Biotest AG: Biotest AG receives positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for approval of Zutectra across the EU
Biotest AG / Miscellaneous
28.09.2009
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Dreieich, 28 September 2009. The Committee for Medicinal Products for Human
Use (CHMP) of the European Medicines Agency (EMEA) has adopted a positive
opinion for approval of Biotest's hepatitis B immunoglobulin Zutectra. The
positive assessment is based on the comprehensive data available to the
EMEA, which was reviewed as part of the centralised approval procedure. In
the next step, this positive opinion of the CHMP is referred to the
European Commission, which is responsible for granting final marketing
authorisation for the entire EU. As a rule, the European Commission grants
approval of new drugs after a formal review within a time frame of three
months following a positive CHMP opinion.
Zutectra is worldwide the first ready-to-use hepatitis B immunoglobulin
solution in a pre-filled syringe for subcutaneous administration. Biotest
developed the product specifically for the long-term treatment of patients
after liver transplantation; it enables patients to self-medication. This
provides the attending physician with a time-saving and simpler treatment
option and patients with a significant benefit, since subcutaneous
administration is more comfortable than intravenous or intramuscular
administration. The recommended dosage is 1 to 2 injections per week.
Zutectra complements the Biotest immunoglobulin Hepatect(R) CP, which will
remain indispensable also in the future for high-dosage therapy in the
initial phase of transplantation. With the expected launch of the new
product, Biotest AG offers an innovative product portfolio for this market
segment that facilitates further expansion of the company's market
leadership in the prevention of re-infection with hepatitis B after liver
transplantation.
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
Securities' ID No., ISIN ordinary shares: 522720, DE0005227201
Securities' ID No., ISIN preference shares: 522723, DE0005227235
Listing: Prime Standard/Official traded
Frankfurt, Berlin, Düsseldorf, Hamburg, Stuttgart
28.09.2009 Financial News transmitted by DGAP
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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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