) recently submitted a supplemental new drug application (sNDA)
to the US Food and Drug Administration (FDA) for the intravenous
(IV) dose of Feraheme (ferumoxytol). AMAG is looking to expand
Feraheme's label as a treatment for anemia in adults suffering
from iron deficiency anemia (IDA) with a history of unsuccessful
oral iron therapy.
AMAG's sNDA submission was based on data from two phase III
clinical trials (IDA-301 and IDA-302) which evaluated the use of
Feraheme in adults suffering from IDA. Both the studies were
successful in achieving their primary objective of meaningful
improvements in hemoglobin from baseline.
We note that Feraheme is already approved in the US as an IV
iron therapy to treat IDA in adults suffering from chronic kidney
disease (CKD). In November this year, AMAG's European partner
Takeda Pharmaceutical Company Limited
) launched the drug for the same indication in the EU under the
trade name, Rienso. Rienso is also approved and launched in
Canada where it is also marketed by Takeda.
AMAG recorded third quarter 2012 Feraheme sales of $16.2
million. The company expects 2012 Feraheme revenue in the range
of $58-$60 million.
We believe that successful label expansion of the drug will
drive revenue further. We expect investor focus to remain on
Feraheme's performance in the US as well as the EU.
We currently have an Outperform recommendation on the stock,
which carries a Zacks #2 Rank (Buy). Other stocks in the pharma
sector that carry a Zacks #1 (Strong Buy) Rank are
AMAG PHARMA INC (AMAG): Free Stock Analysis
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