Keryx Says More EU Kidney Drug Trials Unneeded
From Associated Press (May 2, 2011)
NEW YORK -- Keryx Biopharmaceuticals Inc. said Monday that it does not expect to be required to conduct additional studies of its kidney drug Zerenex to win regulatory approval in Europe.
The company said it was informed by a European Union advisory committee that if its current late-stage clinical trial is successful, that study would provide enough data to support a marketing application in the EU. The study would be submitted along with safety data from other trials. The late-stage trial is being conducted in the U.S., and drug companies often have to run separate clinical trials to win approvals in different markets.
Zerenex is intended to treat high phosphate levels in patients with chronic kidney disease. Keryx is seeking approval to market the drug for use by patients with chronic kidney disease who are not yet on dialysis, and patients with end-stage kidney disease who are undergoing dialysis. The New York drug maker has licensed the drug in most markets, aside from some Asia-Pacific countries.
Keryx reported its first-quarter results on Friday. The company said it took a larger loss as its research and development costs increased. It lost $6.4 million, or 10 cents per share. A year earlier, Keryx lost $4 million, or 7 cents per share. The company's total expenses rose to $4.9 million from $2.8 million, as research expenses increased to $4.6 million from $2.6 million.
Analysts expected a loss of 10 cents per share, according to FactSet.
Shares of Keryx rose 10 cents to $5.39 in afternoon trading.
Posted: May 2011