The U.S. Food and Drug Administration (FDA) has accepted for review Fresenius Kabi's Biologics License Application (BLA) for MSB11456, a biosimilar candidate of Actemra®*(tocilizumab). This is an important achievement in the development of Fresenius Kabi’s biosimilar pipeline in the US. The BLA includes presentations for both subcutaneous (prefilled syringe and autoinjector) and intravenous administrations.
*Actemra® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.
Thiotepa Injection, a cancer therapeutic, is now available from Fresenius Kabi in the United States. It has multiple indications, including for the treatment of patients with adenocarcinoma of the breast or ovary. This is the newest addition to the company’s portfolio of generic IV oncology products - the largest such portfolio in the U.S.
Iodixanol Injection, a radiographic contrast agent, is now available from Fresenius Kabi in the United States. It is the first FDA-approved generic iso-osmolar, dimeric iodinated contrast media agent, which is used during diagnostic x-ray-based imaging such as computed tomography (CT) scans. The launch represents the first move of Fresenius Kabi North America into radiology, another key area of the hospital.
Romidepsin Injection, a drug used to treat cutaneous T-cell lymphoma (CTCL) in adults, is now available from Fresenius Kabi in the United States. This is the newest addition to the company’s portfolio of generic IV oncology products - the largest such portfolio in the U.S.
PEMEtrexed for injection, a drug used to treat adult patients with lung cancer and malignant pleural mesothelioma, is now available from Fresenius Kabi in the United States. This is the newest addition to the company’s portfolio of generic IV oncology products - the largest such portfolio in the U.S.
The Fresenius Management SE Supervisory Board has unanimously appointed Sara Hennicken (41), currently Senior Vice President Global Treasury & Corporate Finance at Fresenius, to become the company’s new Chief Financial Officer as of September 1, 2022. She will succeed Rachel Empey (45), who joined the Management Board of Fresenius as CFO on August 1, 2017 and will leave the company at her own request at the end of August.
Sara Hennicken joined Fresenius in 2019. Previously, she spent 14 years in investment banking, including nine years at Deutsche Bank, lastly as Managing Director and Senior Client Executive in Corporate Finance Coverage before moving to Fresenius. Between 2005 and 2010 she worked for Citigroup in Frankfurt and London. Sara Hennicken studied economics in Germany and in the United States.
Rachel Empey said: “The good and trusting collaboration with my colleagues in the Management Board, and with my team has been personally fulfilling. Fresenius is a great company with outstanding prospects; together we have moved the company forward. The last years have been very intense, and challenging, yet also a great and very enriching experience. So, leaving was not an easy decision for me, but now I am looking forward to the next chapter of my life. I personally brought Sara Hennicken on board in 2019, and I know my duties and tasks are in good hands with her. I’m very happy for Sara and wish her a lot of luck, success and happiness in her new position, with the additional responsibility she will be taking on.”
Wolfgang Kirsch, Chairman of the Supervisory Board of Fresenius, said: “Rachel Empey further developed Fresenius’ finance department and made it ready for the future. During her time here – part of which was heavily impacted by the pandemic – she also set in motion important changes and improvements in her other areas of responsibility, such as IT. On behalf of the entire Supervisory Board, I want to thank her for all her contributions and hard work. In Sara Hennicken, we have an innovative, young and yet highly experienced financial expert from within the company who will assure continuity in this area but also bring in new ideas. She is ideally qualified for this position. Together with our CEO Stephan Sturm and her other Management Board colleagues, she will contribute to the future success of our healthcare group.”
Stephan Sturm, CEO of Fresenius, said: “I’m sorry that Rachel is leaving our company. Over these last years, we always worked well together, very collegially and with great trust, and I especially valued her as a sparring partner during our discussions about the company’s growth strategy. But, of course, I respect her decision, and wish Rachel all the very best for this new chapter of her life. At the same time, I am very much looking forward to working with Sara, who will enrich our management team with her personality, experience and ideas. We will be working together even more closely than before to create the optimal foundations for financing our healthy growth, and the sustainable success of our company.”
Sara Hennicken said: “I am very happy about the confidence and trust being placed in me, and greatly looking forward to the new tasks ahead. As a globally active healthcare company, Fresenius makes an important contribution to society with which I can very much identify. Over the past years, I’ve been able to realign my department and modernize our financing structure. The excellent group-wide collaboration with my colleagues has been especially valuable. In my new position I want to build on this, for the benefit of our company.”
This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g. changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, the availability of financing and unforeseen impacts of international conflicts.
Fresenius does not undertake any responsibility to update the forward-looking statements in this release.
Bortezomib for Injection, an affordable treatment option for adult patients with multiple myeloma and mantle cell lymphoma, is now available from Fresenius Kabi in the United States and indicated for two routes of administration – intravenous and subcutaneous. This is the newest addition to the company’s expansive oncology portfolio in the United States.
Fresenius Kabi and the U.S. based company Cerus Corporation signed a new agreement for the production of systems for pathogen inactivation in blood components. The collaboration will help expanding access to pathogen-reduced blood components to patients. For many years, Cerus and Fresenius Kabi have collaborated regarding medical products specializing in pathogen inactivation for platelets and plasma. Since market launch of Cerus’ INTERCEPT systems, more than 11 million units have been in use worldwide.
Calcium Gluconate in Sodium Chloride Injection is now available in ready-to-administer non-DEHP, non-PVC containers, complementing the company’s existing vial presentations in the United States. Fresenius Kabi now has the broadest portfolio of Calcium Gluconate in Sodium Chloride Injection products available from any manufacturer in the United States.
Fresenius Kabi announced today that it has received 510(k) regulatory clearance from the U.S. Food and Drug Administration (FDA) for its wireless Agilia® Connect Infusion System which includes the Agilia Volumetric Pump and the Agilia Syringe Pump with Vigilant® Software Suite-Vigilant Master Med technology. Both pumps are the first to be cleared by following TIR101 standards, which were developed by the Association for the Advancement of Medical Instrumentation (AAMI) in 2021. The product offering for hospitals and clinics enables the centralized distribution of drug libraries, warehousing of infusion data for reporting and analysis, and wireless maintenance and calibration of devices. The clearance is an important milestone for the company’s infusion therapy business in the U.S.