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News Article | May 4, 2017
Site: globenewswire.com

BOSTON, May 04, 2017 (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a biopharmaceutical company focused on bringing innovative medicines to people with renal disease, today announced its financial results for the quarter ended March 31, 2017. The company also reviewed its commercial progress with Auryxia and upcoming milestones. “In the first quarter, prescription growth continued across the dialysis patient population, with strong demand from both new patients and patients who have switched from another phosphate binder,” said Greg Madison, president and chief executive officer of Keryx. “We believe with more physicians gaining clinical experience, strong brand awareness, and broad patient access, we will bring this medicine to many more people with hyperphosphatemia on dialysis.” Mr. Madison continued, “While we remain focused on increasing the number of dialysis patients on Auryxia, we recognize the unique opportunity we have with this medicine to potentially treat another complication of chronic kidney disease. Our sNDA to expand Auryxia’s label to treat iron deficiency anemia (IDA) in non-dialysis-dependent (NDD) chronic kidney disease (CKD) is under review, with potential approval and launch in November 2017. The vast majority of patients with CKD are not optimally treated today with current oral iron therapies. If approved, Auryxia would be the only FDA-approved oral iron specifically for patients with NDD-CKD. We are preparing for a successful launch in this potential indication that will leverage our infrastructure as well as the formulary access, familiarity and relationships we continue to build for Auryxia in dialysis.” FIRST QUARTER 2017 FINANCIAL RESULTS AND RECENT BUSINESS HIGHLIGHTS First Quarter March 31, 2017 Financial Results “We are very pleased with the recent growth in Auryxia’s prescriptions,” said Scott Holmes, senior vice president and chief financial officer of Keryx Biopharmaceuticals. “Specifically, we reported net U.S. product sales of $10.5 million in the first quarter of 2017, with significant month-over-month growth. We project continued strong prescription growth that we expect will result in $56 to $60 million in net Auryxia product sales for the full year 2017.” Total revenues for the quarter ended March 31, 2017 were $11.8 million, compared with $6.8 million during the same period in 2016. Total revenues for the first quarter of 2017 consist of $10.5 million in net U.S. Auryxia product sales, compared to $5.6 million in the first quarter of 2016. Total revenue for the first quarter of 2017 also includes $1.3 million in license revenues as compared to $1.2 million during the same period in 2016. Cost of goods sold for the quarter ended March 31, 2017 were $4.3 million, compared with $1.1 million during the same period in 2016. Research and development expenses for the quarter ended March 31, 2017 were $6.8 million, as compared to $7.6 million during the same period in 2016. The decrease was primarily related to a reduction in development work at our contract manufacturers following approval of a second drug product contract manufacturer in the fourth quarter of 2016, as well as a decrease in clinical costs following the completion of our Phase 3 clinical trial in early 2016. Selling, general and administrative expenses for the quarter ended March 31, 2017 were $23.1 million, as compared to $20.8 million during the same period in 2016. The increase was related to the continued commercialization of Auryxia, and preparations for Auryxia’s potential launch in IDA later this year. Net loss for the quarter ended March 31, 2017 was $23.0 million, or $0.21 per share, compared to a net loss of $41.0 million, or $0.39 per share, for the comparable period in 2016. Cash and cash equivalents as of March 31, 2017 totaled $90.9 million, representing a net cash burn of $20.9 million in the first quarter of 2017. 2017 Financial Guidance This section contains forward-looking guidance about the financial outlook for Keryx Biopharmaceuticals Keryx today provided financial guidance for full year 2017 net U.S. Auryxia product sales of $56 to $60 million. The guidance is based on the company’s current understanding of Auryxia prescriptions trends in dialysis. Guidance excludes potential sales from the potential approval in November 2017 of ferric citrate in the U.S. for the treatment of adults with NDD-CKD and iron deficiency anemia. Conference Call Information Keryx will host an investor conference call today, Thursday, May 4, 2017, at 8:00 a.m. ET to discuss financial results for the first quarter of 2017. To participate in the conference call, please call 1-(888) 396-2320 (U.S.), 1-(774) 264-7560 (outside the U.S.), call-in ID: 8810002. The call will also be webcast with slides, which will be accessible through the Investors section of the company's website at www.keryx.com. The audio replay will be available at http://www.keryx.com for approximately 15 days after the call. About Iron Deficiency Anemia, NDD-CKD Iron deficiency anemia is a common complication in patients with non-dialysis dependent chronic kidney disease (NDD-CKD), and the prevalence and severity of IDA increases as kidney disease progresses. Today, there are no FDA approved oral irons for the treatment of IDA in CKD patients and the efficacy and tolerability of current oral iron supplements are mixed. Intravenous (IV) iron administration is associated with important risks and burdens. The company estimates that of the 1.7 million Americans with CKD under the care of a nephrologist, approximately 650,000 people are treated for IDA and another 250,000 – 400,000 people could have IDA but are not treated today. About Auryxia 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 CKD on dialysis. The U.S. approval of Auryxia was based on data from the company's Phase 3 registration program in dialysis patients. 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). 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 and the U.S. full prescribing information, visit www.Auryxia.com. Use of ferric citrate in patients with NDD-CKD and IDA, as highlighted above, is investigational and has not been determined to be safe or efficacious. IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA® (ferric citrate) Contraindication: Patients with iron overload syndrome, e.g. hemochromatosis, should not take Auryxia®. 