PAION AG

  • WKN: A0B65S
  • ISIN: DE000A0B65S3
  • Land: Deutschland

Nachricht vom 02.09.2021 | 14:00

PAION SIGNS EXCLUSIVE UK SUPPLY AND DISTRIBUTION AGREEMENT WITH CLINIGEN

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."

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About remimazolam (Byfavo(R))
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/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.

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

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
Clinigen Group plc (AIM: CLIN) is a global, specialist pharmaceutical services and products platform focused on providing ethical access to medicines. Its mission is to deliver the right medicine to the right patient at the right time. The Group operates from sites in North America, Europe, Africa and the Asia Pacific.
Clinigen has more than 1,000 employees across five continents in 16 countries, with supply and distribution hubs and operational centres of excellence in key long-term growth regions. The Group works with 34 of the top 50 pharmaceutical companies; interacting with over 5,000 hospitals across more than 115 countries.

For more information on Clinigen, please visit http://www.clinigen.com

Contact PAION AG
Ralf Penner
Vice President Investor Relations/Public Relations
PAION AG
Heussstrasse 25
52078 Aachen - Germany
Phone +49 241 4453-152
E-mail r.penner@paion.com
www.paion.com

Contact Clinigen Group plc
Sam Herbert
Group Chief Operating Officer & Head of Products Division
+44 (0) 1283 495010
investors@clinigengroup.com

Disclaimer:
This release contains certain forward-looking statements concerning the future business of PAION AG. These forward-looking statements contained herein are based on the current expectations, estimates and projections of PAION AG' management as of the date of this release. They are subject to a number of assumptions and involve known and unknown risks, uncertainties and other factors. Should actual conditions differ from PAION's assumptions, actual results and actions may differ materially from any future results and developments expressed or implied by such forward-looking statements. Considering the risks, uncertainties and other factors involved, recipients should not rely unreasonably upon these forward-looking statements. PAION AG has no obligation to periodically update such forward-looking statements to reflect future events or developments.



02.09.2021 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

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