Correction: Keryx-Drug Approval story
NEW YORK (AP) — In a Sept. 5 story about a new drug from Keryx Biopharmaceuticals, The Associated Press misstated the timing of the company's stock movement. The stock had been falling before the FDA drug approval announcement was made.
A corrected version of the story is below:
Keryx kidney drug gets OK for dialysis patients
Keryx pill for kidney disease patients wins FDA approval but with unexpected warning language
NEW YORK (AP) — Keryx Biopharmaceuticals received U.S. approval Friday for a new pill to treat complications of kidney disease, though warning language in the drug's label surprised some analysts.
The Food and Drug Administration approved the company's ferric citrate drug to treat patients on dialysis with hyperphosphatemia, or elevated levels of phosphates, which can increase the risk of heart disease, bone density problems and death.
Keryx previously highlighted the drug's ability to also boost patients' iron levels, a feature the company said would enable patients to reduce use of anemia drugs and intravenous iron often taken by dialysis patients. However, the FDA-approved label warns that the drug can cause "iron overload," and that doctors must monitor patients' iron levels while taking the drug.
"The expectations were that the label would have an indication for anemia management," FBR Capital Markets analyst Andrew Berens said in an interview with The Associated Press. "Instead where it appeared was in the warning section, which is kind of strange because it's like turning a benefit into a warning."
Despite the warning, Berens said the company should still be able to market the drug's iron-boosting ability to physicians based on company studies that showed patients were able to cut down on anemia drugs and iron infusions. Berens holds a "market perform" rating on the stock.
Analysts on a company conference call Friday asked Keryx executives how they would promote the drug to doctors, given the labeling language.
"The details of how we're going to do that and the exact messaging — that's all the work that we're going to do in the next couple of weeks now that we have a final label," said Keryx chief operating officer, Greg Madison.
Shares of Keryx Biopharmaceuticals Inc. fell 98 cents, or 5.45 percent, to close at $17.01 in regular trading. The company's stock traded as low as $14.80. Company shares have increased 29.7 percent for the year.
Keryx estimates that between 350,000 and 375,000 U.S. dialysis patients take medication to control their phosphate levels, representing a total market of $1.2 billion.
"This is a drug that has demonstrated a clear ability to benefit a very sick and burdened patient population," CEO Ron Bentsur said in an interview with The Associated Press. Benstur said the company will launch the drug in the U.S. in the next 12 weeks.
Ferric citrate is designed to be taken in two pills with each meal, for a daily regimen of six pills.
The company had initially planned to market the drug under the brand name Zerenex, though the FDA recently ruled that the name was too similar to a drug already on the market. Keryx plans to develop a new brand name ahead of the drug's launch.
It's the first U.S. product approval for the New York-based drugmaker, which licensed ferric citrate from a Taiwanese drugmaker in 2005. Keryx has rights to market the drug in North America, Europe and Japan, where the pill launched in May.
The company plans to soon begin late-stage testing of the drug in kidney disease patients who are not yet on dialysis.
More than 20 million people in the U.S. have chronic kidney disease and roughly 400,000 receive dialysis treatment, in which a machine filters waste from the blood in place of healthy kidneys.