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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.

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Head of Corporate Communications
T +49 (0) 6172 608-96008
pr-fre@fresenius.com

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Q1 2011:

• Sales: €4.0 billion, +9% at actual rates, +7% in constant currency
• EBIT: €575 million, +15% at actual rates, +13% in constant currency
• Net income*: €170 million, +43% at actual rates, +39% in constant currency

• Group raises 2011 outlook for sales and earnings* growth
• Fresenius Medical Care and Fresenius Kabi raise 2011 outlook
• Fresenius Helios – narrows earnings guidance to upper half of range
• Fresenius Vamed fully confirms guidance

Ulf Mark Schneider, CEO of Fresenius, commented: „After record results in 2010, we are pleased to report strong sales and earnings growth for the first quarter of 2011. All of our business segments had an excellent start. We have seen particularly strong growth at Fresenius Kabi in North America, where we continue to benefit from successful product launches and supply constraints in the injectable drugs market. Based on Fresenius Kabi's prospects, Fresenius Medical Care's successful implementation of the ESRD prospective payment system in the United States and Fresenius Helios' strong earnings development, we raise our Group's sales and earnings guidance for 2011."

For 2011, Fresenius Group now expects sales growth of 7% to 8% and net income growth of 12% to 16%, both in constant currency. Previously, the company expected sales growth of ≥7% and net income growth of 8% to 12%, both in constant currency.

The Group plans to invest approximately 5% of sales in property, plant and equipment.

The net debt/EBITDA ratio is expected to stay in the range of 2.5 to 3.0.

*Net income attributable to Fresenius SE & Co. KGaA; adjusted for the effects of mark-to-market accounting of the Mandatory Exchangeable Bonds (MEB) and the Contingent Value Rights (CVR) related to the acquisition of APP Pharmaceuticals. Both are non-cash items.

Strong organic sales growth
Group sales increased by 9% (7% in constant currency) to €3,962 million (Q1 2010: €3,643 million). Organic sales growth was 6%. Acquisitions contributed a further 1%. Currency translation had a positive effect of 2%.

Sales growth in the business segments was as follows:



Organic sales growth was 5% in North America and 2% in Europe. Prior year sales in Europe were positively influenced by Fresenius Vamed's large medical supply contract to the Ukraine. Organic sales growth reached 13% in Latin America, 18% in Asia-Pacific and 28% in Africa.



Excellent earnings growth
Group EBITDA increased by 13% (12% in constant currency) to €737 million (Q1 2010: €650 million). Group EBIT increased by 15% (13% in constant currency) to €575 million (Q1 2010: €501 million). The EBIT margin increased to 14.5% (Q1 2010: 13.8%).

Group net interest improved to -€135 million (Q1 2010: -€143 million).

The other financial result was -€62 million and includes valuation changes of the fair redemption value of the Mandatory Exchangeable Bonds (MEB) of -€67 million and the Contingent Value Rights (CVR) of €5 million. Both are non-cash items. The CVR were delisted in March 2011. The MEB will come to maturity in August 2011.

The Group tax rate* was 30.7% (Q1 2010: 33.2%). The prior year was impacted by non-tax deductible charges related to the devaluation of the Venezuelan Bolivar.
Noncontrolling interest increased to €135 million (Q1 2010: €120 million), of which 93% was attributable to the noncontrolling interest in Fresenius Medical Care.

Group net income** increased by 43% (39% in constant currency) to €170 million (Q1 2010: €119 million). Earnings per ordinary share increased by 41% to €1.05. A reconciliation to adjusted earnings according to U.S. GAAP can be found on page 14 of the pdf of this Press Release.

Group net income*** (including special items) reached €128 million or €0.79 per ordinary share.

*Adjusted for the effect of mark-to-market accounting of the Mandatory Exchangeable Bonds (MEB) related to the acquisition of APP Pharmaceuticals
**Net income attributable to Fresenius SE & Co. KGaA; adjusted for the effects of mark-to-market accounting of the Mandatory Exchangeable Bonds (MEB) and the Contingent Value Rights (CVR) related to the acquisition of APP Pharmaceuticals. Both are non-cash items.
***Net income attributable to Fresenius SE & Co. KGaA

Continued investments in growth
The Fresenius Group spent €136 million on property, plant and equipment (Q1 2010: €124 million). Acquisition spending was €311 million (Q1 2010: €81 million), mainly due to acquisitions at Fresenius Medical Care.

Cash flow development
Operating cash flow was €278 million (Q1 2010: €438 million). Strong earnings growth was more than offset by increased DSOs (days sales outstanding), primarily related to the introduction of the new Medicare end-stage renal disease prospective payment system in the U.S. dialysis service business, and raised inventory levels. The cash flow margin was 7.0% (Q1 2010: 12.0%). Net capital expenditure increased to €147 million (Q1 2010: €130 million). Free cash flow before acquisitions and dividends was €131 million (Q1 2010: €308 million). Free cash flow after acquisitions and dividends was -€133 million (Q1 2010: €218 million).

Solid balance sheet structure
The Group's total assets were €23,572 million (Dec. 31, 2010: €23,577 million). In constant currency, the increase was 4%. Current assets increased by 6% (9% in constant currency) to €6,808 million (Dec. 31, 2010: €6,435 million). Non-current assets were €16,764 million (Dec. 31, 20010: €17,142 million). In constant currency, the increase was 2%.

Total shareholders' equity decreased by 1% to €8,788 million (Dec. 31, 2010: €8,844 million). In constant currency, the increase was 4%. The equity ratio was 37.3% (Dec. 31, 2010: 37.5%).

Group debt remained almost unchanged (4% growth in constant currency) at €8,823 million (Dec. 31, 2010: €8,784 million). Net debt decreased by 1% to €7,929 million (Dec. 31, 2010: €8,015 million). In constant currency, net debt increased by 3%.

The net debt/EBITDA ratio improved to 2.52 as of March 31, 2011 (Dec. 31, 2010: 2.62).

Number of employees increased
As of March 31, 2011, Fresenius Group increased the number of its employees by 2% to 140,111 (Dec. 31, 2010: 137,552).

Fresenius Biotech
Fresenius Biotech develops innovative therapies with trifunctional antibodies for the treatment of cancer. In the field of polyclonal antibodies, Fresenius Biotech has successfully marketed ATG-Fresenius S for many years. ATG-Fresenius S is an immunosuppressive agent used to prevent and treat graft rejection following organ transplantation.

Fresenius Biotech sales increased by 16% to €7.3 million in the first quarter 2011 (Q1 2010: € 6.3 million). The immunosuppressive agent ATG contributed €6.5 million and the trifunctional antibody Removab (catumaxomab) €0.8 million to sales.

