(By Balachander) AMAG Pharmaceuticals Inc. (NASDAQ: AMAG) said ferumoxytol, its treatment for iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD), has received marketing authorization from the European Commission.
Takeda Pharmaceutical Co. Ltd. (TYO), AMAG's partner in Europe, plans to launch ferumoxytol in Europe under the brand name Rienso in 2012.
The marketing authorization triggers a $15 million milestone payment to Lexington, Massachusetts-based AMAG from Takeda. The first commercial sale of Rienso in Europe will trigger another $15 million milestone payment to AMAG. AMAG is also entitled to receive tiered, double-digit royalties on sales of Rienso in the licensed territories.
Ferumoxytol was approved for the same indication in the US under the brand name Feraheme in June 2009. Ferumoxytol received marketing approval in Canada in December 2011, where it will be marketed by Takeda as Feraheme.
The marketing authorization is based on data obtained from an extensive clinical development program, AMAG said.
"AMAG 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," said William Heiden, president and chief executive officer of AMAG.
Iron deficiency is a common cause of anemia in CKD patients, and is very common in the later stages of CKD as renal function deteriorates and erythropoiesis (red blood cell production) declines.
On Friday, AMAG shares added 3.25 percent to trade at $14.91. Over the past year, the stock has been trading between $12.43 and $19.62.