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.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. 2 IV iron is recommended for use to increase hemoglobin levels in CKD patients with IDA and can also serve to minimize the dose of ESA required to manage anemia in CKD. 2 Approximately one million grams of IV iron are administered to IDA patients in the EU each year. About AMAG Pharmaceuticals, Inc. AMAG Pharmaceuticals, Inc. is a biopharmaceutical company that manufactures and markets ferumoxytol under the brand name Feraheme® in the United States. For additional company information, please visit www.amagpharma.com. About Feraheme (ferumoxytol) In the United States, Feraheme® (ferumoxytol) Injection for Intravenous (IV) use is indicated for the treatment of iron deficiency anemia in adult chronic kidney disease (CKD) patients. Feraheme received marketing approval from the U.S. Food and Drug Administration on June 30, 2009 and was commercially launched by AMAG in the U.S. shortly thereafter. Feraheme received marketing approval in Canada in December 2011. For additional product information, please visit www.feraheme.com. AMAG Pharmaceuticals and Feraheme are registered trademarks of AMAG Pharmaceuticals, Inc. Rienso is a registered trademark of Takeda Pharmaceutical Company Limited.