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Fresenius Kabi

Fresenius Kabi’s research and development activities concentrate on products for the therapy and care of critically and chronically ill patients. Our focus is on areas with high medical needs, such as in the treatment of oncology patients. Our products help to support medical advancements in acute and post-acute care and improve the patients’ quality of life. We develop new products in areas such as clinical nutrition. In addition, we develop generic drug formulations ready to launch at the time of market formation as well as new formulations for non-patented drugs. Our medical devices significantly contribute to a safe and effective application of infusion solutions and clinical nutrition. In transfusion technology our R & D focus is on medical devices and disposables to support the secure, user-friendly, and efficient production of blood products.

Our development expertise 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. We cover 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 secures our competitive advantage in the longterm.

IV drugs and infusion therapies

In the area of IV drugs, we are developing an extensive portfolio of active drugs that are expected to come on the market in the next few years. In 2013, we worked on more than 110 development projects for generic drugs.

In an ongoing development effort, we aim to provide ready-to-use solutions for IV drugs, which currently exist only in lyophilized or powder form. In 2013, we worked intensively on these solutions and we plan to bring them to market in the coming years.

In addition, we are working hard to find solutions in innovative primary packaging. One example of this is pre-filled syringes. The first of these products is to be launched in 2014.

Worldwide, many of our drugs were approved in 2013 (please see table below).

In 2013, we committed to the European Medicines Agency (EMA) carrying out additional studies with our blood volume substitutes. The clinical trials required by the EMA of all manufacturers of drugs containing HES (hydroxyethyl starch) are being conducted for elective surgery and trauma patients. Based on the restrictions on use that the EMA places on blood volume substitutes containing HES – which affect all manufacturers – we have begun to modify the package leaflet accordingly.

PRODUCT APPROVALS IV DRUGS


ProductCountry / RegionIndication
Levofloxacin FFXUSAAnti-infectives
CapecitabineEuropeOncology
Gemcitabine RTUEuropeOncology
Zoledronic AcidEuropeOncology
MeropenemAsia-PacificAnti-infectives
RopivacaineAsia-PacificAnesthesia
RocuroniumLatin AmericaAnesthesia
ParacetamolLatin AmericaCritical Care

ProductCountry / RegionIndication
Levofloxacin FFXUSAAnti-infectives
CapecitabineEuropeOncology
Gemcitabine RTUEuropeOncology
Zoledronic AcidEuropeOncology
MeropenemAsia-PacificAnti-infectives
RopivacaineAsia-PacificAnesthesia
RocuroniumLatin AmericaAnesthesia
ParacetamolLatin AmericaCritical Care

Clinical nutrition

In parenteral nutrition 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

Among other things, our efforts focused on the early and correct use of parenteral nutrition in order to avoid malnutrition and its consequences. According to the results of a research collaboration published in 2013, early parenteral nutrition of critically ill patients can shorten the duration of mechanical ventilation and reduce muscle wasting as compared with standard treatment. In turn, this can help to reduce hospital costs.¹

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.

In addition, in 2013, we supported clinical studies with our products Fresubin 2kcal, Diben, and Supportan. The results of these studies showed that the addition of these products significantly improved the nutritional status for critically ill patients as well as for diabetes and cancer patients.²

Medical devices

In the development of our medical equipment and consumables, we focus on the application of IV drugs and infusion therapies as well as enteral and parenteral nutrition products.

In 2013, our Agilia infusion pump was approved in the United States. For the market launch, we have adjusted the menu navigation and technical details to the requirements of the U.S. market.

In the area of autotransfusion devices, we are currently working on an updated version of our C.A.T.S. device. In addition, we are planning to introduce a new generation of cell processors in 2014.

1 Doig GS, et al., JAMA. 2013;309(20):2130-8. Doig GS, et al., Clinicoecon Outcomes Res. 2013;5:369-79. 2 Fietkau R, et al., Cancer. 2013;119(18):3343-53. Paul C, Vestweber KH. Clinical Nutrition. 2013; 32, Suppl1: S227. Mayr P. Clinical Nutrition. 2013; 32, Suppl1: S69.
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