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FDA Grants Approvable Letter For Fosrenol (Lanthanum Carbonate) For Treatment Related To Kidney Disease

VANCOUVER, BC -- March 3, 2003 -- AnorMED Inc. (TSX:AOM) announced today 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.

AnorMED's core strength involves the application of chemistry, biochemistry and biology to the discovery and development of small molecule therapeutics for the treatment of diseases including HIV, rheumatoid arthritis, asthma and cancer. The Company has four clinical products in development and a research program focused on a novel class of compounds that target specific chemokine receptors known to be involved in a variety of diseases. Additional information on AnorMED Inc is available on the Company's website http://www.anormed.com

Note: Certain of the statements contained in this press release contain forward-looking statements which involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. The Company does not expect to update forward-looking statements continually as conditions change. Investors are referred to the full discussion of risk factors associated with the Company's business contained in the Company's Annual Information Form filed with securities regulatory authorities dated August 16, 2002.

References:

(1) US renal data system 2002 annual data report: Atlas of ESRD in US, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland, MD. 2002 page 44.

(2) Numbers of patients on dialysis broadly equates to patients with end stage kidney disease. Source: Market Research, Insight International, Dec 01/Jan 02

(3) Davies MR, Hruska K. Pathophysiological mechanisms of vascular calcification in end-stage renal disease. Kidney Int. 2001 Aug; 60(2): 472-9

Fosrenol® (Lanthanum carbonate) is a novel non-calcium, non-aluminum, potent phosphate binder. It is available as a convenient chewable tablet to be taken at mealtimes unlike existing treatments that must be taken with water. Patients on dialysis need to restrict their fluid intake. Fosrenol works by binding to dietary phosphate throughout the GI tract forming a highly insoluble complex that cannot pass through the stomach lining and into the blood stream. The complex is eliminated from the body through the GI tract.

As a result, overall phosphate absorption from the diet is decreased significantly. Shire has conducted an extensive clinical research program for Fosrenol involving almost 1700 patients, some of whom have been treated for 36 months or more.


SOURCE: AnorMED Inc

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