DGAP-Ad-hoc: PAION AG / Key word(s): Regulatory Approval
PAION RECEIVES EUROPEAN COMMISSION APPROVAL OF BYFAVO(R) (REMIMAZOLAM) FOR PROCEDURAL SEDATION
- Byfavo(R) is a rapid onset/offset intravenous benzodiazepine sedative for use during medical procedures such as colonoscopy and bronchoscopy
- PAION is preparing to launch Byfavo(R) and two additional critical care and specialty hospital products in selected European markets in the second half of 2021
End of inside information
Information and Explanation of the Issuer to this News:
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.'
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 BYFAVOTM) 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 BYFAVOTM) and Southeast Asia with Hana Pharm and in Taiwan with TTY Biopharm. For all other markets except Western Europe, remimazolam is available for licensing.
In addition to Byfavo(R) (remimazolam), PAION is preparing to launch the two products GIAPREZA(R) (Angiotensin II) and XERAVA(R) (Eravacycline) in Europe. 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.
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) with an additional site in Cambridge (United Kingdom).
27-March-2021 CET/CEST The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
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|EQS News ID:||1179135|
|End of Announcement||DGAP News Service|
1179135 27-March-2021 CET/CEST