Friday, September 29, 2023
Aachen, Germany, 28. September 2023 – PAION AG (ISIN DE000A3E5EG5; Frankfurt Stock Exchange, Prime Standard: PA8), a specialty pharmaceutical company with innovative compounds for use in outpatient and hospital sedation, anesthesia and critical care announces that Mundipharma, licensee of remimazolam (Japanese Trade name: Anerem®) for Japan, has informed PAION that it has submitted an application for an additional indication for remimazolam (Anerem® 50mg) for intravenous injection with the indication of “sedation during examination and procedures in gastrointestinal endoscopy". In addition, a new application was submitted for an additional dosage form of remimazolam (Anerem® 20 mg) for Intravenous Injection for the indications of “induction and maintenance of general anaesthesia” and “sedation during examination and procedures in gastrointestinal endoscopy”.
Both applications are based on the results of domestic physician led clinical trials Phase II and III studies. Both studies were conducted in adult patients undergoing gastrointestinal endoscopy procedures to assess the efficacy (e.g. success rate of sedation) and safety of the agent. In both studies, the administration of the drug was found to provide adequate sedation regardless of the endoscopy/procedure site and demonstrated a favourable safety profile.
Tilmann Bur, CEO of PAION AG, commented: "Congratulations to our valued partner, Mundipharma, on the remarkable progress achieved in advancing remimazolam in Japan. Together, we are making significant strides in addressing unmet medical needs and improving patient care. We look forward to a future filled with continued success and innovation in healthcare."
Remimazolam (Anerem® 50 mg) for intravenous injection was first approved in Japan in January 2020 for the indication of induction and maintenance of general anesthesia, ahead of the rest of the world, and was launched in August 2020.
About PAION
PAION AG is a publicly listed specialty pharmaceutical company with innovative drugs to be used in hospital-based sedation, anesthesia and critical care services. PAION’s lead compound is Byfavo® (remimazolam), an intravenous, ultra-short-acting and controllable benzodiazepine sedative/anesthetic. PAION is rolling out Byfavo® in selected European markets. Byfavo® is partnered in multiple territories outside of Europe. Byfavo® is approved in the U.S., the EU/EEA/UK, China, South Korea and Taiwan for procedural sedation and in the EU/EEA/UK, Japan, the Philippines and South Korea for general anesthesia.
In addition, PAION markets two intensive care products in selected European countries: Angiotensin II (GIAPREZA®), a vasoconstrictor indicated for the treatment of refractory hypotension in adults with septic or other distributive shock, and eravacycline (XERAVA®), a novel fluorocycline type of antibiotic 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.
