Fresenius Medical Care, the world's largest provider of dialysis products and services, has launched a new therapy programme for peritoneal dialysis (PD). ‘P3', the first comprehensive PD care concept of its kind, was introduced at the 9th European Peritoneal Dialysis Meeting "EuroPD" in Strasbourg, France this week.

In contrast to the mere provision of individual products and services, ‘P3' for the first time provides PD therapy as an integrated care programme, incorporating all aspects of treatment, from the PD machine, or "cycler", and related equipment to special software and services for the monitoring of treatment safety and quality. With this holistic approach, ‘P3' aims to support physicians and nurses in adjusting treatment even more closely to a patient's individual needs – improving the overall quality of PD therapy.

This aim is reflected in the programme's name: ‘P3' stands for ‘Protect', ‘Preserve' and ‘Prolong'. ‘Protect' refers to Fresenius Medical Care's portfolio of PD cyclers and equipment, which include special safety features such as automatic bag connection and highly intuitive, easy-to-understand design. Such elements offer advanced protection from infections as well as from incorrect handling, which is especially important as many patients undergo treatment at home. ‘Preserve' alludes to the Company's PD fluids, which, due to their physiological pH and low amount of glucose degradation products, contribute particularly well to the preservation of a patient's peritoneal membrane and residual renal functions. ‘Prolong', finally, refers to the aim of ‘P3' to prolong high-quality treatment outcomes, for example through complementary therapies for the control of a patient's body fluid balance or special monitoring software to individually adjust and optimize a patient's treatment parameters.

"It is Fresenius Medical Care's mission to deliver excellent care to patients through innovative programs, the latest technology, continuous improvement and a focus on superior customer service. ‘P3' is a further step on this mission, helping our PD patients to be more successful on dialysis so they can live their lives to the fullest", says Dr. Teresa Portela, Marketing Director Home Therapies at Fresenius Medical Care.

In peritoneal dialysis, or PD, the patient's peritoneum is used as the dialyzing membrane. A sterile dialysis solution is introduced and discharged through a catheter that has been surgically implanted into the patient's abdominal cavity. The solution removes toxins along with excess water. The patient administers the treatments several times a day or during the night supported by a machine, the cycler.

Fresenius Medical Care, the world's largest provider of dialysis products and services, today announces the presentation of the first results from the CALcium acetate MAGnesium carbonate evaluation study (CALMAG study) for the new phosphate binder OsvaRen® at the Renal Week 2009 in San Diego, USA.1 The CALMAG study examines efficacy and safety of OsvaRen®.

The poster will be presented:

• 29th of October 2009, 10 am – 12 midday
• Poster board: TH-PO615
• Lead investigator: Prof. Angel Luis Martín de Francisco, Universidad de Cantabria, Santander (Spain).

"Investment in the CALMAG study underlines our commitment to the best treatment for dialysis patients", said Dr. Emanuele Gatti, Chief Executive Officer of Fresenius Medical Care for the regions Europe, Latin America, Middle East and Africa. "These results bring us one step closer to our vision of truly integrated care."

Background information:

About the CALMAG study
The CALMAG study is a 24-week randomised, controlled, multicentre, head-to-head clinical study comparing the efficacy of two phosphate binders, OsvaRen® (calcium acetate/magnesium carbonate from Fresenius Medical Care) and sevelamer hydrochloride (Renagel® from Genzyme Corporation) in patients with chronic kidney disease on dialysis. The CALMAG study was conducted in five European countries.

About OsvaRen®
OsvaRen®, consisting of 435 mg calcium acetate (110 mg calcium) and 235 mg magnesium carbonate (60 mg magnesium), allows effective and safe control of serum phosphorus levels in patients on dialysis. Elevated serum phosphorus levels are an independent predictor of mortality in patients with chronic renal failure and require effective treatment for better achievement of K/DOQI2 and KDIGO3 target ranges. OsvaRen® is now approved in 28 European countries for the treatment of hyperphosphataemia associated with chronic renal insufficiency in patients undergoing dialysis. OsvaRen® is not yet available in all countries and prescribing information may differ between countries. Please consult your local prescribing information. For more information about OsvaRen®, please visit our website www.fmc-renalpharma.com.

