Fresenius Medical Care has released a new single-use adsorber for the treatment of IgE (ImmunoglobulinE)-mediated diseases in the European market.

Latest epidemiological data shows that IgE-mediated diseases affect more than 25 percent of the world’s population. Of this group, an estimated 10 percent suffer from severe allergic symptoms such as asthma and atopic dermatitis. The new adsorber, called IgEnio®, is intended to provide a therapy option for these patients.

IgEnio® complements the growing portfolio of Fresenius Medical Care’s Therapeutic Apheresis business, which already offers adsorbers targeting the reduction of ImmunoglobulinG (a therapy for autoimmune diseases) and the removal of other, specific pathogens.

IgEnio® was developed on the basis of Fresenius Medical Care’s longstanding expertise in extracorporeal treatments, and represents a further step in the strategic expansion of this important therapy field. IgEnio® was co-developed with Biomay AG, a global leader in allergy immunotherapy products, based in Vienna.

The clinical results of IgEnio® were presented for the first time at a scientific congress in Barcelona in June. IgEnio® will be introduced in selected markets – France, Germany, Italy, Spain and the United Kingdom – in the course of 2015. Fresenius Medical Care will continue the rollout within its Europe, Middle East and Africa region.

The IgE synthesis pathway and the IgE-mediated allergic/inflammatory pathway are important targets in intervening in the pathological processes of allergy. IgEnio® is a single-use, single-pass adsorber that selectively decreases IgE levels in the plasma. The first clinical trial of IgEnio®, called ESPIRA, included patients with severe allergic asthma not sufficiently controlled by inhaled steroids and other medications. These patients, who have high IgE levels in their plasma, currently have very limited treatment options.

The primary end point of the ESPIRA study was to reduce IgE levels by more than 50 percent over the treatment period and to demonstrate safe application in clinical practice. Within the study, patients underwent nine apheresis treatments with IgEnio®, with each treatment lasting for approximately four hours. As a result of the treatments, a highly significant reduction of more than 80 percent in plasma IgE was observed (p<0.001). For highly allergic patients in the ESPIRA study setting, lgEnio® was safe and well tolerated.

To strengthen the scientific evidence base and to create more clinical expertise, Fresenius Medical Care will conduct further clinical investigations in the coming years.

 

 

 

Everybody who has to fulfill demanding tasks with the help of technical devices during their daily clinical routine needs a sense of safety and reliability. The more extensive the tasks are the more important is the easy and intuitive handling of the complex technology. Fresenius Medical Care’s multiFiltratePRO is specifically tailored to meet these needs.

Dominik Wehner, chief executive officer for Europe, Middle East and Africa commented: “User-friendly operations, reliability as well as the usage for various extracorporeal therapies are the key strengths of this new therapy system multiFiltratePRO. This powerful technology increases efficiency and ergonomics and is equally easy to operate.”

A multitude of features supports physicians and caregivers who are increasingly experiencing raising workloads and high working pressure: a large touch screen monitor comprehensively displays all needed information; intuitive handling; fully integrated fluid heaters reliably provide the right temperature of the fluid; a “Care-Mode” prevents unnecessary alarms and a functional chassis allows easy mobility also in the narrow space at the bedside.

The multiFiltratePRO platform is based on modern technology and builds on substantial experience with our successfully established Ci-Ca® regional anticoagulation which results in less bleeding for the patients.

Dr. Olaf Schermeier, chief executive officer for Global Research and Development stated: “Over the time we expect to expand this new therapy platform. The reliable and simple user interface helps reducing the demand on personnel while providing the highest treatment quality. And spending less time with handling complex technology offers the opportunity to pay more attention to the patient itself.”

