) recently presented new data on Feraheme from two pivotal phase
III studies (IDA-301 and IDA-302) at the annual meeting of the
American Society of Hematology's ("ASH").
The studies were conducted in patients suffering from iron
deficiency anemia (IDA) irrespective of the underlying cause of
the disease. The IDA patients had either failed or could not
tolerate oral iron treatment. While one study compared Feraheme
with intravenous iron sucrose, the other compared Feraheme with
AMAG included safety and efficacy data from each of the
studies in its presentation. Moreover, outcome data from IDA-301
was presented. The outcome data showed a direct relationship
between the rise in hemoglobin and improvement in
patient-reported measures of fatigue. AMAG also presented data
from an investigator-initiated study which evaluated a one gram
15-minute infusion of the drug.
The data from these studies will be the basis of its
supplemental new drug application (sNDA) in the US, which is
expected to be submitted later this month. AMAG is looking to
expand Feraheme's label as a treatment for anemia in adults
suffering from IDA with a history of unsuccessful oral iron
We note that Feraheme is already approved in the US as an
intravenous (IV) iron therapy to treat IDA in adults suffering
from chronic kidney disease (CKD). In November this year, AMAG's
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
Rienso's performance in the EU as well as in the US.
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 Rank are
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