Fresenius today announced encouraging results in the non-ovarian cancer patient stratum of a phase II/III pivotal study on malignant ascites using the trifunctional antibody removab® (catumaxomab). After positive results in the treatment of patients with ascites from ovarian cancer (see Press Release of December 18, 2006 for ovarian stratum), the antibody again showed a clear advantage over a therapy with puncture alone. The median puncture-free survival period (primary endpoint) in the patient group treated with removab® was significantly longer compared to the control group and clinically relevant. The median puncture-free survival was 37 days in the removab® group versus 14 days in the control group (p< 0.0001).

In the subgroup of patients with ascites from gastric cancer (51 % of all non-ovarian cancer patients) the difference was even more marked with a median puncture-free survival of 44 days in the removab® group versus 15 days in the control group (p<0.0001). All other patients (10 % breast, 7 % pancreatic, 6 % colorectal cancer, 26 % others) had a median puncture-free survival of 30 days (removab®) versus 9 days in the control group (p<0.0003). On a pooled basis for both strata (ovarian and non-ovarian cancers) the median puncture-free survival was 46 days in the removab® group versus 11 days in the control group (p<0001).

Positive results were also achieved in key secondary endpoints. Of special importance was the length of time between treatment and first therapeutic puncture (median time to the first therapeutic puncture). In contrast to the primary endpoint, patients who died before the next puncture were not included in this metric. As a result, this secondary endpoint is not affected by the prognosis of these patients at the onset of ascites. The median time to the first therapeutic puncture for all non-ovarian cancers was 80 days (control group: 15 days; p< 0.0001). Patients with gastric cancer benefited especially from the treatment. Median time to the first therapeutic puncture was 118 days in the removab® group versus 15 days in the control group (p< 0.0001). For all other patients the median time to the first therapeutic puncture in the removab® group was 69 versus 15 days in the control group (p< 0.0001). On a pooled basis for both strata (ovarian and non-ovarian cancers) the median time to the first therapeutic puncture was 77 days in the treatment group versus 13 days in the control group (p< 0.0001). In addition, the EpCAM-positive tumor cell concentration in the ascites fluid decreased in patients treated with removab®. At the same time, an increase in CD45-positive leukocytes was seen. Both results indicate a direct anti-tumor effect of the trifunctional antibody.

Removab® showed a very good safety profile in this stratum. This is particularly important as malignant ascites occurs at a very late stage in patients with non-ovarian cancers. Drug-related adverse events due to cytokine release were mild to moderate and mostly fully reversible, with fever, nausea and vomiting being the most common. Pathologic increases of liver parameters and undesirable changes in white blood cell counts were also mild to moderate, transient and mostly without clinical relevance.

"These results continue to support the potential of removab. They demonstrate the significant benefit for ascites patients due to non-ovarian cancers even though they have a worse prognosis compared to ovarian cancer. This indicates that removab® could also play an important role in the treatment of ascites for all underlying non-ovarian cancers," said Dr. Thomas Gottwald, President Fresenius Biotech.

The phase II/III pivotal trial with the trifunctional antibody removab® included a total of 258 patients divided in two strata: ovarian cancer (129 patients) and non-ovarian cancers (129 patients). Based on a 2:1 randomization ratio, the removab® arm in the non-ovarian stratum included 85 patients, of which 62 received all four doses of 10, 20, 50 und 150 µg each. The intraperitoneal infusions were administered over a six-hour period in intervals of three to four days.

Non-ovarian cancer patients account for about 80 % of all malignant ascites cases. The encouraging results of this study significantly increase the number of patients that is potentially eligible for the removab® treatment.

Data on overall survival in connection with the study are expected in the second quarter of 2007 due to the longer follow-up period associated with this secondary endpoint. Market launch of removab® is expected in 2008.

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Puncture-free survival period
Period between the last infusion (control group: day of the puncture) and the first subsequent necessary puncture or death, which ever occurs first.

