PRESS RELEASE

Biotest receives approval for phase III clinical trial in pregnant women for prevention of CMV infection of the unborn baby

• Infection of the foetus with Cytomegalovirus (CMV) may cause developmental retardation and hearing loss of the new born
• High unmet medical need due to large amount of babies born with CMV-related disorders
• Significant reduction in CMV transmission from mother to foetus is expected after treatment with Cytotect CP Biotest^(R)
• Recently published results of an observational study show a CMV transmission rate of 6.5%, which is much lower compared to historical data of 35.2%¹

Dreieich, 26 August 2021. Biotest today announced that their application to conduct the clinical trial PreCyssion (Prevention of maternal-foetal Cytomegalovirus transmission after primary maternal infection) was approved by the Competent Authority and the responsible Ethics Committee in Germany.

"We are very pleased that the regulatory agencies recognize the urgent need for a treatment option to prevent CMV transmission from a pregnant women to the unborn baby and we are committed to address this unmet need. With this trial, Biotest will make a significant contribution to prevent the most frequent congenital infection." said Dr Silke Aigner, responsible Head of Clinical Strategy & Development at Biotest.

Cytomegalovirus causes a life-long infection, which is usually unproblematic in healthy individuals. In CMV-negative pregnant women, however, who are infected with CMV for the first time ("primary infection"), there is a ~30-40% risk that the virus gets transmitted to the foetus, potentially causing neurological and developmental defects. Notably, the risk for symptomatic babies is highest, when primary infection occurs during the first 20 weeks of pregnancy. In Europe and the USA it is estimated that more than 50,000 babies are born with CMV infection each year. CMV infection is the leading cause of non-genetic childhood sensorineural hearing loss and more than 10% of infected unborn babies may suffer from symptomatic developmental disorders at birth. Currently, there is no medicine authorised for prevention of maternal-foetal CMV transmission.

This open-label, single-arm, prospective phase III clinical trial is investigating the efficacy and safety of Biotest's CMV hyperimmunoglobulin (CMVIG) Cytotect CP Biotest^(R) for treatment of CMV infected pregnant women to prevent CMV transmission to the foetus. The trial will be conducted in Germany and enrol approximately 80 women with confirmed primary CMV infection in early pregnancy (gestational age <= 14 weeks). After confirmation of primary CMV infection, the women will be treated with 2ml of Cytotect CP Biotest^(R) per kg body weight every second week until about 18 weeks' gestation. For the assessment of CMV status of the foetus (primary endpoint), each woman will undergo amniocentesis after end of treatment at about 20 weeks' gestation.

The clinical concept of this pivotal phase III trial builds on strong data from an observational study coordinated by the University of Tübingen. In this study, Cytotect CP Biotest^(R) was given to pregnant women with primary CMV infection during early pregnancy. In 149 women treated (153 foetuses), transmission of the virus to the foetus occurred in ten cases at time of amniocentesis (around gestational week 20). This corresponds to a transmission rate (primary endpoint) of 6.5%, which is substantially lower compared to a historical group with a transmission rate of 35.2%.^[1]

About Cytotect CP Biotest^(R)
Cytotect CP Biotest^(R) 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^(R) is also marketed as Megalotect^(R), Megalotect CP^(R), Cytomegatect^(R) and NeoCytotect^(R) in different countries.

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: [email protected]

PR contact
Dirk Neumüller
Phone: +49-6103-801-269
Mail: [email protected]

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.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] Karl Oliver Kagan et al. Ultrasound Obstet Gynecol 57 (4) 560-7 /2021