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Fresenius Group Additional Group Information Research and Development 
Further results in the secondary endpoints of the study indicate that the trifunctional antibody has a direct influence on the underlying tumor. The median time until the tumor disease progressed again was 111 days with Removab® as compared to 35 days in the control group. This is further significant indication of its efficacy. A positive trend was also observed for overall survival. The safety profile of Removab® in the study was good.
The results of this study were presented in 2007 at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago and at the European CanCer Organisation (ECCO) Congress in Barcelona. In light of the statistically significant results of the phase II/III study, Fresenius Biotech dispatched an application to the European Medicines Agency (EMEA) at the end of 2007 for approval of Removab® for the intraperitoneal treatment of malignant ascites following epithelial tumors in cases where standard therapies are not available or are no longer feasible. The application documents contain not only the results of the clinical study but also data from preclinical studies as well as information about production and product quality.
Parallel with the authorization process, Fresenius Biotech began preparations for marketing Removab® in Europe. Fresenius Biotech is currently also offering Removab® to potential development and marketing partners for the United States and Japan.
The effectiveness and safety of Removab® in the indication of malignant ascites are currently also being tested in a US phase II study. This study is largely pursuing the same aims as the successful European authorization study.
Two phase II studies have been initiated on the effectiveness and safety of Removab® for advanced ovarian cancer. One has since been completed. In the European study, the safety, tolerance and effectiveness of the intraperitoneal administration of the trifunctional antibody during and after removal of the tumor by surgery were compared with treatment by surgery alone.
Other phase II studies – in the United States and in Europe – are testing the effectiveness and safety of Removab® on patients with ovarian cancer. In the US study, patients who no longer reacted to a platinum-based standard chemotherapy, and who therefore had no further therapy options, were treated with Removab®. The European study is examining whether early therapy with Removab® is compatible and whether it has an effect on the recurrence of the tumor.
The development program for the antibody Rexomun® (INN: ertumaxomab) is continuing as planned with phase II studies on patients with advanced breast cancer. Two European studies are investigating the effectiveness of Rexomun® on patients who, following the failure of a hormone therapy, are not suitable for other antibody therapies and for whom there is no standard therapy.
Further information on the clinical studies can be found on our website at http://www.fresenius.com/ Fresenius Biotech.
Immunosuppressive agent ATG-Fresenius S
In the field of polyclonal antibodies, we generated sales of ATG-Fresenius S of around € 19 million (2006: €19 million). The clinical development of ATG-Fresenius S for other applications and distribution in new markets was continued. An important project is the clinical trial for the use of ATG-Fresenius S in stem cell transplantation. The study examines the effect of ATG-Fresenius S on the prophylaxis of acute Graft-versus-Host Disease. The standard therapy (Cyclosporin A and methotrexate) is being compared with the standard therapy plus the additional administration of ATG-Fresenius S. The recruitment of patients was completed in the first quarter of 2007. Two intermediate analyses have confirmed that ATG-Fresenius S is safe at the selected dosage. A final report will be published in 2009, at the end of the two-year observation period.
In our development program for the United States, we took over a study from our former cooperation partner Nabi Biopharmaceuticals at the end of 2007. This study, currently in progress, uses ATG-Fresenius S in lung transplantation. The study compares the effects of two different ATG dosage regimes and a placebo (double-blind and placebo controlled) on organ rejection and mortality rates on patients six months after transplantation.
R & D financial figures can be found in the Management Report.
