Keryx Biopharmaceuticals Announces PDUFA Goal Date for Zerenex(TM) New Drug Application
Montag, 21.10.2013 14:35 von DGAP
Keryx Biopharmaceuticals, Inc.
21.10.2013 14:30
---------------------------------------------------------------------------
NEW YORK, 2013-10-21 14:30 CEST (GLOBE NEWSWIRE) --
Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) announced today that the U.S. Food
and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA)
goal date of June 7, 2014, for the Company's New Drug Application (NDA) for
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.
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 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, EMA, and/or the Japanese
Ministry of Health, Labour and Welfare ultimately deny approval of the U.S.
NDA, MAA and/or 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@keryx.com
News Source: NASDAQ OMX
21.10.2013 Dissemination of a Corporate News, transmitted by DGAP -
a company of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------------
Language: English
Company: Keryx Biopharmaceuticals, Inc.
United States
Phone:
Fax:
E-mail:
Internet:
ISIN: US4925151015
WKN:
End of Announcement DGAP News-Service
---------------------------------------------------------------------------