) received breakthrough therapy designation for its primary
product, Esbriet (pirfenidone), from the FDA. InterMune is looking
to get Esbriet approved in the U.S. for the treatment of adults
suffering from idiopathic pulmonary fibrosis (IPF).
Breakthrough therapy designation is a status provided to candidates
that show superiority over existing therapies for the treatment of
serious or life threatening diseases or conditions. The designation
helps to speed up the development and review process for
experimental drugs targeting serious and life-threatening diseases.
A candidate with breakthrough therapy designation could benefit
from the FDA's existing fast track development program features as
well as more intensive FDA guidance on efficient development of the
In May 2014, InterMune resubmitted its New Drug Application (NDA)
for Esbriet based on encouraging top-line results from the phase
III ASCEND study which was announced in February this year.
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 its primary objective.
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
Esbriet is already approved and available in several EU countries
including Germany, France, Italy and the UK among others. 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 million to $140 million.
Though Esbriet is the only approved medicine for IPF, several
companies are developing their candidates to tap the IPF market.
The nearest threat for InterMune is from Boehringer Ingelheim's IPF
candidate nintedanib, which was filed in the U.S. in Jul 2014.
Nintedanib was also granted a breakthrough therapy designation by
the FDA earlier in the month. Nintedanib is under review in the EU
as well. Companies like
) are also developing candidates for IPF.
InterMune, a biotech company, presently carries a Zacks Rank #2
(Buy). Another stock worth considering in the same sector is
) carrying a Zacks Rank #1 (Strong Buy).
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