Renal Industry Veteran to Lead Commercialization Effort for Zerenex
February 10, 2014 08:30 | Source: Keryx Biopharmaceuticals, Inc.
NEW YORK CITY, Feb. 10, 2014 (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), (the "Company"), a biopharmaceutical company focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease, today announced the appointment of Greg Madison as Executive Vice President and Chief Operating Officer. In this role, Mr. Madison will lead the build-out of the commercial organization and related functions to support a potential Zerenex™ product launch in the United States and internationally. The Company's New Drug Application for Zerenex (ferric citrate coordination complex), an oral, ferric iron-based compound, is currently under review by the FDA with an assigned Prescription Drug User Fee Act (PDUFA) goal date of June 7, 2014. With Mr. Madison's appointment, Keryx will establish an office in the Boston area.
"We believe that Mr. Madison's track record of success in leadership roles spanning the various aspects of product launch and sales in the renal space will be invaluable to the Company as we prepare for the potential launch of Zerenex. We are thrilled to welcome Greg to the Company and look forward to leveraging his broad commercial expertise," said Ron Bentsur, CEO of Keryx Biopharmaceuticals.
Daniel P. Regan, a member of the Company's Board of Directors, commented, "I had the privilege of working with Greg for several years, including at Genzyme/Sanofi, where in 2010 he succeeded me as global head of the Renal division. I believe that Mr. Madison has a strong understanding of the pillars of a successful launch and product commercialization and proven execution capabilities of such strategies."
Mr. Madison joins the Company from AMAG Pharmaceuticals (Nasdaq:AMAG), where he served as the Executive Vice President and Chief Commercial Officer. Prior to AMAG, Mr. Madison spent 12 years at Genzyme/Sanofi developing extensive commercial and general management expertise as he progressed into roles of increasing responsibilities and leadership, culminating in his most recent role as Vice President and General Manager of the Renal division. In this role, Mr. Madison led a global organization with three marketed products in 76 countries and drove top-line growth, with combined revenues exceeding $1 billion. Mr. Madison's prior experience in the Renal division included serving as vice president and general manager of the U.S. business; vice president of U.S. sales; and vice president of U.S. marketing where he led all pre-launch preparation for Renvela®, now the leading phosphate binder in the U.S. market. During his tenure with Genzyme, Mr. Madison also had roles in sales management, training, managed markets and reimbursement. Prior to joining Genzyme, Mr. Madison spent five years at Jannsen Pharmaceuticals in sales and sales management roles, and began his career in the pharmaceutical industry in sales with Wyeth-Ayerst. He holds a Bachelor of Business Administration in Finance from the University of Massachusetts, Amherst.
"I am pleased to join Keryx during this very important time in the Company's development. There are a multitude of patients who suffer from the devastating effects of hyperphosphatemia and iron deficiency anemia, and are in need of effective new treatment options," stated Mr. Madison. "Over the next several months, we will accelerate our preparation for the potential launch of Zerenex, pending regulatory approval. I look forward to building and working with our team to bring forward innovative solutions for patients and caregivers alike."
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 ZerenexTM (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. Top-line results from this Phase 2 study were announced in November 2013. 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.
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.
Director - Investor Relations
Keryx Biopharmaceuticals, Inc.