Vertex down 15%

[Upbeat]

Oh my

Just noticed that Vertex stock is down over 5 bucks a share. Over 15%.  I wonder who knows what. I don't own the stock but I hope its not a bad omen for the meeting.

                                                                                                                                        Ron

[mremeet]

Yep, it's slippin' hard. I think the recent good news about SCH503034 is driving it down this time. Could be major competition for VX950, especially if SCH503034 doesn't have the rash problem that Telaprevir does. Plus, SCH503034 is at the same level of development as telaprevir is (phase IIb), so it could be FDA approved no later than Telaprevir...maybe even sooner. And this doesn;t even factor in Alinia and what it might bring to the table. Could be pretty dicey for VRTX stock for some time I think.

[Willy50]

As I type this Vertex was down about 20% to about $29.  It seems to be in the wake of positive data on boceprevir, the New compound being developed by Sherring Plough.  It looks as if the SGP compound will be comparable, but they only released a little data.  

IF boceprevir had better response rates then Vertex might not be the "lead" compound.  That means many investors could jump ship.

Per one of our posters here that was on the trial they reported that the SGP trials allowed "rescue drugs" whereas the Vertex trial did not.  This could be a situation where apples are being compared to oranges since the 2 trials are not set up the same.

Either way...... if you are a Vertex investor you might be crying.  If you are only an HCV infected person you might see this as having 2 potentially successful componds in development; a win-win.

When I first saw the stock drop like that I naturally assumed that it meant there was something amiss about Telaprevir.  I'm not so sure about that now; I think it's just the stock market going nuts over early news.  

Willy

[mremeet]

"Per one of our posters here that was on the trial they reported that the SGP trials allowed "rescue drugs" whereas the Vertex trial did not."

Not exactly. In the Vertex Prove 1 and 2 trials rescue drugs were prohibited only during the first 12 weeks when the research drug was in play. After that rescue drugs were permitted. In prove 3 Teleprevir dosage exceeded 12 weeks in some arms, so I'm not sure if rescue drugs were still prohibited after that time...but I think they still were (someone correct me if I'm wrong). There were also at least some cirrhotics in prove 3, not sure if any cirrhotitcs were allowed into the SCH503034 trial. Inclusion of cirrhotics will probably lower the overall SVR rate somewhat, so that might be another apples to oranges comparison. Either way, for the patient this is win win. For the investor, it's going to be rough going trying ot predict ahead of time who's gonna come out on top.

[Proactive]

"A total of 595 patients have been treated in the HCV SPRINT-1 study at sites across the United States, Canada and Europe, including 491 patients treated with boceprevir. Overall, 77 percent of patients in the study were enrolled in the United States. African-Americans represent 16 percent of the patients enrolled in the study and 7 percent of patients in the study are cirrhotic"

[jmjm530]

Pro: African-Americans represent 16 percent of the patients enrolled in the study and 7 percent of patients in the study are cirrhotic"
-----------------------
That could def account for the low SVR rates in the SOC group. It also makes the Boceprevir numbers look even better.

I agree, this is a win-win for us -- as to the investors, biotechs have always been chancy.

-- Jim

[Willy50]

here's a link to that thread;
http://www.medhelp.org/posts/show/324456

Mre, thanks.  I went back to this thread and saw it was a larger study and that appeared to have good..... in in some regards perhaps better results although really we've not seen much real data.

I think the point I was trying to make was that on the Vertex trials certain rescue drugs were prohibited during the VX treatment phase, not during the entire trial.  I got the impression that the Sherring trial allowed them during the trial compound treatment but it wasn't totally clear from the posts.  

IF the Sherring compound has comparable efficacy and fewer sides it could provide some real competition for Vertex.  About 2 weeks to go to AASLD.

here's a hot off the presses article by Adam Feuerstein on the subject;

http://www.thestreet.com/_yahoo/newsanalysis/biotech/10385195.html?
cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA

Willy

[mremeet]

Yeah, not sure what's up with the procrit/anemia thing with the Boceprevir. According to a recent "quote of a quote" from Ironduke "I'm in the Scherring-Plough trial.  They weren't going to allow rescue drugs but so many people headed toward anemia that they changed the protocol and they sprung for Procrit." Not sure if this means anemia is a bigger problem with Boceprevir than it is with Telaprevir (which to my knowledge and experience is pretty minimal).

