DGAP-News

Biotest AG: Biotest supports a large international retrospective study to record data on clinical use of Cytotect(R) after heart and lung transplantation

DGAP-News: Biotest AG / Key word(s): Research Update
Biotest AG: Biotest supports a large international retrospective study to
record data on clinical use of Cytotect(R) after heart and lung
transplantation

23.11.2016 / 07:00
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PRESS RELEASE

Biotest supports a large international retrospective study to record data
on clinical use of Cytotect(R) after heart and lung transplantation

- Results will provide a basis for design of a new transplantation study

- Evaluation of the optimal treatment regimen as a basis for adapting
international treatment guidelines

- Marked medium-term increase of the market potential of Cytotect(R), the
only CMV hyperimmunoglobulin licensed in Europe, is anticipated

Dreieich, 23 November 2016. Cytomegalovirus (CMV) is a globally distributed
herpes virus. Infection with CMV generally does not pose a risk to healthy
individuals and usually passes unnoticed. In persons with a weakened immune
system, however, especially patients after organ transplantation, the virus
can cause serious complications and may even be life-threatening.

Since transplant patients receive strong immunosuppressive treatment,
especially after heart and lung transplantation, CMV disease is one of the
most feared complications, affecting approximately 30% of all heart and
over 40% of all lung transplant recipients. For this reason, most patients
are treated prophylactically directly after transplantation with CMV-
suppressing antiviral medications (virostatics) for several weeks to
months. In addition, these patients may be treated with the CMV-specific
hyperimmunoglobulin Cytotect(R).

Cytotect(R) is a hyperimmunoglobulin produced from human plasma for
prophylaxis of CMV infection, which is used especially in transplant
patients. In Europe it is the only product of its kind, with a highly
effective mode of action, allowing for virus neutralisation and modulation
of the immune system .[1]

The aim of the international retrospective study that has now been
initiated is to identify the optimal treatment frequency and dosage for
patients following heart or lung transplantation. Under the direction of
Associate Professor Dr. Florian Wagner of the University Hospital Hamburg-
Eppendorf (UKE), data from 1,600 patients of leading international
transplantation centres will be analysed.

"Cytotect(R) represents an ideal addition and, in select cases, an
alternative to monotherapy with virostatics to prevent or treat a CMV