Trifunctional Antibodies
Trifunctional antibodies are developed by Fresenius Biotech in cooperation with TRION Pharma. Trifunctional antibodies are proteins that bring together cancer cells with two different cell types of the immune system: T-cells and accessory cells (e.g., natural killer cells, macrophages). This mode of action of the trifunctional antibody is the basis for an immune response against the tumor.

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Fresenius Biotech is a company of the Fresenius Group, focused on the development and marketing of biopharmaceuticals in the fields of oncology, immunology and regenerative medicine.

For more information visit the company's website at www.fresenius-biotech.com.

Fresenius is a health care group with international operations, providing products and services for dialysis, hospital and the ambulatory medical care of patients. In 2006 group sales were about € 10.8 billion. On December 31, 2006 the Fresenius Group had 104,872 employees worldwide.

Most dialysis patients have a significantly better chance of survival if they are treated with high-flux dialyzers rather than low-flux dialyzers. This is the conclusion of a new international study conducted under the direction of the Italian renal specialist Prof. Francesco Locatelli from the Alessandro Manzoni Hospital in Lecco.

The results of the study were presented last weekend during the European Dialysis and Transplantation Association/European Renal Association (EDTA/ERA) Congress in Barcelona. The study showed that dialysis patients with a low albumin concentration in their blood that were treated with high-flux dialyzers had a 37% lower mortality risk during the three to seven-and-a-half years of the study than those that were treated with low-flux dialyzers. Depending on the country, 56% to 85% of dialysis patients have a low albumin concentration in their blood (four grams per deciliter or less).

The study was conducted over seven-and-a-half years in nine European countries. The 738 patients involved were treated three times a week. Half of the patients received treatment with high-flux dialyzers – predominantly dialyzers from Fresenius Medical Care. The other half received therapy with low-flux dialyzers.

This is the first time a prospective randomized clinical study scientifically proves that treatment with high-flux dialyzers reduces the mortality risk of patients with severe chronic kidney disease. Indications of a lower mortality risk first appeared in the mid-90s.

Specialists attribute the increased survival rates from high-flux dialyzers to a more efficient filtering of larger uremic toxins from the blood. High-flux membranes have a greater water permeability and pores that are two-and-a-half times larger than low-flux membranes. The filtering capabilities of high-flux membranes are closer to the natural kidney function and allow the body to remove large amounts of liquids and toxic uremic substances in a short period of time. High-flux dialyzers can also help maintain any remaining kidney function for a longer period of time.

High-flux dialyzers have the most technically advanced membranes. Their use is increasing worldwide and, in many countries, more than 60% of the patients are treated with high-flux dialyzers. "The positive results of the new study validate our efforts to offer innovative dialysis products such as our high-flux dialyzers with Helixone membranes so that dialysis patients can look toward the future with more confidence. We expect demand for high-flux dialyzers to continue to increase. And we are proud that the majority of the patients in the study's high-flux-group were treated with our dialyzers," said Dr. Emanuele Gatti, Fresenius Medical Care Chief Executive Officer for Europe, Latin America, Middle East and Africa.

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Helixone is a registered trademark of Fresenius Medical Care.

Fresenius Medical Care is the world's largest integrated provider of products and services for individuals undergoing dialysis because of chronic kidney failure, a condition that affects more than 1,500,000 individuals worldwide. Through its network of 2,194 dialysis clinics in North America, Europe, Latin America, Asia-Pacific and Africa, Fresenius Medical Care provides dialysis treatment to 169,216 patients around the globe. Fresenius Medical Care is also the world's leading provider of dialysis products such as hemodialysis machines, dialyzers and related disposable products. Fresenius Medical Care is listed on the Frankfurt Stock Exchange (FME, FME3) and the New York Stock Exchange (FMS, FMS/P).

For more information about Fresenius Medical Care visit the Company's website at www.fmc-ag.com.

