Biotest AG: Orphan drug status for Cytotect® in the USA
Biotest AG / Regulatory Approval
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The issuer is solely responsible for the content of this announcement.
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The decision of the US approval authority (FDA) ensures seven years' of
exclusive market access to the treatment of cytomegalovirus infections in
pregnancy. Biotest estimates that the additional market potential for this
new indication will amount to EUR 70 million per year.
Dreieich, 5 January 2007. The US Food and Drug Administration (FDA) has
granted orphan drug status to Biotest's hyperimmunoglobulin Cytotect® in
the treatment of cytomegalovirus infections in pregnancy. Orphan drug
status provides drugs used to treat rare and serious diseases with market
exclusiveness for a period of up to seven years in the United States. The
FDA's decision follows just a few weeks after Cytotect® was granted the
same status by the European Medicines Agency (EMEA) within the European
Union, where market exclusiveness is guaranteed for a period of up to 10
years. This also supports clinical trials in both the USA and Europe as
well as providing for a reduction in the approval procedure costs.
Cytomegalovirus is a widespread viral infection, which is generally
harmless and produces flu-like symptoms. However, pregnant women who become
infected with cytomegalovirus (CMV) face the risk that this can cause
serious harm to their baby, for instance blindness or deafness. An Italian
study carried out in 2005 and published in the New England Journal of
Medicine concluded that both the therapeutic and prophylactic application
of Cytotect® drastically reduced the occurrence of these severe disorders.
According to the Federal Association of Gynaecologists (BVF), the
indication can already be considered as a treatment option for
gynaecologists.
Following exhaustive medical evaluation, Cytotect® has already been adopted
as part of the treatment of cytomegalovirus infections in pregnant women in
some cases. This year, Biotest will launch a study in which significant
investment has been made, in order to receive approval for this new
indication in the EU and the USA. The additional market potential which
this will open up is estimated to total approximately EUR 70 million.
About Cytotect®
The hyperimmunoglobuline Cytotect®, is currently used mainly in
transplantation medicine for the prevention of infection by the cytomegaly
virus. The preparation is approved in many European countries and, in terms
of sales, the world’s leading preparation in this area of application.
About Biotest
Biotest AG, Dreieich, Germany, is a company that researches and
manufactures pharmaceutical, biotherapeutic and diagnostic products and has
specialised in immunology and haematology. In its Pharmaceutical segment,
Biotest develops immunoglobulines, clotting factors and albumins based on
human blood plasma. These are used for diseases of the immune system or
haematopoietic system. In the Biotherapeutics segment, Biotest researches
into the clinical development of monoclonal antibodies, including in the
indications of rheumatoid arthritis and blood cancer. The Diagnostic
segment spans reagents and serology and microbiology systems which are
used, for example, in blood transfusions. Biotest has around 1,100
employees worldwide and its shares are listed in the Frankfurt Stock
Exchange's Prime Standard.
Biotest AG: Dr. Michael Ramroth, Tel. +49 6103 801-338
Fax: +49 6103 801-347, e-mail: michael.ramroth@biotest.de
Biotest AG, Landsteinerstr. 5, D-63303 Dreieich, www.biotest.de
WKN, ISIN ordinary share: 522720, DE0005227201
WKN, ISIN preference share: 522723, DE0005227235
Listed: Prime Standard/official trading
Frankfurt, Berlin, Düsseldorf, Hamburg, Stuttgart
DGAP 04.01.2007
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Language: English
Issuer: Biotest AG
Landsteinerstr. 5
63303 Dreieich Deutschland
Phone: +49 - 6103 / 801 - 0
Fax: +49 - 6103 / 801 - 150
E-mail: mail@biotest.de
WWW: www.biotest.de
ISIN: DE0005227201, DE0005227235
WKN: 522720, 522723
Indices:
Listed: Amtlicher Markt in Frankfurt (Prime Standard); Freiverkehr in
Berlin-Bremen, Düsseldorf, Hamburg, Stuttgart
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