Fresenius SE & Co. KGaA
Investor Relations & Sustainability
+49 (0) 6172 608-2485
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Product and process development and the improvement of therapies are at the core of our growth strategy. Fresenius focuses its R & D efforts on its core competencies in the following areas:
Apart from new products, we are concentrating on developing optimized or completely new therapies, treatment methods, and services.
The effects of the COVID-19 pandemic did not have a significant impact on our research and development activities in 2020.
Research and development expenses1 were € 748 million (2019: € 677 million), approximately 7.2% of our product sales (2019: 6.8%). Research services provided by third parties are mainly used by Fresenius Kabi, especially in the field of biosimilars. Detailed figures are included in the segment reporting.
1 Before revaluations of biosimilarsBiosimilarsA biosimilar is a drug that is “similar” to another biologic drug already approved. contingent purchase price liabilities
As of December 31, 2020, there were 3,565 employees in research and development (2019: 3,412). Of that number, 1,262 were employed at Fresenius Medical Care (2019: 1,200) and 2,288 at Fresenius Kabi (2019: 2,200).
Our main research sites are in Europe, the United States, and India. Product-related development activities are also carried out in China.
|R & D expenses, € in millions1||748||677||649||538||515|
|as % of product sales1, 2||7.2||6.8||6.7||5.7||5.5|
|R & D employees||3,565||3,412||3,042||2,772||2,770|
|1 2020, 2019, and 2018 before revaluations of biosimilars contingent purchase price liabilities|
|2 2016, 2018, and 2019 excluding impairment losses from capitalized in-process R & D activities|
Our aim is to continuously improve our patients’ quality of life and the outcomes of their treatment. To this end, we are not only working on new products that are close to market launch, but also on an extensive portfolio of innovation projects. These focus on technologies in our core business as well as related areas of strategic interest.
We intend to deliver innovative, competitive products and strengthen our focus on developing countries.
In addition to research and development activities within our company, we collaborate with external partners with the aim of building a comprehensive innovation and technology network. These partners include numerous academic institutions, such as research institutes at prestigious universities in the United States. Another is the Renal Research Institute (RRI) in New York. This subsidiary of Fresenius Medical Care North America is a renowned institution in the field of clinical research into all aspects of chronic kidney failure. Together, we are working on fundamental issues relating to renal therapies. We are also increasingly collaborating with start-ups with the objective of promoting innovation and enabling access to the latest technologies.
The COVID-19 pandemic had no major influence on our R & D activities. In 2020, we continued with our research and development work.
Our Optiflux Enexa F500 with Endexo technology is a new dialyzer designed to support the treatment of patients without the need for heparin. Endexo is a surface-modifying polymer that is added to the dialyzer during manufacturing. It makes the surface of the membrane less thrombogenic, so that the blood is less likely to clot. The Optiflux Enexa F500 was recently given FDAFDA (U.S. Food & Drug Administration)Official authority for food observation and drug registration in the United States. 510(k) clearance and has therefore passed a key hurdle prior to market launch. It is now in the last stage of development before being marketed in the United States.
For many patients, peritoneal dialysis is the dialysis treatment modality of choice and the gentlest option during the first years of renal replacement therapy. The new SILENCIA® Automated Peritoneal DialysisDialysisForm of renal replacement therapy where a semipermeable membrane – in peritoneal dialysis the peritoneum of the patient, in hemodialysis the membrane of the dialyzer – is used to clean a patient’s blood. (APD) therapy system, due to be launched in 2021, promises cost-effective, state-of-the-art dialysis quality for peritoneal dialysis patients, especially in emerging markets. The robust, functional design of the cycler ensures quick setup and easy operation. It allows silent and reliable treatment at night while the patient sleeps.
Fresenius Kabi focuses its research and development activities on products for the therapy and care of critically and chronically ill patients. With our products we want to support medical advancements in acute and post-acute care and improve patients’ quality of life. We are also committed to providing access to high-quality, state-of-the-art therapies for an increasing number of people worldwide.
Our development expertise covers all relevant components such as drug raw materials, pharmaceutical formulations, primary packaging, medical technologies for the application of drugs and infusions, and production technology. In the area of biosimilars, we have specialized in the development of products for the treatment of oncology and autoimmune diseases.
We were able to successfully continue all development projects in the reporting year. Although some activities – such as the collaboration with internal and external stakeholders – could only take place virtually due to the COVID-19 pandemic, no relevant delays occurred in our development projects.
