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| |  WCN: Foznol (Lanthanum) Effective/Well-tolerated in Hyperphosphataemia VANCOUVER, BC -- October 16, 2001 -- AnorMED Inc. announces that U.S. Phase III clinical data for Foznol™ (lanthanum carbonate) in the treatment of hyperphosphataemia, presented today at the 2001 World Congress of Nephrology (WCN) meeting, indicate that Foznol is able to maintain and control blood phosphate levels in patients. At the study endpoint, 59 percent of patients treated with Foznol achieved serum phosphate control versus 23 percent on placebo. The difference of 36 percent between Foznol and placebo was highly statistically significant. "These results are very encouraging and continue to support that Foznol is well tolerated and effective. The significant reductions in calcium x phosphate product and parathyroid hormone, without hypercalcaemia, may make Foznol the preferred phosphate binder", said Dr. Michael J. Abrams, President and Chief Executive Officer of AnorMED. "This is the first presentation of Phase III clinical data and represents another step forward in establishing Foznol as a viable therapeutic option for chronic renal failure patients around the globe." This study, together with longer term Phase III European clinical data in over 800 patients, form part of the clinical dataset that has been submitted to a Reference Member State in the European Union (EU) Mutual Recognition Procedure. These regulatory authorities review the data provided and determine whether the product has an appropriate safety, efficacy and quality profile to be granted an approval to market. Full details of this study and the European Phase III study will be published at a future date. Phase III clinical trials are ongoing in the U.S. and Europe and Shire plans to file a New Drug Application (NDA) with the Food and Drug Administration by the end of this year. The U.S. Phase III trial was a multicentre, randomised, dose titration, parallel group study, that enrolled 163 end stage renal disease (ESRD) patients. Only those patients whose phosphate levels reached 5.9mg/dL or above during the no treatment ‘washout phase” were entered into the open label, six-week dose-titration phase of the study. All 126 patients entered into this phase received active treatment with lanthanum carbonate. Each patient was individually dose titrated up to the optimal dose of lanthanum required to reduce their serum phosphate to below 5.9mg/dL using five pre-defined dose levels (375, 750, 1500, 2250 and 3000mg daily). Patients were then randomised to receive either lanthanum carbonate or placebo for a four-week maintenance treatment. The primary objective of the study was to assess the maintenance and control of serum phosphate levels with lanthanum carbonate treatment compared to placebo. The secondary objectives were to assess the effect of dose titration on serum phosphate, calcium-phosphate product (PO4 x Ca++), serum calcium levels and the effect of lanthanum carbonate on parathyroid hormone (PTH). These biochemical measures are all well-established parameters for assessing and monitoring patients with chronic renal failure and may contribute to body and blood vessel calcification. At the end of the four-week randomised treatment phase (the study endpoint) 59 percent of patients treated with lanthanum carbonate compared with only 23 percent of patients treated with placebo had achieved a U.S. clinically acceptable blood phosphate level of below 5.9mg/dL. The difference of 36 percent between the lanthanum and placebo patients was highly statistically significant (p equals 0.0011). Less than 2 percent of the adverse events recorded were categorised as "related to study drug". SOURCE: AnorMED Inc.
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