DGAP-News: Keryx Biopharmaceuticals Announces FDA Acceptance for Filing of Zerenex(TM) New Drug Application
(firmenpresse) - Keryx Biopharmaceuticals, Inc.
08.10.2013 14:30
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NEW YORK, 2013-10-08 14:30 CEST (GLOBE NEWSWIRE) --
Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) today announced that its New Drug
Application (NDA) for Zerenex(tm) (ferric citrate coordination complex) has been
accepted for filing by the U.S. Food and Drug Administration (FDA). The
acceptance for filing of the NDA indicates the determination by the FDA that
the application is sufficiently complete to permit a substantive review.
Ron Bentsur, the Company's Chief Executive Officer, said, 'We are very pleased
with the FDA's acceptance for filing of our NDA for Zerenex, as this represents
an important achievement in the development of Zerenex. We believe that Zerenex
has the potential to make a meaningful difference in the lives of patients with
chronic kidney disease on dialysis, and we look forward to continuing to work
with the FDA in its review process of the Zerenex NDA.'
The Company's NDA, submitted on August 7, 2013, seeks approval for the
marketing and sale of Zerenex as a treatment for elevated serum phosphorus
levels, or hyperphosphatemia, in patients with chronic kidney disease (CKD) on
dialysis. Included in the NDA filing are safety and efficacy datasets derived
from the Company's Phase 3 registration program, which was conducted pursuant
to a Special Protocol Assessment (SPA) agreement with the FDA, as well as
safety and efficacy data from several additional studies, including four Phase
3 studies conducted in Japan in CKD patients on dialysis.
Keryx holds a worldwide license (except for certain Asian Pacific countries) to
Zerenex from Panion&BF Biotech, Inc. The Japanese rights are sublicensed by
Keryx to Japan Tobacco Inc. (JT) and Torii Pharmaceutical Co., Ltd. (Torii). On
January 7, 2013, JT announced the filing of its NDA with the Japanese Ministry
of Health, Labour and Welfare for marketing approval of ferric citrate in Japan
for the treatment of hyperphosphatemia in patients with CKD.
Zerenex is also in Phase 2 development in the U.S. for the management of
elevated phosphorus and iron deficiency in anemic patients with Stage 3 to 5
non-dialysis dependent CKD.
About Special Protocol Assessments
The Special Protocol Assessment (SPA) process is a procedure by which the FDA
provides official evaluation and written guidance on the design and size of
proposed protocols that are intended to form the basis for a new drug
application. Final marketing approval depends on the efficacy and safety
results, including the adverse event profile, and an evaluation of the
benefit/risk of treatment demonstrated in the Phase 3 clinical program. The SPA
agreement may only be changed through a written agreement between the sponsor
and the FDA, or if the FDA becomes aware of a substantial scientific issue
essential to product efficacy or safety. For more information on Special
Protocol Assessment, please visit:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guida
nces/ucm080571.pdf.
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
http://www.keryx.com. The information found on our website, and the FDA
website, is not incorporated by reference into this press release and is
included for reference purposes only.
Lauren Fischer
Director - Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5965
E-mail: lfischer(at)keryx.com
News Source: NASDAQ OMX
08.10.2013 Dissemination of a Corporate News, transmitted by DGAP -
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Language: English
Company: Keryx Biopharmaceuticals, Inc.
United States
Phone:
Fax:
E-mail:
Internet:
ISIN: US4925151015
WKN:
End of Announcement DGAP News-Service
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