PAION LAUNCHES ERAVACYCLINE FOR THE TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTIONS IN ADULTS IN GERMANY

DGAP-News: PAION AG

/ Key word(s): Market Launch

PAION LAUNCHES ERAVACYCLINE FOR THE TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTIONS IN ADULTS IN GERMANY
01.08.2022 / 10:00

The issuer is solely responsible for the content of this announcement.

PAION Launches eravacycline for the treatment of complicated intra-abdominal infections in Adults in Germany
 

  • Eravacycline has the status as a reserve antibiotic
  • Providing broad-spectrum coverage against bacterial pathogens

 

Aachen (Germany), 01 August 2022 – The Specialty Pharma Company PAION AG (PA8; ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard) today announces that eravacycline (XERAVA®) has been launched and is now commercially available in Germany for order and delivery to customers through direct sales.

In April 2022, the Federal Joint Committee (G-BA) voted in favour of PAION’s application for eravacycline as a reserve antibiotic. This means that eravacycline is automatically considered to provide added benefit to standard of care and can be considered, if standard generic treatment fails or would be inappropriate to use. PAION is now exempt from providing a full benefit dossier and has recently submitted an abbreviated dossier as a prerequisite for the launch.

Eravacycline 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. Eravacyclineis a fluorocycline antibiotic within the tetracycline class of antibacterial drugs and provides broad-spectrum coverage against different bacterial pathogens responsible for cIAI.

Complicated intra-abdominal infections 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.

Dr. Jim Phillips, Chief Executive Officer of PAION AG, stated: “The status as a reserve antibiotic will be helpful for the commercialization in Germany. Eravacycline is an important new treatment option for patients suffering from serious intra-abdominal infections. With its broad-spectrum antibacterial activity, we believe eravacycline offers an urgently needed alternative to treat life-threatening infections caused by multidrug-resistant pathogens. Eravacycline was licenced from U.S.-based company LaJolla Pharmaceutical in 2021.”

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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 eravacycline (XERAVA®)

Eravacycline for injection is a novel fluorocycline of the tetracycline class. Eravacycline 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.

Eravacycline 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, eravacyclinewas compared with the antibiotic ertapenem. After about one month, 87% of patients treated with eravacycline were cured of their infection, compared with 89% of patients treated with ertapenem. In the second trial, involving 499 patients, eravacycline was compared with meropenem (a carbapenem antibiotic commonly used in Europe in this indication). After about one month, 92% of patients treated with eravacycline 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. PAION is rolling out remimazolam (Byfavo®) in selected European markets. Remimazolam is partnered in multiple territories outside of Europe. Remimazolam is approved in the U.S., the EU/EEA/UK, China and South Korea for procedural sedation and in Japan and South Korea for general anesthesia.

In addition, PAION markets two intensive care products in selected European countries: Angiotensin II (GIAPREZA®), a vasoconstrictor indicated for the treatment of refractory hypotension in adults with septic or other distributive shock, and eravacycline (XERAVA®), 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)

 

 


01.08.2022 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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