AMAG Seeks Feraheme Label Expansion

AMAG Pharmaceuticals (AMAG - Snapshot Report) 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 (TKPYY) 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.

Our Recommendation

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 Targacept (TRGT - Snapshot Report) and Repligen (RGEN).