In the area of generic IV drugs, we are continuously expanding our product portfolio and especially focus our activities on launching new generic drug formulations directly after the patents of the branded products expire. In the reporting year, we have launched the first generic version of the antifungal drug Micafungin on the U.S. market, in line with a patent agreement with the originator of the original drug. In addition, we have worked on the continuous improvement of IV drugs that are already available on the market, such as new formulations and dosage forms, as well as primary packaging. Moreover, we have worked on more than 100 generics projects in 2020. Our activities here included complex formulations such as active ingredients in liposomal1 solutions and product improvements that bring added value to both medical staff and patients. Thus, we develop ready-to-use products that are especially convenient and safe and help to prevent application errors in day-to-day medical care. Our respective product portfolio includes ready-to-use solutions in our freeflex infusion bags and pre-filled syringes. Drugs in pre-filled syringes are easier and safer to use than traditional applications. In the reporting year, we introduced several products in pre-filled syringes, including the neuroleptic drug Haloperidol Lactat, which we launched on the U.S. market.
1 Liposomes are tiny capsules filled with drugs. They allow for targeted transportation of active ingredients to the locations where they are needed within an organism.
In the area of biosimilars, we have a pipeline of molecules at different stages of development focusing on oncology and autoimmune diseases. A biosimilar is a biological product that is highly similar to the “reference product”, another already-approved biological product. The biosimilar product is the equivalent of the reference product in terms of effectiveness and safety.
We apply the same high-quality standards in development and production of our biosimilar products as are required for the reference product. With our biosimilars, we provide access to affordable, lifesaving medicines to more patients around the world.
In the reporting year, we continued our development activities in the areas of autoimmune and oncology diseases, and we opened a dedicated, state-of-the-art research and innovation center in Eysins, Switzerland, in September 2019.
Our first biosimilar, Idacio – an adalimumab1 biosimilar, which can be used for chronic inflammatory diseases such as rheumatoid arthritis, Crohn’s disease, and psoriasis (skin disease) – was already launched in numerous European countries in 2019. In the reporting year, we worked on additional approvals of Idacio: we received the marketing authorization for several countries in Latin America and Asia-Pacific, as well as for Israel and Canada, and prepared the market launches.
The clinical development of MSB 11455, a biosimilar candidate of pegfilgrastim2, was successfully finalized, and the submissions for marketing authorization are under review and approval by the European Medicines Agency and U.S. Food and Drug Administration (FDA). MSB 11455 is a molecule that stimulates the growth of specific white blood cells. These blood cells are essential for fighting infections, which are a frequent side effect of cancer patients receiving chemotherapy.
MSB 114563 is a biosimilar candidate of tocilizumab, which is used, among other things, in rheumatoid arthritis. The clinical trial for MSB 11456, which was conducted with healthy volunteer test subjects, reached its primary endpoint in 2019, showing bioequivalence with all pharmacokinetic parameters. The pivotal safety and efficacy clinical trial with rheumatoid arthritis patients was started in several countries in 2020.
1 Idacio is a biosimilar of Humira® and has not yet been approved by all relevant health authorities. Humira® (adalimumab) is a registered trademark of AbbVie Biotechnology Ltd.
2 MSB 11455 is a biosimilar candidate of Neulasta® and has not yet been approved by the relevant health authorities. Neulasta® (pegfilgrastim) is a registered trademark of Amgen Inc.
3 MSB 11456 is a tocilizumab biosimilar candidate and has not yet been approved by the relevant health authorities. Actemra® / RoActemra® (tocilizumab) are registered trademarks of Chugai Seiyaku Kabushiki Kaisha
Clinical nutrition provides nutrition for patients who cannot nourish themselves at all or sufficiently with regular food. This includes, for example, patients in intensive care and those who are seriously or chronically ill or malnourished. If clinical nutrition is applied early and in accordance with therapeutic needs, malnutrition and its consequences can be avoided.
In the product segment of parenteral nutrition, we focus our research and development activities on products that significantly contribute to improving clinical treatment and the nutritional condition of patients, as well as on containers such as our multi-chamber bags that are safe and easy to use in daily health care practice.
