AMAG Pharmaceuticals, Inc.
) European partner
Takeda Pharmaceutical Company Limited
) recently launched Rienso (ferumoxytol) in the EU. Rienso is an
intravenous (IV) iron therapy to treat iron deficiency anemia
(IDA) in adult patients with chronic kidney disease (CKD).
We note that Rienso gained marketing authorization from the
European Commission in June this year. AMAG received marketing
authorization based on extensive clinical development program
Takeda will be making a milestone payment of $15 million to
AMAG for first sales of Rienso in Europe. The company will also
receive tiered, double-digit royalties on sales of Rienso in the
We note that Rienso is already approved in the US for the same
indication under the trade name of Feraheme. Rienso is also
approved and launched in Canada where it is marketed by
AMAG recorded third quarter 2012 sales of $16.2 million for
Feraheme. The company expects 2012 Feraheme revenue in the range
of $58-$60 million.
Moreover, the company is working on expanding Feraheme's
label. The company is conducting two studies in patients with IDA
regardless of the underlying cause. AMAG reported positive
results from the second phase III study during the third quarter
of 2012. AMAG intends to submit a supplemental new drug
application (sNDA) to the US Food and Drug Administration (FDA)
for this indication by year end.
We currently have an Outperform recommendation on the stock,
which carries a Zacks #2 Rank (short-term Buy rating).
We are pleased with the EU approval of the drug and believe
that successful label expansion of the drug will drive revenue
further. We expect investor focus to remain on Rienso's
performance in the EU as well as in the US.
AMAG PHARMA INC (AMAG): Free Stock Analysis
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