InvestorsHub Logo
icon url

dewophile

05/24/16 4:05 PM

#201568 RE: DewDiligence #201566

It doesn't offer an 8 week option for GT1 like harvoni, so makes sense. I think it's safe to assume it will be priced on the higher end if limited to GT3 which now is very costly w sofosbuvir and daklinza - so good for ABBV/ENTA in GT3 w next gen regimen

I have to think GILD will stop making stand alone sovaldi though and also use sof/vel for GT2. That would stop companies from piggy backing on sovaldi to make competing regimens (e.g. BMY dropping the price of daklinza to compete in GT3 w sofo/vel)
icon url

willyw

05/25/16 9:06 AM

#201586 RE: DewDiligence #201566

This is what interested me;

http://seekingalpha.com/article/3977133-gilead-sciences-gild-management-presents-2016-ubs-global-healthcare-conference-transcript?page=2


"we have a triple combination in Phase 3, this is sofosbuvir/velpatasvir, voxilaprevir........
Vox is a pan-genotypic PI and we are looking at two avenues with this triple combination, first of all, eight weeks of treatment duration for treatment naive patients and then 12 weeks of treatment duration for people that have previously failed therapy. So we are looking at this the value of this will be - this is a universal salvage regimen of course if the data support that."

=================
(my comment)
1) I am thinking that this means that choosing a gilead program will be a bit more confusing; it will not be quite as pan-genotypic as Abbvies.

2) The main source of Abbvie competition will be against Sov-Vel or Harvoni. I look for Daclatasvir use to dwindle, or the cost will have to drop and there is the possibility that single agent Sovaldi may be phased out which could serve to prevent Daclatasvir or Simeprevir bolt on therapies.

3) Whereas we don't have confirmatory data in deep numbers, it appears that the Abbvie program may offer comparable efficacy across genotypes, may offer higher efficacy or shorter treatment times in some genotypes, and it may come very close (excepting in cirrhotics) to the Gilead triple therapy, which may be a salvage program anyway.

4) IF the mix of naives or treatment naive non cirrhotic increases, it would seem to me that Abbvie/ENTA will have the potential for many 8 week treatments (Abbvie CEO has mentioned this also). This could also serve as a more economical program since 8 weeks will cost less than 12 weeks.

icon url

DewDiligence

05/27/16 9:17 AM

#201629 RE: DewDiligence #201566

CHMP approves GILD’s Epclusa (SOF/VEL) for all genotypes of HCV:

http://finance.yahoo.com/news/european-chmp-adopts-positive-opinion-112500863.html

Formal approval for marketing by the EU Commission will follow in 2-3 months

As previously discussed on this board, Epclusa does not have an 8-week option and its commercial uptake is expected to be primarily in GT3 patients, who currently lack an adequate single-vendor regimen.

In the US, SOF/VEL has a PDUFA date of 6/28/16.