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. Ciprofloxacin should be taken at least 2 hours before or after Auryxia. For Full Prescribing Information for Auryxia, please visit http://auryxia.com/important-safety-information/ Forward Looking Statements Some of the statements included in this press release, particularly those regarding the commercialization and ongoing clinical development of Auryxia, our 2017 financial guidance and the submission of an sNDA to the FDA to expand the label of ferric citrate to include the treatment of IDA in adults with stage 3-5 NDD-CKD and the potential approval in this indication and the impact thereof on Keryx, 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 we can increase adoption of Auryxia in patients with CKD on dialysis in order to achieve our 2017 financial guidance; whether we can maintain our operating expenses to projected levels while continuing our current clinical, regulatory and commercial activities; the risk that the FDA may not concur with our interpretation of our Phase 3 study results in NDD- CKD, supportive data, conduct of the studies, or any other part of our regulatory submission and could ultimately deny approval of ferric citrate for the treatment of IDA in adults with stage 3-5 NDD-CKD; the risk that if approved for use in NDD-CKD that we may not be able to successfully market Auryxia for use in this indication; our ability to continue to supply Auryxia following the recent resupply to the market; 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. About Keryx Biopharmaceuticals, Inc. Keryx Biopharmaceuticals, Inc., with headquarters in Boston, Massachusetts, is a commercial stage company focused on bringing innovative medicines to people with renal disease. Keryx developed and commercializes Auryxia® (ferric citrate), an iron-based phosphate binder, in the U.S. Ferric citrate is marketed as Riona® by Keryx’s Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd. In September 2015, the European Commission granted European market authorization for Fexeric® (ferric citrate coordination complex). Keryx has programs underway to leverage its development and commercial infrastructure, including evaluation of iron deficiency anemia in adults with non-dialysis dependent chronic kidney disease and in-licensing medicines for renal disease. For more information about Keryx, please visit www.keryx.com.


BOSTON, May 01, 2017 (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a biopharmaceutical company focused on bringing innovative medicines to people with renal disease, today announced that an additional large Medicare Part D plan sponsor has added Auryxia to its Medicare Part D plan formularies, effective June 1, 2017. Auryxia is currently indicated in the U.S. for the control of serum phosphorus levels in people with chronic kidney disease (CKD) on dialysis. Auryxia’s formulary status at this new Part D plan sponsor is effective for the remainder of 2017 and the full year 2018. The broad formulary status across Part D and commercial plans will support continuing growth of Auryxia in dialysis and provide access to Auryxia for people with iron deficiency anemia (IDA) and non-dialysis dependent (NDD) CKD, pending approval of this indication later this year. “We are pleased that this final large payer has added Auryxia to its formulary, bringing unrestricted access to Auryxia to 95 percent of dialysis patients on phosphate binders with commercial or Medicare Part D insurance, on par with the market-leading phosphate binder,” said Greg Madison, president and chief executive officer of Keryx Biopharmaceuticals. “Given that 30 to 40 percent of dialysis patients have phosphorous levels that are out of range, patients on dialysis need treatment options and Auryxia, as a non-calcium, non-chewable phosphate binder, is an important option for these patients.” It is estimated that there are approximately 450,000 people in the U.S. who have End Stage Renal Disease (ESRD) and who require dialysis treatment. The majority of ESRD patients require chronic treatment with phosphate-binding medicines to lower and maintain serum phosphorus at acceptable levels. Medicare Part D and commercial insurance companies cover most of the prescription drug costs for people with ESRD, including the vast majority of phosphate binder prescriptions. Keryx is also seeking a label expansion for ferric citrate to include the treatment of iron deficiency anemia in adults with non-dialysis dependent CKD. A supplemental new drug application is under review by the U.S. FDA, with a Prescription Drug User Fee Act (PDUFA) target action date of November 6, 2017 for completion. 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 CKD on dialysis. The U.S. approval of Auryxia was based on data from the company's Phase 3 registration program in dialysis patients. In the Phase 3 clinical trials, Auryxia effectively reduced serum phosphorus levels to within the established 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). 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 and the U.S. full prescribing information, visit www.Auryxia.com. Use of ferric citrate in patients with NDD-CKD and IDA, as highlighted above, is investigational and has not been determined to be safe or efficacious. Contraindication: Patients with iron overload syndrome, e.g. hemochromatosis, should not take Auryxia®. 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. Ciprofloxacin should be taken at least 2 hours before or after Auryxia. For Full Prescribing Information for Auryxia, please visit http://auryxia.com/important-safety-information/ Forward Looking Statements Some of the statements included in this press release, particularly those regarding the commercialization and ongoing clinical development of Auryxia, the expected impact of the new formulary coverage for Auryxia and the submission of an sNDA to the FDA to expand the label of ferric citrate to include the treatment of IDA in adults with stage 3-5 NDD-CKD and the potential approval in this indication and the impact thereof on Keryx, 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 we can increase adoption of Auryxia in patients with CKD on dialysis; the risk that expanded formulary access to Auryxia may not lead to increased adoption or sales; the risk that the FDA may not concur with our interpretation of our Phase 3 study results in NDD- CKD, supportive data, conduct of the studies, or any other part of our regulatory submission and could ultimately deny approval of ferric citrate for the treatment of IDA in adults with stage 3-5 NDD-CKD; the risk that if approved for use in NDD-CKD that we may not be able to successfully market Auryxia for use in this indication; our ability to continue to supply Auryxia following the recent resupply to the market; 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. About Keryx Biopharmaceuticals, Inc. Keryx Biopharmaceuticals, Inc., with headquarters in Boston, Massachusetts, is a commercial stage company focused on bringing innovative medicines to people with renal disease. Keryx developed and commercializes Auryxia® (ferric citrate) in the U.S. Ferric citrate is marketed as Riona® by Keryx’s Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd. In September 2015, the European Commission granted European market authorization for Fexeric® (ferric citrate coordination complex). Keryx has programs underway to leverage its development and commercial infrastructure, including evaluation of iron deficiency anemia in adults with non-dialysis depended chronic kidney disease and in-licensing medicines for renal disease. For more information about Keryx, please visit www.keryx.com.


