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| |  FDA Approves Renagel Tablets (Sevelamer Hydrochloride) For Hemodialysis Patients CAMBRIDGE and WALTHAM, MA -- July 13, 2000 -- Genzyme General and GelTex Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Renagel® Tablets (sevelamer hydrochloride) in 800 mg and 400 mg dosages for the reduction of serum phosphorus in hemodialysis patients with end-stage renal disease. Renagel is currently available in a 403 mg capsule form. The new tablet formulation of Renagel will provide physicians with two new dosing options to more easily manage patients into the normal serum phosphorus range. The 400 mg tablet is much smaller than the current capsule, while the 800 mg tablet can be used by physicians to manage patients who may need higher dosages but have been reluctant to take the required number of pills. "The introduction of Renagel Capsules twenty months ago represented a significant advance in the control of serum phosphorus for the dialysis patient population," said Christi van Heek, president of Genzyme General's therapeutics business. "The introduction of a new tablet formulation of Renagel continues Genzyme's commitment to improving the treatment of end-stage renal disease." Mark Skaletsky, chairman and chief executive officer of GelTex Pharmaceuticals, said: "We are pleased to be able to bring this new form of our effective phosphate binder to physicians to help their dialysis patients. We expect a rapid adoption of these tablets when they become available to physicians later this year." Patients on dialysis are at high risk of having dangerously elevated phosphorus and calcium levels. If left untreated, elevated blood phosphorus levels can lead to a number of serious conditions, including cardiac and other soft tissue calcifications, renal bone disease, and death. Renagel, marketed by Genzyme under a joint venture with GelTex, is designed to bind and remove dietary phosphorus in the gastrointestinal tract and eliminate phosphorus through normal digestive processes. One of the major benefits of Renagel is that it does not contain calcium. The number of patients undergoing dialysis for end-stage renal disease is estimated to be 280,000 in the United States and 170,000 in Europe. These numbers are increasing by 7-8 percent annually. Renagel was introduced in the United States in late 1998, and is also available in Europe, Canada, and Israel. Genzyme filed for European marketing approval of Renagel Tablets during the first quarter of this year and expects to file in Canada during the third quarter of this year. Renagel is indicated for the reduction of serum phosphorus in patients with end-stage renal disease on hemodialysis. Renagel is contraindicated in patients with hypophosphatemia or bowel obstruction. The drug should be used with caution in patients with swallowing or severe gastrointestinal motility disorders or major GI surgery. In a placebo-controlled study, adverse events were similar to placebo. The most common treatment-emergent adverse events in a Phase 3 crossover study were not dose related and included diarrhea, infection, and pain. Related Links: Renagel Tablets (sevelamer hydrochloride), Genzyme General and GelTex Pharmaceuticals Inc.
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