Exelixis, Ipsen deal

Exelixis granted Ipsen exclusive rights to develop and commercialize cabozantinib ( XL184) outside of the U.S., Canada and Japan. Swedish Orphan Biovitrum AB (SSE:SOBI; Stockholm, Sweden) markets cabozantinib capsules as Cometriq in the European Union, Switzerland, Norway, Russia and Turkey to treat medullary thyroid cancer (MTC) under a 2013 deal with Exelixis. Exelixis will terminate that agreement with Swedish Orphan for an undisclosed termination fee. An NDA and MAA for cabozantinib tablets are under review to treat advanced renal cell carcinoma (RCC) in patients who have received one prior therapy. The PDUFA date for the NDA is June 22; cabozantinib is under accelerated assessment in the EU. Next year, the partners expect data from the Phase III CELESTIAL trial of cabozantinib to treat hepatocellular carcinoma (HCC). Exelixis will fund development of existing trials, and Ipsen will cover 35% of future development costs.

Exelixis will receive $200 million up front and is eligible for milestone payments of $60 million upon approval of cabozantinib in the EU to treat second-line RCC; $10 million upon submission of a regulatory application to EMA for cabozantinib in second-line HCC; and $40 million upon approval of the second-line HCC indication. Exelixis will be eligible for additional undisclosed regulatory milestones and up to $545 million in sales milestones, including two $10 million milestones upon the launch of cabozantinib in the first two of Germany, France, Italy, Spain and the U.K. ...