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Swiss Issue for AMAG/Takeda's Rienso

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AMAG Pharmaceuticals Inc. (AMAG) has been recently informed by partner, Takeda Pharmaceutical (TKPYY), that the latter is recalling a specific batch of Rienso from the Swiss market.

Takeda’s reason to recall the specific batch of Rienso was primarily due to some post-marketing adverse event reports concerning hypersensitivity reactions of varying severity after the administration of Rienso from that batch. We note that Takeda is the exclusive distributor of Rienso in Canada and the EU. Both companies are currently investigating the batch. Takeda will introduce a new batch of the drug in that area post investigating reports and approval from Swissmedic.

We note that Rienso is approved in the EU as an IV iron therapy to treat iron deficiency anemia (IDA) in adults suffering from chronic kidney disease (:CKD). The drug is also available in the US for the same indication under the trade name Feraheme.

Meanwhile, AMAG is expected to present data from a new sub-group analysis from the phase III study (IDA-301) on Feraheme at a poster session of the Digestive Disease Week 2013 (:DDW) meeting in Orlando, Fla.

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

In the full IDA-301 study, adults suffering from IDA for whom oral iron treatment was found to be inadequate, were treated with Feraheme (n=608) and placebo (n=200). However, the sub-group analysis of the IDA-301 study was based on 231 patients suffering from gastrointestinal (:GI) disease. Out of the 231 patients, 173 were treated under Feraheme and the rest were under the placebo arm.

The GI sub-group analysis showed that at week 5, 82.1% of the patients under the Feraheme arm demonstrated an increase in hemoglobin in comparison to 1.7% of patients in the placebo arm. Moreover patients in the Feraheme arm demonstrated an 11.6 point improvement in self-reported fatigue compared to that of 7.9 point in patients in the placebo arm.

Apart from the IDA-301 study, the sNDA submission was also based on positive results from another phase III study, IDA-302. 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) and Santarus Inc. (SNTS) currently look more attractive in the pharma space with a Zacks Rank #1 (Strong Buy).

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