EQS-News: PAION receives UK MHRA approval of Byfavo® (remimazolam) for the induction and maintenance of general anesthesia in adults

PAION receives UK MHRA approval of Byfavo® (remimazolam) for the induction and maintenance of general anesthesia in adults

Aachen (Germany), 31 August 2023 - PAION AG (ISIN DE000A3E5EG5; Frankfurt Stock Exchange, Prime Standard: PA8), a specialty pharmaceutical company with innovative compounds for use in outpatient and in-hospital sedation, anesthesia and intensive care, today announces that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has approved Byfavo^® (remimazolam) for the induction and maintenance of general anesthesia in adults. The decision follows the approval of the European Commission in the EU (covering the European Economic Area (EEA) countries) from April 2023.

Gregor Siebert, CEO of PAION AG, commented: “We are excited that the MHRA has approved Byfavo^® for the induction and maintenance of general anesthesia in adults. This further expands the growth opportunities for PAION in the area of general anesthesia. We are currently preparing for the UK launch, which will take place during the 2023 AAGBI Annual Congress in Edinburgh, September 13-15, including a scientific symposium on Byfavo^® in general anesthesia on 14 September 2023. The UK is one of Europe’s strongest markets and we have good expectations for the uptake of Byfavo^® in this key market.”

The MHRA 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. Byfavo^® was already approved in the EU, Japan, the Philippines and South Korea for general anesthesia.

About Byfavo^®

Byfavo^® (remimazolam) is an ultra-short-acting intravenous benzodiazepine sedative and anaesthetic. In humans, Byfavo^® is largely degraded to an inactive metabolite by hepatic esterases, a widely distributed type of enzyme, rather than by cytochrome-dependent degradation pathways in the liver. As with other benzodiazepines, an antidote is available in flumazenil for rapid reversal of the patient's sedation or anesthesia if needed. Data show that Byfavo^® has a rapid onset of action and a rapid recovery, with a favorable cardiorespiratory safety profile.

Byfavo^® is partnered in the USA (trade name BYFAVO^TM) with Eagle Pharmaceutical, in Japan (trade name Anerem^®) with Mundipharma, in South Korea (trade name Byfavo^TM) and Southeast Asia with Hana Pharm, in Latin America with Cristália and in Taiwan with TTY Biopharm. In addition, PAION has distribution partnerships with Viatris for Belgium, Poland, France and Romania as well as the Southern European countries Italy, Spain and Greece and in Eastern Europe (Estonia, Latvia and Lithuania, Czech Republic, Slovakia, Hungary, Croatia, Slovenia and Bulgaria) with Medis. These markets are currently not served by PAION itself.

About PAION

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

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

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.