DGAP-News: Keryx Biopharmaceuticals' Zerenex(TM) (Ferric Citrate Coordination Complex) Data Selected for Oral and Poster Presentations at the American Society of Nephrology's Kidney Week 2013
(firmenpresse) - Keryx Biopharmaceuticals, Inc.
17.10.2013 14:30
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NEW YORK, 2013-10-17 14:30 CEST (GLOBE NEWSWIRE) --
Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) today announced that abstracts
highlighting Zerenex(tm) (ferric citrate coordination complex), the Company's drug
candidate for the treatment of elevated serum phosphorus levels, or
hyperphosphatemia, in patients with chronic kidney disease (CKD) on dialysis,
have been selected for oral and poster presentations during the American
Society of Nephrology (ASN) Kidney Week 2013 annual meeting. This annual
meeting of the ASN will be held in Atlanta, Georgia, from November 5-10, 2013.
Summary of Zerenex(tm) (ferric citrate coordination complex) Data Presentations:
ORAL PRESENTATION:
Saturday, November 9th:
Abstract#: SA-OR083
- Title: Ferric Citrate, a Phosphate Binder, Increases Iron Stores but Is Not
Associated with Evidence of the Malnutrition-Inflammation-Cachexia Syndrome
- Session Name: Dialysis: Anemia, Inflammation, Malnutrition, and Metabolism
- Presentation Time: 5:30pm
CLINICAL POSTER PRESENTATIONS:
Thursday, November 7th:
Abstract #: TH-PO521
- Title: Ferric Citrate as a Phosphate Binder Reduces IV Iron and
Erythropoietin Stimulating Agent (ESA) Use
- Session Name: Dialysis: Anemia, Inflammation, Malnutrition,&Metabolism - I
- Presentation Time: 10:00am
Saturday, November 9th:
Abstract #: SA-PO382
- Title: Achieved Iron Stores and Clinical Outcomes in a Trial of Ferric
Citrate as a Phosphate Binder
- Session Name: Dialysis: Anemia, Inflammation, Malnutrition,&Metabolism - II
- Presentation Time: 10:00am
Abstract #: SA-PO540
- Title: Ferric Citrate as a Phosphate Binder Has a Safety Profile Similar to
Sevelamer Carbonate and Calcium Acetate
- Session Name: Mineral Disease: CKD-MBD - II
- Presentation Time: 10:00am
Abstract #: SA-PO542
- Title: Ferric Citrate Binds Phosphorus, Delivers Iron, and Reduces IV Iron
and Erythropoietic Stimulating Agent Use in End-Stage Renal Disease
- Session Name: Mineral Disease: CKD-MBD - II
- Presentation Time: 10:00am
Abstract #: SA-PO543
- Title: Impact of Ferric Citrate, an Oral Phosphate Binder, on Mineral and
Bone Metabolism Markers in Dialysis
- Session Name: Mineral Disease: CKD-MBD - II
- Presentation Time: 10:00am
In addition, one abstract from the Company's Japanese partner for Zerenex,
Japan Tobacco, Inc., relating to its Phase 3, multicenter, randomized,
double-blind, placebo-controlled study in non-dialysis dependent Japanese
patients with CKD, has also been accepted for poster presentation during the
annual meeting:
Abstract #: SA-PO544
- Title: The Effect of JTT-751 (Ferric Citrate Hydrate) on Phosphorus and
FGF-23 in Chronic Kidney Disease
- Session Name: Mineral Disease: CKD-MBD - II
- Presentation Date/Time: Saturday, November 9th, 10:00am
The above abstracts are currently available online for viewing through the ASN
website at: http://www.asn-online.org/education/kidneyweek/archives/.
Keryx holds a worldwide license (except for certain Asian Pacific countries) to
Zerenex (ferric citrate coordination complex) from Panion&BF Biotech, Inc.
The Japanese rights are sublicensed by Keryx to Japan Tobacco Inc. and Torii
Pharmaceutical Co., Ltd.
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals is focused on the acquisition, development and
commercialization of medically important pharmaceutical products for the
treatment of renal disease. Keryx is developing Zerenex (ferric citrate
coordination complex), an oral, ferric iron-based compound that has the
capacity to bind to phosphate and form non-absorbable complexes. 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 on dialysis, conducted pursuant to a Special Protocol Assessment
(SPA) agreement with the Food and Drug Administration (FDA), and the Company's
New Drug Application is currently under review by the FDA. The Marketing
Authorization Application filing with the European Medicines Agency (EMA) is
pending submission. Zerenex is also in Phase 2 development in the U.S. for the
management of elevated phosphorus and iron deficiency in anemic patients with
Stages 3 to 5 non-dialysis dependent chronic kidney disease. In addition,
Keryx's Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd.
has filed its New Drug Application for marketing approval of ferric citrate in
Japan for the treatment of hyperphosphatemia in patients with chronic kidney
disease. 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
the timing of any such review, 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: acceptance of the NDA filing does not
represent final evaluation of the adequacy of the data submitted in the NDA;
whether the FDA will complete its review of the NDA on a timely basis; the risk
that the FDA, EMA, and Japanese Ministry of Health, Labour and Welfare
ultimately deny approval of the U.S. NDA, MAA and Japanese NDA, 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, Zerenex, if approved, 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
www.keryx.com.The information on our website, and on the ASN website, is not
incorporated by reference into this press release and is included as an
inactive textual reference only.
KERYX CONTACT:
Lauren Fischer
Director - Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5965
E-mail: lfischer(at)keryx.com
News Source: NASDAQ OMX
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Language: English
Company: Keryx Biopharmaceuticals, Inc.
United States
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ISIN: US4925151015
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Datum: 17.10.2013 - 14:30 Uhr
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