PAION AG: HANA PHARM RECEIVES MARKET APPROVAL FOR BYFAVO (REMIMAZOLAM) IN PROCEDURAL SEDATION IN SOUTH KOREA

DGAP-News: PAION AG / Key word(s): Regulatory Approval
31.08.2021 / 09:32
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PAION AG: HANA PHARM RECEIVES MARKET APPROVAL FOR BYFAVO (REMIMAZOLAM) IN PROCEDURAL SEDATION IN SOUTH KOREA

- Fully-fledged entry into the endoscopy market by adding an indication for 'induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less'

- Use expanded to various surgeries, with 'Byfavo 50mg' (induction and maintenance of general anesthesia in adults) launched in March 2021

Aachen (Germany), 31 August 2021 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) announces that Hana Pharm, remimazolam licensee for South Korea, informed PAION that South Korea's Ministry of Food and Drug Safety (MFDS) has approved 'Byfavo 20mg' on 30 August 2021 for the indication "Induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less" as well as for the indication "induction and maintenance of general anesthesia in adults". 'Byfavo 50mg' was already approved for the latter indication in January 2021.

This additional approval of 'Byfavo 20mg' is expected to be widely used in endoscopy-related sedation procedures and surgeries.

"We are very pleased with this progress from our partner, and we congratulate Hana Pharm on this achievement," said Dr. Jim Phillips, CEO of PAION AG. "With the recently started market launch of Byfavo, this approval and the continued construction of a new production plant, our partner continues to demonstrate the support of Byfavo to bring this to a commercial success."

"We are pleased to launch a new drug that overcomes the limitations of midazolam, which is widely used in procedural sedation, as well as propofol, with the additional indication for 'Induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less'. This has expanded options for intravenous anesthesia and sedation according to the patient's physical condition. Now that we have obtained both indications for anesthesia and procedural sedation, we will do our best to expand patient's access to the new intravenous anesthetic named Byfavo.", said Dr. Younha Lee, CEO of Hana Pharm.

PAION granted Hana Pharm the exclusive rights to develop and commercialize Byfavo for the South Korean market in 2013. Under the terms of the agreement, PAION is entitled to receive 10% royalties on Hana Pharm's remimazolam revenues in South Korea.

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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, South Korea 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 company 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, South Korea 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. 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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