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April 21, 2010

Genzyme Loses $115M In Q1 On FDA Fine

Genzyme Corp. reported a $114.9 million loss for the first quarter after the U.S. Food and Drug Administration demanded a $175 million payment related to difficulties at the company's Allston manufacturing plant.

Genzyme, which is based in Cambridge and has significant operations in MetroWest, said it brought in revenue of $1.07 billion during the quarter compared to $1.15 billion a year earlier.

In the first quarter of 2009, the company made a profit of $195.5 million.

The FDA's consent decree demands an "upfront disgorgement of past profits of $175 million," the company said. The consent decree is being negotiated, Genzyme said, but "because of this likely outcome," the company booked the expense in the first quarter.

The biotech and pharmaceuticals company said it and the FDA are negotiating a possible move of "fill/finish" operations from the Allston plant. The plant manufactures the drugs Cerezyme and Fabrazyme.

The plant ceased operations last year after a virus was detected there during an inspection.

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