Healthcare Industry News: Zerenex
News Release - January 21, 2014
Keryx Biopharmaceuticals Announces Appointment of Daniel W. Olmstead as Vice President, Payer AccessFormerly Senior Director, Corporate Accounts at Genzyme/Sanofi Renal
NEW YORK, Jan. 21, 2014 -- (Healthcare Sales & Marketing Network) -- Keryx Biopharmaceuticals, Inc. (KERX), a biopharmaceutical company focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease (the "Company"), today announced the appointment of Daniel W. Olmstead to the newly created position of Vice President, Payer Access. In this role, Mr. Olmstead will lead the Company's strategic global market access, managed care and reimbursement initiatives.
Mr. Olmstead brings more than 25 years of healthcare experience, with the majority of this time spent in a variety of managed market roles, including reimbursement access, contracting, and product launch planning and execution. Prior to joining the Company, Mr. Olmstead was a National Account Director for Walgreen Co. (WAG), where he represented all Walgreens business units with Express Scripts, its largest volume retail client. Prior to joining Walgreens in 2012, Mr. Olmstead spent more than 7 years with Genzyme/Sanofi, ultimately rising to Senior Director, Corporate Accounts. During his tenure at Genzyme/Sanofi, Mr. Olmstead served in roles of increasing responsibility within the Renal Division, including coverage of key national and regional health plans, managed markets product launch planning, and playing an integral role in establishing Renal pricing and contracting strategies for Renagel(R)/Renvela(R), Hectorol(R) and other products. Mr. Olmstead received his Bachelor's degree from the University of Michigan, Ann Arbor.
Daniel P. Regan, a member of Keryx's Board of Directors, and formerly Global General Manager, Senior Vice President of the Renal Franchise at Genzyme/Sanofi, commented, "Having worked with Dan at Genzyme/Sanofi for several years, I believe that he will be a tremendous asset to the Company at this critical juncture. Dan is a consummate professional and I believe that his breadth of experience, particularly in the Renal space, will help the Company develop and implement sound pricing, market access and reimbursement approaches globally to achieve commercial success."
Ron Bentsur, Keryx's Chief Executive Officer, said, "We are excited to welcome Dan to the Company and we look forward to leveraging his expertise as we prepare for the potential launch of Zerenex."
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. 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. The Marketing Authorization Application (MAA) filing with the European Medicines Agency (EMA) is pending. The Company is also developing Zerenex in the U.S. for the treatment of iron deficiency anemia and management of elevated phosphorus in patients with Stage 3 to 5 non-dialysis dependent CKD.
In addition, Keryx's Japanese partner, Japan Tobacco Inc. (JT) and Torii Pharmaceutical Co., Ltd. (Torii), has received manufacturing and marketing approval of ferric citrate from the Japanese Ministry of Health, Labour and Welfare. Ferric citrate, to be marketed in Japan by JT's subsidiary, Torii, under the brand name Riona(R), is indicated as an oral treatment 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 commercial opportunity, competitive positioning, and 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, 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.
Source: Keryx Biopharmaceuticals
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