15.08.2018
Biotest AG DE0005227235
DGAP-News: Biotest AG: Cytotect(R) CP prevents transmission of Cytomegalovirus (CMV) to the unborn baby in pregnant women who are infected with CMV for the first time
DGAP-News: Biotest AG / Key word(s): Research Update
Biotest AG: Cytotect(R) CP prevents transmission of Cytomegalovirus (CMV) to
the unborn baby in pregnant women who are infected with CMV for the first
time
15.08.2018 / 07:00
The issuer is solely responsible for the content of this announcement.
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PRESS RELEASE
Cytotect(R) CP prevents transmission of Cytomegalovirus (CMV) to the unborn
baby in pregnant women who are infected with CMV for the first time
- Transmission of CMV from pregnant women to the foetus is a main cause of
post-natal complications in newborns
- High medical need as 700 - 1,400 babies are born with developmental
disorders due to CMV in Germany every year
- Studycoordinated by the University of Tübingen shows strong reduction of
maternal-foetal CMV transmission from 35.2% to 2.5% (primary endpoint)
- Cytotect(R) CP shown to be effective and safe for use in pregnant women
Dreieich, 15 August 2018. The results of a recently published study by Kagan
et al. indicate excellent efficacy and safe use of Cytotect(R) CP in
pregnant women [1]. The study was conducted independently and without
financial support from Biotest.
Cytomegalovirus (CMV) causes a life-long infection, which is usually
unproblematic in healthy individuals. In CMV-negative pregnant women,
however, who get infected with CMV for the first time ("primary infection"),
there is a ~40% risk that the virus gets transmitted to the foetus,
potentially causing neurological and developmental defects. In Germany about
700-1,400 babies with developmental disorders due to CMV are born each year.
Prevention of CMV transmission to the foetus protects from those negative
effects. Currently, there is no medicine authorised for use in this setting.
In a new prospective observational study coordinated from the University of
Tübingen, Cytotect(R) CP was given to pregnant women with primary CMV
infection during early pregnancy. Cytotect(R) CP, a CMV-specific
hyperimmunoglobulin, has a high content of antibodies that specifically
target CMV. In 40 women treated in this study, transmission of the virus to
the foetus occurred in only one case at time of amniocentesis around
gestational week 20 (primary endpoint). This corresponds to a transmission
rate of 2.5%, which is significantly lower compared to a historical control
group with a transmission rate of 35.2% (38 of 108 women). Additionally,
there were two late CMV transmissions, thus, a total of three infected
babies were observed, all without symptoms at birth. The administration of
Cytotect(R) CP was safe and no serious adverse problems were observed. The
authors of the study conclude that administration of a CMV
hyperimmunoglobulin is safe end efficacious when administered to pregnant
women before gestational week 20, even at a relatively high dose.
In contrast to previous studies with CMV hyperimmunoglobulin in this
setting, only women with an early primary CMV infection were included and
treatment was started as soon as possible in biweekly intervals. Notably,
the risk for symptomatic babies is highest, when primary infection occurs
during the first 20 weeks of pregnancy.
A different clinical trial with BT094, an investigational CMV
hyperimmunoglobulin, was conducted by Biotest in the same indication (Study
963). As part of this study, more than 15,000 pregnant women were screened.
However, the study was terminated early due to lower than expected case
numbers. Therefore, the calculated sample size to achieve statistical
significance was not reached. In contrast to the study by Kagan et al., the
Biotest study treated pregnant women whose primary infection occurred up to
the 35th week of pregnancy.
Despite low case numbers, a trend towards prevention of foetal CMV infection
was observed in the treatment group compared to the control group. Treatment
with BT094 was well tolerated with no unexpected safety findings. No new
risks or signals were identified in pregnant women, foetuses, and
newborns/infants in this clinical trial. Biotest is currently in the process
of analysing all data of this clinical trial and will prepare a manuscript
for publication of the results in the near future.
1] Karl Oliver Kagan et al. Ultrasound in Obstetrics & Gynecology,
doi:10.1002/uog.19164
About Cytotect(R) CP
Cytotect(R) CP is a cytomegalovirus (CMV)-specific hyperimmunoglobulin
preparation with a high antibody titre against CMV. The product is approved
for prophylaxis of clinical manifestations of CMV infection in patients
subjected to immunosuppressive therapy, particularly in transplant
recipients.
About Biotest
Biotest is a provider of plasma proteins and biological drugs. With a value
added chain that extends from pre-clinical and clinical development to
worldwide sales, Biotest has specialised primarily in the areas of clinical
immunology, haematology and intensive medicine. 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 addition, Biotest develops monoclonal antibodies in the
indications of cancer of plasma cells and systemic lupus erythematosus which
are produced by recombinant technologies. Biotest has more than 1,600
employees worldwide. The preference shares of Biotest AG are listed in the
SDAX on the Frankfurt stock exchange.
IR contact
Dr Monika Buttkereit
Phone: +49-6103-801-4406
Mail: [email protected]
PR contact
Dirk Neumüller
Phone: +49-6103-801-269
Mail: [email protected]
Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com
Ordinary shares: securities' ID No. 522720; ISIN DE0005227201
Preference shares: securities' ID No. 522723; ISIN DE0005227235
Listing: Frankfurt (Prime Standard)
Open Market: Berlin, Düsseldorf, Hamburg/ Hanover, Munich, Stuttgart,
Tradegate
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.
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15.08.2018 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
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Language: English
Company: Biotest AG
Landsteinerstraße 5
63303 Dreieich
Germany
Phone: 0 61 03 - 8 01-0
Fax: 0 61 03 - 8 01-150
E-mail: [email protected]
Internet: http://www.biotest.de
ISIN: DE0005227235, DE0005227201
WKN: 522723, 522720
Indices: SDAX
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated
Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover,
Munich, Stuttgart, Tradegate Exchange
End of News DGAP News Service
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