Further developments
 
Intratect®: In the clinical Phase III trial for the indication fibromyalgia (chronic pain syndrome) it has been shown that a significant clinical improvement was reached in 30% of patients.
 
Zutectra®: the subcutaneously administered variant of the Hepatitis B immunoglobulin was granted its Europe-wide authorisation by the European Commission in December 2009. This gives Biotest a preparation with which patients can be protected long-term from re-infection following a liver transplant necessitated by Hepatitis B.
Zutectra® is injected subcutaneously and its dosage is so designed that patients are able to treat themselves once a week.
 
Cytotect®: We are developing the immunoglobulin for the indication of the prevention of fetal infection with the cytomegaly virus (CMV) during pregnancy in women with a primary CMV infection. The ongoing Phase III study is intended to show that the administration of Cytotect® can prevent transmission of the virus to the unborn child.
So far, more than 8,000 pregnant women have been examined, an interim analysis of the study will follow in the end of 2011. 
 
New developments
 
Intravenous immunoglobulin Bivigam™ (IVIG): a Phase III authorisation study for the IVIG from Biotest Pharmaceuticals Corp. was concluded in the 2nd Quarter of 2009. The marketing authorizatin dossier was submitted to the FDA  on 03 November 2010.
The IVIG will be marketed in future under the name Bivigam™. The preparation possesses comparable properties to Intratect®, and is being developed for the UR market.
 
IgM concentrate: The IgM concentrate is being developed for a comparable spectrum of indications to Pentaglobin® which is already licensed. The focus is on the treatment of serious bacterial infections, or sepsis. In 2011 the development was continued with a phase II study. The phase I study of IgM concentrate was successfully completed.
 
Civacir™: is being developed for the prophylaxis of Hepatitis C virus re-infection following liver transplantations. As a first step, the manufacturing process and the consistency of the product have been optimised with the aim of achieving the optimum antibody concentration in the finished preparation at all times.
These results are now to be substantiated in further preclinical studies, before we proceed with the clinical development.