Exelixis, Inc. and Ipsen have entered an exclusive licensing agreement for the further development and commercialization of cabozantinib, Exelixis’ lead oncology drug. Ipsen will have exclusive commercialization rights for current and future indications outside of the U.S., Canada and Japan. This agreement also includes rights to COMETRIQ, currently approved in the EU for progressive, unresectable, locally advanced or metastatic medullary thyroid cancer (MTC). Exelixis will maintain exclusive commercial rights for cabozantinib in the U.S. and Canada, and continue its discussions to partner rights in Japan.

Exelixis will receive $200 million upfront and is eligible to receive regulatory milestones, including $60 million upon approval of cabozantinib in Europe for advanced renal cell carcinoma (RCC) and $50 million for approval in advanced hepatocellular carcinoma (HCC), as well as milestones for potential further indications. The agreement also includes as much as $545 million of potential commercial milestones and royalties.

Marc de Garidel, chairman and chief executive officer of Ipsen said, “The robust results from the METEOR study in advanced renal cell carcinoma demonstrate that cabozantinib has the potential to become a key oncology product in Europe. This transaction will help Ipsen accelerate the growth of the company and strengthen its oncology footprint in Europe. We are excited to bring cabozantinib to patients and clinicians around the world.”

“In Ipsen, Exelixis has an ideal partner to maximize the potential for cabozantinib to have a positive impact on the treatment of cancer on a global basis,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “Ipsen’s established international oncology marketing presence, late-stage clinical development expertise and shared vision with Exelixis for the franchise potential of cabozantinib will accelerate cabozantinib’s commercialization in its territories, while Exelixis remains focused on our launch in the United States. While our immediate priority will be on advanced renal cell carcinoma, Exelixis and Ipsen are committed to exploring and potentially developing cabozantinib in a variety of cancer settings.”