PAION LAUNCHES XERAVA(R) (ERAVACYCLINE) FOR THE TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTIONS IN ADULTS IN THE NETHERLANDS

DGAP-News: PAION AG / Key word(s): Market launch
01.09.2021 / 10:00
The issuer is solely responsible for the content of this announcement.

PAION LAUNCHES XERAVA^(R) (ERAVACYCLINE) FOR THE TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTIONS IN ADULTS IN THE NETHERLANDS

- Providing broad-spectrum coverage against bacterial pathogens

- XERAVA^(R) is the third product launched by PAION in Europe

Aachen (Germany), 01 September 2021 - The Specialty Pharma Company PAION AG (PA8; ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard) today announces that XERAVA^(R) (eravacycline) has been launched and is now commercially available in the Netherlands for order and delivery to customers through direct sales.

XERAVA^(R) is approved by the European Commission and the UK Medicines Agency for the treatment of complicated intra-abdominal infections (cIAI) in adults. Consideration should be given to official guidance on the appropriate use of antibacterial agents. XERAVA^(R) is a fluorocycline antibiotic within the tetracycline class of antibacterial drugs and provides broad-spectrum coverage against different bacterial pathogens responsible for complicated intra-abdominal infections (cIAI).

cIAI are the second most common source of severe sepsis in the ICU^[1]. Three million patients with cIAI receive a broad-spectrum antibiotic in the U.S. and EU5 (France, Germany, Italy, Spain and the UK)^[2] annually. Due to a growing concern of multi-drug resistant organisms (MDRO), especially against betalactams, including carbapenem antibiotics, PAION decided to make XERAVA^(R) available to patients as soon as possible, starting in the Netherlands, with other European markets to follow in the coming months. The initial focus of the commercial teams across Europe over the first year after launch will be to ensure that XERAVA^(R) is appropriately integrated into relevant stewardship programs and 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: "XERAVA is an important new treatment option for patients suffering from serious intra-abdominal infections. With its broad-spectrum antibacterial activity, we believe XERAVA offers an urgently needed alternative to treat life-threatening infections caused by multidrug-resistant pathogens. We are excited about our third product launch in two months to bring new treatment options to the medical community."

PAION is currently launching 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 are planned to have been conducted in most key European markets.

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About complicated intra-abdominal infections (cIAI)
Intra-abdominal infections are common in clinical practice and comprise a wide variety of clinical presentations and differing sources of infection. According to the Infectious Diseases Society of America (IDSA), a complicated intra-abdominal infection is defined as an infection that extends beyond the wall of a hollow viscus of origin into the abdominal cavity while being associated with an abscess or peritonitis.

About XERAVA^(R) (eravacycline)
XERAVA^(R) (eravacycline) for injection is a novel fluorocycline of the tetracycline class. XERAVA^(R) is an antibiotic used to treat complicated intra-abdominal infections (cIAI) in adults.

The mechanism of action of eravacycline is to interfere with bacterial protein synthesis by binding to the ribosomal subunit 30S, thereby preventing the incorporation of amino acid residues into extended peptide chains.

XERAVA^(R) has been shown to be as effective as alternative antibiotics in two main trials in adults with cIAI. The main indicator of efficacy in both trials was the cure rate of infections. In the first trial, involving 538 patients, XERAVA^(R) was compared with the antibiotic ertapenem. After about one month, 87% of patients treated with XERAVA^(R) were cured of their infection, compared with 89% of patients treated with ertapenem. In the second trial, involving 499 patients, XERAVA^(R) was compared with meropenem (a carbapenem antibiotic commonly used in Europe in this indication). After about one month, 92% of patients treated with XERAVA^(R) and 92% of patients treated with meropenem were cured of their infection.

The European Summary of Product Characteristics is available on the European Medicines Agency website:
https://www.ema.europa.eu/en/medicines/human/EPAR/xerava

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).

Contact
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

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] Brun-Buisson et al, JAMA 1995 ; 274(12) : 968-974
^[2] Decision Resources AMR Hospital Database (2014)

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