December 31, 2014
By Mark Terry, BioSpace.com Breaking News Staff
New York City-based Keryx Biopharmaceuticals is poised to go head-to-head with Genzyme with a drug for kidney dialysis patients.
On Dec. 22 Keryx announced it has begun selling Auryxia (ferric citrate) tablets in the U.S. Auryxia is approved for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis.
“Dialysis patients and their healthcare providers will benefit from having an additional phosphate binder available,” said Julia Lewis, nephrologist and professor of medicine at Vanderbilt University Medical Center in a press statement. “Auryxia’s clinical profile is compelling and I believe will be of value for my patients.”
This places Keryx in direct competition for the same patients with Genzyme’s Renvela. Renvela was approved in 2007 and has hit sales of $595 million in the U.S. since 2012.
In comparison trials, Auryxia improved the patient’s stored iron levels better than either Renvela or a generic drug called Phoslo. Its price is slightly lower than that of Genzyme’s Renvela.
However, immediately after Auryxia’s approval in September, the FDA mandated a warning that patients had to be monitored for iron overload. Company stock took a hit, dropping 28 percent. At that time, Keryx CEO stated that the labeling was “grossly misunderstood and misinterpreted” by investors. Patients on kidney dialysis have their iron levels monitored already.
This is probably true, and does not seem to currently be an issue. Stock has been on the upswing for the last few days, currently going for $14.37 per share.
In addition, Impax Laboratories Inc. began marketing a generic version of Renvela in April. Sales of Renvela in the U.S. were about $907 million in the 12-month period ending in February 2014, according to IMS Health.
Some analysts have projected that Auryxia could rack up $600 million in sales, not bad at all for a company that employs about 160 people in total. The company initiated a Phase 3 trial in September to determine if Auryxia would be appropriate for patients with anemia, instead of patients on dialysis. This would make the drug available for another two million people. Results are expected late in 2015.
“We are extremely proud to bring Auryxia to market in the U.S. Auryxia is a new treatment option for nephrologists that fits squarely into their current treatment protocols,” said Ron Bentsur, Keryx’s chief executive, in a statement. “We have built a world-class renal commercial team at Keryx and are eager to deliver the first and only absorbable-iron-based phosphate binder to dialysis patients.”
