Keryx Biopharmaceuticals Announces Zerenex(TM) (Ferric Citrate Coordination Complex) Phase 2 Results in Non-Dialysis Dependen...
April 09 2014 - 8:30AM
Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) (the "Company") today
announced that Phase 2 clinical results of Zerenex™ (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™ (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 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
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