Fresenius Medical Care AG & Co. KGaA today announced that it has completed the acquisition of the worldwide phosphate binder business (PhosLo) from Nabi Biopharmaceuticals Inc.

With the acquisition, Fresenius Medical Care further expands its market position in the field of dialysis-related drugs. PhosLo is a calcium acetate phosphate binder for oral application in end-stage renal disease patients.

# # #

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 1,400,000 individuals worldwide. Through its network of 2,085 dialysis clinics in North America, Europe, Latin America, Asia-Pacific and Africa, Fresenius Medical Care provides dialysis treatment to 161,433 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 website: www.fmc-ag.com.

Fresenius Medical Care AG & Co. KGaA today announced positive results from the PhosLo (calcium acetate) CARE-2 (Calcium Acetate Renagel Evaluation) study. The study demonstrated that when lipid levels are kept constant in both treatment groups, there is no difference in cardiovascular calcification between patients treated with PhosLo and those treated with Renagel (sevelamer hydrochloride). The data refute the hypothesis that the calcium in PhosLo contributes to cardiovascular calcification. The findings were presented by Dr. Wajeh Qunibi, of the University of Texas Health Science Center, San Antonio at the American Society of Nephrology's Renal Week 2006 Conference in San Diego, California.

The CARE-2 study was a randomized, controlled head-to-head comparison between PhosLo and Renagel with the addition of Lipitor (atorvastatin calcium), as appropriate, in both treatment groups to control LDL (Low Density Cholesterol) levels. The study found no statistically significant difference in the progression in cardiovascular calcification (CAC) between the two treatment groups after 12 months of treatment. Patients treated with PhosLo and Renagel achieved comparable reductions in Serum-Phosphorus and Calcium-Phosphorus product and even more importantly K/DOQI target levels were reached significantly faster with PhosLo.

PhosLo, Renagel and Lipitor are registered trademarks.

About PhosLo
PhosLo is administered orally, and when given with food, combines with dietary phosphate to form insoluble calcium phosphate complexes that are eliminated from the body, thereby reducing phosphorus absorption, helping to prevent excess blood phosphorus levels. Patients should have serum calcium levels closely monitored and their dose of PhosLo adjusted or terminated to bring levels to normal. PhosLo is contraindicated in patients with hypercalcemia. No other calcium supplements should be given concurrently with PhosLo. PhosLo is well tolerated and has an excellent safety profile. Nausea, hypercalcemia, and pruritus (itching) have occasionally been reported during PhosLo therapy.

# # #

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 1,400,000 individuals worldwide. Through its network of 2,085 dialysis clinics in North America, Europe, Latin America, Asia-Pacific and Africa, Fresenius Medical Care provides dialysis treatment to 161,433 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 website: www.fmc-ag.com.  

For more information about the CARE-2 study visit the website: www.advancedrenaleducation.com.

Fresenius Biotech today announced that the European Commission has granted Orphan Drug Designation for the removab® (catumaxomab) trifunctional antibody to treat gastric cancer. The Orphan Drug Designation entitles Fresenius to up to 10 years market exclusivity in the EU upon marketing approval.

Results from an ongoing phase II study using catumaxomab in about 50 gastric-cancer patients are expected in the second half of 2007. A previous phase I study in patients with advanced peritoneal carcinomatosis (spread and growth of tumor cells in the abdominal cavity) also included patients with gastric cancer and was completed successfully.

Gastric cancer affects an average of three out of 10,000 people in the EU and accounts for about twelve percent of cancer fatalities around the world, making it the second-leading cause of death caused by cancer. Despite medical advances, gastric cancer patients continue to face a low survival rate. Most patients are first diagnosed at an advanced stage because early symptoms are missing or are very unspecific. In addition, many patients face early relapse after surgical resection of the tumor and subsequent chemotherapy, making new, innovative treatments for gastric cancer a high medical need.

Orphan Drug
The EU grants the Orphan Drug Designation to medicinal products used for rare, life-threatening or chronic diseases that affect no more than five in every 10,000 people in the EU and for which no sufficient effective treatment exists. The European Medicines Agency, the EU pharmaceutical regulatory body, supports businesses that research, develop and market such medicines during the development and regulatory approval process.

# # #

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 are expected to increase to more than € 10.7 billion. On September 30, 2006 the Fresenius Group had 104,179 employees worldwide.