Fresenius today announced that further secondary endpoint data from a phase II/III study with removab® (catumaxomab) in patients with malignant ascites confirm clear benefits for patients treated with the antibody. Trial data show that removab significantly increases time to tumor progression and has a positive influence on overall survival time. Moreover, a prolonged interval between punctures was seen in the removab group compared to the control group and this effect was also observed beyond the end of study.

The results of the randomized study include treatment data from 258 patients with malignant ascites caused by various cancers. Most patients had late-stage disease with a median life expectancy of two to three months. The primary endpoint of the study had already demonstrated that patients receiving removab had a four-fold increased puncture-free survival over a therapy with puncture alone (median 46 vs. 11 days, p<0.0001). The median time to the first therapeutic puncture, a key secondary endpoint, improved to 77 days in the removab group versus 13 days in the control group (p<0.0001). In contrast to the primary endpoint, patients who died before the next puncture were not included in this metric.

There was a clear difference between the two study arms with regard to the time to progression (TTP) of the underlying cancer. The median TTP (secondary endpoint) for the 170 patients treated with removab was 111 days, compared to 35 days for the 88 patients of the control group (p<0.0001). In the subgroup of patients with ascites from ovarian cancer, removab-treated TTP was also 111 days, compared to patients in the control group with 35 days (p=0.0002). In addition, patients with other primary cancers receiving removab also showed significant improvement in TTP, with a median of 110 days versus 34 days with puncture-therapy alone (p<0.0001).

A positive trend was also observed for overall survival. Median overall survival in the 170 patients in the removab group was 72 days, compared to 68 days of the 88 patients in the control group (p=0.0846). In a prospectively planned evaluation of 131 patients treated per protocol, a median survival advantage of 18 days was shown (removab: 86 days vs. control group: 68 days, p=0.0085). removab treatment also showed a positive influence on the overall survival of ovarian cancer patients with a median survival of 110 days over 81 days for patients receiving puncture-therapy alone (p=0.1543). In patients with gastric cancer (the largest subgroup among patients with cancers other than ovarian cancer) the median survival advantage was 27 days (71 vs. 44 days, p=0.0313).

After the primary end point of the study (puncture-free survival) was reached, the data showed that puncture intervals in patients treated with removab continued to be longer than those of the patients in the control group. The intervals between the first and second puncture were 26 and 24 days in the ovarian and non-ovarian cancer group treated with removab vs. 13 and 16 days in the control group.

Secondary study endpoints and other data collected from patients after reaching the primary endpoint confirm the benefit of removab treatment for this patient group at a late stage of their disease. Collectively, the study results further indicate the efficacy of removab in the treatment of various primary cancers. "The results of the phase II/III study show clear benefits for patients being treated with removab", says Dr. Bernhard Ehmer, President Fresenius Biotech. "The results also suggest a direct antitumor effect of the trifunctional antibody. Primary and secondary endpoints as well as post study data are consistent, and demonstrate a pronounced positive trend. They all point in the right direction and this gives us confidence in our ongoing development program for ovarian and gastric cancer."

Fresenius Biotech confirms that the submission for marketing authorization with EMEA is expected in late 2007.

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About the phase II/III study with removab
A total of 258 patients with end-stage cancer and recurrent symptomatic malignant ascites, who either no longer responded to or could no longer be treated with chemotherapy, were enrolled in this study. 129 of the patients had ovarian cancer and 129 participants had other forms of epithelial tumors (gastric 51 %, breast 10 %, pancreatic 7 %, colorectal 6 %, others 26 %). Participants in the study were randomized in a 2:1 ratio, with 170 patients randomized to treatment with removab and 88 patients to puncture therapy alone. After reaching the study endpoint 51% of patients in the control arm were also given removab (crossover). removab was administered intraperitoneally at ascending doses through infusions, following paracentesis on days 0, 3, 7, and 10. 131 patients received all four infusions of 10, 20, 50, and 150 µg.

