Keryx Biopharmaceuticals, Inc.
GlobeNewswire Press Release: Keryx Biopharmaceuticals, Inc.

DGAP-News: Keryx Biopharmaceuticals, Inc. /

09.04.2014 / 14:30

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

Keryx Biopharmaceuticals Announces Zerenex(TM) (Ferric Citrate Coordination
Complex) Phase 2 Results in Non-Dialysis Dependent Chronic Kidney Disease
Selected as a Late Breaking Oral Presentation at the Upcoming National Kidney
Foundation 2014 Spring Clinical Meeting 

Several Other Pharmacoeconomic and Clinical Ferric Citrate Abstracts Selected
for Poster Presentation 

NEW YORK, 2014-04-09 14:30 CEST (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals,
Inc. (Nasdaq:KERX) (the 'Company') today announced that Phase 2 clinical
results of Zerenex(tm) (ferric citrate coordination complex) in non-dialysis
dependent chronic kidney disease (NDD-CKD) patients with elevated serum
phosphorus and iron deficiency anemia has been selected as a Late Breaking oral
presentation at the National Kidney Foundation 2014 Spring Clinical Meeting,
taking place April 22-26, 2014 in Las Vegas, NV. This presentation, entitled
'Zerenex(tm) (Ferric Citrate) for the Treatment of Iron-Deficiency Anemia and
Reduction of Serum Phosphate in Non-Dialysis Dependent CKD,' will be made
during the Late Breaking Session on Friday, April 25, 2014, from 9:30am -
11:00am PDT, by Dr. Geoffrey Block, Director of Clinical Research at Denver
Nephrology and Co-Chairman for this study. 

In addition to the late-breaking oral presentation, the following four
abstracts have also been selected for poster presentation during the meeting. 

  -- 'Phosphorus Binding with Ferric Citrate is Associated with Fewer
     Hospitalizations and Reduced Hospitalization Costs,' R. Rodby, poster
     number 422;
  -- 'Economic Impact of Ferric Citrate Versus Standard of Care for Hemodialysis
     Patients,' S. Brunelli, poster number 156;
  -- 'Phosphorus Binding with Ferric Citrate Reduces Erythropoiesis-Stimulating
     Agent (ESA) and IV Iron Usage and Cost in Patients with ESRD,' R. Rodby,
     poster number 415; and
  -- 'Oral Ferric Citrate Eliminates the Need for Intravenous (IV) Iron in
     Dialysis Patients,' M. Sika, poster number 79.

Posters will be presented in the Exhibit Hall on Wednesday, April 23, from
6:00pm-7:30pm PDT. 

Each of the above mentioned abstracts are currently available on the National
Kidney Foundation's website:
http://www.kidney.org/news/meetings/clinical/abstract/index.cfm. 

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
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 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 Tobacco, Inc.
and Torii Pharmaceutical Co., Ltd.; whether, Zerenex, if approved by the FDA
and/or EMA, will be successfully launched and marketed; and other risk factors
identified from time to time in our reports filed with the Securities and
Exchange Commission. Any forward-looking statements set forth in this press
release speak only as of the date of this press release. We do not undertake to
update any of these forward-looking statements to reflect events or
circumstances that occur after the date hereof. This press release and prior
releases are available at http://www.keryx.com. The information found on our
website, or on the website of the National Kidney Foundation at
http://www.kidney.org, is not incorporated by reference into this press release
and is included for reference purposes only. 


         CONTACT: Keryx Contact:
         Lauren Fischer
         Director - Investor Relations
         Keryx Biopharmaceuticals, Inc.
         Tel: 212.531.5965
         E-mail: lfischer@keryx.com
News Source: NASDAQ OMX


End of Corporate News

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

09.04.2014 Dissemination of a Corporate News, transmitted by DGAP - a
company of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de

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


Language:    English                         
Company:     Keryx Biopharmaceuticals, Inc.  
 
 
             United States                   
ISIN:        US4925151015                    
 
 
End of News    DGAP News-Service  
---------------------------------------------------------------------  
262404 09.04.2014