Also, isn't it odd that such a large cohort of over 800 Boceprevir test subjects are out there somewhere, and yet the only two I've seen since I've been on this forum (for over a year now) are "Ironduke" and "JOHNWS"? And those two just magically popped in here simultaneously just yesterday right on the eve of this test result press announcement? I dunno, I guess I'm getting paranoid in my old age, but what's that all about?? ;-)

[glucklich]

In this study of well-documented null nonresponders, some patients achieved a sustained virologic response (SVR). Overall, 7-14 percent of patients in the boceprevir crossover arms achieved SVR compared to 2 percent in the control arm.

Intersting

[Willy50]

working backwards;

Glucklich; "This study was complex, involving seven different treatment arms. Patients were initially randomized to low doses of boceprevir (100, 200, 400 mg TID) before initiating an 800 mg TID boceprevir arm."

I guess that this was their way of working into the drug but it may not provide the strongest antiiral response.  The jury isout on this one but they may be able to up the SVR rate.  When I saw that I assumed that the Vertex rate could be comparable.  I'm hoping for far more robust response rates in the Vertex trial.  This data scared me a little if you could extrapolate it into likely Vertex Prove 3 results.

MREmeet; Did you see the discontinuation results in this trial?
"Treatment discontinuations due to adverse events were 12, 9, and 8 percent for patients in the boceprevir regimens, respectively, compared to 5 percent for the control arm."

This treatment still may correspond roughly with the Vertex discontinuation results.  Frankly some of the information out there doesn't quite line up.  We have to actually wait till the data is out there and try to make actual comparisons.  Due to the trial designs I'm really not sure that we can accurately.

We may also be faced with a situation where ....lets say for argument if Vertex were more potent but had worse sides..... which way would people go?  We seem to be getting hype that the SGP drug has no sides and yet the discointinuations seem comparable to Vertex and yet some or even many of the folks were on rescue drugs.  

Willy

[JOHNWS]

I think they allowed rescue drugs. I beleive it was a trial coordinator decision. However with me they reduced the riba dose to control the anemia, the hep doc was not a big believer in procrit. I have been reading post lately, I jumped in recently because I received my last batch of drugs. I will continue to post and give updates for my post treatment blood results

[willows]

I second your paranoia and raise you a question...where have these folks been?

Willow

[Proactive]

seems you only show up when vrtx stock is discussed so I'll ask you..In light of todays stock price drop, which obviously is their currency, how much more profit/rights to sales of vx950 do you expect them to have to give away before marketability of the drug? When reviewing their cash burn rate, cash on hand & equivlents it certainly looks like the will have to dip into the well again to go the distance...What do you expect to be leftover for current shareholders?
Let's remeber what they already have given away..
"Under the agreement, Janssen will have exclusive rights in Europe, South America, the Middle East, Africa and Australia, and Vertex will retain exclusive commercial rights to VX-950 in North America."

[Proactive]

PS: I'll appologize now (for everyone) for posting my above question, because I do know we are on the wrong board!
....;^)

[jmjm530]

Mike may disagree with me, but I think you're on the right board. At least previous VX stock talk has been here.

The reason I think it's the right side is because any discussion of Telaprevir's price invariably turns into a discussion of Telaprevir, which belongs on this side. Anyway, as you know, there is a fuzzy line between the two sides and there can be honest disagreement over what goes where. Thanks for the update, it made for an interesting discussion and probably introduced Boceprevir to a lot of folks.

-- Jim

[glucklich]

Frankly I never get the stock enthusiasm. Given that the duration of treatment is so long and the demographics of the HCV population world wide is not conducive to a treatment with severe side effects, I think the market potential is tagged a bit high.

[willows]

Well, as a non responder, stage 3, waiting for telaprevir, yes, I guess the only time I get vocal is when Vertex stock is talked about.  Beats whining about how bad I feel, so many people here working hard on making it thru tx, my story does not add much.  

As for giving away rights...I think the people in charge of Vertex will give away whatever it takes to bring telaprevir to market.  They receive milestone payments from J&J for goals met on the trials, but I haven't seen one of those mentioned for a while.   With the CDC figuring there are about 4 million folks infected with HCV in the US right now and another 1 million in Canada, I believe Vertex will do just fine.  

