Dainippon Sumitomo in up to $315 million deal with Intercept for liver disease drug obeticholic

Japanese drug major Dainippon Sumitomo Pharma (4506:JP) has entered into an exclusive licensing agreement  with privately held US firm Intercept Pharmaceuticals for the development and commercialization of Intercept's first-in-class FXR agonist obeticholic acid (OCA, also known as INT-747).

Under the terms of the deal, Intercept will receive an initial $15 million from DSP and will be eligible to receive around $300 million in additional milestones associated with the successful development and commercialization of OCA. Upon launch of the drug, Intercept will be entitled to receive tiered double-digit royalties from DSP based on sales in its territory. DSP has the exclusive option to add several other Asian countries to its territory, including Korea and Taiwan, and to pursue additional indications. DSP will be responsible for the costs of developing and commercializing OCA in its territory.

DSP will advance OCA in Japan and China for the treatment of chronic liver diseases, with an initial focus on primary biliary cirrhosis (PBC) and non-alcoholic steatohepatitis (NASH). Intercept is currently preparing for the initiation of a Phase III PBC program in the USA and Europe and, under the company's cooperative R&D agreement (CRADA) with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), a large placebo-controlled trial of OCA in NASH patients recently started enrolling in the USA.