AMAG receives Swiss marketing authorization for ferumoxytol to treat iron deficiency anemia

AMAG Pharmaceuticals, Inc.Sep 6 2012

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that the Swiss Agency for Therapeutic Products (Swissmedic) has granted marketing authorization in Switzerland for ferumoxytol, an intravenous (IV) iron therapy to treat iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD). Ferumoxytol was approved for the same indication in the European Union in June 2012, and in the United States and Canada under the brand name Feraheme® in June 2009 and December 2011, respectively.    

AMAG's partner, Takeda Pharmaceutical Company Limited, is responsible for commercialization of ferumoxytol in Switzerland, the EU and Canada, among other territories. Takeda plans to launch ferumoxytol in Switzerland under the brand name Rienso®. AMAG is entitled to receive tiered, double-digit royalties on product sales in the licensed territories. AMAG has sole commercial rights for Feraheme in the United States.

"International expansion is one of four key areas of opportunity for Feraheme/Rienso, and Swiss approval marks continued progress on this front," said William Heiden, president and chief executive officer of AMAG. "Through Takeda's commercial efforts, Feraheme/Rienso will soon be available to CKD patients in several countries around the world as a new treatment option for their iron deficiency anemia. We believe that these international launches, coupled with continued market penetration in the United States, the potential for a broad IDA label and overall IV iron market expansion, provide multiple avenues of growth for Feraheme."