AnorMED Inc announced that its licensee, Shire Pharmaceuticals Group plc, has received an approvable letter from the U.S Food & Drug Administration (FDA) for Fosrenol (lanthanum carbonate).

The approvable letter asks for additional data and analysis to address a number of remaining questions. Shire is initiating a dialogue with the FDA to agree on the balance between pre and post approval commitments that will resolve the questions. Shire will provide further updates when it is in a position to be more specific about the timing of approval and subsequent launch. Until that point, Shire maintains its forecast of a US launch prior to the end of 2003.

"This is an important milestone for AnorMED, as Fosrenol will be the Company's first approved product. We are pleased that dialysis patients treated across the United States will have a new alternative to current therapies and look forward to hearing from the European regulatory agency in due course," said Dr. Michael Abrams, President and CEO of AnorMED Inc.

Fosrenol is a treatment for high phosphate levels in the blood, which occur in patients undergoing dialysis as a result of chronic kidney failure. Estimates show there are 269,000(1) dialysis patients in the United States. Even with a low-phosphate diet, as many as 80% of dialysis patients develop hyperphosphataemia(2) and need treatment with a phosphate binder, such as Fosrenol. If left untreated, hyperphosphataemia can lead to the bone disease renal osteodystrophy, which causes bone pain, skeletal deformities, and can result in fractures. Recent research also suggests that hyperphosphataemia is associated with the development of cardiovascular disease, which accounts for nearly 50% of all deaths in dialysis patients(3).

Submissions have also been made by Shire to gain marketing approval in Europe and Canada, whilst development continues for Japan.

AnorMED granted Shire Pharmaceuticals Group plc an exclusive worldwide license to develop, manufacture, use and sell Fosrenol in 1996. Under this license agreement, Shire assumed all responsibility and costs for the development and commercialization of Fosrenol. Upon regulatory approval for marketing, AnorMED will receive a single digit royalty on the net sales of Fosrenol.