The European Commission has granted marketing authorization for AMAG Pharmaceuticals' intravenous iron therapy, ferumoxytol, to treat iron deficiency anemia (IDA) in chronic kidney disease (CKD) patients.
The marketing authorization is valid in the current European Union Member States as well as in Iceland and Norway.
AMAG president and chief executive officer William Heiden said the company has four significant organic growth opportunities for ferumoxytol, continued share gains in the US CKD IDA market, international launches and market penetration, label expansion in the US and abroad, and overall IV iron market expansion.
"Through Takeda's efforts, patients outside the US with CKD will soon benefit from a new therapy to treat their IDA," Heiden added.
AMAG's partner in Europe, Takeda Pharmaceutical Company Limited, is expected to launch ferumoxytol in Europe under the brand name Rienso in 2012.
With EU marketing authorization, AMAG will earn a $15m milestone payment from Takeda and the first commercial sale of the product will trigger another $15m milestone payment.
AMAG is also eligible to receive tiered, double-digit royalties on sales of Rienso in the licensed territories.
In June 2009, Ferumoxytol was approved for the same indication in the US under the brand name Feraheme.
