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Fresenius closes licensing agreement for intravenous iron products

Fresenius Medical Care, a provider of dialysis products and services, has closed an exclusive license agreement with Luitpold Pharmaceuticals and its subsidiary American Regent for the manufacture and distribution of intravenous iron products in the US.

The closing follows completion of the US Federal Trade Commission’s review of the license agreement under the Hart-Scott-Rodino Act and the issuance of a consent order to permit the closing.

In the US, the license agreement among Fresenius USA Manufacturing (FUSA), Luitpold Pharmaceuticals and American Regent provides FUSA with exclusive rights to manufacture and distribute Venofer to freestanding US dialysis facilities. Luitpold Pharmaceuticals will continue to sell Venofer for use in treating chronic kidney disease patients not yet on dialysis and in treating patients with renal failure in hospitals.

Fresenius Medical Care has previously entered into a separate and independent license and distribution agreement with Galenica and its subsidiary Vifor Pharma, for certain countries in Europe and the Middle East, to market and distribute intravenous iron products, such as Venofer and Ferinject for dialysis treatment.

Ben Lipps, CEO of Fresenius Medical Care, said: “We are delighted to have Galenica, Vifor Pharma, Luitpold Pharmaceuticals and American Regent as our partners dedicated to improving the treatment of iron deficiency anemia experienced by dialysis patients. The license to make and distribute these products is an important milestone in the execution of Fresenius Medical Care’s renal pharma strategy.”