Exelixis, Inc. (NASDAQ: EXEL) and Ipsen (Euronext: IPN; ADR: IPSEY) today jointly announced an amendment to the exclusive collaboration and licensing agreement for the commercialization and continued development of cabozantinib,  to include commercialization rights in Canada for Ipsen where Ipsen has an established business (Mississauga, Ontario). Signed in February 2016, the original agreement gave Ipsen exclusive commercialization rights for current and potential future cabozantinib indications outside of the United States, Canada and Japan. Following the amendment, Exelixis maintains exclusive rights for cabozantinib in the United States and Japan, and is continuing discussions with potential partners for commercial rights in Japan.

Under the terms of the amendment, Exelixis will receive a $10 million upfront payment.  Exelixis is eligible to receive regulatory milestones, for the approvals of cabozantinib in Canada for advanced renal cell carcinoma (RCC) after prior treatment, for first-line RCC, and advanced hepatocellular carcinoma (HCC), as well as additional regulatory milestones for potential further indications. In line with the prior transaction between the parties, the agreement also includes commercial milestones and provides for Exelixis to receive tiered royalties on Ipsen’s net sales of cabozantinib in Canada.

“Exelixis and Ipsen have made significant progress together since signing our collaboration and licensing agreement in February, and considering the substantial business resources that Ipsen has in Canada, amending the terms to grant Ipsen Canadian rights is a natural next step,” said Michael M. Morrissey, President and Chief Executive Officer of Exelixis. “Over the past nine months, CABOMETYX^TM received regulatory approval for advanced RCC in the United States as well as the European Union, where Ipsen recently began launching the product.  Our collaboration with Ipsen is strong, and we look forward to continued progress as they pursue approval and commercialization in Canada.” 

David Meek, Chief Executive Officer of Ipsen, said, “Gaining commercial rights for CABOMETYX^TM in Canada expands our geographic footprint and strengthens our Oncology franchise in North America, one of our key geographic regions and main drivers of growth. This announcement follows numerous advancements in the CABOMETYX^TM program, including the recent approval in Europe. We are now focused on a successful European launch and are pleased to offer advanced renal cell carcinoma patients a new treatment option supported by a strong clinical profile. We look forward to continue working with our partner Exelixis to advance the cabozantinib program.”

CABOMETYX^TM was approved in the European Union (EU) on September 9, 2016 for the treatment of RCC in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy. Ipsen is currently initiating the launch of CABOMETYX^TM in the EU. The regulatory filing in Canada is expected in 2017, with regulatory approval anticipated in early 2018.