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Biotest AG: Biotest supports a large international registry study to record data on use of Pentaglobin(R) in patients with severe bacterial infections

News: Biotest AG / Key word(s): Miscellaneous

13.03.2018 / 07:00
The issuer is solely responsible for the content of this announcement.


PRESS RELEASE

 

Biotest supports a large international registry study to record data on use of Pentaglobin(R) in patients with severe bacterial infections

- High medical need due to high mortality and large patient population

- Aim of this registry is to record the use of Pentaglobin(R) under real life conditions

- Results will provide data to optimize treatment strategies with Pentaglobin(R)

- Up to 400 adult patients will be included in the multi-centric international registry

 

Dreieich, 13 March 2018. Biotest AG today announced that the first patient has been enrolled into the PERFORM (Pentaglobin(R) Registry For Outcome Report and Monitoring) registry - a non-interventional study assessing the efficacy and safety of Pentaglobin(R) in critically ill adult patients with severe bacterial infections or sepsis. Biotest supports the PERFORM registry, which is conducted by the University Hospital Jena, Center for Clinical Trials, as a scientifically driven study.

Sepsis is one of the leading causes of death in intensive care units and affects millions of people around the globe every year. Despite the development of new antibiotics, sepsis continues to lead to death in at least one in four patients and supportive treatment options are needed. Pentaglobin(R) is used as adjunctive therapy for severe bacterial infections and has shown to be effective in reducing mortality of patients with sepsis, severe sepsis and septic shock. The aim of this registry is to record the use of Pentaglobin(R) under real life conditions and the results we guide optimal treatment strategies.

"We are pleased to enroll the first patient in the PERFORM registry" said Prof. Frank Brunkhorst from Jena University Hospital, Center for Clinical Studies "this will further our understanding of the efficacy of Pentaglobin(R) in adult patients with severe bacterial infections and optimize the quality of its therapeutic application".

About the PERFORM registry
This multi-centric, international, non-interventional registry trial is planning to recruit up to 400 adult patients with severe bacterial infections receiving Pentaglobin(R). The aim of this registry is to record the use of Pentaglobin(R) under real life conditions. The study population comprises of patients with severe bacterial infection who undergo treatment with Pentaglobin(R) from 40 centers in Germany, Austria, Italy, Hungary and other countries where Pentaglobin(R) is available.

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's(R) mode of action, is both anti-bacterial by fast neutralization of bacterial endo- and exotoxins and anti-inflammatory by scavenging excessively activated complement factors. Pentaglobin(R) is licensed in several countries, mainly for the treatment of severe bacterial infections in combination with antibiotics.

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 medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumins based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. In addition, Biotest develops monoclonal antibodies in the indications of cancer of plasma cells and systemic lupus erythematosus which are produced by recombinant technologies. Biotest has more than 1,600 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt 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

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com

Ordinary shares: securities' ID No. 522720; ISIN DE0005227201
Preference shares: securities' ID No. 522723; ISIN DE0005227235
Listing: Frankfurt (Prime Standard)
Open Market: Berlin, Düsseldorf, Hamburg/ Hanover, Munich, Stuttgart, Tradegate

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.



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