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Fresenius Kabi

Fresenius Kabi’s R & D activities concentrate on products for the therapy and care of critically and chronically ill patients. Our focus is on therapy areas with high medical needs, such as in the therapy of oncology patients. We develop products that help to support medical advancements in acute and post-acute care and improve the patients’ quality of life. At the same time, we want to make high-quality treatments available to patients worldwide through our comprehensive range of generics. Our focus in the medical device segment is to develop products significantly contributing to a safe and effective application of infusion solutions and clinical nutrition. With the Fenwal acquisition we strengthened our R & D competencies in transfusion technology to support medical advancements in the medical devices area as well.

Our R & D strategy is aligned with this focus:

  • develop innovative products in areas where we hold a leading position, such as clinical nutrition
  • develop own generic drug formulations ready to launch at the time of market formation
  • develop new formulations for non-patented drugs
  • continue to develop and refine our existing portfolio of pharmaceuticals
  • develop innovative medical devices.

We have comprehensive development expertise, which includes all the related components: the drug raw material, the pharmaceutical formulation, the primary packaging, the medical device needed for application, and the production technology for high-quality and cost-efficient manufacturing. Fresenius Kabi covers the entire production chain for IV drugs: from the processing of raw materials and the production of the active ingredient all the way through to manufacturing the drug. Producing the pharmaceutical active ingredient in our own production facilities gives us a major advantage, as it ensures that we always maintain the same high quality. It also allows us to continually improve and develop the raw materials we use as well as the ways we process them. For instance, we significantly improved the synthesis steps for the raw material in our product Paclitaxel, which enabled us to increase the efficiency of our production processes.

Another important element of our activities is to obtain marketing approval for new products. We work continuously on dossiers for the registration of our products in every major market in the world. This applies both to our established portfolio, where we expand our distribution internationally through marketing approvals in new local markets. In addition, we work to obtain approvals for new products in order to expand our product portfolio.

Infusion therapies

In 2012, we continued to develop a manufacturing technology for our infusion solution plastic bottle. During the so-called “stretch blow molding” process, a preform of the plastic bottle is formed to its ultimate shape. After filling, the cap is molded onto the container as the last process step. One advantage of this manufacturing technology is the mechanical strength resistance of the container.

Moreover, at production lines with high capacity we can achieve cost savings by using this technology. In 2012, we began to set up our first production line for this manufacturing technology.

Intravenously administered drugs

For our IV drugs, we are working on developing a comprehensive range of generics for the therapy areas of anesthetics, analgesics, infectious diseases, oncology, and critical diseases medicine, and develop both generic and also, if appropriate, new and improved drug formulations.

Another example of this work is our ongoing development effort to provide ready-to-use solutions for IV drugs, which currently exist only in lyophilized powder form. The switch to a ready-to-use form requires modifying the drug formula in such a way that the pharmaceutical drug is stable in liquid form. We used such a new formulation for our cancer drug Docetaxel, and the European Medicines Agency (EMA), approved it in Europe. The new product consists of a 20 mg/ml Docetaxel concentrate and is added directly to the infusion solution, which eliminates the initial dilution step required by the current product. This makes preparation easier, safer, and less time-consuming.

We are also increasingly utilizing our freeflex® bag for our IV drugs. It provides excellent drug compatibility, and the port system allows for safe use in day-to-day medical care. The bag also plays a role in our development of ready-to-use solutions for IV drugs in an appropriate carrier solution. The advantage here is in eliminating the step of injecting the solution into the carrier solution, which reduces a potential source of error in day-to-day medical care.

Our development portfolio contains an extensive range of active drugs that we expect to bring to market over the next few years. We are currently working on more than 120 projects to develop generic drugs, of which more than a third were initiated in 2012 alone. The aim is to be able to offer a top-quality generic right after patent expiry of the originator or branded drug. Accordingly, in 2012, we received approvals for IV drugs that will first be introduced in one to two years.

