Fresenius signs agreements for intravenous iron products

Fresenius signs agreements for intravenous iron products

Friday, July 11, 2008 12:00 IST
Bad Homburg, Germany

Fresenius Medical Care AG & Co. KGaA, the world's largest provider of dialysis products and services, announced that it signed exclusive license agreements for the intravenous (IV) Iron products Venofer (iron sucrose) and Ferinject (ferric carboxymaltose) to treat iron deficiency anaemia experienced by dialysis patients. Venofer is the leading IV Iron product worldwide.

Galenica Ltd., its subsidiary Vifor Pharma and Fresenius Medical Care are entering into a strategic joint venture for dialysis to market and distribute the two iron products Venofer and Ferinject in Europe, Middle East, Africa and Latin America. The agreement concerns all commercialization activities for these IV Iron products in the field of dialysis and is expected to become effective not later than January 1, 2009.

Commercialization of these respective IV Iron products outside the field of dialysis will remain fully the responsibility of Vifor Pharma and its existing key partners.

The total market for IV Iron in Europe, Middle East, Africa and Latin America was greater than $120 million in 2007. After the first year of the agreement, Fresenius Medical Care expects yearly sales from both IV Iron products to be in excess of $50 million.

In North America, a second agreement provides for an exclusive US manufacturing and distribution sublicense for Venofer with Luitpold Pharmaceuticals Inc (Luitpold). In addition, it includes a similar sublicense for the next generation of iron products for the US and Canada known as Injectafer (ferric carboxymaltose) injection, which is expected to enhance the treatment of anaemia in the dialysis patient population through the application of innovative drug administration techniques. The transaction is subject to customary closing conditions including expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Act. The closing of the transaction is anticipated in 2008.

Luitpold will continue to sell Venofer for use in treating chronic kidney disease patients not yet on dialysis and in treating patients with acute renal failure in hospitals. Venofer® is currently the market leader in sales in the injectable iron market in the US. Currently, the total purchases of IV Iron in the US are approximately US$ 500 million. Venofer has a US market share of approximately 55%. Galenica Ltd., through its Vifor Pharma subsidiary, exclusively licenses the Venofer and Injectafer products to Luitpold and American Regent for the US and Canada.

As part of the 10-year agreement for North America, Luitpold will continue to contract manufacture the products for Fresenius Medical Care. Luitpold will continue to pay royalties to Vifor Pharma, based in St. Gallen, Switzerland, which supplies the active pharmaceutical ingredient to Luitpold.

Ben Lipps, chief executive officer of Fresenius Medical Care, commented: "We are very pleased to have Galenica Ltd., Vifor Pharma, Luitpold Pharmaceuticals, Inc. and American Regent, Inc., as our partners dedicated to improving the treatment of iron deficiency anaemia experienced by dialysis patients. It is an excellent opportunity for us to access a proven and effective IV Iron product portfolio. With these agreements we will also deploy our "Pharmatech" strategy, aimed to introduce new drug delivery systems to improve quality and safety of dialysis treatments."

Fresenius Medical Care is the world's largest integrated provider of products and services for individuals undergoing dialysis because of chronic kidney failure, a condition that affects more than 1,600,000 individuals worldwide.

Galenica is a diversified group active throughout the healthcare market which, among other things, develops, manufactures and commercialises pharmaceutical products, runs pharmacies, provides logistical and database services and sets up networks.

Luitpold Pharmaceuticals, Inc., headquartered in Shirley, NY, manufactures and distributes over 65 pharmaceutical products including Venofer (iron sucrose injection, USP), the leading IV iron therapy in the US, through its human health subsidiary, American Regent, Inc.

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