EMA CHMP recommends approval of AMAG’s ferumoxytol

AMAG PharmaceuticalsApr 21 2012

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today 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.    

"International expansion of ferumoxytol is an important growth opportunity for AMAG," said Frank Thomas, interim president and chief executive officer of AMAG. "Following the approval of ferumoxytol in Canada, which we received in late 2011, European approval would mark the third region where ferumoxytol would be available for the treatment of iron deficiency anemia in patients with CKD. Continued growth in our U.S. CKD business, coupled with geographic expansion and the opportunity to further expand the product's label to include all patients with IDA, would significantly enhance the growth prospects for ferumoxytol."

European approval and the subsequent first commercial sale of ferumoxytol in Europe would trigger $30 million 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.

"Iron deficiency anemia can be a debilitating condition for chronic kidney disease patients and appropriate management of this condition can carry positive clinical implications for patients. Therefore, treatment of anemia at all stages of CKD is important and the potential availability of ferumoxytol in Europe would offer an additional therapeutic option to help effectively manage this condition," said Professor Iain Macdougall ¹, consultant nephrologist and professor of clinical nephrology at King's College Hospital, London.