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334847 tn?1206530240

VX-950 Class Action Sec. Fraud

I have been an reader of these boards for several years - (don't participate - just mostly read).  I was interested a few years ago in the data on the Vertex (VX-950 Telepravir) Prove 1 Prove 2, and the ongoing trials.  It's been a while since I came by to see how the trials were doing or how folks in the trials were doing.  The boards have changed since I've been by (been a few months).   I don't see much "talk" on VX-950 on the boards (not like I used to - might be because I'm not looking in the right place), but anyhow - I came by to see if anyone had posted on the class action law suit that's been filed against Vertex (on behalf of investors / stock holders).   Was just wondering - have you all heard this?    I've gotten several news alerts on it in the last several days.   Thought some here might be interested.  You can read the complaint filed by going to the several law firms representing the plaintiffs if you're interested in seeing it.  Just google Vertex Class Action.   I've quoted from one law firm here without using their names  (don't know if that's allowed - if not - sorry.)   There is a deadline for investors - May 12,2008.


Symbol:  VRTX
Purchase Dates:  June 12th, 2007 - November 2nd, 2007
Deadline for Filing Lead Plaintiff Motion:  May 12th, 2008
Download the Complaint:  Vertex Complaint.pdf

March 18, 2008 - The law firm of Schatz Nobel Izard P.C., which has significant experience representing investors in prosecuting claims of securities fraud, announces that a lawsuit seeking class action status has been filed in the United States District Court for the District of Massachusetts on behalf of all persons who purchased the publicly traded securities of Vertex Pharmaceuticals, Inc. ("Vertex" or the "Company")(NASDAQ: VRTX) between June 12, 2007 and November 2, 2007, inclusive (the "Class Period").

The Complaint charges that Vertex and certain of its officers and directors violated federal securities laws. Specifically, defendants’ statements regarding the development of Vertex’s HCV protease inhibitor, telaprevir or VX-950, for the treatment of hepatitis C and the PROVE 2 trial were materially false and misleading because they failed to disclose unfavorable data regarding VX-950 from the PROVE 2 trial compared to PROVE 1. Specifically, PROVE 1 showed that patients taking VX-950 experienced 16% greater total viral reduction after twelve weeks compared to the control group. The results of PROVE 2, which defendants did not disclose during the Class Period, showed an advantage over the control group of only six percent. When the truth was disclosed on November 2, 2007, Vertex’s stock price dropped from $31.64 to $24.08 in two trading days.

If you are a member of the class, you may, no later than May 12, 2008, request that the Court appoint you as lead plaintiff of the class. A lead plaintiff is a class member that acts on behalf of other class members in directing the litigation. Although your ability to share in any recovery is not affected by the decision whether or not to seek appointment as a lead plaintiff, lead plaintiffs make important decisions which could affect the overall recovery for class members.

95 Responses
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750120 tn?1252455030
So UND means Undetectable viral load, and SVR means Sustained Viral Response as in continued undetectable?
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80575 tn?1207132364
Sorry for the delay.  Now that I'm SVR I don't come here every day.

Your stats sound promising.  I was UND between week 1-2, at weeks 12 and 24.  Today I'm about 15 months post tx and still UND.  I predict the same for you.

Cheers,

miked

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750120 tn?1252455030
I am going to "keep it simple" as most of us are not sufficiently schooled medically to undersand all of the technical terms used in these Hep C forums.  I do appreciate all of your comments, both positive and negative toward the drug company/companies and lawyers.  Taken all together, it is informative, educational and therefore, positive/meaningful.
I am presently in phase 2 clinical trials taking pegasys, ribaviren and the telepravir.  Of course I do not know whether I am getting telepravir or a placebo at this time.  Time and blood tests will tell.  I am hopeful that I am getting all 3 of the study drugs.  My Viral load count was 11,200,000 when I began on January 9, 2009.  I was taken off the combination therapy after 6-months the first time (several years ago) because I got too sick and never zero'd out.
I started this study informed by my physician of the up's and down's pros and cons.  Nobody lied to me (hopefully) and I trust my doctor.  I would think he is in the business of saving lives, not hurting people (Liver Specialist of Texas, Houston).  Anyone who has Hep C has hope for a cure, not unlike others with a disease that will eventually kill.  I would ask that we all tweak our correspondence by sticking with facts as opposed to speculation and irrational fears.  Anyone who has been on the treatment for Hep C is aware of the varied side effects and differing degrees of their effects.  It is very hard for some of us and others have it pretty easy.  Let's keep asking questions and talking about it.  We need that support (and the information is useful too).
It appears that many of us in this forum are friends of Bill W, Doctor Bob and the other fellowship.  I wish us all success in our journey to find a cure.------Joey J.
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80575 tn?1207132364
Hi guys,

Sorry I haven't been around for awhile.

