Shares of Intercept Pharmaceuticals, Inc. (ICPT - Free Report) have gained 59.2% in the year so far, against the industry’s decline of 25.6%.
Intercept’s focus is on treating orphan and more prevalent liver diseases with limited treatment options. The company received a significant boost with the FDA approval for lead drug Ocaliva (obeticholic acid/OCA) in combination with UDCA, for the treatment of primary biliary cholangitis (PBC) in adults with an inadequate response to UDCA or as monotherapy in adults who are intolerant to UDCA in May 2016.
The FDA approved Ocaliva under its accelerated approval program based on a reduction in alkaline phosphatase (ALP), since an improvement in survival or disease-related symptoms has not been established yet. Additionally, in December 2016, the European Commission granted conditional approval to Ocaliva in combination with UDCA. In May 2017, the drug was approved in Canada.
The initial uptake was encouraging. However, sales took a hit due to safety and dosing issues. Earleir, the FDA reported 19 deaths due to incorrect dosing of Ocaliva, and stated that the drug may also affect the liver. In February 2018, Ocaliva’s label was updated in the United States, to include a boxed warning and a dosing table that reinforced the existing dosing schedule in PBC patients with Child-Pugh Class B or C, or decompensated cirrhosis.
Nevertheless, management’s efforts to increase awareness about the updated label and promote Ocaliva, thereafter, is reaping results. Ocaliva recorded $46.6 million of sales in the third quarter, up from $43.2 million recorded in the second quarter of 2018. The company has expanded its sales force to reach out to more physicians, and sales are expected to ramp up to come between $170 million and $185 million in 2018.
Meanwhile, Ocaliva is also being evaluated for other indications, including non-alcoholic steatohepatitis (“NASH”) and primary sclerosing cholangitis (“PSC”). The phase III NASH program includes the REGENERATE trial among patients with advanced liver fibrosis and the REVERSE trial among patients with compensated cirrhosis.
The FDA earlier approved a redesign of the phase III REGENERATE trial on Ocaliva for the safety and efficacy in treating NASH patients with liver fibrosis. The company now needs to achieve only one co-primary endpoint, either fibrosis improvement or NASH resolution compared with the earlier target of achieving both.
Top-line results from the REGENERATE trial are expected in the first half of 2019. The REVERSE trial is designed to evaluate the efficacy and safety of Ocaliva in NASH patients with compensated cirrhosis.
The trial is currently enrolling.
Per estimates, NASH is expected to surpass hepatitis C as the leading reason for liver transplants in the United States and Europe. NASH market has huge potential, and a tentative approval will boost Ocaliva’s prospects, further. This space has been in focus in 2018, with shares of a few companies soaring on positive data from their NASH candidates.
Gilead Sciences Inc. (GILD - Free Report) has a promising late-stage NASH candidate. Israel-based Galmed Pharmaceuticals (GLMD - Free Report) earlier reported positive data on its NASH candidate, Aramchol. Madrigal Pharmaceuticals (MDGL - Free Report) also has a promising candidate for NASH.
Intercept currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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