Biotest AG: EMEA Committee in favour of Orphan Drug status for Cytotect®
Biotest AG / Miscellaneous
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EMEA Committee in favour of Orphan Drug status for Cytotect®
Large market potential for treatment of cytomegalovirus infections during
pregnancy / Europe-wide authorisation study to begin at the start of 2007 /
Good chances of Orphan Drug status in the USA too / Positive reactions from
Gynaecologists and private health insurers
Dreieich, 28 September 2006. The hyperimmunoglobuline, Cytotect®, produced
by Biotest AG has overcome an important hurdle on the path to successful
Europe-wide marketing of the treatment of cytomegalovirus infection during
pregnancy. The Committee for Orphan Medicinal Products (COMP), part of the
European Medicines Agency (EMEA), has argued in favour of granting Orphan
Drug status. The EMEA is expected to announce its final decision in the
next few weeks. Biotest will also be applying for an Orphan Drug
designation in the USA and expects a positive decision from the Food and
Drug Administration (FDA) by the end of 2006. An Orphan Drug status allows
medications that treat rare and serious illnesses market exclusivity of up
to ten years within the EU and up to seven years in the USA. This also
helps to support clinical trials and lower the costs of approval processes.
The prerequisites of Cycotect® for market approval in the new area of
application have been further improved by the prospective Orphan Drug
status. Cytomegaly is a wide-spread viral infection, which is generally
harmless, resulting in flu-like symptoms. However, if pregnant women become
infected with the cytomegaly virus (CMV), it can result in severe
disabilities such as blindness or deafness in babies. An Italian study
conducted last year and published in the New England Journal of Medicine
concluded that both therapeutic and preventative use of Cytotect®
drastically reduces the incidence of these severe deformities.
In another published consensus paper, the BVF (the German association of
gynaecologists) concludes that on the basis of the newly available
treatment, special consideration must be given to the diagnosis of CMV
infections during pregnancy. Following approval of Cytotect® in this area
of application, the BVF will “support the commitment to diagnosis and
prevention of connatal CMV infection in the area of prenatal healthcare.”
The results of the Italian study can already be seen as a treatment option
for gynaecologists.
Biotest intends to conduct the Europe-wide approval study (phase III) in
cooperation with an international clinical diagnostics company.
Negotiations are already underway. Based on the excellent results of the
Italian researcher, Biotest Cytotect® is already being used to treat
patients who have undergone the appropriate medical examination. The
absorption of costs has already enabled positive discussions with private
health insurers. Discussions with state health insurers are in preparation.
The added market potential given to Cytotect® by the new area of
application is estimated at around 30 million euros in the EU and in the
USA.
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 addition, Biotest also 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 28.09.2006
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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
End of News DGAP News-Service
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