Fresenius Kabi

Fresenius Kabi is focused on developing products that significantly support medical advancements in the acute and postacute treatment of critically and chronically ill patients and on helping to improve their quality of life. At the same time, we want to make high-quality treatments available to patients worldwide.

Our R & D strategy is aligned with this focus:

  • develop innovative products in areas where we hold a leading position, such as blood volume replacement and clinical nutrition
  • develop new formulations for drugs no longer protected by patent
  • continue to develop and refine our existing portfolio of pharmaceuticals and medical devices

Our development competency encompasses all the relevant components: the pharmaceutical solution, the primary packaging, the medical device for application, and the production technology. We are also one of the few companies in the world that cover the entire production chain for IV drugs: from the processing of the raw materials and the production of the active pharmaceutical ingredient through to the manufacture of the drug.

A key focus of our R & D work is to expand global distribution of our product portfolio. We continuously apply for authorization to market our products in major sales regions throughout the world – including the United States, where our acquisition of APP Pharmaceuticals will grant us key access to the North American market.

Infusion therapies

In 2009, we continued our research and development efforts in the area of blood volume replacement. More than 130 published studies support the efficacy and safety of our product Voluven®. In the course of our R & D activities we also continued to support randomized, double-blind studies with Voluven® 6 % for sepsis, trauma, and caesarian section. In 2009, we also started a clinical study that examines our product Voluven® 6 % in comparison with crystalloids in the treatment of about 7,000 intensive care patients.

We also intensified our development work on HESylation® technology. This technology enables an active pharmaceutical ingredient to be coupled to specific hydroxyethyl starch molecules, decisively modifying a drug’s profile. Such coupled products show a longer half-life and a better safety profile than unmodified drugs. In 2009, we entered into partnerships with Bayer Schering Pharma and the Swiss company Octapharma.

Intravenously administered drugs

In the field of IV drugs we focus on high-quality generics for the therapy areas of anesthetics, analgesics, infectious diseases, oncology, and drugs for the treatment of critical diseases.

Our long experience in developing infusion therapies enables us to transfer our extensive expertise in this field, as well as modern pharmaceutical technologies, to the development of generics and achieve specifically targeted improvements in known drugs. The safe application of our products in day-today medical care is another important focus for us. Intelligent packaging concepts, like our color code safety concept for instance, enable all products and their different active substance concentrations to be easily distinguished. This guarantees a high degree of safety for the patient and the nursing staff. The clear, safe, and readily transparent system complies with national and international standards.

Our R & D pipeline contains an extensive portfolio of active drugs that will be coming to market in the next few years. We currently have about 125 products at different stages of development.

In 2009, we worked intensively on dossiers for the registration of new generics in order to obtain marketing authorization quickly once originator drugs go off-patent. In line with our internationalization strategy for generic IV drugs, we are placing priority on marketing approvals for Europe, North America, Asia-Pacific, and Latin America.

In 2009, our US subsidiary APP Pharmaceuticals obtained marketing authorization for seven generics for the US market. APP currently has 35 ANDAs (Abbreviated New Drug Applications) pending at the FDA.

In the area of generics for critical diseases, we are working intensively on broadening our product portfolio for the European market. In 2009, we filed for four drug applications for this market, and plan to launch nine products in different presentation forms and for various countries in 2010 and 2011.

We also see the launch of new oncology generics as an important driver of future growth. In oncology, we offer an extensive range of drugs in different formulations and dosage forms. In 2009, we filed applications worldwide for the marketing authorization of 15 drugs for products in different formulations and dosage forms. We plan to launch these products in 2010 and 2011.

Clinical nutrition

In parenteral nutrition we concentrate on developing products which have a high 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

One of our core development areas is the use of lipids in parenteral nutrition therapy. SMOFlipid®, for instance, is a lipid emulsion which has clinical benefits over ordinary lipid emulsions due to its composition and the fact it contains four different lipid components.

The product has become successfully established for severely ill adult patients. Nutrition is also particularly important in pediatric care as only an adequate supply of nutrients suited to the child’s age can assure normal growth and proper development. Undeveloped or severe gastrointestinal defects at birth and acute ailments are indications for parenteral nutrition in pediatric patients. In 2009, we obtained approval for SMOFlipid® for use in pediatric care. This product can provide the fat component of a parenteral nutrition therapy supplying all nutrients necessary to prevent malnutrition and support the growth and development of pediatric patients.

In 2009, we introduced a dosage increase of our product Dipeptiven® on the market. Dipeptiven® is a concentrate of alanyl glutamine that, when compatible, can be added to any parenteral nutrition regime. Glutamine is administered to patients in a highly catabolic metabolic condition, which can occur for instance in intensive-care or after major surgery. In such cases glutamine is required in large amounts by the intestinal and immune cells as an essential source of energy and nitrogen to maintain their functioning. Glutamine deficiencies otherwise can lead to functional disorders.

The high relevance of glutamine in parenteral nutrition for the clinical outcomes of intensive care patients was also confirmed by the European Society for Clinical Nutrition and Metabolism (ESPEN) in its updated guidelines, which recommend that intensive-care patients with an indication for parenteral nutrition receive glutamine.

In our development activities in the area of enteral nutrition, we are focusing on sip and tube feed nutrition products for malnourished patients and on therapeutic products for dysphagia, diabetes, oncology, and critical illness. We are thus combining the latest insights in both medical and nutritional science and food and process technology into our product development. This approach enables us to offer innovative nutrition products matched to the specific patient profile. At the same time, we are countering side-effects that arise during long-term therapy, e. g. patients growing tired of the taste, with a broad range of sip feed products featuring different flavors.

In 2009, we continued work on our new product concept in diabetic therapy that can be used especially for diabetes mellitus patients with impaired glucose tolerance and insulin resistance. We plan to launch our new products in 2010.

We also continued to broaden our product offering for dysphagia patients and worked on the development of further Fresubin® products. We plan to launch these new products in the market in 2010. Dysphagia is a term used to refer to difficulties in controlling the swallowing process, which can have a wide range of causes, for instance stroke, cancer diseases, neurological ailments, and Parkinson’s disease. In patients with dysphagia the swallowing reflex is delayed or completely inoperative. About 60 % of elderly people in hospitals or living in nursing homes suffer from dysphagia.1 Nutritional deficiencies and dehydration can be effectively remedied with a product line specially designed for this group of patients.

In the field of medical devices for the application of enteral nutrition, we are constantly working on new technologies that ensure necessary nutrients are supplied safely, efficiently, and conveniently. In 2009, one focus was the development of an innovative connector system for the application of enteral nutrition products. In infusion therapy, connectors are the connecting devices to syringes, canulas, and infusion lines. To avoid the risk of misconnections of enteral nutrition lines in day-to-day medical care, we are working on a novel connector system that excludes accidental connection with intravenous application techniques. A patent application has been filed for the system and we plan to successfully complete development work in the course of 2010.

1 Clavé P et al. Rev Esp Enferm Dig 2004; 96: 119–131

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