Fresenius provides an incentive to inventors for what often is a long path from their initial flash of genius to ultimately achieving a marketable product. In this endeavor, the health care group aims to promote innovative developments within all medical sectors. For the event's 11th running, bright minds will be able to present their ingenuity during the Fresenius Inventors' Fair. The biennial event will be staged in conjunction with MEDICA 2010, the world's largest medical trade fair, held in Düsseldorf Nov. 17–20. The adjunct fair offers participating researchers, developers and inventors an international forum to attract the attention of potential business partners and investors for the marketing and advancement of their initial innovations up to market-ready products. The top three entries are chosen on the opening day of the MEDICA event by an independent jury comprised of medical specialists and business professionals. The Fresenius Inventors' Award carries cash prizes totaling €10,000. Above all, recognition is based on the criteria of potential usefulness, innovativeness and feasibility of being implemented. Registration of entries for the competition is now open.

An engineer hailing from Karlsruhe, Dr. Nicole Kikillus was the winner of the 2008 Fresenius Inventors' Award. She developed a particularly reliable method of detecting atrial fibrillation in patients, even if no such fibrillation occurs during a medical checkup. This condition is the leading clinical type of cardiac arrhythmia and increases the risk of stroke. Kikillus' software analyzes a 30- to 60-minute single-channel electrocardiogram, yielding an early diagnosis of atrial fibrillation patients and enabling therapy to reduce the chances of stroke.

As of immediately, physicians, researchers, engineers and other practitioners from the hospital field and medical care profession can submit their entries for consideration. Fresenius will provide winning entries display space and an exhibit booth at the fair free of charge. Selected from among numerous professionals from all medical fields who entered the previous competition, 20 such exhibitors presented their innovations at the 2008 Fresenius Inventors' Fair.

The deadline for competition entries is Oct. 1, 2010. Further details about the Fresenius Inventors' Fair can be found at www.fresenius.com/inventorsfair; and about the MEDICA event at www.medica-tradefair.com. Contact: Fresenius SE; Keyword: "Inventors' Fair", 61346 Bad Homburg, Telefax: +49 61 72 - 6 08 22 94, E-mail: daniela.hegemann@fresenius.com.

The trifunctional antibody Removab^® (Catumaxomab) from Fresenius Biotech was awarded this year's Galenus von Pergamon Prize in the "Specialist Care" category. The jury acknowledged Removab^®'s new therapeutic mechanism and medical relevance for the treatment of malignant ascites. The prize underlines Removab^®'s unique position among innovative oncology drugs. The Galenus von Pergamon Prize awarded by "Springer Medizin Ärzte Zeitung" honors research and innovative drug development in Germany. An independent jury awards the prize annually in the "Primary Care" category and in the "Specialist Care" category. This year's awards ceremony was held on October 21.

Dr. Christian Schetter, CEO of Fresenius Biotech: "Winning the Galenus von Pergamon Prize is a significant recognition of our work. The trifunctional antibody Removab^® offers not only a new approach to cancer treatment, it also significantly improves our patients' quality of life. We are currently preparing studies to investigate the antibody's effectiveness in the treatment of other indications as well as for intravenous administration."

Removab^®, with its trifunctional mode of action, represents the first of a new generation of antibodies. Removab^® binds to three different cell types simultaneously: One arm of the antibody binds to the EpCAM (epithelial cell adhesion molecule) antigen in carcinoma cells, another arm binds to the CD3 molecule of T cells, and the third binds to the intact Fc region of accessory immune effector 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 that are the main cause of ascites.

Removab^® has been available in the European Union for treatment of malignant ascites since April 2009. Catumaxomab (Removab^®) is a trifunctional antibody developed by TRION Pharma GmbH. Fresenius Biotech is responsible for the clinical development, approval and commercialization of Removab^®.

Promising innovations from a variety of medical specialties will be on display Nov. 17-19 during the 11th Fresenius Inventors' Fair in conjunction with the Medica international trade fair and congress in Dusseldorf, Germany. The event is the first time the ideas of 22 specially selected researchers, developers and inventors will be shown to a broad audience. The top three entries will be honored with the Fresenius Inventors' Award, which includes prize money totaling €10,000. The winning entries are picked on Medica's opening day by a jury comprised of medical specialists and industry representatives. About 40 doctors, scientists, engineers, technicians and health care professionals are among the entrants this year. The competition covers a broad spectrum of innovations - from a device for detecting contagious diseases in a person's breath to a mobile EKG (electrocardiograph) to submersible training equipment for knee and hip joints. The Fresenius Inventors' Fair is held every two years during the Medica event.

