Biotest AG: European Commission grants approval of Zutectra(R)
Biotest AG / Regulatory Approval
03.12.2009
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European Commission grants approval of Zutectra(R)
* Worldwide the first ready-to-use Hepatitis B Immunoglobulin solution
for subcutaneous administration
* Marketing in Europe can start now
Dreieich, 3. December 2009. The European Commission has granted marketing
approval to Biotest for the hepatitis B immunoglobulin Zutectra(R) after
the Committee for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency (EMEA) had adopted a positive opinion for approval at the
end of September. With this approval the product can be marketed in all
EU-member countries.
Zutectra(R) was specifically developed by Biotest for the long-term
treatment of patients after liver transplantation. It is worldwide the
first ready-to-use hepatitis B immunoglobulin solution in a pre-filled
syringe for subcutaneous administration and it enables patients to
self-medication. This provides the attending physicians and patients with a
time-saving and simpler treatment option.
The positive assessment is based on comprehensive data available to the
EMEA, which was reviewed as part of the centralised approval procedure.
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.
About Biotest
Biotest is a company involved in research and development as well as in
manufacturing and marketing of pharmaceutical, biotherapeutic and
diagnostic products and has specialised in the areas of application of
immunology and haematology. In its Plasma Protein segment, 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 the Biotherapeutic segment, Biotest researches
into the clinical development of monoclonal antibodies, including in the
indications of rheumatoid arthritis and cancer of plasma cells. The
products of the Microbiological Monitoring segment are primarily used in
hygiene monitoring, while those of Medical Diagnostics are used, for
example, in blood transfusions and transplants. Biotest has more than 2,000
employees worldwide. The shares of Biotest AG are listed in the SDAX on the
Frankfurt stock exchange.
Biotest AG, Landsteinerstr. 5, D-63303 Dreieich, www.biotest.de
Dr. Monika Buttkereit
tel.: +49 (0) 6103 801-4406,
e-mail: investor_relations@biotest.de
fax: +49 (0) 6103 801-347
03.12.2009 Financial News distributed by DGAP. Media archive at www.medientreff.de and www.dgap.de
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Language: English
Company: Biotest AG
Landsteinerstraße 5
63303 Dreieich
Deutschland
Phone: 0 61 03 - 8 01-0
Fax: 0 61 03 - 8 01-150
E-mail: investor_relations@biotest.de
Internet: http://www.biotest.de
ISIN: DE0005227235, DE0005227201
WKN: 522723, 522720
Indices: SDAX
Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
in Berlin, Düsseldorf, Hamburg, Stuttgart
End of News DGAP News-Service
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