FOSRENOL

FOSRENOL is a novel phosphate binder based on lanthanum carbonate to treat hyperphosphatemia in kidney failure patients. It has a higher affinity for binding to phosphate than calcium or aluminum and has low systemic absorption; therefore, it is easily passed through the body.

AnorMED sold the global patents for FOSRENOL to Shire Pharmaceuticals Group plc, and one of its wholly owned subsidiaries in March 2004.

Agreement Terms

AnorMED will receive U.S. $18M upon U.S. approval
AnorMED will receive U.S. $7M upon relevant E.U. approval countries
AnorMED will receive U.S. $6M upon Japanese approval
Shire’s royalty obligations to AnorMED shall cease throughout the world
FOSRENOL Status

Shire received appproval in the U.S., October 2004
Shire received approval in Sweden, March 2004
Additional E.U. approvals and launch in the E.U. expected in 2004
Studies in Japan are ongoing
Chronic Kidney Failure
In patients with chronic kidney failure hyperphosphataemia can result from the inability of damaged kidneys to effectively filter out any excess phosphate that enters the body in food. Together with other biochemical disturbances, elevated phosphate levels, if untreated, can result in a bone disorder known as renal osteodystrophy. Bone pain is a common feature of this condition and the individual may suffer fractures and skeletal deformity. Recent clinical data also suggest that hyperphosphataemia is associated with the development of cardiovascular disease which accounts for nearly 50% of all deaths in dialysis patients. Hyperphosphataemia and an elevated calcium-phosphate product, together with an elevated parathyroid hormone level, can promote the build up of calcium deposits (calcification) around the body and in blood vessels. This is a particular problem when the main blood vessel from the heart, the coronary artery, is affected.

Conventional dialysis and a phosphate restricted diet are generally unable to reduce phosphate levels results in the formation of a relatively water insoluble compound, lanthanum phosphate, which cannot pass easily through the gut lining into the blood stream. As a consequence, phosphate absorption from the diet is decreased. As FOSRENOL does not contain calcium it enables the physician to separate the control of calcium from phosphate. Evidence to date suggests that FOSRENOL does not cause raised blood calcium levels in patients.

Page updated: October 29, 2004