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| |  Europe Approves Renagel Capsules For Hyperphosphatemia In Hemodialysis CAMBRIDGE, MA -- February 4, 2000 --Genzyme General and GelTex Pharmaceuticals, Inc. announced that the European Commission has granted marketing approval in Europe for Renagel® Capsules for the control of hyperphosphatemia in adult patients on hemodialysis. Marketing authorization for Renagel is valid in the 15 member states of the European Union. Renagel received marketing approval in the United States in October 1998 and is being commercialized through a joint venture between Genzyme General and GelTex. Renagel also received marketing approval in Israel in September 1999. During 2000, the joint venture plans to launch Renagel on a country-by- country basis, following pricing and reimbursement approvals. The joint venture expects to begin the introduction of Renagel in Germany, the United Kingdom, Sweden, Ireland, and Denmark in the first quarter of 2000. Introduction in Italy and France will begin later in the year. Genzyme intends to build a dedicated 20-person sales team to support this effort. "Receiving approval for Renagel in Europe allows us to expand into new markets for this product," said Henri A. Termeer, chairman and chief executive officer of Genzyme Corp. "Genzyme has a track record of successful product introductions in Europe by our experienced European medical, clinical, regulatory team, and our highly respected sales and marketing organization. We anticipate that Renagel sales in Europe will build on the exciting results we have achieved in the United States." The number of total prescriptions for Renagel continues to rise steadily, reflecting the product's growing acceptance in the health care marketplace. For 1999, approximately 145,000 prescriptions were written for Renagel, and an estimated 30,000 patients in the United States are currently taking the product. Revenues from Renagel sales in the United States in 1999 were approximately $20 million. 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 soft tissue and vascular calcifications, renal bone disease, and death. The number of patients undergoing dialysis for end-stage renal disease is an estimated 280,000 in the United States, and 170,000 in Europe. Renagel is used to control serum phosphorous levels without adding calcium in patients on dialysis. Elevated serum phosphorous and calcium levels have been correlated with increased morbidity and mortality in these patients. Renagel is contraindicated in patients with hypophosphatemia or bowel obstruction. In a placebo-controlled study, there were no differences between Renagel Capsules and placebo for any adverse event. In a crossover study comparing Renagel with calcium acetate, the adverse events reported for Renagel Capsules were similar to those reported for calcium acetate. Related links: RenaGel, Genzyme General and GelTex, Pharmaceuticals Inc.
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