The competition's previous winner is a good example of just how innovative the ideas are at the Fresenius Inventors' Fair: Dr. Nicole Kikillus, an engineer from Karlsruhe, Germany, developed a particularly reliable method for detecting atrial fibrillation, even if no atrial fibrillation occurs during a medical checkup. This enables an early diagnosis and reduces the risk of stroke. The second-place finisher – a fluorescent method to identify and perform a sentinel node biopsy in cancer patients – already is being used in clinics. Other innovations from previous competitions include a special pen for diagnosing and treating neurological illnesses such as Parkinson's disease, a needle that facilitates taking blood samples from newborns, an endoscope for nearly pain-free colonoscopies, a new procedure for manufacturing nitrate monoxide, and a mobile washing station for bedridden patients.

"Many promising medical inventions often go unnoticed, rather than benefitting as many patients as possible," said jury member Martin Hepper. "Fresenius wants to help researchers find companies to further develop or market their ideas. During the Inventor's Fair, they have the opportunity to present their innovations to a broad audience of specialists and industry contacts." As the experience of previous fair participants shows, many researchers have been successful in establishing instrumental liaisons with companies. Last year, Medica had more than 138,000 visitors from Germany and abroad.

The Fresenius Inventors' Fair will be held Nov. 17-19 in Hall 8b during the Medica international trade fair and congress in Dusseldorf, Germany. The award ceremony will begin at 2 p.m. on Wednesday, Nov. 17. Medica runs Nov. 17-20, 2010, from 10 a.m. to 6:30 p.m. (Saturday until 5 p.m.). Additional information on the Inventors' Fair is available at www.fresenius.com/inventorsfair; and about the MEDICA event at www.medica-tradefair.com.

A jury of experts today presented the 2010 Fresenius Inventors' Award to a portable, capacitive-electrode-based electrocardiogram (EKG) system. Dr. Martin Oehler, an engineer from the Technische Universität of Braunschweig, Germany, won first place and €5,000 for his invention at the 11th Fresenius Inventors' Fair held in conjunction with the Medica international trade fair and congress in Dusseldorf, Germany. Second place and €3,000 were awarded to Jan-Marten Seitz, a mechanical engineer from the Institute of Materials Science at Gottfried Wilhelm Leibniz Universität in Hanover, Germany, who developed a process for the manufacture of bioresorbable magnesium stents (vessel wall supports). Physics Professor Werner Mäntele from the Institute for Biophysics at the Goethe University in Frankfurt am Main, Germany, was happy to receive the third prize and €2,000 for his device enabling the measurement of heparin concentration in blood by means of static diffusion of light.

The top prize-winning portable EKG system is equipped with over 29 capacitive sensors. These enable a high-resolution EKG measurement through clothing. The system can be applied directly over a patient's clothing and delivers an EKG signal within a few seconds. "Patients have to be disrobed in the case of conventional EKG measurements employing gel-based or dry electrodes, which causes delays. Furthermore, there is a risk of skin irritations as well as additional costs for consumable supplies in the use of adhesive electrodes," said award winner Oehler. "The capacitive EKG system we developed can save crucial time and is entirely reusable." An EKG records the electrical activity of coronary fibers. This information provides important parameters such as heart rate or cardiac rhythm, which render indications of heart conditions and coronary problems such as irregular heartbeat or a heart attack.

Seitz received the second prize for his process enabling the manufacture of bioresorbable magnesium stents. Stents are vessel wall supports which can be implanted in hollow organs in order to keep them fully open for example during paranasal sinus operations. Nonresorbable stents, for example made of silicon, are currently used for such applications. These either remain in the body, which can lead to complications for the patient, or subsequently must be removed, which can result in trauma and the formation of scar tissue. In contrast, the magnesium-alloy stents developed by Seitz are entirely bioresorbable, whereby their disintegration can be regulated by means of a special coating process.

