DGAP-News

Keryx Biopharmaceuticals Announces EMA Validation of Marketing Authorization Application for Zerenex(TM)

DGAP-News: Keryx Biopharmaceuticals, Inc. /
Keryx Biopharmaceuticals Announces EMA Validation of Marketing
Authorization Application for Zerenex(TM)

02.04.2014 / 14:30

---------------------------------------------------------------------

NEW YORK, 2014-04-02 14:30 CEST (GLOBE NEWSWIRE) --
Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) (the 'Company') today announced
that the European Medicines Agency ('EMA') has determined that the Company's
Marketing Authorization Application ('MAA') seeking the approval of Zerenex(tm)
(ferric citrate coordination complex) as a treatment for hyperphosphatemia in
patients with chronic kidney disease ('CKD'), including dialysis- and
non-dialysis-dependent CKD, is valid. Validation of the MAA confirms that the
submission is sufficiently complete to begin the formal review process.

The EMA's review of the application will follow the centralized marketing
authorization procedure. If approved by the EMA, Zerenex(tm) will receive
marketing authorization in all 27 member states of the European Union, as well
as in Norway, Liechtenstein and Iceland.

Ron Bentsur, Chief Executive Officer of Keryx, commented, 'We are grateful for
the EMA's quick validation of our MAA submission and look forward to working
with the EMA during the MAA review process.'

The Company also has a New Drug Application for Zerenex under review by the FDA
with an assigned Prescription Drug User Fee Act (PDUFA) goal date of June 7,
2014 seeking the approval of Zerenex for the treatment of hyperphosphatemia in
patients with CKD on dialysis. In January, it was announced that the Company's
Japanese partner, Japan Tobacco, Inc. and Torii Pharmaceutical Co., Ltd.
('JT/Torii'), received marketing approval of ferric citrate (branded Riona(r)) in
Japan for the improvement of hyperphosphatemia in patients with CKD, including
dialysis and non-dialysis dependent CKD.

Keryx Biopharmaceuticals retains a worldwide exclusive license (except for the
Asian Pacific Region) to Zerenex from Panion & BF Biotech, Inc. The Company has
sublicensed the development of ferric citrate in Japan to JT/Torii.

About Keryx Biopharmaceuticals, Inc.

Keryx Biopharmaceuticals focuses on the acquisition, development and
commercialization of pharmaceutical products for the treatment of renal
disease. Keryx is developing Zerenex (ferric citrate coordination complex), an
oral, ferric iron-based compound. Keryx has completed a U.S.-based Phase 3
clinical program for Zerenex for the treatment of hyperphosphatemia (elevated