AMAG Pharmaceuticals Inc. (AMAG - Free Report) recently announced that ferumoxytol received marketing authorization from the European Commission. Ferumoxytol is an intravenous (IV) iron therapy to treat iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD).
EU approval did not come as a surprise as earlier, in April 2012, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency had given a positive opinion on ferumoxytol. AMAG received marketing authorization based on extensive clinical development program data.
The marketing authorization applies to the current European Union Member States along with Iceland and Norway. AMAG’s European partner, Takeda Pharmaceuticals , plans to launch ferumoxytol in Europe in 2012, under the trade name of Rienso.
Takeda will be making a milestone payment of $15 million to AMAG for the EU marketing authorization and another $15 million for first sales of Rienso in Europe. AMAG will also receive tiered, double-digit royalties on sales of Rienso in the licensed territories.
We note that ferumoxytol is already approved in the US for the same indication under the trade name of Feraheme. Ferumoxytol is also approved in Canada and is marketed by Takeda.
AMAG recorded first quarter 2012 sales of $13.6 million for ferumoxytol. The company expects 2012 ferumoxytol revenue to be in the range of $53–$57 million. AMAG is also focusing on the label expansion of the drug. The company is currently running two phase III studies (IDA-302 and IDA-301), one comparing Feraheme with intravenous iron sucrose and the other comparing Feraheme with placebo. AMAG plans to file for approval in the US by the end of this year for the second study (IDA-301).
We currently have a Neutral recommendation on the stock, which carries a Zacks #3 Rank (short-term Hold rating). We believe investor focus will stay on the commercialization of Rienso in Europe and Feraheme’s performance in the US.