NEW YORK, April 15, 2014 (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 three key executives in high priority strategic roles integral to the preparation for the potential Zerenex™ (ferric citrate coordination complex) product launch. The Company's New Drug Application for Zerenex™, an oral, ferric iron-based compound, is currently under review by the FDA with an assigned Prescription Drug User Fee Act (PDUFA) target goal date of June 7, 2014.
Brian R. Adams has been appointed Vice President, General Counsel. Mr. Adams comes to the Company with significant legal and business management experience within the pharmaceutical industry. Mr. Adams joins the Company from Algeta ASA, where he served as its General Counsel, with oversight of all global legal matters, corporate governance, alliance management and strategic transactions, including the highly successful launch of of Xofigo® in prostate cancer, resulting in a $2.9B acquisition bid for Algeta by Bayer AG. Prior to joining Algeta in 2012, Mr. Adams spent six years as an in-house counsel for Genzyme Corporation and AVEO Oncology. Throughout his career, Mr. Adams has provided domestic and international legal support for product development, operations, commercialization, securities, healthcare compliance and licensing/M&A transactions. Prior to joining Genzyme, Mr. Adams practiced in the Boston office of Bingham McCutchen LLP, where he advised private equity sponsors, biotech and other emerging technology companies on a broad range of corporate matters and financing transactions. Mr. Adams received a BA from Harvard University and a law degree (JD) from the Catholic University of America's Columbus School of Law.
Thomas M. Edwards has been appointed Vice President, US Sales, and will focus on building and leading the US Sales and Sales Training organization. With a pharmaceutical sales career spanning more than 22 years, Mr. Edwards brings a strong background in sales management, training and leadership development, with extensive product launch experience across multiple specialty indications. Over the course of his career, Mr. Edwards has built and led high-performing teams that have contributed to the overall success of specialty pharmaceutical products at Eli Lilly, Genentech and Genzyme. Mr. Edwards comes to the Company from Genzyme Corporation, where, since 2006, he has served in positions of increasing leadership responsibility, culminating in the role of Head of US Sales for the Metabolic and Cardiovascular division. Mr. Edwards received his Bachelors of Science in Business Administration from Boston University.
Amy B. Sullivan has been appointed Vice President, Corporate Development and Public Affairs, and will be responsible for strategic planning, corporate reputation management, corporate communications, investor relations, government affairs and employee communications. Ms. Sullivan has more than two decades of experience working with life science companies at every stage of development, helping organizations to position and differentiate themselves and their products in competitive environments. Most recently, and since 2009, Ms. Sullivan served as Vice President of Investor Relations and Corporate Communications for AMAG Pharmaceuticals, overseeing the company's investor relations, public relations, and employee communications activities. Previous experience includes Idenix Pharmaceuticals, Genencor International, Perkin Elmer and Thermo Fisher. Ms. Sullivan holds a Masters in Business Administration degree from Bentley University and her Bachelor of Science degree from Salem University.
Greg Madison, the Company's Executive Vice President and Chief Operating Officer, commented, "Tom, Amy and Brian are valuable additions to the Keryx team, and I am excited to be welcoming them to the Company. They each bring with them a wealth of industry leadership, experience and knowledge, which will be instrumental in driving our ability to maximize the sales and marketing potential of Zerenex™ and position the Company for future commercial success."
Keryx plans to establish a Boston, MA office, in which Messrs. Adams and Edwards, and Ms. Sullivan, will be based.
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals focuses on the acquisition, development and commercialization of 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 (CKD) 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, and its Marketing Authorization Application, seeking the approval of Zerenex as a treatment of hyperphosphatemia in patients with CKD, including dialysis and non-dialysis dependent CKD, is currently under review by the European Medicines Agency (EMA). The Company is also developing Zerenex in the U.S. for the management of iron deficiency anemia and elevated serum phosphorus in patients with Stage 3 to 5 non-dialysis dependent CKD. In addition, Keryx's Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd. has received marketing approval of ferric citrate (branded Riona®) in Japan for the improvement of hyperphosphatemia in patients with CKD, including dialysis and non-dialysis dependent CKD. Keryx is headquartered in New York City.
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® 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.
CONTACT: KERYX CONTACT: Amy Sullivan Vice President - Corporate Development and Public Affairs Keryx Biopharmaceuticals, Inc. Tel: 508.479.3480 E-mail: firstname.lastname@example.org
Source:Keryx Biopharmaceuticals, Inc.