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Adenosine, a drug used in critical care settings, is now available in the United States in the company’s Simplist™ ready-to-administer prefilled syringes. Fresenius Kabi now offers the broadest portfolio of Adenosine Injection.
The European Commission (EC) granted Fresenius Kabi the marketing authorization for IDACIO®, an adalimumab biosimilar, for all indications of the reference medicine. With this EC approval, IDACIO® is the first approved molecule of the Fresenius Kabi biosimilars portfolio.
The European Commission (EC) granted Fresenius Kabi the marketing authorization for IDACIO®, an adalimumab biosimilar, for all indications of the reference medicine. With this EC approval, IDACIO® is the first approved molecule of the Fresenius Kabi biosimilars portfolio.
Fresenius Medical Care, the world’s largest provider of dialysis products and services, announced today that it has entered into a Non-Prosecution Agreement with the U.S. Department of Justice (DOJ) and a separate agreement with the Securities and Exchange Commission to resolve matters governed by the U.S. Foreign Corrupt Practices Act (FCPA).
In 2012, Fresenius Medical Care had voluntarily notified the U.S. government about internal investigations into conduct in countries outside the U.S. that might violate the FCPA.
Fresenius Medical Care will pay a combined total in disgorgement and penalties of approximately $231.7 million to the two US agencies in connection with these resolutions, which was reserved and announced by the company last year. Given these accruals already made, the resolutions will have no effect on the company’s 2019 and 2020 outlook. The company has also agreed to engage an independent compliance monitor for a period of two years, after which it will self-report for one year.
Rice Powell, CEO of Fresenius Medical Care, said: “We are pleased to have concluded these investigations and to have resolved the issues that we identified and voluntarily disclosed to the U.S. authorities. Since the investigation began we have taken extensive steps to further a culture of ethical business behavior throughout the entire company and to strengthen our compliance programs and internal controls. And we will continue to do so in close cooperation with the authorities. Enhancing these programs is an ongoing effort that will also help us to improve our service to our patients, which is our primary mission.”
This release contains forward-looking statements that are subject to various risks and uncertainties. Actual results could differ materially from those described in these forward-looking statements due to various factors, including, but not limited to, changes in business, economic and competitive conditions, legal changes, regulatory approvals, results of clinical studies, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. These and other risks and uncertainties are detailed in Fresenius Medical Care AG & Co. KGaA's reports filed with the U.S. Securities and Exchange Commission. Fresenius Medical Care AG & Co. KGaA does not undertake any responsibility to update the forward-looking statements in this release.
Consolidated Financial Statements and Management Report (IFRS)
Fresenius Medical Care, the world’s largest provider of dialysis products and services, announced today that it has appointed Dr. Frank Maddux as Global Chief Medical Officer. With this newly created position the company further advances the great importance of applying clinical science at an ever-higher level. This includes also the facilitation of enhanced cooperation and exchange of knowledge across the entire Fresenius Medical Care network to ensure high-quality outcomes for patients worldwide.
Rice Powell, Chief Executive Officer of Fresenius Medical Care and Chairman of the Management Board, said: “Each of us understands that the well-being of our patients is our priority, and key to the company’s success all over the world. To continuously deliver on this commitment, it is becoming increasingly important that we also coordinate the interpretation of clinical science and medical practice patterns on a global basis. With Dr. Maddux we have a Global Chief Medical Officer with a well-deserved, excellent reputation inside and outside our company. He will ensure that we utilize the benefits of our global, vertically integrated approach to achieve the best clinical outcomes for our patients, their families and the payor community as well. Our Medical Office led by Dr. Maddux will be key to our ability to drive value for our patients by pursuing new and evolving medical opportunities, such as a more focused home therapies offering, regenerative medicine or enhancing our care coordinated business model throughout the world.”
Dr. Maddux is a physician, IT entrepreneur and health care executive with more than 30 years of health care experience. He has been working for Fresenius Medical Care since 2009. Most recently Dr. Maddux served as Executive Vice President for Clinical & Scientific Affairs and Chief Medical Officer for Fresenius Medical Care North America with responsibility for the delivery of high-quality, value-based care for the largest integrated renal care network in the U.S. His outstanding expertise and research interests have been focused on the quality of care for chronic kidney disease patients.
This release contains forward-looking statements that are subject to various risks and uncertainties. Actual results could differ materially from those described in these forward-looking statements due to various factors, including, but not limited to, changes in business, economic and competitive conditions, legal changes, regulatory approvals, results of clinical studies, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. These and other risks and uncertainties are detailed in Fresenius Medical Care AG & Co. KGaA's reports filed with the U.S. Securities and Exchange Commission. Fresenius Medical Care AG & Co. KGaA does not undertake any responsibility to update the forward-looking statements in this release.
