Benzinga | Nov 27, 2020 08:02AM EST

Exelixis Reports Partner Takeda Receives Approval In Japan For CABOMETYX For Treatment Of Unresectable Hepatocellular Carcnioma

Exelixis, Inc. (NASDAQ:EXEL) today announced that Takeda Pharmaceutical Company Limited (Takeda), its partner responsible for the clinical development and commercialization of CABOMETYX(r) (cabozantinib) in Japan, received approval from the Japanese Ministry of Health, Labor and Welfare to manufacture and market CABOMETYX as a treatment for patients with unresectable hepatocellular carcinoma (HCC) that has progressed after prior systemic therapy.

Takeda's application is based on the results of two clinical trials in patients with advanced HCC who had received prior systemic therapy: CELESTIAL (XL184-309), a global, randomized, placebo-controlled, double-blind phase 3 clinical trial, and Cabozantinib-2003, a phase 2 clinical trial conducted in Japan. The CELESTIAL trial was the basis for the CABOMETYX approvals in the U.S. and the EU for the treatment of patients with HCC who have been previously treated with sorafenib.

"Hepatocellular carcinoma causes approximately 30,000 deaths in Japan each year and is a leading cause of cancer-related death worldwide," said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. "The approval of CABOMETYX in Japan is an exciting next step toward bringing this treatment to liver cancer patients who otherwise have limited treatment options following prior systemic therapy. We're proud to collaborate with Takeda as we work to bring this treatment to patients in Japan."

Per the terms of Exelixis and Takeda's collaboration and license agreement, Exelixis is eligible to receive a $15 million milestone payment from Takeda upon the first commercial sale of CABOMETYX for unresectable HCC, which is expected to occur in the fourth quarter of 2020. In January 2020, Takeda's application for approval to manufacture and sell CABOMETYX as a treatment for patients with unresectable HCC that had progressed after prior systemic therapy in Japan triggered a $10 million milestone payment. Exelixis continues to be eligible to receive additional development, regulatory and first-sale milestones for potential future cabozantinib indications and is also eligible for sales revenue milestones and royalties on net sales of cabozantinib in Japan.

Takeda fully funds cabozantinib development activities that are exclusively for the benefit of Japan and has the opportunity to share the costs associated with global cabozantinib clinical trials, providing the company opts into those trials.