Genzyme has initiated shipping vials of newly produced Cerezyme (imiglucerase for injection) manufactured at Allston Landing plant. The company also provided an update on its progress to restore supplies of Cerezyme and Fabrazyme (agalsidase beta) for patients.
The company said that the initial Cerezyme shipments is expected to 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.
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 experience. 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.
The company will continue to ship 30% of Fabrazyme demand during the first quarter of 2010 to ensure continued treatment for all patients and to build inventory to begin shipping 70-100% of demand in the second quarter.
The company has added that 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.
Henri Termeer, chairman and CEO of Genzyme, said: “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. 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.”