DGAP-News: PAION AG / Key word(s): Conference
PAION AG: REMIMAZOLAM PHASE III BRONCOSCOPY DATA TO BE PRESENTED AT THE CHEST ANNUAL MEETING 2017

18.10.2017 / 14:00
The issuer is solely responsible for the content of this announcement.


 

REMIMAZOLAM PHASE III BRONCOSCOPY DATA TO BE PRESENTED AT THE CHEST ANNUAL MEETING 2017

- Phase III bronchoscopy study data accepted as a late breaker

- Primary investigator Prof. Gerard A. Silvestri will present study data on Wednesday, 01 November 2017

Aachen, 18 October 2017 - PAION AG, a specialty pharma company (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces that the clinical data of the U.S. Phase III bronchoscopy trial with remimazolam have been accepted for an oral presentation at the CHEST Annual Meeting. Remimazolam is an innovative, ultra-short acting anesthetic/sedative for which positive headline data from this trial were announced in June 2017.

Gerard A. Silvestri, M.D., M.S, Professor of Medicine (Medical University of South Carolina, Charleston, South Carolina, U.S.), the principal investigator of this Phase III trial, will present the data in the Late-Breaking Abstracts session that runs from 4:00 - 4:15 pm EDT on 01 November 2017 at CHEST in Toronto, Canada. The title of the abstract is: "Results of a Phase 3, Multi-center, Randomized, Placebo-Controlled Trial of Remimazolam: A New Ultra Short Acting Benzodiazepine for Bronchoscopy."

Dr. Silvestri commented: "Late breaking abstracts are generally reserved for high-impact randomized controlled trials. I look forward to presenting the results of the remimazolam Phase III study in patients undergoing bronchoscopy at the upcoming Chest meeting in Toronto."

"We are proud that the data of the final Phase III trial performed by PAION were accepted as a late breaker. As the premier chest medicine education meeting for clinicians, the CHEST Annual Meeting is an important venue for this data to be discussed", Dr. Wolfgang Söhngen, CEO of PAION AG, commented. "In addition to scientific and medical activities, we are working closely with our U.S. licensing partner Cosmo Pharmaceuticals as they will prepare for an NDA filing."

PAION will be available for discussions at booth 1236 in the exhibition hall.

About the U.S. Phase III trial in bronchoscopy:
The Phase III trial enrolled 446 patients at 15 U.S. sites and was designed to evaluate the efficacy and safety of remimazolam compared to placebo (with midazolam rescue medication) in procedural sedation in patients undergoing bronchoscopy. The primary endpoint and important secondary endpoints were achieved with high statistical significance.

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About remimazolam
Remimazolam is an ultra-short-acting intravenous benzodiazepine sedative/anesthetic that has already shown positive results in clinical Phase III trials. 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. During clinical studies, remimazolam demonstrated efficacy and safety in over 1,500 volunteers and 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 the final stage of clinical 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 the 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 Pharmaceuticals, Pharmascience (Pendopharm), Yichang Humanwell, R-Pharm, TR-Pharma 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 which is in the final stage of clinical development for use in procedural sedation in the U.S. Currently, PAION is mainly focusing 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. A full clinical development program for general anesthesia was completed in Japan and PAION is preparing filing in Japan. In the EU, PAION is currently planning to continue the clinical development program. 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
Vice President 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.



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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, Tradegate Exchange

 
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619689  18.10.2017 

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