At 48 weeks after stopping tx I was still UND and thus cured.  

miked
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220090 tn?1379167187
I also bought the stock when I saw the results. So far, I am only aware of one person that did not SVR with triple therapy.
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Avatar universal
forgot to mention that I had never bought stock before and probably never will again. Just figured I would take a chance seeing how this drug worked for me.  There is no better way for someone to get information on a new drug then to do it themselves.
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Avatar universal
My personal experience with the stock is that it is making me money so far. The day after seeing my UNDE 3 week pcr i purchased $5000 worth of vertex stock. Today a month later that stock is worth $7300 at $30 per share. I can see that stock easily hitting the $50-100 per share price when Telaprevir gets FDA approval. I look at it this way, I'm a paid lab rat :-)
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Avatar universal
sorry folks for some mumble jumble lately, but I'm using voice recognition software to rest my tendinitis, and like my ex-girlfriend the software often just doesn't want to listen to me LOL
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Avatar universal
In case anyone missed it, this thread is almost a year old. I do remember something about a suit last year, but parent why things are been resolved at least in the sense that the new trial results are very promising, then that the stock has done quite well this past year. In fact, if I remember correctly,Vertex was a number one performing stock in 2008 in the Nasdaq. Granted, not a great year for the NASDAQ :) but still Vertex was number 1, up up I think somewhere around 30%.

-- Jim
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Avatar universal
Miked is SVR. Hope you will be too.
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Avatar universal
You mentioned you were UND at week 2 and week 12, by taking  vx950 and ribivirin and Peg.  I was wondering the outcome when you were checked at wk 24. Cured or not.  
I finished my treatment on dec 4th. I was UND at wk 2 and also at wk 12.  At wk 24 doc called me to say stop treatments.  I was still UND.On dec 4th i took my last dose of ribivirin and peg. The doc drew blood that day.  I go back on Jan 5th to draw blood again. This will really tell the tale, since I have not had any drugs in my system for a month.
Please get back to me and let me know how you are doing. I will also let you know how I am doing.  I am praying for you and my family has prayed a lot for me.  I am grateful for that.









vx
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233616 tn?1312787196
I remember a huge scuttle butt about Vertex skewing numbers last year. Guess we all thought it got resolved but maybe not.

It could be the reduction in percentage is due to a tighter control in phase 2.
I mean, since they had so much trouble with cryopenia they may have lowered the dosing across the board, and hence gotten less results. (Of course if rescue drugs were allowed, then the greater dosages and hence results might follow.

In any case, the way they garbled their numbers I'm not sure anyone would know which ones to believe.
Maybe it's just important to know some of us will get something that might help...even if it does only turn out to give a 5 percent bump.
Like with HIV 12 drugs equally 20 extra years.....we'll take whatever we can get!
Of course, if I counted a penny for every time a stock I owned had doctored their numbers I could take you all to lunch!!
mb
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Avatar universal
I was in the PROVE2 trial and drew the no riba group.  I did not SVR.

I do have an issue with the trial, which is that it was never explained to me about the possible consequences re. that I might develop resistance to telaprevir if I got the drug and failed to SVR.  I accepted from the outset that the trial tx might fail, but I did not know that it was my one and only shot with telaprevir.  If I had been informed of that I don't think I would have done the trial.  Furthermore, it has been explained by HR on this forum that any experienced virologist would have known about the danger of developing resistance, from the history of the development of HIV antivirals.

Trial recruits are supposed to give 'informed' consent and to be informed by the study doc.  So there was definitely pertinent negative information witheld from me.  I find it a sad comment on this society that people can sue because they allegedly lost money by information being witheld but not because they may have lost their chance at a cure and in theory their fight for life.  The no-riba groups were an out-and-out scandal but it seems that anything goes as far as trial participants' rights.    

As for the posting of this thread, I'm all for making information public.  As far as I can make out, most folk with hepC try their best to make informed choices with insufficient information to go on and there's no need to perpetuate that by suppressing what information there is.  Thanks for posting, anonymice.

