PAION RECEIVES EUROPEAN COMMISSION APPROVAL OF BYFAVO(R) (REMIMAZOLAM) FOR PROCEDURAL SEDATION

Remimazolam is also in development for general anesthesia. Based on the positive results in the European Phase III trial in this indication, PAION plans to submit an extension variation to the Marketing Authorization for remimazolam for general anesthesia by the end of 2021. The approval process for an extension variation is generally faster than for a Marketing Authorization Application (MAA).

Dr. Jim Phillips, CEO of PAION AG, commented: ‘We are excited that the European Commission has approved Byfavo^(R), and thank all healthcare professionals, patients and partners who have been involved in the development of remimazolam. This approval marks one of the most important steps in PAION’s transformation into a specialty pharmaceutical company bringing novel anesthesia and critical care products to hospitals. With our recently acquired products GIAPREZA^(R) and XERAVA^(R), we are looking forward to launching three products in a staggered approach in selected European countries starting in the second half of 2021. We currently estimate annual peak sales potential of approximately EUR 50 million to EUR 60 million in procedural sedation in Europe.’

Professor James East, Consultant Gastroenterologist and Endoscopist, John Radcliffe Hospital, Oxford, UK commented: ‘The approval of BYFAVO^(R) is exciting for proceduralists as the field has not seen a new sedation medications added to our armamentarium in a decade. The drug performed well in clinical trials delivering an efficient sedation process from start to finish. The safety profile was encouraging, including in patients with severe systemic diseases, and the overall patient journey was optimized due to the rapid onset/offset of the sedative effect.’

The MAA included the data from a comprehensive U.S. Phase III clinical program in procedural sedation in patients undergoing bronchoscopy or colonoscopy. The safety and efficacy of Byfavo^(R) was evaluated in three pivotal studies in 984 patients undergoing colonoscopy (two studies) or bronchoscopy (one study), of whom 639 received Byfavo^(R). In these studies, the most common adverse reactions (incidence greater than 10%) following administration of Byfavo^(R) were hypotension, hypertension, diastolic hypertension, systolic hypertension, hypoxia, and diastolic hypotension.

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 demonstrate 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., the EU/EEA and China for procedural sedation and in Japan and South Korea for general anesthesia.

For more information on the safety of Byfavo^(R) (remimazolam), please refer to the EMA Summary of Product Characteristics (SmPC) and will be accessible via https://www.ema.europa.eu/en/medicines/human/EPAR/byfavo in the near future.

In addition to procedural sedation and general anesthesia, intensive care unit (ICU) sedation is under evaluation 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, in South Korea (brand name BYFAVO^TM) and Southeast Asia with Hana Pharm and in Taiwan with TTY Biopharm. For all other markets except Western Europe, remimazolam is available for licensing.

Further information.