PR: PROVE program to prepare for Phase 3

[chcnme]

SOURCE: http://biz.yahoo.com/prnews/070108/clm068.html?.v=60

Press Release Source: Vertex Pharmaceuticals Incorporated


Vertex Pharmaceuticals Announces 2007 Business Objectives at 25th Annual JPMorgan Healthcare Conference
Monday January 8, 8:30 am ET  
-- PROVE program to prepare for Phase 3 initiation of telaprevir (VX-950)--
-- Expanding clinical development into important HCV sub-populations --
-- Vertex building foundation for commercialization of telaprevir --


CAMBRIDGE, Mass., Jan. 8 /PRNewswire-FirstCall/ -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX - News) today announced its key business objectives for 2007 and provided an overview of recent developments, including highlights from research and development programs. Joshua Boger, Ph.D., President and Chief Executive Officer of Vertex Pharmaceuticals, will provide a corporate update at the 25th Annual JPMorgan Healthcare Conference in San Francisco on Tuesday, January 9, 2007. A live webcast of the presentation will be available on Vertex's website, www.vrtx.com, at 2:00 p.m. PST, January 9, 2007.
"2006 was a year characterized by significant clinical progress, including the first clinical data from the global Phase 2 development program, which established telaprevir as a leading investigational drug candidate for hepatitis C virus (HCV) infection," stated Dr. Boger. "With these important advancements, we are uniquely positioned in 2007 to build Vertex on telaprevir."

Continued

[chcnme]

"The initiation of Phase 3 clinical development with telaprevir is our primary objective for 2007. We anticipate that information derived from the PROVE program and other studies will support the design and initiation of a Phase 3 program," continued Dr. Boger. "More broadly, we are building our capabilities and adding expertise in key areas--clinical development, regulatory affairs, quality control, supply chain management, and commercial development--designed to support an NDA filing in 2008."


    2007 Clinical and Corporate Objectives

    - Broad clinical development program for telaprevir (VX-950)

      - Vertex today announced it has completed patient recruitment in the
        PROVE 2 trial in Europe of treatment naive patients with HCV.
        Additionally, patient recruitment in the PROVE 3 trial is expected to
        commence in January.  PROVE 3 is a Phase 2b study of telaprevir in
        more than 400 patients with genotype-1 HCV who have not achieved SVR
        with a previous interferon-based treatment.

      - To date, more than 600 patients have been enrolled in telaprevir
        clinical trials. PROVE 3 will increase this number to more than 1,000
        patients.  Vertex expects that clinical results from the PROVE program
        will provide important information supporting the design and
        initiation of Phase 3 trials in 2007.

      - Vertex expects that it will expand clinical development of telaprevir
        into important HCV sub-populations in 2007, including patients with
        genotype 2 and genotype 3 HCV infection.  Vertex also anticipates that
        it will initiate in 2007 a clinical trial exploring twice-daily dosing
        of telaprevir.

      - Vertex is conducting a variety of clinical, manufacturing, regulatory
        and market development activities in 2007 to support an NDA filing in
        2008.



Continued
Source: http://biz.yahoo.com/prnews/070108/clm068.html?.v=60

and see press release SOURCE:  www.vrtx.com

===============================================
NOTE:  "To support an NDA filing in 2008"

Keeping fingers crossed for everyone

[cigaso]

"To support an NDA filing in 2008."

How long would it be after the New Drug Application filing in 2008 would VX-950 be going to market? Assuming all went well.

[chcnme]

Assuming all went well?   hmmm.. really don't know.  I would like to think a year.

[chcnme]

Hey! yep, I think that's a blip we now see on the radar screen.  (ain't it a nice looking blip :)  Hope you're doing good.  Looks like they're going to be getting this going soon (PDQ :) and with the projection (now) for Vertex to file for an NAD in 2008, could it be?  hmmm...well no one knows, but I know I'm going to be asking the second opinion hep doc to do a blankety blank biopsy for me so I can make a blankety blank BLANK decision on what blankety blank direction I might want to go - no matter what - but especially with VX launching PROVE3 with more data in the next six months and possibly... just possibly ... on the near horizon, somewhere ....over yonder :)

[Imagine]

Is that a blip I see on the radar screen now for phaseIII ?

