Additional Data on InterMune's Esbriet - Analyst Blog

InterMune, Inc. ITMN presented analyses of pooled data from the phase III ASCEND study and the two previous phase III CAPACITY studies on Esbriet at the 2014 International Conference of the American Thoracic Society (ATS). InterMune also announced the publication of long-term safety results on patients suffering from idiopathic pulmonary fibrosis IPF and receiving Esbriet treatment in the journal Respirology.

One-year pooled analysis revealed favorable data with respect to forced vital capacity (FVC) on Esbriet treatment compared to placebo. The analysis further revealed that Esbriet showed significant treatment effects in the six-minute walk test distance change and progression-free survival.

The pooled data also revealed that the risk of all-cause mortality was cut by 48% in the Esbriet group against the placebo group. However, the drug failed to demonstrate any significant difference in dyspnea scores compared to placebo. Results were consistent in the 72-week analysis as well.

Meanwhile, InterMune presented long-term safety results on Esbriet. Results revealed that the product showed a favorable safety profile and was generally well tolerated up to 7.7 years.

Esbriet, an IPF treatment, is approved and available in Germany, France, Italy and the UK among several other EU countries. 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.

However, the drug is not yet available for IPF patients in the U.S. InterMune plans to resubmit the New Drug Application (NDA) for Esbriet in the U.S. soon. In May 2010, the company had received a complete response letter from the FDA regarding the approval of Esbriet for the IPF indication. We expect investors focus to remain on Esbriet's status in the U.S.

We note that Esbriet is the only approved drug in the world for the treatment of IPF. Meanwhile, Boehringer Ingelheim has completed a phase III study on BIBF-1120 for the IPF indication and is expecting results shortly. Companies like Novartis NVS and Sanofi SNY are also developing candidates for IPF.

InterMune, a biotech company, presently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the same sector include Gilead Sciences Inc. GILD, carrying a Zacks Rank #1 (Strong Buy).