Not A good report about vx-950

Vertex Pharm Needham & Co downgrades Buy to Hold. Needham downgrades VRTX to Hold from Buy saying after the Vertex Investor Meeting held last Thursday, they now believe that the H.C.V drug candidate may not reach the market until late 2010/ early 2011. They have prolonged their launch projections for two reasons: 1) The firm believes the FDA will recommend that the co submit an N.D.A with 72-week comparator arm data; and 2) They believe the FDA is also likely to suggest the need for a large Phase 3 trial comparable in scale to other pivotal H.C.V trials (~1000 patients). They believe recruitment for and completion of such a trial will require time well beyond the company guidance for a 1H09 NDA submission.

[nygirl7]

Ouch a 72 week arm?  I don't think many people are going to be up for that one........but wish they had had that arm out while I was doing the 72 cause I would have done it.

That is so not good news but nothing solid yet.

But in light of the fact that you can't googleup just about any news at all from the bologna conference - I think that is a very bad sign myself.  If there were any possible good news to be had - they'd put it out now...and save their investment $$$$$s and avert the BUY.

No way around that fact.

[jmjm530]

I think you mis-read that on a "72-week Arm". What they said is that Vertex may need "72-week DATA". I interpret that to mean they want a longer follow-up period, not a longer treatment period. My understanding is that the treatment period will be 24-weeks maximum. Nothing official here, just an analysts projection.
http://www.businessweek.com/ap/financialnews/D8OMB1180.htm

[3txsofar]

Needham is definitely in the second or third rank of analysts, not one to base a decision on.

Right after the Barcelona, did you mean that and not Bologna, conference, UBS, United Bank of Switzerland, which is one of the absolute top analysts came out and reiterated their "Buy" rating.

As far as Needham goes, the question is what news came out of EASL that would have led them to their conclusions?  I saw and my daughter, who is an Infectious Disease specialist, saw nothing but good, solid results.  

[nygirl7]

Barcelona - Bologna
Tomato - Tomahto
Some days I can't even spell my name correctly post tx

I'm not sure if I am or I'm not still UND after 72 weeks but trying to decide Infergen or wait to see if this will pan out might be the final pushI need off the ledge.

Only time will tell.

Sorry bout that!

[Imagine]

To my way of thinking this really is not bad news but expected news. It may be bad news for those investors who had hoped that the stock would continue to show a steep slope of value as it had previously during speculative buying. Long term growth I believe still shows a lot of promise. Vertex is so much further ahead in this class of drug than anyone else.

The projected launch date really does not surprise me at all. I think there may have been

[jmjm530]

Another point is that a potential expansion of Phase III testing, means that more people will be able to get into a Vertex trial. So, it's not necessarily that everyone needs to wait until FDA approval, as witnessed by some of our group who are already in trial.

[Willy50]

Ya.... I saw this Monday morning and have watched it.  It's not to be ignored.  I'm also not sure that it is to be believed either; it's one group's opinion of a possible outcome.  It's an "if this happens and then if this happens then this could happen" type statement.  When one looks at the efficacy of the drug it blows me away.  Most analysts know their charts but are less aware of all the peripheral information about the disease and it's treatment.  This drug looks as if it will make a major change in treatment.  On the "D" arm if you throw out the one person who dropped out after one dose the EVR data would be 6 divided by 16= 37.5% SVR20 2 weeks ago.  In about 2 weeks they will be "official" SVR's.  That is a roughly equivalent SVR rate compared to current SOC rates in one quarter of the time (12 weeks versus 48 weeks).  We'll just have to wait to see what the future brings.  It looks like a no-brainer that the 12 and 12 will be even more effective; 12 weeks only may be the threshold of what this compound can treat effectively.  The news will keep rolling out though and there will be less and less speculation as time goes on.  

best,
willy

[Forseegood]

I've been thinking this all along, I agree with Jim that the next trial will be much expanded, like the present SOC trials were way back when...(I was just diagnosed so I remember) I remember many people (on the present peg drugs) in trials that were held years ago from all the hep support groups I went to.....my doc said the new Vertex trials should be startin up in the fall...Coeric said he heard the same thing from his doc...

[jmjm530]

Yes, a greatly expand phase III trial isn't the same as FDA approval, but it does mean that many who want Telaprevir (VX-950) won't have to wait that much longer. Certainly becomes one more option to be considered. I also remember when the phase III trials for what is now SOC got started, maybe 5-6 years ago? I just wasn't ready to treat at that time but it seemed very easy to get into.

-- Jim

[r4c7]

Not a good report?  Take it from a long-time investor whose lost plenty of money. Analysts' comments are what they are...at best nothing more than educated nonsense...at a minimum nothing but a ploy to influence the stock price to their benefit. Either way, analysts have no more of a clue when the FDA will approve a drug than you or I.  And anyone that seriously listens to these clowns is probably spending too much time on the Yahoo message boards.

As far as the FDA is concerned, their challenge simply put is to balance the public pressure to find a more-effective and tolerable drug with the need for a drug that is safe for the public to use. Once a sufficient balance is achieved, Telepravir will be approved. Case closed.

In the meantime, the best person to listen is a good hepatologist.

  

[warnerwh]

Upbeat is absolutely right. I've spent too many years around the market to have any faith in what an analyst says. If anyone listens to them you'll find they contradict each other daily.

This new medication looks excellent. Hopefully it will get approved sooner rather than later.