InterMune Resubmits Esbriet NDA - Analyst Blog

InterMune, Inc. ITMN resubmitted its New Drug Application (NDA) for Esbriet (pirfenidone) in the U.S. in response to a Complete Response Letter CRL received in May 2010. InterMune is looking to get U.S. approval for Esbriet for the treatment of adults suffering from idiopathic pulmonary fibrosis IPF.

In Feb 2014, InterMune announced encouraging top-line results from the phase III ASCEND study on Esbriet. The ASCEND study is evaluating Esbriet in patients suffering from IPF in the U.S. Results from the study showed that treatment with Esbriet significantly reduced IPF disease progression at week 52, thus meeting the primary objective of the study. Esbriet also demonstrated significant treatment effects in the six-minute walk test distance change and progression-free survival. Moreover, the drug demonstrated favorable safety and tolerability profiles.

We believe the chances of getting Esbriet approved in the U.S. are brighter now, backed by strong ASCEND data. The U.S. Food and Drug Administration will have 74 days to evaluate the submission and will render a final decision within 6 months of the receipt of the NDA.

Esbriet is already approved and available in several EU countries including Germany, France, Italy and the UK. The drug is also approved in countries like Canada, Japan, China, India, Argentina and Mexico. The company recorded Esbriet sales of $30.3 million in the first quarter of 2014. Esbriet sales in 2014 are expected in the range of $130−$140 million.

We note that Esbriet is the only approved drug in the world for the treatment of IPF. Boehringer Ingelheim's BIBF-1120 is undergoing late stage development for the IPF indication. Companies like Novartis NVS and Sanofi SNY are also developing candidates for IPF.

InterMune, a biotech company, presently carries a Zacks Rank #3 (Hold). A better-ranked stock in the same sector is Gilead Sciences Inc. GILD. The stock carries a Zacks Rank #1 (Strong Buy).

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