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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.
This is the first I heard of this. I am a Prove 3 patient.
The lawsuit basically says that Vertex failed to report unfavorable information in Prove 2.
My hope has been the Prove 2 data that geno 1s receiving VX950+RBV+INF for 12 weeks followed by 12 weeks SOC and experienced RVR....the odds are quite high.
Does anyone have information about what the unfavorable data was for Prove 2?
anonymice...thanks for the post.
miked
The lawsuit basically says that Vertex failed to report unfavorable information in Prove 2.
My hope has been the Prove 2 data that geno 1s receiving VX950+RBV+INF for 12 weeks followed by 12 weeks SOC and experienced RVR....the odds are quite high.
Does anyone have information about what the unfavorable data was for Prove 2?
anonymice...thanks for the post.
miked
Great idea, this class action stuff!!!
Now instead of using time, energy, and money to develop drugs that might even save the lives of some of the members of this forum, lets saddle Vertex with lawsuits. These lawsuits will, of course, greatly benefit the greedy, money-sucking lawyers and perhaps a few short term stock speculators but will harm millions of people around the world with hepc and other diseases.
It will even harm those stock investors who bought have bought the stock with the hope that eventually VX 950 will be approved and will result in an increased cure rate for those who would not be cured by existing medications.
Everything that I have seen looks like Teleprevir will increase the cure rate for Geno 1's in less treatment time.
Yea buddy!! Lets continue to drive up the costs of Trials (note the word Trial) so that fewer companies have the money to attempt trials and fewer new drugs will be developed.
Anon, are you are party to this lawsuit or a member of this law firm?
Now instead of using time, energy, and money to develop drugs that might even save the lives of some of the members of this forum, lets saddle Vertex with lawsuits. These lawsuits will, of course, greatly benefit the greedy, money-sucking lawyers and perhaps a few short term stock speculators but will harm millions of people around the world with hepc and other diseases.
It will even harm those stock investors who bought have bought the stock with the hope that eventually VX 950 will be approved and will result in an increased cure rate for those who would not be cured by existing medications.
Everything that I have seen looks like Teleprevir will increase the cure rate for Geno 1's in less treatment time.
Yea buddy!! Lets continue to drive up the costs of Trials (note the word Trial) so that fewer companies have the money to attempt trials and fewer new drugs will be developed.
Anon, are you are party to this lawsuit or a member of this law firm?
I really think burned74 hit the nail on the head with his post. First off I don't see why anyone would post such negative information on a site where alot of people have benefited from the clinical studies involving Teleprevir. It just doesn't make any sense, I doubt if anyone on this forum bought any stock from Vertex. So anonymice can you explain your thinking on posting this information. The way it appears, and I could be wrong but it looks like you're just trying to stir up some dust or drum up business. I don't get it, please explain as I don't like being wrong. I've heard that it takes around 10 years to get an investigational new drug registered with the fda. The studies that are being conducted currently around the world are helping quite a few people and so what if Vertex gave incorrect infomation? It could have been an innocent mistake and even if it wasn't the drug has obviously showed enormous potential so where are you coming from on this subject???
My heart sank as I read this. I have been trying to get a call back from a couple of different places regarding Phase 3 trial locations and after leaving many messages, not one call back from my local centers. Someone from Vertex did respond, left me a voicemail saying to just keep checking the clinical trials site. Wish I hadn't missed the call so I could have spoken with them.
I thought, great, maybe this is causing delays for anything moving forward. I keep checking clinicaltrials and nothing more is posted as we near the end of March.
I am so bummed and I suppose reading more into this than there really is. I am having some real ups and downs here after getting bad news from HR (feeling real stupid that I put off treating for two years when it turns out I was a stage 4).
Do you think that they are just behind schedule as usual or will this lawsuit mess things up for Phase 3?
I thought, great, maybe this is causing delays for anything moving forward. I keep checking clinicaltrials and nothing more is posted as we near the end of March.
I am so bummed and I suppose reading more into this than there really is. I am having some real ups and downs here after getting bad news from HR (feeling real stupid that I put off treating for two years when it turns out I was a stage 4).
Do you think that they are just behind schedule as usual or will this lawsuit mess things up for Phase 3?
I agree with Susie.
