DGAP-Adhoc

​​​​​​​PAION RECEIVES POSITIVE CHMP OPINION RECOMMENDING APPROVAL OF BYFAVO(R) (REMIMAZOLAM) IN PROCEDURAL SEDATION - Seite 2

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 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.

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.