Ferumoxytol is Approved in Europe

The injectable iron drug Feraheme (ferumoxytol) received European approval to treat iron deficiency anemia in adult patients with chronic kidney disease on dialysis. This triggered a $15 million milestone payment from Takeda Pharmaceutical company to its partner AMAG Pharmaceuticals, the manufacturer of Feraheme.

The drug is now being tested as a treatment for anyone with iron deficiency anemia. In July AMAG completed a second phase III trial in 808 patients at 136 sites worldwide that confirmed earlier findings that the drug increased hemoglobin levels in general patients with iron-deficiency anemia.

“With both phase III studies in our global registrational program for Feraheme now complete, we will seek approval for Feraheme for the treatment of a broader population of patients,” said Lee Allen, AMAG’s chief medical officer. The company plans to submit a marketing application for approval of Feraheme in the United States for the expanded indication by the end of this year. Takeda Pharmaceutical plans to file for approval in Europe next year, AMAG reported.

AMAG has sharpened its business focus lately and reorganized in the past few months. The company aims “to focus resources on Feraheme and on expanding its product portfolio with specialty drugs.” AMAG also reported it will stop production of GastroMark, a contrast agent used in bowel magnetic resonance imaging, and has decided to simplify its cost structure and plans to divest its manufacturing facility, with a loss of 45 jobs. The Wall Street Journal reported on July 18 that the cut is about one-fourth of AMAG’s work force.

According to the July 26 AMAG announcement, Feraheme’s net product revenues in the United States for the second quarter of calendar-year 2012 were $14.1 million, a 10 percent increase from $12.8 million reported in the same quarter of 2011.

AMAG confirmed expectations of growth and noted in its half-year report that 2012 revenues at this point are on track for Feraheme product revenues of $55 million to $58 million, excluding any royalties and product sales outside the United States. The company also expects to hit milestone payments totaling $33 million from regulatory approvals and commercial launches.

September 2012 (Vol. 4, Number 9)