AMAG falls on restructuring, potential Feraheme warning

AMAG Pharmaceuticals Inc. (NASDAQ:AMAG) fell $3.39 (18%) to $15.90 on Friday after announcing headcount reductions and the possibility of a boxed warning for Feraheme ferumoxytol injection. The company and FDA are discussing potential label changes, including a boxed warning and an extension of the observation period following administration, after the IV iron replacement therapy was included in the agency's 2Q10 list of drugs it is reviewing for potential safety issues. AMAG said that as of Oct. 4 it had identified 146 cases of serious adverse events, including hypersensitivity and cardiac events. AMAG said the reporting rate is in line with the adverse event rate on the drug's label.

Third quarter sales of Feraheme were $15.1 million. AMAG said that its sales in the dialysis segment have begun to decline at a rate quicker than growth in the non-dialysis chronic kidney disease (CKD) segment. As a result, it plans to reduce headcount by 68 (24%) to save cash. The cuts are expected to save about $12 million annually. At Sept. 30, AMAG had $308 million in cash and a nine-month operating loss of $62.8 million. ...