NEW YORK, June 18, 2014 (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) announced today that the U.S. Patent and Trademark Office has issued U.S. Patents No. 8,754,257 and No. 8,754,258. The patents, which expire in 2024, claim pharmaceutical compositions comprising a form of ferric citrate having an intrinsic dissolution rate of 1.88-4.0 mg/cm2/min, and orally administrable forms of ferric citrate prepared from a form of ferric citrate having an intrinsic dissolution rate of at least 1.88/mg/cm2/min, respectively. The active pharmaceutical ingredient (API) of Zerenex is ferric citrate. In addition, U.S. Patent No. 8,754,257 contains claims directed to the dosing and daily administration regimen of Zerenex that is included in the proposed New Drug Application for Zerenex, which is currently under review by the U.S. Food and Drug Administration (FDA).
These newly issued patents further enhance the Company's key patent family, which includes U.S. Patent Nos. 7,767,851, 8,299,298, 8,338,642 and 8,609,896, which expire in 2024, and U.S. Patent No. 8,093,423, which expires in 2028, without patent term extension. Each of these patents contains composition and method of use claims covering Zerenex.
Ron Bentsur, Chief Executive Officer of Keryx, commented, "The patents that issued today are significant in that they link the Zerenex API with orally administrable dosage forms. Moreover, the timing of issuance, which is merely 6 months after the issuance of U.S. Patent No. 8,609,896 last December, provides substantiating evidence of our rapidly growing patent portfolio which covers many aspects of Zerenex and its API."
The Company continues to prosecute additional patent applications for Zerenex, which, if issued, would expand the scope of patent claims covering Zerenex beyond 2030.
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 September 7, 2014.
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals, headquartered in New York, is focused on bringing innovative therapies to market for patients suffering from renal disease. In the United States, ZerenexTM (ferric citrate) is currently under review by the Food and Drug Administration (FDA) for the treatment of hyperphosphatemia in dialysis-dependent chronic kidney disease (CKD) patients. In January 2014, ferric citrate was approved for the treatment of patients with all stages of CKD in Japan, where it is being marketed as Riona® by Keryx's Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd.
Cautionary Statement
Some of the statements included in this press release particularly those regarding Keryx's additional patent applications that may cover 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 include the fact that the U.S. Patent and Trademark Office, or other similar foreign patent authorities, may not issue those patents 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.