PAION LAUNCHES BYFAVO(R) (REMIMAZOLAM) IN THE UK FOR PROCEDURAL SEDATION

DGAP-News: PAION AG / Key word(s): Product Launch
16.08.2021 / 11:00
The issuer is solely responsible for the content of this announcement.

PAION LAUNCHES BYFAVO^(R) (REMIMAZOLAM) IN THE UK FOR PROCEDURAL SEDATION

- Millions of procedures take place in the UK annually such as colonoscopies and bronchoscopies that require the use of procedural sedation

- Byfavo^(R) is the first product developed by PAION approved and launched in Europe

Aachen (Germany), 16 August 2021 - The Specialty Pharma Company PAION AG (PA8; ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard) today announces that Byfavo^(R) has been launched and is now commercially available in the UK for order and delivery to customers through a major wholesaler.

Byfavo^(R) was approved by the European Commission in the EU (including European Economic Area (EEA) countries) in March 2021 followed by the UK Medicines & Healthcare products Regulatory Agency (MHRA) approval in June 2021.

PAION has built experienced sales, marketing, medical education and operational support teams over the past year to support the introduction of Byfavo^(R) in the UK. With millions of procedures in the UK annually that require the use of procedural sedation, Byfavo^(R) addresses a large market opportunity. The initial focus of the commercial team for the first year after launch is to ensure that Byfavo^(R) is listed on hospital formularies, based on the unmet needs it can address and the health economic benefits it can deliver. In addition supporting healthcare professionals through medical education, reinforcing the importance of safe sedation practice, and answering their questions regarding Byfavo^(R)'s clinical data will be of high importance.

Dr. Jim Phillips, Chief Executive Officer of PAION AG, stated: "We are delighted to make Byfavo^(R) available to sedation providers for patients across the UK who require moderate sedation to undergo certain medical procedures. Byfavo^(R) has been shown to safely and rapidly allow recovery of patients after such procedures, which may allow them to be quickly discharged home."

Katja Lundell, Country Manager UK of PAION UK Ltd, added: "The launch comes at a time when COVID-19 has caused significant backlogs for elective surgeries and routine procedures. We hope that Byfavo^(R) can help to improve patient throughput, enabling more people to get the procedures that they had put on hold. We believe that this, together with ongoing shortages for existing drugs in these therapeutic areas, puts PAION in a strong position as we are entering these markets."

PAION plans to launch Byfavo^(R) in a staggered manner by country so that by the end of 2022, the product will have been launched in all selected European markets. In the top five European countries approximately 20 million procedures take place annually that require the use of procedural sedation.

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About remimazolam (Byfavo^(R))
Remimazolam is an ultra-short-acting intravenous benzodiazepine sedative/anesthetic. In the human body, remimazolam is rapidly metabolized to an inactive metabolite by tissue esterases and is not metabolized by cytochrome-dependent hepatic pathways. Like other benzodiazepines, remimazolam can be reversed with flumazenil to rapidly terminate sedation or anesthesia if necessary. Data demonstrate that remimazolam has a rapid onset and offset of action combined with a favorable cardio-respiratory safety profile.

Remimazolam is approved in the U.S., the EU/EEA/UK and China for procedural sedation and in Japan and South Korea for general anesthesia.

In addition to procedural sedation and general anesthesia, intensive care unit (ICU) sedation is another possible indication for remimazolam.

Remimazolam is partnered in the U.S. (brand name BYFAVO^TM) with Acacia Pharma, in Japan (brand name Anerem^(R)) with Mundipharma, in China (brand name Ruima^(R)) with Yichang Humanwell, in Canada with Pharmascience, in Russia/CIS, Turkey and the MENA region with R-Pharm, in South Korea (brand name Byfavo^TM) and Southeast Asia with Hana Pharm and in Taiwan with TTY Biopharm. For all other markets except Western Europe, remimazolam is available for licensing.

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. Remimazolam is partnered in multiple territories outside of Europe. Remimazolam is approved in the U.S., the EU/EEA/UK and China for procedural sedation and in Japan and South Korea for general anesthesia.

In addition to Byfavo^(R) (remimazolam), PAION has two further products, GIAPREZA^(R) (angiotensin II) and XERAVA^(R) (eravacycline), in its portfolio. GIAPREZA^(R) is a vasoconstrictor indicated for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies, and was launched in July 2021. XERAVA^(R) is 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
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.

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