Mode of action of trifunctional antibody removab (catumaxomab)
The therapeutic objective of trifunctional antibodies is to generate a stronger immune reaction against tumor cells. removab has two different antigen binding sites: While one arm of the antibody recognizes and binds to T-cells, the other arm binds EpCAM (epithelial cell adhesion molecule) that is overexpressed in many types of epithelial cancers. Immune effector cells with Fc receptors (macrophages, monocytes, dendritic cells and natural killer cells) can also bind the Fc region of intact trifunctional antibodies. This simultaneous binding subsequently results in the costimulation and activation of T-cells and accessory cells, enabling the generation of a strong immune response against tumor cells. Preclinical data also suggest a potential long-lasting effect to prevent cancer recurrence. Apart from removab two other trifunctional antibodies targeting other cancer antigens are currently undergoing clinical development.

Trifunctional Antibodies
Trifunctional antibodies are proteins that activate different cell types of the immune system simultaneously and target tumor cells specifically. Trifunctional antibodies therefore are very effective in destroying cancer cells and show a therapeutic effect even at very low doses. They are being developed by TRION Pharma GmbH.

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Fresenius Biotech is a company within the Fresenius health care group and is focused on the development and marketing of biopharmaceuticals in the fields of oncology, immunology and regenerative medicine. For further information please visit www.fresenius-biotech.com.

Fresenius is a health care group with international operations, providing products and services for dialysis, hospital and outpatient medical care. In 2006, group sales were about 10.8 billion. On March 31, 2007 the Fresenius Group had 107.348 employees worldwide.

Trion Pharma is a biopharmaceutical company that develops and produces trifunctional antibodies based on a globally patented technology platform together with Fresenius Biotech in Munich. For further information please visit www.trionpharma.de.

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Glossary
Puncture-free survival period: Period between the last infusion (control group: day of the puncture) and the first subsequent necessary puncture or death, which ever occurs first.

TTP (Time to Progression): Time to progression is the length of time between treatment and further growth of the primary tumor or metastases.

During the American Society of Nephrology's Renal Week 2007 additional findings from the Calcium Acetate Renagel Evaluation (CARE 2) data set were presented by Dr. Wajeh Qunibi of the University of Texas Health Science Center, San Antonio. The study showed that there are no significant differences in aortic or mitral valve calcification between hemodialysis patients treated with PhosLo and those treated with selevamer if LDL is kept at constant levels. Previous findings from the same study have already shown that there is no difference in overall cardiovascular calcification in both treatment groups. The new findings also showed that the daily calcium intake from the use of calcium acetate as a phosphate binder for one year did not contribute to the progression of cardiovascular calcification in hemodialysis patients. These conclusions are consistent with the initial CARE-2 data presented at ASN renal week 2006.

PhosLo's safety and efficacy was further validated by the results of the Dialysis Clinical Outcomes Revisited (DCOR) trial, the first interventional outcomes study published in Kidney International, November 2007. The DCOR trial clearly demonstrated that there were no statistically significant differences in the all-cause or cardiovascular mortality among 2,100 hemodialysis patients randomized to sevelamer or calcium-based phosphate binders (CBPB). Additionally, a review of the laboratory data in DCOR demonstrated that the CBPB group had significantly better serum phosphorus and intact parathyroid hormone compared to the selevamer group (p<0.01).

These findings will provide additional data on the safety of PhosLo as the Company works with the Food and Drug Administration (FDA) to expand the PhosLo label indication to chronic kidney disease (CKD) predialysis. On October 16, 2007, the FDA's Cardiovascular and Renal Drugs Advisory Committee's recommended that the FDA extend the use of phosphate binders in predialysis patients with hyperphosphatemia. This favorable vote will allow the Company to work with the FDA on the regulatory pathway to this important label extension.

Dr. Ben Lipps, Chairman of the Management Board and Chief Executive Officer commented, "This data continues to validate our goal of providing safe and effective treatments to patients with bone and mineral abnormalities by offering pharmaceutical treatments as a part of our integrated "pharmatech" therapy."

