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2014-04-09

GlobeNewswire Press Release: Keryx Biopharmaceuticals, Inc.

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, April 9, 2014 (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®) 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® 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
athttp://www.keryx.com. The information found on our website, or on the
website of the National Kidney Foundation athttp://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

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This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Keryx Biopharmaceuticals, Inc. via Globenewswire

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