Important safety information
OsvaRen® is contraindicated in patients with hypophosphataemia, hypercalcaemia, elevated serum magnesium levels of more than 2 mmol/L and/or symptoms of hypermagnesaemia, AV-block III or Myasthenia gravis. Common adverse events reported with OsvaRen® include soft stools, gastrointestinal irritation like nausea, anorexia, sensation of fullness, belching and constipation, diarrhoea. Drug-drug interactions may occur with some medications and should be taken into consideration when instructing patients on how to take OsvaRen®. Patients should be informed to take OsvaRen® with meals and to adhere to their prescribed diets.


References: 

1. de Francisco ALM et al. A controlled randomised comparison of calcium acetate / magnesium carbonate (OsvaRen®) to sevelamer hydrochloride (Renagel®) in hemodialysis patients: the CALMAG study (2009).
   J Am Soc Nephrol 20: TH-PO615
2. K/DOQI clinical practice guidelines for bone metabolism and disease in chronic kidney disease.
   Am J Kidney Dis (2003) 42, p1-p201. 
3. KDIGO Guideline for Chronic Kidney Disease -Mineral and Bone Disorder.
   Kidney International (2009) 76 (Suppl 113), p1–p130.

The path from a brilliant idea to a market-ready product is often long and arduous. Fresenius wants to help inventors along this path to support the spread of innovative concepts from all areas of medicine. The health care group is now announcing the 10th Fresenius Inventors' Fair. Creative types can present their ideas from November 19 to 21, 2008 as part of MEDICA, the world's largest medical trade fair in Dusseldorf. The Inventors' Fair offers an international forum for innovators to find professional partners from the private sector as well as potential investors for the further development and marketing of their ideas. On the first day of the trade fair, the three best inventions are awarded the Fresenius Inventors' Prize, worth 10,000 Euro in total. Applications are currently being accepted.

There are plenty of new developments in diagnostics and therapies as well as medical devices, care and rehabilitation. But for the most possible patients to benefit from these innovations, inventors often need a healthy dose of perseverance and additional expertise. The Fresenius Inventors' Fair offers innovators an opportunity to present their concepts to experts and the media, and to secure specialist and financial support from interested companies. This increases the chance that their idea could enter mass production and benefit from professional marketing.

An independent jury of medical and business specialists will select the three best innovations. Emphasis is placed on the potential benefits and novelty of an idea. "Feasibility is also a key trait of winning innovations," explains Martin Hepper, doctor and member of the 2006 Inventors' Prize jury. One such successful entry came from Orthopedic doctor Michael Arnold: he developed two orthopedic surgical instruments that allow a relatively gentle removal of worn prostheses, regardless of the original model or manufacturer.

Doctors, natural scientists, engineers as well as hospital and care professionals may now submit their ideas. Fresenius will provide select applicants with exhibition space and stands free of charge at the Inventors' Fair. The health care group has again invested in the professional design of the stands. This should allow exhibitors to showcase their innovations while stimulating interesting discussions with specialists and media representatives. Twenty exhibitors took part in the 2006 Inventors' Fair and numerous specialists from a variety of medical specialists entered the competition.

The deadline for applications is October 2, 2008. The Inventors' Fair will be in Hall 8b during MEDICA. The trade fair in Dusseldorf runs from November 19 to 21, 2008 and is open from 10 a.m. to 6:30 p.m. Additional information on the Inventors' Fair may be found at http://www.fresenius-erfindermesse.de/, and on MEDICA at http://www.medica.de. Contact: Fresenius SE, codeword: "Inventors' Fair", 61346 Bad Homburg, Germany, Fax: 0049-61 72-6 08 22 94, E-Mail: daniela.hegemann@fresenius.com.

