Biotest AG:Biotest and Abbott cooperate on a clinical trial for the expansion of the indication of Cytotect®
Biotest AG / Miscellaneous
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Biotest and Abbott cooperate on a clinical trial for the expansion of the
indication of Cytotect®
· Trial with more than 20,000 participants for the approval of the
immunoglobulin in the indication connatal CMV infection
· Abbott acts as diagnostics partner
· Approval would result in a substantial increase in market potential for
Biotest.
Dreieich, 1 August 2007. Biotest AG, Dreieich, has signed an agreement with
Abbott to cooperate on the clinical Phase III trial on the approval of the
immunoglobulin Cytotect® in the indication connatal cytomegalovirus
infection. Abbott will act as diagnostic partner in the trial, for which
Biotest assumes sole responsibility.
Cytomegalovirus is a widespread viral infection, which is generally
harmless and causes flu-like symptoms. However, if a pregnant woman becomes
infected with the cytomegalovirus (CMV), this can result in severe damage
to her unborn baby, such as blindness or deafness. The connatal CMV
infection is the leading cause of malformation in unborn babies. According
to information provided by the Centre of Disease Control, one in 750
newborn infants exhibit CMV-related malformations at birth.
An Italian study published in the New England Journal of Medicine in 2005
concluded that both the therapeutic and the prophylactic application of
Cytotect® drastically reduced such severe deformities. In individual cases
Cytotect® is therefore already used successfully in the treatment of
cytomegalovirus infections in pregnant women, following extensive medical
assessment.
At the request of the regulatory authorities, Biotest will launch a trial
in the third quarter of this year to confirm the results of the Italian
study. More than 20,000 pregnant women are set to be enrolled in the trial,
for which Abbott will provide the systems and tests required for the
diagnosis of CMV. Biotest aims to establish treatment using Cytotect® as
the standard treatment for connatal CMV infections.
At present, Cytotect® is predominantly used in the area of transplantation
medicine. For the indication connatal CMV infection, it has been granted
orphan drug status within the European Union and the USA. One of the
benefits offered by this status is that the company is entitled to
exclusive marketing rights of up to 10 years. Biotest estimates that the
additional market potential generated by approval of the new indication in
the EU and the USA would total around EUR 70 million.
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 immunoglobulins, clotting factors and albumins based on
human blood plasma. These are used for diseases of the immune system or
haematopoietic system. In the Biotherapeutic 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 1,200
employees worldwide and its shares are listed in the Frankfurt Stock
Exchange's Prime Standard.
Biotest AG:
Biotest AG, Landsteinerstr. 5, D-63303 Dreieich, www.biotest.de
Dr. Marion Wendorff, Tel: +49 (0) 6103 801-520, e-mail:
marion_wendorff@biotest.de
Fax: +49 (0) 6103 801-7840
WKN, ISIN ordinary share: 522720, DE0005227201
WKN, ISIN preference share: 522723, DE0005227235
Listed: Prime Standard/official trading
Frankfurt, Berlin, Düsseldorf, Hamburg, Stuttgart
DGAP 01.08.2007
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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
Internet: www.biotest.de
ISIN: DE0005227201, DE0005227235
WKN: 522720, 522723
Indices:
Listed: Amtlicher Markt in Frankfurt (Prime Standard); Freiverkehr in
Berlin, Düsseldorf, Hamburg, Stuttgart
End of News DGAP News-Service
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