It pains me to write this because I know how important it is to have hope and how depressing it is when seemingly disappointing news comes out.  But the other side of that is the kind of blind optimism which got me into a train wreck.  I hope Vertex gets approval and gets telaprevir on to the shelves pronto because it obviously works.  That doesn't mean that we should ignore the trail of wreckage it left behind on the way.  There are many more drugs and many more trials to come.  Hopefully lessons can be learned which will add up to less people getting hurt in future trials.    

dointime    
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Avatar universal
Not planning to treat for awhile but how many of you were involved in trials that are still presently here and how are you doing
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86075 tn?1238115091
I'm soooo glad of your success, after that long of trying with soc... and I'm sure your giving many hope when they didn't have much...good on you!!!!!
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Avatar universal
If Vertex can cure me it can cure anyone. A huge problem with the PROVE trials is patient compliance, it was constantly stressed that taking the medicine every 8 hours was cucial to success. It took daily phone calls and reminder emails from my husband while I was at work and alarms all over our condo to keep me up to speed. This worked though, as I had never gone below 114K viral load on SOC and I fell from 14 million to 0 in 10 days on this stuff and have been there ever since. Those of you suing the company should hope you never need the help of an experimental drug to save your life; no matter how much money you milk Vertex for there is still no way your money can buy health.
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220090 tn?1379167187
I agree with you 100%.  I aargued repeatedly here that Vertex has done their best to produce a great new drug.  Many people in spite of overwhelming evidence to the contrary, insist the trials are rigged.
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Avatar universal
All I can say is that I am grateful to Vertex and their drug, I do NOT believe for one second that Telaprevir will fail or that it is "over-hyped". I failed 96 total weeks of SOC and after 25 years of infection and severe scarring, this drug has finally done the trick and cured me. We need to look beyond the stock price and to who the real victims are here; those are the patients infected who will one day face death or a transplant because we would rather crucify a company for being excited about its trials. No one should die from being a victim of red tape.
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220090 tn?1379167187
Schering-Plough(SGP - Cramer's Take - Stockpickr) may not be the formidable competitor to Vertex Pharmaceuticals(VRTX - Cramer's Take - Stockpickr) as previously thought, according to clinical data released Monday on their respective hepatitis C drugs.

The new clinical data, released in advance of next month's European liver disease meeting, pushed Vertex shares up almost 18% to $21.96 in recent trading.

Also aiding Vertex on Monday was new clinical data of its own showing that its drug telaprevir was effective in hepatitis C patients who cannot be treated with currently prescribed drugs.

Schering-Plough's experimental hepatitis C drug boceprevir given in combination with pegylated interferon and ribavirin pushed the virus below detectable levels in 38% of newly diagnosed patients after four weeks of treatment, according to new data from a phase II study released Monday.

In another group of patients who were pretreated with interferon and ribavirin before receiving boceprevir, 62% of patients achieved undetectable viral loads after four weeks.

This antiviral response at four weeks is known as a rapid virologic response, or RVR. It's widely believed that a vast majority of hepatitis C patients who achieve an RVR at four weeks will go on to be fully cured of their disease once a full course of treatment is completed.

This boceprevir data is not a robust as similar results previously presented by Vertex's hepatitis C drug telaprevir. In two phase II studies, 79% and 75% patients given telaprevir achieved so-called rapid virologic in two phase II studies.
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220090 tn?1379167187
And thank you for the apology as well.  

I don't know what is happening to me.  I completed treatment a week ago and feel like I am on speed.  I have more energy than I did for many years.  All this is a good thing, but it makes my more argumentative than usual.

Yes sailing is great.  Do you sail?

eric
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232778 tn?1217447111
I realize that many people have benefited from rescue drugs, by I did not use them (aside from a sleeping pill), and if you do not need to, many would prefer not to. My preference for the trials is that rescue drugs are not used, as it would seem to me, to "taint" the outcome, who knows what interactions they may or may not cause. Additionally, if we mask the side effects, how can we honestly compare the value of new drugs? All I know is that I suspect we will be waiting quite a while for the answers, I would be shocked if any of these drugs is approved in the next 5 years (except perhaps for limited circumstances) just based on the amount of "discussion" they generate on these boards alone. I also think that maybe more research should be done on the disease itself, looking for a fundamentally better treatment, rather than more "get rich  quick add ons". As it is, many are afraid of treatment due to toxicity concerns, added more drugs, even if shortening the treatment time, may just add to those fears, and drop out rates.
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334847 tn?1206530240
Hi Willie (and others).  I've got only a second on-line right now.   I read your note very quick, but .....oh yes indeedy  - do I ever remember the "rescue drugs"  (or VX not allowing them and SCH allowing them and how I wound up being so very glad everyone here was talking about "RESCUE DRUGS RESCUE DRUGS - you HAVE to have RESCUE DRUGS!!" .  If I get time to get back on-line later, maybe I'll bend your ear about how thrilled I was when my hep doc told me last year that HCV 796 DID allow rescue drugs!   Trials -.....they can make a body tired :)

