Keryx Biopharmeceuticals

The stock price of Keryx Biopharmaceuticals (NASDAQ:KERX) jumped by more than 90 percent to around $6.50 a share as of this writing after the company announced the successful results from the long-term Phase 3 study of its experimental drug, Zerenex for the treatment of patients on dialysis suffering from end stage renal disease (ESRD).

According to the company, Zerenex met the primary endpoint of the study and demonstrated a highly statistical significant change in serum phosphorous versus  a placebo over the four-week Efficacy Assessment Period of the study.

The drug also met its key secondary endpoints (anemia management). According to Ron Bentsur, CEO of Keryx Biopharmaceuticals (NASDAQ:KERX), Zerenex demonstrated robust increases in ferritin (51%) and transferring saturation (TSAT) scores (26%) while the active control group remained flat. The changes in ferritin and TSAT scores happened and peaked after only four to five months, according to Bentsur.

Bentsur also said, “What is also very compelling is that the ferritin and TSAT levels plateau at these higher levels. We believe that this maybe the body’s natural iron absorption mechanism being utilized. It’s the striking reductions in IV iron, and ESA use observed in the study that are truly a potential game changer.”

Zerenex demonstrated a 52% drop in average cumulative IV iron use and 27% drop in average cumulative ESA versus the active control group who were given a placebo in the study.

Bentsur emphasized that the ESA and IV iron dialysis market in the United States are approximately worth $2 billion and $400 million, respectively. According to him, Zerenex result of reducing 52 percent of IV iron use and 27% ESA use could potentially provide $750 million savings annually to the health care system.

Bentsur said, “There is no question that Zerenex delivered strong data today. We believe the data presented today clearly suggests that Zerenex has the potential to become the market leader” for this type of treatment.

According to Reni Benjamin, analyst at Burrill Institutional Research, phosphate binder drugs generate $1.5 billion sales every year. He said, “Keryx can compete quite favorably once generics enter the marketplace in 2014.”

Keryx Biopharmaceuticals (NASDAQ:KERX) plans to file for a New Drug Application (NDA) with the FDA and a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for Zerenex in the second quarter of 2013.