Genzyme Corp announced that U.S. and European regulatory authorities have approved the first of two new manufacturing plants in Haverhill, United Kingdom. Both are built for bulk production of sevelamer hydrocholoride, the primary active ingredient in the Renagel phosphate binder product for patients with end-stage renal disease who are on hemodialysis.
The U.S. Food and Drug Administration and European Medicines Evaluation Agency approved Genzyme's new cGMP manufacturing facility which will provide increased capacity to support the growth of Renagel. The product is the only non-absorbed, calcium-free, metal-free phosphate binder available to patients.
Genzyme expects this new U.K. plant to eventually produce more than 200 tons of bulk sevelamer. The second plant, which is in the final stage of qualification, is even larger, with a design capacity of more than 300 tons of sevelamer. The combined output of these plants, a fivefold increase over current in-house levels, is expected to be sufficient to supply Renagel patients worldwide well into the future.
"Completion of this first step in the expansion of our U.K. manufacturing program underscores our long-term commitment to Renagel," said Mark Bamforth, Genzyme's senior vice president for corporate operations. "It enables us to assume greater control over product supply to meet the growing demand for Renagel, and will lead to improved product margins. We are thankful to all of our employees and to the outside organizations whose commitment to the design, construction and qualification of these plants has led to these important approvals."
Product from the U.K. will be shipped to Genzyme's tableting facility in Waterford, Ireland, which is designed to supply Renagel to markets around the world. Genzyme expects to obtain FDA approval of the tableting facility during the second half of 2003, following approval by the EMEA last March.