DGAP-News: Keryx Biopharmaceuticals Announces Issuance of

DGAP-News: Keryx Biopharmaceuticals, Inc. / Keryx Biopharmaceuticals Announces Issuance of U.S. Patent for Zerenex(TM) Covering Orally Administrable Forms of Ferric Citrate 18.12.2013 / 14:30 --------------------------------------------------------------------- NEW YORK, 2013-12-18 14:30 CET (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 this objective.' 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 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. Cautionary Statement 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: Lauren Fischer Director - Investor Relations Keryx Biopharmaceuticals, Inc. Tel: 212.531.5965 E-mail: lfischer@keryx.com News Source: NASDAQ OMX End of Corporate News --------------------------------------------------------------------- 18.12.2013 Dissemination of a Corporate News, transmitted by DGAP - a company of EQS Group AG. The issuer is solely responsible for the content of this announcement. DGAP's Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and www.dgap.de --------------------------------------------------------------------- Language: English Company: Keryx Biopharmaceuticals, Inc. United States ISIN: US4925151015 End of News DGAP News-Service --------------------------------------------------------------------- 245377 18.12.2013