Telaprevir Webcast In 15 Minutes

[jmjm530]

Investor Webcast, 1:30 EST. Go to: http://www.vpharm.com/

Then click on "Events Planner more"
You may need to pre-register, takes about ten seconds. No doubt they will talk more about the late-breaking presentation and future plans.

I believe the webcast will be archived for a set number of days.

[willows]

The investor boards are all abuzz already, says the numbers were 79% after 4 weeks.  They aren't very smart on most of the boards, tho, but I think I like the sound of the foolish stock babble they are making.  Cross your fingers, personally, I'll take 80% anyday and be glad, no, heartbreakingly greatful for it.  Have a good one.

Willow

[chcnme]

intro speaker said

RVR rates and UND after 12 wks - "unprecedented data"

listening to Mchutchinson now - talking about ...he's excited about curing with Telaprevir and that 24 weeks will probably be way to go.  

additional data will be coming from Prove 1 and Prove 2 to desgign Phase 3 program - will be submited to FDA to support moving into phase 3 and to support design and registeration program.

12 + 12 arm - data will come over summer

Next few weeks and months more data will be coming - regulatory discussions, going foward, anticipate starting phase III before end of year.  

increased confidence of eradicating virus with shorter duration therapy

addresses Dr. Jacobson ....(didn't speak)   conclusion of web cast.

says they are very exicted about data

===========================
sorry for shabby and choppy transcript/ key points I heard, but - I just wanted to jot it down as I listened.  


  

[jmjm530]

Obviously those aren't the brightest light bulbs, but I'm sure that more educated analysts will put this in perspective from an investors point of view. From where I sit, it just means that things will hang on the 24-week results which haven't been released but we should all be optimistic about.

Chm,

Thanks for the partial transcript. I went out to eat at the beg of the webcast and can't seem to access it now. Maybe a time gap between the live feed and when it gets archived. Did they mention when the 24-week group data will be released? Previously, they suggested that data would be flowing in all througout '07 and hope they hold to it.

-- Jim

[copyman]

i listened to broadcast and my take on it is that 12 weeks tx was a success and is what they are going for and will present to the FDA later this year. they need some more data but it looks very promising for a short 12 week tx duration. i think they said they will design the prove 3 trials around 12 week tx. anyway i'm very happy with what was said :-)

[jmjm530]

I wasn't able to access the actual webcast, but what you say seems to contradict the release, as well as some of the webcast slides I saw. My understanding is that they found the 12-week results a "success" on a number of levels, but not regarding SVR rates, and that therefer they are shooting for a 24-week treatment. I do look forward to hearing the webcast later.

-- Jim

[chcnme]

Yes they did, Jim  (I think -I'm almost certain they did).  I think they also mentioned having collected over 5000 patient's data in the last two weeks to present today and that more data (that they were unable to get for this conference) would be forthcoming throughout the summer (so yes - throughout 07.)  

I also typed this on my notepad while listening

"phase II clinical trial results big step forward towards realizing product.    will get more data throughout the year -- this is first significant step towards product."  

I hope you get to hear it soon.   It was a good (great in my opinion :) webcast.  Have a great wknd!

[jmjm530]

I'm basing what I said on the written release in the other thread.
Principal investigator Hutchinson says, "...

[Sincebirth]

I listened to the webcast and have some conclusions regarding the data:

I jotted this down from one of the slides

Arm D patients
Total patients = 17
1 withdrew consent
Total patients on treatment = 16

Out of these 16 patients, 3 stopped treatment - 1 relapsed, 1 had acid reflux?, 1 had bad anemia.

That leaves 13 patients that completed 12 weeks - 4 did not achieve RVR at 4 weeks and continued treatment.

So now down to 9 patients that had RVR (all stopped treatment) and 6 went on to achieve SVR 20.

Hutchinson said it is very hard to determine a SVR percentage from this data because it is such a small subset of patients and there are too many variables of patients that "could" have achieved SVR that stopped treatment. And some (4 patients) are still on treatment.

But if you disregard the patients that had Acid reflux?, Anemia, and withdrew consent; you now have a subset of 14 patients. 6 of 14 went on to achieve SVR. (43% SVR) And 4 additional patients are still on treatment that could have potentially achieved SVR.  (Potential SVR rate 71%)

So we are probably looking at a bare bones minimum SVR rate of 45 to 50% for 12 weeks of treatment.

Hutchinson was clearly favoring the 24-week treatment regimen as potential SOC, not the 12 weeks regimen.

I am very excited to get the 24-week treatment arm data.

They also posted a slide regarding 2007 milestones:

Prove 1 12+12 duration arm due out in September (SVR 12)
Prove 2 12-week duration arm due out in September (SVR 12)
Prove 2 12+12 duration arm due out in December (SVR 12)
Regulatory Discussion starts in June
Phase 3 begins in November

[r4c7]

The results presented by Vertex at the Barcelona conference remind me of something my hepatologist said when I first saw him in February: He said, "with standard therapy, geno 1's have a 40% chance.  With VX-950, the percentage is more like 80%, and the treatment time is roughly half."  

Did he call it or what?  Whew!!!

[jmjm530]

I think your doctor will be proved correct, however as best I can tell, we don't have that data as of now.

