European Authorities Approve Larger-Scale Production of Genzyme’s Myozyme
Genzyme Corporation announced that the European Commission has approved the production of Myozyme® (alglucosidase alfa) at the 4000 liter (L) bioreactor scale at its manufacturing facility in Geel, Belgium. The product will be made commercially available immediately. Myozyme is the only approved treatment for Pompe disease, a progressively debilitating and often fatal inherited disorder.
During January and February, there was widespread adult patient compliance with the request to adjust infusion schedules to preserve product supply for infants and children. With this approval, the availability of product supply will now enable adult patients internationally to resume regular infusion schedules, and will allow new patients to initiate therapy. Sales are expected to accelerate starting in the second quarter and continue to increase throughout the second half of the year. Genzyme expects Myozyme sales for the first quarter of 2009 to be similar to the fourth quarter of 2008.
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