Renagel is emerging as a first-line therapy because of new guidelines for the treatment of dialysis patients
and data from ongoing clinical studies. This usage is supported by the 2003 guidelines of the U.S. Kidney
Disease Outcomes Quality Initiative (K/DOQI), which not only target lower serum phosphate levels in dialysis
patients, but also recommend against adding to the calcium burden in many patients. Renagel is the only
phosphate binder available that contains neither calcium nor metal, providing phosphorus controls without
concerns about the accumulation of these substances.
A mounting body of clinical evidence supports the use of our therapy. In the fourth quarter of 2004, Genzyme
released positive preliminary data from our post-marketing study of Renagel in patients who are new to dialysis,
confirming results of our earlier treat-to-goal study. The data indicate that patients who use Renagel from the
time they begin dialysis exhibit significantly less coronary artery calcification over 18 months than those on a
calcium-based phosphate binder, while still achieving the K/DOQI target levels of phosphorus and calcium-phosphorus
products. In 2005, we expect to release data from a 2,100-patient study of outcomes for patients receiving Renagel
and those receiving calcium-based phosphate binders.