Genzyme expanding U.S. plant opened last year

Genzyme's Framingham, MA, plant came to the rescue last year. It allowed Sanofi's biotech subsidiary to get solidly back in the game of supplying its rare-disease drug Fabrazyme that had been in short supply after viral contamination forced the closure of another facility in 2009. Now, the drugmaker intends to invest $80 million in downstream processing at the facility as sales of its Fabry disease drug have soared.

The company said it will erect the new facility next to the site where it does the cell culture manufacturing for Fabrazyme. The new processing facility will allow it to purify more of the material harvested from the cell culture manufacturing process to meet anticipated demand for the drug. Fabrazyme sales have rocketed as the drugmaker sold into pent-up demand hitting €292 million ($395.1 million) last year, up 96.4%. They were €91 million ($123.1 million) in the second quarter.

"Following last year's regulatory approvals of our manufacturing facility in Framingham and a new vial filling line at our plant in Waterford, Ireland, we continue to execute on our global manufacturing strategy, enhancing our capabilities across the entire manufacturing process for Fabrazyme," said Genzyme CEO David Meeker. He said the company's "focus also remains on the future needs of the global Fabry community."

Shortages of Fabrazyme started in 2009, when viral contamination was found at a Genzyme plant in Allston, MA, where Fabrazyme and Genzyme's Gaucher disease drug Cerezyme were made and where the fill/finish work on its thyroid drug, Thyrogen, was done. The quality problems led to investor dissatisfaction for Genzyme. As it scrambled to clean up the facility, it drew buyout interest from Sanofi ($SNY), which promised that its manufacturing expertise was what Genzyme needed. That led to a $20.1 billion deal and the move to build the new plant in Framingham.  

Fabrazyme is an infusion product, and Genzyme handles the fill and finish work for it at a plant in Waterford, Ireland. In 2011, Sanofi poured €150 million ($200.4 million) into the Waterford plant, doubling capacity so it could fill and finish Genzyme drugs there after the Allston plant closed. The company said this year it would invest another €44 million ($59 million) in the Waterford facility to equip it to manufacture Lantus, its world-leading, long-acting insulin.

- here's the announcement

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