PRESS RELEASE : PAION LAUNCHES GIAPREZA(R) (ANGIOTENSIN II) FOR THE TREATMENT OF REFRACTORY HYPOTENSION IN ADULTS WITH SEPTIC OR OTHER DISTRIBUTIVE SHOCK IN GERMANY

DGAP-News: PAION AG / Key word(s): Product Launch 
PAION LAUNCHES GIAPREZA(R) (ANGIOTENSIN II) FOR THE TREATMENT OF REFRACTORY HYPOTENSION IN ADULTS WITH SEPTIC OR OTHER 
DISTRIBUTIVE SHOCK IN GERMANY 
2021-07-16 / 11:09 
The issuer is solely responsible for the content of this announcement. 
=---------------------------------------------------------------------------------------------------------------------- 
PAION LAUNCHES GIAPREZA^(R) (ANGIOTENSIN II) FOR THE TREATMENT OF REFRACTORY HYPOTENSION IN ADULTS WITH SEPTIC OR OTHER 
DISTRIBUTIVE SHOCK IN GERMANY 
- GIAPREZA^(R) is the first product launched by PAION in Europe 
Aachen (Germany), 16 July 2021 - The Specialty Pharma Company PAION AG (PA8; ISIN DE000A0B65S3; Frankfurt Stock 
Exchange Prime Standard) today announces that GIAPREZA^(R) (angiotensin II) has been launched and is now commercially 
available in Germany for order and delivery to customers through direct sales. 
GIAPREZA^(R) is approved by the European Commission 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. GIAPREZA^(R) is a synthetic human angiotensin II acting the 
same way as the body's endogenous regulatory peptide that is central to the renin-angiotensin-aldosterone system to 
increase blood pressure. 
PAION estimates about 150,000 septic or other distributive shock patients in Europe annually remaining below target 
blood pressure levels despite treatment with existing therapies leading to a high mortality rate in those critically 
ill patients. In 2013, the mortality rate of patients in Germany with severe septic shock was as high as almost 60%^[1] 
. Due to this significant unmet need, PAION decided to make GIAPREZA^(R) available to patients as soon as possible and 
before establishing a commercial structure in Germany with other European markets to follow over the course of the next 
months. The initial focus of the commercial teams across Europe over the first year after launch will be to ensure that 
GIAPREZA^(R) 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: "Septic and other distributive shock is a serious 
condition that results in increased mortality in hospitalized patients. We are excited with this first PAION product 
launch to bring a new treatment option to critically ill patients who contract this terrible condition." 
PAION plans to launch all of its products - Byfavo^(R), GIAPREZA^(R) and XERAVA^(R) - in a staggered manner by country 
so that, by the end of 2022, launches will have been conducted in all selected European markets. 
### 
About septic or other distributive shock 
Distributive shock is the most common type of shock in the inpatient setting. The inability to achieve or maintain 
adequate blood pressure results in inadequate blood flow to the body's organs and tissues and is associated with a 
mortality rate exceeding most acute conditions requiring hospitalization. 
GIAPREZA^(R) (angiotensin II) 
GIAPREZA^(R) for infusion is an FDA-approved vasoconstrictor to increase blood pressure in adults with septic or other 
distributive shock. GIAPREZA^(R) is approved by the European Commission and the UK Medicines Agency 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. GIAPREZA^(R) is a 
synthetic human angiotensin II acting the same way as the body's endogenous angiotensin II peptide, which is central to 
the renin-angiotensin-aldosterone system, which in turn regulates blood pressure. 
The pivotal Phase III trial of angiotensin II for the treatment of high-output shock (ATHOS-3) was a randomized, 
placebo-controlled, double-blind, international, multicenter Phase III safety and efficacy trial in which 321 adults 
with septic or other distributive shock who had hypotension despite fluid and vasopressor therapy were randomized 1:1 
to GIAPREZA^(R) or placebo. The primary efficacy endpoint, an increase in blood pressure, was achieved by 70% of 
patients randomized to GIAPREZA^(R) compared to 23% of patients treated with placebo; p < 0.0001 (a treatment effect of 
47%). 
The European Summary of Product Characteristics is available on the European Medicines Agency website: 
www.ema.europa.eu/en/medicines/human/EPAR/giapreza 
About PAION 
PAION AG is a publicly listed specialty pharmaceutical 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 and China for procedural sedation and in Japan and South Korea for 
general anesthesia. 
In addition to Byfavo^(R) (remimazolam), PAION has two additional 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 
Ralf Penner 
Vice President Investor Relations/Public Relations 
PAION AG 
Heussstrasse 25 
52078 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' 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. 
^[1] Fleischmann, C., Thomas-Rueddel, D. O., Hartmann, M., Hartog, C. S., Welte, T. et al.: Hospital Incidence and 
Mortality Rates of Sepsis. Dtsch Arztebl Int 2016; 113(10): 159-66. 
=---------------------------------------------------------------------------------------------------------------------- 
2021-07-16 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 
=---------------------------------------------------------------------------------------------------------------------- 
Language:     English 
Company:      PAION AG 
              Heussstraße 25 
              52078 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:  1216779 
 
End of News   DGAP News Service 
=------------ 

1216779 2021-07-16

 
Image link: 
https://eqs-cockpit.com/cgi-bin/fncls.ssp?fn=show_t_gif&application_id=1216779&application_name=news

(END) Dow Jones Newswires

July 16, 2021 05:09 ET (09:09 GMT)