AEGiS-PRn: AnorMED announces Foznol(TM) NDA submitted to FDA PRNewswireImportant note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.
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AnorMED announces Foznol(TM) NDA submitted to FDA

PRNewswire - April 30, 2002


VANCOUVER - AnorMED Inc. (TSE:AOM) announced today that its licensee, Shire Pharmaceuticals Group plc, has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for Foznol (likely to be renamed Fosrenol, lanthanum carbonate) as a treatment for elevated blood phosphate levels, in patients with end stage kidney disease.

"Fosrenol is our most advanced product in development. This FDA filing, and the anticipated first country approval in the E.U. by the end of the second quarter of 2002 are both significant milestones for AnorMED. Shire anticipates that the U.S. will be the largest market for Fosrenol and, pending FDA regulatory approval, we look forward to seeing this product made available to the many patients who need it. To date clinical studies in the U.S. and elsewhere suggest that it is a promising treatment for lowering phosphate levels in kidney dialysis patients," said Dr. Michael Abrams, President and CEO of AnorMED Inc.

Shire Pharmaceuticals Group plc, an international specialty pharmaceutical company, was granted an exclusive license to develop, manufacture, use and sell Fosrenol worldwide. Shire has conducted extensive clinical studies of Fosrenol, in both Europe and the U.S., treating over 1660 patients. Clinical data from these studies will begin to be published during the second half of 2002. Shire expects to receive E.U. marketing approval in the second quarter of 2002. The median time for other recent FDA Standard Reviews of New Drug Applications have been 12 to 14 months and once Fosrenol is launched, a single-digit royalty on net sales will be payable to AnorMED.

It is estimated that there are approximately 280,000 kidney dialysis patients in the U.S., 225,000 in Europe, 190,000 in Japan and 90,000 in the Pacific Rim region. 1 The majority of these patients will experience elevated blood phosphate levels, described as hyperphosphataemia. If untreated, this elevated phosphate level together with other biochemical disturbances can result in bone disorders known as renal osteodystrophies. Recent clinical data also suggest that excess phosphate may also be associated with the development of cardiovascular disease, which accounts for nearly 50% of all deaths in dialysis patients.2

Fosrenol, developed as a convenient chewable tablet, binds to the dietary phosphate in the digestive system. Once bound, the Fosrenol/phosphate complex cannot pass through the system into the blood stream and is eliminated from the body. As a consequence, phosphate absorption from the diet is decreased significantly.

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

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

AnorMED is focused on the discovery and development of small molecule therapeutics for the treatment of diseases including inflammation, cancer and HIV. AnorMED's late stage clinical products include: Fosrenol, which is on track for a European market approval by mid-year 2002; AMD-473, an anti-cancer agent in ongoing Phase II trials; AMD-3100, a potential new agent for stem cell transplant in cancer patients, currently in a Phase I trial; and Apomate, a prognostic imaging agent for cancer and other diseases in Phase I/II trials. The Company is also focused on a novel class of compounds that target specific receptors known to be involved in HIV, rheumatoid arthritis, asthma and cancer. AnorMED continues to build upon its drug discovery and clinical development capabilities to support the rapid advancement of its most promising therapeutic candidates into clinical trials and to attract corporate partners

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 17, 2001.

SOURCE AnorMED Inc.
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