Genzyme revives Fabrazyme with EMA plant OK

Genzyme flexed some market muscle Wednesday when it announced the European Medicines Agency's approval of a new U.S. facility for production of Fabrazyme. Perhaps most immediately affected by the approval is U.K.-based Shire, whose Replagal competes with Fabrazyme for the treatment of the genetic disorder Fabry disease.

Replagal enjoyed pre-approval availability and then fast-track status from the FDA because of the Fabrazyme supply shortage that followed Genzyme shutting down an ailing Boston-area manufacturing facility.

The new plant in Framingham, about 20 miles west of the unit's Cambridge, MA, headquarters, is taking over the Fabrazyme assignment from that Boston plant. In addition to Fabrazyme, the plant produced Gaucher disease treatment Cerezyme. Equipment in the Boston facility suffered a viral contamination in 2009; Genzyme entered a consent decree with the FDA in 2010.

The Framingham plant approval is an "important milestone in our manufacturing recovery," Genzyme CEO David Meeker said in a company statement. Approval of the Framingham plant for Fabrazyme will free up production capacity in Boston for Cerezyme.

The approval appeared to have a noticeable effect on Shire, whose shares dropped about 35 cents, according to The Guardian. One analyst wrote the approval "should result in significant head-winds for the company's Replagal franchise. We reiterate our sell recommendation." 

Genzyme, a unit of Sanofi ($SNY), advised in the release that additional regulatory approvals remain and normal worldwide supply levels of Fabrazyme will become available only after the approvals and a period of production lead time are complete. The company expects the approvals to occur throughout the year, according to the Worcester Business Journal.

- here's the release
- see the WBJ story
- here's a Boston Globe article
- here's more from Mass High Tech
and The Guardian story

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