Fresenius Medical Care AG & Co. KGaA, the world's largest provider of dialysis products and services, today announced that it signed exclusive license agreements for the intravenous (IV) Iron products Venofer® (iron sucrose) and Ferinject® (ferric carboxymaltose) to treat iron deficiency anemia experienced by dialysis patients. Venofer® is the leading IV Iron product worldwide.

Galenica Ltd., its subsidiary Vifor Pharma and Fresenius Medical Care are entering into a strategic joint venture for dialysis to market and distribute the two iron products Venofer® and Ferinject® in Europe, Middle East, Africa and Latin America. The agreement concerns all commercialization activities for these IV Iron products in the field of dialysis and is expected to become effective not later than January 1st, 2009.

Commercialization of these respective IV Iron products outside the field of dialysis will remain fully the responsibility of Vifor Pharma and its existing key partners.

The total market for IV Iron in Europe, Middle East, Africa and Latin America was greater than $120 million in 2007. After the first year of the agreement, Fresenius Medical Care expects yearly sales from both IV Iron products to be in excess of $50 million.
In North America, a second Agreement provides for an exclusive U.S. manufacturing and distribution sublicense for Venofer® with Luitpold Pharmaceuticals Inc (Luitpold). In addition, it includes a similar sublicense for the next generation of iron products for the U.S. and Canada known as Injectafer® (ferric carboxymaltose) injection, which is expected to enhance the treatment of anemia in the dialysis patient population through the application of innovative drug administration techniques. The transaction is subject to customary closing conditions including expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Act. The closing of the transaction is anticipated in 2008.

Luitpold will continue to sell Venofer® for use in treating chronic kidney disease patients not yet on dialysis and in treating patients with acute renal failure in hospitals. Venofer® is currently the market leader in sales in the injectable iron market in the U.S. Currently, the total purchases of IV Iron in the U.S are approximately US$ 500 million. Venofer® has a U.S. market share of approximately 55%. Galenica Ltd., through its Vifor Pharma subsidiary, exclusively licenses the Venofer® and Injectafer® products to Luitpold and American Regent for the U.S. and Canada.

As part of the 10-year Agreement for North America, Luitpold will continue to contract manufacture the products for Fresenius Medical Care. Luitpold will continue to pay royalties to Vifor Pharma, based in St. Gallen, Switzerland, which supplies the active pharmaceutical ingredient to Luitpold.

Ben Lipps, Chief Executive Officer of Fresenius Medical Care, commented: "We are very pleased to have Galenica Ltd., Vifor Pharma, Luitpold Pharmaceuticals, Inc. and American Regent, Inc., as our partners dedicated to improving the treatment of iron deficiency anemia experienced by dialysis patients. It is an excellent opportunity for us to access a proven and effective IV Iron product portfolio. With these agreements we will also deploy our "Pharmatech" strategy, aimed to introduce new drug delivery systems to improve quality and safety of dialysis treatments."

The tenth Fresenius Inventors' Fair will give 20 chosen researchers, developers and inventors the opportunity to present their ideas to a broad audience during the world's largest medical trade fair MEDICA in Düsseldorf from November 19 to 21, 2008. The top three entries will be selected by Fresenius and receive awards totaling €10,000. The winning entries are picked on the first day of MEDICA by a jury comprising medical specialists and business representatives. About 50 doctors, scientists, engineers, technicians and care professionals are among the entrants this year. Their proposals include a broad spectrum, ranging from methods to detect cancer to a novel, synthetic heart valve to a vibrating training device for wheelchair users. The Fresenius Inventors' Fair is held every two years during MEDICA.

The winning project of the last Fresenius Inventors' Fair came from a team of scientists from Regensburg University of Applied Sciences as well as Passau University. They developed a pen equipped with sensor technology to record neuromuscular activity of the hand. The sensor pen provides data that can prove useful in the diagnosis of diseases, such as Parkinson's, schizophrenia and stroke. The second place was awarded to two new orthopedic surgical instruments, which are already being marketed, that allow for careful removal of worn implants while causing minimal bone damage. Other winners in past years have included a needle to easily draw blood from premature babies, a device for a virtually pain free colonoscopy, a new method for the manufacture of nitrogen monoxide and a mobile device to wash bedridden patients.

