Back to top

Analyst Blog

Zacks Equity Research

ITMN's Esbriet Safe Long Term

ITMN

 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.

InterMune, Inc. (ITMN - Snapshot Report) recently presented new data which demonstrated that its lead drug Esbriet (pirfenidone), indicated for the treatment of idiopathic pulmonary fibrosis (IPF), was safe even for use over a long period of time. Data presented at the European Respiratory Society (ERS) Annual Congress from the RECAP trial showed that there was no change in the safety profile of Esbriet even when dosed for more than three years.

RECAP is an extension study of the pivotal CAPACITY trials (n=779) to assess the long-term safety of Esbriet. Of the 626 patients who completed the CAPACITY program, 603 were enrolled in RECAP. We believe this data would encourage long-term use of the drug.

Esbriet, already approved in the EU, was launched in Germany in mid September. It is expected to be launched in France, Spain and Italy in the first half of 2012 and in the United Kingdom in the third quarter of 2012. The company plans to launch Esbriet in all other major European countries by the third quarter of 2012. Esbriet is sold in Japan by InterMune’s partner Shionogi in the trade name Pirespa since 2008.

In the US, InterMune is conducting a late stage additional study (ASCEND; n~500) of Esbriet for the treatment of IPF. InterMune had received a complete response letter (CRL) from the US Food and Drug Administration (FDA) in early May 2010. The regulatory body had requested data from an additional clinical trial before considering the regulatory approval of Esbriet. Accordingly, InterMune began the ASCEND study to meet the requirements of the FDA. The trial is expected to be fully enrolled by the first half of 2012 with data to be presented in mid 2013. InterMune intends to resubmit the new drug application (NDA), in the second half of 2013, containing data from the ASCEND study.

Currently, there is no FDA approved therapy for the treatment of IPF, a fatal lung disease, in the US. With the EU approval of Esbriet, InterMune became the first company to offer an IPF medicine in Europe. Hence, we believe a huge market opportunity exists for the drug.

Our Recommendation

We currently have a Neutral recommendation on InterMune. The stock carries a Zacks #3 Rank (short-term ‘Hold’ rating). We consider the EU approval of Esbriet as a major positive for InterMune. However, we prefer to remain neutral until visibility improves on its US approval.

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%