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Industrial production of infusion solutions at Fresenius Kabi's plant in Friedberg, Germany. Visual check of freeflex® bags.
Fresenius Kabi and Becton, Dickinson and Company (BD) announced today that Fresenius Kabi has acquired the BD Rx business, which includes a pharmaceutical manufacturing plant in Wilson, N.C., and the BD line of seven drugs in ready-to-administer prefilled glass syringes. Fresenius Kabi and BD have also signed a 10-year supply and distribution agreement under which Fresenius Kabi will supply BD with a portfolio of intravenous (IV) solutions.
Prefilled injectable medicines are designed to help improve patient care and safety by decreasing the number of steps in the traditional vial and syringe injection sequence, reducing the potential risk of medication error.
“Ready-to-administer, prefilled syringes are a growing segment in health care due to increased focus on medication safety and labor-saving efficiency,” said John Ducker, President and CEO of Fresenius Kabi USA. “They are a natural complement to our portfolio, enabling us to offer customers more choices and a broader range of specialty injectable medicines in vials as well as ready-to-administer presentations.”
The North Carolina plant, which employs about 100 people, features advanced pharmaceutical manufacturing and packaging technologies, and was approved by the FDA in 2012. It currently produces seven drugs in ready-to-administer prefilled syringes and has capacity for future growth. Fresenius Kabi expects to invest in the facility over time, making it its global center of excellence for prefilled syringe production. The two companies will work together to assure a smooth transition for employees and customers.
“We believe Fresenius Kabi is a better owner for the BD Rx business, because it complements their existing capabilities in the injectable pharmaceutical industry,” said Tom Polen, President of BD’s Medical Segment. “In addition, we look forward to working with Fresenius Kabi to extend our medication management strategy through the addition of a portfolio of IV fluids, which will broaden our clinical and economical end-to-end solutions for our customers and their patients.”
Fresenius Kabi plans to register more IV drugs for the prefilled syringe format. As a consequence of these investments, the transaction is not expected to be accretive to earnings in the short-term.
Financial and contractual terms of the transactions were not disclosed.
This release 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 does not undertake any responsibility to update the forward-looking statements in this release.
Fresenius Kabi and Becton, Dickinson and Company (BD) announced today that Fresenius Kabi has acquired the BD Rx business, which includes a pharmaceutical manufacturing plant in Wilson, N.C., and the BD line of seven drugs in ready-to-administer prefilled glass syringes. Fresenius Kabi and BD have also signed a 10-year supply and distribution agreement under which Fresenius Kabi will supply BD with a portfolio of intravenous (IV) solutions.
Prefilled injectable medicines are designed to help improve patient care and safety by decreasing the number of steps in the traditional vial and syringe injection sequence, reducing the potential risk of medication error.
“Ready-to-administer, prefilled syringes are a growing segment in health care due to increased focus on medication safety and labor-saving efficiency,” said John Ducker, President and CEO of Fresenius Kabi USA. “They are a natural complement to our portfolio, enabling us to offer customers more choices and a broader range of specialty injectable medicines in vials as well as ready-to-administer presentations.”
The North Carolina plant, which employs about 100 people, features advanced pharmaceutical manufacturing and packaging technologies, and was approved by the FDA in 2012. It currently produces seven drugs in ready-to-administer prefilled syringes and has capacity for future growth. Fresenius Kabi expects to invest in the facility over time, making it its global center of excellence for prefilled syringe production. The two companies will work together to assure a smooth transition for employees and customers.
“We believe Fresenius Kabi is a better owner for the BD Rx business, because it complements their existing capabilities in the injectable pharmaceutical industry,” said Tom Polen, President of BD’s Medical Segment. “In addition, we look forward to working with Fresenius Kabi to extend our medication management strategy through the addition of a portfolio of IV fluids, which will broaden our clinical and economical end-to-end solutions for our customers and their patients.”
Fresenius Kabi plans to register more IV drugs for the prefilled syringe format. As a consequence of these investments, the transaction is not expected to be accretive to earnings in the short-term.
Financial and contractual terms of the transactions were not disclosed.
This release 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 does not undertake any responsibility to update the forward-looking statements in this release.
Fresenius Kabi received a Warning Letter, dated August 16, from the U.S. Food and Drug Administration (FDA) related to an April 2013 inspection of its Fenwal blood bag manufacturing plant in Maricao, Puerto Rico. Fresenius Kabi acquired Fenwal in December 2012.
The Warning Letter observations are primarily related to complaint-handling procedures, labeling issues, and filing of field alerts not in accordance with FDA regulations. The Warning Letter was not issued as a result of adverse events related to patient safety.
Following the inspection, Fresenius Kabi submitted a detailed remediation action plan to the FDA. The company has made significant progress in remedying the issues cited in the Warning Letter including improvements to its procedures and documentation. Production at the plant is continuing.
The company takes this matter very seriously and intends to respond in a timely and comprehensive manner to the Warning Letter. No material sales and earnings impact on Fresenius Kabi's business is expected. Fresenius Kabi fully confirms its 2013 guidance.
A copy of the FDA Warning Letter is attached to this document.
This release 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 does not undertake any responsibility to update the forward-looking statements in this release.
The company's proprietary Freeflex IV containers allow easy handling with enhanced safety. Fresenius Kabi offers the broadest ropivacaine anaesthetics portfolio in the U.S.
According to IMS, Fresenius Kabi’s market share for Propofol and its equivalent, Diprivan, was 73% in November 2014 (October: 73%). Since March 2014, IMS data on our competition has included direct sales to hospitals. Fresenius Kabi does not report direct sales; our market share is therefore not fully reflected in IMS data.
Fresenius Kabi has received FDA approval for Neostigmine Methylsulfate Injection. Neostigmine is used after surgery to reverse the actions of drugs that block nerve and muscle function.