At the Extraordinary General Meeting in Frankfurt, Germany, a large majority of Fresenius AG's shareholders approved the Management and Supervisory Boards' proposal to convert the Company's legal form from a German stock corporation (Aktiengesellschaft) into a European Company (Societas Europaea – SE). A share split with capital increase from the Company's funds that will triple the number of shares issued was also approved by a vast majority.

The new legal form reflects the international focus of Fresenius Group's business. Through the conversion, all employees in the European Union and in the signatory states to the European Economic Area may now participate in appointing employee representatives to the Supervisory Board. In addition, Fresenius SE's Supervisory Board will continue to have twelve members. Dr. Ulf M. Schneider, Chairman of the Management Board of Fresenius AG, said: "We are convinced that with the new legal form we can successfully continue our high-quality and efficient corporate governance. The SE particularly facilitates an open and international corporate culture. The conversion of Fresenius AG into a European Company and the share split are two consistent steps in the development of the Company. Combined with our long-term strategy focused on profitable growth, these steps will further strengthen Fresenius."

At the Extraordinary General Meeting, 99.99 percent of the ordinary share capital represented approved the conversion of Fresenius AG into an SE. An SE is a public limited-liability company under European law. The conversion will have no effect on the Company's corporate structure and management organization; the legal and economic identity will be preserved. The conversion becomes effective upon the registration in the commercial register. This is scheduled in the third quarter of 2007 after the completion of the procedure for the involvement of the employees.

99.99 percent of the represented ordinary share capital approved the share split. The subscribed capital of Fresenius AG currently amounts to approximately € 131.7 million. It is divided into 25,725,646 ordinary shares and 25,725,646 preference shares. Through a conversion of capital reserves, the subscribed capital will first be increased to approximately € 154.4 million and then divided into 77,176,938 ordinary shares and 77,176,938 preference shares. The new proportionate amount of the subscribed capital will be 1 € per share. After the share split, every holder of an ordinary share will hold three ordinary shares and every holder of a preference share will hold three preference shares. As a result of the share split, the share price will be reduced arithmetically without affecting the overall value for shareholders. The proposed share split is intended to promote trading activity in Fresenius shares and to increase the shares' attractiveness for a broader group of investors. The share split becomes effective upon the registration in the commercial register, which is expected in the first quarter of 2007.

About 79.95 percent of the ordinary share capital was represented at the Extraordinary General Meeting. Only ordinary shareholders were entitled to vote.

# # #

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 are expected to increase to more than € 10.7 billion. On September 30, 2006 the Fresenius Group had 104,179 employees worldwide.

Fresenius today announced encouraging results from a phase II/III pivotal study on malignant ascites in patients with ovarian cancer using the trifunctional antibody removab® (catumaxomab). The antibody showed a clear advantage over a therapy with puncture alone. The median puncture-free survival period (primary endpoint) in the group of patients treated with removab® was significantly longer compared to the control group and clinically relevant. The median puncture-free survival was 52 days in the removab® group versus 11 days in the control group (p< 0.0001).

Positive results were also achieved with regard to key secondary endpoints. The median time to the first therapeutic puncture was 71 days (control group: 11 days; p< 0.0001). In contrast to the primary endpoint, patients who died before the next puncture were not included in this metric. Also, the EpCAM-positive tumor cell concentration in the ascites fluid decreased significantly in patients treated with removab® (p< 0.0009). At the same time, an increase in CD45-positive leukocytes was seen. Both results indicate a direct anti-tumor effect of the trifunctional antibody.

Moreover, removab® showed a very good safety profile. Side effects were mild to moderate 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 without clinical relevance.

"To date, there are only limited therapy options for ovarian cancer patients with malignant ascites. Our data indicate that removab® could become an important new therapy option for this disease. The positive results of the phase I/II study have been fully confirmed by this pivotal phase II/III trial," said Dr. Thomas Gottwald, President Fresenius Biotech.
The results of this two-arm, randomized, open-label study include treatment data of 129 ovarian cancer patients with ascites. The removab® arm included 85 patients, of which 73 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.

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

The current phase II/III study with the trifunctional antibody removab® included a total of 257 patients. The results of the second group (128 patients) with tumor diseases other than ovarian cancer (e.g. gastric cancer) are expected for the first half of 2007.

# # #

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.

# # #

Fresenius Biotech is a company of the Fresenius health care group, focused on the development and marketing of biopharmaceuticals in the fields of oncology, immunology and regenerative medicine. Additional information is available on the Internet at www.fresenius-biotech.com.  

