InterMune, Inc. 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 candidate.
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 profiles.
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 Novartis (NVS - Free Report) and Sanofi (SNY - Free Report) 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 Actelion Ltd. carrying a Zacks Rank #1 (Strong Buy).