During June 2009, Genzyme announced the presence of a virus that impairs cell growth in a bioreactor used for Cerezyme production at its Allston facility, which resulted in a temporary interruption of production from the facility that produces Cerezyme, Fabrazyme and Myozyme for sanitization. All Myozyme/Lumizyme (alglucosidase alfa) production will occur at the company's 4,000 L scale facility in Belgium. Genzyme The sanitization of the facility has been completed and production of Fabrazyme (agalsidase beta) and Cerezyme (imiglucerase for injection) has resumed.

The Company also reported that FDA approval of the 4,000 L process, which is now expected during 1Q10, will be necessary to expand supply and support an increase in U.S. sales. GENZ will begin to transition U.S. patients in the Myozyme Temporary Access Program from the product produced at the 2,000 L scale to that produced at the 4,000 L scale and will be providing 4,000 L data to the FDA to support this transition. The PDUFA date for Lumizyme (the 2,000 L product) is 11/14/09. Upon approval, Genzyme will submit a supplemental BLA (sBLA) for the 4,000 L process, and the Company anticipates a four-month FDA review of the sBLA, and if the FDA acts by the PDUFA date, a potential approval by the end of March 2010.

Genzyme announced it is preparing to begin enrollment in two global, multi-center, phase 3 trials of GENZ-112638, a potential new oral therapy for Gaucher disease type 1 as a follow-on product to succeed the intravenously (IV) infused Cerezyme (which posted $1.2 billion in sales during 2008). The first, a randomized, double-blind, placebo-controlled study, will include untreated Gaucher disease patients. It is expected to enroll 36 patients who will be treated for 9 months. The second trial will be a randomized conversion study involving patients who have previously received Cerezyme, with an anticipated enrollment of approximately 96 patients and a 9-month treatment period. Genzyme is seeking to accelerate the regulatory process for this product globally in order to speed its approval.

On 7/31/09, Genzyme announced that the FDA will re-inspect the company's Allston Landing manufacturing facility. The re-inspection is a follow-up to an inspection the agency conducted in May 2009 and is intended to verify that all corrective and preventative actions identified in a February warning letter have been implemented. In its letter to Genzyme, the Agency indicated that all promised actions had not been either fully or adequately implemented at the time of the May inspection.