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Pending Approvals Hold Major Implications For Myozyme Growth

This article was originally published in The Pink Sheet Daily

Executive Summary

Genzyme reports increasing sales for Pompe disease drug, but upcoming EU and FDA decisions could spur or stifle product’s growth.

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Genzyme Receives Complete Response, Warning Letters For Lumizyme

The hits just keep on coming for Genzyme. On a March 2 call with investors, the firm had to announce not just a "complete response" letter for its 2000-liter scale-up of Myozyme (which will be called Lumizyme for the larger production scale), but also that its Allston Landing manufacturing site had received a 483 report from FDA and a subsequent warning letter

Genzyme Receives Complete Response, Warning Letters For Lumizyme

The hits just keep on coming for Genzyme. On a March 2 call with investors, the firm had to announce not just a "complete response" letter for its 2000-liter scale-up of Myozyme (which will be called Lumizyme for the larger production scale), but also that its Allston Landing manufacturing site had received a 483 report from FDA and a subsequent warning letter

Genzyme Receives Complete Response, Warning Letters For Lumizyme

Despite receiving a “complete response” letter and manufacturing warning letter on the same day, Genzyme remains upbeat about the likelihood of approval for its 2,000L scale-up of Myozyme.

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