BOSTON, May 01, 2017 (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a biopharmaceutical company focused on bringing innovative medicines to people with renal disease, today announced that an additional large Medicare Part D plan sponsor has added Auryxia to its Medicare Part D plan formularies, effective June 1, 2017. Auryxia is currently indicated in the U.S. for the control of serum phosphorus levels in people with chronic kidney disease (CKD) on dialysis. Auryxia’s formulary status at this new Part D plan sponsor is effective for the remainder of 2017 and the full year 2018. The broad formulary status across Part D and commercial plans will support continuing growth of Auryxia in dialysis and provide access to Auryxia for people with iron deficiency anemia (IDA) and non-dialysis dependent (NDD) CKD, pending approval of this indication later this year. “We are pleased that this final large payer has added Auryxia to its formulary, bringing unrestricted access to Auryxia to 95 percent of dialysis patients on phosphate binders with commercial or Medicare Part D insurance, on par with the market-leading phosphate binder,” said Greg Madison, president and chief executive officer of Keryx Biopharmaceuticals. “Given that 30 to 40 percent of dialysis patients have phosphorous levels that are out of range, patients on dialysis need treatment options and Auryxia, as a non-calcium, non-chewable phosphate binder, is an important option for these patients.” It is estimated that there are approximately 450,000 people in the U.S. who have End Stage Renal Disease (ESRD) and who require dialysis treatment. The majority of ESRD patients require chronic treatment with phosphate-binding medicines to lower and maintain serum phosphorus at acceptable levels. Medicare Part D and commercial insurance companies cover most of the prescription drug costs for people with ESRD, including the vast majority of phosphate binder prescriptions. Keryx is also seeking a label expansion for ferric citrate to include the treatment of iron deficiency anemia in adults with non-dialysis dependent CKD. A supplemental new drug application is under review by the U.S. FDA, with a Prescription Drug User Fee Act (PDUFA) target action date of November 6, 2017 for completion. 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 CKD on dialysis. The U.S. approval of Auryxia was based on data from the company's Phase 3 registration program in dialysis patients. In the Phase 3 clinical trials, Auryxia effectively reduced serum phosphorus levels to within the established 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). 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 and the U.S. full prescribing information, visit www.Auryxia.com. Use of ferric citrate in patients with NDD-CKD and IDA, as highlighted above, is investigational and has not been determined to be safe or efficacious. Contraindication: Patients with iron overload syndrome, e.g. hemochromatosis, should not take Auryxia®. 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. Ciprofloxacin should be taken at least 2 hours before or after Auryxia. For Full Prescribing Information for Auryxia, please visit http://auryxia.com/important-safety-information/ Forward Looking Statements Some of the statements included in this press release, particularly those regarding the commercialization and ongoing clinical development of Auryxia, the expected impact of the new formulary coverage for Auryxia and the submission of an sNDA to the FDA to expand the label of ferric citrate to include the treatment of IDA in adults with stage 3-5 NDD-CKD and the potential approval in this indication and the impact thereof on Keryx, 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 we can increase adoption of Auryxia in patients with CKD on dialysis; the risk that expanded formulary access to Auryxia may not lead to increased adoption or sales; the risk that the FDA may not concur with our interpretation of our Phase 3 study results in NDD- CKD, supportive data, conduct of the studies, or any other part of our regulatory submission and could ultimately deny approval of ferric citrate for the treatment of IDA in adults with stage 3-5 NDD-CKD; the risk that if approved for use in NDD-CKD that we may not be able to successfully market Auryxia for use in this indication; our ability to continue to supply Auryxia following the recent resupply to the market; 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. About Keryx Biopharmaceuticals, Inc. Keryx Biopharmaceuticals, Inc., with headquarters in Boston, Massachusetts, is a commercial stage company focused on bringing innovative medicines to people with renal disease. Keryx developed and commercializes Auryxia® (ferric citrate) in the U.S. Ferric citrate is marketed as Riona® by Keryx’s Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd. In September 2015, the European Commission granted European market authorization for Fexeric® (ferric citrate coordination complex). Keryx has programs underway to leverage its development and commercial infrastructure, including evaluation of iron deficiency anemia in adults with non-dialysis depended chronic kidney disease and in-licensing medicines for renal disease. For more information about Keryx, please visit www.keryx.com.


