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Zerenex Phase II data open way for broader indications from FDA
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Shares in the company Keryx Biopharmaceuticals' received a 20% boost this week following further positive results for its (CKD) drug Zerenex. Zerenex passed a Phase II trial on non-dialysis-dependent patients, opening up the possibly of broader indications for the drug when the FDA make a final decision on it in June of next year.

Zerenex is designed to treat hyperphosphatemia. This is a common problem among patients with CKD as one of the functions of the kidneys is to excrete excess dietary phosphate; therefore patients with CKD can suffer from phosphate overload and hyperphosphatemia. Hyperphosphatemia is a risk factor for vascular calcification, cardiovascular mortality, left ventricular hypertrophy, and CKD progression in CKD patients.

Zerenex passed phase III trials measuring reduction in serum phosphorous in end-stage renal disease patients on dialysis versus placebo earlier this year, leading to a boost in share prices. However, concerns had been growing that emerging generic competitors for Zerenex in dialysis patients, including Renvela (Sanofi) and Fosrenol (Shire), could erode its value. The latest Phase II results are on a less critically ill cohort of 149 anaemic, non-dialysis-dependent CKD patients. Significant reductions in their serum phosphorous and increases in their iron were observed over 12 weeks. Keryx are hopeful that these results will prompt the FDA to give the drug a labelled indication to treat a broader population of less critical CKD patients with iron-deficiency anaemia. Zerenex has tertiary benefits that Keryx are anxious to emphasise, including reduced need for intravenous iron and erythropoiesis-stimulating agents, which could help to distinguish it from its emerging generic competitors. However, Zerenex may still fact problems in being given New Chemical Entity status from the FDA as its active ingredient is very similar to that in Ferriseltz (Otsuka). Thus generic competition issues may become a problem for Keryx sooner than they would like.

Sources

http://www.fiercebiotech.com/story/keryx...2013-11-05 [Accessed 7 November 2013].

http://www.fiercebiotech.com/story/keryx...2013-01-28 [Accessed 7 November 2013].

GONZALEZ-PARRA, E., TUÑÓN, J., EGIDO, J. and ORTIZ, A., 2012. Phosphate: a stealthier killer than previously thought? Cardiovascular Pathology: The Official Journal Of The Society For Cardiovascular Pathology [Cardiovasc Pathol], 21(5), pp. 372-81.
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