SOURCE: PAION AG

PAION AG

October 12, 2015 08:00 ET

Remimazolam Posters at Anesthesiology® 2015

PAION and Remimazolam poster presentations at Anesthesiology® 2015, the American Society of Anesthesiologists (ASA) annual meeting, 24-28 October 2015, San Diego; PAION at the American College of Gastroenterology (ACG) Annual Scientific Meeting, 16-21 October 2015, Honolulu

MAHWAH, NJ--(Marketwired - October 12, 2015) - PAION, Inc., a wholly owned subsidiary of PAION AG (XETRA: PA8), today announced its presence (booth 2315) and the presentation of results so far generated in the completed clinical trials in general anesthesia with Remimazolam at Anesthesiology® 2015.

PAION will also be available for discussions at booth 1426 at the American College of Gastroenterology (ACG) Annual Scientific Meeting.

Dr. Wolfgang Söhngen, CEO of PAION AG, commented: "With a total of three Remimazolam oral and poster presentations we will intensify the dialogue with international anesthesiologists and key opinion leaders. In addition, we will receive suggestions for the positioning and further profiling of Remimazolam."

Anesthesiology® 2015

Three posters/oral presentations on Remimazolam, PAION's ultra-short-acting sedative and anesthetic, will be given by lead investigators from the Phase I-III Japanese clinical trial program in general anesthesia and from the Phase II European program in cardiac surgery.

Japanese development program:  
  
(1)Remimazolam dose finding studies for anesthetic/sedative use in general anesthesia. (Japanese clinical phase I and II trials)
  
 Oral presentation by Dr. Doi, from the Hamamatsu University School of Medicine, Hamamatsu, Japan, on October 26, 1:15 - 2:45 pm.
  
(2)Remimazolam, a new ultra-short-acting anesthetic, shows similar efficacy and a favorable hemodynamic stability vs. propofol in general surgery patients with TIVA: Results of a randomized, non-inferiority, Japanese Phase IIb/III trial.
  
 Poster presentation by Dr. Sato, from the Suzukake Central Hospital, Hamamatsu, Japan, on October 28, 8:00 - 9:30 am.
  
EU development program: 
  
(3)"Difference in vasopressor use and usage patterns in patients undergoing cardiac surgery with Remimazolam vs. propofol/sevoflurane for general anesthesia." (European Phase II study)
  
 Oral presentation by Dr. Probst, from the heart center Leipzig - university hospital, Germany, on October 27, 9:45 - 11:15 am.

About Remimazolam

Remimazolam is an ultra-short-acting intravenous sedative and anesthetic currently in Phase III clinical development for procedural sedation and general anesthesia. Remimazolam is a member of the class of substances known as benzodiazepines. 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 in order to rapidly terminate sedation if necessary.

Efficacy and safety of Remimazolam has been investigated in clinical studies in more than 1,000 patients. Confirmatory Phase III programs are now in progress. Data so far indicate that Remimazolam has the expected rapid onset and offset of action combined with a favourable hemodynamic stability profile.

In the US, Remimazolam is initially being developed for procedural sedation during procedures such as colonoscopy.

In EU and most other major markets, Remimazolam is initially being developed for general anesthesia in patients undergoing non-cardiac and cardiac surgery, including sedation in intensive care units (ICUs) for up to 24 hours after the operation.

In Japan a clinical Phase III program in anesthesia has also been conducted.

Development of an indication for ICU sedation beyond 24 hours is planned following successful completion of the currently ongoing above mentioned Phase III programmes. A pediatric development plan has been agreed with the FDA and will be implemented following approval of Remimazolam for adult patients. A similar approach is planned for EU.

Remimazolam is available for licensing outside China, Russia (CIS), Turkey, the 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 Pharmaceutical Company headquartered in Aachen (Germany) with operations in Cambridge (United Kingdom) and New Jersey (USA).

PAION's lead substance, Remimazolam, is an intravenous ultra-short-acting anesthetic that is currently in Phase III clinical development for procedural sedation and general anesthesia. Remimazolam is designed to complement and improve currently available treatment options for patients requiring sedation and anesthesia.

PAION is focusing its clinical development activities on Remimazolam and has initiated pre-commercial activities according to PAION's vision to become an acknowledged "PAIONeer" in sedation and anesthesia.

For more information please visit 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.

Contact Information

  • 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