The U.S. Food and Drug Administration (FDA) has approved Fresenius Kabi’s pegfilgrastim biosimilar, Stimufend®, for use in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. 
The company expects to launch the product in a prefilled syringe next year and additionally in an on-body injector following FDA approval. 
This is another important achievement in the development of Fresenius Kabi’s biosimilar pipeline, representing Fresenius Kabi’s first U.S. approved therapy in its biosimilar portfolio. 

* Stimufend® (pegfilgrastim) is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries. Stimufend is a pegfilgrastim biosimilar medicine of Neulasta®, which is a registered trademark of Amgen Inc. 
 

Fresenius Medical Care, the world's leading provider of products and services for individuals with kidney diseases, has closed the three-way merger including Fresenius Health Partners, the value-based care division of Fresenius Medical Care North America. The transaction, first announced in March 2022, has satisfied customary closing conditions and received regulatory clearance in the U.S. 

The new company, which will operate under the InterWell Health brand, brings together Fresenius Health Partners’ expertise in kidney care value-based contracting and performance, InterWell Health’s clinical care models and strong network of 1,700 nephrologists and Cricket Health’s tech-enabled care model that utilizes its proprietary informatics, StageSmart™️ and patient engagement platforms to create an innovative, stand-alone entity poised to transform kidney care. 

With the completion of the merger, the new company expects to engage and manage the care of more than 270,000 Americans living with kidney disease with more than $11 billion in costs under management by 2025, an increase from 100,000 covered lives and $6 billion currently under management. The strategic expansion along the Renal Care Continuum significantly expands InterWell Health’s total addressable market in the U.S. from approximately $50 billion to $170 billion.

Helen Giza, Deputy CEO of Fresenius Medical Care, said: “I am enthusiastic to see this merger being completed which will support our sustainable profitable growth. InterWell Health will be the premier value-based kidney care provider in the U.S., combining and leveraging innovative new tools, vast experience, and a deep nephrologist network. By further expanding into the strategically important chronic kidney disease stage-3-to-5-market, we will be able to support even more patients throughout the Renal Care Continuum, including earlier interventions to prevent disease prior to kidney failure. This is good for patients, the payers, and our shareholders.”

Bill Valle, CEO of Fresenius Medical Care North America and of the future Care Delivery segment for Fresenius Medical Care, said: “We are excited to see the transformative impact we will have on patient outcomes and kidney care delivery in the U.S. as we bring together three leading value-based kidney care entities. InterWell Health is well positioned to improve patient outcomes with fewer hospital admissions, slow disease progression, increase transplant referrals and rates, and continue our transition to home dialysis. We expect results to be a higher quality of life for patients, improved health equity, and lower total costs for the healthcare industry.”

Any potential book gains arising with closing of the transaction are not expected to be material on Fresenius Medical Care’s earnings and will be treated as a special item. 

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Head of Corporate Communications
T +49 (0) 6172 608-96008
pr-fre@fresenius.com

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Michael Sen (53) will become Chief Executive Officer of Fresenius on October 1, 2022. He was appointed unanimously by the Supervisory Board of Fresenius Management SE today to succeed Stephan Sturm (59), who will leave the company on good terms on September 30. Michael Sen will, in addition, continue to serve as CEO of Fresenius Kabi until a successor is decided for this position.

Michael Sen has been responsible for the Fresenius Kabi business segment on the Fresenius Management Board since April 2021. Previously, he was a member of the Management Board of Siemens AG, where he was responsible for the healthcare business Siemens Healthineers and for Siemens’ energy business. From 2015 to 2017 he was Chief Financial Officer of E.ON SE.

Stephan Sturm has been a member of the Fresenius Management Board since 2005, beginning as CFO. He became CEO of Fresenius on July 1, 2016.

Stephan Sturm said: “Fresenius has always been more than just a job to me. This company was and is still close to my heart. I look back with gratitude and pride on my more than 17 years here, during which we accomplished a lot together and developed Fresenius into a leading global healthcare company – one that provides ever more people with ever better medicine. I’m especially thankful for the many colleagues with whom I was privileged to work, and with whom I will remain connected even after my time at Fresenius. This is a great company, with outstanding growth prospects.”

Wolfgang Kirsch, Chairman of the Supervisory Board of Fresenius, said: “On behalf of the entire Supervisory Board, I want to thank Stephan Sturm for his many years of outstanding commitment and service to Fresenius. Starting from his time as CFO he has played a major role in our successful development and in our continued, profitable growth. As CEO he has steered our company through increasingly rough waters over the past few years, and kept it on course. The pandemic, in particular, did not make this easy. Stephan Sturm has identified totally with our company and devoted all his energy and capabilities to its success. For this we owe him respect and great thanks. Following the orderly transition to his successor, I sincerely wish him all the very best for the future.

“At the same time, I’m very pleased that in our own ranks we have, in the person of Michael Sen, an outstanding manager who is supremely well qualified to take on this important position,” Kirsch added. “He has extensive and relevant experience in industry. He is accomplished in designing and implementing transformation and change processes. And he has strategic skills, as he has shown during his first year-and-a-half as CEO of Fresenius Kabi with the development of ‘Vision 2026’ and the successful start to its implementation. My colleagues on the Supervisory Board and I are firmly convinced that the Management Board, under Michael Sen’s leadership, will give new impetus to our growth strategy. In this he has our full support. I wish him good luck and great success.”

