Genzyme Flops at FDA: Allston Plant Problems Delay Drug Review [Boston Herald]
Boston Herald (MA) - Nov. 17, 2009
Nov. 17--The U.S. Food and Drug Administration is holding off on its review of Lumizyme, a treatment for the rare muscular disorder Pompe disease, until drug maker Genzyme Corp. resolves manufacturing problems at its Allston plant.
The Cambridge biotechnology firm said it is adding new internal controls, updating its finish/fill capabilities, which is the final stage in the manufacturing process, and outsourcing activities to other sites, including Waterford, Ireland.
"We're taking a very comprehensive approach to the recently reported problems," Henri Termeer, Genzyme's chairman and chief executive, said during a conference call yesterday.
Last week, after a five-week review of the Allston plant, the FDA reported that pieces of steel, rubber and fiber were found in five Genzyme drugs made there. Those drugs are Cerezyme, a treatment for Gaucher disease; Fabrazyme, for Fabry disease; Myozyme, which treats Pompe disease; Aldurazyme, for mucopolysaccharidosis, a metabolic disorder; and Thyrogen, for thyroid cancer.
The report came about five months after an unrelated virus was discovered in some tanks at the same Allston facility. Genzyme's temporary shutdown of that facilty led to worldwide shortages of Cerezyme and Fabrazyme.
Termeer said problems related to the fill/finish line "reflect the age of the equipment," some of which dates back to 1984.
Genzyme's $4.6 billion in annual revenue comes in large part from making drugs to treat rare diseases.
Despite the negative news from the FDA, investors were apparently happy to hear that Genzyme expects to start shipping Cerezyme and Fabrazyme by the end of the year. The company's shares edged up 21 cents to $49.49 yesterday.
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Posted: November 2009