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DGAP-News: PAION AG
/ Key word(s): Product Launch
PAION LAUNCHES BYFAVO(R) (REMIMAZOLAM) IN THE UK FOR PROCEDURAL SEDATION - Millions of procedures take place in the UK annually such as colonoscopies and bronchoscopies that require the use of procedural sedation - Byfavo(R) is the first product developed by PAION approved and launched in Europe Aachen (Germany), 16 August 2021 - The Specialty Pharma Company PAION AG (PA8; ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard) today announces that Byfavo(R) has been launched and is now commercially available in the UK for order and delivery to customers through a major wholesaler. Byfavo(R) was approved by the European Commission in the EU (including European Economic Area (EEA) countries) in March 2021 followed by the UK Medicines & Healthcare products Regulatory Agency (MHRA) approval in June 2021. PAION has built experienced sales, marketing, medical education and operational support teams over the past year to support the introduction of Byfavo(R) in the UK. With millions of procedures in the UK annually that require the use of procedural sedation, Byfavo(R) addresses a large market opportunity. The initial focus of the commercial team for the first year after launch is to ensure that Byfavo(R) is listed on hospital formularies, based on the unmet needs it can address and the health economic benefits it can deliver. In addition supporting healthcare professionals through medical education, reinforcing the importance of safe sedation practice, and answering their questions regarding Byfavo(R)'s clinical data will be of high importance. Dr. Jim Phillips, Chief Executive Officer of PAION AG, stated: "We are delighted to make Byfavo(R) available to sedation providers for patients across the UK who require moderate sedation to undergo certain medical procedures. Byfavo(R) has been shown to safely and rapidly allow recovery of patients after such procedures, which may allow them to be quickly discharged home." Katja Lundell, Country Manager UK of PAION UK Ltd, added: "The launch comes at a time when COVID-19 has caused significant backlogs for elective surgeries and routine procedures. We hope that Byfavo(R) can help to improve patient throughput, enabling more people to get the procedures that they had put on hold. We believe that this, together with ongoing shortages for existing drugs in these therapeutic areas, puts PAION in a strong position as we are entering these markets." PAION plans to launch Byfavo(R) in a staggered manner by country so that by the end of 2022, the product will have been launched in all selected European markets. In the top five European countries approximately 20 million procedures take place annually that require the use of procedural sedation. ### Aboutremimazolam (Byfavo(R)) Remimazolam is approved in the U.S., the EU/EEA/UK 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 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, and was launched in July 2021. 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). Contact Disclaimer:
16.08.2021 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. |
| Language: | English |
| Company: | PAION AG |
| Heussstraße 25 | |
| 52078 Aachen | |
| Germany | |
| Phone: | +49 (0)241-4453-0 |
| Fax: | +49 (0)241-4453-100 |
| E-mail: | |
| Internet: | |
| ISIN: | DE000A0B65S3 |
| WKN: | A0B65S |
| Listed: | Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange |
| EQS News ID: | 1225651 |
| End of News | DGAP News Service |
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1225651 16.08.2021
