- Marketing Approval Triggers Milestone
Payment to Keryx
NEW YORK, Jan. 17, 2014 /PRNewswire/ -- Keryx
Biopharmaceuticals, Inc. (NASDAQ:KERX) today announced that its
Japanese partner, Japan Tobacco Inc. (JT), has received
manufacturing and marketing approval of ferric citrate from the
Japanese Ministry of Health, Labour and Welfare. Ferric citrate, to
be marketed in Japan by JT's
subsidiary, Torii Pharmaceutical Co., Ltd., under the brand name
Riona®, is indicated as an oral treatment for the improvement of
hyperphosphatemia in patients with chronic kidney disease (CKD),
including dialysis and non-dialysis dependent CKD.
Under the license agreement with JT and Torii, within 30 days,
Keryx will receive a non-refundable payment of $10 million for the achievement of the marketing
approval milestone. Keryx will also receive double-digit
tiered royalties on net sales of Riona® in Japan, as well as up to an additional
$55 million upon the achievement of
certain annual net sales milestones.
Ron Bentsur, Chief Executive
Officer of Keryx, commented, "This first regulatory approval of
ferric citrate is a monumental achievement for the Zerenex program,
and we congratulate our partner, JT/Torii, on achieving this
important and exciting milestone." Mr. Bentsur continued, "We
believe that Riona® will become the phosphate binder of choice in
Japan in both dialysis and
pre-dialysis patients."
The U.S. New Drug Application for Zerenex is currently under
review by the Food and Drug Administration with an assigned
Prescription Drug User Fee Act (PDUFA) goal date of June 7, 2014.
Keryx Biopharmaceuticals retains a worldwide exclusive license
(except for the Asian Pacific Region) to Zerenex (ferric citrate
coordination complex) from Panion & BF Biotech, Inc. The
Company has sublicensed the development of ferric citrate in
Japan to JT and Torii.
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. 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. The Marketing Authorization
Application filing with the European Medicines Agency (EMA) is
pending. The Company is also developing Zerenex in the U.S.
for the management of elevated phosphorus and iron deficiency
anemia 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, 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: 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 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, JT and Torii;
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.
KERYX CONTACT:
Lauren Fischer
Director - Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: +1-212.531.5965
E-mail: lfischer@keryx.com