Fresenius is a global health care group with products and services for dialysis, the hospital and the medical care of patients at home. Group sales for the full year 2006 are expected to increase to more than Euro 10.7 billion. As of 30 September 2006, the Fresenius Group had 104,179 employees worldwide.

Fresenius ProServe today announced that it has signed a definitive agreement to sell its subsidiary Pharmaplan GmbH to NNE A/S (NNE). NNE is a wholly owned subsidiary of Novo Nordisk A/S, Copenhagen, a major pharmaceutical company with 22,000 employees worldwide and annual sales of € 4,531 million in 2005.

Pharmaplan provides consulting, engineering and qualification/validation services for the pharmaceutical and GMP-oriented industry worldwide. In 2005, the company had sales of about € 49 million. Pharmaplan currently has about 320 employees, including 130 in Germany. The sale of Pharmaplan is a further step by Fresenius ProServe to focus on its business with hospitals and other healthcare facilities. The company offers the full line of services from the planning and construction of hospitals to technical and operational management in its two core areas of hospital management (HELIOS Kliniken) and hospital engineering and services (VAMED). Fresenius ProServe is now well-positioned to successfully participate in the privatization of the hospital market.

NNE is a leading engineering company focused on the biotech and pharma industries. The company is a full-service provider offering conceptual design, validation and operational support. Pharmaplan and NNE's activities and markets complement each other well. The combination of both businesses offers Pharmaplan and its employees exceptional opportunities for future development.

The transaction requires antitrust approval. The Company anticipates the closing of the transaction in the first quarter of 2007. Pharmatec, a Pharmaplan subsidiary with production sites in Dresden, Germany and Ternitz, Austria will not be included in the transaction and will be divested at a later date. Pharmatec manufactures high quality pure steam, pure water and sterilization equipment for the pharmaceutical industry.

As part of its 10-year anniversary, Fresenius Medical Care, the worldwide dialysis market leader, will donate € 150,000 to charitable organizations that aid dialysis patients. The German National Kidney Association (Bundesverband Niere e.V.) will receive € 50,000 while similar organizations in North America and the Asia-Pacific region will obtain the remaining € 100,000. The Company consciously decided against celebrating the occasion with receptions and parties. The approximately 18,000 members of the German National Kidney Association are dedicated to improving the lives of patients with chronic kidney disease. The Association will use the funds donated by Fresenius Medical Care for its self-help, prevention and information programs as well as to assist those affected by kidney disease.

Fresenius Medical Care looks back on ten years of successful growth. In 1996, Fresenius acquired the largest dialysis clinic operator in the world, National Medical Care, and merged the company with its own dialysis equipment division to create the new company. Fresenius used the opportunity to take a major step into the market for dialysis care. Since then, both revenue and the number of employees have more than doubled, the number of dialysis clinics has more than tripled and the Company was added to Germany's benchmark DAX 30 index in 1999.

Today, Fresenius Medical Care is the leading provider of dialysis services treating about 161,433 patients in its 2,085 own clinics worldwide. Fresenius Medical Care also is the undisputed leader in the dialysis products. When it comes to the two key products for hemodialysis, the Company has created an even wider gap to its competitors – nearly every other new dialysis machine and nearly every other new dialyzer is a Fresenius Medical Care product.

The Company remains on the path for growth. Fresenius Medical Care plans on increasing sales by 2010 to $ 11.5 billion. This growth will be attained both organically and through attractive acquisitions that further strengthen its network of dialysis clinics. The Company's unique vertical structure will also aid its expansion as its innovative products are combined with its patient care services. Furthermore, a new initiative will create horizontal growth by combining the Company's product technology, its treatment expertise and its abilities as a care provider into new "Pharma-Tech" therapies utilizing proven drugs.

# # #

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 1,400,000 individuals worldwide. Through its network of 2,085 dialysis clinics in North America, Europe, Latin America, Asia-Pacific and Africa, Fresenius Medical Care provides dialysis treatment to 161,433 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 website: www.fmc-ag.com.

The Fresenius Health Care Group will donate cash and goods worth more than $1.1 million to victims of the tsunami in Southeast Asia.

Dr. Ulf M. Schneider, Chairman of the Management Board of Fresenius AG: "We are deeply moved by the suffering caused by the disaster in Asia. To offer swift and unbureaucratic assistance, we have organized an immediate-aid package that includes cash donations, life-saving medical supplies and construction assistance for medical facilities. Our subsidiaries in the region are in close contact with local aid agencies and will handle some of the donations directly."