The third-place device developed by Mäntele employs static diffusion of light to measure the concentration of heparin present in a patient's blood. Heparin is a medication to prevent the coagulation of blood. It is used, for example, during coronary surgery, in the course of hemodialysis treatments was well as in thrombosis prevention. Mäntele's apparatus measures the diffusion of light from nanoparticles formed within a blood plasma sample between heparin and the protamine peptide which counters the heparin's effectivity. Results are delivered within a matter of minutes and thus enable a precise control of blood coagulation both during and subsequent to an operation.

A total of 23 selected researchers and developers will be presenting their ideas until Nov. 19 during the Fresenius Inventors' Fair. A jury comprised of medical specialists and industry representatives chose the three prize winners from among the field of entries. The health care company sponsors the Fresenius Inventors' Fair to help researchers find professional business partners and industrial contacts as well as potential investors in order to further develop and market their ideas. Fresenius provides all the exhibiting entries display space and an exhibit booth at the fair free of charge, enabling them to present their developments to trade experts and media representatives from around the world. About 40 doctors, scientists, engineers, technicians and health care professionals were among the entrants this year. The Fresenius Inventors' Fair is held every two years during the Medica event. Last year, Medica had more than 138,000 visitors from Germany and abroad.

The Fresenius Inventors' Fair will be held Nov. 17-19 in Hall 8b during the Medica international trade fair and congress in Dusseldorf, Germany. Medica runs Nov. 17-20, 2010, from 10 a.m. to 6:30 p.m. (Saturday until 5 p.m.). Additional information on the Inventors' Fair is available at www.fresenius.com/inventorsfair; and about the Medica event at www.medica-tradefair.com.

Photographs of the award winners can be accessed online at http://tinyurl.com/erfinderpreis-2010.

Fresenius Medical Care AG & Co. KGaA (Frankfurt Stock Exchange: FME / New York Stock Exchange: FMS), the world's largest provider of dialysis products and services, yesterday introduced the 2008T, a smart-platform dialysis system featuring Fresenius Clinical Data Exchange® (CDX) software, at the American Society of Nephrology's 43rd Annual Meeting and Scientific Exposition in Denver, Colorado. The groundbreaking technology is the first fully integrated dialysis therapy and management information system on the market and was developed to help physicians and clinic operators adjust to the new bundled payment environment due to take effect in the United States in January 2011. Available immediately, the 2008T currently is scheduled to be marketed in North America and is cleared for use in the USA and Canada by the U.S. Food and Drug Administration and Health Canada.

The 2008T combines the company's most advanced hemodialysis delivery system with Fresenius Clinical Data Exchange® (CDX) to provide caregivers, for the first time, chairside access to both dialysis treatment and medical information system (MIS) data to facilitate real-time adjustments to therapy and care plans. The platform accommodates MIS software from third-party vendors as well as the company's proprietary systems, providing immediate access to all dialysis treatment and clinical trending data traditionally held in multiple locations. This integrated approach streamlines workflow and maximizes data collection for comprehensive billing.

The 2008T was developed in close association with the Renal Research Institute, one of the pre-eminent research institutions in the United States focused on improving the clinical care and quality of life of patients with chronic kidney disease.

The European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) today issued a positive opinion recommending approval of Removab for the intraperitoneal treatment of malignant ascites.

The approval by the European Commission (EC) is expected within a few months. The decision, which is usually based on the CHMP opinion, will apply to all EU member states. Removab would be the first drug worldwide with a regulatory label for the treatment of malignant ascites. Fresenius Biotech is prepared to launch Removab upon approval.

The CHMP opinion is based on the results of one large international phase II/III pivotal study with the primary endpoint of puncture-free survival*. The study demonstrated that patients receiving Removab experienced a four-fold increase in puncture-free survival over a therapy consisting of puncture alone. These data were presented at the 2008 Annual ASCO Meeting in Chicago, Illinois.

