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VX950 analysis from thestreet.com

Vertex Shareholders Stay Vexed
By Adam Feuerstein 3/21/2007 7:57 AM EDT

New clinical data from Vertex  regarding its hepatitis C drug telaprevir, expected at a medical meeting next month, seem to have investors on edge.

Shares of the biotech firm continue show weakness on worries that telaprevir won't live up to expectations when new phase II data are presented at the EASL on April 11-15.
25 Responses
179856 tn?1333550962
OK so what I think they are saying out of all of this is..even if it does work in some patients - it might turn out that the additional risks of toxicity and sides aren't worth adding the drug to an already proven FDA approved drug - which in fact might be the reason that some of the patients are 'cured' anyway because there is no way to prove it's Vertex and not current combo tx that is doing it anyway?

Well - that is what I sort of took away from it and in fact if I wrote down my thought process well enough for someone to know what I mean...it makes sense.

Avatar universal
Wow. I didn't come out with that impression at all. Just a slight mention of the "side effect profile" as something to look at in terms of drop out rates. The article as I read it just talked about the complexity of interpreting the Prove I data which in reality isn't as complex as the author makes out for those of us who actually understand the difference between ""UND, "SVR", "relapse", etc -- terms probably foreign to many investors to which the article was written for.

-- Jim
85135 tn?1227293372
The article gets a bit confusing on the last page or so.
65 percent SVR on a 24 week tx is not so rosy at the worst? That sounds good to me.
It looks like at the end of the article  he states that SOC is 24 weeks with a 50 percent SVR. HUH?
179856 tn?1333550962
What he's saying is that there is a 15% increase in chance of SVR if you are one of the people that does not drop out due to the sides or non-response rate as where the typical current treatment only has a 3% drop out rate the Vertex drop out rate is almost 10%.
Combo tx = 3% drop out rate and 50% SVR
Triple tx = 9% drop out rate and 65% SVR



Avatar universal
We both read it the same way. After reading NY I had to check the link because it didn't sound at all like what I read in the link I posted. Mike
137025 tn?1217768341
Well, I'll take the additional percentages, being someone who couldn't get UND at 12 weeks, I find the posts here from VX lab rats being UND at 4 WEEKS delightful.  And that fact, all by itself, gives Telapravir much market value, even for those shortsided folks just focused in on a total cure.

I don't think it will ever be easy as a one pill cure.  Telapravir shortens time by 24 weeks, and increases odds by 15% and both of these issues are pretty darn positive when you sit where I sit.  I think there are about 500,000 of us, sitting in the same place, on SOC or non-responders.  We could create our own political action committee, give the FDA one big push.

Wish it WAS that easy.

Willow wishing  
Avatar universal
Yeah. Think some folks are reading too much into an article that was primarily directed toward investors. In five weeks we'll know the actual data at the Barcelona Conference. Until then, I'm pretty optimistic based on everything I've read/heard so far. But my feelings -- and everyone else's 'feelings' -- will mean nothing until the data is released.

-- Jim
85135 tn?1227293372
On the face of the math, I agree with you completely. What I was pointing out was the writer making it seem like SOC for 24 weeks has a 50 percent SVR rate.
I do know if one has an EVR at 4 weeks UND, a short course of tx might work but I never saw a SVR rating based on a short tx.

Best of luck on your PCR. I have you in my prayers.
Dana
Avatar universal
Suspot,

I think the data was reported for 24 weeks of SVR (not SOC), meaning that 24 weeks after stopping the treatment these people still were virus negative (after the 48 weeks of treatment).

So many people ... so many opinions! :)
179856 tn?1333550962
My main concern is that if when the folks at Vertex find out what the mechanism of the rash increase is and then they reformulate to fix it...don't they then have to start the trials all over again for the FDA?

I just think a 10% drop out rate is not great for a product that has been in pretty limited testing. I mean honestly I had such a problem with the regular old riba rash (and the scars to prove it) that I wonder how these people can even manage it.

It's all a crapshoot in the end.

Until we know SVR rates - it's all just a guess any way.

I still want a new drug and hope somebody comes out with one.  I've suffered side effects that will be with me for the rest of my life now thanks to Mr. Interferon - he's all we got but he's NOT a good friend, you know?

Adding to combo and getting better results is a fantastic thing but honestly - I couldn't handle any more difficult sides.

I'm just hoping for something new - that people who can't tolerate ifn/riba like Mr. Beagle - can do and something that doesnt' kill off your thyroid at the drop of a hat.

Until then................I will keep crusading.
Avatar universal
Your math is right and in line with what doc told me last Nov when he pulled me from tx.  After getting a second opinion from a doc which is heavily involved in conducting current trials, the increase to a 10% dropout rate is what makes many more skeptical about the viability of this med towards improving SVR rates amoung patients.

