Intercept Pharmaceuticals, Inc. ICPT announced that it has achieved two important regulatory milestones related to its lead candidate, obeticholic acid (OCA).
The company has completed submitting a rolling new drug application with the FDA (initiated in Dec 2014) for an accelerated approval for OCA for the above indication. Additionally, the company’s marketing authorization application for the candidate has been accepted for review for the same indication by the European Medicines Agency.
We note that Intercept Pharma is looking to get OCA (in combination with ursodeoxycholic acid (UDCA)) approved for the treatment of primary biliary cirrhosis (PBC) in patients who respond inadequately to UDCA or as monotherapy in those unable to tolerate UDCA.
According to Intercept Pharma, PBC is the second-leading cause of liver transplant among women in the U.S. and affects roughly 1 in 1,000 patients over the age of 40. In Europe, 50% of liver transplants due to cholestatic diseases and 6% of all liver transplants are associated to PBC. Given that UDCA is the only approved treatment for PBC, and majority of patients undergoing UDCA therapy experience persistent elevations in serum marker alkaline phosphatase beyond the upper limit of normal, the company believes that there is a critical need for new treatments for PBC.
We note that OCA enjoys both orphan drug and fast track designation for PBC in the U.S. In Europe it enjoys orphan drug status for PBC. In Dec 2014, Intercept Pharma commenced a phase IIIb confirmatory clinical outcomes study on OCA for PBC as per the FDA’s accelerated approval regulations. This study will enroll about 350 patients suffering from advanced PBC and is expected to be completed on a post-marketing basis.
We are pleased with the company’s efforts to develop and commercialize its lead candidate. If approved, OCA stands to gain a large share of the PBC market. We expect investor focus to remain on regulatory updates from the company.
Meanwhile, Intercept Pharma is evaluating OCA for other chronic liver diseases including nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis and biliary atresia. The company intends to initiate a double-blind, placebo-controlled phase III study on OCA for NASH in the third quarter of 2015.
Intercept Pharma carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Gilead Sciences Inc. GILD, Johnson & Johnson JNJ and Abbott Laboratories ABT. While Gilead holds a Zacks Rank #1 (Strong Buy), J&J and Abbott carry a Zacks Rank #2 (Buy).
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