"The Fresenius Inventors' Fair offers exhibitors the chance to present their innovations to industry representatives and doctors," Jury Member and physician Martin Hepper said. "Fresenius hopes to help link inventors with companies that will further develop or market their innovations. Groundbreaking ideas should help treat the sick rather than land in an archive somewhere." Past fairs have proven to be useful platforms for inventors to network with businesses. In the past year, more than 137,000 foreign and local visitors have attended MEDICA.

The Fresenius Inventor's Fair can be found at MEDICA in Hall 8b. The award ceremony starts at 1 p.m. on Wednesday, November 19. MEDICA is open from 10 a.m. to 6:30 p.m. from November 19 to 21 in Düsseldorf. Additional information on the Inventors' Fair may be found at www.fresenius-erfindermesse.de, and on MEDICA at www.medica.de.

The tenth Fresenius Inventors' Fair will give 20 chosen researchers, developers and inventors the opportunity to present their ideas to a broad audience during the world's largest medical trade fair MEDICA in Düsseldorf from November 19 to 21, 2008. The top three entries will be selected by Fresenius and receive awards totaling €10,000. The winning entries are picked on the first day of MEDICA by a jury comprising medical specialists and business representatives. About 50 doctors, scientists, engineers, technicians and care professionals are among the entrants this year. Their proposals include a broad spectrum, ranging from methods to detect cancer to a novel, synthetic heart valve to a vibrating training device for wheelchair users. The Fresenius Inventors' Fair is held every two years during MEDICA.

The winning project of the last Fresenius Inventors' Fair came from a team of scientists from Regensburg University of Applied Sciences as well as Passau University. They developed a pen equipped with sensor technology to record neuromuscular activity of the hand. The sensor pen provides data that can prove useful in the diagnosis of diseases, such as Parkinson's, schizophrenia and stroke. The second place was awarded to two new orthopedic surgical instruments, which are already being marketed, that allow for careful removal of worn implants while causing minimal bone damage. Other winners in past years have included a needle to easily draw blood from premature babies, a device for a virtually pain free colonoscopy, a new method for the manufacture of nitrogen monoxide and a mobile device to wash bedridden patients.

"The Fresenius Inventors' Fair offers exhibitors the chance to present their innovations to industry representatives and doctors," Jury Member and physician Martin Hepper said. "Fresenius hopes to help link inventors with companies that will further develop or market their innovations. Groundbreaking ideas should help treat the sick rather than land in an archive somewhere." Past fairs have proven to be useful platforms for inventors to network with businesses. In the past year, more than 137,000 foreign and local visitors have attended MEDICA.

The Fresenius Inventor's Fair can be found at MEDICA in Hall 8b. The award ceremony starts at 1 p.m. on Wednesday, November 19. MEDICA is open from 10 a.m. to 6:30 p.m. from November 19 to 21 in Düsseldorf. Additional information on the Inventors' Fair may be found at www.fresenius-erfindermesse.de, and on MEDICA at www.medica.de.

Numerous peritoneal dialysis (PD) products of Fresenius Medical Care are now certified by Nordic Ecolabel, making it the first health care company in the world to receive this designation for its medical products. The license covers nearly all disposable products made of PVC-free Material Biofine®, developed by Fresenius Medical Care. The products include bags for PD solutions as well as accessories for PD machines, offered in many European countries.

Nordic Ecolabel is the official Ecolabel in the Scandinavian countries of Denmark, Finland, Iceland, Norway and Sweden and signals the environmental impact of a product or service. As one of the most popular Ecolabels worldwide, it has been awarded to products and services in 66 categories so far. It is also known as "Swan" by most Scandinavians because of its logo, a stylized white swan across a green background. According to the Nordic Ecolabelling Board (NMN), which awards the Ecolabel, two-thirds of Scandinavians are familiar with Nordic Ecolabel and its significance.

