PAION AG: HANA PHARM RECEIVES MARKET APPROVAL FOR BYFAVO IN GENERAL ANESTHESIA IN THE PHILIPPINES

EQS-News: PAION AG / Key word(s): Regulatory Approval
PAION AG: HANA PHARM RECEIVES MARKET APPROVAL FOR BYFAVO IN GENERAL ANESTHESIA IN THE PHILIPPINES
17.07.2023 / 10:00 CET/CEST
The issuer is solely responsible for the content of this announcement.

PAION AG: HANA PHARM RECEIVES MARKET APPROVAL FOR BYFAVO IN GENERAL ANESTHESIA IN THE PHILIPPINES

• Byfavo^TM launch in the Philippines expected in the fourth quarter of 2023
• Hana Pharm's Byfavo^TM sales increased by 260% in South Korea in 2022

Aachen, Germany, 17. July 2023 – PAION AG (ISIN DE000A3E5EG5; Frankfurt Stock Exchange, Prime Standard: PA8K), a specialty pharmaceutical company with innovative compounds for use in outpatient and hospital sedation, anesthesia and critical care, announces that Hana Pharm, licensee of Byfavo^® for South Korea and Southeast Asia, has informed PAION that "Byfavo^TM 50mg (Remimazolam besylate)" has been approved by the Philippine FDA for the induction and maintenance of general anesthesia. Hana Pharm plans to launch the product in the Philippines in the fourth quarter of this year.

The approval of Byfavo^TM in general anesthesia in the Philippines is the first approval in the six Southeast Asian (SEA) countries. Hana Pharm expects this approval to have a positive impact on approvals in the remaining five Southeast Asian countries and contribute to increased sales in South Korea.

According to Hana Pharm, Southeast Asia is one of the fastest growing pharmaceutical markets. With an average annual growth rate of 6% to 9%, it is a highly attractive market compared to South Korea with an average annual growth rate of 5%. According to the Korea Health Industry Development Institute (KHIDI), the Philippines is forecast to grow at a rate of around 8.5% by 2023.

Hana Pharm further disclosed that its sales in South Korea increased by 260% in 2022 compared to 2021. A Hana Pharm representative stated: "With the recent approval obtained in the Philippines, we anticipate that it will contribute significantly to revenue growth through overseas markets, including the six Southeast Asian countries."

Taehong Choi, CEO at Hana Pharm, commented: "The approval obtained in the Philippines is a testament to Hana Pharm’s global business capabilities. We will make efforts to ensure the successful establishment and reputation of Byfavo^TM (Remimazolam besylate) as an anesthesia drug in the Philippines through its academic development. Taking advantage of the attractive Southeast Asian market, known as the 'Pharmerging Market,' we plan to further grow as a global pharmaceutical company."

"We are very pleased that our partner Hana Pharm has reached an important milestone with the approval of Byfavo^TM for general anesthesia and is thus able to start marketing in the Philippines soon. This underlines once again that the Asian market offers great potential for our product portfolio. We see that especially in the Asian countries Hana Pharm and our other partners are making good progress. Thus, we are optimistic that PAION will continue to expand in Asia in the field of anesthesia and critical care in the coming years," said Gregor Siebert, CEO of PAION AG.

PAION granted Hana Pharm exclusive rights to develop and commercialize Byfavo^® for the South Korean market in 2013. In 2020, the licensing rights in Southeast Asia followed. Under the agreements, PAION is entitled to royalties in the low double-digit percentage range in Hana Pharm's licensed territory.

###

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, the Phillipines 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).

IR contact:

Ralf Penner

SVP 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.

17.07.2023 CET/CEST Dissemination of a Corporate News, transmitted by EQS News - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.eqs-news.com