Press release: Biotest: New study doubles the market potential of Cytotect^®

First successful treatment of cytomegalo-virus infection during pregnancy / effective protection of the unborn child

Dreieich, 29th September 2005. In a multicenter clinical trial the antibody preparation Cytotect^® of Biotest AG has for the first time proven that cytomegalo-virus infections during pregnancy can be treated successfully. The newborn infants showed congenital disorders markedly less frequent than the children of untreated mothers. This is the result of a large –scale Italian study that was recently published in the prestigious New England Journal of Medicine. For Cytotect^® – already the world’s leading hyperimmunoglobuin for treating cytomegalo-virus infection – this opens up a whole new area of application in gynecology with potential sales in the tens of millions.

Cytomegalo-virus infection is a wide-spread in most cases, harmless, viral disease. However, the virus is dangerous during pregnancy. About 10 % of children infected before birth exhibit severe brain damage, diseases of the liver and kidneys, and damage to the eyes and ears. These symptoms can lead, among other things, to blindness, deafness and mental retardation.

The study conducted on 181 pregnant women with a primary CMV infection concluded that both the therapeutic and prophylactic administration of Cytotect^® drastically reduces these severe malformations. Only 3 % of children showed these disordes in the therapy group compared with 50 % in the control group (p<0.001). No undesirable effects during treatment with Cytotect^® were observed.

Cytotect^®, which is derived from human blood plasma, is thus the only drug that is suitable for treating cytomegalo-virus infection during pregnancy. Conventional drugs (virostatics) cannot be used because of their side effects. As a result, many pregnant women diagnosed with the infection with suspicion of fetal malformation have opted for a termination until now. Cytomegalovirus infection occurs in around 7,000 pregnancies each year in Germany alone.

Cytotect^® is currently used mainly in transplantation medicine to prevent infections with cytomegalo-virus. The product is licensed in many European countries.

About Biotest
Biotest AG in Dreieich is a company that researches and produces pharmaceutical, biotherapeutic and diagnostic products and has specialised in the fields of immunology and haematology. The Pharmaceutical Division of Biotest has developed immunoglobulins, clotting factors and albumins based on human blood plasma and these are used in diseases of the immune system and of the haematopoietic system. In addition, Biotest  also researches into the clinical development of monoclonal antibodies, including in the indications of rheumatioid arthritis and blood cancer. The Diagnostics Division specialises in reagents and systems for serology and microbiology, as used for example in the field of blood transfusions. Biotest employs about 1100 staff worldwide. The shares of Biotest AG are noted in the Prime Standard.

Investor Relations:
Hubert Bötsch
Tel.: +49 (0) 6103 801-444,
Fax: +49 (0) 6103 801-880
E-Mail: hubert_boetsch@biotest.de
Biotest AG, Landsteinerstr. 5, D-63303 Dreieich, www.biotest.de

WKN, ISIN Stammaktie (stock shares): 522720, DE0005227201
WKN, ISIN Vorzugsaktie (preference shares): 522723, DE0005227235
Notiert: Prime Standard/Amtlicher Handel Frankfurt, Berlin, Düsseldorf, Hamburg, Stuttgart