Nordic Ecolabelled PD products must meet strict criteria. They must, among other things, not contain PVC and substances that are toxic or resist degradation (persistent), which are deposited in organisms (bioaccumulative) or disrupt the endocrine system (endocrine disrupters). Furthermore, the manufacturing process needs to adhere to state of the art quality standards.

"We developed Biofine® because an important concern of our company is to preserve nature and to save natural resources," said Dr. Emanuele Gatti, Chief Executive Officer of Fresenius Medical Care for the regions Europe, Latin America, Middle East and Africa. "Our Biofine® technology is unique and therefore we are pleased to be the first health care company ever to offer medical products with the Nordic Ecolabel. This is another building block in our extensive environmental program. Our products are environmentally friendly and innovative. They offer the best quality of care for the benefit of patients."

For more information about the Nordic Ecolabel and the certification of Fresenius Medical Care's PD products visit www.svanen.nu/eng.

A Phase II study with the trifunctional antibody catumaxomab in the treatment of patients with gastric cancer showed the antibody was well tolerated. The primary endpoint of the study – safety and tolerability of catumaxomab administration after tumor resection – was achieved. With this study, controlled results for perioperative administration of catumaxomab are presented for the first time.

The randomized, open-label study included 55 patients with resectable gastric cancer. Tumors of all patients were removed by surgery. 28 patients were included in the catumaxomab arm and treated intraoperatively with 10µg of catumaxomab. Seven days after surgery, these patients were given 10, 20, 50 and 150µg doses of catumaxomab by intraperitoneal administration in intervals of three days. The 27 patients in the control group received no anti-tumor therapy except tumor resection within the study period.

The pattern of complications from surgery was comparable in both groups, with catumaxomab having no impact. Most of the side effects in the catumaxomab group were mild to moderate and based on the mode of action of the antibody. Side effects were mostly limited to the treatment period and were, if needed, treated symptomatically.

Secondary study endpoints were efficacy parameters, e.g. overall survival. As expected, the study showed no statistically or clinically relevant differences between the catumaxomab arm and the control group 12 months after treatment. Due to this short follow-up period and the low number of patients it was not possible to reach specific conclusions regarding the efficacy of the therapy. Other studies with similar patient populations showed a difference in overall survival just after about two years.

After finalization of the ongoing second study in patients with gastric cancer, including neoadjuvant chemotherapy prior to surgery, the safety and tolerability data of catumaxomab administration during surgery will be evaluated. Additional analyses on efficacy of the therapy are also planned.


Background information:

Gastric Cancer
Gastric cancer is the fifth most common type of cancer in men and the seventh most common type of cancer in women. In 2004, about 11,000 men and about 7,800 women had gastric cancer in Germany. In men the incidence peak is at the age of approx. 70, in women it is above 75. (Source: Robert Koch Institute)
The prognosis of patients depends heavily on the stage of the tumor. While five-year survival rates for patients in stage I are up to 80 %, they decline in advanced stages, with a survival rate of about 20 % for patients in stage IIIb and below 5 % for stage IV.
The only curative treatment option is the partial or complete resection of the stomach (gastrectomy) and the regional lymph nodes. If the general condition of the patient is good, the surgery can be preceded by a neoadjuvant chemotherapy to reduce the size of the tumor, which led to a significant improvement of five-year survival to 36 % in a first Phase III study (MAGIC). If tumor tissue remains after the surgery, an additive chemotherapy is administered which might enable a second successful resection. In case of inoperable tumors or distant metastases, a palliative chemotherapy can be administered to alleviate the symptoms and prolong life.

Second Phase II Gastric Cancer Study GC03
In the second study IP-CAT-GC-03, a single-arm trial, gastrectomy follows chemotherapy (neoadjuvant). The primary endpoint of the study is safety and tolerability of the trifunctional antibody catumaxomab. The secondary endpoints are efficacy parameters such as overall survival and disease-free survival.

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.


