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Biotest supports clinical study with Pentaglobin^(R) in COVID-19 at the University Hospital AKH Vienna

• University Hospital AKH Vienna investigates various COVID-19 therapies in platform trial (ACOVACT)
• Additional study arm with Pentaglobin^(R) started
• Pentaglobin^(R) supports the immune system in eliminating bacteria and toxins and can regulate excessive immune responses

Dreieich, 23 February 2021. In a study arm of the ACOVACT trial, the treatment of patients with severe COVID-19 with Pentaglobin^(R) has been started. ACOVACT (Austrian CoronaVirus Adaptive Clinical Trial) is a multicentre, randomised, controlled, open-label platform trial initiated by the University Hospital AKH Vienna to study various antiviral and adjunctive therapies for COVID-19 patients.

In the study arm, investigating immunomodulatory therapies, 20 COVID-19 patients in intensive care with pneumonia and elevated inflammatory markers and with a risk of developing sepsis or acute respiratory failure will be treated with Pentaglobin^(R).

"Due to its immunomodulating effect, we believe Pentaglobin^(R) offers a promising approach for treating severe courses of COVID-19 disease and we aim to investigate this more in detail in the ACOVACT trial," emphasises Univ.-Prof. Dr. Roman Ullrich, Senior Consultant Intensive Care Medicine at the University Clinic for Anaesthesia at the Medical University Vienna who is the principal investigator of the sub-study with Pentaglobin^(R).

The IgM-enriched immunoglobulin preparation Pentaglobin^(R) is an established treatment option for patients with severe bacterial infections. A meta-analysis of patients with sepsis and septic shock demonstrated a significant reduction in mortality and a shorter duration of mechanical ventilation.^[1] Pentaglobin^(R) has an immunomodulatory effect and could therefore help to positively influence the often excessive immune response in severe courses of COVID-19. In addition, the antibodies in Pentaglobin^(R) can bind to a variety of bacteria and their toxins, supporting their destruction by the immune system. Secondary bacterial infections are increasingly being observed in COVID-19 patients with severe courses of the disease. Biotest supports the project within the scope of an academic-industry collaboration (Investigator Initiated Study).

About Pentaglobin^(R)
Pentaglobin^(R) is the first and only IgM-enriched immunoglobulin preparation for intravenous use. Pentaglobin^(R) significantly increases the survival rate of patients with severe bacterial infections and acts against a broad spectrum of bacterial pathogens. Pentaglobin^(R) acts anti-bacterial by neutralization of bacterial endo- and exotoxins and anti-inflammatory by scavenging excessively activated complement factors. Pentaglobin^(R) is licensed in several countries for the treatment of severe bacterial infections in combination with antibiotics.

About COVID-19
COVID-19 is a respiratory disease caused by the novel severe acute respiratory syndrome corona virus 2 variant (SARS-CoV-2). While most cases are mild or asymptomatic, COVID-19 patients may present at the hospital with typical signs of pneumonia requiring oxygen support. This disease stage is regularly accompanied by an excessive immune response and can lead to systemic inflammation reactions. Furthermore, patients may progress to critical disease with need for intensive care, including invasive mechanical ventilation. This clinical picture and course of the disease resembles that of severe community acquired pneumonia (sCAP) caused by other pathogens.

About Biotest
Biotest is a provider of plasma proteins and biological drugs. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of clinical immunology, haematology and intensive care medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. Biotest has more than 1,900 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German stock exchange.

IR contact
Dr Monika Buttkereit
Phone: +49-6103-801-4406
Mail: investor_relations@biotest.de

PR contact
Dirk Neumüller
Phone: +49-6103-801-269
Mail: pr@biotest.com

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Disclaimer
This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and assets position of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developments from expected developments. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.

^[1] Cui et al. Ann. Intensive Care 9, 27 (2019). https://doi.org/10.1186/s13613-019-0501-3