logo
Share SHARE
FONT-SIZE Plus   Neg

AMAG Pharma Says Ferumoxytol Gets European Marketing Authorization To Treat IDA

AMAG Pharmaceuticals Inc. (AMAG) 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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Best Buy Co., Inc. (BBY) reported first-quarter non-GAAP earnings per share from continuing operations of $0.44, an increase of 19% from $0.37, a year ago. On average, 21 analysts polled by Thomson Reuters expected the company to report profit per share of $0.35 for the quarter. Analysts' estimates typically... Automotive parts retailer AutoZone, Inc. on Tuesday reported a 6 percent increase in profit for the third quarter from last year, reflecting growth in sales and higher inventory on new store openings. However, both revenue and earnings per share for the quarter missed analysts' expectations. Toll Brothers, Inc. (TOL), the nation's leading builder of luxury homes, reported second-quarter net income of $89.1 million, or $0.51 per share, compared to $67.9 million, or $0.37 per share, prior year. Pre-tax income increased to $140.4 million from $86.5 million. On average, 18 analysts polled by...
comments powered by Disqus
Follow RTT