In March 2011, Fresenius Biotech received Paul-Ehrlich-Institut approval to use a polyclonal antibody in stem cell transplantations. As a result, ATG-Fresenius S now can be used in the indication "prophylaxis of graft-versus-host disease (GVHD) for unrelated stem cell transplant donors in adults".

In addition, reimbursement negotiations for Removab in Italy were successfully concluded.

In the first quarter of 2011, Fresenius Biotech's EBIT was -€7 million (Q1 2010: -€8 million). For 2011, Fresenius Biotech expects an EBIT of about -€30 million.


Business Segments

Fresenius Medical Care
Fresenius Medical Care is the world's leading provider of services and products for patients with chronic kidney failure. As of March 31, 2011, Fresenius Medical Care was treating 216,942 patients in 2,769 dialysis clinics.

• Strong start into the year – despite the impact of the new Medicare prospective payment system in the U.S.
• Outlook 2011 raised: Sales above US$13 billion and net income* of US$1,070 million to US$1,090 million

Fresenius Medical Care achieved sales growth of 5% to US$3,036 million (Q1 2010: US$2,882 million). Organic growth was 3%, acquisitions contributed a further 2%.

Sales in dialysis service increased by 5% to US$2,285 million (Q1 2010: US$2,171 million). Dialysis product sales grew by 6% to US$751 million (Q1 2010: US$711 million).

In North America, sales increased by 1% to US$1,977 million (Q1 2010: US$1,960 million). Dialysis services sales increased by 1% to US$1,782 million. Average sales per treatment for U.S. clinics decreased to US$348 in the first quarter of 2011 compared to US$355 for the corresponding quarter in 2010 as a result of the implementation of the new Medicare end-stage renal disease prospective payment system. Dialysis product sales were US$195 million (Q1 2010: US$200 million).

Sales outside North America ("International" segment) grew by 14% to US$1,055 million (Q1 2010: US$922 million). Sales in dialysis services increased by 23% to US$503 million. Dialysis product sales increased by 8% to US$552 million, mainly driven by higher sales of peritoneal dialysis products, dialyzers, bloodlines and products for acute care treatments.

EBIT increased by 5% to US$445 million (Q1 2010: US$425 million) resulting in an EBIT margin of 14.7% (Q1 2010: 14.8%).

In North America, the EBIT margin increased to 15.8% (Q1 2010: 15.7%). The favorable development of pharmaceutical costs was largely offset by the effects of the implementation of the new Medicare end-stage renal disease prospective payment system in the U.S.

In the International segment, the EBIT margin was 16.2% (Q1 2010: 16.4%).

Net income* increased by 5% to US$221 million (Q1 2010: US$211 million).

On March 8, 2011, Fresenius Medical Care announced the acquisition of all assets of Hema Metrics LLC related to its Crit-Line® system. Based on its strong dialysis product business and sales organization, Fresenius Medical Care intends to establish this technology as the standard of care for fluid and anemia management in the North American market.

Based on the strong financial results in the first quarter of 2011 and the elimination of the "transition adjustment" imposed on dialysis facilities (as part of the new Medicare end-stage renal disease prospective payment system) in the U.S., the company raises its outlook for the full year 2011. Fresenius Medical Care now projects sales of more than US$13 billion. Previously, the company expected sales between US$12.8 billion and US$13.0 billion. Net income* is now expected between US$1,070 million and US$1,090 million. Previously, Fresenius Medical Care expected net income between US$1,035 million and US$1,055 million.

For further information, please see Fresenius Medical Care's press release at www.fmc-ag.com.

*Net income attributable to Fresenius Medical Care AG & Co. KGaA


Fresenius Kabi
Fresenius Kabi offers infusion therapies, intravenously administered generic drugs and clinical nutrition for seriously and chronically ill patients in the hospital and outpatient environments. The company is also a leading supplier of medical devices and transfusion technology products.

• Excellent first quarter – Outstanding organic sales growth of 16%
• Outlook 2011 raised: Organic sales growth >5% on top of challenging 2010 base - EBIT margin between 19% and 20%

Fresenius Kabi had a very successful start into 2011. Strong sales and earnings growth was mainly driven by continued high demand in North America. Product launches as well as continued supply constraints in the injectable drug market which had expanded in March 2010 had a positive effect. Moreover, Fresenius Kabi achieved excellent organic sales growth of 10% outside of North America.

Sales increased by 20% to €960 million (Q1 2010: €800 million). Organic growth was excellent and increased by 16%. Acquisitions contributed 1%. Currency translation had a positive effect of 3%, mainly attributable to the strength of the currencies in China, Brazil and Australia against the Euro.

In Europe, sales grew by 10% to €449 million (Q1 2010: €409 million), driven by strong organic growth of 8%. In North America, sales increased by 42% to €254 million (Q1 2010: €179 million). Organic sales growth was an exceptional 39%. In Asia-Pacific, Fresenius Kabi achieved sales growth of 22% to €156 million (Q1 2010: €128 million), driven by organic sales growth of 16%. Sales in Latin America and Africa increased by 20% to €101 million (Q1 2010: €84 million) with organic sales growth contributing 13%.

EBIT grew by 36% to €197 million (Q1 2010: €145 million). The EBIT margin improved significantly to 20.5% (Q1 2010: 18.1%), mainly driven by the strong development in North America.

Net interest improved to -€68 million (Q1 2010: -€74 million).

Net income* increased by 89% to €87 million (Q1 2010: €46 million).

Fresenius Kabi's operating cash flow was €67 million (Q1 2010: €74 million). The cash flow margin was 7.0% (Q1 2010: 9.3%). Cash flow before acquisitions and dividends was €22 million (Q1 2010: €42 million).

Fresenius Kabi raises its outlook for 2011 and forecasts organic sales growth of >5%. Previously, organic sales growth of approximately 5% was expected. Furthermore, Fresenius Kabi expects an EBIT margin of 19% to 20% with net income* surpassing 2010 earnings. Previously, an EBIT margin of >19% was projected.

Special items relating to the acquisition of APP Pharmaceuticals are included in the segment "Corporate/Other".

*Net income attributable to Fresenius Kabi AG


Fresenius Helios
Fresenius Helios is one of the largest private hospital operators in Germany. HELIOS Kliniken Group owns 63 hospitals, including five maximum care hospitals in Berlin-Buch, Erfurt, Krefeld, Schwerin and Wuppertal. HELIOS treats more than 2 million patients per year, thereof ~600,000 inpatients, and operates a total of more than 18,500 beds.

• Strong organic sales growth of 5% continued
• Excellent earnings growth – EBIT margin improved to 9.0%
• Outlook 2011 – EBIT guidance narrowed to upper half of range

Sales increased by 7% to €648 million (Q1 2010: €608 million). Organic sales growth was 5%, mainly driven by an increase in hospital admissions. Acquisitions contributed 2% to overall sales growth, due to the consolidation of St. Marienberg hospital in Helmstedt / Lower Saxony with 267 beds.

