Alexion reports 2Q14 earnings, EMA to review asfotase alfa

Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) reported 2Q14 earnings that beat the Street on Thursday and separately said EMA accepted and granted accelerated assessment to an MAA for asfotase alfa to treat hypophosphatasia (HPP). The company expects to complete a rolling BLA submission for the product -- a fusion protein incorporating the catalytic domain of human tissue non-specific alkaline phosphatase ( TNSALP) and a bone-targeting peptide -- this fall. HPP is an inherited metabolic disease characterized by defective bone mineralization. An accelerated assessment shortens the review period to 150 days from 210.

Separately, Alexion reported 2Q14 non-GAAP diluted EPS of $1.12, beating the Street's $1.07 estimate and up from $0.73 in 2Q13. Sales of Soliris eculizumab, Alexion's sole marketed product, were $512.5 million, up 38% from the prior year's quarter and topping the Street's $510.3 million estimate. Soliris, a humanized mAb targeting complement 5 (C5), is approved in the U.S., EU, Japan and other countries to treat atypical hemolytic uremic syndrome (aHUS) and paroxysmal nocturnal hemoglobinuria (PNH). ...