DGAP-News: PAION AG / Key word(s): Research Update PAION ANNOUNCES INITIATION OF US PHASE III CLINICAL TRIAL OF REMIMAZOLAM FOR PROCEDURAL SEDATION DURING COLONOSCOPY 31.03.2015 / 13:00 --------------------------------------------------------------------- PAION ANNOUNCES INITIATION OF U.S. PHASE III CLINICAL TRIAL OF REMIMAZOLAM FOR PROCEDURAL SEDATION DURING COLONOSCOPY - Remimazolam's U.S. Phase III program to include two pivotal trials and one smaller safety trial launching in 2015 - Patient recruitment for Phase III in colonoscopy is expected to complete before end of 2015 Aachen, 31 March 2015 - PAION AG, a Specialty Pharma Company (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announced the initiation of a U.S. Phase III clinical trial of Remimazolam, an ultra-short-acting sedative/anesthetic, for procedural sedation in patients undergoing colonoscopy. During Phase II clinical trials, Remimazolam displayed faster onset of sedation and greater procedural success compared to midazolam. Remimazolam showed a benign safety profile and patients experienced rapid recovery from sedation including faster recovery of cognitive function as compared to midazolam. The initiation of the Phase III trial in patients undergoing colonoscopies marks the start of PAION's Phase III clinical program, which includes a second pivotal Phase III trial in patients undergoing bronchoscopies and a third smaller safety trial in high-risk patients undergoing colonoscopies. In parallel, PAION will conduct three Phase I studies. Wolfgang Söhngen, M.D., Ph.D., chief executive officer of PAION AG, said: "The initiation of the Phase III trial in patients undergoing colonoscopy is an important milestone for PAION. We expect the current study to further confirm Phase II data that showed Remimazolam was safe and highly effective in providing procedural sedation. Midazolam has been selected as a comparator because PAION aims to get a label similar to Midazolam." Greg Papaz, president and chief executive officer of PAION, Inc., added: "The change in the reimbursement of colonoscopies in the U.S. underscores the medical need for an alternative sedation agent. We expect Remimazolam to compete with the safest prescribed sedatives and enable high-patient throughput with a fast onset/rapid recovery, a profile currently unmet in the anesthetic space." This Phase III clinical trial is a prospective, double-blind, randomized, placebo and midazolam-controlled, U.S. multicenter study in 460 patients undergoing colonoscopies for diagnostic or therapeutic reasons. Patients will be randomized to receive Remimazolam, midazolam or placebo in addition to fentanyl to achieve moderate sedation. The primary objective of this study is to investigate the short-term sedation, and hence the success of a colonoscopy compared to placebo and midazolam. The primary endpoint is the successful completion of the colonoscopy procedure with no requirement for alternative sedative. The completion of patient recruitment is expected before the end of 2015. ### About Remimazolam Remimazolam is an innovative ultra-short-acting general sedative/anesthetic. As a result of its short duration of action and good controllability, it has a preferable efficacy and safety profile relative to other currently marketed anesthesia compounds. Remimazolam's rapid offset is a consequence of its metabolism by tissue esterase enzymes that are widely distributed throughout the body. Remimazolam has potential in three indications: - Procedural sedation (Lead indication U.S.) - General anesthesia (Lead indication EU, Japan) - ICU sedation (Phase II Japan) Remimazolam is available for licensing outside China, Russia (CIS) Turkey, MENA Region, South Korea and Canada, where the compound is partnered with Yichang Humanwell, R-Pharm, TR-Pharm, Hana Pharm and Pendopharm. About PAION PAION AG is a publicly-listed Specialty Pharma Company headquartered in Aachen, Germany with further sites in Cambridge, UK and New Jersey, U.S. The company has a track record of developing hospital-based treatments for which there is substantial unmet medical need. PAION's strategy is to participate in the commercialization of Remimazolam and extend its business with a focus on anesthesia/critical care products. Remimazolam is the building block for its future marketing activities. For more information please visit www.paion.com PAION 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. --------------------------------------------------------------------- 31.03.2015 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement. The DGAP 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: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart End of News DGAP News-Service --------------------------------------------------------------------- 339335 31.03.2015
DGAP-News: PAION ANNOUNCES INITIATION OF US PHASE III CLINICAL TRIAL OF REMIMAZOLAM FOR PROCEDURAL SEDATION DURING COLONOSCOPY
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