EBIT grew by 12% to €58 million (Q1 2010: €52 million). The EBIT margin improved to 9.0% (Q1 2010: 8.6%).

The established clinics increased sales by 5% to €639 million. EBIT improved by 12% to €58 million. The EBIT margin was at 9.1%.

Net income* increased by 18% to €33 million (Q1 2010: €28 million).

In the first quarter of 2011, Fresenius Helios announced the acquisition of the municipal hospital in Rottweil, southwestern Germany. The 264-bed acute care clinic has approximately 600 employees and generated sales of approximately €31 million in 2009. The acquisition has been already approved by the German anti-trust authorities. Helios expects to close the transaction in the third quarter of 2011.

Fresenius Helios fully confirms its outlook for 2011. The company expects organic sales growth of 3% to 5%. EBIT is projected to increase to €250 million to €260 million; the company expects to achieve the upper half of this range.

*Net income attributable to HELIOS Kliniken GmbH


Fresenius Vamed
Fresenius Vamed offers engineering and services for hospitals and other health care facilities.
 

• €842 million order backlog – new all-time high
• Sales and earnings fully in line with our expectations
• Outlook 2011 fully confirmed

Fresenius Vamed's sales reached €140 million (Q1 2010: €156 million). Sales in the project business were €84 million (Q1 2010: €102 million). Prior year sales included a substantial medical supply contract with the Ukraine. Sales in the service business increased by 4% to €56 million (Q1 2010: €54 million).

Fresenius Vamed achieved an EBIT of €5 million (Q1 2010: €7 million). The EBIT margin was 3.6%. Net income* was €4 million (Q1 2010: €6 million).

As of March 31, 2011, order backlog increased by 5% to a new all-time high of €842 million (Dec. 31, 2010: €801 million), driven by strong order intake of €127 million (Q1 2010: €260 million). Order intake includes a €67 million project to build a private health care facility in the Ukraine and a €29 million medical equipment contract for the National Cancer Institute in Malaysia.

Fresenius Vamed fully confirms its 2011 outlook and expects to achieve both sales and EBIT growth between 5% and 10%.

*Net income attributable to VAMED AG

Conference Call and Audio Webcast
As part of the publication of the results for the first quarter of 2011, a conference call will be held on May 4, 2011 at 2.00 p.m. CET (8.00 a.m. EST). You are cordially invited to follow the conference in a live broadcast over the Internet at www.fresenius.com, see Press, Audio/Video Service. Following the meeting, a recording of the conference will be available as video-on-demand.

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After record results in 2010, Fresenius expects another outstanding year in 2011. At the company's annual general meeting held today in Frankfurt am Main, Ulf Mark Schneider, CEO of Fresenius, fully confirmed the Group outlook raised in early May following an excellent start into the current fiscal year: Sales are expected to increase by 7% to 8% in constant currency. Net income* is expected to increase by 12% to 16% in constant currency. Schneider also confirmed the Group's mid-term net income target of more than €1 billion in 2014. "This is an ambitious goal. Based on €660 million in net income in 2010, we have to accomplish compounded annual net income growth of 11% over the next four years," Schneider said.

Fresenius anticipates particularly strong growth due to rising demand for health care in emerging markets: "In the Asia-Pacific and Latin American regions, Fresenius maintains an extensive production and distribution network that ensures our competitiveness. Our goal is to increase sales by more than €1 billion to more than €3 billion in 2013."

At the annual general meeting, a 99.99% majority of Fresenius SE & Co. KGaA's shareholders approved the 18th consecutive dividend increase proposed by the general partner and the supervisory board. Shareholders will receive €0.86 per share (2009: €0.75). This is an increase of 15%.

In addition, with a majority of over 96%, shareholders approved a resolution on the cancellation of existing Authorized Capitals I to V and the creation of new Authorized Capital I of up to €40.32 million.

A shareholder majority of over 99% approved the actions of both the management and supervisory boards for the 2010 fiscal year.

At the annual general meeting, 76% of the subscribed capital was represented.

*Net income attributable to Fresenius SE & Co. KGaA; adjusted for the effects of mark-to-market accounting of the Mandatory Exchangeable Bonds (MEB) and the Contingent Value Rights (CVR) related to the acquisition of APP Pharmaceuticals. Both are non-cash items.

Contact

Head of Corporate Communications
T +49 (0) 6172 608-96008
pr-fre@fresenius.com

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Fresenius Biotech has received approval from the Austrian Federal Office for Safety in Health Care for the use of a polyclonal antibody in stem cell transplantations (SCT). The preparation - ATG-Fresenius S - can be used in the indication "conditioning prior to SCT for prevention of graft-versus-host disease (GVHD) after SCT". The approval is based on proof of significantly fewer GVHD complications following administration of ATG-Fresenius S. Austria is now the fifth country to approve the preparation in this indication, after Germany, Argentina, Portugal and Thailand.

According to the approval, ATG-Fresenius S may be used to treat adult patients with malignant hematologic diseases who undergo SCT involving HLA-compatible, unrelated donors. In such cases, ATG-Fresenius S is administered in combination with standard GVHD prophylaxis. The approval is based on results of a prospective, randomized, multi-center study of HLA-compatible unrelated SCT with 201 patients. The study compared the efficacy and tolerability of ATG-Fresenius S in combination with standard GVHD prophylaxis versus standard GVHD prophylaxis alone. One-year data were published in October 2009 in "The Lancet Oncology" medical journal (Finke et al.)*.

New long-term data were published in April 2011 in the "Blood" medical journal (Socie et al.)**. With regard to acute GVHD grade III-IV, study results showed a significantly reduced incidence of 11.7% vs. 25.5% (p=0.0392) in ATG-Fresenius S and non-ATG-Fresenius S groups, respectively. The extensive chronic GVHD rate was significantly lower in ATG-Fresenius S patients, compared with the control group (12.2% vs. 45%; p<0.0001). The probability of survival without systemic immunosuppression therapy was three times higher in the ATG-Fresenius S group. Relapse of underlying malignant disease, mortality and overall survival were comparable between both groups.

*Finke 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
**Socie et al., Chronic graft-versus-host disease: long-term results from a randomized trial on GvHD prophylaxis with or without anti-T-cell globulin ATG-fresenius, Blood, published April 5, 2011, 10.1182/Blood-2011-01-329821

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.

Contact

Head of Corporate Communications
T +49 (0) 6172 608-96008
pr-fre@fresenius.com

Documents

Text as PDF document (PDF, 50 KB)

At the 47th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago (June 3-7, 2011), Fresenius Biotech presented new data on the trifunctional antibody Removab® with 11 contributions.

