Keryx Biopharmaceuticals Inc. (Nasdaq: KERX;) has suffered a blow from which it will find it difficult to recover, with the failure of Phase III trials for its drug, Sulonex (sulodexide) for the treatment of diabetic nephropathy. The company said the trial failed to meet the primary objective of the study, although it did not make any mention of an attempt to save the product by carrying out further statistical analysis or testing it in sub-groups. This, therefore, would appear to be the final word on the fate of Sulonex for the time being.
Keryx will hold a conference call tomorrow (Monday) before the start of trading, at which it will try to explain how a drug, which was so successful in Phase II trials, proved such a resounding failure in a large multi-center trial, and convince investors that it still has a promising product pipeline.
Keryx has another drug, Zerenex, for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease which, it says, should be commencing Phase II trials by the end of the year, as well as KRX-0401, a drug for the treatment of multiple tumor types, also due to begin Phase II trials in the near future.
Keryx's trial of the failed Sulonex costs it tens of millions of dollars, although it had $64 million in cash at the end of 2007.
Published by Globes [online], Israel business news - www.globes-online.com - on March 9, 2008
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