"The positive opinion is important news for all cancer patients diagnosed with malignant ascites and we look forward to filling a high unmet medical need with Removab" says Ulf Mark Schneider, Chairman of the Management Board of Fresenius SE. "The launch of Removab is a significant milestone for Fresenius Biotech as it progresses from the development to the successful commercialization of biopharmaceutical products."


Background information:

*About the Pivotal Study
The study involved 258 patients with malignant ascites due to carcinomas. Of those, 129 suffered from ovarian cancer while another 129 had non-ovarian cancers. Patients received both puncture (paracentesis) and four intraperitoneal infusions of Removab within 11 days, or paracentesis alone (control group).
The trial met its primary endpoint with high statistical significance. Patients treated with Removab showed a median puncture-free survival (primary endpoint) of 46 days compared with 11 days in the control group (p< 0.0001) (Hazard Ratio: 0.254). Puncture-free survival was defined as the period between the last infusion and the first subsequent necessary puncture or death, whichever occurred first. The median puncture-free time – a secondary endpoint which did not include the data from patients who died before the next ascites puncture was due – was 77 days versus 13 days (p< 0.0001).

The most common side effects observed during the trial, such as fever, nausea and vomiting were all due to Removab's postulated mode of action.
These side effects were predictable, limited, manageable and mostly fully transient.

Malignant Ascites
Malignant ascites can be caused by different carcinomas. Abdominal spread of cancer cells leads to an accumulation of fluid in the abdominal cavity and is associated with a poor prognosis. The most commonly used treatment of malignant ascites is puncture (paracentesis), which has to be carried out on average every one to two weeks and can lead to complications such as infection and fluid or protein deprivation. The trifunctional antibody Removab is known to kill cancer cells in the peritoneal cavity and therefore attacks the primary cause of ascites formation.

Trifunctional Antibody 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 reaction against cancer cells. Removab binds to three different cell types simultaneously: One arm of the antibody recognizes and binds to T cells, the other arm binds EpCAM (epithelial cell adhesion molecule) that is expressed in many types of carcinomas. In addition, immune effector cells with Fc receptors (such as macrophages, monocytes, dendritic cells and natural killer cells) bind to the Fc region of Removab. This simultaneous binding subsequently results in the co-stimulation and activation of T cells and accessory cells, enabling the generation of a strong immune response against cancer cells.
Preclinical data for trifunctional antibodies also suggest a potential long-lasting effect to prevent cancer recurrence. Removab is further developed in various indications (e.g. gastric and ovarian cancer) addressing the underlying cancer.
Catumaxomab is a trifunctional antibody developed by TRION Pharma GmbH.

The European Commission has approved Removab (catumaxomab) for the treatment of malignant ascites with immediate effect. It is the first drug worldwide with a regulatory label for the treatment of malignant ascites and provides an important new therapy approach. The approval is based on the results of a large international phase II/III pivotal study which demonstrated a statistically significant improvement of the primary endpoint puncture-free survival. Patients receiving Removab had a four-fold increase in puncture-free survival over a therapy with puncture alone.

The European Commission's decision will apply to all EU member states. Removab will initially be launched in Germany within the next few weeks and will subsequently be introduced in other European countries. With its trifunctional mode of action Removab represents a new generation of antibodies using the body's own immune system to help fight the tumor cells. It is approved for the treatment of malignant ascites in patients with EpCAM positive carcinomas where standard therapy is not available or no longer feasible. The antibody will be administered as four intraperitoneal infusions with ascending doses following a paracentesis.

Malignant ascites is most common in ovarian, pancreatic and gastric cancers with an incidence of 20 to 50% of all cases. Malignant ascites develops late in the course of the cancer disease and regularly has a strong impact on the patient's quality of life. Removab effectively destroys cancer cells in the peritoneal cavity and therefore attacks the primary cause of ascites formation leading to a significant improvement in the quality of life.



