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)
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)
June 09, 2020
Bad Homburg, Germany
Goldman Sachs – 41st Annual Global Healthcare Conference Webcast
June 9 – 10, 2020
Webcast: June 10, 11:20 - 12:00 EDT
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)
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)
Fresenius Medical Care, the world’s largest provider of dialysis products and services, is aware that patient data from some of the company’s dialysis centers in Serbia has been published by unauthorized persons. The company’s understanding is that this is associated with the IT incident which affected parts of Fresenius’s IT environment a few weeks ago and that hackers were able to steal certain data. The investigation is ongoing.
Fresenius Medical Care has immediately filed a complaint against the unknown attackers with the public prosecutor in Germany. The company is committed to fully cooperate with the relevant authorities. Furthermore, the company will contact the patients who are affected by the illegal data publication.
The company’s operations in Serbia continue and the care of patients has been safeguarded.
The company deeply regrets this invasion of some patients’ privacy, is doing its utmost to prevent further data to be published and to save affected patients and other stakeholders from harm.
Internal and external specialists are continuously working to prevent further potential attacks or unauthorized data access.
Disclaimer
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.
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Fresenius Medical Care, the world’s largest provider of dialysis products and services, today successfully placed bonds in two tranches with an aggregate volume of €1.25 billion:
- €500 million bonds with a 6-year maturity and a coupon of 1.000% were issued at a price of 99.405% resulting in a yield of 1.103%,
- €750 million bonds with a 10-year maturity and a coupon of 1.500% were issued at a price of 99.742% resulting in a yield of 1.528%.
The proceeds will be used for general corporate purposes, including refinancing of existing financial liabilities.
Helen Giza, CFO of Fresenius Medical Care, said: “I am very pleased with this successful bond issuance, showing our ability to raise debt at attractive conditions also in this challenging market environment. With this, we are enhancing our strong financial position which is the basis for investing in our sustainable long-term growth.”
The bonds were drawn under the European Medium Term Note (EMTN) Program by Fresenius Medical Care. The company has applied to the Luxembourg Stock Exchange to admit the bonds to trading on its regulated market.
The envisaged settlement date is May 29, 2020.
This announcement does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, securities of Fresenius Medical Care to any person in Australia, Canada, Japan, or the United States of America (the “United States”) or in any jurisdiction to whom or in which such offer or solicitation is unlawful. The securities referred to herein have not been and will not be registered under U.S. Securities Act of 1933, as amended (the “Securities Act”) and may not be offered or sold in the United States or to, or for the account or benefit of, U.S. persons, absent such registration, except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act. Subject to certain exceptions, the securities referred to herein may not be offered or sold in Australia, Canada or Japan or to, or for the account or benefit of, any national, resident or citizen of Australia, Canada or Japan. The offer and sale of the securities referred to herein has not been and will not be registered under the Securities Act or under the applicable securities laws of Australia, Canada or Japan. There will be no public offer of the securities in the United States.
This announcement neither constitutes an offer to sell nor a solicitation to buy any securities of Fresenius Medical Care. The securities referred to in this announcement have already been sold.
No action has been taken that would permit an offering of the securities or possession or distribution of this announcement in any jurisdiction where action for that purpose is required. Persons into whose possession this announcement comes are required to inform themselves about and to observe any such restrictions. This announcement has been prepared on the basis that any offer of Notes in any member state of the European Economic Area (EEA) (each, a “Member State”) will only be made (i) pursuant to a prospectus prepared by Fresenius Medical Care pursuant to Regulation (EU) 1129/2017 (the “Prospectus Regulation”), or (ii) pursuant to an exemption under the Prospectus Regulation from the requirement to publish a prospectus for offers of securities. Fresenius Medical Care has not authorized, nor does it authorize, the making of any offer of securities in circumstances in which an obligation arises for Fresenius Medical Care or any other person to publish or supplement a prospectus for such offer.
This announcement is directed at and/or for distribution in the United Kingdom only to (i) persons who have professional experience in matters relating to investments falling within article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”) or (ii) high net worth entities falling within article 49(2)(a) to (d) of the Order (all such persons are referred to herein as “relevant persons”). This announcement is directed only at relevant persons. Any person who is not a relevant person should not act or rely on this announcement or any of its contents. Any investment or investment activity to which this announcement relates is available only to relevant persons and will be engaged in only with relevant persons.
This announcement contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g. changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius Medical Care does not undertake any responsibility to update the forward-looking statements in this announcement.
The information contained in this announcement is for background purposes only and does not purport to be full or complete. No reliance may be placed for any purpose on the information contained in this announcement or its accuracy or completeness. The information in this announcement is subject to change.
June 03, 2020
Bad Homburg, Germany
dbAccess Virtual Berlin Conference
June 3 – 4, 2020
June 08, 2020
Bad Homburg, Germany
Exane BNP Paribas Virtual 22nd European CEO Conference
June 8 – 9, 2020