EMEA approves Renagel production at Genzyme's Irish plant

The European Medicines Evaluation Agency (EMEA) has approved the production of Renagel (sevelamer hydrochloride) tablets at Genzyme's new cGMP manufacturing facility in Waterford, Ireland.

The facility is a cornerstone in Genzyme's programme to expand manufacturing capacity to support the world-wide growth of Renagel, a non-absorbed, calcium-free, metal-free phosphate binder for patients with end-stage renal disease who are on hemodialysis.

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 US FDA approval around the middle of this year.

The company also expects mid-year approval from European and US regulatory authorities of the first of two new manufacturing plants in Haverhill in the UK, which will produce sevelamer hydrochloride in bulk. On completion, the Haverhill expansion will result in a fivefold increase in 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 UK, will enable us to assume greater control over product supply and will lead to improved product margins.'