EC grants marketing authorization for AMAG's ferumoxytol to treat IDA

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that the European Commission has granted marketing authorization for ferumoxytol, an intravenous (IV) iron therapy to treat iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD). The marketing authorization follows a positive opinion, issued on April 19, 2012, by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. Ferumoxytol was approved for the same indication in the US under the brand name Feraheme® in June 2009.

The marketing authorization is valid in the current European Union Member States as well as in Iceland and Norway, and is based on data obtained from an extensive clinical development program. Takeda Pharmaceutical Company Limited, AMAG's partner in Europe, plans to launch ferumoxytol in Europe under the brand name Rienso® in 2012. The EU marketing authorization triggers a $15 million milestone payment to AMAG from Takeda; the first commercial sale of Rienso® in Europe will trigger another $15 million milestone payment to AMAG. Additionally, AMAG is entitled to receive tiered, double-digit royalties on sales of Rienso® in the licensed territories.

"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. "We are very fortunate to have a committed partner with an outstanding reputation in the pharmaceutical industry responsible for the launch of ferumoxytol in many regions outside of the United States. Through Takeda's efforts, patients outside the US with CKD will soon benefit from a new therapy to treat their IDA."

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. IDA can have a profound impact on patients' lives, causing fatigue, shortness of breath and an increase in the risk of cardiovascular complications including congestive heart failure.¹ IV iron is recommended for use to increase hemoglobin levels in CKD patients with IDA.¹ Approximately one million grams of IV iron are administered to IDA patients in the EU each year.

"While treatments for iron deficiency anemia have been widely available for many years, the disease continues to place a significant burden on the everyday life of CKD patients worldwide, and its management should be tailored to appropriately address the clinical consequences of this debilitating condition," said Francesco Locatelli, Scientific Director, Division of Nephrology and Dialysis, Alessandro Manzoni Hospital, Lecco, Italy. "Ferumoxytol offers an effective alternative to current therapies in the management of anemia, and news of its approval will be warmly received by the European renal community."

Source: AMAG Pharmaceuticals, Inc.