DGAP-News: PAION AG
/ Key word(s): Miscellaneous
02.09.2021 / 14:00
The issuer is solely responsible for the content of this announcement.
PAION SIGNS EXCLUSIVE UK SUPPLY AND DISTRIBUTION AGREEMENT WITH CLINIGEN
Aachen (Germany), 02 September 2021 – The Specialty Pharma Company PAION AG (PA8; ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard) today announces that PAION has signed an exclusive partnership agreement with Clinigen for the supply and distribution of its products into the UK.
The first product within the agreement will be Byfavo(R) (remimazolam) which has been approved by the European Commission in the EU in March 2021 and by the Medicines & Healthcare products Regulatory Agency (MHRA) in the UK in June 2021. Byfavo(R) is the first product developed by PAION approved and launched in Europe. In addition, PAION has two further products, GIAPREZA(R) (angiotensin II) and XERAVA(R) (eravacycline), in its portfolio that have also been launched recently outside the UK.
Under the terms of the agreement Clinigen will manage the supply and distribution of PAION’s licensed products in the UK.
Katja Lundell, Country Manager UK of PAION UK Ltd, commented: “We are delighted to partner with Clinigen for the commercial launch of Byfavo(R), leveraging their strong regulatory, supply and distribution capabilities to ensure broad access of this important product in the UK. We look forward to working with them on this and our other products.“
Sam Herbert, Chief Operating Officer and Head of Products Division, Clinigen, said: “We are pleased to be partnering with PAION for their first commercial launch in the UK and to be able to offer Byfavo(R) to healthcare providers across the UK through our lifecycle platform. We look forward to building a long and successful relationship with PAION that can help patients in the UK get access to the healthcare they need.”
Remimazolam is approved in the U.S., the EU/EEA/UK, South Korea and China for procedural sedation and in Japan and South Korea for general anesthesia.
In addition to procedural sedation and general anesthesia, intensive care unit (ICU) sedation is another possible indication 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 has two further products, GIAPREZA(R) (angiotensin II) and XERAVA(R) (eravacycline), in its portfolio. 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 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.
PAION is headquartered in Aachen (Germany).
About Clinigen Group
For more information on Clinigen, please visit http://www.clinigen.com
Contact PAION AG
Contact Clinigen Group plc
The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
|Listed:||Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange|
|EQS News ID:||1230378|
|End of News||DGAP News Service|