AMAG Pharmaceuticals (AMAG)

[surf1944]

9:33AM AMAG Pharma announces a positive CHMP opinion for the approval of ferumoxytol in Europe for the treatment of iron deficiency anemia in adult patients with chronic kidney disease (AMAG) 15.44 +0.18 : Co announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the approval of ferumoxytol, an intravenous (IV) iron therapy, for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD). In the European Union, ferumoxytol will be marketed as Rienso by AMAG's partner, Takeda Pharmaceutical Company Limited. European approval and the subsequent first commercial sale of ferumoxytol in Europe would trigger $30 mln in milestone payments to AMAG from Takeda. Additionally, AMAG is entitled to receive tiered, double-digit royalties on sales of ferumoxytol in licensed territories. Upon EU Commission approval, Takeda is planning to launch Rienso in the second half of 2012.