About CARE-2
The CARE-2 study was a prospective, randomized, controlled head-to-head comparison between PhosLo and sevelamer with the addition of atorvastain calcium, as appropriate, in both treatment groups to control LDL (low density lipoprotein) levels. The study found not statistically significant difference in the progression of cardiovascular calcification (CAC) between the two treatment groups after 12 months of treatment. Patients treated with PhosLo and sevelamer achieved comparable reductions in serum phosphorus and calcium-phosphorus product and even more importantly K/DOQI target levels were reached significantly faster with PhosLo.

About PhosLo
PhosLo is a calcium acetate phosphate binder for oral application in renal disease patients. Excess phosphate consumed with food is normally removed by the kidneys in a process that can only partially be replaced by dialysis in patients with chronic kidney failure. Too much phosphate in the blood can result in a number of adverse events, including bone disease, thyroid problems and vascular calcification. The risk of such damage in end-stage renal disease patients can be lowered by regularly taking phosphate binders. Currently, the phosphate binder market exceeds $500 million worldwide. PhosLo is a trademark of Fresenius Medical Care.

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Fresenius Medical Care is the world's largest integrated provider of products and services for individuals undergoing dialysis because of chronic kidney failure, a condition that affects more than 1,500,000 individuals worldwide. Through its network of 2,221 dialysis clinics in North America, Europe, Latin America, Asia-Pacific and Africa, Fresenius Medical Care provides dialysis treatment to 172,227 patients around the globe. Fresenius Medical Care is also the world's leading provider of dialysis products such as hemodialysis machines, dialyzers and related disposable products. Fresenius Medical Care is listed on the Frankfurt Stock Exchange (FME, FME3) and the New York Stock Exchange (FMS, FMS/P).

For more information about Fresenius Medical Care visit the Company's website at www.fmc-ag.com.

Fresenius Biotech has dispatched the marketing authorization application for the trifunctional antibody Removab (INN: catumaxomab) in patients with malignant ascites to the European Medicines Agency (EMEA) as planned. The company applies for the EU authorization of Removab for the intraperitoneal treatment of malignant ascites in patients with epithelial cancers where no standard therapy is available or no longer feasible. The results of the phase II/III pivotal study announced in December 2006 as well as in March and July 2007 are an essential part of the marketing authorization application. In addition to the clinical results, the application contains preclinical data as well as production and product quality information. The scientific assessment of the marketing authorization application will start in early 2008 after the completion of the validation by EMEA.

Dr. Ulf M. Schneider, Chairman of the Management Board of Fresenius SE, commented: "The marketing authorization application for our Removab antibody is an important milestone for Fresenius Biotech. The results of the phase II/III pivotal study show clear benefits for patients treated with Removab. We believe that Removab could become a new therapy option for malignant ascites. We are encouraged to continue our Removab clinical trial program and will focus on applications in solid tumors."

Trifunctional Antibodies
Trifunctional antibodies are proteins that activate different cell types of the immune system simultaneously and direct these to the tumor cells by a targeted approach. Trifunctional antibodies therefore are very effective in destroying cancer cells and show a therapeutic effect even at very low doses. They are being developed by TRION Pharma GmbH.

Mode of action of trifunctional antibody removab (catumaxomab)
The therapeutic objective of trifunctional antibodies is to generate a stronger immune reaction against tumor cells. removab has two different antigen binding sites: While one arm of the antibody recognizes and binds to T-cells, the other arm binds EpCAM (epithelial cell adhesion molecule) that is overexpressed in many types of epithelial cancers. Immune effector cells with Fc receptors (macrophages, monocytes, dendritic cells and natural killer cells) can also bind the Fc region of intact trifunctional antibodies. This simultaneous binding subsequently results in the costimulation and activation of T-cells and accessory cells, enabling the generation of a strong immune response against tumor cells. Preclinical data also suggest a potential long-lasting effect to prevent cancer recurrence. Apart from removab two other trifunctional antibodies targeting other cancer antigens are currently undergoing clinical development.

