Fresenius Medical Care and Galenica are establishing a new pharmaceutical company focused on the renal disease segment. To be called Vifor-Fresenius Medical Care Renal Pharma, the company will develop and distribute on a worldwide basis products to treat iron deficiency anemia and bone mineral metabolism for predialysis and dialysis patients.
Fresenius Medical Care will hold a 45% share in the new company with headquarters in Switzerland. The company provides products and services for individuals undergoing dialysis. It has a network of 2,716 dialysis clinics in North America, Europe, Latin America, Asia-Pacific, and Africa. The firm supplies dialysis products such as hemodialysis machines, dialyzers, and related disposable products.
Galenica will contribute to the new entity intravenous (IV) iron products Venofer® and Ferinject® approved for use in the dialysis and predialysis market, or chronic kidney disease (CKD) stages III to V, globally.
The market for IV iron products used in dialysis and predialysis was approximately $1 billion in 2009, according to Galenica and Fresenius. Commercialization of Venofer and Ferinject outside the field of CKD stages III to V will remain fully the responsibility of Galenica and its existing key partners.
Galenica will also contribute all rights for PA21, an iron-based phosphate binder. Vifor-Fresenius Medical Care Renal Pharma will hold the exclusive, worldwide license, while Galenica will develop and market this product in Japan with Kissei.
PA21 is currently in preparation for Phase III studies. Regulatory filings in the U.S. and Europe are anticipated in 2012. The phosphate binder market had a value of $1.5 billion in 2009, according to Galenica and Fresenius.