Fresenius Kabi and the pharmaceutical company medac have agreed to cooperate in Germany in the area of treatments for rheumatic illnesses. On June 1, medac’s sales representatives will begin offering the adalimumab biosimilar IDACIO® as an additional therapy option to the rheumatologists and dermatologists they work with. This biosimilar, developed by Fresenius Kabi and launched last year in Europe, is used to treat autoimmune illnesses such as arthritis and psoriasis. medac is a leading provider of methotrexate (metex® PEN, metex® FS) for the parenteral treatment of patients with chronic inflammatory diseases. Since affected patients are often treated with a combination of methotrexate and adalimumab, the partnership between Fresenius Kabi and medac will offer patients and doctors new benefits and synergies in therapy offerings as well as consulting.

Fresenius Kabi announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company`s Biologics License Application (BLA) for MSB11455, a biosimilar candidate of Neulasta® (pegfilgrastim)*. This is an important achievement in the development of Fresenius Kabi’s biosimilar pipeline in the US. Fresenius Kabi also received acceptance for review of its regulatory submission for its pegfilgrastim biosimilar candidate from the European Medicines Agency this month. (* Neulasta® is a registered trademark of Amgen)

The European Medicines Agency (EMA) has accepted for review Fresenius Kabi`s Marketing Authorization Application (MAA) for MSB11455, a biosimilar candidate of Neulasta® (pegfilgrastim)*. This is another milestone for Fresenius Kabi following last year`s approval and launch of the company`s adalimumab biosimilar (Idacio®) in Europe. (* Neulasta® is a registered trademark of Amgen)

Micafungin for injection, an antifungal medicine, expands the company's anti-infective portfolio.

Potassium Phosphates Injection is now available in the United States in three FDA-approved presentations. Fresenius Kabi offers the broadest portfolio of Potassium Phosphates Injection in the United States.

Fresenius Helios has developed a secure and highly effective process for purifying medical protective masks so they can be safely reused. It is being employed for FFP2- and FFP3-type masks, which help protect medical and care personnel who are treating COVID-19 patients. Going well beyond the safety standard set out by the Robert Koch Institute, Germany’s government agency responsible for disease control and prevention, the process allows the purified masks to be used by any staff member – not just the previous user. Starting immediately, Helios Germany’s hospitals can purify 8,000 masks daily using the process, which was developed with the support of Fresenius Vamed and Fresenius Medical Care. The company has chosen not to commercialize the process and is making complete information about it available online, free of charge.

To obtain and secure important data for research into SARS-CoV 2, Fresenius Helios has established a multi-center COVID-19 register. Since back in February a team of Helios experts, supported by the Brandenburg Medical School outside of Berlin, has been gathering pseudonymized data on patients treated for COVID-19 in Germany. The goal is to develop insights and knowledge for the battle against the new virus. First research findings from the project, which is scheduled to last a year and is financed by Helios, are now being readied for publication.

• Production of critical drugs scaled up with priority supply for COVID 19 patients
• Commitment to price stability for essential drugs for COVID-19 patients during pandemic

Fresenius Kabi is responding to the significant increase in worldwide demand for essential drugs for the treatment of COVID-19 patients, especially medicines used for sedation such as Propofol and pain management drugs. The company is maximizing supply with all compatible manufacturing capacity now dedicated to these vital drugs. Fresenius Kabi has made significant, future-oriented investments in recent years into both automation and capacity in its manufacturing facilities; these are now enabling treatment for more patients worldwide.

Fresenius Kabi will continue to align its manufacturing capacities to the dynamically developing demand resulting from the COVID-19 pandemic.

Fresenius Kabi is dedicated to protecting its workforce in all aspects and has introduced increased safety measures for employees across the organization. These safeguards will also facilitate continued operations at its production sites. To ensure uninterrupted access to the company’s medicines, devices and technologies Fresenius Kabi is working closely with governments and public health authorities around the world.

Stephan Sturm, CEO of Fresenius, said: “The COVID-19 pandemic poses particular challenges for our society. As a healthcare company whose mission is to offer better and affordable medicine to ever more people, we have a special responsibility that we will live up to also during these testing times. Irrespective of demand beyond our ability to supply, we commit ourselves to keeping prices for essential drugs for COVID-19 patients stable during this pandemic. My special thanks go to our employees around the world. I am very grateful for their extraordinary commitment.”

Mats Henriksson, CEO of Fresenius Kabi, said: “Our purpose is to put lifesaving medicines and technologies in the hands of healthcare professionals and to find answers to the challenges they face. This purpose has never been more important than today. We do whatever is possible to further increase manufacturing output and the supply of urgently needed products. I am inspired by the dedication of our employees who are committed to maintaining the supply of our medicines to patients and their families.”

