Intercept Pharmaceuticals, Inc. announced that key results of a phase III (POISE) study on its lead drug, Ocaliva (obeticholic acid) for the treatment of patients with primary biliary cholangitis, formerly known as primary biliary cirrhosis (PBC), were published in the New England Journal of Medicine.

The POISE study evaluated the safety and efficacy of once-daily treatment with Ocaliva in PBC patients with an inadequate therapeutic response to, or who are unable to tolerate ursodeoxycholic acid (UDCA). On a background of standard-of-care or when given as a monotherapy, results showed that both Ocaliva 5–10 mg (46%) and Ocaliva 10 mg (47%) were statistically superior to placebo (10%), thereby meeting the primary endpoint of the study.

In addition, Ocaliva improved multiple biochemical disease markers as compared to placebo, again with a high statistical significance.

We remind investors that Ocaliva was granted accelerated approval by the FDA in May 2016. The drug was approved in combination with UDCA for the treatment of PBC in adults with an inadequate response to UDCA, or as a monotherapy in adults who are intolerant to UDCA.

Ocaliva generated net sales of $75,000 in the second quarter of 2016, following its launch in June. The drug is currently under review in the EU with a response expected around 2016 end. The company continues to prepare for an initial launch in key European countries in 2017.

Intercept is currently conducting a phase IV confirmatory outcomes study – COBALT – on Ocaliva. Ocaliva is also being evaluated for additional indications including nonalcoholic steatohepatitis and primary sclerosing cholangitis.

Label and geographical expansion of the drug would boost Ocaliva’s commercial potential further. We expect investor focus to remain on the sales ramp-up of Ocaliva.

Intercept currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Actelion Ltd. , ANI Pharmaceuticals, Inc. (ANIP Quick QuoteANIP - Free Report) and Geron Corporation (GERN Quick QuoteGERN - Free Report) . All three stocks sport a Zacks Rank #1 (Strong Buy).

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