AMAG Pharmaceuticals Inc.
) 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
), 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
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.
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