Significant overall survival benefit in patients with higher relative lymphocyte count
Follow-up results for the pivotal study in patients with malignant ascites show a statistically significant benefit in overall survival for Removab®-treated patients (p=0.0219, HR=0.649). The six-month survival rate in Removab®-treated patients was more than four times higher compared to control patients (28.9% vs. 6.7%). A higher baseline-relative lymphocyte count (RLC) had a significant impact on overall survival. In patients with a RLC >13%, the six-month survival rate with Removab® was more than seven times higher than in control patients (37.0% vs. 5.2%), leading to a mean overall survival benefit of 131 days (p=0.0072, HR=0.518). The RLC was previously identified as a biomarker in an independent hypothesis-generating study.

Removab® improves quality of life in patients with malignant ascites
In addition to improving overall survival, Removab®-treated patients were shown to have an improved quality of life (QoL). Analysis of pivotal trial data using the EORTC QLQ-C30 questionnaire showed a significantly higher percentage of patients with improvement in QoL scores at day 30. This effect appeared consistently across multiple scores. While nearly all (97%) patients treated with Removab® at least maintained their QoL level ("Global QoL score"), 30% of patients in the control group had a rapid deterioration in QoL within the first 30 days.

Integrated safety analysis supports shorter infusion time
A shorter infusion time of 3 hours for Removab® is supported by new results from an integrated safety analysis. Based on this analysis, the safety profile of Removab® after a more tolerable and convenient 3-hour infusion was largely comparable to the currently approved 6-hour infusion time.

# # #

About Removab® (catumaxomab)
Removab®, with its trifunctional mode of action, represents the first antibody of a new generation. The therapeutic objective of Removab® is to generate a stronger immune response to cancer cells that are the main cause of ascites. Removab® binds to three different cell types simultaneously: One arm of the antibody binds to the EpCAM (epithelial cell adhesion molecule) antigen on carcinoma cells, another arm binds to CD3 on T cells. Thirdly, the intact Fc region of Removab® binds to Fc-gamma receptors on accessory cells (such as macrophages, monocytes, dendritic cells and natural killer cells). This simultaneous binding subsequently results in the mutual stimulation and activation of T cells and accessory cells, enabling the generation of a stronger immune response and destruction of cancer cells. Data from animal studies with trifunctional antibodies also suggest a potential long-lasting effect to prevent cancer recurrence. Removab® is under further development for new indications. Catumaxomab (Removab®) is a trifunctional antibody developed by TRION Pharma GmbH.

Removab® has been approved in the European Union since April 2009 for intraperitoneal treatment of malignant ascites in patients with EpCAM-positive carcinomas where standard therapy is not available or no longer feasible.
Fresenius Biotech is responsible for the clinical development and commercialization of Removab®.

For more information, please visit www.removab.com.

About the pivotal study
The study involved 258 patients with malignant ascites due to various carcinomas. Of those, 129 suffered from ovarian cancer, while another 129 had other types of cancer. Patients received paracentesis followed by four intraperitoneal infusions of Removab®, or paracentesis alone (control group). Details of the study results are published by Heiss et al, Int J Cancer 2010;127:2209–21

About Biomarker
A characteristic that is objectively measured and evaluated as an indicator of normal biological processes, a pathogenic process, or pharmacologic responses to a therapeutic intervention.

About relative lymphocyte count (RLC)
The relative lymphocyte count describes the percentage of lymphocytes among the total of leukocytes in the peripheral blood.

About epithelial cell-adhesion molecule (EpCAM)
EpCAM is a tumor-associated antigen expressed on the vast majority of epithelial tumors. EpCAM is expressed on tumor cells in the ascites fluid of patients with EpCAM-positive tumors.

About malignant ascites
Malignant ascites can be caused by various kinds of tumors. The peritoneal spread of tumor cells leads to an accumulation of fluid in the peritoneal cavity and is associated with an unfavorable prognosis for the patient. The most common method of treatment is paracentesis, which generally must be repeated at intervals of one to two weeks and can lead to complications such as infections or elevated losses of fluids and proteins. Removab® destroys the peritoneal cancer cells and thus directly attacks the cause of malignant ascites.

About EORTC QLQ-C30
The EORTC QLQ-C30 is a quality of life questionnaire designed for use in a wide range of cancer patients. It is an accepted and valid measure of QoL in cancer patients. The EORTC QLQ-C30 has been translated into and validated in more than 80 different languages.

Contact

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The Italian Medicines Agency, AIFA, has added Fresenius Biotech's antibody Removab® to its list of reimbursable medications. As of June 25, 2011, use of Removab® for the treatment of malignant ascites in patients with EpCAM-positive carcinomas will be fully reimbursed. Removab® is a trifunctional monoclonal antibody approved throughout the European Union. It has been launched in Austria, France, Germany, Scandinavia and the UK.

"The positive decision concerning reimbursement is another step in the successful implementation of our European marketing strategy for Removab®," said Dr. Christian Schetter, CEO of Fresenius Biotech. "It enables patients in Italy to benefit from treatment with Removab® quickly and without bureaucratic hurdles."

Follow-up results for the pivotal study, recently presented at the 47th Annual Meeting of the American Society of Clinical Oncology (ASCO), showed a statistically significant benefit in overall survival for Removab®-treated patients. After six months, nearly 30% of all patients treated with Removab® were still alive, which is a fourfold increase compared to the control group (around 7%). In addition, Removab®-treated patients were shown to have an improved quality of life.

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About Removab® (catumaxomab)
Removab®, with its trifunctional mode of action, represents the first antibody of a new generation. The therapeutic objective of Removab® is to generate a stronger immune response to cancer cells that are the main cause of ascites. Removab® binds to three different cell types simultaneously: One arm of the antibody binds to the EpCAM (epithelial cell adhesion molecule) antigen on carcinoma cells, another arm binds to CD3 on T cells. Thirdly, the intact Fc region of Removab® binds to Fc receptors on accessory cells (such as macrophages, monocytes, dendritic cells and natural killer cells). This simultaneous binding subsequently results in the mutual stimulation and activation of T cells and accessory cells, enabling the generation of a stronger immune response and destruction of cancer cells. Data from animal studies with trifunctional antibodies also suggest a potential long-lasting effect to prevent cancer recurrence. Removab® is under further development for new indications. Catumaxomab (Removab®) is a trifunctional antibody developed by TRION Pharma GmbH.
Removab® has been approved in the European Union since April 2009 for intraperitoneal treatment of malignant ascites in patients with EpCAM-positive carcinomas where standard therapy is not available or no longer feasible.
Fresenius Biotech is responsible for the clinical development and commercialization of Removab®.
For more information, please visit www.removab.com.

