DGAP-News

​​​​​​​PAION AG PUBLISHES GROUP QUARTERLY STATEMENT FOR THE FIRST QUARTER OF 2022 - Seite 2

The sale of angiotensin II (GIAPREZA)was expanded from Germany to the Netherlands and Austria in early 2022.

In April 2022, PAION was informed that the Federal Joint Committee (G-BA) voted in favor of PAION’s application for eravacycline (XERAVA) as a reserve antibiotic. This means that eravacycline is considered to provide added benefit to standard of care. PAION is now exempt from providing a full benefit dossier and is only required to provide an abbreviated dossier, which is due by 1^st August 2022.

Initial product use indicates good market acceptance of the products, and PAION has received positive feedback from customers on initial experiences with its products, particularly remimazolam.

Based on the positive results from the EU Phase III trial in general anesthesia, PAION submitted an extension application to the marketing authorization for remimazolam for general anesthesia to the European Medicines Agency (EMA) in December 2021. A decision by the EMA is expected in the first quarter of 2023. This application also will be submitted to the MHRA (Medicines and Healthcare products Regulatory Agency) via the ECDRP (European Commission Decision Reliance Procedure) to obtain approval in the UK.

Remimazolam activities in licensed territories in the first quarter of 2022

Licensees generated remimazolam revenues totalling EUR 0.9 million in the first quarter of 2022, amounting to royalties for PAION of EUR 0.1 million.

In the U.S., remimazolam (BYFAVO^TM) has been marketed by Acacia for procedural sedation since the beginning of 2021. Recently, Eagle Pharmaceutical, a well-established US specialty pharma company made an offer to acquire Acacia. Should this acquisition occur, the license agreement for remimazolam would remain unchanged and would be transferred to Eagle Pharmaceutical. Eagle Pharmaceutical is a publicly traded U.S. specialty pharmaceutical company with revenues of over USD 170 million in critical care, oncology and rare diseases. PAION expects, that this proposed transaction would have a positive impact on the sales development of remimazolam in the U.S.