Genzyme metabolic news
Genzyme will move the manufacturing of alglucosidase alfa to its 4,000-liter scale facility in Belgium from its 2,000-liter scale facility in Allston, Mass. The Allston facility, which closed in June due to viral contamination, will make only Cerezyme imiglucerase to treat Type I Gaucher's disease and Fabrazyme agalsidase beta to treat Fabry's disease when it reopens this month.
Myozyme alglucosidase alfa, produced at the 4,000-liter scale, is approved in the EU to treat Pompe's disease but will require new approval in the U.S., where only product made at the 160-liter scale is approved. The name Lumizyme is used in the U.S. for product made at the 2,000-liter scale. Lumizyme has a Nov. 14 PDUFA date. Following approval of Lumizyme, Genzyme plans to submit an sBLA for the 4,000-liter scale product, which the company says could be approved by March 2010. Myozyme is a recombinant human acid alpha-glucosidase enzyme ( rhGAA) (see BioCentury, June 22). ...