its Japanese development partner, Ono Pharmaceutical Co., Ltd. ('Ono') has informed PAION AG, that it has completed a phase II/III clinical study of Remimazolam (development codes: ONO-2745/CNS 7056) in its lead indication of General Anaesthesia successfully met the primary endpoint. The study was conducted in Japan as a multi-centre randomized parallel-group study with propofol as a control in surgery patients undergoing general anaesthesia in combination with analgesics. Remimazolam and propofol were intravenously administered to 375 patients (2 Remimazolam groups with induction doses of 6 mg/kg/h or 12 mg/kg/h and started at the rate of 1 mg/kg/h for maintenance, 150 subjects per group) and 75 patients received a standard dose of propofol, respectively, to compare success rates of induction and maintenance of general anaesthesia. All 375 patients achieved loss of consciousness and underwent successful intubation. The primary efficacy endpoint of effectiveness as a general anaesthetic (defined as no intraoperative awakening/memory, no body motion and no rescue therapy for sedative effect necessary) was achieved by 100% of patients in all groups. Typically for an anaesthesia study the study was designed as non-inferiority study vs. standard of care, in this case i.v. propofol. No adverse events of concern were observed. The incidence rates of adverse events were 84.7%, 80.7% and 84.0% in 6 mg/kg/h and 12 mg/kg/h of Remimazolam and propofol groups, respectively. Common adverse events included decrease of blood pressure, primary wound complication, abnormal laboratory test results, nausea/vomiting and injection site pain (observed only in the propofol group) etc, which corresponded with relatively common events typically observed in perioperative patients. The incidence rates of decrease in blood pressure were 35.3%, 34.7% and 60.0% in 6 mg/kg/h and 12 mg/kg/h of Remimazolam and propofol groups, respectively. This suggests that Remimazolam has a clinically meaningfully less cardio depressive effect as compared to propofol. The incidence rate was significantly lower in each Remimazolam group as compared to the propofol group (p=0.0004 and p=0.0003 for the 6 and 12 mg/kg/h doses vs. propofol). Pharmacokinetic and pharmacodynamic modelling is still ongoing. ONO entered into a license agreement with PAION (formerly CeNeS) in August 2007, acquiring the exclusive right to develop and market Remimazolam in Japan. Dr. Mariola Söhngen, the Chief Medical Officer at PAION states: 'We congratulate our partner ONO on the completion of the Phase II/III study in anaesthesia and meeting the primary endpoint. Importantly this data will be a major contribution for our own development in General Anaesthesia and the overall safety data base for Remimazolam. The fact that Remimazolam caused significantly less drops in blood pressure is particularly important and very encouraging, specifically with respect to our ongoing Phase II study in cardiac surgery patients, where this is one of the key expected outcomes.' ### 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 Ono In keeping with its philosophy of 'Dedicated to Man's Fight against Disease and Pain' Ono has always striven to achieve its goal of serving as an R&D-oriented global speciality pharmaceuticals, aiming to develop innovative and globally recognized drugs. Ono offers a number of drugs in disease area where we have high medical needs including a new class of drug for type II diabetes (Glactiv(R) Tablet) and chemotherapy-induced nausea and vomiting (Emend(R) Capsule, Proemend(R) for intravenous infusion) and a transdermal drug for Alzheimer's disease (Rivastach(R) Patch). About Remimazolam Remimazolam is an innovative short-acting general anaesthetic/sedative. Due to its short duration of action and good controllability, it has a favorable 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 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 --------------------------------------------------------------------- 14.11.2013 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 --------------------------------------------------------------------- 239853 14.11.2013