Mode of action of trifunctional antibody catumaxomab
The therapeutic objective of trifunctional antibodies is to generate a stronger immune reaction against tumor cells. Catumaxomab 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 Medical Care is expanding the dialyzer production capacity at the St. Wendel (Germany) production facility by 40%. A total of € 36 million will be invested including associated investment in additional production capacity for proprietary Helixone fibers. The new production line for FX-Class dialyzers is expected to start operating in spring 2008 and will increase the annual capacity for single-use dialyzers from 25 million to 35 million.

The expansion plan at Fresenius Medical Care's major European dialyzer production facility in St. Wendel (Germany) follows recent significant expansion projects at the Company's facilities in Ogden (Utah, U.S.) and Buzen (Japan). As a result of these two expansion projects, the total annual capacity is expected to increase by about 11 million dialyzers worldwide.

Dr. Ben Lipps, Chief Executive Officer of Fresenius Medical Care, commented: "The continued expansion of our global production network is in response to the strong increase in global demand for Fresenius Medical Care's single-use dialyzers and other innovative products to treat patients with chronic kidney disease. Furthermore, the investment at the St. Wendel plant demonstrates our strong commitment to our home country Germany and to our more than 1,500 employees, who have built up tremendous proprietary expertise for cost-effective production of high-quality, innovative and successful dialysis products."

In hemodialysis, the dialyzer acts as an artificial kidney, providing the vital functions of the natural organ: Blood flows through as many as 20,000 nearly hair-fine tubes (capillaries) in a plastic housing. The Helixone capillaries are made from Polysulfone, a special polymer with very good filtering capabilities and excellent biocompatibility. Toxins as well as excess water are filtered from the blood through pores in the capillaries and removed with dialysis fluid (dialysate).

# # #

Helixone and Fresenius Polysulfone are registered trade marks 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 1,400,000 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 today announced the submission of a supplemental New Drug Application (sNDA) with the U.S. Food & Drug Administration (FDA) to allow the Company's proprietary phosphate binder, PhosLo to be labeled for use by patients diagnosed with Stage 4 chronic kidney disease (CKD). The U.S. National Kidney Foundation divides kidney disease into five stages depending on the glomerular filtration rate (GFR) which ranges from more than 90 ml/min in healthy kidneys (Stage 1) to less than 15 ml/min (Stage 5) where dialysis or a kidney transplant is needed. Persons with CKD Stage 4 have advanced kidney damage with a severe decrease in the GFR to 15-29 ml/min, i.e. the filtration rate is significantly lower compared to average healthy kidneys. It is likely someone with Stage 4 CKD will need dialysis or a kidney transplant in the near future. There are approximately 400,000 patients with Stage 4 CKD in the U.S.

The submission of the sNDA is based on data from the "Effect of Calcium Acetate on Phosphorus Levels in Patients with Advanced Chronic Kidney Disease" (EPIC) study. The study, which was presented at the International Society of Nephrology meeting in Copenhagen, Denmark, October 13, 2006, was a prospective, multi-center, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of PhosLo in 110 Stage 4 CKD patients. The study achieved its primary endpoint of superior control of serum phosphorus levels (p=0.0003), the calcium-phosphorus product (p=0.001) and serum parathyroid hormone (PTH) (p=0.001) versus placebo.

Dr. Ben Lipps, Chief Executive Officer of Fresenius Medical Care, commented: "We are pleased with the outcome of the EPIC study, which has resulted in the FDA submission. When the application is granted, PhosLo will provide nephrologists another therapeutic option that will allow them to start treatment of hyperphosphatemia earlier."

# # #

PhosLo is a registered trademark of Fresenius Medical Care.

About Hyperphosphatemia
Hyperphosphatemia is an electrolyte disturbance in which there is an abnormally elevated level of phosphate in the blood. Often, calcium levels are lowered (hypocalcemia) due to precipitation of phosphate with the calcium in tissues. It is associated with secondary hyperparathyroidism and commonly seen in chronic renal failure. High phosphate levels can be avoided with phosphate binders and dietary restriction of phosphate.

About PhosLo
PhosLo is an oral prescription calcium acetate phosphate binder currently indicated for the control of elevated phosphorous levels in patients with end stage renal disease (ESRD). PhosLo is administered orally, and when given with food, it 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.