"The pharma companies often manipulate the trials to make the drugs seem better than they are. They handpick participants, report great SVR rates but don't mention the trial disqualified anyone with late stage disease or genotype 1.....stuff like that."
IMO too many people on this forum take the SVR percentages from the drug company studies as gospel. OH COME ON. These people are not doing us any favors. They are trying to sell a product.
I have talked to several GI's and a hepatologist not involved with clinical trials and they all said do not trust the SVR rates. They are false. My own GI told me last week the real rate is now closer to 30%. Not 50%. All the information on Clinicalcareoptions dot com is from is good current info but the DR's are involved in the clinical trials and basically work for the drug companies.
Please keep an open mind when reading the trial info. I know most of us are hoping that the SVR rates are true (even myself) because we want to be cured in such a bad way. But hoping will not cure us.
Bobby
"The pharma companies often manipulate the trials to make the drugs seem better than they are. They handpick participants, report great SVR rates but don't mention the trial disqualified anyone with late stage disease or genotype 1.....stuff like that."
IMO too many people on this forum take the SVR percentages from the drug company studies as gospel. OH COME ON. These people are not doing us any favors. They are trying to sell a product.
I have talked to several GI's and a hepatologist not involved with clinical trials and they all said do not trust the SVR rates. They are false. My own GI told me last week the real rate is now closer to 30%. Not 50%. All the information on Clinicalcareoptions dot com is from is good current info but the DR's are involved in the clinical trials and basically work for the drug companies.
Please keep an open mind when reading the trial info. I know most of us are hoping that the SVR rates are true (even myself) because we want to be cured in such a bad way. But hoping will not cure us.
Bobby
Well thanks for putting a different spin on this issue and this includes what Bobby1952 had to say. If you can't trust the clinical trial reports or even the people who work at the clinical trial sites then who can you trust? Sure I will be doing more homework on the subject but I'll give you an example here. The nurse I spoke to at the training hospital near me who gives some of the clinical trials gave me an SVR rate closer to 70% and she said that is going on with the current study that started in Dec. 2007 or Jan. 2008. What gives? Is she being deceived or is she intentionally saying that to make their numbers sound better to recruit me. Dang!! I'm good to go and I'm tired of waiting I have two choices I can go with the regular insurance or I can go with a clinical study. Any advice on this?? I know it's a personal decision I will have to make on my own but if you can throw me a bone to chew on, so to speak, please throw it my way... thanks
To be honest, I do not know enough about what was or was not being said by management to give rise to the class action suit. But if they were misleading the public for their own personal gain, or the companies gain, they were not only misleading investors, but also those patients who were influenced incorrectly into postponing regular treatment in the "hope" that this drug was just around the corner.
While I would like to see a miracle drug, I fear that it will be a long time before something as well understood and effective as current combination therapy comes along, despite the marketing hype otherwise.
While I would like to see a miracle drug, I fear that it will be a long time before something as well understood and effective as current combination therapy comes along, despite the marketing hype otherwise.
With regards to past studies done on Telaprevir, I believe the results are public and I believe have been presented at past years at the AASLD and if you google for such things you may find them. You do have to read study results with your own critical eye and look at the variables and controls they used to see if it skews the data in any way that causes a question mark about the results they put out. I never take any study at face value without reading it from various angles.
I also think it's important, yet dismaying to read the post that started this thread. When you enter a trial, you read the data from the past trials and you hope like hell that it's accurate because that's partly what you're basing your decision on whether you enter the next phase of that trial. If the success rate is lower than stated, maybe you'd choose regular SOC that you can manipulate, for example.
As SusieQ said and I quote: "Who knows., you may help someone make a decision whether or not to enter a trial or wait for approval of the drug. "
I say Right On. I would be very upset if a pharmaceutical company skewed their data and had people entering trials based on skewed data and hindering our ability to make good decisions for ourselves.
There are also people making decisions on whether to treat now or wait for new drugs to come along and having accurate data on those drugs is also important.
Now........I haven't read this article or other articles pertaining to this and it could be that the suit is smoke and mirrors. So just because a lawsuit has been launched doesn't make it so .... but I'd think we all have a vested interest in knowing the answer to that, seems to me.
I also think it's important, yet dismaying to read the post that started this thread. When you enter a trial, you read the data from the past trials and you hope like hell that it's accurate because that's partly what you're basing your decision on whether you enter the next phase of that trial. If the success rate is lower than stated, maybe you'd choose regular SOC that you can manipulate, for example.
