› RENAGEL® / sevelamer hydrochloride
› RENVELA® / sevelamer carbonate
› HECTOROL® / doxercalciferol
With a portfolio of products and pipeline of therapies in development that are among the strongest and deepest in the marketplace, renal disease is a key area of commitment for Genzyme. We collaborate with businesses across Genzyme, including transplant, genetic diseases and cardiovascular, to maximize treatments for kidney disease patients.
Renagel, our therapy to reduce the phosphorus levels in kidney disease patients on dialysis, is the leader in a highly competitive global market. We're driving sustainable growth for Renagel by expanding worldwide availability and increasing use in current markets. Three published studies citing Renagel's clinical outcomes benefit are contributing to the success of the product-in 2007 it became the first phosphate binder in the United States to reach one million prescriptions.
Hectorol, our therapy for secondary hyperparathyroidism in kidney patients, represents entry into the chronic kidney disease (CKD) field that we're leveraging to expand globally. In the United States, Hectorol is also an important product used for the same indication in patients on dialysis. Hectorol's clinical and operating synergies are driving leverage in our sales and marketing investments, while positioning Genzyme among providers as a company offering solutions across multiple disease areas affecting their patients. We're increasing Hectorol's manufacturing efficiencies in 2008 by expanding capacity in our New Jersey and Ireland plants. Renvela, the newest addition to our renal franchise, received U.S. approval in late 2007 and launched in early 2008.
Renvela is a buffered form of Renagel that solidifies our market leadership in hemodialysis while serving as a catalyst into a much larger market: CKD patients who are not on dialysis. We have filed for approval in Brazil for dialysis patients and in Europe for the same indication as well as for patients not on dialysis. We also plan to launch Renvela in its powder formulation in Europe and will file a marketing application in the U.S. in 2008.
Kidney sclerosis, polycystic kidney disease and acute kidney injury continue to be important areas of R&D investment. GC1008 for kidney sclerosis is currently in phase 1-2 trials; we plan to file an IND for Genz 644470, a new, novel polymer phosphate binder in pre-clinical development offering advances over current therapies, by the end of 2008.