Michael Sen, CEO of Fresenius Kabi and designated CEO of Fresenius, said: “I’m very pleased about the trust being placed in me and in my capabilities. I am taking on leading this company, which brings both great responsibility and excitement, with respect but above all with great joy and confidence. This is because, despite the temporary challenges and headwinds we encounter, our prospects for achieving future success are very promising: The markets we are active in are fundamentally attractive, and our businesses in many areas are strongly positioned. Being agile and taking prudent strategic decisions will enable us to tap into our full potential and accelerate our growth dynamics again. Together with my Management Board colleagues and all our employees, I will devote my full energy to this. Fresenius is a fantastic company that creates value in so many ways, and I have a strong personal commitment to advancing innovation in medicine for the health and well-being of all people. I want to contribute so that, going forward, all our stakeholders will benefit even more from an even stronger Fresenius.”

Contact

Senior Vice President Investor Relations
Head of Investor Relations
T: +49 (0) 6172 608-2485
markus.georgi@fresenius.com

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Michael Sen (53) will become Chief Executive Officer of Fresenius on October 1, 2022. He was appointed unanimously by the Supervisory Board of Fresenius Management SE today to succeed Stephan Sturm (59), who will leave the company on good terms on September 30. Michael Sen will, in addition, continue to serve as CEO of Fresenius Kabi until a successor is decided for this position.

Michael Sen has been responsible for the Fresenius Kabi business segment on the Fresenius Management Board since April 2021. Previously, he was a member of the Management Board of Siemens AG, where he was responsible for the healthcare business Siemens Healthineers and for Siemens’ energy business. From 2015 to 2017 he was Chief Financial Officer of E.ON SE.

Stephan Sturm has been a member of the Fresenius Management Board since 2005, beginning as CFO. He became CEO of Fresenius on July 1, 2016.

Stephan Sturm said: “Fresenius has always been more than just a job to me. This company was and is still close to my heart. I look back with gratitude and pride on my more than 17 years here, during which we accomplished a lot together and developed Fresenius into a leading global healthcare company – one that provides ever more people with ever better medicine. I’m especially thankful for the many colleagues with whom I was privileged to work, and with whom I will remain connected even after my time at Fresenius. This is a great company, with outstanding growth prospects.”

Wolfgang Kirsch, Chairman of the Supervisory Board of Fresenius, said: “On behalf of the entire Supervisory Board, I want to thank Stephan Sturm for his many years of outstanding commitment and service to Fresenius. Starting from his time as CFO he has played a major role in our successful development and in our continued, profitable growth. As CEO he has steered our company through increasingly rough waters over the past few years, and kept it on course. The pandemic, in particular, did not make this easy. Stephan Sturm has identified totally with our company and devoted all his energy and capabilities to its success. For this we owe him respect and great thanks. Following the orderly transition to his successor, I sincerely wish him all the very best for the future.

“At the same time, I’m very pleased that in our own ranks we have, in the person of Michael Sen, an outstanding manager who is supremely well qualified to take on this important position,” Kirsch added. “He has extensive and relevant experience in industry. He is accomplished in designing and implementing transformation and change processes. And he has strategic skills, as he has shown during his first year-and-a-half as CEO of Fresenius Kabi with the development of ‘Vision 2026’ and the successful start to its implementation. My colleagues on the Supervisory Board and I are firmly convinced that the Management Board, under Michael Sen’s leadership, will give new impetus to our growth strategy. In this he has our full support. I wish him good luck and great success.”

Michael Sen, CEO of Fresenius Kabi and designated CEO of Fresenius, said: “I’m very pleased about the trust being placed in me and in my capabilities. I am taking on leading this company, which brings both great responsibility and excitement, with respect but above all with great joy and confidence. This is because, despite the temporary challenges and headwinds we encounter, our prospects for achieving future success are very promising: The markets we are active in are fundamentally attractive, and our businesses in many areas are strongly positioned. Being agile and taking prudent strategic decisions will enable us to tap into our full potential and accelerate our growth dynamics again. Together with my Management Board colleagues and all our employees, I will devote my full energy to this. Fresenius is a fantastic company that creates value in so many ways, and I have a strong personal commitment to advancing innovation in medicine for the health and well-being of all people. I want to contribute so that, going forward, all our stakeholders will benefit even more from an even stronger Fresenius.”

The European Medicines Agency (EMA) has accepted for review Fresenius Kabi’s Marketing Authorization Application (MAA) for MSB11456, a biosimilar candidate of RoActemra®*(tocilizumab). This is an important achievement in the development of Fresenius Kabi’s biosimilar pipeline, representing the company’s third biosimilar candidate submitted in the European Union. The MAA includes clinical data for both subcutaneous (prefilled syringe and autoinjector) and intravenous administrations. 

*RoActemra® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.
 

The European Medicines Agency (EMA) has accepted for review Fresenius Kabi’s Marketing Authorization Application (MAA) for MSB11456, a biosimilar candidate of RoActemra®*(tocilizumab). This is an important achievement in the development of Fresenius Kabi’s biosimilar pipeline, representing the company’s third biosimilar candidate submitted in the European Union. The MAA includes clinical data for both subcutaneous (prefilled syringe and autoinjector) and intravenous administrations. 

*RoActemra® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.