VX-950 Could circumvent a large Phase 111 trial

McDonald and a number of other Wall Street analysts still have high hopes for VX-950, a developmental-stage treatment for hepatitis C. Sales of VX-950 are expected to peak at $1.4 billion in 2011, according to McDonald.

The analyst said VX-950 has a chance of receiving regulatory approval earlier than expected if results of two upcoming mid-stage trials prove the drug's efficacy, which would allow the company to circumvent a large-scale Phase III trial.

"This would give VX-950 a one-year advantage over the competition and the ability to reach a forecast $1.7 billion of sales by 2011," he said.

This is news to me.  I thought you has to do phase 111 before going to market.
                                                    Ron

[Upbeat]

They have always maintained 3 months of treatment. If all works out in 9 months we will have the answer.  So far everything looks good.
                                                Ron

[FlGuy]

For them to estimate sales they would have to have a ballpark understanding of length of treatment, cost to consumers and number of potential consumers etc.  See any of that kind of data?

[cigaso]

I stopped tx about 5 months a go. I am contemplating starting again. However, VX-950 has me very intrigued. I live in Central Florida and called Shands' Hepatology/Liver department. They will have a phase II clinical trial for VX-950 starting this summer. It will be for tx naive people(eliminates me). It will consist of Pega/Riba/VX-950. The 950 will be taken for 12 weeks, but this group will continue to take Pega/Riba for the additional 36 weeks. I think they will compile their info for the VX-950, but I'm not sure why they this group will continue on to 48 weeks. I hope your right about phase III. Does anyone have a link? Thanks in advance.

[miked]

Upbeat,

Where did you get this information?  

Mike

[rossrad]

Hi Everyone,  I haven't been around for some time.  Been off on tangent researching OI (orthostatic intolerance).  I haven't made much headway determining the cause of my symptoms.  I still don't know if it's secoundary to the HCV, IFN Tx, or if I have a dysautonomia as a completely seperate issue.  I am hoping to start some good testing with neurologists at UCSF.  I guess I have come full circle again back to the HCV as a likely cause.  
Anyhow, reading the posts, I would like to say that for me I really hope phase 3 is not circumvented because I rely on the clinical trial as a source of having these very expensive meds paid for. And, for me, phase 3 is the only level of clinical trial worth the risk.  But, that's just me.  I know that for the greatest good it may best to get the stuff on the market.  I don't watch vx950 too closely because vertex is only planning to run trials for tx naive patients (rules me out).  But, in talking with vertex, it sounds as though a trial with vx950 for non responders may happen in 2007.   I have been watching  Scherings protease inhibitor for phase 3, which is anticipated late this year.  Schering has also been granted "fast track" for it's protease inhibitor.  So,  I don't see how vertex could have a years jump on them.
I know next to nothing about "fast track" status, but what I've read is that it basically gives the pharmaceutical company a direct link to the FDA analyst team.  They just get to bypass all the red tape.  I thought it meant they may enabled to begin phase 3 sooner, and maybe even concurrently with the ending of phase 2. But, I had not heard that they could completely bypass phase 3.  Hmmmmmmmmmmm.  Very interesting.
  
ross
  
ps. I know I've asked this before, but is anyone dealing with OI, who believes it may be due to their HCV, or caused by tx for HCV?