Genzyme Corp. said that it has received Food and DrugAdministration approval to begin Phase III clinical trials of itsrecombinant beta-glucocerebrosidase enzyme for the treatmentof Gaucher disease, a genetic disorder caused by insufficientactivity of the enzyme.
The trials will compare r-GCR with the Cambridge, Mass.,company's Ceredase, which is derived from human tissue.Ceredase received FDA marketing approval in April for Type IGaucher disease. The genetically engineered version willprovide an alternative source.
Genzyme shares (NASDAQ:GENZ) closed at $46.50, up $1.50, onMonday.
Genzyme also said it will build in Massachusetts a $75 millionmanufacturing plant to produce r-GCR and Thyrogen, arecombinant human thyroid stimulating hormone. The100,000-square-foot facility is expected to begin in mid-1992and to be completed by mid-1994 and will initially employabout 200 people.
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