AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that Takeda Pharmaceutical Company Limited, AMAG’s partner in Europe, has launched ferumoxytol in its first European Union (EU) market, under the brand name Rienso®. The launch follows the European marketing authorization, which was received in June 2012, for the use of Rienso to treat iron deficiency anemia in adult patients with chronic kidney disease. Ferumoxytol was approved for the same indication in the US under the brand name Feraheme® in June 2009.
The first commercial sale of Rienso in Europe triggers a $15 million milestone payment to AMAG from Takeda. Additionally, AMAG is entitled to receive tiered, double-digit royalties on sales of Rienso® in the licensed territories.
“We have four significant organic growth opportunities globally for ferumoxytol – continued share gains in the US CKD IDA market, international launches and market penetration, potential label expansion in the US and abroad, and overall IV iron market expansion – and we are making progress on all fronts,” said William Heiden, president and chief executive officer of AMAG. “This first launch in the European Union means patients and physicians there can now benefit from treatment with Rienso. We are very fortunate to have such a committed partner as Takeda for the launch of ferumoxytol in many regions outside of the United States.”
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.For more information, please see the Takeda Pharmaceuticals press release, entitled ‘Launch of Rienso ® (ferumoxytol) offers adult patients with chronic kidney disease a new option for the treatment of iron deficiency anaemia’ issued on November 1, 2012. About Feraheme (ferumoxytol)/Rienso 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 US Food and Drug Administration on June 30, 2009 and was commercially launched by AMAG in the US shortly thereafter. Ferumoxytol received marketing approval in Canada in December 2011, where it will be marketed by Takeda as Feraheme®, and in the European Union in June 2012 and Switzerland in August 2012, where it will be marketed by Takeda as Rienso®. For additional product information, please visit www.feraheme.com. About AMAG AMAG Pharmaceuticals, Inc. is a specialty pharmaceutical company that manufactures and markets Feraheme® in the United States. For additional company information, please visit www.amagpharma.com. 1 National Kidney Foundation. KDOQI clinical practice guidelines and clinical practice recommendations for anemia in chronic kidney disease. Am J Kidney Dis 2006;47(suppl 3):11–1458 AMAG Pharmaceuticals and Feraheme are registered trademarks of AMAG Pharmaceuticals, Inc.