PAION AG

  • WKN: A0B65S
  • ISIN: DE000A0B65S3
  • Land: Deutschland

Nachricht vom 31.12.2021 | 12:38

PAION SUBMITS EXTENSION APPLICATION OF MARKETING AUTHORIZATION FOR REMIMAZOLAM IN THE INDICATION GENERAL ANESTHESIA TO THE EUROPEAN MEDICINES AGENCY

DGAP-News: PAION AG / Key word(s): Regulatory Admission
31.12.2021 / 12:38
The issuer is solely responsible for the content of this announcement.

PAION SUBMITS EXTENSION APPLICATION OF MARKETING AUTHORIZATION FOR REMIMAZOLAM IN THE INDICATION GENERAL ANESTHESIA TO THE EUROPEAN MEDICINES AGENCY

Aachen (Germany), 31 December 2021 - The Specialty Pharma Company PAION AG (FSE: PA8) today announces that PAION has submitted an extension application to the Marketing Authorization for remimazolam (Byfavo(R)), PAION's ultra-short-acting intravenous benzodiazepine sedative/anesthetic, for the indication general anesthesia to the European Medicines Agency (EMA).

The European Commission approved remimazolam in the EU (including European Economic Area (EEA) countries) for procedural sedation in March 2021. Based on the positive results in the EU Phase III trial in general anesthesia, PAION has now submitted an extension application to the marketing authorization for remimazolam in the indication of general anesthesia. A decision by the EMA is expected at the end of 2022 or beginning of 2023.

"The submission of the extension application to the Marketing Authorization in general anesthesia is another important milestone for PAION as we continue to expand our European hospital product portfolio, as the need for safe and effective anesthetics, especially for complex surgeries and high-risk patients, is growing in Europe," said Dr. Jim Phillips, CEO of PAION AG. "Remimazolam has already been approved for general anesthesia in Japan and South Korea. We now look forward to working with the EMA during the review process with the goal of making remimazolam available to patients in Europe in this indication as soon as possible."

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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. PAION has started to launch remimazolam (Byfavo(R)) in selected European markets. Remimazolam is partnered in multiple territories outside of Europe. Remimazolam is approved in the U.S., the EU/EEA/UK, China and South Korea for procedural sedation and in Japan and South Korea for general anesthesia.

In addition, PAION markets two intensive care products in selected European countries: Angiotensin II (GIAPREZA(R)), a vasoconstrictor indicated for the treatment of refractory hypotension in adults with septic or other distributive shock, and eravacycline (XERAVA(R)), 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'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.



31.12.2021 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
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