Our aim is to offer a comprehensive range of top-quality generic drugs on a global basis. To this end, we intensely focused on obtaining approvals in the various markets over the course of 2012. The table below lists some of our major approvals.

Product Launches IV Drugs


Product Country/Region Indication
Cytarabine several European countries Oncology
Docetaxel 1 Vial (RTU) Europe Oncology
Remifentanil additional European countries Anesthesia
Imipenem Cilastatin USA Anti-infectives
Meropenem USA Anti-infectives
Methotrexate USA Oncology
Oxaliplatin (RTU) USA Oncology
Propofol LCT 100 ml Japan Anesthesia

Product Country/Region Indication
Cytarabine several European countries Oncology
Docetaxel 1 Vial (RTU) Europe Oncology
Remifentanil additional European countries Anesthesia
Imipenem Cilastatin USA Anti-infectives
Meropenem USA Anti-infectives
Methotrexate USA Oncology
Oxaliplatin (RTU) USA Oncology
Propofol LCT 100 ml Japan Anesthesia

Clinical nutrition

In parenteral nutrition we develop products that have a strong therapeutic effect in the care of critically and chronically ill patients. Our focuses are:

  • parenteral nutrition products that improve the therapy of patients in hospital
  • innovative containers, e. g. multi-chamber bags that allow maximum application safety and convenience in everyday use

Our development departments continually work on preparation for introducing new products on a global basis. The planned introduction of our parenteral nutrition products in the United States, for example, is of great significance. We have placed intensive effort on the documentation needed for approval of these products.

One focus of our development work in parenteral nutrition therapy involves the use of lipids, particularly for premature and new born infants, nurslings, and children. The fatty acid profile and especially the amount of fish oil in our product SMOFlipid® make it an ideal lipid emulsion for pediatrics. We already supply this product to many countries in Europe for pediatric use. In 2012, we received supplemental approval for SMOFlipid® to be applied when parenteral nutrition treatment is required over an extended period for children or adults.

Furthermore, additional clinical data were published based on studies of SMOFlipid® used in pediatrics as well as in extended nutrition treatment periods. These data confirm the product’s good tolerability and effectiveness.

In enteral nutrition, we focus on sip and tube feed products for malnourished – often geriatric – patients and on therapeutic products for dysphagia (difficulties in swallowing), diabetes, oncology, and critical illness. We are thus combining the latest insights in both medical and nutritional science as well as nutrition and process technology into our product development. This approach enables us to offer innovative nutrition products matched to the specific patient profile. In the area of dysphagia, we are working on products that would have the same consistency and flow characteristics as a contrast medium used for esophageal tests. It would make the swallowing process safer for patients by significantly reducing the risk of fluids or food entering the airways or lungs.

We are also constantly working on new, improved flavors for our sip feed products to counter side effects that arise during long-term therapy, e. g. patients growing tired of the taste. Our broad range of products in different flavors increases patients’ adherence to the dietetic regime and simultaneously helps to improve their quality of life.

We are intensively examining the consequences of malnutrition. Nutritional and energy deficiencies are often due to heightened needs, e. g. as a result of tumor diseases, injuries, or surgery, or due to insufficient intake resulting, for example, from difficulties chewing or swallowing. Neurological disorders or excessive loss of nutrients, possibly due to intestinal disorders, can also lead to malnutrition. We are working together with the European Society for Clinical Nutrition and Metabolism (ESPEN), the Dysphagia Research Society (DRS), the European Nutrition for Health Alliance (ENHA), and the International Medical Nutrition Industry Group (MNI) on ways to inform people about the consequences of malnutrition for patients and possible therapies.

A major focus of our development of medical devices is on the internationalization of our product portfolio. To this end, we adapt products to meet local regulatory and country-specific requirements. This involves not only language adaptations but also modifications to match the specific medical practice and routine in the various countries. In 2012, we continued to work on adapting our medical devices to meet specific requirements in the United States.

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