DGAP-News

Keryx Biopharmaceuticals Announces EMA Validation of Marketing Authorization Application for Zerenex(TM) - Seite 2

phosphate levels) in patients with chronic kidney disease (CKD) on dialysis,
conducted pursuant to a Special Protocol Assessment (SPA) agreement with the
Food and Drug Administration (FDA). The Company's New Drug Application (NDA) is
currently under review by the FDA with an assigned Prescription Drug User Fee
Act (PDUFA) goal date of June 7, 2014, and its Marketing Authorization
Application, seeking the approval of Zerenex as a treatment of
hyperphosphatemia in patients with CKD, including dialysis and non-dialysis
dependent CKD, is currently under review by the European Medicines Agency
(EMA). The Company is also developing Zerenex in the U.S. for the management of
iron deficiency anemia and elevated serum phosphorus in patients with Stage 3
to 5 non-dialysis dependent CKD. In addition, Keryx's Japanese partner, Japan
Tobacco Inc. and Torii Pharmaceutical Co., Ltd. has 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 is headquartered in New York City.

Cautionary Statement

Some of the statements included in this press release, particularly those
relating to the results of clinical trials, the clinical benefits to be derived
from Zerenex (ferric citrate coordination complex), regulatory submissions and
approvals, the commercial opportunity and competitive positioning, and any
business prospects for Zerenex, may be forward-looking statements that involve
a number of risks and uncertainties. For those statements, we claim the
protection of the safe harbor for forward-looking statements contained in the
Private Securities Litigation Reform Act of 1995. Among the factors that could
cause our actual results to differ materially are the following: the risk that
the validation of the Zerenex MAA by the EMA, which is being reported today,
represents only a preliminary evaluation of the application and is not
indicative of deficiencies that may be identified during the EMA review
process; the FDA PDUFA goal date for our Zerenex NDA is subject to change and
does not guarantee that the review of the NDA will be completed on a timely
basis; the risk that the FDA, and/or EMA ultimately deny approval of the U.S.
NDA, and/or MAA, respectively; the risk that SPAs are not a guarantee that the
FDA will ultimately approve a product candidate following filing acceptance;
whether the FDA and EMA will concur with our interpretation of our Phase 3
study results, supportive data, or the conduct of the studies; whether Riona(r)
will be successfully launched and marketed by our Japanese partner, Japan