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DGAP-News: PAION AG / Key word(s): Product Launch
28.01.2021 / 07:06
The issuer is solely responsible for the content of this announcement.


- Approximately 40 million procedures take place annually in the U.S. that require the use of procedural sedation

- BYFAVO(TM) is the second Acacia Pharma product approved and launched in the U.S. in the last year and extends its portfolio of new products targeting unmet needs in anesthesia

Aachen (Germany), 28 January 2021 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces that its U.S. BYFAVO(TM) (remimazolam) licensee Acacia Pharma (Acacia) has informed PAION today that BYFAVO(TM) has been launched and is now commercially available in the U.S. for order and delivery to customers through major wholesalers and specialty distributors.

BYFAVO(TM) was approved by the U.S. Food and Drug Administration (FDA) on 2 July 2020 for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. It received its Schedule IV designation from the U.S. Drug Enforcement Administration (DEA) on 6 October 2020, finalizing the approval process and clearing the way for final packaging and shipping to the U.S.

Acacia has built critical sales, marketing, medical education and operational support teams over the past two years to allow it to directly commercialize both BYFAVO(TM) and BARHEMSYS(R) in the U.S. through its own sales channels. Acacia's experienced commercial team is focused on addressing the combined large market opportunities for procedural sedation and prevention and treatment of post-operative nausea & vomiting (PONV), which BYFAVO(TM) and BARHEMSYS(R) target, respectively, that exist in the U.S. hospital market. The initial focus of the commercial team over the first year of launch is to ensure that BYFAVO(TM) is listed on hospital formularies, based on the unmet needs it can address and the health economic benefits it can deliver.

Dr. Jim Phillips, Chief Executive Officer of PAION AG, stated: "We are excited to support Acacia in their commercialization process, and we are delighted by the strong commitment to BYFAVO(TM) by our U.S. partner. As sales build through the next months and years PAION will be receiving royalties of between 20-25% in the U.S. We look forward to a successful launch of what is a unique new product entering the market."

Mike Bolinder, Acacia Pharma's CEO, commented: "We are delighted to make BYFAVO(TM) available to anesthesia providers and to the millions of patients across the U.S. who require moderate sedation to undergo medical procedures each year. BYFAVO(TM) and BARHEMSYS(R) have a clear and shared value proposition focused on safely and rapidly mobilizing patients after such procedures, which drives revenues of hospitals and surgical centers in the U.S. The launches come at a time when Covid-19 has had a significant impact on such centers, creating significant patient backlogs and impacting ongoing revenues. We believe our products can help improve patient throughput, which is now even more relevant for healthcare providers and their patients. We believe that the ability to help address the current backlog of elective surgeries, together with ongoing shortages for existing drugs in these therapeutic areas, puts Acacia Pharma in a strong position as the Company enters these markets."

Mr. Bolinder added: "It is a tremendous achievement for our company to gain approval and launch two new products in the U.S. within the course of the last year. I would like to thank PAION, our partners as well as the Acacia Pharma team and our stakeholders who have enabled us to bring this new and innovative therapeutic to market, particularly given the challenges caused by the pandemic over the past year."

BYFAVO(TM) is now available for ordering in the U.S. through the major wholesalers and selected specialty distributors, including Cardinal Health, Amerisource Bergen, Besse, McKesson, McKesson Medsurg, Morris and Dickson, and Curascript.


About remimazolam
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 so far indicate 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. and China for procedural sedation and in Japan and South Korea for general anesthesia. In Europe, PAION submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in procedural sedation in November 2019.

In addition to procedural sedation and general anesthesia, based on positive Phase II study results, 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, and in South Korea (brand name BYFAVOTM) and Southeast Asia with Hana Pharm.

PAION AG is a publicly listed specialty pharmaceutical company focused on developing and commercializing innovative drugs for out-patient and 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. and China for procedural sedation and in Japan and South Korea for general anesthesia.

In Europe, PAION is seeking approval of Byfavo(R) (remimazolam) for general anesthesia and for procedural sedation. PAION submitted a Marketing Authorization Application (MAA) for procedural sedation in November 2019. It is planned to commercialize Byfavo(R) once approved in Europe together with GIAPREZA(TM) as 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 XERAVA(TM) 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).

Ralf Penner
Vice President Investor Relations/Public Relations
Martinstrasse 10-12
52062 Aachen - Germany
Phone +49 241 4453-152

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's 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 the Company'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 any such forward-looking statements to reflect future events or developments.

28.01.2021 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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Language: English
Company: PAION AG
Martinstr. 10-12
52062 Aachen
Phone: +49 (0)241-4453-0
Fax: +49 (0)241-4453-100
ISIN: DE000A0B65S3
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 1163748

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Last Updated: 28-Jan-2021