I have the greatest doctor from the University of Washington hospital, he is so very enthusiastic about telaprevir....I just gotta believe him and hang until it is my turn.   As for the stock in Vertex, my gosh, talk about a wing and a prayer.  The whole market is in a very turbulent time, and biotech has always been so risky...ask any investor in Idenix.  So all I can do is walk the line and keep up with the latest news, because it means so very much to me personally.

[Proactive]

fair enough willows, and of course wish you the very best as a non responder..
"With the CDC figuring there are about 4 million folks infected with HCV in the US right now and another 1 million in Canada" Do you have any idea how many people are currently treating with SOC? At one time I found a number (I'll look again), but that number was tiny....are you expecting a flood of new treaters as a result of new PI's?

[Proactive]

Jim since we are straying a bit, I recall you mentioning you have been prescribed various ribas. Did you feel any difference with the various pills? I just started in with capsules, after 2 different tablets and thought maybe I felt a bit different, but figured it was just in my head because I did my morning shot today....Pro

[willows]

Well, conventional wisdom says that many younger folks are avoiding tx right now because of the horrific stories they have heard about IFN and riba.  If the odds are upped to 80% and tx time shortened to 24 weeks, seems to me that many more folks will do treatment.  I know I will try it again, in a heartbeat.  Has to be a piece of cake compared to 30 weeks of SOC, only to have viral breathru and have to quit.  In retrospect, that 30 weeks may have been a worse experience than I realized, my doc is concerned for any non-responder like me with viral breakthru, my virus mutated against IFN and does that mean that I will have a harder time than a naive patient?  Probably, but I think non-responders like me will become very much more rare in time, with the addition of PI's to tx.

After the $6.00 drop this morning, I have done some research on Scherings SCH503430.  It is worth the time to drop the name in google and go back to 2005 and read comparisions to Schering and telaprevir.  Telaprevir has been performing better for two years now, even with the re working of Scherings trials.  As I said before, space/time flows the same for any company and Vertex is so far ahead of Schering...I'm thinking it will be the first PI for about two years and then we will be flooded with so many new drugs.  All this is comparable to the history and evolution of the HIV/Aids arc.  Those sufferers now have 200 drugs to choose from...less of them are dying than from Hep C.  So I think there's room for telaprevir and Schering.  And I hope a lot more.

[Proactive]

I do agree. The price alone makes treatment of any type extremely exclusive.

[mremeet]

Forgive me for being a bit suspicious, but I'm just curious why you guys have come out of the woodwork only now? The very day of the first real news release, and both of you making your appearance more or less simultaneously (although ironduke made a post about a month ago). Do you guys know each other? Just seems a bit odd that we haven't seen any boceprevir subjects here, at least I haven't. Not a one in over a year of hanging here, and then you two guys come along exactly at the same time and on the exact date of the first real press release concerning the first test results. Plus both of you have happy stories concerning your viral performance in conjunction with minimal sides. If I were the suspicious and paranoid sort, I might think you guys are here to "manage" the interpretation of this newly released information. Please, tell me I'm a complete paranoid and allay concerns that you two might not what you appear to be. ;-)

[Proactive]

"Well, conventional wisdom says that many younger folks are avoiding tx right now because of the horrific stories they have heard about IFN and riba"..I think that is stretching it a bit. The sandman is knocking at my door and the evening fog is rolling in...'nite Pro

[Cheesegrater]

I took a look at the text at
http://www.natap.org/2006/EASL/EASL_15.htm

I'll cut and paste here...

Sequence Analysis of HCV Protease
-- 18/19 patients had no detectable variants
-- patient #105: a single mutation at position T54 was identified during SCH 503034 mono- and combination tx
-- Variant became non-detectable after washout period
-- Quasi-species analysis are under way
NOTE from Jules Levin: at the meeting after Zeuzem gave his talk I asked him from the microphone why they had so little resistance, 1 mutation in 1 patient, compared to VX-950, for which Vertex presented much resistance data, the response Zeuzem said was-the resistance test used in this study was not as sensitive and SCH503034 was not potent enough to cause resistance.

I guess we might hear more about mutations and resistance as the trial continues, or when all the data is in.
The current schering data is from an ongoing trial, is it not?

Cheese

[merryBe]

can't find trial 3 anywhere, and now this....from my days trading stock I'd say those in the know have already blown town. That and how is the competion doing, market wise?