InterMune, Inc.'s (NASDAQ: ITMN) shares were up around 13.4% on May 19 after the company announced that it presented results from its phase III ASCEND study on Esbriet (pirfenidone) at the International Conference of the American Thoracic Society (ATS). Results were also published on-line in the New England Journal of Medicine.
The ASCEND study is evaluating Esbriet in patients suffering from idiopathic pulmonary fibrosis (ETF:IPF) in the U.S. Results showed that Esbriet reduced decline in lung function. Moreover, Esbriet demonstrated significant treatment effects in the six-minute walk test distance change and progression-free survival. The drug also demonstrated favorable safety and tolerability profiles.
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 yet to be 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 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 (NYSE: NVS) and Sanofi (NYSE: 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. (NASDAQ: GILD) carrying a Zacks Rank #1 (Strong Buy).
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