BAD HOMBURG, Germany—Fresenius Medical Care AG and Galenica Ltd. announced Dec. 1 the formation of a new renal pharmaceutical company designed to develop and distribute on a worldwide basis products to treat iron deficiency anemia and bone mineral metabolism for pre-dialysis and dialysis patients.
The newly formed company will be called Vifor-Fresenius Medical Care Renal Pharma Ltd., and it extends existing agreements with Galenica, according to Fresenius.
Galenica will contribute to the company the intravenous (IV) iron products Venofer and Ferinject for use in the dialysis and pre-dialysis market on a worldwide basis. Commercialization of both IV iron products outside the field of CKD stages 3 to 5 will remain fully the responsibility of Galenica and its existing key partners.
Iron deficiency is the most common cause of anemia. The market for intravenous iron products used in dialysis and pre-dialysis was approximately $1 billion in 2009, according to Fresenius.
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 percent 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 Unites States and Europe in 2012.
Fresenius Medical Care will hold a 45 percent share in the new company with headquarters in Switzerland. The transaction is subject to final anti-trust approval in certain regions.
“This investment allows Fresenius Medical Care to take the next major implementation step in its renal pharmaceutical strategy,” said Ben Lipps, CEO of Fresenius Medical Care. “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.”
