AMAG Pharmaceuticals, Inc. and Takeda Pharmaceutical Company Limited provided a regulatory and clinical update for Feraheme (ferumoxytol) injection for intravenous (IV) use.

On June 1, 2010, AMAG submitted a marketing authorization application (MAA) for Feraheme for the treatment of iron deficiency anaemia (IDA) in chronic kidney disease patients to the European Medicines Agency (EMA). The EMA has since notified AMAG that the submission has been validated for review.

The companies are also pleased to report that the global registrational programme to expand the indication of Feraheme to include the treatment of IDA regardless of the underlying cause has been initiated. The programme consists of two phase III studies - one 800 patient, double-blind, placebo-controlled study and the other a 600 patient open label, active-controlled study comparing ferumoxytol to IV iron sucrose. Both trials will evaluate changes in haemoglobin levels as well as other efficacy and safety endpoints. The programme is now enrolling patients; the companies expect that it will take up to 18 months to complete enrolment.

"We have thus far made great progress on our key objectives for this year," said Brian J.G. Pereira, MD, president and chief executive officer of AMAG Pharmaceuticals, Inc. "With the MAA filing validated by the EMA and the global registrational programme for Feraheme for the broader indication of the treatment of iron deficiency anaemia underway, we are several steps closer to expanding the reach of Feraheme, both geographically and to new patient populations."

Dr. Erich Brunn, chief executive officer, Takeda Pharmaceuticals Europe said: "For Takeda in Europe, this represents an important first step forward in our entry into a new therapeutic area. Feraheme has the potential to provide physicians in Europe with an important new approach in the treatment of patients with iron deficiency anaemia."

In the United States, Feraheme (ferumoxytol) injection for intravenous (IV) use is indicated for the treatment of iron deficiency anaemia in adult chronic kidney disease (CKD) patients. Feraheme received marketing approval from the US Food and Drug Administration on June 30, 2009 and was commercially launched by AMAG in the US shortly thereafter. Feraheme is under regulatory review in Canada and Europe for the treatment of chronic kidney disease patients with iron deficiency anaemia.

AMAG is seeking to expand the label and geographic availability of Feraheme to treat patients with iron deficiency anaemia regardless of the underlying cause by conducting additional clinical trials and by forming strategic partnerships around the world. AMAG has two partners for the development and commercialization of Feraheme outside of the US: 3SBio Inc. to develop and commercialize Feraheme for CKD in China; and Takeda Pharmaceutical Company to develop and commercialize Feraheme for all therapeutic applications in five ex-US regions, including Europe, Canada, Turkey, the Commonwealth of Independent States and several Asia Pacific countries. AMAG has exclusive rights to commercialize Feraheme in the US and certain ex-US territories.

In addition to the global iron deficiency anaemia registrational programme, AMAG is evaluating Feraheme in a clinical trial, the ferumoxytol compared to iron sucrose trial (FIRST), which will enrol 150 patients with chronic kidney disease and iron deficiency anaemia, and has plans to initiate paediatric studies and a Feraheme retreatment study in the coming year.

Feraheme was discovered, developed and is manufactured by AMAG Pharmaceuticals, Inc.

AMAG Pharmaceuticals, Inc. is a biopharmaceutical company that utilizes its proprietary technology for the development and commercialization of a therapeutic iron compound to treat iron deficiency anaemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease.

Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine.