Shire withdraws Replagal BLA

Shire plc (LSE:SHP; NASDAQ:SHPGY) disclosed in its 2Q10 financial results that it withdrew a rolling BLA for Replagal agalsidase alfa to treat Fabry's disease. On a conference call, Shire said the prolonged shortage of Fabrazyme agalsidase beta from Genzyme Corp. (NASDAQ:GENZ) will allow Shire to gather additional data to enhance the clinical portion of the application and obtain a potentially better label. Shire is already providing access to the injectable alpha-galactosidase A (Alpha-gal A) enzyme in the U.S. under a treatment protocol. Fabrazyme has faced supply shortages since June 2009 due to viral contamination and other problems at Genzyme's Allston, Mass., facility.

Shire reported 2Q10 non-GAAP diluted earnings per ADS of $1.03, beating by $0.15 the Street's estimate of $0.88 and up 72% from $0.60 in 2Q09. Second quarter revenues were $849 million, an increase of 35% from $630 million in 2Q09 and above the Street's estimate of $809.6 million. ...