PAION Announces Initiation of U.S. Clinical Safety Trial of Remimazolam in High Risk Patients Undergoing Colonoscopy - Seite 2

In clinical studies, Remimazolam demonstrated efficacy and safety 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 favorable hemodynamic stability profile.

In the U.S., Remimazolam is initially being developed for procedural sedation during procedures such as colonoscopies.

In the 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 been successfully completed, and a Pre-NDA meeting is expected to take place in the beginning of 2016.

Development of an indication for ICU sedation beyond 24 hours is planned following successful completion of the currently ongoing above-mentioned Phase III programs. 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. In the U.S. and EU, PAION focuses on the attractive opportunity of an own commercialization.

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.

PAION Contact
Ralf Penner
Director Investor Relations / Public Relations
PAION AG
Martinstrasse 10-12
52062 Aachen - Germany
Phone: [phone]
E-mail: [e-mail]
www.paion.com