Myozyme/Lumizyme Production Completely Moved to Geel, BelgiumMyozyme/Lumizyme Production Completely Moved to Geel, Belgium
October 21, 2009
In a press release Genzyme reports third-quarter financial results, and gives updates on the production at Allston Manufacturing Facility and on the Myozyme®/Lumizyme™ production at Geel, Belgium.
The third-quarter revenue dropped by 8.6% compared to the same period a year ago and 13.8% compared to the second quarter of this year, caused by the temporary interruption in production of Cerezyme® and Fabrazyme® at the Allston facility. The net income in Q3/2009 dropped 86.6% compared to Q3/2008.
Genzyme reports that the production of Cerezyme and Fabrazyme was re-started in all six bioreactors at Allston. The production of Myozyme®/Lumizyme™ was transitioned to the factory in Geel, Belgium. A third 4000 L bioreactor is being added to increase the manufacturing capacity for Myozyme. U.S. patients will be transitioned from the product produced at the 2000 L scale (in Allston) to that produced at the 4000 L scale (in Geel). If FDA approves the 2000 L Lumizyme product, Genzyme plans to file for approval for the 4000 L process as well, which would enable commercial access to the treatment for all U.S. patients starting earliest in Q2/2010.
The number of patients on enzyme replacement therapy using Myozyme is increasing since the supply constraint from early 2009 ended: about 100 new patients in Europe alone, as Henri Termeer (Chairman, President and CEO of Genzyme Corporation) mentions in the Genzyme Corporation Q3 2009 Earnings Call Transcript on October 21, 2009. The production capacity in Geel (3 bioreactors) is sufficient for around 3000 patients - enough to meet the demand exceeding the 1100 to 1200 patients being worldwide on therapy now.