Genzyme Corporation’s (GENZ) Lumizyme failed to receive approval from the US Food and Drug Administration (FDA) for the treatment of Pompe disease. The FDA issued a complete response letter (CRL) stating that the agency will not grant approval unless the company addresses the manufacturing issues at its Allston Landing plant in Boston.
Genzyme said that it believes that other elements like the Risk Evaluation and Mitigation Strategy (REMS), product label and post-marketing requirements, have been satisfactorily addressed.
The FDA’s response on Lumizyme does not come as a surprise. The news regarding the delay in Lumizyme’s approval follows a recent announcement regarding the detection of contamination in vials of five drugs marketed by the company.
The agency completed its inspection of the company’s plant last week and has provided Genzyme with a list related to the manufacturing deficiencies found at the plant. The company stated that the deficiencies were mostly related to the fill/finish capabilities at the plant.
Genzyme intends to address these issues by taking measures like the establishment of additional internal controls, updating of fill/finish capabilities, transferring of additional filling activities to contract manufacturers, and the utilization of excess capacity at Genzyme’s manufacturing facility in Waterford, Ireland. The company intends to fill its lead product, Cerezyme, at the Waterford facility going forward.
Meanwhile, Genzyme announced that it remains on track to resume supply of new lots of Cerezyme and Fabrazyme. While new shipments of Cerezyme are scheduled to commence later this month, Fabrazyme should be shipped from late December. Additional details regarding the dose and timing of Cerezyme re-supply will be provided.
We currently have an Underperform rating on Genzyme. We expect investor focus to remain on the resolution of the manufacturing deficiencies observed by the FDA and the resumption of supply of new lots of Cerezyme and Fabrazyme.
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