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."
AMAG Pharmaceuticals, Inc.