PAION receives European Commission approval of remimazolam for the Induction and maintenance of general anesthesia in adults

PAION AG / Key word(s): Regulatory Approval
PAION receives European Commission approval of remimazolam for the Induction and maintenance of general anesthesia in adults

03-Apr-2023 / 13:20 CET/CEST
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PAION receives European Commission approval of remimazolam for the Induction and maintenance of general anesthesia in adults

Aachen (Germany), 03 April 2023 – The specialty pharmaceutical company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8) announces that today the European Commission (EC) has approved remimazolam for the induction and maintenance of general anesthesia in adults in the EU (including the countries of the European Economic Area, EEA).

In addition, the UK Medicines & Healthcare products Regulatory Agency (MHRA) is currently reviewing a possible approval in the UK.

End of inside information

The approval is based on the data from a comprehensive clinical program in general anesthesia. This demonstrated, among other things, a lower incidence of hemodynamic side effects compared with propofol. Remimazolam was already approved in Japan and South Korea for general anesthesia.

Gregor Siebert, CEO at PAION AG, commented: “We are excited that the European Commission has approved remimazolam, and thank all healthcare professionals, patients and partners who have been involved in the development of remimazolam. After having successfully started the marketing of remimazolam for the indication procedural sedation in the European core markets, we continue to drive forward the sales activities here and are planning the market launch in general anesthesia in the second half of 2023. Together with our further products angiotensin II and eravacycline, we are thus offering an attractive portfolio for both anesthetists and intensive care specialists in important markets around the world.”

Contact

Ralf Penner

Senior Vice President Investor Relations & Corporate Communications

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’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 PAION AG'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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