Perhaps this is what the stock price is reflecting and making investors hedgy. Then again, pharmacutical companies often do not hang their hat upon a single med and many other factors could be involved with current speculations.
Avatar universal
Sorry, sunspot... my mistake
Avatar universal
The prove 3 trial has an extended treatment arm with 48 weeks of standard tx plus 24 weeks of vx-950.

Perhaps they are doing the extended trial because early data indicates low SVR rates at 12 weeks and 24 weeks.
Avatar universal
In above post meant to say "Willy50 quote" not willows quote.
Avatar universal
Interesting thread here's my takes on some responses in the order they were made;

Sunspot, the "65 percent SVR on a 24 week tx" was ONLY an example.  Adam is just giving some example so he can demonstrate the numbers and how they work.  A large portion of his point is that you need to know how many people they are basing a percentage rate on.  If people are migrating from one arm to the next the numbers get slippery.  Given that the 88% clear rate and the 9% drop out rate were taken from uncompleted 12 week trials either of those percentages could go up or down as others finished their first 12 weeks of TVR & SOC.  (who completed and cleared or didn't complete and failed)  In 3 weeks we should have real numbers.  Remember the first set of numbers were derived from an incomplete 12 week study; they could be better or worse than reported after the studies completion.

Willows, Vertex says there are about 900,000 of us in the USA who are diagnosed.  It is estimated that there are at least 2 million undiagnosed and that could be underestimated by a million.  
         By the way....... I'd rather do 24 weeks than 48 weeks even with the same SVR rates.  At the EASL we we see how many were able to achieve SVR 12 after only 12 weeks of treatment (these are all geno 1's).  On the darker side we will also see how serious the rash problem was.

Sunspot the SOC generally is 40-50% SVR.  The data we will get at EASL should still only be a 12 week SVR rate for all that tested in trials.  Vertex thinks this will be within about 2% of the 6 month SVR rate (as it is for TX/SOC)

nygirl7, the 10% dropout rate was actually 9% compared with 3% dropout rate in the SOC control group (in 12 weeks).  IF the SOC's continue  to treat for a year the ultimate drop out rate is about 13%.  We still don't know what the final drop out rates are (for either soc only or SOC/TVR combo), what the first 12 week TVR with SOC rates will be or the SVR 12 rates; but we should in about 3 weeks @EASL.

andiamo, the extended TX leg was devised before the trial started, not something done on the fly.  If I understand it correctly if some trial participants were RVR (clear at 4 weeks thru 10 weeks) they could roll into the D arm and treat for 12 weeks only with no followup with SOC.  I also believe that is some didn't respond well enough they could also roll into a longer treatment arm.

There is a bit of conflicting information out there, some of it is muddy (like how they computed the numbers), and of course the is a lot of withholding of information.  It's no wonder there is some confusion.  I may not be right about my answers above but they are what I think I understand of the situation.

at the 2007 EASL;
Might we see the 6 or 9 month month SVR rate for the 12 who cleared after treating this time last year?  (last I heard was 12 treated with 1 relapse)

I think we'll see data on the 12 week D arm arm,  SVR 12

the 12 week SOC &TVR followed by SOC for 12 weeks  PCR results?
Information on if Ribiviren is needed for treatment (that could impact on the rash problem)

Possibly projections on treating genotype 2's and 3's based on data from Prove 1

Possible preliminary data on toxicology results

Hey!! How about Sherring Plough's PI?  I'd bet there will also be information on those trials as well (how about some love for S-P? ; ) )

best,
Willy
Avatar universal
""""(willow quote) If I understand it correctly if some trial participants were RVR (clear at 4 weeks thru 10 weeks) they could roll into the D arm and treat for 12 weeks only with no followup with SOC. I also believe that is some didn't respond well enough they could also roll into a longer treatment arm.""""

If this is true, it will skew the data!  

Because they are new selecting the most natural rapid responders to lump them all into group D and removing any slower responders into other groups.   These people may be more naturally sensitive tx and therefore give a higher SVR rate.

It is like having 100 people on SOC and picking the 20 of them that had RVR and then measuring how many of them had SVR.  It would not represent the general public and the SVR rate would be much higher like 85-90% and not the 45% that is known to be standard.
Avatar universal
You are right.  I had to go back and listen to the presentation again but I believe you already had to be in arm D (no being moved into it regardless of your response).  I was trying to take notes and what they said was that the patients were randomized into a treatment arm.  I had it all transcribed and the page dissipeared (it expired) so I can't post it now but the bottom line is that yes, I misunderstood it.  Being randomized into the arm would be when they origionally placed the people into the arms of the trial.  The sequence followed the brief summary and I assumed it was sequential.  It's hard trying to transcribe and think.   : ) I goofed.

The second part I'm guessing is how will they tally those who don't respond quickly enough and are rolled into a longer term treatment arm.  It's just a  guess but if they counted them as a failure they could still treat them AND still try to cure them. (without messing up the stats, but of course I don't know what they'll do)

I'll have to look over the rest of what I wrote and see if my flub changes what else I wrote.  Essentially the stats and methodology from December are still not understood.  I hope it is all clear after the EASL.

