Keryx Biopharmaceuticals Announces Filing of New Drug Application
for Marketing Approval of Ferric Citrate (Zerenex™) in Japan by
Partner, Japan Tobacco Inc.
- NDA Filing Milestone Triggers Payment to Keryx
NEW YORK, Jan. 7, 2013 /PRNewswire/ -- Keryx
Biopharmaceuticals, Inc. (NASDAQ:KERX) today announced that its
Japanese partner, Japan Tobacco Inc. (JT), has filed its New Drug
Application (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 chronic kidney disease (CKD). The NDA filing
is supported by efficacy and safety data from several successfully
completed Phase 3 studies in CKD patients with hyperphosphatemia in
Japan.
Under the license agreement with JT and its subsidiary Torii
Pharmaceutical Co., Ltd. (Torii), within 30 days, Keryx will
receive a non-refundable payment of $7
million for the achievement of the NDA filing milestone.
Ron Bentsur, Chief Executive
Officer of Keryx, commented, "We congratulate our partner,
JT/Torii, on achieving this important and exciting milestone and we
applaud the tremendous sense of purpose with which they have been
developing ferric citrate in Japan." Mr. Bentsur continued, "We
eagerly await our top-line results from our U.S. long-term Phase 3
study in dialysis patients and the anticipated U.S. NDA and
European MAA filings which will follow suit."
Zerenex™ (ferric citrate), a ferric iron-based phosphate binder,
has recently completed a long-term Phase 3 study, under Special
Protocol Assessment, as a treatment for end-stage renal disease
patients with hyperphosphatemia on dialysis, and the top-line data
from this Phase 3 study is expected to be announced
imminently. Zerenex is also being explored in a Phase 2 study
in managing serum phosphorus and iron deficiency in anemic patients
with Stage 3 to 5 CKD not on dialysis.
Keryx Biopharmaceuticals retains a worldwide exclusive license
(except for the Asian Pacific Region) to Zerenex (ferric citrate)
from Panion & BF Biotech, Inc. The Company has sublicensed the
development of ferric citrate in Japan to JT and Torii.
Sublicense Agreement with Japan Tobacco & Torii
Pharmaceutical
In September 2007, Keryx
sublicensed to JT and Torii the exclusive rights for the
development and commercialization of its hyperphosphatemia drug,
Zerenex (ferric citrate), in Japan. The licensing arrangement calls for JT
and Torii to pay to Keryx up to $100
million in up-front license fees and payments upon the
achievement of specified milestones, of which $35 million has been received by Keryx to date
(including the milestone achieved today). In addition, upon
commercialization, JT and Torii will make royalty payments to Keryx
on net sales of the drug in Japan.
JT and Torii are responsible for all development and
commercialization costs in Japan.
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), an oral, ferric iron-based
compound that has the capacity to bind to phosphate and form
non-absorbable complexes. The U.S.-based Phase 3 clinical program
of Zerenex for the treatment of hyperphosphatemia (elevated
phosphate levels) in patients with end-stage renal disease is being
conducted pursuant to a Special Protocol Assessment (SPA) agreement
with the FDA. Zerenex is also in Phase 2 development for the
management of phosphorus and iron deficiency in anemic 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. 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 anticipating any clinical trials and business
prospects for Zerenex (ferric citrate) 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: our
ability to successfully and cost-effectively complete clinical
trials for Zerenex (ferric citrate); the risk that the data (both
safety and efficacy) from the long-term Phase 3 trial of Zerenex
(ferric citrate) will not coincide with the data analyses from
previous clinical trials reported by the Company; the risk that the
data (both safety and efficacy) from the ongoing Phase 2 study in
non-dialysis dependent chronic kidney disease will be negative or
inconclusive; our ability to meet anticipated development timelines
for Zerenex due to clinical trial results, manufacturing
capabilities or other factors; our Japanese partner's ability to
successfully obtain marketing approval for ferric citrate in
Japan; 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.
KERYX CONTACT:
Lauren Fischer
Director - Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5965
E-mail: lfischer@keryx.com