ARTICLE | Top Story

Genzyme falls as FDA takes action

March 25, 2010 12:47 AM UTC

Genzyme Corp. (NASDAQ:GENZ) fell $3.77 to $55.33 on Wednesday after FDA verbally informed the company of plans to take enforcement action at its Allston, Mass., manufacturing plant. Genzyme said it expects that the action will result in a Consent Decree, which the company said could include inspection costs, fines on past and future sales of products, and expenses related to a third-party quality assurance firm that would oversee the plant. FDA will negotiate with Genzyme over the next month to determine the exact terms of the enforcement action.

Genzyme said it expects shipments of Cerezyme imiglucerase for Gaucher's disease, Fabrazyme agalsidase beta for Fabry's disease and Myozyme alglucosidase alfa for Pompe's disease to continue due to their medical necessity. Genzyme said it does not expect FDA's action to affect the ongoing review of Lumizyme alglucosidase alfa, the 4,000L version of Myozyme that the company produces in Belgium. Lumizyme's PDUFA date is June 17. The company also said that its new plant in Framingham, Mass., remains on track for approval in late 2011. ...