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Print Edition StoriesThursday, March 25, 2010
Shire data shows switch from Genzyme drug to be safe
By Mass High Tech staff
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Shire plc is reporting data the company says proves it is safe to switch to the company’s newly approved drug to treat Gaucher’s disease, from a better-known rival produced by Genzyme Corp.
The release of the data comes as Cambridge-based Genzyme is hit with an FDA enforcement action over the plant that produces its Gaucher drug, Cerezyme.
There has been a shortage of Cerezyme since Genzyme temporarily closed the Allston plan over the summer, after the discovery of a virus in the manufacturing process.
UK-based Shire’s competing therapy, now called VPRIV, was fast-tracked by regulators and given approval by the U.S. Food and Drug Administration due to the shortage of Cerezyme,
Shire officials said a Phase 3 study showed that when patients switched to VPRIV from Cerezyme, in the same dosage, several key health indicators remained the same.
Gaucher disease affects one in every 50,000 people. It causes enlargement of the spleen and liver, among other symptoms and can be fatal.
U.K.-based Shire manufactures VPRIV in Cambridge and has its Human Genetic Therapies division headquartered in Cambridge and Lexington.
The company stands to benefit further from Genzyme’s troubles. In February, analysts said a second Shire drug target, for Fabry disease, is all but certain to be fast-tracked by the FDA, too.
Genzyme’s existing Fabry treatment also was affected by its Allston-plant troubles.
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