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Genzyme has begun shipping vials of newly produced Cerezyme manufactured at its Allston Landing plant
December 1, 2009
By: Tim Wright
Editor-in-Chief, Contract Pharma
Genzyme has begun shipping vials of newly produced Cerezyme manufactured at its Allston Landing plant. The company also provided an update on its progress to restore supplies of Cerezyme and Fabrazyme for patients worldwide. The initial Cerezyme shipments will provide uninterrupted treatment for the most vulnerable patients under the current supply conservation guidelines. By the end of this month, Genzyme will expand shipments of Cerezyme to patients worldwide who have experienced interruptions in their treatment this year. The company contends that it can meet anticipated worldwide demand and allow all patients to return to their normal infusion and dosing regimen during the first quarter of next year. Patients have been asked to contact their treating physicians for information on the timing and process to re-start their infusion program. Genzyme is also preparing to ship vials of newly produced Fabrazyme from the Allston plant. The first two bioreactor runs of Fabrazyme have completed their production cycles, and the output from these runs has been at the low end of Genzyme’s expectations. The company is currently producing Fabrazyme at a rate of approximately 70% of anticipated demand for 2010, and is intensively working to improve the productivity of Fabrazyme manufacturing. Genzyme will continue to ship 30% of Fabrazyme demand during 1Q10 to ensure continued treatment for all patients and to build inventory to begin shipping 70-100% of demand in the second quarter. The range and timing of shipments depends on restarting fill/finish for Fabrazyme at the Allston facility and on restoring the overall productivity of Fabrazyme manufacturing. Genzyme will have more information and will communicate further details about Fabrazyme supply in February 2010. “Shipping the first new product manufactured in Allston is a critical milestone in our effort to again fully meet the needs of patients with Gaucher and Fabry disease around the world,” said Henri A. Termeer, Genzyme’s chairman and chief executive officer. “We continue to work in a very intense and comprehensive way to build a world-class manufacturing program and to ensure continuous supply of these products in the future.”
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