27.03.2017 - 07:32:41



- Remimazolam administration appeared safe

- Efficacy and efficiency gains comparable to confirmatory U.S. Phase III pivotal trial

Aachen (Germany), 27 March 2017 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces that remimazolam, its ultra-short-acting benzodiazepine, appeared safe in a study comparing remimazolam sedation to placebo with midazolam rescue in high risk (ASA III/IV) patients (American Society of Anesthesiologists classification; ASA III: patients with severe systemic disease, ASA IV: patients with severe systemic disease that is a constant threat to life) undergoing colonoscopy.

In addition the efficacy and efficiency gains were comparable to the first pivotal U.S. Phase III trial in colonoscopy patients. As ASA III/IV patients can develop symptoms that require immediate stabilizing interventions, these patients are mostly treated in a hospital environment. The classification of the patients' ASA status was checked by an external anesthesiologist who was not otherwise involved in the trial.

This Phase III trial is part of the U.S. development program agreed upon between PAION and the U.S. Food and Drug Administration (FDA) for the filing of remimazolam for market approval in the targeted indication procedural sedation.

This prospective, double-blind, randomized, placebo- and active controlled, multicenter, parallel group study enrolled 79 high-risk patients (i.e. ASA III/IV) undergoing a colonoscopy into a remimazolam, midazolam or placebo (including midazolam 'rescue' sedation) treatment group. The disposition for ASA III and IV were equally distributed for the remimazolam and control patients.

The primary objective was to assess the safety of multiple doses (initial dose and additional top-up doses) of remimazolam compared to placebo and midazolam, following administration of a standard dose of fentanyl. The fentanyl, remimazolam and midazolam doses were reduced compared to the pivotal U.S. Phase III trials as indicated in the label for midazolam which PAION is targeting for remimazolam.

In PAION's view, this safety trial confirms remimazolam's safety profile and tolerability shown in all previous studies in a more vulnerable patient population. Overall, remimazolam demonstrated good respiratory and cardiovascular stability as compared to placebo with midazolam rescue. No adverse events of concern were observed in either group.

There were several additional outcome measures included to assess efficacy: One such outcome was a composite endpoint, composed of success of the procedure, no need for rescue medication, and completion of the procedure with no more than 5 doses given within any 15-minute interval. This endpoint was achieved in 84.4% of the patients in the remimazolam arm and 0% in the placebo arm. Further relevant endpoints for remimazolam showed a median time from start of medication to start of procedure of 5.0 minutes (placebo 18.5 minutes) and a median time from end of procedure to return to full alertness of 3.0 minutes (placebo 5.0 minutes).

This study also included an open label arm in which midazolam was dosed according to U.S. label. Success of the procedure was achieved in 12.9% of the midazolam patients. Midazolam patients showed a median time from start of medication to start of procedure of 19.0 minutes and a median time from end of procedure to return to full alertness of 7.0 minutes. "The study results reassures us in the expectation that remimazolam has the potential to be an important addition to existing options for sedating patients undergoing procedures such as colonoscopy", commented Professor Douglas Rex M.D., co-ordinating investigator, Indiana University, Indianapolis, U.S.A. "Next to the excellent efficacy I am pleased to see that remimazolam also confirmed our hopes on the safety aspects."

Dr. Wolfgang Söhngen, PAION AG's CEO, commented: "We are excited about the headline data from remimazolam's safety trial in high risk patients. The data confirmed the good safety and efficacy of remimazolam seen in the first U.S. Phase III colonoscopy trial. Remimazolam has the potential to improve patient satisfaction and enhance patient care also in high risk patients." ###About remimazolam Remimazolam is an ultra-short-acting intravenous benzodiazepine sedative/anesthetic. In the human body, remimazolam is rapidly metabolized to an inactive metabolite by tissue esterases and not metabolized by cytochrome-dependent hepatic pathways. Like other benzodiazepines, remimazolam can be reversed with flumazenil to rapidly terminate sedation and anesthesia if necessary.

In clinical studies, remimazolam demonstrated efficacy and safety in far over 1,000 patients. Data so far indicate that remimazolam has a rapid onset and offset of action combined with a favorable cardio-respiratory safety profile.

Remimazolam is currently in clinical Phase III development for procedural sedation in the U.S. After completion of the ongoing development, the implementation of a pediatric development plan already agreed with the FDA is planned. A full clinical development program for general anesthesia was completed in Japan, and a Phase II study in general anesthesia was completed in the EU. Based on the positive results of a Phase II study, development for ICU sedation beyond 24 hours is another attractive indication. Remimazolam is partnered in the U.S., Canada, China, Russia (CIS), Turkey, the MENA region, and South Korea with Cosmo, Pharmascience (Pendopharm), Yichang Humanwell, R-Pharm, TR-Pharm, and Hana Pharm, respectively. For all other markets, remimazolam is available for licensing.About PAION PAION AG is a publicly listed specialty pharmaceutical company developing and aiming to commercialize innovative drugs to be used in out-patient and hospital-based sedation, anesthesia and critical care services. PAION's lead compound is remimazolam, an intravenous, ultra-short-acting and controllable benzodiazepine sedative/anesthetic drug candidate. Currently, remimazolam is in Phase III clinical development for use in procedural sedation in the U.S., where PAION is focusing all its business and financial resources on successfully completing its ongoing clinical development program in procedural sedation. Outside the U.S., PAION has so far focused on the development of remimazolam in the indication general anesthesia. Development of remimazolam in the indication intensive care unit (ICU) sedation is also part of the longer term life-cycle plan for remimazolam. PAION is headquartered in Aachen (Germany) with a further site in Cambridge (United Kingdom).

PAION's vision is to become an acknowledged "PAIONeer" in sedation and anesthesia.

PAION Contact Ralf Penner Director Investor Relations / Public Relations PAION AG Martinstrasse 10-12 52062 Aachen - Germany Phone: +49 241 4453-152 E-mail:


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.

27.03.2017 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. Archive at

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: Internet: ISIN: DE000A0B65S3 WKN: A0B65S Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange   End of News DGAP News Service

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