InterMune, Inc.’s (ITMN) shares escalated a massive 170.8% and also touched a 52-week high after the company announced encouraging top-line results from the phase III ASCEND study on Esbriet (pirfenidone).
The ASCEND study is evaluating Esbriet in patients suffering from idiopathic pulmonary fibrosis (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.
InterMune further mentioned that 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.
The positive ASCEND data is a remarkable achievement for InterMune. Esbriet 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. However, it is yet to be available for IPF patients in the U.S. As per the company, there are about 70,000 diagnosed IPF cases in the U.S. InterMune also believes that the number is increasing by 15,000 to 20,000 with new diagnosed patients each year.
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.
U.S. Approval Chances Brighten
We believe that the positive result from the study brightens the chances of the drug gaining U.S. approval. The drug has encountered hiccups in its bid to gain approval in the country. In May 2010, the company received a complete response letter from the U.S. Food and Drug Administration (:FDA) regarding Esbriet’s approval for the IPF indication. InterMune intends to resubmit the New Drug Application (:NDA) in the third quarter this year. InterMune will launch Esbriet in the second quarter of 2015 in the U.S. assuming approval.
InterMune recorded Esbriet sales of $70.3 million for the year 2013, compared with the 2012 figure of $26.2 million.
InterMune presently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the same sector include Biogen Idec Inc. (BIIB) carrying a Zacks Rank #1 (Strong Buy).
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