As SusieQ said and I quote: "Who knows., you may help someone make a decision whether or not to enter a trial or wait for approval of the drug. "
I say Right On. I would be very upset if a pharmaceutical company skewed their data and had people entering trials based on skewed data and hindering our ability to make good decisions for ourselves.
There are also people making decisions on whether to treat now or wait for new drugs to come along and having accurate data on those drugs is also important.
Now........I haven't read this article or other articles pertaining to this and it could be that the suit is smoke and mirrors. So just because a lawsuit has been launched doesn't make it so .... but I'd think we all have a vested interest in knowing the answer to that, seems to me.
The Vertex management probably hyped the stock more than they should have, but I am unaware of any study that shows such a poor response to Telaprevir. I have only my own personal experience with it and the accounts of others on this board.
In my previous tries with SOC, I experienced a 2 log drop by week 12 and undetectable by week 24. With Telaprevir, my viral load went from 8,000,000 at the start to >30 in one week and undetectable by week 2. This is after 7 previous tries with various flavors of interferon and ribaviron. My personal experience and that reported by Vertex a couple of days ago shows this to be one of the most powerful new drugs if not the most powerful.
Listen to the latest presentation on the Vertex web site.
In my previous tries with SOC, I experienced a 2 log drop by week 12 and undetectable by week 24. With Telaprevir, my viral load went from 8,000,000 at the start to >30 in one week and undetectable by week 2. This is after 7 previous tries with various flavors of interferon and ribaviron. My personal experience and that reported by Vertex a couple of days ago shows this to be one of the most powerful new drugs if not the most powerful.
Listen to the latest presentation on the Vertex web site.
then why did this (albeit small) sample of people who came on here and were part of the trials....have such relatively good rates? I forgot how many exactly, and what everyone's outcome was.... but I think most of them SVRed right? maybe I'm wrong on this...course you can't deduce much with such a relatively small sample of people, but I might think differently, if, within this relatively small sample, most of them didnt svr...but they did...someone correct me if I'm wrong...thanks....
Boohoo for the poor corporation that falsified data to drive their stock price up. Demanding some type of accountability from them isn't what raises the cost of medicine.
I think the acusation, is that they not so much falsified data, as hid data, which was less favourable.
When this less favourable data was released, the stock price dramatically dropped - so investors are asking, why the slow rate of release? Why were people sitting on this information (if they were sitting on it)?
I had a remarkable drop in the first 2 weeks with my viral load on the VX. Yes, I did get the rash. No, I was not in the group that gave the Riba. I was randomized into group C - the no Riba group. I have no complaints with the Vertex group. The only thing is, I just wish that I had been able to get all 3 drugs and have been able to get SVR (which is the luck of the draw) when you get into randomized clinical trials.
Susan
Susan
I don't think any negative data was withheld. The stock dropped because the market crashed and one analysts decided that Vertex would have to have a 48 week phase 3 trial. That turned out to be false based on the latest data on the Vertex site and the phase 3 application.
When all the prove 3 data is in, I think there is a good chance that the drug will be fast tracked for non responders and relapsers. All the prove 3 people on this board that I am aware of, save one, have had excellent results.
When all the prove 3 data is in, I think there is a good chance that the drug will be fast tracked for non responders and relapsers. All the prove 3 people on this board that I am aware of, save one, have had excellent results.
By the way, in my paranoid TX state, I came to believe that many of the negative or positive comments about drug companies are attempts to manipulate the stock price.
Personally, based on the latest Vertex data, I am going to buy the stock tomorrow morning.
Personally, based on the latest Vertex data, I am going to buy the stock tomorrow morning.
thanks for the positive comments...I just remember seeing the trial participants on here having good results...and I do believe our Susan would have svred had she been given the riba...some reason I just think that...I hope she will at some point , of course...
Andiamo1 - unlike you, I don't buy and sell stock, so I have no interest in seeing the price inflated or deflated. All I said above, was that the acusation is that information was withheld. I don't know if that was true or not. I do see there are concerns over all the new treatments though. Even if viral load is initially impacted, does that translate into SVR, and is that worth the additional sides (or rash, and who knows yet, what else), for a 7% improvement over SOC (if that is what the reuslts end up as)?