Fresenius Biotech is a company within the Fresenius health care group and is focused on the development and marketing of biopharmaceuticals in the fields of oncology, immunology and regenerative medicine. For further information please visit www.fresenius-biotech.com.

Fresenius is a health care group with international operations, providing products and services for dialysis, hospital and outpatient medical care. In 2006, group sales were approx. € 10.8 billion. On September 30, 2007 the Fresenius Group had 110,379 employees worldwide.

TRION Pharma is a biopharmaceutical company that develops and produces trifunctional antibodies based on a globally patented technology platform together with Fresenius Biotech in Munich. For further information please visit www.trionpharma.de.

Using Online Hemodiafiltration (HDF) to treat patients with chronic kidney failure can lead to a significantly lower risk of mortality compared to treatment with standard hemodialysis. A study has just been presented during the European Dialysis and Transplantation Association (EDTA) / European Renal Association (ERA) Congress in Istanbul and shows that the mortality rate among patients that received Online-HDF treatment was 35% lower than that of patients receiving conventional hemodialysis therapy. Data were gathered over a one-year period from more than 2,500 patients in 56 European dialysis clinics of Fresenius Medical Care.

The study provides substantial scientific evidence that the treatment method can significantly reduce the mortality of patients with chronic renal failure. Following the positive results, Fresenius Medical Care now expects an increase in demand for online-HDF, which is already considered the best possible treatment because of its ability to remove a wider range of toxins from the blood of patients with chronic kidney failure. Fresenius Medical Care offers Online-HDF since 1996 through a module for the 4008 dialysis machine and is now included as standard equipment in the new 5008 therapy system, which was launched in Istanbul.

"Online-HDF is gradually establishing itself as an advanced and innovative treatment modality in dialysis. It significantly improves life expectancy and the quality of life of patients," said Emanuele Gatti, Fresenius Medical Care Management Board Member for Europe, Latin America, Middle East and Africa.

According to a South Korean study now published in the journal Peritoneal Dialysis International (Vol 25, pp 248-255), patients live significantly longer if they use the PD solution balance developed by Fresenius Medical Care rather than conventional fluids. More than 1,100 patients were included in the retrospective analysis. This is the largest analysis on survival comparing conventional and new, more biocompatible PD solutions.

The researchers compared 611 patients treated with balance and 551 patients who received treatment with conventional dialysis fluid. The follow up period was up to 30 months. When treated with biocompatible balance, the relative mortality risk was reduced by 25% compared to conventional high quality treatment (also from Fresenius Medical Care). Differences in age or sex of the patients between both groups were taken into account.

The biocompatible dialysis fluid balance has a neutral pH and has extremely low levels of glucose degradation products (GDPs) compared to conventional PD fluids. A randomized, prospective multicenter study published in the journal Kidney International in 2004 (Vol. 66, pp. 408-418) demonstrated that the biocompatible dialysis fluid balance had less negative impact on the mesothelial cells of the peritoneum and in addition better preserves residual renal function. The positive impact of residual renal function on patient survival has been demonstrated already in clinical studies and is a key indicator of positive survival outcomes.

This relationship could be the reason for the better survival of patients treated with balance. "This study, for the first time, suggests that treatment with a novel biocompatible peritoneal dialysis fluid confers a significant survival advantage," says Professor Ho Yung Lee from the Department of Internal Medicine, Yonsei University College of Medicine in Seoul.

South Korea is one of the countries with the highest number of peritoneal dialysis patients. Worldwide, about 150.000 patients are treated with this therapy. In peritoneal dialysis, which is one of two methods of treatment for patients with chronic kidney failure, the peritoneum serves as a dialysis membrane. Using a surgically implanted catheter, dialysis fluid is introduced into the peritoneal cavity and removed from it after a while. Toxins and surplus water, the latter with the help of the osmotic activity of glucose, are being moved through the peritoneum into the fluid and thus removed from the blood.
 

