Genzyme to resubmit Lumizyme BLA

Genzyme Corp. (NASDAQ:GENZ) said it expects to resubmit a BLA for Lumizyme alglucosidase alfa for Pompe's disease by year end, seeking approval of the product produced at the 4,000L bioreactor scale at its facility in Geel, Belgium. In November, FDA issued a complete response letter for a BLA for Lumizyme produced at the 2,000L scale in Allston, Mass., citing deficiencies at the Allston facility, which stopped making Lumizyme following a vesivirus contamination in June. Genzyme had hoped to seek approval of the 4,000L product as an sBLA following approval of the 2,000L product. In the U.S., 160L alglucosidase alfa is known as Myozyme; all production volumes are called Myozyme elsewhere (See BioCentury, Nov. 16, 2009). ...