Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

AMAG Pharma Says Ferumoxytol Gets European Marketing Authorization To Treat IDA

RELATED NEWS
Trade AMAG now with 

AMAG Pharmaceuticals Inc. (AMAG: Quote) announced that the European Commission has granted marketing authorization for ferumoxytol, an intravenous or IV iron therapy to treat iron deficiency anemia or IDA in adult patients with chronic kidney disease or CKD.

The company said that the marketing authorization followed a positive opinion, issued on April 19, 2012, by the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency.

Ferumoxytol was approved for the same indication in the US under the brand name Feraheme in June 2009.

The company said that the marketing authorization is valid in the current European Union Member States as well as in Iceland and Norway, and is based on data obtained from an extensive clinical development program. Takeda Pharmaceutical Company Limited, AMAG's partner in Europe, plans to launch ferumoxytol in Europe under the brand name Rienso in 2012.

The company also said that the EU marketing authorization triggers a $15 million milestone payment to AMAG from Takeda; the first commercial sale of Riensoin Europe will trigger another $15 million milestone payment to AMAG. Additionally, AMAG is entitled to receive tiered, double-digit royalties on sales of Rienso in the licensed territories.

Register
To receive FREE breaking news email alerts for AMAG Pharmaceuticals Inc. and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Global consumer confidence increased in the second quarter to reach the highest levels since the first quarter in 2007 as job optimism improved, results of a survey by Nielsen showed Tuesday. The Nielsen Global Consumer Confidence Index rose a point from the previous quarter to 97 in the second quarter.... Texas Instruments Inc., the world's largest maker of analog chips, said Monday after the markets closed that its second quarter profit rose 3% from last year, as revenue increased 8%. The company's quarterly earnings per share also came in above analysts' expectations as did its quarterly revenue. At the same time, the company gave an upbeat outlook for the third quarter. After coming under pressure in early trading on Monday, stocks regained some ground over the course of the trading session but still closed modestly lower. The pullback on the day partly offset the strength that was seen last week.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.