Biotest AG

05/23/2018 | Press release | Distributed by Public on 05/22/2018 23:16

Biotest AG: Efficacy and safety of Cytotect(R) CP was demonstrated in patients after stem cell transplantation

23.05.2018 / 07:00
The issuer is solely responsible for the content of this announcement.


Efficacy and safety of Cytotect(R) CP was demonstrated in patients after stem cell transplantation

- 78% of 'difficult-to-treat' patients responded to Cytotect(R) CP administration

- 70% of patients cleared CMV infection to undetectable levels

- Good tolerability confirmed

Dreieich, 23 May 2018. Cytomegalovirus (CMV) infection is a frequent complication leading to significant morbidity and mortality in patients after hematopoietic stem cell transplantation (HSCT). Approximately, 40,000 stem cell transplantations are performed in Europe annually, most often to treat certain types of blood cancers, such as myeloma or leukaemia.

A recently published retrospective data collection from France highlights the benefit of Cytotect(R) CP, a CMV-specific hyperimmunoglobulin, for treatment of CMV in HSCT patients[1]. This is the first study that investigated the efficacy and safety of Cytotect(R) CP in patients with CMV infection in case of antiviral failure or resistance after HSCT from a genetically different (allogeneic) donor. Almost 50% of all stem cell transplantations are performed in the allogeneic setting. In France, Cytotect(R) CP can only be administered on a named-patient basis as last-line therapy in the compassionate use setting.

The study was designed as a retrospective data analysis and included 23 allogeneic HSCT patients from eight French transplant centres. High-risk patients received Cytotect(R) CP after failure of antiviral drugs. In those patients, no clinically significant adverse events were observed due to administration of the CMV-specific hyperimmunoglobulin. The overall response rate in patients was 78%. Notably, 16/23 patients, i.e. 70% of all patients, cleared CMV infection, which is an excellent result considering the previous failure of alternative treatment approaches in those patients.

The authors of the study recommend Cytotect(R) CP to be considered not only in the last-line setting, but also as CMV prophylaxis after HSCT, where the unmet medical needs remain high. Cytotect(R) CP is authorised in more than 15 countries for the prophylaxis of clinical manifestations of CMV infection in patients receiving immunosuppressive treatment, particularly transplant recipients.

Cytotect(R) CP is also marketed under the brand name Megalotect(R) in some countries. Biotest currently is in a process of applying for approval for Cytotect(R) CP in additional markets.

[1] Alsuliman et al. 'Cytotect(R) CP as salvage therapy in patients with CMV infection following allogeneic hematopoietic cell transplantation: a multicenter retrospective study'. Bone Marrow Transplant (2018)

About Cytotect(R) CP
Cytotect(R) CP is a cytomegalovirus (CMV)-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.

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
email: [email protected]

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

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany,

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

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.

23.05.2018 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
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