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

PAION AG / Key word(s): Regulatory Approval
PAION AG: HANA PHARM RECEIVES MARKET APPROVAL FOR REMIMAZOLAM (BYFAVO) IN GENERAL ANESTHESIA IN SOUTH KOREA

07-Jan-2021 / 11:14 CET/CEST
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PAION AG: HANA PHARM RECEIVES MARKET APPROVAL FOR REMIMAZOLAM (BYFAVO^TM) IN GENERAL ANESTHESIA IN SOUTH KOREA

Aachen (Germany), 07 January 2021 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) announces that Hana Pharm, remimazolam licensee for South Korea, today informed PAION that South Korea's Ministry of Food and Drug Safety (MFDS) has approved the New Drug Application (NDA) for BYFAVO^TM (remimazolam) in general anesthesia.

The NDA approval of BYFAVO^TM in South Korea triggers a milestone payment of EUR 1 million from Hana Pharm.

End of inside information

'With the next marketing approval the year 2021 gets off to a promising start for PAION, and we congratulate Hana Pharm on this achievement,' said Dr. Jim Phillips, CEO of PAION AG. 'With the recently started construction of their own production plant for BYFAVO^TM, our partner continues to invest in the success of BYFAVO^TM and we are looking forward to the upcoming market launch.'

Dr. Younha Lee, CEO of Hana Pharm, announced: 'We are thrilled to announce BYFAVO^TM approval in South Korea and sincerely thankful for the rewarding partnership with PAION since 2013. Today's approval allows us to leverage Hana Pharm's significant development and commercialization expertise in anesthesiology in South Korea. We will be accelerating the remaining process towards product launch in South Korea and also the regulatory and commercial partnering progress in Singapore, Thailand, Vietnam, Indonesia, the Philippines and Malaysia this year.'

PAION granted Hana Pharm the exclusive rights to develop and commercialize BYFAVO^TM 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
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 so far indicate 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. and China for procedural sedation and in Japan and South Korea for general anesthesia. In Europe, PAION submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in procedural sedation in November 2019.

In addition to procedural sedation and general anesthesia, based on positive Phase II study results, 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, and in South Korea (brand name BYFAVO^TM) and Southeast Asia with Hana Pharm. For all other markets including parts of the EU, remimazolam is available for licensing.

About PAION
PAION AG is a publicly listed specialty pharmaceutical company focused on developing and commercializing innovative drugs for out-patient and 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. and China for procedural sedation and in Japan and South Korea for general anesthesia.

In Europe, PAION is seeking approval of remimazolam for general anesthesia and for procedural sedation. PAION submitted a Marketing Authorization Application (MAA) for procedural sedation in November 2019.

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 & other stakeholders in healthcare.

PAION is headquartered in Aachen (Germany) with an additional site in Cambridge (United Kingdom).

Contact
Ralf Penner
Vice President Investor Relations/Public Relations
PAION AG
Martinstrasse 10-12
52062 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 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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