BOSTON, May 01, 2017 (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a biopharmaceutical company focused on bringing innovative medicines to people with renal disease, today announced that an additional large Medicare Part D plan sponsor has added Auryxia to its Medicare Part D plan formularies, effective June 1, 2017. Auryxia is currently indicated in the U.S. for the control of serum phosphorus levels in people with chronic kidney disease (CKD) on dialysis. Auryxia’s formulary status at this new Part D plan sponsor is effective for the remainder of 2017 and the full year 2018. The broad formulary status across Part D and commercial plans will support continuing growth of Auryxia in dialysis and provide access to Auryxia for people with iron deficiency anemia (IDA) and non-dialysis dependent (NDD) CKD, pending approval of this indication later this year. “We are pleased that this final large payer has added Auryxia to its formulary, bringing unrestricted access to Auryxia to 95 percent of dialysis patients on phosphate binders with commercial or Medicare Part D insurance, on par with the market-leading phosphate binder,” said Greg Madison, president and chief executive officer of Keryx Biopharmaceuticals. “Given that 30 to 40 percent of dialysis patients have phosphorous levels that are out of range, patients on dialysis need treatment options and Auryxia, as a non-calcium, non-chewable phosphate binder, is an important option for these patients.” It is estimated that there are approximately 450,000 people in the U.S. who have End Stage Renal Disease (ESRD) and who require dialysis treatment. The majority of ESRD patients require chronic treatment with phosphate-binding medicines to lower and maintain serum phosphorus at acceptable levels. Medicare Part D and commercial insurance companies cover most of the prescription drug costs for people with ESRD, including the vast majority of phosphate binder prescriptions. Keryx is also seeking a label expansion for ferric citrate to include the treatment of iron deficiency anemia in adults with non-dialysis dependent CKD. A supplemental new drug application is under review by the U.S. FDA, with a Prescription Drug User Fee Act (PDUFA) target action date of November 6, 2017 for completion. 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 CKD on dialysis. The U.S. approval of Auryxia was based on data from the company's Phase 3 registration program in dialysis patients. In the Phase 3 clinical trials, Auryxia effectively reduced serum phosphorus levels to within the established 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). 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 and the U.S. full prescribing information, visit www.Auryxia.com. Use of ferric citrate in patients with NDD-CKD and IDA, as highlighted above, is investigational and has not been determined to be safe or efficacious. Contraindication: Patients with iron overload syndrome, e.g. hemochromatosis, should not take Auryxia®. 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. Ciprofloxacin should be taken at least 2 hours before or after Auryxia. For Full Prescribing Information for Auryxia, please visit http://auryxia.com/important-safety-information/ Forward Looking Statements Some of the statements included in this press release, particularly those regarding the commercialization and ongoing clinical development of Auryxia, the expected impact of the new formulary coverage for Auryxia and the submission of an sNDA to the FDA to expand the label of ferric citrate to include the treatment of IDA in adults with stage 3-5 NDD-CKD and the potential approval in this indication and the impact thereof on Keryx, 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 we can increase adoption of Auryxia in patients with CKD on dialysis; the risk that expanded formulary access to Auryxia may not lead to increased adoption or sales; the risk that the FDA may not concur with our interpretation of our Phase 3 study results in NDD- CKD, supportive data, conduct of the studies, or any other part of our regulatory submission and could ultimately deny approval of ferric citrate for the treatment of IDA in adults with stage 3-5 NDD-CKD; the risk that if approved for use in NDD-CKD that we may not be able to successfully market Auryxia for use in this indication; our ability to continue to supply Auryxia following the recent resupply to the market; 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. About Keryx Biopharmaceuticals, Inc. Keryx Biopharmaceuticals, Inc., with headquarters in Boston, Massachusetts, is a commercial stage company focused on bringing innovative medicines to people with renal disease. Keryx developed and commercializes Auryxia® (ferric citrate) in the U.S. Ferric citrate is marketed as Riona® by Keryx’s Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd. In September 2015, the European Commission granted European market authorization for Fexeric® (ferric citrate coordination complex). Keryx has programs underway to leverage its development and commercial infrastructure, including evaluation of iron deficiency anemia in adults with non-dialysis depended chronic kidney disease and in-licensing medicines for renal disease. For more information about Keryx, please visit www.keryx.com.


