Rienso® (Ferumoxytol) Receives Swiss Marketing Authorization For The Treatment Of Iron Deficiency Anemia In Adult Patients With Chronic Kidney Disease
AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that the Swiss
Agency for Therapeutic Products (Swissmedic) has granted marketing
authorization in Switzerland for ferumoxytol, an intravenous (IV) iron
AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that the Swiss Agency for Therapeutic Products (Swissmedic) has granted marketing authorization in Switzerland for ferumoxytol, an intravenous (IV) iron therapy to treat iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD). Ferumoxytol was approved for the same indication in the European Union in June 2012, and in the United States and Canada under the brand name Feraheme® in June 2009 and December 2011, respectively. AMAG’s partner, Takeda Pharmaceutical Company Limited, is responsible for commercialization of ferumoxytol in Switzerland, the EU and Canada, among other territories. Takeda plans to launch ferumoxytol in Switzerland under the brand name Rienso®. AMAG is entitled to receive tiered, double-digit royalties on product sales in the licensed territories. AMAG has sole commercial rights for Feraheme in the United States. “International expansion is one of four key areas of opportunity for Feraheme/Rienso, and Swiss approval marks continued progress on this front,” said William Heiden, president and chief executive officer of AMAG. “Through Takeda’s commercial efforts, Feraheme/Rienso will soon be available to CKD patients in several countries around the world as a new treatment option for their iron deficiency anemia. We believe that these international launches, coupled with continued market penetration in the United States, the potential for a broad IDA label and overall IV iron market expansion, provide multiple avenues of growth for Feraheme.” 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. 1About AMAG Pharmaceuticals, Inc. AMAG Pharmaceuticals, Inc. is a specialty pharmaceutical 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)/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. AMAG Pharmaceuticals and Feraheme are registered trademarks of AMAG Pharmaceuticals, Inc. Rienso is a registered trademark of Takeda Pharmaceutical Company Limited.