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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

In 2011, we continued to focus on the marketing of Removab (catumaxomab). Since market launch in May 2009, we have generated total sales to date of approximately €8.4 million, about €4 million of which was in 2011. The majority of the sales are still generated in Germany and Austria, where we are increasingly able to position Removab for malignant ascites.

We have made progress with regard to the European market launch. We entered, for example, into a distribution agreement with Swedish Orphan Biovitrum, which covers Scandinavia and Eastern Europe. We have also received the reimbursement approval for the price-controlled countries Italy and Belgium.

Several studies were conducted to support the ongoing marketing of Removab. The CASIMAS study, which was being carried out in key European countries parallel with the market introduction, was successfully concluded at the end of 2011. This randomized phase IIIb study examined the tolerability, safety, and effectiveness of a treatment with Removab, applied as a three-hour infusion combined with a simultaneous premedication of a corticosteroid. The outcome of the study supports the application of Removab as a three-hour infusion. The results also confirmed the outcome of the first pivotal study. In 2011, the by three hours shorter infusion time was approved by the European Medicines Agency (EMA). Consequently, the infusion time can be cut in half, which is an important aspect in the oncological practice.

In 2011, we continued to analyze the data from the pivotal study for malignant ascites and presented the results at international congresses. These analyses show for patients with malignant ascites, who were treated with Removab, a statistically significant survival benefit. The six-month survival rate of these patients was more than four times as high as of the patients in the control group. In addition to an improved survival rate, patients treated with Removab also enjoyed a better quality of life. We believe that this aspect will gain importance also when it comes to the reimbursability of drugs.

In addition, we have started a study on the safety and feasibility of the repeated intravenous application of Removab. This form of application enables the use of Removab, as the only antibody in the world currently approved for EpCAMpositive 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 a proven immunosuppressive agent that is used for two therapeutic areas: It has been used for many years for organ transplant patients in order to avoid the rejection of transplanted organs. In addition, medical data from a European study demonstrated the efficacy of ATG-S in the prop of Graft-versus-Host-Disease (GvHD) in stem cell transplantation. Based on these results, Fresenius Biotech was granted approval for this therapeutic area for countries such as Germany and Austria in 2011.

Fresenius Biotech is in contact with European authorities in order to obtain approval for the indication of stem cell transplantation in other countries. A pivotal phase III study was initiated in the U.S. Its objective is to obtain FDA approval for ATG-Fresenius S at the prophylaxis of GvHD.

In 2011, ATG-Fresenius S was awarded with the Drug Award of the Munich Medical Journal (Münchener Medizinische Wochenschrift (MMW)) in recognition for its specific effect and its contribution for successful transplantations. This award is specifically given to drugs that, over many years, have become a fixed-point as a therapeutic instrument, while at the same time continue to broaden the indications to be used against.

Sales of ATG-Fresenius S were about €27 million in 2011.

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