Keryx Biopharmaceuticals Announces Issuance of U.S. Patent for Zerenex(TM) Covering Orally Administrable Forms of Ferric Citrate
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.Â The Marketing
Authorization Application filing with the European Medicines Agency (EMA) is
pending.Â 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. Â 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
CONTACT: KERYX CONTACT:
Director - Investor Relations
Keryx Biopharmaceuticals, Inc.
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Source: Keryx Biopharmaceuticals, Inc. via GlobeNewswire