Shares of Keryx Biopharmaceuticals
(NASDAQ:KERX) are surging after the company said
its experimental drug for kidney dialysis patients met its goal for effectiveness in a late-stage study. Keryx plans to seek US and European approval for the drug in the second quarter.
Shares of Keryx jumped more than 40% to $4.82 in late-morning trading Monday. The stock is up 56% over the past 12 months.
The New York-based company said its drug Zerenex met its study target for lowering phosphate levels in the blood of patients with kidney failure. Patients on Keryx’s drug showed a statistically significant reduction compared with those trial participants who were given a placebo. (As kidney function deteriorates, blood phosphate levels rise.)
"There is no question that Zerenex delivered strong data today,” Keryx CEO Ron Bentsur told analysts and investors on a conference call Monday morning. “We believe the data presented today clearly suggests that Zerenex has the potential to become the market leader” for this type of treatment.
The market for so-called phosphate binders, drugs designed to address this problem in kidney patients, is about $1.5 billion in annual sales, says Burrill Institutional Research analyst Reni Benjamin.
(NYSE:SNY) Renagel and Renvela drugs make up about half that market now, Benjamin says. Impax Laboratories
(NASDAQ:IPXL) is licensed to sell generic versions of the drugs following a legal settlement
with Sanofi announced last year.
“We believe Keryx can compete quite favorably once generics enter the marketplace in 2014,” Benjamin says in a recent note.
Keryx’s drug also met secondary goals of improving iron levels in patients and reducing the need for intravenous delivery of the mineral. Bentsur says the positive results for the secondary endpoints further distinguishes Zerenex from other similar medicines.
In the US alone, there are almost a half million patients with end-stage renal disease -- complete or nearly complete kidney failure -- and that number is going to rise about 60% by 2020, according to figures cited by Keryx. More than 350,000 kidney failure patients now require dialysis, Keryx says.
Full results of the Keryx study will be available at an upcoming medical meeting.
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