Lumizyme complete response cites Allston issues

Genzyme Corp. (NASDAQ:GENZ) received a complete response letter from FDA for Lumizyme alglucosidase alfa to treat Pompe's disease, citing fill/finish deficiencies at the company's manufacturing plant in Allston, Mass. Genzyme will temporarily shut down fill/finish at the plant to update equipment. The company is evaluating how the shutdown will affect shipment of new Fabrazyme agalsidase beta for Fabry's disease, saying that a shipment is still expected at the end of December and further timelines will be updated by early December. Fill/finish for Cerezyme imiglucerase for Gaucher's disease will be moved to Waterford, Ireland, allowing shipments to begin in late November as planned.

Genzyme said it will request a meeting with FDA to determine the fastest route to approval for alglucosidase alfa at the 4,000L scale -- Genzyme had planned to submit an sBLA for the 4,000L product following approval of Lumizyme, which is alglucosidase alfa produced at the 2,000L scale. Genzyme has since moved production to its 4,000L facility in Geel, Belgium. In the U.S., 160L alglucosidase alfa is known as Myozyme; all production volumes are called Myozyme elsewhere. Genzyme said it believes the risk evaluation and mitigation strategy (REMS), labeling and post-market requirements for Lumizyme have been satisfactorily addressed with FDA. ...