In addition to our own development activities, Fresenius Kabi also supports external development projects that contribute to improving the nutritional care of critically ill patients. In 2019, we started the funding program “Jumpstart”: with this program, we support the research work of young scientists in the area of parenteral nutrition for critically ill patients and enable them to receive a research prize to support their work. An independent jury, consisting of internationally renowned scientists in the area of clinical nutrition, is responsible for selecting the fellowship holders. In the reporting year, we continued the funding program and announced another research prize, which will be awarded in 2021.
In 2020, we continued the development work in the area of parenteral products. We focus on formulations that are tailored to the needs of individual patient groups. In addition to our global development projects, we are working on parenteral nutrition products for specific markets such as the United States, China, and Europe.
One main focus is placed on the use of fish oil in parenteral nutrition. Parenteral nutritionParenteral nutritionApplication of nutrients directly into the bloodstream of the patient (intravenously). This is necessary if the condition of a patient does not allow them to absorb and metabolize essential nutrients orally or as sip and tube feed in a sufficient quantity. with fish oil has numerous positive effects on important biological functions, including the modulation of the immune and inflammatory response. Using fish oil in parenteral nutrition products contributes to improving clinical results such as infection or sepsis rates, or the duration of ICU and hospital stays in general. This was confirmed in the reporting year by an international panel of leading experts for clinical nutrition, lipid metabolism, and pharmacology within the framework of a consensus recommendation; the recommendation includes guidelines on the use of fish oil-containing lipid emulsions in clinical practice.
In enteral nutritionEnteral nutritionApplication of liquid nutrition as a tube or sip feed via the gastrointestinal tract., we focus our research and development activities on product concepts that support therapeutic compliance and thus the success of therapy.
This includes, for example, the development of products with a larger variety of flavors to provide users with variations and support them optimally in implementing the necessary nutrition therapy. A special focus of our work is placed on the development of products with a higher concentration of nutrients to facilitate the complete intake of the necessary amount of nutrients in low volumes for the user. In addition to global product developments, we are working on product developments for specific market requirements. The focus is placed on products for markets with high growth potential in Asia, especially China.
In the area of infusion solutions, we are continuously working on new primary containers and already introduced containers to further increase their efficiency and safety in daily hospital routine and facilitate their use. In the reporting year, we continued, for example, to further advance the development of our freeflex+ infusion bag with a needle-free injection port. With this product, we want to contribute to reducing the risk of potential injuries in daily hospital routine. Moreover, we are continuously working on the expansion of our product offering, which we want to launch on a global basis, as well as on products that allow us to further tap into the U.S. market.
In the area of medical devices, we focus on developing new products as well as on further developing our existing portfolio. Particularly in the field of infusion technology, new software connections can contribute to facilitating daily hospital practice. In the reporting year, we have, for example, continued the development work on our Vigilant Software Suite and supported international market launches; this included the localization of the software and all technical documents in the respective local languages, local regulatory measures, and supporting the installation of the devices in hospitals. With the Vigilant Software Suite, all software solutions used by hospitals in combination with our infusion pump system Agilia Connect can be combined into one therapy information system, thus creating more data and license security.
In addition, we have continued the development work on a new infusion management system in the reporting year. This system is equipped with a modern operating concept and will enable new therapy and treatment procedures in the intensive care unit and operating room.
In the research and development of our transfusion technology business, we are working intensively on products for use in cell therapy; our focus is placed on product developments for automated washing and concentration of cell concentrates. These products are used in the CAR-T cell1 and similar cell therapies. In 2020, our focus was placed on the finalization of the CUECUECue is an automated cell processing system capable of washing, concentrating, and preparing white blood cell suspensions for cryopreservation (freezing in liquid nitrogen) and/or dispensing into final containers. cell processing device. This device has been specifically developed for smaller filling quantities and end-use applications in the area of cell therapies. It will complement our LOVO1 cell processing system, which is already available on the market. We will launch CUE in 2021.
1 For more information, see glossary
In the area of extracorporeal photopheresis (ECP), we continue to place our focus on the introduction of the Amicus Blue system and the corresponding Phelix light box in Europe, as well as on further developing an ECP application method, which only requires one vascular access. With this treatment method, specific blood cells are extracorporeally treated with ultraviolet light (phototherapy). This method is used for the treatment of different immunological diseases to, for example, kill malignant immune cells (lymphocytes) outside of the body.
Another focus area is continuously further developing our devices and the corresponding data management software; this includes our transfusion technology devices for plasma (Aurora/Aurora Xi), blood processing (CompoMat G5 Plus), and blood platelets (Amicus/AmiCORE).
Corporate performance criteria