[Sincebirth]

Vertex just released a Webcast of their future with VX-950 you can listen here.  You may have to log in but it is worth it.  Just scroll down to Vertex.

http://www.mapdigital.com/jpmorgan/healthcare07/ondemand.html?archives=windowsmedia#v

[Kalio1]

This is from the FDA's website:


Drug Review Steps
1.Preclinical (animal) testing. Pre-IND
2.An investigational new drug application (IND) outlines what the sponsor of a new drug proposes for human testing in clinical trials.
3.Phase 1 studies (typically involve 20 to 80 people).
4.Phase 2 studies (typically involve a few dozen to about 300 people).
5.Phase 3 studies (typically involve several hundred to about 3,000 people).
6.The pre-NDA period, just before a new drug application (NDA) is submitted. A common time for the FDA and drug sponsors to meet.
7.Submission of an NDA is the formal step asking the FDA to consider a drug for marketing approval.
8.After an NDA is received, the FDA has 60 days to decide whether to file it so it can be reviewed.
9.If the FDA files the NDA, an FDA review team is assigned to evaluate the sponsor's research on the drug's safety and effectiveness.
10.The FDA reviews information that goes on a drug's professional labeling (information on how to use the drug).
11.The FDA inspects the facilities where the drug will be manufactured as part of the approval process.
12.FDA reviewers will approve the application or find it either "approvable" or "not approvable."

[chcnme]

Hi Flguy. I guess it's important to remember "fast track" when trying to put this information together, and then look at it comparatively (or opposed to a drug not fast-tracked.)

If you look at the new drug review (drugs not fast tracked)  by the FDA, phase 1 typically involves a few dozen to 300;  phase 2 typically involve a few dozen to about 300;  phase 3 typically involves several hundred to about 3,000 people).  

------------------------------

If you factor in fast-track status and look at projections, analysis, reports, plans, press-releases, conferences on VX-950 (this data can be found from several sources, such as the first one I put here or from vrtx,  http://www.vrtx.com/Pressreleases2007/pr010807.html

You will find  

PROVE 3 is a Phase 2b study with 400 patients with genotype-1. To date, more than 600 patients have been enrolled in telaprevir
clinical trials.

PROVE 3 will increase this number to more than 1,000
patients. Vertex expects that clinical results from the PROVE program will provide important information supporting the design and initiation of Phase 3 trials in 2007.

-------------------------------

Vertex reported several months ago

"We have begun to manufacture telaprevir (VX-950) drug product, in advance of obtaining regulatory marketing approval, in sufficient quantities to support a timely commercial product launch if we are successful in obtaining such approval."

(In advance is the key word; they are manufacturing in advance and prior to filing the NDA.)  

VX-950 was fast tracked by the FDA.  This means this drug could be pushed to market faster than drugs not fast tracked.  

Forward looking statements?  I'd say yes, for sure.

Looking good regardless of the forward-looking statements?  I'd also say yes, for sure :)  

[chcnme]

"We have successfully completed the technical development work for the Phase 3 and commercial formulation of telaprevir (VX-950). With this formulation, the dosing of telaprevir (VX-950) will be comprised of two 375 mg tablets to be taken every eight hours. We have begun to manufacture telaprevir (VX-950) drug product, in advance of obtaining regulatory marketing approval, in sufficient quantities to support a timely commercial product launch if we are successful in obtaining such approval. We expect that the level of our investment in commercial supply of telaprevir (VX-950) will increase significantly in 2007, and that we will incur significant costs to manufacture and store this inventory between now and the projected product launch."

"Maximize the value of telaprevir (VX-950).    

Our plan is to invest early and fully in the clinical development and preparation for launch of telaprevir (VX-950), in order to maximize the value of this compound. We have designed a comprehensive clinical development program for telaprevir (VX-950) consisting of multiple concurrent trials that will study the use of telaprevir (VX-950) in over 1,000 patients through the end of Phase 2b trials, which we believe will accelerate the time to market for this compound, if approved. In addition, we have begun to manufacture telaprevir (VX-950) drug product to ensure that we have sufficient quantities to support a timely commercial product launch if we are successful in obtaining marketing approval. We expect that the level of our investment in commercial supply of telaprevir (VX-950) will increase significantly in 2007, and that we will incur significant costs to manufacture and store this inventory between now and the projected product launch. We also have retained rights to telaprevir (VX-950) in North America and will benefit from Janssen and Mitsubishi's resources and development efforts in the rest of the world as we advance the development of this compound in our territory. The goal of this early and comprehensive investment strategy in telaprevir (VX-950) is to capture the full commercial potential of the compound if it is approved for sale.


http://apps.shareholder.com/sec/viewerContent.aspx?companyid=VRTX&docid=4648279

[FlGuy]

I guess those would be considered forward-looking statements.  In reading the results I noticed their definition of rvr at '10 iu/ml'.  Wasnt't the discussion around a trial pcr reported at '29' or '30' - or maybe that was in 'copies'.

[ChrisDDD]

I want to thank you for the link to this presentation.  I listened to it tonight and was very encouraged, particularly when I hear any indication that this may become a stand-alone drug that can be used in combination with other stand-alone drug and IFN won't be needed?  I still hope to be allowed into the Prove 3 trial, trying to keep it off my mind while anxiously waiting by the phone for the research assistant to call for commencement of pre-screening.