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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 postacute 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

We continued our existing research and development efforts in the area of blood volume replacement. In this regard it is important for us to continuously add to clinical evidence. Voluven® is one of our most successful blood volume replacement products. About 30 million1 patients have been treated with this preparation. We have continued to support a clinical study that is examining our product Voluven® 6% in comparison with crystalloids in the treatment of about 7,000 intensive care patients. Furthermore, the randomized double-blinded studies with Voluven® 6% for patients with penetrating trauma and caesarean section, which we had financed, were concluded. Both studies had positive results for the treatment with Voluven® compared to crystalloid solutions. Patients who had undergone a caesarean section under spinal anesthesia and who had been given Voluven® had significantly fewer low blood pressure phases. Also, the frequency of vomiting and nausea caused by the treatment was lower in this group. In patients with a penetrating trauma, Voluven® achieved a quick and consistent, but most of all, safe hemodynamic stabilization.

We also supported several studies about anesthesia and intensive care medicine for our product Volulyte®, which includes our proven HES ingredient (hydroxyethyl starch) in a balanced electrolyte solution.

Intravenously administered drugs

In the development of 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 developed both generic and also, if appropriate, new and improved drug formulations.

In 2011, we continued our work to make it possible that intravenously administered drugs, that currently only exist in lyophilized form as a powder, can be offered in a ready-to-use solution. The conversion to the ready-to-use solution requires modification of the drug formulation in such a way that the pharmaceutical drugs are also stable in liquid form. The ready-to-use solutions can be administered directly by the medical staff. This makes their use in the day-to-day hospital routine safe and simple, and saves time in their preparation. We plan to introduce the first products in a ready-to-use solution in 2012.

The packaging of our IV drugs is critical as well. We therefore developed intelligent packaging concepts, like our color code safety concept. This provides the possibility to easily distinguish all products and their different active substance concentrations. It is therewith guaranteeing a high degree of safety for patients and nursing staff. This clear, safe, and readily transparent system complies with national and international standards. We are already offering the majority of our products in the new packaging concept.

Furthermore we are already using our freeflex® bag as the liquid container for selected IV drugs. This PVC-free bag is characterized by very good drug compatibility and can safely be used in day-to-day medical care due to its port system.

Our R & D pipeline contains an extensive portfolio of active drugs that are expected to be coming to market in the next few years. Our aim is to offer a comprehensive portfolio of high-quality generics globally. It is important that we bring products to the market as quickly as possible. In our marketing approval activities we therefore worked intensively on dossiers for the registration of new generics.

The table below lists important approvals obtained in 2011.

Product Country/Region Indication
Bicalutamide Taiwan Oncology
Cisatricurium Several European countries Anesthesia/Analgesia
Clonidine Hydrochloride USA Critical Care
Gemcitabine USA Oncology
Letrozole Phillipines Oncology
Nafcilin USA Anti-infectives
Piperacillin/Tazobactam USA Anti-infectives
Remifentanil Several European countries Anesthesia/Analgesia
Topotecan Several European countries Oncology
Vancomycin Several European countries Anti-infectives

Product Country/Region Indication
Bicalutamide Taiwan Oncology
Cisatricurium Several European countries Anesthesia/Analgesia
Clonidine Hydrochloride USA Critical Care
Gemcitabine USA Oncology
Letrozole Phillipines Oncology
Nafcilin USA Anti-infectives
Piperacillin/Tazobactam USA Anti-infectives
Remifentanil Several European countries Anesthesia/Analgesia
Topotecan Several European countries Oncology
Vancomycin Several European countries Anti-infectives

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.

One of our development focuses in parenteral nutrition is the use of lipids, especially in the area of premature and newborn infants, nurslings, and children. This includes, for example, the international launch of Omegaven®, a unique product 100% based on fish oil.

Our product SmoFlipid® is a lipid emulsion, which has more balanced composition of the lipid components than currently used lipid emulsions. In 2011, we continued our development activities on another variation of our product SmofKabiven®.

In the 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. In the area of dysphagia, we are working on products that would have the same consistency and flow characteristics as a contrast medium that is used for esophageal tests. It would make the swallowing process safer for patients, because the risk that fluids or food enter the air ways or the lungs is significantly reduced.

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.

For critically ill patients with chronic inflammatory bowel diseases, pancreatic insufficiency, and short bowel syndrome, we have introduced the tube feed nutrition product Survimed OPD NH in the market. This product is characterized by increased protein to balance out protein catabolic conditions.

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. In 2011, we organized our own scientific symposium FRANC (Fresenius Advanced Nutrition Course) and initiated a symposium specifically on dysphagia.

In the field of medical devices we have set ourselves the goal to develop safe application products for effective therapies. One main focus of our development work was the international expansion and adaptation to local and/or regional specifications. We plan to offer selected medical devices on the U.S. market. In 2011, we adapted the products to local requirements and for example modified menu navigation.


1 Fresenius Kabi market research

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