PA21 dossier submitted for approval to US FDA

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PA21 dossier submitted for approval to US FDA

Monday, 11 February 2013

The New Drug Application (NDA) for PA21 has been submitted to the US Food and Drug Administration (FDA). Separately, the European Medicines Agency (EMA) has accepted the Marketing Authorisation Application (MAA) which was submitted December 2012 to seek approval in the European Union. The filing for Singapore was submitted at the beginning of 2013 and further submissions for approval are being prepared.

PA21 is a chewable, iron-based phosphate binder for the control of hyperphosphatemia in patients with chronic kidney disease (CKD). The pivotal Phase III study was successfully completed in July 2012, meets its primary and secondary endpoints and serves as the basis for registration filings in markets around the world. The data demonstrated that the new phosphate binder successfully controls hyperphosphatemia in patients with CKD. Full results from the phase III study were presented at the American Society of Nephrology (ASN) Kidney Week in San Diego, California, in November 2012. Results will also be submitted to peer-review journals.

The six month extension of the pivotal Phase III study has also been completed recently. Preliminary results show that the safety and efficacy of PA21 are maintained with the advantage of a low pill burden. These results will be submitted for presentation at the 50th ERA-EDTA (European Renal Association - European Dialysis and Transplant Association) congress, taking place in Istanbul, Turkey, in May 2013.

The new phosphate binder PA21 was developed by Vifor Pharma. In 2011, all rights were transferred to Vifor Fresenius Medical Care Renal Pharma, a common company of Galenica and Fresenius Medical Care.

Galenica is a diversified Group active throughout the health care market which, among other things, develops, manufactures and markets pharmaceutical products, runs pharmacies, provides logistical and database services and sets up networks. The Galenica Group enjoys a leading position in all its business sectors – Pharma, Logistics, Retail and Healthcare Information. 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).

Fritz Hirsbrunner

Head of Investor Relations
Galenica Ltd.

Board of Directors
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CH-3027 Bern

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Christina Hertig
Christina Hertig

Head of Corporate Communications
Galenica Ltd.

Corp. Communications
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CH-3027 Bern

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