[willows]

The one part of the webcast that stuck in my head was what they called "12+12".  Which equals 24, which we already knew, but it was still good to hear shortened tx time being talked about.  

You are right, there was little SVR rates, but a lot of RVR rates.  I will plant my little seed of hope in the empirical knowledge that a RVR at 4 weeks increases the odds of SVR dramatically.  They did not give us SVR numbers, too soon, but I do not feel premature in being happy from the RVR numbers, they were great.  To be UND at 4 weeks when I tried in 2003 would have been a gift from the gods.  So, good RVR numbers........is good enough for me today.  Take care.

Willows

[jmjm530]

Finally started listening to the webcast. It's under "archived" for those interested. But yes, Hutchinson did confirm what he suggested in his paper that 24 weeks appears to be the number they will most probably go with. He sounded extremely optimistic about the whole Telaprevir treatment process.

-- Jim

[jmjm530]

Pretty sloppy webcast btw. The Vertex presenter stubled and bumbled; Hutchinson sounded like he didn't have much sleep the night before and admitted that some promised data was not ready on time (what the f*ck);and Jacobsen another principal investigator who was supposed to be there was a no show, huh? Also, they didn't appear to take questions from the audience (or the web)like previous webcasts which was also disappointing.

Main points, however, mirrored the written presentation and did again suggest that the 24 (12 plus 12 group) is where the focus now lies and also not to try and extrapolate SVR numbers from such a small group presented upon today.

All that aside, I still think we have every reason to be optimistic about Teleprevir and this entire new category of treatment drugs, and to give Vertex a break, they have been running full steam ahead with this drug, and given the normally slow medical beurocracy, they seem more efficient than most.

Maybe it's because in my business -- marketing -- looks (presentations) do count -- but anyone else feel that the webcast presentation sucked?

-- Jim

[Pdilly]

Is it 12 + 12 for all genotypes?

[copyman]

i mis-understood when i listened. i heard what i wanted to hear, lol. still 24 weeks beats 48+ so i'm still happy being a 1a and possibility of not having these harsh drugs in my body for a whole year when i treat in the future. now i hope that the data that continues to come in stays positive so this has a chance to fast track to market within the next few years.

[Upbeat]

I take it there was no news from the Europe trial?  I am waiting to hear how the group with just vx-950 without the riba fared.

                                                                                                       Ron
                                                                                                  

[friole]

I just listened to the webcast.  I thought the presenter was a stutterer and did a good job - not a bumbler.

Sincebirth wrote down just what I did.  They only had the final data from 17 participants - and are still waiting to compile the data of another 80 from this trial.  

In the overall only 6/17 reached SVR 20 weeks post but they need the data on the other 80 before they can really do any percents.

Of note was that the data of any one not completing for one reason or another was not included in the final SVR number, however, several of fthe persons discontinuing did  stay negative.  He also mentioned that one dropped out due to anemia and some of the dropouts would not have happened in a normal situation (I am assuming he was talking about the use of resuce drugs).

The 12/12 as I understand it is 12 weeks of INF, RB and Teleprevir and 12 weeks of INF and RB.

Will be interesting to see what the stock does Monday.  

I am encouraged.
frijole

[chcnme]

Interesting transcript (long - question / answer-type session)  as it compares to what was presented today with respect to goals, expectations, plans, development, etc.  

http://seekingalpha.com/article/25843

[susan400]

I haven't been able to tell by looking at my consent form (for the screening part), whether it's Prove 2, or Prove 3.  I don't see anywhere on it where there's anything about Prove.  It does say, "A Phase 2 Study of Teleprevir (VX-950) in combination with Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Subjects w/Genotype 1 Hepatitis C who have not achieved Sustained Viral Response with a Prior course of Interferon-Based Therapy          Then, it goes on from there, but that's the Title of the study.    Should I assume from this that it's Prove 2?        Anyway, I'm hoping that I'm accepted in to it (first of all) and then, I'll go from there.  

Susan

[dmhrdh]

It's Prove 3.  It get's confusing because it's still a phase 2 study.  I don't know why it doesn't say Prove 3 on the consent title page.  I haven't looked to see if it's mentioned anywhere else in that stack...

[jmjm530]

Pdilly,

The trials are only for geno 1's so far, but based on In Vitro (test tube) studies, the drug looks extremely promising for genotypes 2, 3 and 4. Vertex plans on running trials for those genotypes in the near future. Relevant abstract below.

Susan,

You're applying for Prove 3, which as you say is a Phase II study. Prove 2 is the European study for treatment naieves. All the best luck getting into the study!

-- Jim
--------------------
TELAPREVIR (VX-950) IS A POTENT INHIBITOR OF HCV NS3 PROTEASES DERIVED FROM GENOTYPE NON-1 HCV-INFECTED PATIENTS

C. Lin 1, B.L. Hanzelka 1, U. Muh 1, L. Kovari 1, D.J. Bartels 1, A.M. Tigges 1, J. Miller 1, B.G. Rao 1, A.D. Kwong 1
1 Vertex Pharmaceuticals Incorporated, Cambridge, MA, USA

Background: Telaprevir (TVR, VX-950) is a highly selective HCV NS3