Keryx Biopharmaceuticals Announces EMA Validation of Marketing Authorization Application for Zerenex(TM)
April 02 2014 - 8:30AM
Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) (the "Company") today
announced that the European Medicines Agency ("EMA") has determined
that the Company's Marketing Authorization Application ("MAA")
seeking the approval of Zerenex™ (ferric citrate coordination
complex) as a treatment for hyperphosphatemia in patients with
chronic kidney disease ("CKD"), including dialysis- and
non-dialysis-dependent CKD, is valid. Validation of the MAA
confirms that the submission is sufficiently complete to begin the
formal review process.
The EMA's review of the application will follow the centralized
marketing authorization procedure. If approved by the EMA, Zerenex™
will receive marketing authorization in all 27 member states of the
European Union, as well as in Norway, Liechtenstein and
Iceland.
Ron Bentsur, Chief Executive Officer of Keryx, commented, "We
are grateful for the EMA's quick validation of our MAA submission
and look forward to working with the EMA during the MAA review
process."
The Company also has a New Drug Application for Zerenex under
review by the FDA with an assigned Prescription Drug User Fee Act
(PDUFA) goal date of June 7, 2014 seeking the approval of Zerenex
for the treatment of hyperphosphatemia in patients with CKD on
dialysis. In January, it was announced that the Company's Japanese
partner, Japan Tobacco, Inc. and Torii Pharmaceutical Co., Ltd.
("JT/Torii"), 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 Biopharmaceuticals retains a worldwide exclusive license
(except for the Asian Pacific Region) to Zerenex from Panion &
BF Biotech, Inc. The Company has sublicensed the development of
ferric citrate in Japan to JT/Torii.
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 validation of the Zerenex MAA by the EMA, which is being
reported today, represents only a preliminary evaluation of the
application and is not indicative of deficiencies that may be
identified during the EMA review process; 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 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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