drugset / Press release

PAION ANNOUNCES PRODUCT LAUNCH OF BYFAVO (REMIMAZOLAM) IN SOUTH KOREA BY HANA PHARM

2021-04-07 · Paion UK Ltd. · original paion.com ↗

PAION ANNOUNCES PRODUCT LAUNCH OF BYFAVOTM (REMIMAZOLAM) IN SOUTH KOREA BY HANA PHARM Aachen (Germany), 07 April 2021 - The Specialty Pharma Company PAION AG (PA8; ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard) today announces that Hana Pharm, remimazolam licensee for South Korea, informed PAION about the launch of ByfavoTM (remimazolam) for the use in general anesthesia in South Korea. Remimazolam was approved in South Korea for general anesthesia in January 2021 and will be marketed under the brand name ByfavoTM. Dr. Jim Phillips, Chief Executive Officer of PAION AG, stated: "The launch in South Korea is great news and a testament to the strong commitment of our partner Hana Pharm. PAION is eligible to royalties of 10% of net sales in South Korea. We look forward to a successful 4th country launch and sharing further commercial news when we receive it regarding the South Korean market." ### About remimazolam 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 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 BYFAVOTM) 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 ByfavoTM) 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 and China for procedural sedation and in Japan and South Korea for general anesthesia. In addition to Byfavo(R) (remimazolam), PAION is preparing to launch the two products GIAPREZA(R) (Angiotensin II) and XERAVA(R) (Eravacycline) in Europe. 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 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 [email protected] 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 the Company'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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