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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.
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.
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.
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.
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
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
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.
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!
Later! :) Got many clothes to fold!
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
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
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.
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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