Fresenius Biotech

Fresenius Biotech develops and commercializes innovative therapies with immunotherapeutic products. Two products are currently being marketed: firstly, ATG-Fresenius S in transplantation medicine and, secondly, the trifunctional antibody Removab for the treatment of cancer patients with malignant ascites.

Trifunctional antibodies

A special focus of our activities in 2010 was the marketing of Removab (catumaxomab) after the European Commission had issued its approval for the intraperitoneal treatment of patients with malignant ascites in April 2009. 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 in May 2009 and have generated total sales to date of €4.5 million with the product, about €3 million of which was in 2010. As a new, highly innovative therapy, Removab first has to be gradually introduced in clinics and specialist medical practices before it can become recognized as a standard treatment procedure in the mid-term. In 2010, we continued with the preparations for its market launch in other European countries. As of October 8, 2010, the French Ministry of Health has included Removab in the list of drugs authorized for hospital use. The listing ensures reimbursement of this innovative antibody indicated for the treatment of malignant ascites in hospitals. We have submitted the documentation for the pricing in other regulated European markets; decisions by the relevant authorities are still pending.

Removab’s high innovativeness has been borne out impressively by the award of the Galenus von Pergamon Prize in the Specialist Care category in October 2010. The jury acknowledged its new therapeutic mechanism and the improved quality of life for patients as key reasons for the award. The Galenus von Pergamon Prize honors outstanding research and innovative drug developments in Germany.

Two studies are being conducted to support the marketing of Removab:

For the CASIMAS study, which is being carried out in key European countries parallel with the market introduction, the recruitment of patients has been successfully completed. This randomized phase IIIb 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. The follow-up observation phase will be completed in 2011. It is also planned to file the application for approval of the three-hour infusion with the European authorities in 2011. The SECIMAS study is complementary to the CASIMAS study and examines the safety and tolerability of a repeated Removab cycle. This study enables patients who have benefited from the first application of Removab in the CASIMAS study to receive the therapy again if malignant ascites recurs.

In 2010, we continued to analyze the data from the pivotal study for malignant ascites and presented the results at international congresses. It was found that patients who showed a positive immune reaction response profited above average from the treatment. These data underline Removab’s immunological mode of action.

We undertook preparations for further clinical studies in 2010. Firstly, they are intended to provide further evidence of the effectiveness of the intraperitoneal application of Removab, measured in terms of the overall survival time. The aim is to use Removab at earlier stages of treatment and thus broaden its marketing potential. Secondly, we have prepared a study on the safety and feasibility of repeated intravenous administrations of Removab. This form of application enables the use of Removab, which is the only antibody in the world approved so far for EpCAM-positive tumors, to be extended to indications such as lung cancer.

Immunosuppressive agent ATG−Fresenius S

With ATG-Fresenius S, a polyclonal antibody, Fresenius Biotech has an immunosuppressive agent that has been used successfully for many years for preventing and treating organ rejection in transplantation. Sales of ATG-Fresenius S were about €23 million in 2010. We continued the preclinical and clinical development for further indications and for distribution in new markets. Medical data from a European study demonstrate the efficacy of ATG-Fresenius S in the prophylaxis of Graft-versus-Host disease (GvHD) in stem cell transplantation. Based on these results, Fresenius Biotech received approval from the German Paul-Ehrlich-Institut in January 2011 to extend the application of ATG-Fresenius S to “GvHD prevention in adult stem cell transplantation”. Germany is the first major market for which approval has been issued for the area of stem cell transplantation. Fresenius Biotech is currently in contact with various European authorities to obtain approval for this indication on the basis of the available clinical data. The results so far provide strong support for conducting a pivotal phase III study in order to gain access to further international markets. This is currently at the planning stage.

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