About the pivotal study
The study involved 258 patients with malignant ascites due to various carcinomas. Of those, 129 suffered from ovarian cancer, while another 129 had other types of cancer. Patients received paracentesis followed by four intraperitoneal infusions of Removab®, or paracentesis alone (control group). Details of the study results are published by Heiss et al, Int J Cancer 2010;127:2209–21

About epithelial cell-adhesion molecule (EpCAM)
EpCAM is a tumor-associated antigen expressed on the vast majority of epithelial tumors. EpCAM is expressed on tumor cells in the ascites fluid of patients with EpCAM-positive tumors.

About malignant ascites
Malignant ascites can be caused by various kinds of tumors. The peritoneal spread of tumor cells leads to an accumulation of fluid in the peritoneal cavity and is associated with an unfavorable prognosis for the patient. The most common method of treatment is paracentesis, which generally must be repeated at intervals of one to two weeks and can lead to complications such as infections or elevated losses of fluids and proteins. Removab® destroys the peritoneal cancer cells and thus directly attacks the cause of malignant ascites.

Contact

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T +49 (0) 6172 608-96008
pr-fre@fresenius.com

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H1 2011:

• Sales €8.0 billion, +4% at actual rates, +6% in constant currency
• EBIT €1,207 million, +8% at actual rates, +11% in constant currency
• Net income1 €363 million, +20% at actual rates, +22% in constant currency
• Group earnings1 outlook raised to 15% – 18%
• Fresenius Medical Care fully confirms guidance
• Fresenius Kabi posts excellent growth, raises sales and earnings guidance
• Fresenius Helios raises earnings guidance
• Fresenius Vamed revises guidance due to project delays

Ulf Mark Schneider, CEO of Fresenius, commented: „Fresenius achieved excellent financial results in the first half. We are very pleased with Fresenius Kabi's growth in North America and in emerging markets, in particular in China. Based on the results of the first half of 2011, we raise our 2011 earnings guidance. Fresenius Medical Care's significant M&A activity this year shows that our Group's double-barreled growth strategy combining organic growth and acquisitions remains fully intact."

¹Net income attributable to Fresenius SE & Co. KGaA; adjusted for the effects of mark-to-market accounting of the Mandatory Exchangeable Bonds (MEB) and the Contingent Value Rights (CVR) related to the acquisition of APP Pharmaceuticals. Both are non-cash items.

Group outlook 2011
Fresenius now expects 2011 net income to increase by 15% to 18% in constant currency. Previously, the Company expected net income1 growth of 12% to 16% in constant currency. Fresenius confirms its sales guidance. Sales are expected to increase by 7% to 8% in constant currency.

The Group plans to invest approximately 5% of sales in property, plant and equipment.

In 2011, the net debt/EBITDA ratio is expected to stay in the range of 2.5 to 3.0. Also for calendar year 2012, Fresenius Medical Care's announced and entirely debt-financed acquisitions are not expected to cause Group leverage to exceed that target range.

Strong organic sales growth
Group sales increased by 4% (6% in constant currency) to €8,004 million (H1 2010: €7,686 million). Organic sales growth was 5%. Acquisitions contributed a further 1%. Currency translation had a negative effect of 2%. This is mainly attributable to the average U.S. dollar rate decreasing 5% against the euro in the first half of 2011.

Sales growth in the business segments was as follows:

Organic sales growth was 3% in both, North America and Europe. Prior year sales in Europe were positively influenced by Fresenius Vamed's large medical supply contract to the Ukraine. Organic sales growth reached 15% in Latin America, 19% in Asia-Pacific and 23% in Africa.

¹Net income attributable to Fresenius SE & Co. KGaA; adjusted for the effects of mark-to-market accounting of the Mandatory Exchangeable Bonds (MEB) and the Contingent Value Rights (CVR) related to the acquisition of APP Pharmaceuticals. Both are non-cash items.

Continued strong earnings growth
Group EBITDA grew by 7% (10% in constant currency) to €1,526 million (H1 2010: €1,428 million). Group EBIT increased by 8% (11% in constant currency) to €1,207 million (H1 2010: €1,121 million). The EBIT margin improved by 50 basis points to 15.1% (H1 2010: 14.6%).
Group net interest was -€276 million (H1 2010: -€281 million).

The other financial result was -€151 million and includes valuation changes of the fair redemption value of the Mandatory Exchangeable Bonds (MEB) of -€156 million and the Contingent Value Rights (CVR) of €5 million. Both are non-cash items. As the CVR were delisted in March 2011, the effect relates solely to the first quarter of 2011. The MEB will come to maturity on August 14, 2011.

The Group tax¹ rate was 30.9% (H1 2010: 31.9%).

Noncontrolling interest increased to €280 million (H1 2010: €270 million), of which 93% was attributable to the noncontrolling interest in Fresenius Medical Care.

Group net income¹ increased by 20% (22% in constant currency) to €363 million (H1 2010: €302 million). Earnings per ordinary share increased by 20% to €2.23.

A reconciliation to adjusted earnings according to U.S. GAAP can be found on page 14 of this Investor News.

Group net income¹ (including special items) reached €257 million or €1.58 per ordinary share.

¹Adjusted for the effect of mark-to-market accounting of the Mandatory Exchangeable Bonds (MEB) related to the acquisition of APP Pharmaceuticals
²Net income attributable to Fresenius SE & Co. KGaA; adjusted for the effects of mark-to-market accounting of the Mandatory Exchangeable Bonds (MEB) and the Contingent Value Rights (CVR) related to the acquisition of APP Pharmaceuticals. Both are non-cash items.

Continued investments in growth
The Fresenius Group spent €286 million on property, plant and equipment (H1 2010: €320 million). Acquisition spending was €857 million (H1 2010: €151 million), mainly due to the acquisitions of Euromedic's dialysis service business as well as a minority stake in Renal Advantage, Inc., both by Fresenius Medical Care.

Cash flow development
Operating cash flow was €650 million (H1 2010: €805 million). Strong earnings growth was more than offset by increased DSOs (days sales outstanding), primarily related to the introduction of the new Medicare end-stage renal disease prospective payment system in the U.S. dialysis service business, and raised inventory levels. The cash flow margin was 8.1% (H1 2010: 10.5%). Net capital expenditure was €292 million (H1 2010: €320 million). Free cash flow before acquisitions and dividends was €358 million (H1 2010: €485 million). Free cash flow after acquisitions and dividends was -€791 million (H1 20102 : €58 million).

Solid balance sheet structure
The Group's total assets increased slightly to €23,909 million (Dec. 31, 2010: €23,577 million). In constant currency, the increase was 6%. Current assets increased by 5% (9% in constant currency) to €6,752 million (Dec. 31, 2010: €6,435 million). Non-current assets were €17,157 million (Dec. 31, 20010: €17,142 million). In constant currency, the increase was 5%.

