Business News In Brief

Shire's velaglucerase approved: FDA's clearance of Shire's VPRIV (velaglucerase) on Feb. 26 adds a second approved therapy for Gaucher disease, a rare lysosomal storage disorder, to the U.S. market. The action comes at a key time as Genzyme's Cerezyme, the first drug approved for Gaucher, has been in short supply since Genzyme's primary manufacturing facility was shut down for six weeks last summer due to viral contamination. Velaglucerase and Protalix's telaglucerase (Uplyso, now partnered with Pfizer) have been available under emergency use authorization and accepted for accelerated review. VPRIV's safety and efficacy were evaluated based on three clinical trials involving 82 Gaucher patients, including some who switched over from Cerezyme. In announcing the approval, FDA noted that patients who previously received Cerezyme could switch safely to Shire's product. Shire also is seeking approval for velaglucerase in Europe, where its marketing authorization application has been accepted under accelerated assessment (1"The Pink Sheet" DAILY, Feb. 19, 2010)