DGAP-News

​​​​​​​PAION AG PUBLISHES GROUP QUARTERLY STATEMENT FOR THE FIRST QUARTER OF 2021 - Seite 2

Update and outlook on remimazolam

Regulatory activities
In Europe, remimazolam (trade name Byfavo^(R)) is approved in procedural sedation and in addition PAION is seeking approval for general anesthesia.

Procedural sedation: The European Commission approved Byfavo^(R) in the EU (including European Economic Area (EEA) countries) in March 2021. The decision of the UK Medicines & Healthcare products Regulatory Agency (MHRA) on a potential approval in the UK is expected shortly.

General anesthesia: Based on the positive results in the Phase III trial in general anesthesia and the approval in procedural sedation, PAION plans to submit an extension of the market approval application (MAA) for remimazolam for general anesthesia until the end of 2021. The approval process for an extension application is generally faster than for an MAA.

Partner activities in the first quarter of 2021
Commercialization activities in Japan and China were continued successfully. PAION and Mundipharma have agreed on an amendment of the royalty calculation in the first quarter of 2021. A corresponding contract amendment is currently being put in place, based on which remaining EUR 0.2 million royalties from fiscal year 2020 are expected to be additionally recognized as revenue in fiscal year 2021.

In the U.S., the launch of remimazolam (trade name BYFAVO^TM) by licensee Acacia Pharma (Acacia) was announced in January 2021. Initial feedback from the licensee on market response was very positive.

In South Korea, licensee Hana Pharm received market approval for Byfavo^TM (remimazolam) in general anesthesia in January 2021 and launched in South Korea at the end of March 2021.

In March 2021, PAION and TTY Biopharm ("TTY") entered into a license agreement for remimazolam with PAION granting TTY an exclusive license for the development and commercialization of remimazolam in Taiwan.

GIAPREZA^(R) and XERAVA^(R)
In January 2021, PAION entered into an exclusive license agreement with La Jolla Pharmaceutical Company for the intensive care products GIAPREZA^(R) (angiotensin II) and XERAVA^(R) (eravacycline). The agreement grants PAION an exclusive license for the commercialization of these two approved products in the European Economic Area, the United Kingdom and Switzerland. GIAPREZA^(R) is 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. XERAVA^(R) is a novel fluorocycline indicated for the treatment of complicated intra-abdominal infections in adults.