Regulators in Europe have given the green light to Vifor Fresenius Medical Care Renal Pharma's hyperphosphatemia drug Velphoro.
The approval from the European Commission for Velphoro (sucroferric oxyhydroxide), formerly known as PA21, is based on Phase III data demonstrated that the drug successfully controls the accumulation of phosphorus in the blood. However, it also enjoys the advantage of a much lower pill burden than the current standard of care in patients with chronic kidney disease on dialysis, namely Sanofi's Renvela (sevelamer carbonate).
On average, dialysis patients take 19 pills per day with phosphate binders comprising 50% of that burden. The recommended starting dose of Velphoro is three tablets per day (one per meal), so it should improve compliance.
Velphoro was developed by Switzerland’s Vifor Pharma and in 2011, all rights were transferred to Vifor Fresenius Medical Care Renal Pharma. It was approved in the USA in November 2013 and was launched there by Fresenius Medical Care North America in March.
These are interesting times for Vifor Pharma as earlier this month, parent company Galenica unveiled plans to split its pharmaceutical and healthcare operations into two separate businesses.
The move represents the first step towards potential listings of each unit, though Galenica said it will take three-five years for Vifor Pharma to reach the critical mass necessary for a successful spin-off. Soeren Tulstrup is taking over as chief executive of Vifor Pharma from Galenica CEO (and Vifor head) David Ebsworth, who will advise on special projects until he retires at the end of August 2015.
The news led to rumours that the new structure exposes Vifor Pharma, a well-run and profitable business, as a potential takeover target, even before the split. However Galenica has said the unit will remain within the group until the entity can blossom as a stand-alone entity.