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Label Expansion Sought for AMAG/TKPYY's Rienso

AMAG JAZZ

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AMAG Pharmaceuticals, Inc. (AMAG - Snapshot Report) announced that its partner in Europe, Takeda Pharmaceutical Company Limited , recently submitted a type-II variation to the European Medicines Agency (EMA) for Rienso (ferumoxytol).

We note that AMAG’s sole marketed product Feraheme (US trade name of Rienso) is already available in the EU under the trade name Rienso for the treatment of iron deficiency anemia (IDA) in adults with chronic kidney disease (CKD).

The companies are now looking to expand Rienso’s label to include treatment of IDA in all adults who have a history of unsatisfactory oral iron therapy or who cannot tolerate or do not respond to such therapy.

The EU submission of Rienso was based on positive data from a global phase III program which evaluated the use of Rienso in a broad range of adult IDA patients who could not tolerate or did not respond to oral iron therapy. AMAG enrolled more than 1,400 patients in the phase III studies - IDA-301 (placebo comparator) and IDA-302 (active comparator). Moreover, those who were enrolled in the IDA-301 study were also eligible to participate in the IDA-303 study, an extension study to evaluate repeat dosing of the drug.

We note that AMAG is also looking for a label expansion in the US. AMAG submitted a supplemental new drug application (sNDA) for Feraheme in Dec 2012. AMAG is looking to get Feraheme approved for the treatment of CKD adults suffering from IDA with a history of unsuccessful oral iron therapy, including those suffering from gastrointestinal disease.

The US regulatory body is expected to render a final decision on the proposed label expansion by Oct 21, 2013. We believe that successful label expansion of the drug will boost the sales potential of the drug.

AMAG currently carries a Zacks Rank #3 (Hold). Meanwhile, other stocks such as Jazz Pharmaceuticals Public Limited Company (JAZZ - Analyst Report) and Santarus Inc. currently look more attractive in the pharma space with a Zacks Rank #1 (Strong Buy).

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