PAION launches Byfavo® (remimazolam) in the first European country for General Anesthesia

EQS-News: PAION AG / Key word(s): Product Launch
PAION launches Byfavo® (remimazolam) in the first European country for General Anesthesia
22.08.2023 / 14:00 CET/CEST
The issuer is solely responsible for the content of this announcement.

PAION launches Byfavo® (remimazolam) in the first European country for General Anesthesia

• Byfavo^® is now commercially available in the Netherlands for the use in general anesthesia
• PAION will launch Byfavo^® with its distribution partners in a staggered manner by country
• PAION estimates that approximately 30 million surgeries are performed under general anesthesia in Europe each year

Aachen (Germany), 22 August 2023 - PAION AG (ISIN DE000A3E5EG5; Frankfurt Stock Exchange, Prime Standard: PA8), a specialty pharmaceutical company with innovative drugs for use in outpatient and in-hospital sedation, anesthesia and intensive care, today announces that its lead compound Byfavo^® (remimazolam) has been launched and is now commercially available in the Netherlands for order and delivery to customers for the use in general anesthesia. PAION has thus reached another important milestone in advancing the commercial distribution of its innovative products in Europe.

Byfavo^® was approved by the European Commission in the EU (covering the European Economic Area (EEA) countries) in April 2023 for general anesthesia. Since 2021 it is already approved and available for procedural sedation.

PAION has built experienced sales, marketing, medical education and operational support teams over the past year to support the introduction of Byfavo® in general anesthesia in the EU. With millions of procedures in the EU annually that require the use of general anesthesia, Byfavo® addresses a large market opportunity.

Gregor Siebert, Chief Executive Officer of PAION AG, stated: “We are delighted to make Byfavo^® available to the first patients in the EU who require general anesthesia. Byfavo^® has been shown to safely and rapidly allow recovery of patients after general anesthesia. We expect the number and complexity of medical procedures involving the induction and maintenance of anesthesia to increase in Europe in the future, driven in particular by the expected continued aging of the population and advances in surgical techniques. General anesthesia is offered more frequently to elderly patients than it was a few years ago.”

Byfavo^® will be launched by PAION and its distribution partners in a staggered manner by country. PAION estimates that approximately 30 million surgeries are performed under general anesthesia in Europe each year. Of these, approximately 10 million procedures are performed on high-risk patients (American Society of Anesthesiologists ("ASA") classifications III or higher) who are particularly susceptible to hemodynamic instability.

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About Byfavo^®

Byfavo^® (remimazolam) is an ultra-short-acting intravenous benzodiazepine sedative and anesthetic. 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, Japan, China, 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.

22.08.2023 CET/CEST Dissemination of a Corporate News, transmitted by EQS News - a service of EQS Group AG.
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