Intarcia, Servier deal

Intarcia granted Servier exclusive rights to develop and commercialize ITCA 650 outside of the U.S. and Japan. Intarcia will receive $171 million up front and is eligible for $230 million for three early stage regulatory milestones. The deal also includes $650 million for additional development, regulatory, and sales milestones and tiered royalties from net sales ranging from low double digits up to the mid-30s. Intarcia CEO Kurt Graves would not disclose what will trigger the milestones, but said Intarcia "should get $400 million over the next 2 to 2.5 years." The total deal is valued at over $1 billion.

In October, ITCA 650 met the primary endpoint of reducing HbA1c levels in two Phase III trials to treat Type II diabetes -- FREEDOM-1 and FREEDOM-1 HBL. Intarcia expects full and partial data from two remaining Phase III trials, FREEDOM-2 and FREEDOM-CVO, by the end of summer 2015 and in 2H15 respectively. The company plans to submit an NDA to FDA in early 2016. ...