BOSTON and NEW YORK, April 23, 2015 (GLOBE NEWSWIRE) — Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) (the “Company”), today announced the appointment of John F. Neylan, MD to the newly created position of Chief Medical Officer. In this role, Dr. Neylan will be responsible for oversight of medical affairs, clinical development and pharmacovigilence at Keryx.
“It is my pleasure to welcome John to Keryx,” said Greg Madison, President and Chief Operating Officer of Keryx. “As a nephrologist with extensive clinical development experience, John will be an invaluable member of the Keryx leadership team as we work to fulfill our vision of building a leading renal franchise.”
“I am honored to be joining an organization so clearly dedicated to improving the lives of those with kidney disorders,” said Dr. Neylan. “I look forward to working with my new colleagues as well as the many experts around the world who are helping to bring Auryxia™ (ferric citrate) to patients in need.”
Dr. Neylan is an accomplished nephrologist, transplantation specialist, and biopharmaceutical executive with broad-based experience in therapeutic development, from the preclinical phase to post-marketing development of therapies across primary care, specialty and rare disease indications. Dr. Neylan comes to Keryx from Genzyme Corporation, where since 2008 he served in the capacity of Senior Vice President, Clinical Development, focusing on specialty metabolic diseases. From 2000-2008, Dr. Neylan served as Vice President, Research and Development for Wyeth Research, overseeing the clinical development of transplantation therapeutics and providing medical affairs support to the transplant franchise.
Prior to joining industry, Dr. Neylan held prestigious positions in academia, including Professor of Medicine at Emory University and Assistant Professor of Medicine at UC Davis, serving at both institutions as Medical Director of the respective Renal Transplant Programs, with oversight of the clinical research programs. Dr. Neylan received his BS from Duke University and his MD from Rush Medical School in Chicago. He completed his Internal Medicine residency at Vanderbilt University and fellowships in Nephrology and in Transplantation and Immunogenetics at Brigham and Women’s Hospital, Harvard University. Dr. Neylan has a proven track record for successful INDs, NDA/BLAs, and MAAs involving NCEs, polymers, biologics and RNA-based therapeutics and has authored more than 70 scientific manuscripts and book chapters. He is Past-President of the American Society of Transplantation and past Board Member of the National Kidney Foundation, and a past Industry Representative on the FDA Cardiovascular and Renal Drugs Advisory Committee.
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals, with offices in Boston and New York, is focused on bringing innovative therapies to market for patients with renal disease. In December 2014, the Company launched its first FDA-approved product, Auryxia (ferric citrate), in the United States. Auryxia is indicated for the control of serum phosphorus levels in patients with chronic kidney disease who are on dialysis. In January 2014, ferric citrate was approved for the treatment of patients with all stages of CKD in Japan, where it is being marketed as Riona® by Keryx’s Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd. For more information about Keryx, please visit www.keryx.com.
About Auryxia™ (ferric citrate)
Auryxia™ (ferric citrate) was approved by the U.S. Food and Drug Administration on September 5, 2014 and is indicated in the U.S. for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis. The U.S. approval of Auryxia was based on data from the Company’s Phase 3 registration program. In the Phase 3 clinical trials, Auryxia effectively reduced serum phosphorus levels to within the KDOQI guidelines range of 3.5 to 5.5 mg/dL.
Auryxia binds with dietary phosphate in the GI tract and precipitates as ferric phosphate. The unbound portion of Auryxia has been shown to increase serum iron parameters including ferritin and transferrin saturation (TSAT), whereas these parameters remained relatively constant in patients treated with active control (Renvela® and/or Phoslo®). Iron absorption from Auryxia may lead to excessive elevations in iron stores. Accordingly, physicians should assess and monitor iron parameters before starting and while on Auryxia, and may need to decrease or discontinue IV iron for these patients. The most common adverse events for Auryxia treated patients were gastrointestinal-related, including diarrhea, nausea, vomiting and constipation. For more information about Auryxia, visit www.Auryxia.com.
Auryxia™ (ferric citrate) Important Safety Information
Contraindication: Patients with iron overload syndrome, e.g. hemochromatosis, should not take Auryxia™ (ferric citrate).
Iron Overload: Iron absorption from Auryxia may lead to increased iron in storage sites. Iron parameters should be monitored prior to and while on Auryxia. Patients receiving IV iron may require a reduction in dose or discontinuation of IV iron therapy.
Accidental Overdose of Iron: Accidental overdose of iron containing products is a leading cause of fatal poisoning in children under 6 years of age. Keep Auryxia away from children as it contains iron. Call a poison control center or your physician in case of an accidental overdose in a child.
Patients with Gastrointestinal Bleeding or Inflammation: Safety has not been established for these patients.
Adverse Events: The most common adverse events with Auryxia were diarrhea (21%), nausea (11%), constipation (8%), vomiting (7%) and cough (6%). Gastrointestinal adverse reactions were the most common reason for discontinuing Auryxia (14%). Auryxia contains iron and may cause dark stools, which is considered normal with oral medications containing iron.
Drug Interactions: Doxycycline should be taken at least 1 hour before Auryxia.
For Full Prescribing Information for Auryxia, please visit http://keryx.com/wp-content/uploads/Auryxia_PI_Keryx_112014.pdf.
Some of the statements included in this press release, particularly those regarding the commercialization and subsequent clinical development of Auryxia, 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: whether Auryxia will be successfully launched and marketed in the U.S.; whether Riona® will be successfully marketed in Japan by our Japanese partner, Japan Tobacco, Inc. and Torii Pharmaceutical Co., Ltd; the risk that the EMA may not concur with our interpretation of our Phase 3 study results, supportive data, conduct of the studies, or any other part of our MAA submission and could ultimately deny approval of the MAA; the risk that we may not be successful in the development of Auryxia for the treatment of iron deficiency anemia in non-dialysis dependent chronic kidney disease patients; 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:
Vice President, Corporate Development and Public Affairs
Keryx Biopharmaceuticals, Inc.