BOSTON, Nov. 09, 2016 (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a biopharmaceutical company focused on bringing innovative medicines to people with renal disease, today announced that the U.S. Food and Drug Administration (FDA) has approved its application for a second drug product contract manufacturer. Patheon Manufacturing Services LLC of Greenville, North Carolina, a leading global provider of pharmaceutical manufacturing services, is now an FDA approved drug product manufacturer of Auryxia®. With FDA approval of this manufacturer, the company has rebuilt supply and will promptly make Auryxia available to wholesalers.    “We are pleased with today’s approval, as it expands our manufacturing capabilities and capacity,” said Greg Madison, president and chief executive officer of Keryx Biopharmaceuticals. “Getting a second drug product manufacturer approved was an important step to ensuring long-term supply of Auryxia is consistently available to patients.” Mr. Madison continued, “We are looking forward to attending American Society of Nephrology’s Kidney Week, the global, premier kidney conference. The timing of this conference next week gives us the opportunity to communicate with health care professionals in attendance that Auryxia supply is restored and is once again available for their patients.” About Auryxia® 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 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). 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 and the U.S. full prescribing information, visit www.Auryxia.com. IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA® (ferric citrate) Contraindication: Patients with iron overload syndrome, e.g. hemochromatosis, should not take Auryxia®. 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. Ciprofloxacin should be taken at least 2 hours before or after Auryxia. For Full Prescribing Information for Auryxia, please visit http://auryxia.com/important-safety-information/ Forward Looking Statements Some of the statements included in this press release, particularly those regarding the commercialization and ongoing clinical development of Auryxia as well as the expected impact of the supply interruption 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: our ability to quickly resupply the market with Auryxia following approval of the Patheon facility and our ability to sustain that supply; whether we can increase adoption of Auryxia in patients with CKD on dialysis; whether we can maintain our operating expenses to projected levels while continuing our current clinical, regulatory and commercial activities; the risk that the FDA may not concur with our interpretation of our Phase 3 study results in non-dialysis dependent (NDD) CKD, supportive data, conduct of the studies, or any other part of our regulatory submission and could ultimately deny approval of ferric citrate for the treatment of IDA in adults with stage 3-5 NDD-CKD; the risk that if approved for use in NDD-CKD that we may not be able to successfully market Auryxia for use in this indication; 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. About Keryx Biopharmaceuticals, Inc. Keryx Biopharmaceuticals, with headquarters in Boston, is focused on bringing innovative medicines to market for people with renal disease. In December 2014, the company launched its first FDA-approved medicine, Auryxia® (ferric citrate) in the United States. In January 2014, ferric citrate was approved for use in Japan, where it is being marketed as Riona® by Keryx's Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd. In September 2015, the European Commission granted European market authorization for Fexeric® (ferric citrate coordination complex). For more information about Keryx, please visit www.keryx.com.


BOSTON, March 01, 2017 (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a biopharmaceutical company focused on bringing innovative medicines to people with renal disease, today announced its financial results for the fourth quarter and year ended December 31, 2016. The company also reviewed its commercial progress with Auryxia and upcoming milestones. “We are off to a very good start in 2017 with Auryxia in the dialysis patient population,” said Greg Madison, president and chief executive officer of Keryx. “During a period when the phosphate binder market declined, Auryxia prescriptions grew to approximately 4,650 in January, an increase of 3.3 percent from the approximate 4,500 prescriptions reported in December 2016.” Mr. Madison continued, “we look forward to important milestones over the year that would mark continued progress toward our goal of maximizing Auryxia’s potential. These include continued growth in the U.S. dialysis market, acceptance and assignment of a target review date for the supplemental new drug application submitted in January to the U.S. FDA to expand the indication of Auryxia for the treatment of iron deficiency anemia (IDA) in adults with non-dialysis dependent chronic kidney disease, and the subsequent approval and launch in late 2017. If approved for this indication, Auryxia could be the first FDA-approved oral medicine to treat IDA in this patient population.” FOURTH QUARTER, FULL YEAR 2016 FINANCIAL RESULTS AND RECENT BUSINESS HIGHLIGHTS On January 8, 2017, Keryx provided a review of its preliminary fourth quarter and full year 2016 commercial progress and financial results. The company today provided final results for the same periods in 2016, and the following updates: Total revenues for the quarter ended December 31, 2016 were approximately $9.5 million, compared with $5.8 million during the same period in 2015. Total revenue for the fourth quarter of 2016 consist of approximately $8.2 million in ex-factory Auryxia net U.S. product sales, compared to $4.8 million in the fourth quarter of 2015, which were recorded based on actual prescriptions written during the period. Total revenue for the fourth quarter of 2016 also includes $1.3 million in license revenues as compared to $1.0 million during the same period in 2015. For the year ended 2016, total revenues were approximately $32.0 million as compared to $13.7 million in 2015. Total revenues for 2016 include $27.2 million of Auryxia net U.S. product sales and $4.8 million in license revenues as compared to $10.1 million and $3.5 million, respectively, in 2015. Cost