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keryx biopharmaceuticals (KYX) Snapshot

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keryx biopharmaceuticals (KYX) Details

Keryx Biopharmaceuticals, Inc., a biopharmaceutical company, focuses on the acquisition, development, and commercialization of pharmaceutical products for the treatment of renal disease in the United States. It is developing Zerenex (ferric citrate), an oral, ferric iron-based compound that has the capacity to bind to phosphate in the gastrointestinal tract and form non-absorbable complexes. The company has completed Phase III clinical program for Zerenex for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with chronic kidney disease on dialysis. Zerenex has also completed a Phase II study for the management of elevated serum phosphorus levels and iron deficiency anemia in patients with stages three to five non-dialysis dependent chronic kidney disease. The company has sublicense agreements with Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd. for the development and commercialization of Zerenex in Japan. It also has strategic alliances with Panion & BF Biotech, Inc. Keryx Biopharmaceuticals, Inc. was founded in 1997 and is headquartered in New York, New York.

88 Employees
Last Reported Date: 08/7/14
Founded in 1997

keryx biopharmaceuticals (KYX) Top Compensated Officers

Chief Executive Officer, Director and Member ...
Total Annual Compensation: $475.0K
Chief Financial Officer, Principal Accounting...
Total Annual Compensation: $405.0K
Compensation as of Fiscal Year 2013.

keryx biopharmaceuticals (KYX) Key Developments

Keryx Biopharmaceuticals Initiates Pivotal Phase 3 Study of Ferric Citrate for the Treatment of Iron Deficiency Anemia in Patients with Non-Dialysis Dependent Chronic Kidney Disease

Keryx Biopharmaceuticals Inc. announced the initiation of its pivotal Phase 3 study of Ferric Citrate for the treatment of iron deficiency anemia in patients with non-dialysis dependent (Stage 3-5) chronic kidney disease. On September 5, 2014, the U. S. Food and Drug Administration (FDA) approved Ferric Citrate (formerly known as Zerenex(TM)) for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis. The Phase 3 study initiated on September 29, 2014, entitled 'A Phase 3 Study of KRX-0502 (Ferric Citrate) for the Treatment of Iron Deficiency Anemia in Adult Subjects with Non-Dialysis Dependent Chronic Kidney Disease', is a multi-center clinical trial, comprised of a 16-week, randomized, double-blind, placebo-controlled period, followed by an 8-week open-label safety extension period in which all subjects receive Ferric Citrate, for a total of 24 weeks. Approximately 230 subjects, who have previously had an inadequate response to oral iron supplements, will be randomized into the Randomized Period in a 1:1 ratio to receive either Ferric Citrate or matching placebo. Intravenous (IV) iron and erythropoiesis-stimulating agent (ESA) use is prohibited during and leading up to the study. There are currently no oral iron formulations that are FDA approved for the treatment of iron deficiency anemia in CKD patients. This study's primary endpoint is the between group comparison of the proportion of patients achieving a 1 g/dL or greater increase in hemoglobin at any point during the 16-week Randomized Period. In the 12-week Phase 2 study in NDD-CKD previously conducted by Keryx, a post-hoc analysis of this endpoint demonstrated that the proportion of patients achieving a 1g/dL or greater increase in hemoglobin at any time point during the study was 40% in the Ferric Citrate arm vs. 15% in the placebo arm (p-value <0.001). Secondary endpoints in the Phase 3 study include change from baseline to end of Randomized Period for hemoglobin, ferritin, TSAT and serum phosphorous.

Keryx Biopharmaceuticals Inc. - Special Call

To discuss the approval of Ferric Citrate

Keryx Biopharmaceuticals, Inc. Receives FDA Approval of Ferric Citrate

Keryx Biopharmaceuticals Inc. announced that the U.S. Food and Drug Administration approved Ferric Citrate for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis. The U.S. approval of Ferric Citrate was based on data from its Phase 3 registration program. In the Phase 3 clinical trials, Ferric Citrate effectively reduced serum phosphorus levels to well within the KDOQI guidelines range of 3.5 mg/dL to 5.5 mg/dL. In addition to the effects on serum phosphorus levels, Ferric Citrate's pharmacodynamic properties resulted in increased ferritin and transferrin saturation; whereas these parameters remained relatively constant in patients treated with active control. The most common adverse events for Ferric Citrate treated patients were gastrointestinal-related, including diarrhea, nausea, vomiting and constipation. Recently, the company was informed by the FDA that approval of the brand name Zerenex had been rescinded. Keryx believes the company will have an approved brand name on or prior to launch, although a brand name is not a pre-requisite for the launch of an FDA-approved drug.


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