PRESS RELEASE : PAION AG: ACACIA PHARMA LAUNCHES BYFAVO(TM) (REMIMAZOLAM) IN THE U.S. FOR PROCEDURAL SEDATION IN ADULTS UNDERGOING MEDICAL PROCEDURES LASTING 30 MINUTES OR LESS

DGAP-News: PAION AG / Key word(s): Product Launch 
PAION AG: ACACIA PHARMA LAUNCHES BYFAVO(TM) (REMIMAZOLAM) IN THE U.S. FOR PROCEDURAL SEDATION IN ADULTS UNDERGOING 
MEDICAL PROCEDURES LASTING 30 MINUTES OR LESS 
2021-01-28 / 07:06 
The issuer is solely responsible for the content of this announcement. 
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PAION AG: ACACIA PHARMA LAUNCHES BYFAVO(TM) (REMIMAZOLAM) IN THE U.S. FOR PROCEDURAL SEDATION IN ADULTS UNDERGOING 
MEDICAL PROCEDURES LASTING 30 MINUTES OR LESS 
- 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. 
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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 BYFAVO^TM) 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 BYFAVO^TM) and Southeast Asia with Hana Pharm. 
About PAION 
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). 
Contact 
Ralf Penner 
Vice President Investor Relations/Public Relations 
PAION AG 
Martinstrasse 10-12 
52062 Aachen - Germany 
Phone [phone] 
E-mail [e-mail] 
www.paion.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'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. 
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2021-01-28 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. 
The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. 
Archive at www.dgap.de 
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Language:     English 
Company:      PAION AG 
              Martinstr. 10-12 
              52062 Aachen 
              Germany 
Phone:        [phone] 
Fax:          [phone] 
E-mail:       [e-mail] 
Internet:     www.paion.com 
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:  1163748 
 
End of News   DGAP News Service 
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1163748 2021-01-28

(END) Dow Jones Newswires

January 28, 2021 01:08 ET (06:08 GMT)