of goods sold for the quarter ended December 31, 2016 were approximately $13.4 million, compared with $1.1 million during the same period in 2015. Cost of goods sold for the fourth quarter of 2016 include approximately $11.8 million in write-offs of work-in-process inventory that was determined to no longer be suitable for commercial manufacture. For the year ended 2016, total cost of goods sold were approximately $37.8 million, as compared to $4.5 million in 2015. Total 2016 cost of goods include $25.6 million in write-offs of work-in-process inventory that was determined to no longer be suitable for commercial manufacture and approximately $2.6 million related to manufacturing charges incurred as a result of not fully utilizing planned production at the company’s third-party drug product manufacturers. Total 2015 cost of goods sold included $2.6 million related to manufacturing charges incurred as a result of not fully utilizing planned production at the company’s third-party drug product manufacturers. Research and development expenses for the quarter ended December 31, 2016 were $6.2 million, as compared to $8.0 million during the same period in 2015. The decrease was primarily related to a reduction in development work at our contract manufacturers following approval of a second drug product contract manufacturer in the fourth quarter of 2016, as well as a decrease in clinical costs following the completion of our Phase 3 clinical trial in early 2016. Selling, general and administrative expenses for the quarter ended December 31, 2016 were $23.0 million, as compared to $21.6 million during the same period in 2015. The increase was related to the continued commercialization of Auryxia, including an expanded sales force in the fourth quarter of 2016 as compared to the same period in 2015. Net loss for the quarter ended December 31, 2016 was $33.8 million, or $0.32 per share, compared to a net loss of $37.8 million, or $0.36 per share, for the comparable period in 2015.  For the full year 2016, net loss was $161.1 million, or $1.52 per share, as compared to $123.1 million, or $1.19 per share in 2015. Cash and cash equivalents as of December 31, 2016 totaled approximately $111.8 million. Conference Call Information Keryx will host an investor conference call today, Wednesday, March 1, 2017, at 8:00 a.m. ET to discuss financial results for the fourth quarter and full year of 2016. To participate in the conference call, please call 1-(888) 396-2320 (U.S.), 1-(774) 264-7560 (outside the U.S.), call-in ID: 74238520. The call will also be webcast with slides, which will be accessible through the Investors section of the company's website at www.keryx.com. The audio replay will be available at http://www.keryx.com for approximately 15 days after the call. About Iron Deficiency Anemia, NDD-CKD Iron deficiency anemia is a common complication in patients with non-dialysis dependent chronic kidney disease (NDD-CKD), and the prevalence and severity of IDA increases as kidney disease progresses. It is estimated that there are approximately 1.6 million people living in the U.S. with stage 3-5 non-dialysis dependent chronic kidney disease and iron deficiency anemia. Efficacy and tolerability of current oral iron supplements are mixed. Intravenous (IV) iron administration is associated with important risks and burdens. About Auryxia 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 CKD on dialysis. The U.S. approval of Auryxia was based on data from the company's Phase 3 registration program in dialysis patients. 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). 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 and the U.S. full prescribing information, visit www.Auryxia.com. Use of ferric citrate in patients with NDD-CKD and IDA, as highlighted above, is investigational and has not been determined to be safe or efficacious. IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA® (ferric citrate) Contraindication: Patients with iron overload syndrome, e.g. hemochromatosis, should not take Auryxia®. 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. Ciprofloxacin should be taken at least 2 hours before or after Auryxia. For Full Prescribing Information for Auryxia, please visit http://auryxia.com/important-safety-information/ Forward Looking Statements Some of the statements included in this press release, particularly those regarding the commercialization and ongoing clinical development of Auryxia and the submission of an sNDA to the FDA to expand the label of ferric citrate to include the treatment of IDA in adults with stage 3-5 NDD-CKD and the potential approval in this indication and the impact thereof on Keryx, 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 we can increase adoption of Auryxia in patients with CKD on dialysis; whether we can maintain our operating expenses to projected levels while continuing our current clinical, regulatory and commercial activities; the risk that the FDA may not concur with our interpretation of our Phase 3 study results in NDD- CKD, supportive data, conduct of the studies, or any other part of our regulatory submission and could ultimately deny approval of ferric citrate for the treatment of IDA in adults with stage 3-5 NDD-CKD; the risk that if approved for use in NDD-CKD that we may not be able to successfully market Auryxia for use in this indication; our ability to continue to supply Auryxia following the recent resupply to the market; 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. About Keryx Biopharmaceuticals, Inc. Keryx Biopharmaceuticals, Inc., with headquarters in Boston, Massachusetts, is a commercial stage company focused on bringing innovative medicines to people with renal disease. Keryx developed and commercializes Auryxia® (ferric citrate), an iron-based phosphate binder, in the U.S. Ferric citrate is marketed as Riona® by Keryx’s Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd. In September 2015, the European Commission granted European market authorization for Fexeric® (ferric citrate coordination complex). Keryx has programs underway to leverage its development and commercial infrastructure, including evaluation of iron deficiency anemia in adults with non-dialysis dependent chronic kidney disease and in-licensing medicines for renal disease. For more information about Keryx, please visit www.keryx.com.