Fresenius Medical Care will donate $500,000 and Fresenius Kabi will give € 500,000 for aid work in the affected region. A major part will be used to provide financial support to various aid agencies in India, Indonesia, Sri Lanka and Thailand. Furthermore, Fresenius will donate vital medical supplies to hospitals in the region and life-saving products and services for patients with kidney failure.

Fresenius employees have also voluntarily collected donations in many countries including one fund-raising program in India where colleagues agreed to donate a day's pay to victims in the disaster region.

Fresenius Biotech and the US Company Enzon Pharmaceuticals, Inc. today announced the recruitment of the first North American patient for a phase II study for approval of ATG-Fresenius S. The polyclonal antibody suppresses the immune reaction against transplanted organs to reduce the risk of rejection. It is already marketed in over 60 countries. The entry of the first patient into the clinical study is an important milestone to introduce this successful product in the North American market. The cooperation partner Enzon is responsible for the clinical development and approval in the U.S., Fresenius Biotech will manufacture and deliver ATG-Fresenius S.

Enzon and Fresenius Biotech also announced today that the US Food and Drug Administration (FDA) granted Fast Track Status in the approval process for the use of ATG-Fresenius S in lung transplantation. The Fast Track process provides a particularly close working relationship with the FDA in order to accelerate the development and approval of pharmaceuticals that are appropriate to treat critically ill patients where adequate therapeutic modalities are not available. A phase III study using ATG-Fresenius S in renal transplant patients is currently being prepared.

Fresenius Biotech signed a cooperation contract with Enzon Pharmaceuticals in 2003 for the U.S. approval of ATG-Fresenius S. This product is expected to be introduced to the U.S. market in 2007.

Enzon Pharmaceuticals is a biopharmaceutical company dedicated to the discovery, development and commercialization of therapeutics to treat life-threatening diseases. Further information can be found on the Company's website www.enzon.com

Fresenius Biotech GmbH is a subsidiary of the health care company Fresenius. Fresenius Biotech is committed to the development and marketing of biopharmaceutics in the areas of oncology, immunology and regenerative medicine.
 

Fresenius Kabi AG, a subsidiary of Fresenius AG, today announced an agreement to acquire Labesfal – Laboratório de Especialidades Farmacêuticas Almiro S.A. The company is headquartered in Campo de Besteiros in central Portugal and offers intravenously administered drugs (I.V. drugs) for the domestic market. This acquisition will significantly expand the I.V. drug portfolio of Fresenius Kabi, the European market leader in infusion and nutrition therapy. Fresenius Kabi plans to introduce Labesfal's products throughout Europe. The acquisition is an important step in the company's growth strategy. "We have announced in the past that we intend to expand the I.V. drug business of Fresenius Kabi. The purchase of Labesfal offers excellent growth opportunities in this attractive market segment," said Dr. Ulf M. Schneider, Chairman of the Management Board of Fresenius AG.

Privately-owned Labesfal ranks among the 10 most successful companies in Portugal. In 2004, the company achieved sales of € 56 million and employed approximately 320 people. The acquisition will be accretive to Fresenius Kabi's earnings in the first year and will lead to a further improvement in the EBIT margin of the company. Labesfal holds an excellent position on the Portuguese hospital market with a comprehensive product portfolio of generic I.V. drugs such as antibiotics, analgesics and local anesthetics as well as for treating gastrointestinal diseases.

Labesfal's state-of-the-art production site in Campo de Besteiros has adequate capacity for international expansion. For 2005, Fresenius Kabi plans to establish a competence center for the production of I.V. drugs at this location. The company has significant know-how in the production of sterile infusion solutions.

Fresenius Kabi is a leader in the development, production and distribution of infusion therapy products for hospitals. Labesfal is an excellent fit in this segment. Fresenius Kabi plans to use its existing sales and marketing network to introduce Labesfal's I.V. drug products to the European market. The products are expected to receive European regulatory approval within the next two years. Fresenius Kabi estimates the market size of the European hospital market for the I.V. drugs portfolio of Labesfal at € 1.2 billion*.

The former owner of Labesfal, Joaquim Coimbra, will become Chairman of the newly-created advisory board of the company. The management team will include current Labesfal management and local Fresenius Kabi executives.

The acquisition requires the approval of Portuguese antitrust authorities.

* Source: Fresenius Kabi Internal Research