EC grants marketing authorization for AMAG's ferumoxytol to treat IDA

Published on June 23, 2012 at 1:14 AM · No Comments

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that the European Commission has granted marketing authorization for ferumoxytol, an intravenous (IV) iron therapy to treat iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD). The marketing authorization follows a positive opinion, issued on April 19, 2012, by the Committee for Medicinal Products for Human Use (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 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 EU marketing authorization triggers a $15 million milestone payment to AMAG from Takeda; the first commercial sale of Rienso® in 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.

"AMAG has four significant organic growth opportunities for ferumoxytol - continued share gains in the US CKD IDA market, international launches and market penetration, label expansion in the US and abroad, and overall IV iron market expansion," said William Heiden, president and chief executive officer of AMAG. "We are very fortunate to have a committed partner with an outstanding reputation in the pharmaceutical industry responsible for the launch of ferumoxytol in many regions outside of the United States. Through Takeda's efforts, patients outside the US with CKD will soon benefit from a new therapy to treat their IDA."

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