Total shareholders' equity decreased by 2% to €8,704 million (Dec. 31, 2010: €8,844 million). In constant currency, however, shareholders' equity increased by 4%. The equity ratio was 36.4% (Dec. 31, 2010: 37.5%).

Group debt grew by 3% (8% in constant currency) to €9,012 million (Dec. 31, 2010: €8,784 million) primarily resulting from acquisition financing. Net debt increased by 5% (10% in constant currency) to €8,404 million (Dec. 31, 2010: €8,015 million).

The net debt/EBITDA ratio increased slightly to 2.66 as of June 30, 2011
(Dec. 31, 2010: 2.62).

¹Net income attributable to Fresenius SE & Co. KGaA
²Does not include a €100 million cash out for a short-term bank deposit by Fresenius Medical Care in Q2 2010.

Number of employees increased
As of June 30, 2011, Fresenius Group increased the number of its employees by 4% to 142,933 (Dec. 31, 2010: 137,552).

Fresenius Biotech
Fresenius Biotech develops innovative therapies with trifunctional antibodies for the treatment of cancer. In the field of polyclonal antibodies, Fresenius Biotech has successfully marketed ATG-Fresenius S for many years. ATG-Fresenius S is an immunosuppressive agent used to prevent and treat graft rejection following organ transplantation.

Fresenius Biotech sales increased by 11% to €14.6 million in the first half of 2011 (H1 2010: €13.1 million). ATG sales increased by 9% to €12.8 million and Removab sales by 29% to €1.8 million.
In the second quarter of 2011, Fresenius Biotech received approval from the Austrian Federal Office for Safety in Health Care for the use of ATG-Fresenius S in stem cell transplantations. Austria is the fifth country to approve the immunosuppressive agent in this indication, following Germany, Portugal, Argentina and Thailand.

In June 2011, the Italian Medicines Agency, AIFA, has added Fresenius Biotech's trifunctional antibody Removab to its list of reimbursable medications.
In July 2011, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended a variation of the existing approval of Removab. The infusion time of currently 6 hours can now be reduced to 3 hours, which facilitates the use of Removab in an out-patient setting. Moreover, the CHMP recommendation allows marketing of follow-up results for the pivotal study in patients with malignant ascites showing that the 1-year survival rate in Removab-treated patients was more than four times higher than in the control group (11.4% Removab group vs. 2.6% control group).
In the first half of 2011, Fresenius Biotech's EBIT was -€13 million (H1 2010: -€15 million). For 2011, Fresenius Biotech expects an EBIT of about -€30 million.

Business Segments

Fresenius Medical Care
Fresenius Medical Care is the world's leading provider of services and products for patients with chronic kidney failure. As of June 30, 2011, Fresenius Medical Care was treating 225,909 patients in 2,838 dialysis clinics.

• Acquisitions with a total annual sales volume of more than US$1 billion 
• 2011 outlook fully confirmed

Fresenius Medical Care achieved sales growth of 7% to US$6,230 million (H1 2010: US$5,828 million). Organic sales growth was 3%, acquisitions contributed a further 2%.
Sales in dialysis services increased by 6% to US$4,647 million (H1 2010: US$4,395 million). Dialysis product sales grew by 10% to US$1,583 million (H1 2010: US$1,433 million).

In North America sales were US$4,005 million (H1 2010: US$3,986 million). Dialysis services sales increased by 1% to US$3,610 million. Average sales per treatment for U.S. clinics was US$348 in the second quarter of 2011 compared to US$356 for the corresponding quarter in 2010. This is a result of the targeted implementation of the new Medicare end-stage renal disease prospective payment system. Dialysis product sales decreased to US$395 million (H1 2010: US$408 million) as increased sales of dialysis products could not entirely offset lower pricing of renal drugs.

Sales outside North America ("International" segment) grew by 20% to US$2,218 million (H1 2010: US$1,842 million). Sales in dialysis services increased by 27% to US$1,037 million. Dialysis product sales increased by 15% to US$1,181 million.
EBIT increased by 7% to US$955 million (H1 2010: US$892 million). The EBIT margin of 15.3% remained at previous year's level.

In North America, the EBIT margin increased to 16.5% (H1 2010: 16.1%). This increase was mainly favorably influenced by the development of pharmaceutical costs and higher income from the joint venture with Vifor Pharma.

In the International segment, the EBIT margin was 16.9% (H1 2010: 17.6%), primarily driven by unfavorable currency effects.

Net income¹ increased by 5% to US$481 million (H1 2010: US$459 million).

Acquisition of Liberty Dialysis Holdings, Inc.: Fresenius Medical Care has executed a merger agreement with Liberty Dialysis Holdings, Inc., the holding company for Liberty Dialysis and Renal Advantage. The investment including assumed debt will be approximately US$1.7 billion. In addition, Fresenius Medical Care previously invested approximately US$300 million in Renal Advantage. The transaction is expected to close in early 2012. Liberty Dialysis Holdings, Inc., has annual sales of approximately US$1 billion and operates approximately 260 dialysis clinics. Fresenius Medical Care anticipates that facilities may need to be divested to secure regulatory clearance of the transaction.

Acquisition of American Access Care Holdings, LLC: Fresenius Medical Care has executed an agreement to acquire the U.S. based company American Access Care Holdings, LLC (AAC) for US$385 million. AAC operates 28 freestanding out-patient interventional radiology centers primarily dedicated to serving the vascular access needs of dialysis patients. The transaction is expected to close in the fourth quarter of 2011. On completion, the acquired operations would add approximately US$175 million in annual sales.

Both acquisitions will be financed from cash flow and debt and are expected to be accretive to earnings in the first year after closing of the transactions. Both transactions remain subject to clearance under the Hart–Scott–Rodino Antitrust Improvements Act.

Fresenius Medical Care fully confirms the outlook for 2011. The company projects sales of more than US$13 billion. Net income¹ is expected between US$1,070 million and US$1,090 million.
For further information, please see Fresenius Medical Care's Press Release at www.fmc-ag.com.

¹Net income attributable to Fresenius Medical Care AG & Co. KGaA

Fresenius Kabi
Fresenius Kabi offers infusion therapies, intravenously administered generic drugs and clinical nutrition for seriously and chronically ill patients in the hospital and outpatient environments. The company is also a leading supplier of medical devices and transfusion technology products.

• Strong organic sales growth of 13%, EBIT margin increase to 20.9%
• 2011 outlook raised – Organic sales growth ~8% on challenging 2010 base - EBIT margin ~20%

Fresenius Kabi achieved excellent financial results. Growth in North America was driven by new product launches as well as continued supply constraints in the injectable drug market. Ongoing high demand from emerging markets contributed strongly to Fresenius Kabi's excellent organic sales growth.

