Vertex Pharmaceuticals is expected to sell the rights to certain milestone payments tied to the future regulatory filing, approval and market launch of its hepatitis C virus (HCV) protease inhibitor drug candidate – telaprevir, in Europe.
The company said that as a part of collaboration to develop and commercialize telaprevir for the treatment of HCV, Janssen Pharmaceutica agreed to pay Vertex a total of $250 million in aggregate milestone payments, for successful development and launch of telaprevir in the EU.
The milestones anticipated for telaprevir in Europe include $100 million related to regulatory filing and approval, and $150 million related to launch of telaprevir.
Vertex anticipates to earn these milestones prior to April 2012, based on development and commercial timelines.
Telaprevir is being evaluated in three phase-III studies that have enrolled more than 2,200 patients in the US and Europe.
The company said that the telaprevir dosing portion of all of these studies has been completed, and sustained viral response (SVR) data from all three phase-III studies are expected to be available in mid-2010. This would support planned NDA and Marketing Authorization Application filings in the US and Europe, respectively, in the second half of 2010.