DGAP-News: Keryx Biopharmaceuticals Announces the

DGAP-News: Keryx Biopharmaceuticals, Inc. / Keryx Biopharmaceuticals Announces the Appointment of Abraham Ceesay as Vice President of Marketing 18.02.2014 / 14:30 --------------------------------------------------------------------- Proven Global Renal Marketing Expert Joins Commercial Team NEW YORK, 2014-02-18 14:30 CET (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a biopharmaceutical company focused on the acquisition, development and commercialization of pharmaceutical products for the treatment of renal disease, today announced the appointment of Abraham Ceesay as Vice President of Marketing and Operations. In this role, Mr. Ceesay will develop and lead all aspects of the Zerenex(TM) launch strategy and execution, including brand planning, forecasting and analysis, marketing operations and patient access programs. The Company's new drug application for Zerenex (ferric citrate coordination complex) is currently under review by the FDA with an assigned Prescription Drug User Fee Act (PDUFA) goal date of June 7, 2014. Greg Madison, the Company's Executive Vice President, Chief Operating Officer, commented, 'Mr. Ceesay brings an exceptional track record for successful marketing and product launches of innovative products, including significant renal experience. While at Genzyme, I saw first hand Abe's competencies in the development of launch initiatives, brand creation strategies and marketing efforts to maximize the commercial potential for renal drugs. We look forward to leveraging Abe's capabilities for the potential launch and marketing of Zerenex.' Mr. Ceesay brings to Keryx extensive experience in the launch and growth of innovative therapeutic products and a strong track record in the leadership of global commercial teams. Prior to joining Keryx, Mr. Ceesay served as Vice President, Marketing at Ironwood Pharmaceuticals (Nasdaq:IRWD), where he held responsibility for the management of the U.S. linaclotide P&L, leadership of the Linzess(r) brand team and co-promotion collaboration with Forest Laboratories. In his role, Mr. Ceesay developed and led all facets of the Linzess(r) launch strategy and also led the cross functional U.S. Operating Team responsible for the commercial and development decisions to support the commercialization of Linzess(r). Previous to his career with Ironwood, Mr. Ceesay spent eight years at Genzyme/Sanofi, initially as a field sales specialist and ultimately as the Director, Renal Global Marketing, in which capacity he held marketing responsibility for the company's renal franchise (Renagel(r), Renvela(r), Hectorol(r)). Over the course of his career at Genzyme, Mr. Ceesay developed and implemented brand strategies for the global renal franchise, including all marketing facets of the Renvela(r) launch strategy. Mr. Ceesay holds a bachelors degree from Ithaca College, and a Masters of Business Administration from Suffolk University's Sawyer School of Management. About Keryx Biopharmaceuticals, Inc. Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of pharmaceutical products for the treatment of renal disease. Keryx is developing Zerenex(TM) (ferric citrate coordination complex), an oral, ferric iron-based compound. Zerenex has completed a U.S.-based Phase 3 clinical program 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 FDA. Keryx's New Drug Application ('NDA'), submitted to the FDA in 2013, is currently under review and has an assigned Prescription Drug User Fee Act ('PDUFA') goal date of June 7, 2014. Zerenex has also completed a Phase 2 study in the U.S. for the management of elevated serum phosphorus levels 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., received marketing approval of ferric citrate in Japan for the treatment of hyperphosphatemia in patients with chronic kidney disease on January 17, 2014. 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(r) will be successfully launched and marketed by our Japanese partner, Japan Tobacco, Inc. and Torii Pharmaceutical Co., Ltd.; 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: 212.531.5965 E-mail: lfischer@keryx.com News Source: NASDAQ OMX End of Corporate News --------------------------------------------------------------------- 18.02.2014 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 --------------------------------------------------------------------- 253103 18.02.2014