Exelixis, Inc. and Takeda Pharmaceutical Company Limited Enter into Exclusive Licensing Agreement to Commercialize and Develop Novel Cancer Therapy Cabozantinib in Japan
January 31, 2017
Share
Exelixis, Inc. and Takeda Pharmaceutical Company Limited announced an exclusive licensing agreement for the commercialization and further clinical development in Japan of cabozantinib, Exelixis’ lead oncology medicine. With the signing of the agreement, Takeda gains exclusive commercial rights for all potential future cabozantinib indications in Japan, including advanced renal cell carcinoma (RCC), for which cabozantinib is marketed in the United States and European Union as CABOMETYX™ tablets. The two companies will collaborate on the future clinical development of cabozantinib in Japan. Under the terms of the agreement, Exelixis will receive a $50 million upfront payment. Exelixis is eligible to receive development, regulatory, and first-sales milestones of $95 million for the first three planned indications. In addition, Exelixis will be eligible to receive royalties on sales by Takeda. Exelixis and Takeda will partner on cabozantinib’s clinical development in Japan and on translating existing and forthcoming clinical data for potential regulatory filings in the country. In the METEOR pivotal trial, cabozantinib demonstrated statistically significant improvements in overall survival, progression-free survival and objective response rate, meaningfully differentiating it from other therapies to treat advanced renal cell carcinoma following prior therapy. In addition to advanced RCC, future indications could include advanced hepatocellular cancer (HCC), the subject of the CELESTIAL global pivotal trial for which results are anticipated in 2017. Additional earlier-stage studies are under way through Exelixis’ collaboration with the National Cancer Institute’s Cancer Therapy Evaluation Program, and its ongoing Investigator-Sponsored Trial program. Through these two programs, there are more than 45 ongoing or planned studies including trials in advanced RCC, bladder cancer, colorectal cancer, non-small cell lung cancer, and endometrial cancer.
Exelixis, Inc. is an oncology company. The Company is engaged in developing medicines and combination regimens at the forefront of cancer care. It has produced four marketed pharmaceutical products, two of which are formulations of its flagship molecule, cabozantinib. Cabozantinib is an inhibitor of multiple tyrosine kinases, including MET, AXL, VEGF receptors and RET and has been also approved as CABOMETYX tablets for advanced renal cell carcinoma (RCC), for previously treated hepatocellular carcinoma (HCC) and for previously treated, radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC), and as COMETRIQ capsules for progressive, metastatic medullary thyroid cancer (MTC). The Company's other two products are COTELLIC, an inhibitor of MEK approved as part of multiple combination regimens to treat specific forms of advanced melanoma and MINNEBRO an oral, non-steroidal, selective blocker of the mineralocorticoid receptor (MR) approved the treatment of hypertension.
Exelixis, Inc. and Takeda Pharmaceutical Company Limited Enter into Exclusive Licensing Agreement to Commercialize and Develop Novel Cancer Therapy Cabozantinib in Japan