Exelixis, Inc. (EXEL) said Friday that Takeda Pharmaceutical Co. Limited (TKPHF.PK,TAK) has received approval from the Japanese Ministry of Health, Labor and Welfare to manufacture and market Cabometyx (cabozantinib) as a treatment for patients with unresectable hepatocellular carcinoma (HCC) that has progressed after prior systemic therapy.
Takeda is Exelis' partner responsible for the clinical development and commercialization of Cabometyx in Japan.
"Hepatocellular carcinoma causes approximately 30,000 deaths in Japan each year and is a leading cause of cancer-related death worldwide. 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," said Michael Morrissey, President and Chief Executive Officer of Exelixis.
Under 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 noted that it continues to be eligible to receive additional development, regulatory and first-sale milestones for potential future cabozantinib indications. The company is also eligible for sales revenue milestones and royalties on net sales of cabozantinib in Japan.
Takeda's application in Japan 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, Exelixis said.
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