Genzyme advances Pompe drug application - Boston Business Journal:

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Genzyme recently received a letter from the requesting more informationm before anapproval — which would enable it to essentialluy double its production scale — could be processed. The company predicts that the final approval process will take less thansix Genzyme’s response included clinical data that the FDA said demonstrates the clinicak benefit of Lumizyme. Also includexd in the submission was a risk evaluationn and mitigationstrategy (RIMS) overview as well as a final labelk for the product. Genzyme also said it addressed issues raiseed in a warning letter sent in Octobedr regarding the production of Lumizyme atits Allston, Mass.-based manufacturingh facility.
At the time, the FDA citex problems with equipment maintenance, among other concerns. based in Cambridge, said the FDA is now re-inspectin g the plant. Genzyme said in March that it woulcd ramp downits earning-per-share projection for 2009 to $4.5 8 per share, from $4.70 per share, due to the FDA At the time, the company said the setback would delay the additionalk Lumizyme approval by six The company reduced its projection for the sale of the Pompe diseased drug down $60 million to somewhere between $370 million and $380 million. Patients with Pompwe disease sometimes suffer from severemusclse weakness, or myopathy. Genzyme’s GENZ) shares were trading at $58.
22 in early afternoon trading Thursday, down from $59.14 a share at the previouz day’s close.