Sales increased both organically and at actual rates by 13% to €1,971 million (H1 2010: €1,745 million). Acquisitions contributed 1%. Currency translation had a negative effect of 1%. U.S. dollar weakness was largely offset by the strength of the currencies in Switzerland, Brazil and Australia against the euro.

In Europe, sales grew by 9% to €909 million (H1 2010: €836 million), driven by organic sales growth of 7%. In North America, sales increased by 17% to €519 million (H1 2010: €445 million) with excellent organic sales growth of 22%. In Asia-Pacific, all-organic growth of 19% drove sales to €332 million (H1 2010: €279 million). Sales in Latin America and Africa increased by 14% to €211 million (H1 2010: €185 million) with organic sales growth contributing 12%.

EBIT grew by 18% to €411 million (H1 2010: €347 million). The EBIT margin improved to 20.9% (H1 2010: 19.9%), mainly attributable to the strong development in North America.

Net interest was -€143 million (H1 2010: -€141 million).

Net income1 increased by 33% to €181 million (H1 2010: €136 million).

Fresenius Kabi's operating cash flow increased by 8% to €205 million (H1 2010: €189 million). The cash flow margin was 10.4% (H1 2010: 10.8%). Given increased capital expenditures, cash flow before acquisitions and dividends of €124 million remained unchanged from previous year's level.
In the second quarter of 2011, Fresenius Kabi announced the expansion of its Grand Island, New York, manufacturing facility. A total of US$38 million will be invested over the next two years, adding six additional production lines for I.V. drugs in order to secure the future growth of the business.
Fresenius Kabi further raises its outlook for 2011. The company now forecasts organic sales growth of ~8%. Previously, Fresenius Kabi targeted organic sales growth of >5%. The EBIT margin is now expected to be ~20% with net income clearly surpassing 2010 earnings. The previous guidance was 19% to 20%.

Special items relating to the acquisition of APP Pharmaceuticals are included in the segment "Corporate/Other".

¹Net income attributable to Fresenius Kabi AG

Fresenius Helios
Fresenius Helios is one of the largest private hospital operators in Germany. Helios owns 64 hospitals, including five maximum care hospitals in Berlin-Buch, Erfurt, Krefeld, Schwerin and Wuppertal. Helios treats more than 2 million patients per year, thereof approximately 650,000 inpatients, and operates approximately 19,000 beds.

• Solid organic sales growth at 4%, 50 basis points EBIT margin increase to 9.5%
• 2011 earnings outlook raised – EBIT of ~€260 million expected

Sales increased by 6% to €1,293 million (H1 2010: €1,223 million), mainly driven by solid organic sales growth of 4%. Acquisitions contributed 2% to overall sales growth due to the consolidation of the St. Marienberg hospital in Helmstedt/Lower Saxony.

EBIT grew by 12% to €123 million (H1 2010: €110 million). The EBIT margin improved to 9.5% (H1 2010: 9.0%).

The established clinics increased sales by 4% to €1,276 million. EBIT improved by 13% to €124 million. The EBIT margin was 9.7%.

Net income¹ increased by 16% to €72 million (H1 2010: €62 million).

The acquisition of the municipal hospital in Rottweil, southwestern Germany, was successfully completed in the second quarter of 2011. The hospital was consolidated as from July 1, 2011.

Fresenius Helios raises its EBIT outlook to ~€260 million. Previously, the company expected to reach the upper half of a range from €250 million to €260 million. Fresenius Helios fully confirms its sales outlook and projects organic sales growth of 3% to 5%.

Fresenius Vamed
Fresenius Vamed offers engineering and services for hospitals and other health care facilities.

• Sales and EBIT in line with expectations for the first half of 2011 – order backlog close to all-time high 
• 2011 outlook revised due to expected project delays in H2 – Sales and EBIT growth of 0% to 5% expected

Fresenius Vamed's sales reached €313 million (H1 2010: €338 million). Sales in the project business were €202 million (H1 2010: €230 million). Prior year sales included a substantial medical supply contract with the Ukraine. Sales in the service business increased by 3% to €111 million (H1 2010: €108 million).

EBIT was €12 million (H1 2010: €15 million). The EBIT margin was 3.8% (H1 2010: 4.4%). Net income¹ was €9 million (H1 2010: €12 million).

Order backlog of €762 million as of June 30, 2011, remained close to its all-time high (Dec. 31, 2010: €801 million). Order intake of €164 million (H1 2010: €328 million) was impacted by the postponement of orders to the second half of 2011.

Fresenius Vamed revises its full-year guidance as a consequence of project delays in Middle East / North Africa due to the unrest in the region. The company now projects sales and EBIT growth of 0% to 5%. Previously, the company expected sales and EBIT growth between 5% and 10%. Fresenius Vamed expects a significant increase in order intake in the second half of 2011 and continued sales and earnings growth following the temporary project delays.

Analyst Meeting and Audio Webcast
As part of the publication of the results for the first half of 2011, a conference call will be held on August 2, 2011 at 2.00 p.m. CET (8.00 a.m. EST). You are cordially invited to follow the conference call in a live broadcast via the Internet at www.fresenius.com, Investor Relations, Presentations. Following the call, a replay of the conference call will be available on our website.

Contact

Head of Corporate Communications
T +49 (0) 6172 608-96008
pr-fre@fresenius.com

Documents

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The European Commission has broadened the existing approval of Fresenius Biotech's antibody Removab^® (catumaxomab) to treat malignant ascites by allowing a shorter infusion time. The infusion time for Removab^® can now be halved, from six to three hours. Moreover, the approval allows marketing of follow-up results for the pivotal study in patients with malignant ascites showing that the one-year survival rate in Removab^®-treated patients was more than four times higher than in the control group (11.4% Removab group vs. 2.6% control group). The summary of product characteristics for Removab^® will include the overall survival data from the pivotal study with immediate effect. The broadened approval follows on the recommendation of the Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency (EMA). It is valid in all EU countries and also confirms the safety profile of the trifunctional antibody.

The European Commission's decision is based on the results of an analysis of pooled safety data. In clinical studies, Removab^® was administered intraperitoneally as three or six-hour infusions. The safety profiles for both administrations were comparable.

Thanks to the shortened infusion time, Removab^® will be easier to use in out-patient settings. "Treatment options for patients with malignant ascites must not only be effective, but also minimize the burden for the patient," said Prof. Dr. Barbara Schmalfeldt from the obstetrics and gynecology department at Technical University of Munich. "A shorter infusion time means patients spend less time at their physician's office or day clinic. The new application time for Removab^® addresses this frequent patient request. It also makes applications in day-to-day practice much easier and more efficient."

