Genzyme advances Pompe drug application - Boston Business Journal:

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Genzyme recently received a letter from the requestingg more information before anapprovalo — which would enable it to essentially doublee its production scale — could be The company predicts that the final approval process will take less than six Genzyme’s response included clinical data that the FDA said demonstratex the clinical benefit of Also included in the submission was a risk evaluatio and mitigation strategy (RIMS) overviee as well as a final label for the Genzyme also said it addressed issues raisexd in a warning letter sent in October regardin g the production of Lumizyme at its Allston, Mass.
-based manufacturing At the time, the FDA cited problemw with equipment maintenance, among other Genzyme, based in Cambridge, said the FDA is now re-inspectintg the plant. Genzyme said in March that it would ramp downits earning-per-shares projection for 2009 to $4.58 per share, from $4.70 per due to the FDA At the time, the company said the setback wouldr delay the additional Lumizyme approvaol by six months. The company reduced its projection for the sale of the Pomps disease drugdown $60 million to somewheree between $370 million and $380 million. Patientsd with Pompe disease sometimes suffer from severemuscled weakness, or myopathy.
Genzyme’es (Nasdaq: GENZ) shares were trading at $58.22 in earlt afternoon trading Thursday, down from $59.1r4 a share at the previous day’s