Exelixis, Inc. (NASDAQ: EXEL) today announced that Takeda Pharmaceutical Company Limited (NYSE: TAK), its partner responsible for the clinical development and commercialization of CABOMETYX® (cabozantinib) in Japan, has applied to the Japanese Ministry of Health, Labor and Welfare (MHLW) for Manufacturing and Marketing Approval of cabozantinib as a treatment for patients with unresectable hepatocellular carcinoma (HCC) that had 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.
"We are excited about the progress our partner Takeda has made on advancing cabozantinib toward regulatory approval in Japan for patients with advanced liver cancer," said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. "This regulatory filing is an important milestone for patients in Japan who currently have limited treatment options after they have progressed following systemic therapy. We look forward to our continued collaboration as Takeda works to bring cabozantinib to patients in need of new therapies."
Per the terms of Exelixis and Takeda's collaboration and license agreement, Exelixis is eligible to receive a $10 million milestone payment from Takeda as a result of this latest submission for HCC, which is anticipated to be received in the first quarter of 2020. In April 2019, Takeda applied for approval to manufacture and sell cabozantinib as a treatment for unresectable and metastatic renal cell carcinoma (RCC) in Japan. Following the milestone associated with this HCC regulatory filing, Exelixis will be eligible to receive further development, regulatory and first-sale milestone payments of up to $76 million from Takeda related both to previously treated and previously untreated RCC and previously treated HCC. 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 is responsible for 20% of the costs associated with global cabozantinib clinical trials, providing the company opts into those trials.