Genzyme Corp has been struggling through the roughest patch ever and informed on Monday that regulators have refused to approve its drug for the treatment of Pompe disease until the manufacturing deficiencies are addressed at its Allston Landing plant in Boston.
 
The agency’s announcement last week followed by the ruling by the U.S. Food and Drug Administration that it has discovered foreign particles like steel fragments and non-latex rubber in vials of several Genzyme products which include top-selling Gaucher disease treatment Cerezyme.
 
Executives from Genzyme have informed that the company has shut down the section of its Allston plant which handles vial filling and finishing along with fixing the problem. The company also added that the antiquated machinery was shedding metal fragments.
 
Genzyme said that it is establishing additional internal controls in the fill/finish area in addition to transferring additional filling activities to contract manufacturers and utilizing excess capacity at Genzyme’s facility in Waterford, Ireland.
 
The company assured that no delay will be caused in the shipments of Cerezyme due to any interruption in the fill/finish area though the shipment of Fabrazyme might get affected slightly.
 
Genzyme still hopes to ship new batches of both the drugs by the end of the year. This assurance caused the company’s shares to rise 0.6% in afternoon trading.
 
The company’s Pompe disease drug which received negative ruling follows a five-week inspection of the plant. Lumizyme is the name given in the U.S. to the company’s Pompe disease drug Myozyme.
 
The company now thinks that it has fulfilled FDA’s condition for the drug such as providing a risk management program and prescribing information package.