Keryx Biopharmaceuticals' Zerenex(TM) Data Selected for Poster Presentation at the AMCP's 26th Annual Meeting and Expo
March 17 2014 - 8:30AM
Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) today announced that
data highlighting the potential pharmacoeconomic benefit of
Zerenex™ (ferric citrate coordination complex), the Company's drug
candidate for the treatment of hyperphosphatemia in dialysis
patients, has been selected for poster presentation during the
upcoming Academy of Managed Care Pharmacy's (AMCP) 26th Annual
Meeting and Expo, being held April 1-4, 2014, at the Tampa
Convention Center in Tampa, Florida.
The poster, entitled, "Phosphorus Binding with Ferric Citrate
Reduces Managed Care Costs Through Reduced Use of IV Iron and
Erythropoiesis-Stimulating Agents (ESAs)," is scheduled to be
presented in the poster session on Thursday, April 3, 2014, from
11:30am-2:30 pm, in the West and Central Hall of the convention
center.
The abstract (Abstract No. N1EM) can be viewed online at the
AMCP website:
http://www.amcp.org/WorkArea/DownloadAsset.aspx?id=17843.
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals is focused 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. Zerenex has completed a U.S.-based Phase 3 clinical
program for the treatment of hyperphosphatemia (elevated phosphate
levels) in patients with chronic kidney disease on dialysis,
conducted pursuant to a Special Protocol Assessment agreement with
the FDA. Keryx's New Drug Application, submitted to the FDA in
2013, is currently under review and has an assigned Prescription
Drug User Fee Act (PDUFA) goal date of June 7, 2014. Keryx has
recently submitted a Marketing Authorization Application filing to
the European Medicines Agency. Zerenex has also completed a Phase 2
study in the U.S. for the management of elevated serum phosphorus
levels and iron deficiency anemia in patients with Stage 3 to 5
non-dialysis dependent chronic kidney disease. In addition, Keryx's
Japanese partner, Japan Tobacco, Inc. and Torii Pharmaceutical Co.,
Ltd., received marketing approval of ferric citrate in Japan for
the treatment of hyperphosphatemia in patients with chronic kidney
disease on January 17, 2014. 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 and pharmacoeconomical benefits to be derived from
Zerenex, 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 MAA will not be
accepted for review by the EMA due to deficiencies in the
application or for other reasons; acceptance of the NDA filing
represents only a preliminary evaluation of the application and is
not indicative of deficiencies that may be identified during the
FDA's review; a PDUFA goal date 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 drug
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; if approved, whether any meaningful
pharmacoeconomic benefits will be generated with the use of
Zerenex; 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, and on the website of the Academy
of Managed Care Pharmacy at http://www.amcp.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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