Keryx Biopharmaceuticals' ($KERX) phosphate-lowering drug Zerenex proved effective in a late-stage study, positioning the biotech to make a 2012 run at the market-leading therapy by offering dialysis patients the chance to cut down on the number of pills they need to take.
Investigators recruited 146 patients to try three doses of the drug and found that at six and eight pills a day their phosphate levels slid a respective 25 percent and 29 percent. Dialysis patients frequently suffer from elevated levels of phosphorus, which is linked to bone disease and death. Patients currently often use Renagel and Renvela from Genzyme ($GENZ) to treat the condition, but Keryx says it can gain an edge in the market by reducing the dosage needed.
"The market leader, the Genzyme franchise Renagel and Renvela, has a very high pill burden," Keryx CEO Ron Bentsur told Bloomberg. "Patients need to take nine to 10 pills a day on average to get adequate control. We are proving today that we are going to have a lower pill burden, showing pretty dramatic drops with six and eight pills a day."
"Based on the results of this Phase III study, it appears that the Zerenex efficacy and safety profile is emerging in a way that could make it the phosphate binder of choice for dialysis patients," Dr. Julia Lewis, chairwoman of the Zerenex Phase III study program, said in a statement.
Bentsur adds that the company has enough funds to make it all the way through Phase III to a 2012 marketing application, but he's interested in landing partners as well. Keryx shares were up about 10 percent in pre-market trading this morning.
- read the Keryx release
- and here's the Bloomberg report
- see the Reuters story