Dainippon Sumitomo Pharma (DSP) is paying Intercept Pharmaceuticals $15 million up front for rights to develop the latter’s Phase III-stage chronic liver disease candidate INT-747 (obeticholic acid; OCA), in Japan and China. Under terms of the deal DSP will develop the drug for primary biliary cirrhosis (PBC) and nonalcoholic steatohepatitis (NASH) indications. Intercept could receive another $300 million or so from DSP in development and milestone payments, plus tiered double-digit sales royalties. DSP in addition retains an exclusive option to license the drug for additional Asian territories, including Korea and Taiwan, and to develop OCA for other therapeutic indications.
Intercept recently started in a large U.S.-based placebo-controlled trial evaluating OCA in NASH patients under its CRADA with the National Institute of Diabetes and Digestive Diseases. The firm is separately preparing to start a Phase III trial for the PBC indication in the U.S. and Europe.
DSP says OCA will complement its existing hepatology pipeline, and its marketed alpha interferon Sumiferon®, and hepatocellular carcinoma drug Miripla®. “We strongly believe that OCA has the potential to significantly add to the treatment options that DSP can make,” remarks Masayo Tada, DSP’s president and CEO.
Intercept says the deal validates the potential of its OCA program. “This collaboration with DSP will provide important development support as we advance OCA in parallel for BPC, NASH, and possibly other indications,” comments Mark Pruzanski, M.D., president and CEO.
Intercept is focused on the discovery of modified human bile acids and other synthetic small molecules that selectively target bile acid-regulated nuclear receptors such as the farnesoid X receptor (FXR) and GPCRs including TGR5. Lead candidate OCA is a first-in-class FXR agonist derived from the primary human bile acid chenodeoxycholic acid. Intercept says positive results have already been generated through Phase II studies in patients with PBC and in type 2 diabetics with nonalcoholic fatty liver disease.
The firm’s preclinical pipeline includes a TGR5 agonist (INT-777) derived from cholic acid, and, a dual FXR/TGR5 agonist (INT-767) derived from chenodeoxycholic acid.