I think it will be a while before that is decided, and doubt it will be fastracked as you suggest, but that is just IMO, based on the limited information and doubt I can see.
I think it will be a while before that is decided, and doubt it will be fastracked as you suggest, but that is just IMO, based on the limited information and doubt I can see.
Everything I've researched says that rapid virological response (RVR) is the ticket to getting SVR (cured). On Prove 3 trials (like Andiamo) I too was UND at Week 1-2. Post tx Week 12 I was still UND. This week I go in for post tx Week 24. If still UND (hope and pray) I'm considering myself cured. RVR really is THE KEY for the trials and SOC (standard of care).
Does anyone know what information that Vertex misled on the Prove 2 trials?
Eric: Sorry to not respond to earlier email, I was just off-tx and messed up. How can we talk offline? Also congrats on finishing tx. 8x is a charm!
Does anyone know what information that Vertex misled on the Prove 2 trials?
Eric: Sorry to not respond to earlier email, I was just off-tx and messed up. How can we talk offline? Also congrats on finishing tx. 8x is a charm!
Ok, I guess I'll hurry up and continue waiting, my wife's friend highly recommended the study to me. So I will just stick with my original plan, I really hate changing my mind mid-stream anyways. Patience is a virtue I have so little of anyway, so I will fake it till I make it. Everything that I've heard and read about Teleprevir is positive and to me it doesn't matter if it's 6% positive or 16% positive it's getting positive results and that's the bottom line. I'm really enjoying this forum cause I can see things differently from all angles, thanks.
I did not mean to imply that you were trying to manipulate the stock. You are not the initial poster of this and I don't know what the motivation of the initial poster is.
I do know that people that RVR on Telaprevir have a 95% chance of SVR according to Vertex. I don't know where the 6% improvement over SOC comes from, it does not appear in any study that I have seen. I might certainly have missed it though.
The latest presentation on the Vertex site shows a 25% improvement over SOC in half the time (24 weeks). That's pretty good in my book. The doctor I am seeing believes that Telaprevir is one of the most potent new drugs, if not the most potent.
In addition, the 25% improvement factors in dropouts; that number will improve substantially as the research shows how to better manage the side effects and reduce dropout rates.
I do know that people that RVR on Telaprevir have a 95% chance of SVR according to Vertex. I don't know where the 6% improvement over SOC comes from, it does not appear in any study that I have seen. I might certainly have missed it though.
The latest presentation on the Vertex site shows a 25% improvement over SOC in half the time (24 weeks). That's pretty good in my book. The doctor I am seeing believes that Telaprevir is one of the most potent new drugs, if not the most potent.
In addition, the 25% improvement factors in dropouts; that number will improve substantially as the research shows how to better manage the side effects and reduce dropout rates.
which is only anecdotally of course, I've been here a few years and I've rarely, rarely seen a person who RVRed who did not onto SVR...that's just soc, or the trials...think i have seen it happen, but it's very rare...RVR is the ticket for most people I should think...and it seems that a good percentage of those trial participants rvr'ed...I'd really like to know what ultimately happened to everyone that posted on here who was on the trial, now and in the future....
We now live in an age where people think that if a stock goes down after they buy it that their inherent right to be rich has been violated and they should sue to recover their losses. I don't buy that. Anyone that makes a decision to buy a stock based on a speech given by a CEO, would be better off praying to the tooth fairy. I am not justifying fraud, but I don't think Bogle committed fraud.
Anyone that makes their own decision about waiting to treat or what experimental drug to take, owes it to themselves to do the proper due diligence. I am not defending Vertex management's over hyping the drug, but in the end, it is our decision and we should either listen to our doctor's advice or do the proper due diligence.
So far, the results of the people here taking Telaprevir triple therapy, including me, have been spectacular! Even mremeet that had the severe rash and had to cut the treatment short did SVR.
Anyone that makes their own decision about waiting to treat or what experimental drug to take, owes it to themselves to do the proper due diligence. I am not defending Vertex management's over hyping the drug, but in the end, it is our decision and we should either listen to our doctor's advice or do the proper due diligence.
So far, the results of the people here taking Telaprevir triple therapy, including me, have been spectacular! Even mremeet that had the severe rash and had to cut the treatment short did SVR.
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