InterMune (ITMN) has recently begun a late stage additional study (ASCEND) of its drug Esbriet (pirfenidone) for the treatment of idiopathic pulmonary fibrosis (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 in the US. Accordingly InterMune began the ASCEND study to meet the requirements of the FDA.
Esbriet is already cleared by regulatory authorities in the European Union and is expected to be launched there in September 2011. The drug is also approved in countries such as Norway, Iceland and Japan. Esbriet is sold in Japan by InterMune’s partner Shionogi with the trade name Pirespa.
ASCEND is a multinational, randomized, double-blind, placebo-controlled trial that will evaluate the safety and efficacy of Esbriet in IPF patients with mild-to-moderate impairment in lung function versus placebo. The primary endpoint of the 52-week study will be forced vital capacity (FVC), which is a measure of lung function.
The study will enroll approximately 500 patients at centers in the United States, Mexico, South America, Australia and New Zealand. 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 file the new drug application (NDA) in the second half of 2013, which will contain data from the ASCEND study.
Our Recommendation
We currently have a Neutral recommendation on InterMune. The stock carries a Zacks #3 Rank (short-term hold). 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.
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