Vertex hepatitis C situation is unchanged but its cystic fibrosis drugs will be blockbusters
MD - While it would be wonderful/incredible/amazing to see 809 shipping in 2014, I would say that is too aggressive and unrealistic. VRTX is already a bit behind where they wanted to be for phase III's right now. I would be satisfied with mid-2015 (without mistakes/reporting errors along the way)... Verty & Third - am I right on this? (not to split hairs, just working to set proper expectations).
If they run a one year trial and submit an NDA to the FDA by early 2014, the VX-809/Kalydeco combo could be approved in 2014. Given the fast track status and the early approval of Kalydeco, the VX-809/Kalydeco combo should be on the market before the end of 2014.
While I'd love to see the combo to market by 2014, I think it will be 2015 for these reasons: I think FDA will insist on a 1 year trial (we'll know soon, and if only 6 months required, that will make it quicker). Even if they start in early 2013, it could easily be mid-year before fully enrolled and that is with a fast enrollment which I think is a certainty given EVERYONE wants this combo NOW. Which would mean that it would be, at earliest, mid-2014 before everyone has finished 1 year and then you need some time to evaluate and put together application and then if approved on fast track at least 3 more months. We're in the "if we can only keep DS healthy for another 2 years," coping strategy, which I guess would be end of 2014, but now that I think about it, it is more likely 2.5 years. What might change this: 1) 6 month trial; or 2) steller results after 6 months and FDA allows approval to go forward while still in Phase 3 (1 year period). But it could be early 2015. I know Vertex wants/ needs this to market soon, so it will be doing everything possible to get it there.
Vertex aims to file the NDA to the FDA by the end of Q4-2014 or Q1-2015. With this timelines in mind, add 4-6 months for approval and VX-809 will not be in the market until mid 2015 the soonest, sometime between June-September 2015. Expect that revenues will not be significant until 2016 with few months needed to launch and ramp up sales.