• New date will be specified and communicated as soon as reliable planning is possible
• Health and safety of shareholders and employees is our priority

Due to the coronavirus pandemic, Fresenius SE & Co. KGaA postpones its Annual General Meeting scheduled for 20 May 2020 to a later date within the current financial year. As one of the consequences, this will lead to a postponement of the resolutions regarding the appropriation of net income 2019 and the payout of the dividend. The Company will set and communicate a new date as soon as the conditions for reliable planning and safe execution of the Annual General Meeting are once again in place.

“At present, the primary task is to slow down the spread of the coronavirus and thus to contain it as far as possible. With this decision, we are also supporting this common goal. The health and safety of our shareholders and employees have highest priority,” said Stephan Sturm, CEO of Fresenius.

• Helios Germany is increasing number of intensive care beds by two thirds
• Law to ease financial burden on hospitals likely to offset large part of sales losses and cost increases
• Digital healthcare offerings facilitate continuous medical care for chronically ill and rehabilitation patients

Helios Germany, Germany’s largest private hospital operator and part of the Fresenius Group, is undertaking comprehensive measures to combat the COVID-19 pandemic. In accordance with the German government’s request, surgical procedures are being delayed whenever medically justifiable. The freed-up capacity is reserved for the imminent treatment of COVID-19 patients. Postponed operations should be performed later this year and next. In parallel, Helios Germany will increase the number of ICU beds in its network by two-thirds, from 900 to more than 1,500. This will be accomplished by deploying centrally held equipment reserves across its network as well as by selectively upgrading intermediate care beds and converting operation theatres with already installed ventilator systems.

In order to utilize the incremental capacity most effectively, Helios Germany has selectively adjusted shift models and is prepared to deploy specialist staff across its network to hospitals with particular needs.

Helios Germany is closely monitoring its inventories of important hospital supplies – including disinfectants and protective clothing – and building additional reserves.

Stephan Sturm, CEO of Fresenius, said: “Society is facing very challenging weeks and months ahead. Commitment, sound judgement and close cooperation will all be needed to contain the spread of the coronavirus. At the same time, the best possible care must be provided to patients. Our deepest thanks go to doctors, nurses and care personnel, whether they work at Fresenius or elsewhere: They are needed more than ever, and show tremendous dedication day after day. As a healthcare Group we have a special responsibility in this situation. We must, and we will, meet this responsibility.”

To ease the financial burden on the country’s hospitals during the COVID-19 pandemic, Germany’s Federal Ministry of Health submitted earlier this week a draft law, which was passed by the Bundestag on Wednesday. Among its key provisions:

• Compensation payment of €560 per foregone treatment day compared to 2019.
• Reimbursement of care costs with a flat-rate payment of at least €185 per treatment day.
• Reimbursement of increased costs for protective clothing and other supplies with a flat-rate payment of €50 per patient.
• Public health insurers will settle all treatment invoices in 2020 within five days.
• Significant reduction of health insurers’ (MDK) audit quota and abolition of minimum fines for this year and 2021.
• Co-investment of €50,000 for each new intensive care bed; costs above this amount may be reimbursed by individual state governments.

Fresenius Helios generally welcomes these measures. Assuming the pandemic substantially subsides by the summer, management currently estimates that the financial impact on Helios Germany in 2020, although negative, will not be very significant.

Dr. Francesco De Meo, CEO of Fresenius Helios, said: “It is our approach to combine ethically responsible care for our patients with a high degree of efficiency. To this end, we have invested heavily in our clinics, in our medical technology and also in strengthening our staff in recent years. This is paying off now. The close networking of our hospitals gives us the necessary flexibility to deploy personnel and materials exactly where patients need them most. And we gain insights very swiftly by sharing experiences with our colleagues, through the European exchange that is embedded in Fresenius‘ global network. We are therefore ideally positioned in the joint fight against COVID-19.”

Fresenius is committed to the care of patients with a high infection risk. Given the current treatment restrictions and infection risks, there are significant challenges for the chronically ill to visit local medical practices and get the treatment and support they need. Particularly for these patients, digital healthcare offerings can be a suitable alternative. Following its acquisition of Digitale Gesundheitsgruppe, Fresenius’ subsidiary Curalie now offers an even wider range of digital healthcare services for patients with chronic illnesses such as diabetes, kidney disease and heart disease, through to rehabilitation patients in orthopedic aftercare. For the duration of the current COVID-19 pandemic, Curalie will make its digital healthcare services available free of charge. Thus, Fresenius and Curalie are helping to ensure continuous medical care to these vulnerable patients.