PRESS RELEASE

Biotest grants Renate & Hans Schleussner Research Award for the first time

• Renate & Hans Schleussner Award endowed with € 50,000
• Research project awarded for laboratory studies on the mode of action of cytomegalovirus (CMV) hyperimmunoglobulins in pregnancy to protect the unborn child
• Biotest is currently also conducting a phase III clinical trial with CMV hyperimmunoglobulin in pregnant women.

Dreieich, 25 July 2022. Dr. Philipp Kolb from the Institute of Virology at the University of Freiburg is the first winner of the Renate & Hans Schleussner Research Award. The award supports a research project of the excellent winner in the field of cytomegalovirus (CMV) infection. CMV belongs to the herpes viruses and transmission during pregnancy to the unborn child can lead to severe developmental disorders in the child. Although CMV infections are common, awareness of the problem is low among pregnant women and in obstetrics.

It is estimated that more than 50,000 babies are born with a CMV infection in Europe and the USA every year. The virus can damage numerous organ systems and lead to neurological and developmental disorders, some of which are severe. Newborns infected in the womb may experience growth retardation and, in particular, hearing impairment.

Biotest AG is currently also conducting a clinical phase III study PreCyssion (Prevention of maternal-fetal Cytomegalovirus transmission after primary maternal infection) with a CMV hyperimmunoglobulin (Cytotect CP Biotest^®) for the prevention of a CMV infection in the unborn child in Germany. Currently, there is no approved therapy for this indication. Early treatment with a CMV hyperimmunoglobulin is intended to prevent the transmission of the virus from the mother to the unborn child.

Dr. Kolb's work thus contributes to making this important topic visible and to establishing the mode of action of the use of CMV hyperimmunoglobulins in CMV infection during pregnancy. Dr. Kolb has already successfully established the cell culture model for the studies with CMV on placental cells in his laboratory.

The application phase for the next Renate & Hans Schleussner Research Award, which has the research focus: "Beyond IgG: immunological effects of polyvalent IgM and IgA", will begin in August 2022. Again, researchers with projects from preclinical or clinical research can apply. The award is again € 50,000.

About Cytotect CP Biotest^®

Cytotect CP Biotest^® is a cytomegalovirus-specific hyperimmunoglobulin preparation with a high antibody titre against CMV. The product is approved for prophylaxis of clinical manifestations of CMV infection in patients subjected to immunosuppressive therapy, particularly in transplant recipients. The concomitant use of adequate virostatic agents should be considered for CMV-prophylaxis. Cytotect CP Biotest^® is also marketed as Megalotect^®, Megalotect CP^®, Cytomegatect^® and NeoCytotect^® in different countries.

About the PreCyssion trial

The open-label, single-arm, prospective Phase III clinical trial PreCyssion (Prevention of maternal-fetal Cytomegalovirus transmission after primary maternal infection) is evaluating the efficacy and safety of Biotest's CMV hyperimmunoglobulin Cytotect CP Biotest® for the treatment of pregnant women with CMV infection to prevent the transmission to the foetus. The clinical concept of this pivotal Phase III trial is based on convincing data from an observational study coordinated by the University of Tübingen. In this study, pregnant women with primary CMV infection in early pregnancy were treated with Cytotect CP Biotest®. In 149 treated women (153 foetuses), transmission of the virus to the foetus occurred in ten cases by the time of amniocentesis (around gestational week 20). This corresponds to a transmission rate (primary endpoint) of 6.5%, which is significantly lower than the rate of 35.2% of a historical control group.¹

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
E-mail: [email protected]

PR contact

Dirk Neumüller

Phone: +49-6103-801-269
E-mail: [email protected]

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.