Biotest AG announces successful completion of Mutual Recognition Procedure for marketing authorization of Cytotect(R) CP Biotest in twelve European countries
- Approval in four additional attractive European markets
- Basis for future revenue growth with Cytotect(R) CP Biotest
Dreieich, 21 August 2018. Biotest AG has announced today that the European Mutual Recognition Procedure (MRP) for its cytomegalovirus (CMV)-specific hyperimmunoglobulin preparation Cytotect(R) CP Biotest was successfully completed in twelve selected countries.
The aim of the procedure was to obtain approval of Cytotect(R) CP Biotest in further EU countries and to harmonise approval in the selected EU countries. The procedure was completed on time after 60 days as all the competent authorities had given their consent for approval by then. In addition to the previous eight countries which so far held a national marketing authorisation four more highly interesting markets obtained an approval for Cytotect(R) CP Biotest.
"A declared objective of Biotest's strategy is to tap into new attractive markets, in particular for specialty products such as Cytotect(R) CP Biotest to further develop our product portfolio", explained Enrico D'Aiuto, VP Global Sales & Marketing of Biotest AG. "We are delighted with the positive decision of the authorities, so that we can now provide patients in twelve European countries with a unique drug for this serious infectious disease."
Biotest now expects the national marketing authorisations of Cytotect(R) CP Biotest to be issued promptly in the countries. Subsequently specific market launch activities are planned in the countries. Biotest AG expects that this will significantly increase revenues, especially in the new markets, and secure them across Europe in the long-term.
About Cytotect(R) CP Biotest
Cytotect(R) CP Biotest 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. The concomitant use of adequate virostatic agents should be considered for CMV-prophylaxis.
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.
Dr Monika Buttkereit
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
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.
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