InterMune, Inc. 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.
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.