PRESS RELEASE

First patient treated with Cytotect^® CP Biotest in study after heart and lung transplantation

• High medical need due to severe cytomegalovirus (CMV) infections and resulting mortality after organ transplantation
• Study will provide data to optimise treatment strategies with CMV hyperimmunoglobulins after heart and lung transplantation
• 500 patients in prospective, international observational study

Dreieich, 24 January 2023. Biotest AG announced today that the first patient has been enrolled in Biotest's prospective, multicentre, observational study on the use of CMV hyperimmunoglobulins after heart and lung transplantation. "We are very hopeful and confident that the insights of the new study will allow us to optimise treatment options with CMV hyperimmunoglobulins," emphasises PD Dr Markus Barten, UKE Hamburg, Coordinating Investigator of the study.

The non-interventional study will be conducted in 20 transplant centres in Austria, Belgium, Croatia, Germany, Italy, Spain and the United Kingdom and is expected to enrol a total of around 500 patients. The objectives of the large-scale study are to collect detailed data on the use of Cytotect^® CP and clinical outcomes in the management of cytomegalovirus (CMV) after heart or lung transplantation.

While a CMV infection is usually asymptomatic or mild in healthy people, the virus can lead to serious sequelae and even death in people with a weakened immune system, especially in patients after organ or stem cell transplantation. Cytotect^® CP is a CMV-specific hyperimmunoglobulin from Biotest AG that represents a supplement or, in some cases, an alternative to antiviral therapy in the context of CMV management after transplantation. "Studies have been able to show that prophylactic treatment with CMV hyperimmunoglobulins in patients after organ transplantation is particularly beneficial in patients with a high risk of CMV infection or disease", emphasises PD Dr Markus Barten.

The results of the international study will provide valuable insights into the use and benefits of CMV hyperimmunoglobulins and enable optimisation of treatment strategies for patients after heart and lung transplantation.

About Cytotect^® CP Biotest

Cytotect^® CP is a cytomegalovirus-specific hyperimmunoglobulin preparation with a high antibody titre against CMV. The product is approved for the prophylaxis of clinical manifestations of CMV infection in patients on immunosuppressive therapy, particularly in transplant recipients. Concurrent administration of appropriate antivirals should be considered for CMV prophylaxis. Cytotect^® CP (also marketed in various countries as Megalotect^®, Megalotect CP^®, Cytomegatect^® and NeoCytotect^®.

Cytotect^® CP approved in more than 20 countries. Biotest is currently in the process of applying for approval of Cytotect^® CP in additional markets.

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 2,200 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: ir@biotest.com

PR contact

Dirk Neumüller

Phone: +49-6103-801-269
E-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.