Press release

Velphoro® receives EU Marketing Authorisation

Wednesday, 27 August 2014, ↓ directly to download

Velphoro® receives EU marketing authorisation for treatment of hyperphosphatemia in adult CKD patients on dialysis

Velphoro® (sucroferric oxyhydroxide) has received EU marketing authorisation from the European Commission for the control of serum phosphorus levels in adult patients with Chronic Kidney Disease (CKD) on haemodialysis or peritoneal dialysis. In June, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending marketing authorisation for the product.

Velphoro® is a non-calcium, iron-based, chewable phosphate binder. The EU marketing authorisation for the 28 EU countries was based on a pivotal Phase III study which met its primary and secondary endpoints. The study demonstrated that Velphoro® successfully controls hyperphosphatemia with fewer pills than sevelamer carbonate, the current standard of care in patients with CKD on dialysis. The average daily dose to control hyperphosphatemia was 3.3 pills per day after 52 weeks.

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Galenica is a diversified Group active throughout the healthcare market which, among other activities, develops, manufactures and markets pharmaceutical products, runs pharmacies, provides logistical and database services and sets up networks. With its two Business units Vifor Pharma and Galenica Santé, the Galenica Group enjoys a leading position in all its core business activities. A large part of the Group’s income is generated by international operations. Galenica is listed on the Swiss Stock Exchange (SIX Swiss Exchange, GALN, security number 1,553,646).

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Julien Vignot

Julien Vignot

Head Investor Relations


Galenica Ltd.

Investor Relations
Untermattweg 8
CH-3027 Bern

Phone:
+41 58 852 81 11
Fax:
+41 58 852 81 12

Christina Hertig

Christina Hertig

Head of Corporate Communications


Galenica Ltd.

Corp. Communications
Untermattweg 8
CH-3027 Bern

Phone:
+41 58 852 85 17
Fax:
+41 58 852 85 58

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