Later!  :)  Got many clothes to fold!  
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Avatar universal
No worries and nice to meet you.  Although these threads can sometimes get contentious at times when I look back at some of my favorites it is often these threads that I enjoy the most.  A little back and forth can be fun and often when there is some disagreement the other side digs a little harder.  You can tell from the number of replies there is a high level of interest in this subject.  For me, I sometimes like to be able to play devils advocate and this thread has allowed me that......and perhaps the opportunity to pitch a few points myself that most people are unaware of.  Nice to meet you and perhaps I owe you a thanks for posting the article.  We'll see how it all shakes out.  It kind of reminds me of a lawsuit in which they have to designate a percentage of blame to the defendant.  In this case it would appear that there could be numerous other co-factors involved in the drop in stock price.  One rather large factor previously unmentioned has been the general financial outlook of our economy.  It will be interesting (and probably incredibly tedious as well) to see how they arrive at some sense of justice on this case.

Although there have been many comments in this thread and it's not possible to address them all one I would like to comment on is the notion that the numbers in a study can be skewed to present a more favorable outcome.  That is most certainly so...... but I am of the opinion that that these trials seemed to me to be run pretty objectively.  One must have certain criteria which rejects some trial applicants.  IF a trial would risk a persons life it seems sensible to exclude them.  IF the outcomes were clouded due to peoples other medical conditions it would also seem reasonable to exclude them as well.  Over all the trials were inclusive; although the early ones were limited to genotype 1's there were all ranges of liver damage admitted.  In Prove 3, the trial for past treatment failures they admitted all types of past treatment failures; relapsers, non-responders, breakthroughs and patients who had to stop TX either from their or their doctors decision.  

We also saw that Vertex did not allow "rescue drugs". Sherring-Plough DID allow the use of Procrit I think to keep people in their trial and on fuller dosage.  Why would Vertex do this when Sherring did not?  They were after uncompromised data.  Vertex no doubt knew that IF they allowed for example Procrit that the success rates would look better, but they opted instead for a more pure source of data in spite of the fact that it would make their outcomes look less robust.  In the end..... it might be argued that their stock price dropped through their own insistence at operating a trial without the smoke and mirrors that other companies have used during trials.  Their refusal to share information with stock companies except in the venues favored by the FDA cost them some investment dollars.  Ultimately...... it may mean for us....people with HCV, a better run trial and a smoother path towards approval.  This ultimately could benefit us since a poorly designed or compromised trial could mean delays in FDA approval.

Rather than higher scores the trials have provided an aggregate of scores that will need to be interpreted by the FDA.  It's interesting to note that the Prove 2 SVR rates were better than the Prove 1 rates, but my understanding is that the Europeans...... being generally healthier, often score higher than their North American counterparts.  

There are several dynamics at hand which will affect the trial results.  Since the trial started there may be greater emphasis on greater compliance.  People know that if they can hang on and stay on full dose....particularly in the early trial that they stand a great chance of SVR.  I personally believe that the SVR rates could go up a bit more if due to fewer dropouts, greater compliance, or a change in how they count the results.  My understanding is that any dropout is a number lost to the study; even if they were to SVR.  It is possible that rather than the numbers being artificially high, the numbers have not reflected the actual potential of the compound.  Only time will tell.  

It will be interesting to hear the Vertex results at EASL, as well as the many other competing coumpounds in trials.  

best,
Willy
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233616 tn?1312787196
there was plenty of chatter back when the news that they botched the numbers first came out....the whole study was maybe getting thrown out...

with 10 companies all viaing for the billions the next new drug will make...it's no surprise there will be more scutiny which is good really...

I mean..what if we take one mre poison that gives us 5 percent better odds only??

Tallahassee??  If we are talking MORE crawling skin that I want to rip off my body each night....then I'll skip that 5 percent.
better to take some ANTIfibrotics that do no harm...and may help fight VL then something that will tare you up...for no better odds.
Just my take.

the way I remember this is fuzzy didn't they screw up the numbers so bad it was like....thought someone went brain dead.....and how do you "prove" something like that is deliberate.  

the number a sckewed anyway....for instance, many studies disclose they had a certain drop out rate...but that rate is not included in the final stats....maybe they think it's irrelavant, since they did not make it through due to sides..no way of stating the ever SVR'd.//        However obviously leaving those folks out of the final addition can leave one with numbers twice as good as they really are.....and it's done everyday...
you kind of have to learn to read into the study stats what they are not telling you...
it's not "REALLY criminal".....yet it does tint towards the rosy doen't it.

good luck on getting money back for drug company screw ups.....
stockholders pay always, and lawyers only get rich on these class actions.
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