About the Pivotal Study
The study involved 258 patients with malignant ascites due to carcinomas. Of those, 129 suffered from ovarian cancer while another 129 had non-ovarian cancers.
Patients received paracentesis followed by four intraperitoneal infusions of Removab within 11 days, or paracentesis alone (control group).
The trial met its primary endpoint with high statistical significance. Patients treated with Removab showed a median puncture-free survival (primary endpoint) of 46 days compared with 11 days in the control group (p< 0.0001) (Hazard Ratio: 0.254). Puncture-free survival was defined as the period between the last infusion and the first subsequent necessary paracentesis or death, whichever occurred first. The median puncture-free time – a secondary endpoint which did not include the data from patients who died before the next ascites puncture was due – was 77 days versus 13 days (p< 0.0001).

The most common side effects observed during the trial, such as fever, nausea and vomiting were all due to Removab's postulated mode of action. These side effects were predictable, limited, manageable and mostly fully transient.

Malignant Ascites
Malignant ascites can be caused by different carcinomas. Abdominal spread of cancer cells leads to an accumulation of fluid in the abdominal cavity and is associated with a poor prognosis. The most commonly used treatment of malignant ascites is puncture (paracentesis), which has to be carried out on average every one to two weeks and can lead to complications such as infection and fluid or protein deprivation. The trifunctional antibody Removab is known to kill cancer cells in the peritoneal cavity and therefore attacks the primary cause of ascites formation.
The most common carcinomas causing malignant ascites are: ovarian, gastric, colorectal, pancreatic, breast and endometrial.

Epithelial Cell Adhesion Molecule (EpCAM)
EpCAM is a tumor associated antigen expressed on the vast majority of carcinomas (epithelial tumors). EpCAM is expressed on tumor cells in the majority of effusions (ascites) due to carcinomas.

Trifunctional Antibody 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 reaction against cancer cells. Removab binds to three different cell types simultaneously: One arm of the antibody recognizes and binds to T cells, the other arm binds EpCAM (epithelial cell adhesion molecule) that is expressed in many types of carcinomas. In addition, immune effector cells with Fc receptors (such as macrophages, monocytes, dendritic cells and natural killer cells) bind to the Fc region of Removab. This simultaneous binding subsequently results in the co-stimulation and activation of T cells and accessory cells, enabling the generation of a strong immune response against cancer cells.
Preclinical data for trifunctional antibodies also suggest a potential long-lasting effect to prevent cancer recurrence. Removab is further developed in various indications (e.g. gastric and ovarian cancer) addressing the underlying cancer.
Catumaxomab is a trifunctional antibody licensed from TRION Pharma GmbH.

Fresenius Medical Care AG & Co. KGaA, the world's largest provider of dialysis services and products, has launched a new website focusing on dialysis medications ("renal pharmaceuticals"). At www.fmc-renalpharma.com, doctors as well as patients and the interested public are now able to find information about Fresenius Medical Care's pharmaceutical expertise.

The website provides information about the effectiveness of dialysis medication, proper treatment types, Fresenius Medical Care´s partners and the company itself. In addition, it includes a comprehensive glossary, a space for current news as well as a calendar of trade fairs and other events. The website also offers general information about dialysis medication and related areas of care, providing valuable information to non-specialist individuals. In-depth information about individual dialysis drugs is password protected due to the Medication Advertising Law and is only available to doctors and other medical personnel.

An additional feature of the Renal Pharma website is Dia-PhoCal (also available at www.diaphocal.com). This is an interactive training tool on bone mineral metabolism. Doctors and hospital employees can learn about the interaction between calcium, phosphate, parathormone (which regulates the calcium balance in the blood) and calcitriol (Vitamin D created by the kidneys) in dialysis patients and observe how these parameters in bone metabolism react to the introduction of various drugs. In adherence to Medication Advertising Law, Dia-PhoCal is also protected by a password.

Currently the site is available in English only. In future, further language versions as well as additional information about new products and especially information targeted to patients will be made available.