Fresenius Biotech

Fresenius Biotech develops and commercializes innovative therapies with immunotherapeutic products. In 2009, the trifunctional antibody Removab was approved as anti-cancer therapy, thus validating this targeted, immunological approach. For many years, Fresenius Biotech has been successfully marketing ATG-Fresenius S, a polyclonal antibody. This is an immunosuppressive agent used to control immune reactions in transplantation medicine.

Trifunctional antibodies

After we filed the application for Removab at the end of 2007, the European Commission issued its approval for the intraperitoneal treatment of patients with malignant ascites in April 2009. This approval is valid for all 27 member states of the European Union as well as Iceland, Liechtenstein, and Norway. Removab is the first trifunctional antibody in the world to be approved and is also the first drug for malignant ascites. We began marketing Removab in Germany and Austria in May 2009. In 2009, we achieved sales of more than € 1.6 million with the product. The pricing and market introduction procedures were initiated in other European countries.

Parallel to the market introduction, the CASIMAS study, a randomized phase IIIb study, is being carried out in key European countries. This study is examining the tolerability, safety, and effectiveness of treating ascites patients with Removab, applied as a three-hour infusion versus without a corticosteroid pre-medication. So far approval has been issued for an infusion time of six hours. This study is supporting the market entry of Removab and, if the results are positive, can facilitate application.

New data from further evaluations of the pivotal study for malignant ascites supporting the clinical benefits of Removab were presented at a number of international cancer congresses, such as ASCO, WCGIC, and ESMO in 2009. Removab has been significantly shown to improve clinical progress in patients with malignant ascites independently of the underlying tumor or other prognostic factors. In addition, in gastric cancer patients with malignant ascites, treatment with Removab has been observed to prolong survival to a statistically significant extent, while a trend towards prolonged survival was shown for the overall population of all patients treated.

The clinical studies in the different settings of gastric and ovarian cancer were continued and have produced initial results on the use of Removab in earlier stages of treatment, for instance as intra-operative medication in adjuvant treatment situations. An adjuvant therapy following complete removal of tumor tissue aims to destroy any unapparent tumor cells that might still exist. The results of these phase II studies show that Removab is safe to use perioperatively in an adjuvant setting of gastric cancer as well as in first-line therapy and consolidation therapy in advanced ovarian cancer.

Studies on the trifunctional antibody ertumaxomab for the treatment of metastasized breast cancer were, or are being, terminated prematurely. We have shelved these development activities in order to concentrate more intensively on the further development of Removab.

Immunosuppressive agent ATG−Fresenius S

Sales of ATG-Fresenius S rose by 14 % to € 24 million. The preclinical and clinical development for other applications and distribution in new markets was continued. A clinical study is currently being conducted on the use of ATG-Fresenius S in the prophylaxis of acute Graft-versus-Host disease in stem cell transplantation. The one-year results on its efficacy and safety were very promising. They were published in the medical journal Lancet Oncology 10/2009. The final report on the two-year data is in preparation. Fresenius Biotech filed the marketing authorization application with several European authorities for approval for the prophylaxis of Graft-versus- Host disease.

The study with ATG-Fresenius S in lung transplantation in the United States was continued. 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 among patients six months and twelve months after transplantation. One dosage regime arm of the study was closed due to the results of the intermediate analysis.

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