May 07, 2019
Boston, USA
Deutsche Bank – 44th Annual Health Care Conference
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.