21.08.2018
Biotest AG DE0005227235
DGAP-News: Biotest AG: Biotest AG announces successful completion of Mutual Recognition Procedure for marketing authorization of Cytotect(R) CP Biotest in twelve European countries
DGAP-News: Biotest AG / Key word(s): Regulatory Approval
Biotest AG: Biotest AG announces successful completion of Mutual Recognition
Procedure for marketing authorization of Cytotect(R) CP Biotest in twelve
European countries
21.08.2018 / 07:00
The issuer is solely responsible for the content of this announcement.
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PRESS RELEASE
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.
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
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
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.
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21.08.2018 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
The DGAP Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Archive at www.dgap.de
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Language: English
Company: Biotest AG
Landsteinerstraße 5
63303 Dreieich
Germany
Phone: 0 61 03 - 8 01-0
Fax: 0 61 03 - 8 01-150
E-mail: [email protected]
Internet: http://www.biotest.de
ISIN: DE0005227235, DE0005227201
WKN: 522723, 522720
Indices: SDAX
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated
Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover,
Munich, Stuttgart, Tradegate Exchange
End of News DGAP News Service
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