CHICAGO, Nov. 17, 2016 (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a biopharmaceutical company focused on bringing innovative medicines to people with renal disease, announced presentation of additional data from its pivotal Phase 3 study for iron deficiency anemia (IDA) and non-dialysis dependent chronic kidney disease (NDD-CKD) in four posters at the American Society of Nephrology’s 2016 Kidney Week taking place November 15-20 in Chicago. Data in the posters highlight an investigational use of ferric citrate as a potential oral treatment for adults with IDA and NDD-CKD. These results are a more detailed presentation of top line results announced in March 2016. Ferric citrate (Auryxia®) is currently indicated in the U.S. as a phosphate binder for the control of serum phosphorus levels in patients with CKD on dialysis. Taken together, data in the posters demonstrate that in the Phase 3 trial, the majority of patients treated with ferric citrate, 52.1 percent (61/117), achieved the primary endpoint of ≥1 g/dL increase in hemoglobin at any point during the 16-week efficacy period, 93.4 percent (57/61) of whom had a sustained treatment effect. Increases in hemoglobin in ferric-citrate treated patients were observed as early as one to two weeks after the start of treatment. Efficacy results were consistent across groups with different baseline characteristics. These results were achieved without the concomitant use of erythropoietin-stimulating agents (ESAs) or intravenous (IV) iron. Adverse events were generally similar between treatment arms and consistent with the safety profile described in the U.S. prescribing information for Auryxia, with gastrointestinal (GI) disorders as the most common adverse event. Serum phosphorus levels stayed within target ranges for CKD. “I’m pleased to have been involved in this pivotal Phase 3 study of ferric citrate,” said Steven Fishbane, M.D., chief of nephrology for North Shore University Hospital and Long Island Jewish Medical Center. “The data presented today at Kidney Week continue to underscore ferric citrate’s ability to increase iron stores and hemoglobin in patients with CKD and IDA, and support its potential utilization in non-dialysis dependent chronic kidney disease, if approved by the FDA for this indication.” “People with chronic kidney disease suffer from a range of complications, including two that are very common, hyperphosphatemia and iron deficiency anemia,” said John Neylan, M.D., chief medical officer of Keryx Biopharmaceuticals. “We are pleased to have the opportunity to further characterize the pivotal phase 3 trial results of ferric citrate’s investigational use in a scientific forum. These data support our goal to expand ferric citrate’s label and we look forward to submitting the sNDA for IDA in NDD-CKD patients to the FDA.” About NDD-CKD, Iron Deficiency Anemia Iron deficiency anemia is a common complication in patients with non-dialysis dependent chronic kidney disease (NDD-CKD), and the prevalence and severity of IDA increases as kidney disease progresses. It is estimated that there are approximately 1.6 million people living in the U.S. with stage 3-5 non-dialysis dependent chronic kidney disease and iron deficiency anemia(1) Efficacy and tolerability of current oral iron supplements are mixed. Intravenous (IV) iron administration is associated with important risks and burdens. About the Pivotal Phase 3 Clinical Study The pivotal Phase 3 study randomized 234 patients (233 patients received at least one starting dose of ferric citrate) at 32 clinical sites in the United States. NDD-CKD patients with hemoglobin levels between 9.0 mg/dL and 11.5 mg/dL and who were intolerant to or had inadequate response to oral iron supplements were randomized 1:1 (ferric citrate versus placebo), n=117 and n=116, respectively. Patients enrolled in the study were not allowed to receive any IV or oral iron, or ESAs during this study. The study had a 16-week, randomized, double-blind, placebo-controlled, efficacy period followed by an 8-week open-label safety extension period in which all patients remaining in the study, including the placebo group, received ferric citrate. During the 16-week efficacy period, ferric citrate was administered at a starting dose of three tablets per day with food and could be titrated every four weeks by an additional three tablets for up to a maximum of 12 tablets per day; the mean dose received in ferric citrate treated patients was 5 tablets per day. The primary endpoint was the proportion of patients achieving a ≥1 g/dL increase in hemoglobin at any point during the 16-week efficacy period. Poster Presentations Four posters presented during Kidney Week are related to the Phase 3 clinical trial. Summary of Phase 3 trial data presented in four poster presentations An analysis of the 16-week randomized efficacy period of the Phase 3 data study of ferric citrate (FC) dosed to improve hemoglobin levels showed that ferric citrate was well tolerated. 52.1 percent (61/117) of ferric citrate treated patients achieved the primary endpoint without the use of IV iron or ESA compared to 19.1 percent in the placebo group. Of the patients in the ferric citrate treatment group who achieved the primary endpoint, 93 percent (57/61) had a sustained treatment effect as defined by a mean change from baseline of ≥0.75 mg/dL over any 4-week time period provided that an increase of >1.0 g/dL had occurred during that 4-week period. Increases in hemoglobin were observed as early as one to two weeks after the start of treatment with ferric citrate. Additional analyses of patients at the end of the 16-week efficacy period were conducted and reported in the posters that showed: Use of ferric citrate in patients with NDD-CKD and IDA, as highlighted above, is investigational and has not been determined to be safe or efficacious. About Auryxia 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 CKD on dialysis. The U.S. approval of Auryxia was based on data from the company's Phase 3 registration program in dialysis patients. 