AMAG Pharmaceuticals (AMAG - Free Report) 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 placebo.
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 therapy.
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 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 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 Targacept and Repligen (RGEN - Free Report) .