Willy  (trying to get this corrected as quick as I could)
Avatar universal
The question is who is talking to Adam Feuerstein and what are they saying?

Some trial subjects are talking, and we have seen how one or two posters here have a habit of speaking for the entire population and presenting assumption and opinion as if it were solid fact. Its small wonder that a journalist with a few self-selected sources might produce the kind of story Adam has written.
151263 tn?1243377877
Really, who is talking to Adam and what ARE they saying? We need to get a lid on this bad publicity right away. Right apk? ;-)
Avatar universal
Let he who is without sin, etc
151263 tn?1243377877
Let he who is without sin do what? Conceal the story, the whole story and nothing but the story about telaprevir to someone like Mr. Feuerstein? If so, that'd be a logical paradox...no?

In the meantime, now that you mention it, maybe *I* should contact Mr. Feuerstein and have a chat with him? Waddya think apk? ;-)
Avatar universal
I guess I'm clueless, but I thought all the excitement about Telaprevir was the unheard-of EVR's and UND's in such a short period of time, like days.  I didn't think SOC had ever been able to achieve such impressive results.  I know SOC didn't work at all for me, as it hasn't for so many people, and Telaprevir has succeeded in achieving results never heard of with SOC, especially in non-responders like me who are genotype 1b.

I have all my hopes pinned on PROVE 3, as my fatigue continues to get worse and my memory is like a sieve a year after stopping treatment.  I'm nervous about putting more poisons into my body, but more nervous about possibly being prohibited from ever treating again with IFN and progressing to cirrhosis and liver failure.  I hope and believe that if I can ever get rid of this *#@*ing virus, I can be back to my old self again, in time.
137025 tn?1217768341
wow, whats going on now?  I wrote to Mr. Feuerstein, but "I did not make assumptions" for anyone, just gave him a personal opinion, which the last I remember, was my right......

I posted his response above in my post, where he talked about our board.  He's totally inclined not to believe one word he reads on the forums, sometimes you two make me understand why.

He agreed that sometimes there is a disconnect between wall street types and us real patients, it was that opinion he wanted to use in his column.  

Let's all get over ourselves.  I wrote to him because I disagreed with his figures, I shared with him why.,.....and some information from my doctor and he agreed.   Funny thing is, if you all are interested in teleprevir, there is another article today, even more accurate, available to anyone who wants to read it.  No sinister sources, just free and open information.  I recommend the article, it has some great information.

http://www.fool.com/investing/high-growth/2007/03/22/vertex-looks-ahead.aspx?source=eptyholnk303100&logvisit=y&npu=y

Willows
151263 tn?1243377877
Believe me I don't object to you contacting financial webpage writers, or media types, or the clergy, or little green men from mars. You can talk to whomever you want about whatever you want, whenever you want as far as I'm concerned. It's apk here that objects to this "free flow" of information, very especially when it's even vaguely negative in respect to telaprevir. He tried to deny that our rashes were being caused by telaprevir way back when (before data was released from Vertex proving otherwise), later he became upset and attacked me personally for posting the reported risks and side effect profile (inlcuding details about rash) of telaprevir (which was quoted verbatim directly from the Vertex consent form). And he himself withheld that same side effect profile from everyone here (and he was the first to get it). Just a few of the many reasons why we've not got along, and also why some of us feel he's suspicious. Best case scenario for apk is that since he was fortunate enough to meet with treatment success and not experience bad side effects during his treatment with telaprevir, he's the type of guy that doesn't want to hear or see negative reports from anyone else who may have experienced otherwise. Worst case scenario is that he's not treating at all, and he's here for some ulterior motive.

The only people I'm aware of that have contacted Mr. Feuerstein are yourself and Willy. Obviously apk doesn't think you guys are "qualified" to contact and interface with such a lofty and influential person (i.e., someone who might say something vaguely uncomplimentary about telaprevir). And also, apk obviously disapproved of what Mr. Feuerstein wrote. I don't know why, I read what he wrote, and in balance I thought he presented the pros and cons in a well written, balanced and informative manner. I'm sure apk thought it was a "hit piece" because it spoke openly of the significant side effect profile and the uncertainty of the drugs future as a consequence of that - as I said before, that's a no no in apk's world. From any non-biased rational perspective, Mr Feuerstein wasn't down on vertex, just presenting the facts as they're commonly understood today (which is what his readers expect, of course). And sure, he made a few technical wording errors here and there, but nothing to meaningfully mischaracterize the scenario from (and for) a stock trader's perspective. Also, those minor wording errors are perfectly understandable considering he's not an HCV infected person fully steeped in all of its idiosyncrasies like many of us here are. In general he seems to be well informed for a non-HCV infected person that doesn't specialize only in a single stock dealing with a single disease.
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