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). 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 and the U.S. full prescribing information, visit www.Auryxia.com. IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA® (ferric citrate) Contraindication: Patients with iron overload syndrome, e.g. hemochromatosis, should not take Auryxia®. 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. Ciprofloxacin should be taken at least 2 hours before or after Auryxia. For Full Prescribing Information for Auryxia, please visit http://auryxia.com/important-safety-information/ Forward Looking Statements Some of the statements included in this press release, particularly those regarding the commercialization and ongoing 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 we can increase adoption of Auryxia in patients with CKD on dialysis; the risk that the FDA may not concur with our interpretation of our Phase 3 study results in non-dialysis dependent (NDD) CKD, supportive data, conduct of the studies, or any other part of our regulatory submission and could ultimately deny approval of ferric citrate for the treatment of IDA in adults with stage 3-5 NDD-CKD; the risk that if approved for use in NDD-CKD that we may not be able to successfully market Auryxia for use in this indication; 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. About Keryx Biopharmaceuticals, Inc. Keryx Biopharmaceuticals, with headquarters in Boston, is focused on bringing innovative medicines to market for people with renal disease. In December 2014, the company launched its first FDA-approved medicine, Auryxia® (ferric citrate) in the United States. In January 2014, ferric citrate was approved for use in Japan, where it is being marketed as Riona® by Keryx's Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd. In September 2015, the European Commission granted European market authorization for Fexeric® (ferric citrate coordination complex). For more information about Keryx, please visit www.keryx.com.


BOSTON, Feb. 16, 2017 (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a biopharmaceutical company focused on bringing innovative medicines to market for people with renal disease, today announced that it will host a conference call and webcast on Wednesday, March 1, 2017 at 8:00 a.m. ET to discuss its fourth quarter and full year 2016 financial results and provide corporate updates. To participate in the conference call, please dial 1-888-396-2320 (U.S.), 1-774-264-7560 (international) and refer to conference ID: 74238520. The call will be webcast live with slides and accessible through the Investors section of the company’s website at www.keryx.com for a period of 15 days after the call. Keryx Biopharmaceuticals will announce its financial results for this period in a press release to be issued prior to the call. About Keryx Biopharmaceuticals, Inc. Keryx Biopharmaceuticals, Inc., with headquarters in Boston, Massachusetts is a commercial stage company focused on bringing innovative medicines to people with renal disease. Keryx developed and commercializes Auryxia® (ferric citrate) in the U.S. Ferric citrate is marketed as Riona® by Keryx’s Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd. In September 2015, the European Commission granted European market authorization for Fexeric® (ferric citrate coordination complex). Keryx has programs underway to leverage its development and commercial infrastructure, including potentially expanding the indication of Auryxia and in-licensing medicines for renal disease. For more information about Keryx, please visit www.keryx.com.


BOSTON, Feb. 23, 2017 (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc., (NASDAQ:KERX), a biopharmaceutical company focused on bringing innovative medicines to people with renal disease, today announced it will webcast its corporate presentations at the following investor healthcare conferences: Raymond James 38th Annual Institutional Investors Conference Presenter: Scott Holmes, SVP and Chief Financial Officer Presentation Date: Tuesday, March 7, 2017 Presentation Time: 8:40 a.m. ET 37th Annual Cowen and Company Healthcare Conference Presenter: Greg Madison, President and Chief Executive Officer Presentation Date: Wednesday, March 8, 2017 Presentation Time: 10:00 a.m. ET Live audio webcasts of the presentations will be accessible from Keryx’s website at http://investors.keryx.com within the Investor Relations section under “webcasts and presentations.” An archived version of the webcast will be available for at least 15 days following the conclusion of the live presentation. About Keryx Biopharmaceuticals, Inc. Keryx Biopharmaceuticals, Inc., with headquarters in Boston, Massachusetts, is a commercial stage company focused on bringing innovative medicines to people with renal disease. Keryx developed and commercializes Auryxia® (ferric citrate) in the U.S. Ferric citrate is marketed as Riona® by Keryx’s Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd. In September 2015, the European Commission granted European market authorization for Fexeric® (ferric citrate coordination complex). Keryx has programs underway to leverage its development and commercial infrastructure, including potentially expanding the indication of Auryxia and in-licensing medicines for renal disease. For more information about Keryx, please visit www.keryx.com.


The object of this invention is to provide a novel medicine useful for therapy to improve the skin properties such as skin drying, skin roughening and the skin darkening involved in hyperkeratosis (thickened keratin layer) via a skin moisture retaining effect against the decline of the skin functions brought about by various causes. This invention provides a skin property-improving therapeutic agent comprising a compound having a specific morphinan skeleton typified by a compound 1 represented by the following formula (II) or any of its pharmacologically permissible acid addition salts as an active ingredient.

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Loading Torii Pharmaceutical Co. collaborators