AMAG Pharma (AMAG) Says Ferumoxytol MAA Granted in Europe; Will Get $15M Milestone
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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.
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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.
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