AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that the
Committee for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency (EMA) has issued a positive opinion for the approval of
ferumoxytol, an intravenous (IV) iron therapy, for the treatment of iron
deficiency anemia (IDA) in adult patients with chronic kidney disease
(CKD). In the European Union, ferumoxytol will be marketed as Rienso® by
AMAG's partner, Takeda Pharmaceutical Company Limited.
"International expansion of ferumoxytol is an important growth
opportunity for AMAG," said Frank Thomas, interim president and chief
executive officer of AMAG. "Following the approval of ferumoxytol in
Canada, which we received in late 2011, European approval would mark the
third region where ferumoxytol would be available for the treatment of
iron deficiency anemia in patients with CKD. Continued growth in our
U.S. CKD business, coupled with geographic expansion and the opportunity
to further expand the product's label to include all patients with IDA,
would significantly enhance the growth prospects for ferumoxytol."
European approval and the subsequent first commercial sale of
ferumoxytol in Europe would trigger $30 million in milestone payments to
AMAG from Takeda. Additionally, AMAG is entitled to receive tiered,
double-digit royalties on sales of ferumoxytol in licensed territories.
Upon EU Commission approval, Takeda is planning to launch Rienso in the
second half of 2012.
"Iron deficiency anemia can be a debilitating condition for chronic
kidney disease patients and appropriate management of this condition can
carry positive clinical implications for patients. Therefore, treatment
of anemia at all stages of CKD is important and the potential
availability of ferumoxytol in Europe would offer an additional
therapeutic option to help effectively manage this condition," said
Professor Iain Macdougall 1, consultant nephrologist and
professor of clinical nephrology at King's College Hospital, London.