Genzyme Corp. announced that the European Medicines Evaluation Agency has approved the production of Renagel (sevelamer hydrochloride) tablets at the company's new cGMP manufacturing facility in Waterford, Ireland. The facility is a cornerstone in Genzyme's program to expand manufacturing capacity to support the worldwide growth of Renagel, a phosphate binder for patients with end-stage renal disease who are on hemodialysis.

Renagel is marketed by the Genzyme General division of the corporation. It is the only non-absorbed, calcium-free, metal-free phosphate binder available to patients.

Genzyme is now cleared to begin shipping Renagel tablets produced in Waterford to supply the European market. The facility was approved by the Irish Medicines Board in December 2002 and is expected to gain U.S. Food and Drug Administration approval around the middle of this year.

Genzyme also expects mid-year approval from European and U.S. regulatory authorities of the first of two new manufacturing plants in Haverhill, United Kingdom, built for bulk production of sevelamer hydrochloride, the primary active ingredient in Renagel. Upon completion of both plants, the Haverhill expansion will result in a fivefold increase in sevelamer production capacity at the site. Genzyme expects to continue to use several contract manufacturers as additional supply sources for sevelamer hydrochloride and Renagel formulations.

"Our investment in Waterford signals our confidence in the long-term outlook for Renagel," said Mark Bamforth, Genzyme's senior vice president for corporate operations. "This facility, and our new plants in the U.K., will enable us to assume greater control over product supply and will lead to improved product margins. We are thankful to all those whose commitment to the project has led to this approval, which has come right on schedule."