Keryx Biopharmaceuticals Announces Issuance of U.S. Patent for Zerenex(TM)
Covering Orally Administrable Forms of Ferric Citrate
NEW YORK, Dec. 18, 2013 (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc.
(Nasdaq:KERX) announced today that the U.S. Patent and Trademark Office has
issued U.S. Patent No. 8,609,896. The patent, which expires in 2024, claims
orally administrable forms of Zerenex prepared from ferric citrate having a
BET active surface area greater than about 16 sq. m/g. The active
pharmaceutical ingredient (API) of Zerenex is ferric citrate having a BET
surface area substantially above this surface area threshold.
This newly issued patent further enhances the Company's key patent family,
which includes U.S. Patent Nos. 7,767,851, 8,299,298 and 8,338,642. These U.S.
patents expire in 2024, without patent term extension, and contain composition
and method of use claims covering Zerenex.
Ron Bentsur, Chief Executive Officer of Keryx, commented, "We believe that our
portfolio of patents will provide market exclusivity for Zerenex through at
least 2024, as the high API surface area of our ferric citrate is essential
for Zerenex' activity and dissolution. The patent issued today enhances our IP
portfolio through the protection of orally administrable forms of Zerenex."
Mr. Bentsur continued, "We are committed to protecting the long-term market
potential for Zerenex through the strengthening of the patent portfolio and we
believe that the issued patent today is another significant achievement toward
The Company continues to prosecute additional patent applications for Zerenex,
which, if issued, would expand the scope of patent claims covering Zerenex
The Company'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.
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 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 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.
Some of the statements included in this press release, particularly those
relating to the intellectual property of Zerenex (ferric citrate coordination
complex), 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, 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 is not incorporated by reference into this press release
and is included for reference purposes only.
CONTACT: KERYX CONTACT:
Director - Investor Relations
Keryx Biopharmaceuticals, Inc.
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