) 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
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
) 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.
). The stock carries a Zacks Rank #1 (Strong Buy).
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