# # #

About Removab^® (catumaxomab)
Removab^®, with its trifunctional mode of action, represents the first antibody of a new generation. The therapeutic objective of Removab^® is to generate a stronger immune response to cancer cells that are the main cause of ascites. Removab^® binds to three different cell types simultaneously: One arm of the antibody binds to the EpCAM (epithelial cell adhesion molecule) antigen on carcinoma cells, another arm binds to CD3 on T cells. Thirdly, the intact Fc region of Removab^® binds to Fc-gamma-receptors on accessory cells (such as macrophages, monocytes, dendritic cells and natural killer cells). This simultaneous binding subsequently results in the mutual stimulation and activation of T cells and accessory cells, enabling the generation of a stronger immune response and destruction of cancer cells. Data from animal studies with trifunctional antibodies also suggest a potential long-lasting effect to prevent cancer recurrence. Removab^® is under further development for new indications. Catumaxomab (Removab^®) is a trifunctional antibody developed by TRION Pharma GmbH.
Removab^® has been approved in the European Union since April 2009 for intraperitoneal treatment of malignant ascites in patients with EpCAM-positive carcinomas where standard therapy is not available or no longer feasible.
Fresenius Biotech is responsible for the clinical development and commercialization of Removab^®.
For more information, please visit www.removab.com.

About the pivotal study
The study involved 258 patients with malignant ascites due to various carcinomas. Of those, 129 suffered from ovarian cancer, while another 129 had other types of cancer. Patients received paracentesis followed by four intraperitoneal infusions of Removab®, or paracentesis alone (control group). Details of the study results are published by Heiss et al, Int J Cancer 2010;127:2209–21

About epithelial cell-adhesion molecule (EpCAM)
EpCAM is a tumor-associated antigen expressed on the vast majority of epithelial tumors. EpCAM is expressed on tumor cells in the ascites fluid of patients with EpCAM-positive tumors.

About malignant ascites
Malignant ascites can be caused by various kinds of tumors. The peritoneal spread of tumor cells leads to an accumulation of fluid in the peritoneal cavity and is associated with an unfavorable prognosis for the patient. The most common method of treatment is paracentesis, which generally must be repeated at intervals of one to two weeks and can lead to complications such as infections or elevated losses of fluids and proteins. Removab® destroys the peritoneal cancer cells and thus directly attacks the cause of malignant ascites.

Contact

Head of Corporate Communications
T +49 (0) 6172 608-96008
pr-fre@fresenius.com

Documents

Text as PDF document (PDF, 33 KB)

The Belgian Ministry of Social Affairs and Public Health has added the trifunctional antibody Removab® (catumaxomab) from Fresenius Biotech to its list of reimbursable medications. As of October 1, 2011, use of Removab® for the intraperitoneal treatment of patients with malignant ascites due to EpCAM-positive ovarian carcinoma will be reimbursed, if the eligible patients also fulfill defined additional clinical inclusion criteria. Removab® is a trifunctional monoclonal antibody approved throughout the European Union. It has already been launched in Austria, France, Germany, Scandinavia and the UK. Removab® was also approved for reimbursement in Italy in June. The positive reimbursement decision in Belgium follows a comprehensive appraisal process that thoroughly assessed both the clinical value as well as the cost-effectiveness of Removab®.

###

About Removab® (catumaxomab)
Removab®, with its trifunctional mode of action, represents the first antibody of a new generation. The therapeutic objective of Removab® is to generate a stronger immune response to cancer cells that are the main cause of ascites. Removab® binds to three different cell types simultaneously: One arm of the antibody binds to the EpCAM (epithelial cell adhesion molecule) antigen on carcinoma cells, another arm binds to CD3 on T cells. Thirdly, the intact Fc region of Removab® binds to Fc-gamma receptors on accessory cells (such as macrophages, monocytes, dendritic cells and natural killer cells). This simultaneous binding subsequently results in the mutual stimulation and activation of T cells and accessory cells, enabling the generation of a stronger immune response and destruction of cancer cells. Data from animal studies with trifunctional antibodies also suggest a potential long-lasting effect to prevent cancer recurrence. Removab® is under further development for new indications. Catumaxomab (Removab®) is a trifunctional antibody developed by TRION Pharma GmbH.
Removab® has been approved in the European Union since April 2009 for intraperitoneal treatment of malignant ascites in patients with EpCAM-positive carcinomas where standard therapy is not available or no longer feasible.
Fresenius Biotech is responsible for the clinical development and commercialization of Removab®.
For more information, please visit www.removab.com.

About the pivotal study
The study involved 258 patients with malignant ascites due to various carcinomas. Of those, 129 suffered from ovarian cancer, while another 129 had other types of cancer. Patients received paracentesis followed by four intraperitoneal infusions of Removab®, or paracentesis alone (control group). Details of the study results are published by Heiss et al, Int J Cancer 2010;127:2209–21

About epithelial cell-adhesion molecule (EpCAM)
EpCAM is a tumor-associated antigen expressed on the vast majority of epithelial tumors. EpCAM is expressed on tumor cells in the ascites fluid of patients with EpCAM-positive tumors.

About malignant ascites
Malignant ascites can be caused by various kinds of tumors. The peritoneal spread of tumor cells leads to an accumulation of fluid in the peritoneal cavity and is associated with an unfavorable prognosis for the patient. The most common method of treatment is paracentesis, which generally must be repeated at intervals of one to two weeks and can lead to complications such as infections or elevated losses of fluids and proteins. Removab® destroys the peritoneal cancer cells and thus directly attacks the cause of malignant ascites.

Contact

Head of Corporate Communications
T +49 (0) 6172 608-96008
pr-fre@fresenius.com

Documents

Text as PDF document (PDF, 24 KB)

Fresenius has established a sponsored Level I American Depositary Receipt (ADR) program in the United States. An ADR is a receipt that is issued by a depositary bank representing ownership of a company's underlying shares. ADRs are created to facilitate U.S. investors to hold shares in non-U.S. companies and trade them in the same way as U.S. securities.

Fresenius ADRs will now be available for trading in the U.S. over-the-counter (OTC) market. Eight ADRs represent one Fresenius share. The ticker symbol is FSNUY. Deutsche Bank acts as depositary bank for the ADR program.

Ulf Mark Schneider, CEO of Fresenius, commented: "Fresenius is a global health care group with a strong presence in the United States. For many years, U.S. investors have been an important part of our shareholder base. The new ADR program now allows them to invest in Fresenius in their home market, providing them with the opportunity to participate in our Group's future development."

The Fresenius share is listed on the German stock exchanges in Frankfurt, Düsseldorf and Munich and is a member of the DAX30 stock index.