Fresenius Biotech today announced a Removab® distribution agreement with Swedish Orphan Biovitrum (Sobi). Under the seven-year agreement, Sobi will distribute the trifunctional antibody Removab® exclusively in 15 European countries. The markets covered by the agreement include Bulgaria, the Czech Republic, Denmark, Estonia, Finland, Iceland, Latvia, Lithuania, Norway, Poland, Romania, Slovakia, Slovenia and Sweden. Removab® was granted marketing authorization by the European Commission in April 2009 for the treatment of malignant ascites associated with cancer and so far has been launched in Germany, Austria and France.

"The agreement with Sobi is part of our strategy to complement our own marketing and sales activities with strong partnerships in additional regions. More patients now will be able to benefit from Removab®," said Christian Schetter, CEO of Fresenius Biotech. "Removab® is an innovative product that holds great value for patients with severe medical needs. We are looking forward to the Fresenius Biotech partnership and the additional growth potential Removab® will provide for our business," said Kennet Rooth, CEO of Sobi.

About Removab® (catumaxomab)
Removab® is a trademark registered by Fresenius Biotech GmbH. It is the first drug worldwide with a regulatory label for the treatment of malignant ascites. Removab® is a trifunctional antibody licensed from TRION Pharma GmbH. The therapeutic objective of Removab® is to generate a strong immune reaction against cancer cells, resulting in their elimination.

EU approval is based on results of a large-scale international phase II/III pivotal study which demonstrated a statistically significant fourfold increase in puncture-free survival over a therapy with puncture alone. Removab® effectively destroys cancer cells in the peritoneal cavity and therefore attacks the primary cause of ascites formation. In addition, the results of the study indicate a positive impact on overall survival.

Removab® is approved for the treatment of malignant ascites in patients with EpCAM (Epithelial Cell Adhesion Molecule)-positive carcinomas, where standard therapy is not available or no longer feasible.

EpCAM is a tumor-associated antigen expressed on the vast majority of carcinomas (epithelial tumors). Furthermore, the majority of carcinoma-induced malignant ascites contain EpCAM-positive tumor cells. In healthy tissue, EpCAM is not accessible to binding, which makes it an attractive antigen for tumor-specific targeting.

About malignant ascites
Malignant ascites can be caused by various carcinomas. It is most common in ovarian, pancreatic and gastric cancers, with an incidence of 20 to 50 percent of all cases. Abdominal spread of cancer cells leads to an accumulation of fluid in the abdominal cavity and is associated with a poor prognosis. Malignant ascites develops late in the course of cancer disease and has a strong impact on the patient's quality of life. The most common treatment of malignant ascites is puncture (paracentesis), which must be performed repeatedly and can lead to complications such as infection and fluid or protein deprivation.

Fresenius Biotech is the first company in Germany to receive Paul-Ehrlich-Institut approval to use a polyclonal antibody in stem cell transplantations. As a result, the preparation - ATG-Fresenius S - can be used in the indication "prophylaxis of graft-versus-host disease (GVHD) for unrelated stem cell transplant donors in adults." Germany is now the fourth country to approve the preparation in this indication, after Argentina, Portugal and Thailand.

"The preparation's special mode of action and a steadily growing pool of unrelated donors make the application of ATG-Fresenius S in stem cell transplantations particularly attractive," said Dr. Christian Schetter, CEO of Fresenius Biotech. "Furthermore, there has been a considerable recent increase in the incidence of hematologic diseases which can be treated with stem cell transplantations."

