Takeda Pharmaceutical has signed an exclusive licensing agreement with Exelixis, a South San Francisco, California-based biopharmaceutical company, for the commercialization and further clinical development in Japan of cabozantinib, Exelixis’ lead oncology drug.

Under the agreement, Takeda will make a $50-million upfront payment to Exelixis. Exelixis is also 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.

In turn, Takeda gains exclusive commercial rights for all potential future cabozantinib indications in Japan, including advanced renal cell carcinoma, for which cabozantinib is marketed in the US and European Union (EU) under the brand name Cabometyx. The two companies will collaborate on the future clinical development of cabozantinib in Japan. Cabozantinib is not approved for use in Japan.

Takeda and Exelixis will partner on cabozantinib’s clinical development in Japan and on translating existing and forthcoming clinical data for potential regulatory filings in the country. Exelixis maintains its exclusive rights to develop and commercialize cabozantinib in the US, and its partner, Ipsen, a Paris-headquartered pharmaceutical company, maintains its exclusive commercialization rights for current and potential future cabozantinib indications outside of the US and Japan.

Cabometyx is a tablet formulation of cabozantinib. It was approved by the US Food and Drug Administration in April 2016 for treating patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. In September 2016, Cabometyx was approved by the European Commission for treating advanced renal cell carcinoma in adults who have received prior vascular endothelial growth factor-targeted therapy in the EU, Norway, and Iceland.

In February 2016, Exelixis and Ipsen jointly announced an exclusive licensing agreement for the commercialization and further development of cabozantinib indications outside of the US, Canada, and Japan. In December 2016, Exelixis and Ipsen jointly announced an amendment to their exclusive licensing agreement for the commercialization and development of cabozantinib to include Canada.

Source: Exelixis