Fresenius Medical Care AG & Co. KGaA the world's largest provider of dialysis products and services, and Galenica Ltd. ("Galenica") today announced the formation of a new renal pharmaceutical company (Vifor-Fresenius Medical Care Renal Pharma Ltd.) designed to develop and distribute on a worldwide basis products to treat iron deficiency anaemia and bone mineral metabolism for pre-dialysis and dialysis patients. The newly formed company extends existing agreements with Galenica.
Galenica will contribute to the company the intravenous (IV) iron products Venofer(R) (iron sucrose) and Ferinject(R) (ferric carboxymaltose) for use in the dialysis and pre-dialysis market (Chronic Kidney Disease, CKD stages III to V) on a worldwide basis. Commercialization of both IV iron products outside the field of CKD stages III to V will remain fully the responsibility of Galenica and its existing key partners.
Iron deficiency is the most common cause of anaemia. The market for intravenous iron products used in dialysis and pre-dialysis was approximately $1 billion in 2009. Venofer(R) and Ferinject(R) are market leaders of the global market for intravenous iron products.
Galenica will also contribute all rights for PA21, a novel iron-based phosphate binder exclusively to the new company on a worldwide basis while maintaining the recently announced agreement to develop and market this product in Japan with Kissei.
Phosphate binders are prescribed to patients generating high phosphate levels caused by the failure of their kidneys. In dialysis more than 80% of patients need phosphate binders. The phosphate binder market had a value of $1.5 billion in 2009. PA21, a non-calcium phosphate binder, is currently in preparation for phase III clinical studies and expected to be filed in the USA and Europe in 2012.
Fresenius Medical Care will hold a 45% share in the new company with headquarters in Switzerland. The transaction is subject to final anti-trust approval in certain regions.
Ben Lipps, Chief Executive Officer of Fresenius Medical Care, commented, "This investment allows Fresenius Medical Care to take the next major implementation step in its renal pharmaceutical strategy. With this agreement we are creating a leading worldwide renal pharmaceutical company which will align Fresenius Medical Care and Galenica more closely in developing innovative and effective pharmaceutical products for patients that suffer from chronic kidney disease."
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