Volatilitydue to effect the FDA inquiries will ultimately have on near term pipeline
Genzyme stock dropped for two reaons. First, the stock dropped along with the broader Biotech market because Obama's budget proposed a regulatory pathway for generic biologics. Previously, there was no mechanism for generic biologic drugs to be approved - which meant companies like Amgen don't face generic competition. But Obama's budget proposes to change that.Second, Genzyme announced on March 2nd the FDA would not approve Lumizyme, a Genzyme product to treat a rare genetic disorder called Pompe disease
The beginning of a series of inquiries made by the FDA regarding one of the plants compliance record.
FDA finds one of GENZ plants not in compliance.
Global Financial Crisis
Genzyme announced on Thursday, July 5th that its osteoarthritis drug hylastan failed to provide better pain relief over commonly used steroids. On Friday, July 6th, results from a Phase III clinical trial showed that Genzyme's diarrhea drug tolevamer was no more effective than standard antibiotic treatments.
In its first quarter report, Genzyme showed revenue growth of 21% since the same quarter last year. This
Genzyme announced better-than-expected results for the 2006 fiscal year. Revenue rose 17% from 2005 on