Fresenius Medical Care AG & Co. KGaA, the world’s
largest provider of dialysis products and services, and Galenica Ltd. 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.”
