Fresenius Kabi

Fresenius Kabi’s R & D activities concentrate on products for the treatment and care of critically and chronically ill patients. Our focus is on therapy areas with high medical requirements, such as 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 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 non-patented drugs
  • develop own generic drug formulations for the date when drugs go off-patent
  • continue to develop and refine our existing portfolio of pharmaceuticals and medical devices.

We have an encompassing development competency which includes all the relevant components: the drug raw material, 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 ingredient through to the manufacture of the drug. This competence enables us to offer IV drugs that place special demands on development and especially on production, as is for example the case with oncological products. Here, we also develop and manufacture cytostatics both as finished products and as patient-specific compounding preparations. Wherever possible, we develop and produce the active pharmaceutical ingredient in our own research labs and production facilities in order to ensure first-rate quality.

Another important element of our activities is the preparations for obtaining marketing approval for new products. We are constantly working on dossiers for the registration of our products for all the world’s major markets. This applies to our established portfolio, which we roll out on a broader international basis through marketing authorizations for new local markets, while at the same time we work on applications for new products.

Infusion therapies

In 2010, we continued our research and development efforts in the area of blood volume replacement. Voluven® is one of our most successful blood volume replacement products. About 30 million1 patients have been treated with this preparation since it was launched in 1999. National and international working groups have so far published over 180 studies on Voluven® validating the product’s efficacy and safety. In 2010, we also continued our extensive clinical research program in this area and are thus constantly adding to the clinical evidence in the treatment with blood volume substitutes.

We continued to support randomized, double-blind studies with Voluven® 6% for sepsis, trauma, and caesarean section. We also continued a clinical study that is examining our product Voluven® 6% in comparison with crystalloids in the treatment of about 7,000 intensive care patients. In addition, we supported several studies in the areas of anesthetics and intensive care medicine with our product Volulyte®, which contains our proven HES (hydroxyethyl starch) active ingredient in a balanced electrolyte solution.

Fresenius Kabi is the world’s largest manufacturer of HES products for pharmaceutical use and has been one of the leading companies in this field for decades. Building on our extensive know-how we have developed the HESylation® technology. This technology enables an active pharmaceutical ingredient to be coupled to specific hydroxyethyl starch molecules, decisively modifying a drug’s profile. In this way it is possible to modify important pharmacological parameters such as resorption, decomposition, half-life, water solubility, and safety. We continued to develop our HESylation® technology in 2010 in cooperation with our pharmaceutical industry partners with whom we collaborate on a project basis. Further milestones in the development of the HESylation® technology were reached, for instance, together with Bayer Schering AG and Boehringer Ingelheim RCV, an Austrian company of the Boehringer Ingelheim Group.

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 solutions is a clear advantage in the development of new generics. We work on specifically targeted improvements, for instance in drug formulations and packaging of known drugs, to contribute to the optimized therapy of chronically and critical ill patients. The application security of our products is another important focus in our development work. We develop user-friendly packaging concepts, like for example our color code safety concept. This enables 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. This clear, safe and readily transparent system conforms to 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 135 products at different stages of development. Our aim is to offer a comprehensive portfolio of highquality generics globally. It is important that we bring products to market as quickly as possible. In our marketing approval activities we therefore worked intensively on dossiers for the registration of new generics.

In 2010, APP Pharmaceuticals had 28 drug applications in the marketing approval process with the FDA in the United States, 6 of which were filed by the company in the reporting period. Depending on how long the FDA review process takes, we expect to be able to launch these products within the next three years.

We also see the launch of new oncology generics as an important driver of future growth. In 2010, we filed applications worldwide for the marketing authorization of 35 drugs for products in different formulations and dosage forms. We expect to launch these products within the next two years.

We are also working intensively on marketing approvals for high-quality generics outside North America for the therapy areas of anesthetics, analgesics, infectious diseases, and drugs for the treatment of critical diseases. Here we filed applications for four drugs in 2010 and expect to obtain marketing approvals for 16 products based on new drugs in different formulations and countries within the next three years. In the area of analgesics, we obtained marketing authorization for an intravenously administered paracetamol in 2010. We have filed a patent application for this drug formulation.

Clinical nutrition

In parenteral nutrition we develop products which have a highly 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

The regional rollout of our successful product portfolio is also a central part of our R & D activities. The introduction of our parenteral products in the U.S. market plays an important role. We therefore worked intensively on the documentation for the products for which we wish to obtain marketing approval.

Products for the clinical nutrition of premature and newborn babies, nurslings, and infants are another focus of our R & D. In 2010, we worked on broadening our product portfolio for use in pediatric care. We also worked on the development of a further variant of our SmofKabiven® product and plan to complete this in 2011.

In our development activities in the area of enteral nutrition, we are focusing on sip and tube feed nutrition 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 and food and process technology into our product development. This approach enables us to offer innovative nutrition products matched to the specific patient profile. 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 helps to improve their quality of life at the same time.

We continued our development work on new products in the aforesaid therapy areas and brought products to market. For instance, we launched the Diben Creme product for diabetes mellitus patients.

Informing people about the consequences of malnutrition is an important concern of ours. 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, e. g. because of difficulties chewing or swallowing and neurological ailments, or due to excessive loss, e. g. as a result of intestinal disorders. We are working together with the European Society for Clinical Nutrition and Metabolism (ESPEN), 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. For instance, we see a standardized screening in Europe as an important step forward in fighting malnutrition.

In the field of medical devices we have set ourselves the aim of developing safe application products for effective therapies. Our focus is on their use in day-to-day medical care. To ensure that patients are treated correctly and successfully, complex application methods and different application systems are used to infuse drugs and nutrients and to transfuse blood or blood components. Not only the diversity of these products but also the number of medical staff involved in these processes pose major challenges for safe application.

In 2010, we continued our work on the development of an innovative connector system for the application of enteral nutrition products. In infusion therapy, connectors are the connecting devices to canulas, syringes, and infusion lines. To find the best possible way 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 for this system was already filed in 2009. We plan to launch the system at the end of next year.

The internationalization of our portfolio of medical devices is another focus of our development activities. Firstly, we plan to expand our portfolio’s market presence in Asia-Pacific and, secondly, we want to penetrate the U.S. market with our products. We completed the development work for the launch of our Agilia infusion pump in Japan, for instance. Language modifications had to be made and the device’s software menu was adapted to local requirements. We have also started with preparations to launch our first products in the U.S. market in the medium term.

1 Fresenius Kabi market research

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