Genzyme Corp. (GENZ) recently announced that the US Food and Drug Administration (FDA) has assigned an action date for the company’s Biologics License Application for Lumizyme (alglucosidase alfa) for the treatment of Pompe disease. Genzyme is seeking approval for Lumizyme which has been produced at its 4000 liter-scale manufacturing plant in Geel, Belgium.
 
Earlier, Genzyme had submitted an application seeking approval for Lumizyme manufactured at its 2000 liter bioreactor scale at its Allston Landing manufacturing facility. However, the FDA issued a complete response letter in November 2009 stating it will not grant approval unless the company addresses the manufacturing issues at its Allston plant.
 
Based on subsequent discussions with the agency, Genzyme announced that it would resubmit its application and seek approval for the manufacture of the product at the Geel plant.
 
The FDA has classified the resubmission as a class 2 complete response and assigned a Prescription Drug User Fee Act (PDUFA) date of June 17, 2010. Lumizyme is available outside the US as Myozyme and is approved in about 40 countries.
 
Genzyme also announced that it has reopened enrolment of patients in its Alglucosidase Alfa Temporary Access Program (ATAP), under which severely affected adults with Pompe disease can have access to treatment prior to the commercial approval of Lumizyme. This program will remain open until Lumizyme is approved.
 
Genzyme is slated to announce full results for 2009 on Feb 17, 2010. The company recently reported preliminary revenues for the fourth quarter and full year ended December 31, 2009. With the company facing manufacturing problems since mid 2009, we were not surprised to see fourth quarter revenues decline 8% to $1.08 billion. Full year revenues declined 2% to $4.5 billion. We currently have a Neutral recommendation on the stock.
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