Fresenius Kabi has signed a worldwide settlement and license agreement with AbbVie, settling all pending patent litigations between the two companies. Under the terms of the agreement and subject to marketing authorization by the health authorities, Fresenius Kabi’s biosimilar candidate of Humira^®* (adalimumab), MSB11022**, could be commercialized in the United States from September 30, 2023.

On October 17, 2018 licenses under the agreement came into effect in certain countries in Europe in which AbbVie owns intellectual property. The application for marketing authorization for MSB11022 was submitted by Fresenius Kabi to the European Medicines Agency (EMA) at the end of last year. The dossier is currently under review. A first launch in Europe is expected in the first half of 2019.

“This agreement is a major step on our way to successfully developing and commercializing our biosimilar portfolio," said Dr. Michael Schönhofen, Member of the Fresenius Kabi Management Board and President of the Pharmaceuticals Division. “In line with our caring for life philosophy, our aim is to contribute to broader access to affordable therapies for chronic and acute diseases. Biosimilar drugs are an increasingly important component in reaching this aim – to the benefit of patients and healthcare systems. The agreement with AbbVie provides further clarity regarding when we will be able to commercialize our biosimilar candidate of Humira^®.”

*Humira^® (adalimumab) is a registered trademark of AbbVie Biotechnology Ltd.
**MSB11022 is being developed as a biosimilar candidate of Humira^® and is not yet approved by health authorities.

Fresenius Kabi has opened a new state-of-the-art compounding center in Canada. It involves an investment of 11 million Canadian dollars (more than €7 million), and the new site expands the company’s presence in Mississauga, Ontario. Fresenius Kabi is responding to increasing demand for large batches of compounded medications for patients in Canadian hospitals, and the 35,000-square-foot (3,300-square-meter) compounding center has the capacity to expand. The new facility is expected to employ 70 people by 2022.

Fresenius Kabi has opened a new state-of-the-art compounding center in Canada. It involves an investment of 11 million Canadian dollars (more than €7 million), and the new site expands the company’s presence in Mississauga, Ontario. Fresenius Kabi is responding to increasing demand for large batches of compounded medications for patients in Canadian hospitals, and the 35,000-square-foot (3,300-square-meter) compounding center has the capacity to expand. The new facility is expected to employ 70 people by 2022.

Fresenius Kabi has reached a milestone on the road to approval for another biosimilar. MSB11455, a biosimilar candidate for Neulasta^® (pegfilgrastim), has met its primary endpoints in the two pivotal clinical studies. For more information please see the website of Fresenius Kabi.

Fresenius Kabi has reached a milestone on the road to approval for another biosimilar. MSB11455, a biosimilar candidate for Neulasta^® (pegfilgrastim), has met its primary endpoints in the two pivotal clinical studies. For more information please see the website of Fresenius Kabi.

Atropine Sulfate Injection further expands the company's anesthesia and analgesia portfolio.

Glycopyrrolate Injection is the newest addition to the company’s anesthesia and analgesia portfolio. 

Fresenius Kabi is expanding its production and warehouse capacity in Runcorn, England, to meet increasing demand in United Kingdom’s homecare market and from UK and Ireland hospitals. The expansion’s first stage will be a new distribution and operations center, scheduled to open in early 2019. A second services unit for producing aseptically compounded parenteral nutrition products will be completed by 2020. Fresenius Kabi will invest over €9 million in the expansion.

Fresenius Kabi is expanding its production and warehouse capacity in Runcorn, England, to meet increasing demand in United Kingdom’s homecare market and from UK and Ireland hospitals. The expansion’s first stage will be a new distribution and operations center, scheduled to open in early 2019. A second services unit for producing aseptically compounded parenteral nutrition products will be completed by 2020. Fresenius Kabi will invest over €9 million in the expansion.

Fresenius has decided today to terminate the company’s merger agreement with Akorn, due to Akorn’s failure to fulfill several closing conditions.

Fresenius’ decision is based on, among other factors, material breaches of FDA¹ data integrity requirements relating to Akorn’s operations found during Fresenius’ independent investigation. Fresenius offered to delay its decision in order to allow Akorn additional opportunity to complete its own investigation and present any information it wished Fresenius to consider, but Akorn has declined that offer.

Fresenius confirms its guidance for 2018. The Group continues to expect a sales growth of 5% to 8%² in constant currency. Group net income³ is expected to increase by 6% to 9%⁴ in constant currency (excluding expenditures for the further development of the biosimilars business around 10% to 13%⁵).

On Saturday, Fresenius Medical Care announced the sale of Sound Inpatient Physicians Holdings, LLC. The expected pre-tax book gain of around EUR800 million on this transaction is excluded from Fresenius’ 2018 Group guidance.
Fresenius will report its first-quarter results, as scheduled, on May 3, 2018.

¹ FDA: Food and Drug Administration ² 2017 adjusted for IFRS 15 (EUR486 million at Fresenius Medical Care) ³ Net income attributable to shareholders of Fresenius SE & Co. KGa⁴ Base 2017: EUR1,816 million; 2018 before special items (acquisition-related expenses); including expenditures for further development of biosimilars business (EUR43 million after tax in FY/17 and ~EUR120 million after tax in FY/18) ⁵ Base 2017: EUR1,859 million; 2018 before special items (acquisition-related expenses); excluding expenditures for further development of biosimilars business (EUR43 million after tax in FY/17 and ~EUR120 million after tax in FY/18)

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For additional information on the performance indicators used please refer to our website www.fresenius.com/alternative-performance-measures.