In a randomized, multi-center prospective study with 201 patients, the efficacy and tolerability of ATG-Fresenius S in GVHD prophylaxis was assessed in unrelated donor stem cell transplantations. This study compared ATG-Fresenius S in combination with standard GVHD prophylaxis versus standard GVHD prophylaxis alone. Study results show that the acute and chronic GVHD rate could be reduced significantly following administration of ATG-Fresenius S. The results of this study were first presented in 2008 at the annual meeting of the American Society of Hematology and published in September 2009 in the Lancet Oncology* medical journal.

*Finke J et al., Standard graft-versus-host disease prophylaxis with or without anti-T-cell globulin in haematopoietic cell transplantation from matched unrelated donors: a randomised, open-label, multicentre phase 3 trial, Lancet Oncology 2009;10:855-864

About ATG-Fresenius S
ATG-Fresenius S is a polyclonal antibody that is used for GVHD prophylaxis shortly before stem cell transplantation is performed. The preparation's mode of action, which mainly targets activated T-cells, includes complement-mediated cytolysis and apoptotic induction of T-cells and antigen-presenting cells.
ATG-Fresenius S prevents the adhesion of T-cells to the endothelium, minimizes T-cell infiltration and blocks numerous signal transmission paths within the immune system. Furthermore, ATG-Fresenius S has a propagating effect on regulatory cells. A direct anti-tumor effect is described in various hematologic tumors.
The polyclonal antibody ATG-Fresenius S was developed in Germany over 30 years ago for the treatment and prophylaxis of acute rejection reactions in the transplantation of solid organs. ATG-Fresenius S has been approved for use in these indications worldwide in more than 45 countries.

About GVHD (graft-versus-host disease)
GVHD is a frequent complication of stem cell transplantation, which is associated with a high degree of morbidity and mortality. GVHD is an immunological reaction of the donor lymphocytes to the patient's foreign antigens. The following GVHD risk factors are known: the patient's age, the degree of kinship between the donor and the recipient, the type of preparation used for stem cell transplantation as well as the source of the graft. Several components contribute to GVHD's development, among others, tissue damage during preparations for stem cell transplantation, cytokine production and lymphocyte activation. Various immune cells (T-cells, antigen-presenting cells and natural killer cells) are involved in the GVHD mechanism. GVHD frequently causes severe organ and tissue damage, which can become chronic to some extent. GVHD can affect any organ or tissue; the skin, stomach, intestines, liver and the immune system are most frequently attacked. One of the strategies for GVHD reduction is T-cell depletion. ATG-Fresenius S depletes T-cells and consequently represents an important therapeutic advance in GVHD prevention.

Fresenius Medical Care AG & Co. KGaA ("the company" or "Fresenius Medical Care"), the world's largest provider of dialysis products and services, announced today that the U.S. Agency for Healthcare Research and Quality (AHRQ) officially recognized the company's Patient Safety Organization (PSO). The certification by the U.S. Secretary of the Department of Health and Human Services, the first for a dialysis organization, furthers Fresenius Medical Care's mission of continuously improving patient safety and health care quality.

The purpose of a PSO is to establish a framework by which doctors and other health care providers may voluntarily report information to PSOs, on a privileged and confidential basis, to collect and analyze patient safety events. Regulations outline how the PSO may utilize data and act as a resource for health care providers to understand and minimize the risks and hazards in delivering patient care. A PSO's workforce must have expertise in analyzing patient safety events, such as the identification, analysis, prevention, and reduction or elimination of the risks and hazards associated with the delivery of patient care.

Michael Lazarus, M.D., director of the Fresenius Medical Care Patient Safety Organization: "Each of our more than 1,800 kidney dialysis clinics in the U.S. has a Quality Improvement Committee that investigates the root causes of all patient adverse events, with the objective of continuous improvement in patient safety and quality of care. Our companywide Patient Safety Organization performs a more global root cause analysis of aggregate data. We do this to maximize safe conditions in our facilities and to provide the safest dialysis treatments possible. When we find unsafe situations or processes that lead to errors, it is important to change our approach and to educate the staff as well as the patients about any unsafe conditions so that together we can eliminate them."