Genzyme plant approval marks GMP comeback

The Genzyme unit of Sanofi ($SNY) announced today that it has won FDA approval for its new Framingham, MA, facility, the new production home of Fabry disease drug Fabrazyme. The plant won European approval last week.

Genzyme CEO David Meeker noted his satisfaction with the company's manufacturing recovery in the announcement. The approval keeps Genzyme on track with its 2012 plan "to restore unconstrained [Fabrazyme] supply for all patients globally throughout the course of the year," he said in a statement.

Genzyme has been fighting its way back to full production of drugs Fabrazyme and Cerezyme since 2008, when a fall inspection by the FDA at its Boston-area plant where the drugs are made yielded Warning Letter NWE-08-09W, issued in February 2009. Additional difficulties followed, including the June 2009 shutdown of the plant due to viral contamination.

Genzyme entered a consent decree with the FDA in May 2010. Remediation began at the Boston plant as work proceeded on construction of the Framingham plant.

The company beat the November 2010 deadline of its first consent decree commitment by removing some fill/finish operations from the plant. The work was sent to contractors and other Genzyme facilities. Genzyme had reorganized manufacturing operations and brought in new leadership.

Remediation continued even as the company was pursued and then acquired by Sanofi last year. The deal included milestone payments based on completion of remediation milestones.

- see the release
- here's more from Reuters

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