Intercept Pharmaceuticals' OCA Now Breakthrough Therapy - Analyst Blog

Intercept Pharmaceuticals, Inc. (ICPT) announced that its lead candidate, obeticholic acid (OCA) has been granted Breakthrough Therapy designation by the FDA for the treatment of non-alcoholic steatohepatitis (NASH) in patients suffering from liver fibrosis.

The company stated that according to recent epidemiological studies, over 10% of the U.S. population suffers from NASH with more than 60% of the patients expected to have liver fibrosis or cirrhosis as a result of disease progression. Given that no drugs are currently approved for the treatment of NASH, if successfully developed, OCA should face a significant market opportunity.

We believe that Breakthrough Therapy designation should boost the development process of the candidate for this indication. Intercept Pharma will now be qualified for several benefits including intensive FDA guidance and eligibility for submitting a rolling NDA for the candidate’s approval.

Currently, Intercept Pharma is in the process of finalizing the design of a phase III program on OCA for NASH.

We remind investors that NASH is not the primary indication for which OCA is being developed. Intercept Pharma’s most advanced development program for OCA is for primary biliary cirrhosis (PBC). The candidate is being developed as a second-line treatment for patients who respond inadequately or are intolerant to standard-of-care therapy. The company expects to file for the marketing approval of OCA in this indication in the U.S. and Europe during the first half of 2015.

Additionally, Intercept Pharma is studying its lead candidate for other indications in liver and non-liver related diseases including primary sclerosing cholangitis (PSC). OCA enjoys orphan drug status in the U.S. and Europe for the treatment of PBC and PSC.

We expect investor focus to remain on pipeline updates form the company.

Intercept Pharma carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector are Regado Biosciences, Inc. (RGDO), Celgene Corporation (CELG) and Mallinckrodt plc (MNK). All these stocks carry a Zacks Rank #1 (Strong Buy).


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