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Biotest supports a large international retrospective study to record data on clinical use of Cytotect^(R) after heart and lung transplantation

- Results will provide a basis for design of a new transplantation study

- Evaluation of the optimal treatment regimen as a basis for adapting international treatment guidelines

- Marked medium-term increase of the market potential of Cytotect^(R), the only CMV hyperimmunoglobulin licensed in Europe, is anticipated

Dreieich, 23 November 2016. Cytomegalovirus (CMV) is a globally distributed herpes virus. Infection with CMV generally does not pose a risk to healthy individuals and usually passes unnoticed. In persons with a weakened immune system, however, especially patients after organ transplantation, the virus can cause serious complications and may even be life-threatening.

Since transplant patients receive strong immunosuppressive treatment, especially after heart and lung transplantation, CMV disease is one of the most feared complications, affecting approximately 30% of all heart and over 40% of all lung transplant recipients. For this reason, most patients are treated prophylactically directly after transplantation with CMV-suppressing antiviral medications (virostatics) for several weeks to months. In addition, these patients may be treated with the CMV-specific hyperimmunoglobulin Cytotect^(R).

Cytotect^(R) is a hyperimmunoglobulin produced from human plasma for prophylaxis of CMV infection, which is used especially in transplant patients. In Europe it is the only product of its kind, with a highly effective mode of action, allowing for virus neutralisation and modulation of the immune system .^[1]

The aim of the international retrospective study that has now been initiated is to identify the optimal treatment frequency and dosage for patients following heart or lung transplantation. Under the direction of Associate Professor Dr. Florian Wagner of the University Hospital Hamburg-Eppendorf (UKE), data from 1,600 patients of leading international transplantation centres will be analysed.

"Cytotect^(R) represents an ideal addition and, in select cases, an alternative to monotherapy with virostatics to prevent or treat a CMV infection," Associate Professor Dr. Florian Wagner emphasises. "Because of the immunological mode of action of the CMV hyperimmunoglobulin, which not only neutralises viruses but also has a positive influence on the transplant patient's immune system, the number of CMV infections and their complications following transplantation can possibly be greatly reduced. Furthermore, it is possible that Cytotect^(R) will have a positive effect on the health of the transplant patient and increase overall survival."

Based on the results of this study, Biotest intends to conduct further prospective studies. Positive results could lead to an adaptation of the international treatment guidelines for transplant physicians with inclusion of Cytotect^(R) into the standard therapy for heart and lung transplant patients.

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 2,500 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
email: investor.relations@biotest.com

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

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

Ordinary shares: securities' ID No. 522720; ISIN DE0005227201
Preference shares: securities' ID No. 522723; ISIN DE0005227235
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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] Germer M, Herbener P, Schüttrumpf J. Functional Properties of Human Cytomegalovirus Hyperimmunoglobulin and Standard Immunoglobulin Preparations. Annals of Transplantation. 2016; 21.