2021. január 29., péntek, 11:20

DGAP-Ad-hoc: PAION AG / Key word(s): Miscellaneous


29-Jan-2021 / 11:20 CET/CEST

Disclosure of an inside information acc. to Article 17 MAR of the Regulation (EU) No 596/2014, transmitted by DGAP - a service of EQS Group AG.

The issuer is solely responsible for the content of this announcement.


- Positive CHMP opinion based on the data from a comprehensive clinical program in procedural sedation in adult patients undergoing bronchoscopy or colonoscopy

- Final decision on MAA expected in the first half of 2021

Aachen (Germany), 29 January 2021 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces that the European Medicines Agency"s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Byfavo(R) (remimazolam) in procedural sedation in adult patients.

The European Commission will review the CHMP recommendation and a final decision on the Marketing Authorization Application (MAA) for Byfavo(R) in the EU (including European Economic Area (EEA) countries) is expected in the first half of 2021. The UK Medicines & Healthcare products Regulatory Agency (MHRA) will also consider the positive opinion for a potential approval in the United Kingdom.

End of inside information


Information and Explanation of the Issuer to this News:

The positive CHMP opinion for Byfavo(R) (remimazolam) is based on the clinical program in procedural sedation in adult patients undergoing bronchoscopy or colonoscopy. Remimazolam was approved in China and in the U.S. in July 2020 for the induction and maintenance of procedural sedation in adults.

Remimazolam is also in development for general anesthesia in Europe, and was approved in Japan and South Korea for general anesthesia. Assuming approval in procedural sedation by the European Commission, PAION plans to submit an extension of the marketing authorization for remimazolam for general anesthesia based on the recently announced positive EU Phase III data.

Dr. Jim Phillips, CEO at PAION AG, commented: "This positive CHMP opinion for Byfavo(R) brings us closer to our ambition to delivering the first innovative treatment option for sedation and anesthesia in Europe in more than 30 years. We can now further plan to make the product available to patients and physicians in first European markets with a plan for launches in procedural sedation in the second half of 2021."

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 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, and in South Korea (brand name BYFAVOTM) and Southeast Asia with Hana Pharm.


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 Byfavo(R) (remimazolam) for general anesthesia and for procedural sedation. PAION submitted a Marketing Authorization Application (MAA) for procedural sedation in November 2019. It is planned to commercialize Byfavo(R) once approved in Europe together with GIAPREZA(TM) as 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 XERAVA(TM) 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) with an additional site in Cambridge (United Kingdom).


Ralf Penner

Vice President Investor Relations/Public Relations


Martinstrasse 10-12

52062 Aachen - Germany

Phone +49 241 4453-152

E-mail r.penner@paion.com


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.

29-Jan-2021 CET/CEST The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.dgap.de

Language: English
Company: PAION AG

Martinstr. 10-12

52062 Aachen

Phone: +49 (0)241-4453-0
Fax: +49 (0)241-4453-100
E-mail: info@paion.com
Internet: www.paion.com
ISIN: DE000A0B65S3
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 1163731

End of Announcement DGAP News Service

1163731  29-Jan-2021 CET/CEST

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