Overview
Keryx has obtained a license to develop the drug sulodexide (KRX-101) (a heparin type molecule) to treat diabetic kidney disease (nephropathy) as well as other conditions. Sulodexide is a drug that has been sold in Europe for many years by our licensor for the treatment of vascular conditions and it has a well-established safety profile. Recent phase II level data was presented at a president's poster session at the annual meetings of the American Diabetes Association (ADA) in June, 2000.

In June 2000, on the basis of the extensive safety and impressive efficacy data, we filed an application with the Food and Drug Administration (FDA) to begin advanced stage clinical trials of KRX-101 for the treatment of diabetic nephropathy.

Market
According to the ADA, there are an estimated 10.3 million diagnosed diabetics in the United States and approximately 1-2 million individuals have nephropathy. Accordingly, we believe that the potential annual market available for KRX-101 for the treatment of diabetic nephropathy is in excess of $800 million.

Scientific Background
Diabetes often damages the intricate system of delicate capillary filtering loops (glomeruli) within the kidney. As these loops lose their structural integrity, their ability to selectively filter the blood's contents diminishes, and protein (chiefly albumin) is lost into the urine. The presence of protein in the urine (proteinuria) causes further damage to other vital kidney structures resulting in a vicious cycle of inflammation and scarring. The end result is renal failure, necessitating dialysis or transplant.

Previous clinical trials suggest that KRX-101 protects vital kidney structures by repairing and maintaining glomerular membranes, thus decreasing proteinuria and its resultant inflammation and scarring. These effects may help delay the onset of renal failure thus improving the life of diabetic patients.