Continued Genzyme Problems Offer Gaucher Opportunity To Competitors
Genzyme's Allston Landing, Mass., plant - currently the only facility that produces its Cerezyme and Fabrazyme drugs - resumed working at full capacity on Aug. 28. But it seems the big biotech's manu-facturing woes are far from over: a mid-August visit by the European Medicines Agency found deficiencies, and a critical FDA inspection is still to come
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Vimizim post-marketing requirements could help FDA better understand the clinical significance of anti-drug antibodies commonly seen with enzyme replacement therapies for lysosomal storage diseases and the risks of tolerance induction therapy to manage immunogenicity.
Troubled by viral contamination problems at its enzyme-replacement therapy manufacturing site, Genzyme maintains full-scale production will resume by first-quarter 2010.
As summer turns to fall, Genzyme is trying to place the viral contamination problems at its Allston Landing, Mass., plant in the rear-view mirror. Both Cerezyme and Fabrazyme are back in production after a July shutdown that caused shortages of the two drugs. Cerezyme is the only approved therapy for Gaucher disease, while Fabrazyme is the only U.S.-approved drug for Fabry disease.