(RTTNews) -  Monday, Genzyme Corp. (GENZ: News ) revealed that the U.S. Food and Drug Administration has sought for resolution of deficiencies at its Allston Landing manufacturing plant, primarily related to fill/finish capabilities, before granting approval for Lumizyme, its alglucosidase alfa drug candidate for the treatment of Pompe disease. The company also revealed that Lumizyme is no longer produced at Allston, but at a larger facility in Belgium.

Lumizyme is a drug candidate related to Myozyme, which is approved only for children and infants in the U.S. and is made in 160-liter batches. Genzyme approached the FDA seeking permission to manufacture Myozyme in 2,000-liter batches to address high demand. FDA ruled that the drug belonging to the 2,000-liter batch is slightly different from the 160-liter batch, and therefore requires a new Biologics License Application.

The FDA informed the company about its latest decision through the complete response letter for its marketing application for Lumizyme. The company said the deficiencies highlighted by the FDA at Allston "were mainly related to the fill/finish capabilities at the facility."

A five-week inspection at the Allston plant was completed by the FDA on Friday, following which a Form-483 outlining remaining deficiencies was issued. In July, the FDA announced its intention to re-inspect the Allston plant citing insufficient action by the company to correct equipment maintenance and process control issues. The announcement of inspection was a followup to a warning letter issued by the FDA in February for manufacturing deficiencies.

The Allston facility was shut down for a few weeks in June following a viral contamination in one of the six bioreactors used to develop Cerezyme and Fabrazyme, the two best-selling drugs of Genzyme. Sales of the two enzyme replacements for rare genetic disorders were put on hold for more than a month following the virus detection.
Genzyme said it plans to address the deficiencies listed by FDA by establishing additional internal controls and updating fill/finish capabilities in Allston, transferring additional filling activities to existing contract manufacturers, and utilizing excess capacity at the manufacturing facility in Waterford, Ireland.

The company said its Waterford facility is undergoing expansion, with engineering runs scheduled to begin early next year. This expansion would increase Genzyme's internal filling capacity by four fold. Cerezyme 400-unit vials, which supply over 80% of patients worldwide, would be filled exclusively in Waterford going forward.

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