Back to top

Analyst Blog

Zacks Equity Research

Swiss Issue for AMAG/Takeda's Rienso

AMAG JAZZ

 ZacksTrade Now

This page is temporarily not available.  Please check later as it should be available shortly. If you have any questions, please email customer support at support@zacks.com or call 800-767-3771 ext.  9339.

AMAG Pharmaceuticals Inc. (AMAG - Snapshot Report) has been recently informed by partner, Takeda Pharmaceutical , 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 - Analyst Report) and Santarus Inc. currently look more attractive in the pharma space with a Zacks Rank #1 (Strong Buy).

Please login to Zacks.com or register to post a comment.

New to Zacks?

Start Here

Zacks Investment Research

Close

Are you a new Zacks Member or a visitor to Zacks.com?

Top Zacks Features

Learn more

Start for as little as $4.50 per trade.

My Portfolio Tracker

Is it Time to Sell?

One of the most important steps you can take today is to set up your portfolio tracker on Zacks.com. Once you do, you'll be notified of major events affecting your stocks and/or funds with daily email alerts.

More Zacks Resources

Zacks Rank Home - Evaluate your stocks and use the Zacks Rank to eliminate the losers and keep the winners.

Mutual Fund Rank Home - Evaluate your funds with the Mutual Fund Rank for both your personal and retirement funds.

Stock/Mutual Fund Screening - Find better stocks and mutual funds. The ones most likely to beat the market and provide a positive return.

My Portfolio - Track your Portfolio and find out where your stocks/mutual funds stack up with the Zacks Rank.

Zacks #1 Rank Top Movers for Zacks #1 Rank Top Movers

Company Symbol Price %Chg
DIXIE GROUP DXYN 15.84 +7.90%
BOFL HOLDING BOFI 85.30 +4.97%
RAMBUS INC RMBS 12.31 +4.41%
VIPSHOP HOLD VIPS 148.73 +4.35%
NETFLIX INC NFLX 345.74 +4.32%