PAION AG ANNOUNCES INITIATION OF PIVOTAL STUDY OF REMIMAZOLAM (BYFAVO(R)) IN PEDIATRIC PROCEDURAL SEDATION

DGAP-News: PAION AG / Key word(s): Study
16.09.2021 / 14:00
The issuer is solely responsible for the content of this announcement.

PAION AG ANNOUNCES INITIATION OF PIVOTAL STUDY OF REMIMAZOLAM (BYFAVO^(R)) IN PEDIATRIC PROCEDURAL SEDATION

Aachen (Germany), 16 September 2021 - The Specialty Pharma Company PAION AG (PA8; ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard) announces together with Acacia Pharma (Acacia), remimazolam licensee for the U.S., the initiation of a European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) mandated pivotal study investigating remimazolam (Byfavo^(R)) in the mild to moderate sedation of pediatric patients.

The study will enroll approximately 100 children and adolescents aged up to and including 17 years at leading institutions across the United States and Denmark. If successful and upon approval by EMA (the EMA requires two pediatric studies) and FDA of a supplemental New Drug Application for remimazolam, it is expected that the EU and U.S. label of remimazolam will be expanded to include mild to moderate sedation for procedures in pediatric patients.

Dr. Jim Phillips, Chief Executive Officer of PAION AG, stated: "We are very pleased about the start of the study which is good news as the treatment of children can be an important area of application for remimazolam and look forward to the outcome of the study."

Dr. Gabriel Fox, Chief Medical Officer of Acacia, commented: "The need for moderate sedation in pediatric patients is substantial, covering a wide range of procedures, including, but not limited to, MRI and CT imaging, endoscopies, intravenous cannula placements, dental procedures, and painful wound and burn dressing changes. We are excited to be working with an outstanding group of pediatric sedation experts on this important initiative."

The study, formally titled "A Phase 2/3, prospective, open-label trial evaluating the efficacy, safety, and pharmacokinetics of remimazolam for intravenous sedation in paediatric patients undergoing diagnostic and/or therapeutic procedures" (ClinicalTrials.gov Identifier: NCT04851717), underpins the Pediatric Investigational Plan for remimazolam agreed with the EMA as well as the equivalent Pediatric Study Plan agreed with the FDA. As part of the EU approval, the EMA required the completion of the first of two studies until September 2023, and as part of the U.S. approval of remimazolam, FDA required the completion of this single study by July 2024. However, PAION and Acacia have elected to accelerate the conduct of the study significantly because of the important unmet medical need for remimazolam in pediatric procedural sedation.

About PAION
PAION AG is a publicly listed specialty pharmaceutical with innovative drugs to be used in hospital-based sedation, anesthesia and critical care services. PAION's lead compound is remimazolam, an intravenous, ultra-short-acting and controllable benzodiazepine sedative/anesthetic. PAION is currently launching remimazolam (Byfavo^(R)) in the UK and selected European markets. Remimazolam is partnered in multiple territories outside of Europe. Remimazolam is approved in the U.S., the EU/EEA/UK, China and South Korea for procedural sedation and in Japan and South Korea for general anesthesia.

In addition, PAION markets two intensive care products in selected European countries: Angiotensin II (GIAPREZA^(R)), a vasoconstrictor indicated for the treatment of refractory hypotension in adults with septic or other distributive shock, and eravacycline (XERAVA^(R)), a novel fluorocycline antibiotic indicated for the treatment of complicated intra-abdominal infections in adults.

PAION's mission is to be a leading specialty pharmaceutical company in the fields of anesthesia and critical care by bringing novel products to market to benefit patients, doctors and other stakeholders in healthcare.

PAION is headquartered in Aachen (Germany).

Contact
Ralf Penner
Vice President Investor Relations/Public Relations
PAION AG
Heussstrasse 25
52078 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' 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 PAION'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 such forward-looking statements to reflect future events or developments.

16.09.2021 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.

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