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the company faltered when neither of its original programs panned out. The board lured Bentsur back to the company and named him CEO in 2009.
The stock was in the doldrums, but Bentsur believed the colon cancer and kidney drugs presented an attractive risk-reward balance. “Perifosine was a high-risk, high-reward situation,” he says. The kidney product, on the other hand, “did not have the same amount of pizzazz, but it was a much lower risk profile.”
Now Bentsur is facing his toughest challenge yet: He must persuade Wall Street that that, in fact, there is pizzazz in Keryx’s kidney program. The drug, ferric citrate, is designed to bind to phosphate—a chemical that builds up in the blood of patients with late-stage kidney disease—and shuttle it out of the body. Keryx expects to complete the pivotal trial by the end of the year and apply for FDA approval in the first quarter of next year.
Keryx’s drug, should it be approved, will be entering a fiercely competitive market, though. There are already three phosphate binders on the market, which are sold by Sanofi unit Genzyme, Irish drug giant Shire, and Fresenius Medical Care, which is an operator of dialysis clinics. Together they bring in an estimated $750 million a year in the U.S.
Bentsur believes Keryx’s phosphate binder will prove to be safer than the others—and more convenient. “On average, patients need to take 10 to 12 of these pills per day to get adequate control of their phosphate,” says Bentsur, who is so cognizant of the competition he carries a baggie around with him that contains samples of all his rivals’ phosphate binders. “We think we can cut the pill burden 20 percent at least.”
Keryx is also hoping to prove its drug will lessen the need for kidney patients to take iron supplements and the anemia fighter erythropoietin (EPO), which is marketed by Amgen (NASDAQ: AMGN) and Johnson & Johnson (NYSE: JNJ) . That’s because Keryx’s phosphate binder is made from iron. “Intuitively an iron-based phosphate binder should, over time, increase the iron stores of these patients,” which could in turn relieve the anemia, Bentsur says.
Last November, DaVita Clinical Research—an arm of a large chain of dialysis clinics—presented research at a conference showing that Keryx’s drug could produce cost savings of up to $320 per patient per month, if reductions in EPO use observed in initial trials translate to the real world. “That’s a pretty substantial number,” Bentsur says. Further studies on potential Medicare and managed-care savings were presented earlier this month at a conference of the National Kidney Foundation.
On April 23, Keryx announced positive results from a Japanese trial of its phosphate binder—giving the stock, which had fallen below $1.50, a bump to $1.75. (Shares closed yesterday at $1.78.) Bentsur is resigned to the fact that investors won’t fully regain confidence in Keryx until they see the results from the U.S. trials of the phosphate binder later this year. But he refuses to wallow in the company’s past failures. “It’s disappointing on many levels, and obviously it’s unfortunate for shareholders, and I’m one of them.” Bentsur says. “Our responsibility is not to be depressed for more than a day or two. We need to snap out of it and move forward.”