Biopharmaceutical firm Intercept Pharma (ICPT 125.28, -9.75) trades about 7.2% lower this afternoon despite a better than expected Q2 report and strong results from the company’s CONTROL trial, a placebo-controlled trial to prospectively characterize the lipid metabolic effects of obeticholic acid (OCA) and concomitant statin administration in patients with nonalcoholic steatohepatitis (NASH) with fibrosis or cirrhosis.
First and foremost, ICPT reported that its CONTROL trial met its primary objective by showing that newly initiated treatment with atorvastatin rapidly reversed OCA-associated increases in LDL to below baseline levels. Most of the effect was observed four weeks after initiation of the lowest available dose of atorvastatin and was sustained throughout the study period.
CONTROL is a 16-week double-blind, placebo-controlled, dose-ranging study of 84 NASH patients with fibrosis and compensated cirrhosis, followed by a two-year long-term safety extension (LTSE) open label phase which is currently ongoing.
During the ongoing LTSE phase, there has been one patient death due to acute renal and liver failure. While Intercept determined it could not be ruled out that this was possibly related to treatment, the principal investigator and the independent Data Safety Monitoring Committee determined the death was unlikely related to OCA.
As for the results, ICPT reported a slightly better than expected Q2 loss per share of $3.46 on revenues which grew north of 400% compared to last year to about $30.89 million as the company’s Ocaliva treatment recorded a strong result.
Worldwide Ocaliva sales were $30.4 million on $27.9 million in sales from the US. Net ex-US international Ocaliva sales were about $2.5 million in Q2. Ocaliva was approved by the U.S. Food and Drug Administration (FDA) in May 2016 for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. The company commenced its European commercial launch in January 2017 and was recently granted conditional approval by Health Canada in May 2017.
Additionally, ICPT recognized $0.4 million and $5.4 million of license revenue related to the amortization of the up-front and milestone payments under the collaboration agreement with Sumitomo Dainippon for the three months ended June 30, 2017 and 2016, respectively.
Looking ahead, ICPT expects to launch Ocaliva in key European markets through the remainder of 2017 and will continue to enroll clinical outcomes cohort in REGENERATE (the company’s Phase 3 trial in NASH patients with fibrosis). Further, the company anticipates initiating the Phase 3 trial in NASH patients with cirrhosis during the second half of this year.
Also, ICPT continues to see non-GAAP adjusted operating expenses in the range of $380-420 million. The expenses are planned to support the continued commercialization of Ocaliva in PBC in the United States and other markets, continued clinical development for OCA in PBC, NASH and PSC and the continued development of INT-767 and other pipeline programs.