Vertex hepatitis C situation is unchanged but its cystic fibrosis drugs will be blockbusters
It has long been widely accepted that Incivek would have declining revenues and would be surpassed by an oral hepatitis C regimen sometime in 2014 or 2015. This was apparent to analysts and investors when the share price dropped to $26.50 about one year ago. What no one knew at that time was how successful their CF drugs would turn out to be. First there was the early approval of Kalydeco for those with the 551 mutation. Now there are excellent phase II results with their VX-809/Kalydeco combination therapy for those with the homozygous 508 mutation. With FDA "fast track" status and phase III trials for VX-809/Kalydeco starting in early 2013, it is likely that Vertex will be able to treat most patients with cystic fibrosis sometime in 2014. How much revenue is left to be made from Incivek is almost irrelevant when one considers the staggering revenue potential of these CF drugs.
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).
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.
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.
first of all thank you for your cogent and very helpful posts to this message board. i purchased some Aurora Bio-Sciences stock back in 1999 (before they were bought out by Vertex). since then i have become somewhat familiar with the Hep-C players and the comments from the various analysts about their treatments (both potential and real).
it seems to me that lots of analysts and pharma columnists (meaning people who should know better) minimize (or leave out altogether) the SVR12 and SVR24 results with respect to GILD's drugs. the 100% (or near) "cure" in ELECTRON back in Apr 2012 turns out very differently by Nov 2012 when SVR12 results are tallied.
why should ABT's SVR12 results be judged inferior by so many compared to GILD's Nov 2012 SVR4 results?
also, i have not seen a single analysts or pharma columnist who has commented on the change in results from GILD's ELECTRON SVR4 in Apr 2012 compared to SVR12 in Nov 2012. why is this?
do you see a possible bias here or am i reading more into it than i should?