Is there future shortage?
Thursday March 7, 8:49 am Eastern Time
Press Release
SOURCE: Genzyme General
Genzyme General Reports 2001 Earnings at High End of Guidance
Business Update
The strong performance of Renagel® (sevelamer hydrochloride) continued in the fourth quarter, with revenues more than doubling compared to the fourth quarter a year ago, rising to $55.6 million from $23.9 million. For the year, Renagel sales more than tripled, increasing to $176.9 million from $55.9 million in 2000. Renagel is used to reduce serum phosphorus levels in patients with end-stage renal disease on hemodialysis.
A total of approximately 200,000 prescriptions were written for Renagel in the United States during the fourth quarter, up 8 percent from the third quarter and 63 percent from the same quarter of 2000. The total number of prescriptions covers both retail sales reported by IMS and sales to hospitals and other non-retail outlets. Prescription growth remained strong to start this year, with the total number of Renagel prescriptions in January up 8 percent from December and up 48 percent from the same month last year. Revenues per prescription continue to increase as the product mix shifts toward the 800 mg tablet.
Renagel's growth this year is expected to be supported by a number of significant events, including the publication of Genzyme's Treat-to-Goal study, the release of draft National Kidney Foundation guidelines on bone and mineral metabolism, the expanded introduction of Renagel tablets in Europe, reimbursement approval for Renagel in Brazil, and sales force expansion in the United States and international markets. Product sales for 2002 are expected to reach $260-$280 million, and Genzyme's goal is to manage U.S. wholesaler levels during the year to approximately 4 to 6 weeks.
Genzyme is making good progress toward expanding and diversifying its manufacturing infrastructure for Renagel. It is in the process of qualifying a second tableting line at its existing contract manufacturer and is qualifying a backup contract manufacturer. Genzyme is also well underway with construction of a new tableting facility in Waterford, Ireland. Qualifying runs are expected to begin in Waterford during the second half of this year, with regulatory approval anticipated in the first half of next year. In addition, Genzyme is conducting qualifying production runs of sevelamer-the principal ingredient of Renagel-at the first of two new large-scale manufacturing plants in Haverhill, United Kingdom. Regulatory approval of the new plant is expected during the second half of this year. |
